UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended ~~March~~June 3130, 2025


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-39351

Nuvation Bio Inc.

(Exact Name of Registrant as Specified in its Charter)


Delaware	85-0862255
( State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
1500 Broadway, Suite 1401 New York, New York	10036
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (332) 208-6102

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	TradingSymbol(s)	Name of each exchange on which registered
Class A Common Stock, $0.0001 par value per shareRedeemable Warrants, each whole warrantexercisable for one share of Common Stock at anexercise price of $11.50 per share	NUVB NUVB.WS	The New York Stock Exchange The New York Stock Exchange
Class A Common Stock, $0.0001 par value per shareRedeemable Warrants, each whole warrantexercisable for one share of Class A Common Stock at anexercise price of $11.50 per share	NUVB NUVB.WS	The New York Stock Exchange The New York Stock Exchange

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of ~~April~~July 2531, 2025, the registrant had ~~340~~342,~~262~~272,~~976~~722 shares of Common Stock, $0.0001 par value per share, outstanding.

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will” and “would,” or the negative of these terms or other similar expressions intended to identify statements about the future. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements include, without limitation, statements about:

•

our plans to develop and commercialize IBTROZITM (taletrectinib) and our other product candidates;

•

our ability to obtain regulatory approval of our current and future product candidates, and to maintain regulatory approval for IBTROZI and our future approved products;

•

our expectations regarding the potential market size and the rate and degree of market acceptance of IBTROZI and our current and future product candidates;

•

our ability to recognize the anticipated benefits of the Merger (as defined below), which may be affected by, among other things, competition and our ability to grow and manage growth profitably;

•

our plans to develop and commercialize our product candidates;

the initiation, timing, progress and results of our current and future preclinical studies and clinical trials, as well as our research and development programs;

•

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

•

our ability to successfully acquire or in-license additional product candidates on reasonable terms;

•

our ability to maintain and establish collaborations or obtain additional funding;

•

our ~~ability~~continued reliance on third parties to ~~obtain~~conduct ~~regulatory~~clinical ~~approval~~trials of our ~~current~~product candidates, and ~~future~~for the manufacture of our product candidates for preclinical studies, clinical trials and commercial supply of IBTROZI;

•

our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates;

our continued reliance on third parties to conduct clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials;

our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources;

•

the implementation of our business model and strategic plans for our business and product candidates;

•

our intellectual property position and the duration of our patent rights;

•

developments or disputes concerning our intellectual property or other proprietary rights;

•

our expectations regarding government and third-party payor coverage and reimbursement;

•

our ability to compete in the markets we serve;

•

the impact of government laws and regulations and liabilities thereunder;

•

our need to hire additional personnel and our ability to attract and retain such personnel;

•

our ability to raise additional funding in the future; and

•

the anticipated use of our cash and cash equivalents.

The foregoing list of forward-looking statements is not exhaustive. These statements speak only as of the date of this report and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The section of Part II of this report titled “Section 1A. Risk Factors” identifies important factors that could harm our business and financial performance and cause our actual results to differ materially from those expressed or implied by our forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as required by law.

Table of Contents

		Page
PART I.	FINANCIAL INFORMATION	1
Item 1.	Financial Statements (Unaudited)	1
	Consolidated Balance Sheets	1
	Consolidated Statements of Operations and Comprehensive Loss	2
	Consolidated Statements of Stockholders' Equity	3
	Consolidated Statements of Cash Flows	45
	Notes to Unaudited Consolidated Financial Statements	56
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2125
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	2933
Item 4.	Controls and Procedures	2934
PART II.	OTHER INFORMATION	3135
Item 1.	Legal Proceedings	3135
Item 1A.	Risk Factors	3135
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	8187
Item 3.	Defaults Upon Senior Securities	8187
Item 4.	Mine Safety Disclosures	8187
Item 5.	Other Information	8187
Item 6.	Exhibits	8188
Signatures		8389

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

NUVATION BIO INC. and Subsidiaries

Consolidated Balance Sheets

(In thousands, except share and per share data)

	March 31, 2025			December 31, 2024
	June 30, 2025			December 31, 2024
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	47247,~~977~~970		$	35,723
Accounts receivable, net of allowance for credit loss of $nil		~~409~~2,693			12,722
Inventory		14552			—
Prepaid expenses and other current assets		8,~~415~~257			7,271
Marketable securities		~~413~~359,~~699~~752			466,969
Interest receivable on marketable securities		53,~~053~~984			3,570
Total current assets		~~475~~623,~~567~~208			526,255
Property and equipment, net of accumulated depreciation of $971 and $874, respectively		562			586
Property and equipment, net of accumulated depreciation of $1,042 and $874, respectively		615			586
Intangible assets, net of accumulated amortization of $660 and $448, respectively		4,410			4,622
Intangible assets, net of accumulated amortization of $925 and $448, respectively		12,145			4,622
Operating lease right-of-use assets		54,~~334~~641			2,402
Other non-current assets		6,616			6,761
Total assets	$	~~492~~647,~~489~~225		$	540,626
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	1022,~~537~~419		$	6,348
Current operating lease liabilities		1,~~889~~808			1,663
Contract liabilities, current portion		109,~~769~~725			11,117
Short-term borrowings		5,685			6,283
Liability related to revenue interest financing agreement		2,823			—
Accrued expenses		23,892			32,833
Short-term borrowings		5,583			6,283
Total current liabilities		52,772			58,244
Accrued expenses		23,998			32,833
Warrant liability		2,804			2,053
Total current liabilities		66,356			58,244
Contract liabilities, net of current portion		13,614			15,572
Warrant liability		2,350			2,053
Non-current operating lease liabilities		3,839			969
Contract liabilities, net of current portion		12,459			15,572
Total liabilities		73,029			76,838
Non-current operating lease liabilities		3,399			969
Non-current liability related to revenue interest financing agreement, net of current portion and deferred financing costs of $4,662 and $0 as of June 30, 2025 and December 31, 2024		142,780			—
Long-term borrowings, net of current portion and deferred financing costs of $3,276 and $0 as of June 30, 2025 and December 31, 2024		46,974			—
Total liabilities		274,318			76,838
Commitments and contingencies (Note 11)
Stockholders’ equity
Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; 1,060,000,000 (Class A 1,000,000,000, Class B 60,000,000) shares authorized as of March 31, 2025 and December 31, 2024 respectively, 339,840,425 (Class A 338,840,425, Class B 1,000,000) and 337,837,872 (Class A 336,837,872, Class B 1,000,000) shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively		1,382,894			1,373,958
Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; 1,060,000,000 (Class A 1,000,000,000, Class B 60,000,000) shares authorized as of June 30, 2025 and December 31, 2024 respectively, 342,233,563 (Class A 341,233,563, Class B 1,000,000) and 337,837,872 (Class A 336,837,872, Class B 1,000,000) shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively		1,396,220			1,373,958
Accumulated deficit		(~~963~~1,~~979~~022,986	)		(910,743	)
Accumulated other comprehensive income		545			573
Accumulated other comprehensive (loss) income		(327	)		573
Total stockholders’ equity		~~419~~372,~~460~~907			463,788
Total liabilities and stockholders’ equity	$	~~492~~647,~~489~~225		$	540,626

See accompanying notes to the unaudited consolidated financial statements.

NUVATION BIO INC. and Subsidiaries

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited, In thousands, except per share data)

	For the Three Months Ended March 31,
	For the Three Months Ended June 30,						For the Six Months Ended June 30,
	2025			2024			2025			2024
Revenue	$	3,084		$	—
Revenues:
Cost of revenue		2,094			—
Product revenue, net	$	1,238		$	—		$	1,238		$	—
Gross profit		990			—
Collaboration and license agreements revenue		3,595			1,435			6,679			1,435
Operating expenses:
Total revenues		4,833			1,435			7,917			1,435
Research and development		24,601			12,842
Cost of revenue		2,576			1,347			4,670			1,347
Selling, general and administrative		35,393			7,357
Gross profit		2,257			88			3,247			88
Total operating expenses		59,994			20,199
Operating expenses:
Loss from operations		(59,004	)		(20,199	)
Research and development		27,362			29,247			51,963			42,089
Other income (expense):
Acquired in-process research and development		—			425,070			—			425,070
Interest income		5,321			7,130
Selling, general and administrative		38,484			16,156			73,877			23,513
Interest expense		(54	)		—
Total operating expenses		65,846			470,473			125,840			490,672
Investment advisory fees		(203	)		(265	)
Loss from operations		(63,589	)		(470,385	)		(122,593	)		(490,584	)
Change in fair value of warrant liability		(751	)		(1,459	)
Other income (expense):
Realized gain on marketable securities		3			1
Interest income		4,780			7,144			10,101			14,274
Other income		1,452			—
Interest expense		(421	)		(132	)		(475	)		(132	)
Total other income (expense), net		5,768			5,407
Investment advisory fees		(182	)		(247	)		(385	)		(512	)
Loss before income taxes		(53,236	)		(14,792	)
Change in fair value of warrant liability		454			1,135			(297	)		(324	)
Provision for income taxes		—			—
Realized (loss) gain on marketable securities		(1	)		(7	)		2			(6	)
Net loss	$	(53,236	)	$	(14,792	)
Net loss on disposal of fixed assets		(34	)		—			(34	)		—
Net loss per share attributable to common stockholders, basic and diluted	$	(0.16	)	$	(0.07	)
Other (expense) income		(14	)		—			1,438			—
Weighted average common shares outstanding, basic and diluted		338,612			219,048
Total other income (expense), net		4,582			7,893			10,350			13,300
Comprehensive loss:
Loss before income taxes		(59,007	)		(462,492	)		(112,243	)		(477,284	)
Net loss	$	(53,236	)	$	(14,792	)
Provision for income taxes		—			—			—			—
Other comprehensive loss, net of taxes:
Net loss	$	(59,007	)	$	(462,492	)	$	(112,243	)	$	(477,284	)
Currency translation adjustment		465			—
Net loss per share attributable to common stockholders, basic and diluted	$	(0.17	)	$	(1.89	)	$	(0.33	)	$	(2.06	)
Unrealized loss on available-for-sale securities		(493	)		(1,350	)
Weighted average common shares outstanding, basic and diluted		340,746			244,738			339,685			231,893
Comprehensive loss	$	(53,264	)	$	(16,142	)
Comprehensive loss:
Net loss	$	(59,007	)	$	(462,492	)	$	(112,243	)	$	(477,284	)
Other comprehensive loss, net of taxes:
Currency translation adjustment		(646	)		148			(182	)		148
Change in unrealized loss on available-for-sale securities		(225	)		(245	)		(718	)		(1,595	)
Comprehensive loss	$	(59,878	)	$	(462,589	)	$	(113,143	)	$	(478,731	)

See accompanying notes to the unaudited consolidated financial statements.

NUVATION BIO INC. and Subsidiaries

Consolidated Statements of Stockholders' Equity

(Unaudited, In thousands, except share data)

For the Three and Six Months Ended ~~March~~June 3130, 2025 and 2024

	Common Stock andAdditional Paid-in Capital						Accumulated			AccumulatedOtherComprehensive			TotalStockholders'
	Class A Shares		Class B Shares		Amount		Deficit			Income (Loss)			Equity
Balance, December 31, 2024		336,837,872		1,000,000	$	1,373,958	$	(910,743	)	$	573		$	463,788
Exercise of stock options		1,976,775		—		1,082		—			—			1,082
Issuance of Common Stock for RSUs vested		25,778		—		—		—			—			—
Stock-based compensation		—		—		7,854		—			—			7,854
Net loss		—		—		—		(53,236	)		—			(53,236	)
Currency translation adjustment		—		—		—		—			465			465
Other comprehensive loss		—		—		—		—			(493	)		(493	)
Balance, March 31, 2025		338,840,425		1,000,000	$	1,382,894	$	(963,979	)	$	545		$	419,460
Exercise of stock options		855,851		—		762		—			—			762
Issuance of Common Stock for RSUs vested		1,265,096		—		—		—			—			—
Issuance of Common Stock for purchase under the ESPP		272,191		—		533		—			—			533
Stock-based compensation		—		—		12,031		—			—			12,031
Net loss		—		—		—		(59,007	)		—			(59,007	)
Currency translation adjustment		—		—		—		—			(647	)		(647	)
Other comprehensive loss		—		—		—		—			(225	)		(225	)
Balance, June 30, 2025		341,233,563		1,000,000	$	1,396,220	$	(1,022,986	)	$	(327	)	$	372,907

	Common Stock andAdditional Paid-in Capital						Accumulated			AccumulatedOtherComprehensive			TotalStockholders'
	Class A Shares		Class B Shares		Amount		Deficit			Income (Loss)			Equity
Balance, December 31, 2023		218,046,219		1,000,000	$	947,745	$	(342,804	)	$	181		$	605,122
Exercise of stock options		37,000		—		21		—			—			21
Stock-based compensation		—		—		5,041		—			—			5,041
Net loss		—		—		—		(14,792	)		—			(14,792	)
Other comprehensive loss		—		—		—		—			(1,350	)		(1,350	)
Balance, March 31, 2024		218,083,219		1,000,000	$	952,807	$	(357,596	)	$	(1,169	)	$	594,042

See accompanying notes to the unaudited consolidated financial statements.


	Convertible Preferred Stock					Common Stock and Additional Paid-in Capital						Accumulated			Accumulated Other Comprehensive			Total Stockholders'
	Class A Shares		Amount			Class A Shares		Class B Shares		Amount		Deficit			Income (Loss)			Equity

Balance, December 31, 2023		—	$	—			218,046,219		1,000,000	$	947,745	$	(342,804	)	$	181		$	605,122
Exercise of stock options		—		—			37,000		—		21		—			—			21
Stock-based compensation		—		—			—		—		5,041		—			—			5,041
Net loss		—		—			—		—		—		(14,792	)		—			(14,792	)
Other comprehensive loss		—		—			—		—		—		—			(1,350	)		(1,350	)
Balance, March 31, 2024		—		—			218,083,219		1,000,000		952,807		(357,596	)		(1,169	)		594,042
Issuance of Common Stock for AnHeart acquisition		—		—			27,646,255		—		89,297		—			—			89,297
Issuance of convertible preferred stock related to the AnHeart acquisition		851,202		274,938			—		—		—		—			—			—
Issuance of replacement awards related to the AnHeart acquisition		—		—			—		—		24,818		—			—			24,818
Issuance of Common Stock for purchase under the ESPP		—		—			93,723		—		108		—			—			108
Issuance of Common Stock for RSUs vested		—		—			40,342		—		—		—			—			—
Exercise of stock options		—		—			1,761,190		—		1,948		—			—			1,948
Stock-based compensation		—		—			—		—		9,569		—			—			9,569
Net loss		—		—			—		—		—		(462,492	)		—			(462,492	)
Currency translation adjustment				—	—		—		—				—			148			148
Other comprehensive loss		—		—			—		—		—		—			(245	)		(245	)
Balance, June 30, 2024		851,202	$	274,938			247,624,729		1,000,000	$	1,078,547	$	(820,088	)	$	(1,266	)	$	257,193

See accompanying notes to the unaudited consolidated financial statements.

NUVATION BIO INC. and Subsidiaries

Consolidated Statements of Cash Flows

(Unaudited, In thousands)

For the Three Months Ended March 31,	2025			2024
For the Six Months Ended June 30,	2025			2024
Cash flows from operating activities:
Net loss	$	(53112,~~236~~243	)	$	(14477,~~792~~284	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		719,~~854~~885			514,~~041~~610
Depreciation and amortization		~~310~~666			58302
Non-cash lease expense		~~164~~335			(3877	)
Change in fair value of warrant liability		751			1,459
Non-cash interest on revenue interest financing agreement		266			—
Amortization of premium and discounts on marketable securities		(1,474	)		(2,820	)
Amortization of debt issuance costs		18			—
Net gain on marketable securities		(3	)		(1	)
Change in fair value of warrant liability		297			324
Unrealized foreign currency transaction gain		248			—
Amortization of premium on marketable securities		(2,809	)		(5,244	)
Realized (gain) loss on marketable securities		(2	)		6
Net loss on disposal of fixed assets		34			—
Unrealized foreign currency transaction loss		(205	)		—
Acquired in-process research and development		—			425,070
Change in operating assets and liabilities:
Accounts receivable		1210,~~313~~029			—(117	)
Prepaid expenses and other current assets		(~~1,144~~986	)		(51,~~277~~732	)
Inventory		(14552	)		—
Interest receivable on marketable securities		(~~1,483~~414	)		(~~581~~192	)
Intangible assets		(8,000	)		—
Other non-current assets		145			(488	)
Accounts payable		416,~~189~~071			~~227~~(2,791	)
Contract liabilities		(24,~~306~~505	)		—(1,391	)
Accrued expenses		(8,~~941~~835	)		1(4,~~510~~022	)
Net cash used in operating activities		(4290,~~627~~805	)		(1553,~~702~~026	)
Cash flow from investing activities:
Purchases of marketable securities		(60,706	)		(128,409	)
Cash acquired from AnHeart acquisition		—			19,863
Proceeds from sale of marketable securities		114,960			135,978
Transaction costs related to AnHeart acquisition		—			(7,343	)
Purchases of property and equipment		(72	)		(27	)
Purchases of marketable securities		(142,378	)		(221,939	)
Net cash provided by investing activities		54,182			7,542
Proceeds from sale of marketable securities		251,689			251,261
Purchases of property and equipment		(253	)		(27	)
Net cash provided by (used in) investing activities		109,058			41,815
Cash flow from financing activities:
Payments on borrowings		(534	)		—
Proceeds from borrowings, net of debt issuance costs and debt discounts		48,901			7,035
Proceeds from exercises of options		1,082			21
Proceeds from revenue interest financing agreement		150,000			—
Net cash provided by financing activities		548			21
Payments on borrowings		(700	)		(6,322	)
Effect of foreign exchange rate changes on cash and cash equivalents		151			—
Payments on debt issuance costs		(6,607	)		—
Net increase (decrease) in cash and cash equivalents		12,254			(8,139	)
Proceeds from issuance of Common Stock under ESPP		533			108
Proceeds from exercises of options		1,844			1,948
Net cash provided by financing activities		193,971			2,769
Effect of foreign exchange rate changes on cash and cash equivalents		23			78
Net increase (decrease) in cash and cash equivalents		212,247			(8,364	)
Cash and cash equivalents, beginning of the period		35,723			42,649
Cash and cash equivalents, end of the period	$	47247,~~977~~970		$	34,~~510~~285
Non-cash operating activities:
Right-of-use asset recognized	$	3,~~685~~772		$	—
Non-cash investing activities:
Issuance of Common Stock related to the AnHeart acquisition	$	—		$	89,297
Issuance of convertible preferred stock related to the AnHeart acquisition	$	—		$	274,938
Issuance of warrants related to the AnHeart acquisition	$	—		$	764
Issuance of replacement awards related to the AnHeart acquisition	$	—		$	24,818

See accompanying notes to the unaudited consolidated financial statements.

NUVATION BIO INC. and Subsidiaries

Notes to Consolidated Financial Statements

1. Nature of Operations

Nuvation Bio Inc. and subsidiaries (“Nuvation Bio”), a Delaware corporation, is a ~~biopharmaceutical~~global commercial-stage oncology company focused on tackling some of the ~~greatest~~toughest ~~unmet~~challenges ~~needs~~ in ~~oncology~~cancer treatment by developing ~~differentiated~~therapies ~~and~~that ~~novel~~create ~~therapeutic~~a ~~candidates~~profound, positive impact on patients’ lives. Nuvation Bio was incorporated on March 20, 2018 (inception date) and has offices in New York, San Francisco, Beijing, Guangzhou, Hangzhou, Shanghai and Yantai.

On February 10, 2021, (the “Closing Date”), Nuvation Bio Inc., a Delaware corporation (“Legacy Nuvation Bio”), Panacea Acquisition Corp. (“Panacea”), and Panacea Merger Subsidiary Corp, a Delaware corporation and a direct, wholly owned subsidiary of Panacea (“Merger Sub”) consummated the transactions contemplated by an Agreement and Plan of Merger among them dated October 20, 2020 (“Merger Agreement”).

Pursuant to the terms of the Merger Agreement, a business combination of Panacea and Legacy Nuvation Bio was effected through the merger of Merger Sub with and into Legacy Nuvation Bio, with Legacy Nuvation Bio surviving as a wholly owned subsidiary of Panacea (the “Merger”) and, collectively with the other transactions described in the Merger Agreement. On the Closing Date, Legacy Nuvation Bio changed its name to Nuvation Bio Operating Company Inc. and Panacea changed its name to Nuvation Bio Inc. (the “Company” or “Nuvation Bio”).

On April 9, 2024, (the "Acquisition Date"), the Company completed its acquisition of AnHeart Therapeutics Ltd., an exempted company incorporated under the laws of the Cayman Islands (“AnHeart”), pursuant to that certain Agreement and Plan of Merger (the "AnHeart Merger Agreement"), by and among the Company, AnHeart, Artemis Merger Sub I, Ltd., an exempted company incorporated under the laws of the Cayman Islands and a wholly owned subsidiary of the Company, and Artemis Merger Sub II, Ltd., an exempted company incorporated under the laws of the Cayman Islands and a wholly owned subsidiary of the Company.

2. Significant Accounting Policies

a. Basis of Presentation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.

b. Principles of Consolidation

The consolidated financial statements include the balances of the Company and its subsidiaries. All intercompany transactions and balances are eliminated in consolidation.

c. Unaudited Interim Financial Information

The accompanying unaudited condensed consolidated financial statements as of ~~March~~June 3130, 2025 and for the three and six months ended ~~March~~June 3130, 2025 and 2024, have been prepared in accordance with GAAP for interim financial statements and pursuant to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, all adjustments have been made that are considered necessary for a fair statement of the financial position of the Company as of ~~March~~June 3130, 2025, the results of operations for the three and six months ended ~~March~~June 3130, 2025 and 2024 and the cash flows for the ~~three~~six months ended ~~March~~June 3130, 2025 and 2024. The condensed consolidated balance sheet as of December 31, 2024 has been derived from the Company’s audited consolidated financial statements. Operating results for the three and six months ended ~~March~~June 3130, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025.

Certain information and disclosures normally included in the notes to annual financial statements prepared in accordance with GAAP have been omitted from these interim financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the financial statements for the fiscal year ended December 31, 2024, which are included in the Company’s 10-K filed with the SEC on March 6, 2025.

d. Reclassifications

Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations.

e. Liquidity

As of ~~March~~June 3130, 2025, the Company has an accumulated deficit of approximately $~~964~~1,023.0 million and net cash used in operating activities was approximately $4290.68 million for the ~~three~~six months ended ~~March~~June 3130, 2025. Management expects to continue to incur operating losses and negative cash flows from operations for the foreseeable future.

As of ~~March~~June 3130, 2025, the Company had cash, cash equivalents, and marketable securities of $~~461~~607.7 million. The Company believes that its existing cash, cash equivalents, and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months after the date that these consolidated financial statements are issued. The Company’s research and development ~~and preparation for potentially becoming a commercial stage organization~~ can be costly, and the timing and outcomes are uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated and may be subject to change. The actual amount of the Company’s expenditures will vary depending upon a number of factors including but not limited to the progress of the Company’s commercialization efforts for IBTROZI, research and development activities, potential regulatory approval of its product candidates, and the level of financial resources available.

f. Significant Risks and Uncertainties

The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of research and development, clinical testing and trial activities of the Company’s products, the Company’s ability to obtain and maintain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company’s products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital.

~~Except in China where taletrectinib is being commercialized by our partner Innovent, there can be no assurance that the Company’s research and development will be successfully commercialized.~~ Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and vendors and obtaining and protecting intellectual property.

g. Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenue and expenses during the year. Accordingly, actual results could differ from those estimates and those differences could be significant. Significant estimates and assumptions reflected in the accompanying consolidated financial statements include, but are not limited to, the fair value of in-process research and development acquired, warrant liabilities, leases, stock options granted, revenue recognition, interest expense and depreciation expense.

h. Functional Currency and Foreign Currency Translations

The Company's reporting currency is the U.S. dollar ("USD"). The functional currency of the Company's subsidiaries incorporated in People Republic of China ("PRC") is Renminbi ("RMB"). The functional currency of the Company and its subsidiaries incorporated outside the PRC is USD. Transactions denominated in currencies other than the functional currencies are re-measured into the functional currency of the entity at the exchange rates prevailing on the transaction dates. Foreign currency denominated financial assets and liabilities are re-measured at the balance sheet date exchange rate. The resulting exchange differences are included in the net loss of the statements of operations and comprehensive loss. Assets and liabilities of the Company with functional currency other than USD are translated into USD at fiscal year-end exchange rates. Equity amounts are translated at historical exchange rates. Income and expense items are translated at average exchange rates during the fiscal year. Translation adjustments arising from these are reported as foreign currency translation adjustments and are shown as a component of other comprehensive income (loss).

i. Cash and Cash Equivalents

Cash equivalents include short-term, highly liquid instruments, consisting of money market accounts, a money market mutual fund and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk.

j. Marketable Securities

Debt securities have been classified as available-for-sale which may be sold before maturity or are not classified as held to maturity or trading. Marketable debt securities classified as available-for-sale are carried at fair value with unrealized gains or losses reported in other comprehensive income (loss). Exchange traded funds are equity securities, which are reported as marketable securities

with readily determinable fair values, are also carried at fair value with unrealized gains and losses included in other (expense) income, net. Realized gains and losses on both debt and equity securities are included in other (expense) income, net.

For securities in an unrealized loss position, management considers the extent and duration of the unrealized loss, and the financial condition and near-term prospects of the issuer. Management also assesses whether it intends to sell, or it is more likely than not that it will be required to sell, a security in an unrealized loss position before recovery of its amortized cost basis. If management determines there is any other than temporary impairment, the entire difference between amortized cost and fair value is recognized as impairment through earnings.

The Company is exposed to credit losses primarily through its available-for-sale investments. The Company assesses whether its available-for sale investments are impaired at each reporting period. Unrealized losses or impairments resulting from the amortized cost basis of any available-for-sale debt security exceeding its fair value are evaluated for identification of credit losses and non-credit related losses. Any credit losses are charged to earnings against the allowance for credit losses of the debt security, limited to the difference between the fair value and the amortized cost basis of the debt security. Any difference between the fair value of the debt security and the amortized cost basis, less the allowance for expected credit losses, are reported in other comprehensive income (loss). Expected cash inflows due to improvements in credit are recognized through a reversal of the allowance for expected credit losses subject to the total allowance previously recognized. The Company’s expected loss allowance methodology for the debt securities includes reviewing the extent of the unrealized loss, the size, term, geographical location, and industry of the issuer, the issuers’ credit ratings and any changes in those ratings, as well as reviewing current and future economic market conditions and the issuers’ current status and financial condition. As of ~~March~~June 3130, 2025, the Company has not recognized an allowance for expected credit losses related to available-for-sale investments as the Company has not identified any unrealized losses for these investments attributable to credit factors.

Interest income includes amortization and accretion of purchase premium and discount. Premiums and discounts on debt securities are amortized on the effective-interest method. Gains and losses on sales are recorded on the settlement date and determined using the specific identification method.

k. Acquisition of assets and businesses

Our consolidated financial statements include the operations of acquired businesses after the completion of the acquisitions. We account for acquired businesses using the acquisition method of accounting, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date and that the fair value of acquired in-process research and development be recorded on the balance sheet. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill. When we acquire net assets that do not constitute a business, as defined in GAAP, no goodwill is recognized and acquired in-process research and development is expensed in acquired in-process research and development expenses. Contingent consideration in a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Fair value is generally estimated by using a probability-weighted discounted cash flow approach. Any liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved.

On April 9, 2024, the Company completed its acquisition of AnHeart. The Company accounted for the transaction as an asset acquisition since the lead asset represented substantially all of the fair value of the gross assets acquired.

l. Concentration of Risk

Concentration of credit risk

Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and marketable securities. The Company maintains its cash and cash equivalent balances in the form of business checking accounts and money market accounts, the balances of which, at times, may exceed federally insured limits. Exposure to cash and cash equivalents credit risk is reduced by placing such deposits with major financial institutions and monitoring their credit ratings. Marketable securities consist primarily of government and corporate bonds, municipal securities and exchange traded funds with fixed interest rates. Exposure to credit risk of marketable securities is reduced by maintaining a diverse portfolio and monitoring their credit ratings.

consist primarily of government and corporate bonds, municipal securities and exchange traded funds with fixed interest rates. Exposure to credit risk of marketable securities is reduced by maintaining a diverse portfolio and monitoring their credit ratings.

Concentration of customers

Below customers represent more than 10% of the Company's net revenue for the three and six months ended ~~March~~June 3130, 2025. ~~There~~and ~~was no revenue for the three months March 31,~~ 2024. ~~since~~The ~~the~~ acquisition of AnHeart completed in the second quarter of 2024.

	For the Three Months Ended
	Three Months Ended June 30,				Six Months Ended June 30,
	March 31, 2025
	2025		2024		2025		2024
Customer A		23,~~901~~250		1,096		6,150		1,096
Customer B		183

~~Below customer represents more than 10% of the Company's balances of accounts receivable as of March 31, 2025.~~8

	March 31, 2025
Customer A		297
Customer B		112

Below customer represents more than 10% of the Company's balances of accounts receivable as of June 30, 2025.


	June 30, 2025
Customer A		1,177

m. Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the related assets of generally five years for computers and seven years for furniture and equipment. The cost of leasehold improvements is amortized on the straight-line method over the lesser of the estimated asset life or remaining term of the lease. Maintenance costs are expensed as incurred, while major betterments are capitalized.

n. Impairment of Long-Lived Assets

The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable and an impairment assessment may be performed on the recoverability of the carrying amounts. If an impairment occurs, the loss is measured by comparing the fair value of the asset to its carrying amount.

o. Warrants

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own ordinary shares, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

Following the Merger, there were 5,787,472 warrants to purchase Common Stock outstanding, consisting of 4,791,639 Public Warrants, 162,500 Private Placement Warrants and 833,333 Forward Purchase Warrants (as defined below). Each whole warrant entitles the registered holder to purchase one share of our Class A Common Stock at a price of $11.50 per share. Pursuant to the warrant agreement, a warrant holder may exercise its warrants only for a whole number of shares of our Class A Common Stock.

As part of the consideration for AnHeart, the Company issued warrants collectively exercisable for approximately 2,893,720 shares of the Company’s Class A Common Stock at an exercise price of $11.50 per share (the “Consideration Warrants”). The fair value of the Consideration Warrants was determined to approximate the public warrant trading price as of closing of the Acquisition, yielding a fair value of approximately $0.26 per share. The ~~Consideration Warrants were restricted with respect to the exercise and transfer thereof until receipt of such stockholder approval and otherwise have terms identical to those of the~~ Company’s ~~outstanding Public Warrants. Accordingly, the Company~~ classified the Consideration Warrants as liabilities, consistent with the classification of the Company’s Public Warrants.

Company’s Public Warrants. The Consideration Warrants are no longer restricted with respect to the exercise and transfer based on the stockholder approval from the 2024 Annual Meeting of Stockholders (the “Annual Meeting”) on September 3, 2024.

The Company evaluated Public Warrants, Private Placement Warrants, Consideration Warrants, and Forward Purchase Warrants (the “Warrants”) under ASC 815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity, and concluded that they do not meet the criteria to be classified in stockholders’ equity. Specifically, the settlement value of the Warrants is dependent, in part, on the holder of the Warrants at the time of settlement. Because the holder of an instrument is not an input into the pricing of a fixed-for-fixed option on our Common Stock, the Warrants fail the indexation guidance in ASC 815-40, which would preclude classification in stockholders’ equity. Additionally, the exercise of the Warrants may be settled in cash upon the occurrence of a tender offer or exchange that involves more than 50% of the outstanding shares of the Company’s Common Stock. Because not all of the Company’s stockholders need to participate in such tender offer or exchange to trigger the potential cash settlement and the Company does not control the occurrence of such an event, the Company concluded that the Warrants do not meet the conditions to be classified in equity. Since the Warrants meet the definition of a derivative under ASC 815, the Company recorded these Warrants as liabilities on the balance sheet at fair value upon the closing of the Merger, with subsequent changes in their respective fair values recognized in the consolidated statement of operations and comprehensive loss at each reporting date. The fair value of Consideration, Public, and Forward Purchase Warrants was determined using the closing price of the publicly traded warrants on the NYSE market. The fair value of the Private Placement Warrants was estimated using a Black-Scholes option pricing model (see Note 3).

p. Revenue Recognition

The Company applies ASC Topic 606, "Revenue from Contracts with Customers" ("ASC 606") to account for its revenue transactions. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the five-step model. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct. The Company recognizes as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied. Accounts receivable ~~represent~~represents amounts invoiced and revenues recognized prior to invoicing when the Company has satisfied its performance obligation and has the unconditional right to payment.

Product revenue, net

The Company recognizes product revenue, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer. Product revenue is recorded at the net sales price, or transaction price. The Company records product revenue reserves, which are classified as a reduction in product revenues, to account for the components of variable consideration. Variable consideration includes the following components: chargebacks, government rebates, commercial payer rebates, trade discounts and allowances, product returns, and co-payment assistance. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in applicable regulations and guidelines that would impact the amount of the actual rebates, our expectations regarding future utilization rates and channel inventory data. We review the adequacy of our provisions for sales deductions on a quarterly basis. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that adjustment is appropriate and to reflect actual experience. The most significant items deducted from gross product sales where we exercise judgment are rebates, sales returns and chargebacks.

q. Collaborative Arrangement

In November 2018, the FASB issued Topic 808, "Collaborative Arrangements" ("ASC 808"): Clarifying the Interaction between ASC 808 and ASC 606. This update clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer and precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. The Company adopted this standard for all periods presented. The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates. The Company assessed and determined that none of the collaboration agreements entered into during the periods presented were within the scope of ASC 808, as all of the agreements did not involve active participation by both parties in a joint research activity, and therefore did not qualify as collaborative arrangements under ASC 808. The Company has determined that all the elements of the above collaborations are reflective of a vendor-customer relationship and therefore within the scope of ASC 606. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the five-step model under ASC 606 noted above. The Company recognizes revenue to depict the transfer of control of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to receive in exchange for those goods or services. The Company's collaborative arrangements may contain more than one unit of account, or performance obligation, including grants of licenses to intellectual property rights, agreements to provide research and development services and other deliverables. The collaborative arrangements do not include a right of return for any deliverable. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. In developing the stand-alone selling price for a performance obligation, the Company considers competitor pricing for a similar or identical product, market awareness of and perception of the product, expected product life and current market trends. In general, the consideration allocated to each performance obligation is recognized when the respective obligation is satisfied either by delivering a good or providing a service, limited to the consideration that is not constrained. Non-refundable payments received before all of the relevant criteria for revenue recognition are satisfied are recorded as contract liabilities.

Licenses of intellectual property

If a license to the Company's intellectual property is determined to be distinct from the other promises or performance obligations identified in the contract, the Company recognizes revenue from the portion of the transaction price allocated to the license at a point in time, when the license is transferred to the customer and the customer is able to benefit from the license.

Research and development services

The portion of a transaction price allocated to research and development services performance obligations is deferred and recognized as revenue over time as delivery or performance of such services occurs based on the use of an input method.

Customer options

A customer's right to choose, at its discretion, to make a payment for additional goods or services is generally considered an option. If the Company is not presently obligated to provide and does not have a right to consideration for delivering additional goods or services, the item is considered an option. The Company evaluates the customer options for material rights, such as the ability to acquire additional goods or services for free or a discount. Optional future services that reflect their standalone selling prices do not provide the customer with a material right and, therefore, are not considered performance obligations and are accounted for as separate contracts. The optional future services do not include a material right to be accounted for as performance obligations.

Milestone payments

The Company's collaboration agreements include development and regulatory milestones. The Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company's control or the licensee's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.

Royalties

For sales-based royalties, including milestone payments based on the level of sales, the Company determines whether the sole or predominant item to which the royalties relate is a license. When the license is the sole or predominant item to which the sales-based royalty relates, the Company recognizes revenue at the later of: (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). For the three and six months ended ~~March~~June 3130, 2025, the Company has recognized $0.2 million and $0.5 million, respectively, sales-based royalty revenue resulting from the Company's collaboration agreements.

The Company receives payments from its customers based on billing terms established in the contract. Up-front payments and fees are recorded as contract liabilities (e.g., deferred revenue) upon receipt or when due until the Company performs its obligations under the arrangement.

In the event of an early termination of a collaboration agreement, any contract liabilities would be recognized in the period in which all our obligations under the agreement have been fulfilled.

For a complete discussion of accounting for revenue, see Note 4, "~~Collaboration~~Revenue ~~and License Agreements~~Recognition."

r. Costs to Fulfill a Contract with a Customer

The Company has not capitalized any costs for the three and six months ended ~~March~~June 3130, 2025 and 2024 . The Company is required to capitalize costs incurred to fulfill customer contracts. These costs are required to be amortized to expense on a systematic basis that is consistent with the transfer to the customer of the goods or services to which the asset relates, compared to previously being expensed as incurred. Elements of the costs primarily include (i) payroll and other related costs of personnel related directly to the contract activities; (ii) costs related to pre-clinical testing and clinical trials such as payments to contract research organizations ("CROs") and contract manufacturing organizations ("CMOs"), investigators, and clinical trial sites that conduct the contract activities; (iv) costs to develop the product candidates, including raw materials and supplies, product testing, depreciation, and facility-related expenses; and (v) other research and development costs.

s. Inventory

Inventories are stated at the lower of cost or net realizable value and recognized on a first-in, first-out ("FIFO") method. Inventory is capitalized based on when future economic benefit is expected to be realized.

The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of goods sold in the period in which they are incurred.

The Company outsources the manufacturing of its products to contract manufacturers. The Company expects to use the inventory that is classified within current assets on its consolidated balance sheet over its operating cycle. Inventory that is not expected to be used over the Company’s operating cycle is classified as a non-current asset.

t. ~~Leases~~Interest-bearing loans and borrowings

The Company will indicate that the carrying amount of the liability for sale of future royalties is based on management's estimate of the future royalties to be paid over the life of the arrangement using an imputed rate of interest. The liability is amortized using the effective interest rate method, resulting in recognition of non-cash interest expense over the estimated term of the agreement. If there are changes to the estimate, we recognize the impact to the liability’s amortization schedule and the related non-cash interest expense prospectively. Such costs are recognized under Interest expense in the Consolidated Statements of Operations and Comprehensive Loss and under Accrued expenses on the Consolidated Balance Sheets.

u. Leases

The Company determines if an arrangement contains a lease at inception. For arrangements where the Company is the lessee, operating leases are included in operating lease right-of-use, or ROU assets; current operating lease liabilities; and non-current operating lease liabilities on its balance sheets. The Company currently does not have any finance leases.

Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. ROU assets also include any initial direct costs incurred and any lease payments made on or before the lease commencement date, less lease incentives received. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company’s leases generally do not provide an implicit rate. The incremental borrowing rate is reevaluated upon a lease modification. The operating lease ROU asset also includes any initial direct costs and prepaid lease payments made less any lease incentives. The Company considered information available at the adoption date of Topic 842 to determine the incremental borrowing rate for leases in existence as of this date. The incremental borrowing rate used was the weighted average rate between secured and unsecured lending arrangements. Lease terms may include options to extend or terminate the lease when the Company is reasonably certain that the option will be exercised. Variable payments included in the lease agreement are expensed as incurred. Lease expense is recognized on a straight-line basis over the lease term.

The Company elected to apply each of the practical expedients described in ASC Topic 842-10-65-1(f) which allow companies not to reassess: (i) whether any expired or existing agreements contain leases, (ii) the classification of any expired or existing leases, and (iii) the capitalization of initial direct costs for any existing leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for short-term operating leases. A short-term operating lease is a lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company also elected not to separate non-lease components from lease components and instead to account for each separate lease component and the non-lease components associated with that lease component as a single lease component.

uv. Segment Information

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s operations are focused on oncology development activities. Substantially all revenues were derived from customers located in U.S., China and Japan. For the three months ended ~~March~~June 3130, 2025, the revenues derived from customers located in U.S., China and Japan were $1.2 million, $3.94 million and $0.2 million, respectively. ~~There was no revenue for the three months ended March 31, 2024 since the acquisition of AnHeart completed in the second quarter of 2024.~~

Nuvation Bio's Chief Executive Officer is the Chief Operating Decision Maker (“CODM”). The CODM utilizes the Company’s strategic product development roadmaps and financial models as a key input to resource allocation. The CODM is regularly provided with actual, budgeted and forecasted expense information to make decisions on resource allocation and assess performance of the business and monitor budget versus actual results using income from operations.

Significant expenses within income from operations, as well as within net income, include cost of revenue, research and development, and selling, general and administrative expenses, which are each separately presented on the Company’s Consolidated Statements of Operations and Comprehensive Loss. Other segment items within net income include interest income, interest expense, investment advisory fees, change in fair value of warrant liability, realized loss on marketable securities and other expense, net, and income tax expense.

vw. Research and Development Costs

Costs incurred in connection with research and development activities are expensed as incurred. These costs include fees paid to consultants, vendors and various entities that perform certain research and testing on behalf of the Company.

The Company has acquired rights to develop and commercialize product candidates. Upfront payments that relate to the acquisition of a new product compound, as well as pre-commercial milestone payments, are immediately expensed as acquired in-process research and development in the period in which they are incurred, provided that the new product compound did not also include processes or activities that would constitute a "business" as defined under U.S. GAAP, and the product candidate has not achieved 12

11The Company has acquired rights to develop and commercialize product candidates. Upfront payments that relate to the acquisition of a new product compound, as well as pre-commercial milestone payments, are immediately expensed as acquired in-process research and development in the period in which they are incurred, provided that the new product compound did not also include processes or activities that would constitute a "business" as defined under U.S. GAAP, and the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. Milestone payments made to third parties subsequent to regulatory approval which meet the capitalization criteria would be capitalized as intangible assets and amortized over the estimated remaining useful life of the related product. If the conditions enabling capitalization of development costs as an asset have not yet been met, all development expenditures are recognized in profit or loss when incurred.

~~regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use~~x. Stock-based Milestone payments made to third parties subsequent to regulatory approval which meet the capitalization criteria would be capitalized as intangible assets and amortized over the estimated remaining useful life of the related product. If the conditions enabling capitalization of development costs as an asset have not yet been met, all development expenditures are recognized in profit or loss when incurred.Compensation

w. Stock-based Compensation

The Company recognizes compensation cost for grants of employee stock options using a fair-value measurement method, that is recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. Forfeitures are recorded as they occur instead of estimating forfeitures that are expected to occur.

The Company determines the fair value of stock-based awards that are based only on a service condition using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, volatility, dividend yield, and expected life of the options.

The Company determines the fair value of stock-based awards that are based on both a service condition and achievement of the first to occur of a market or performance condition using a Monte Carlo simulation.

xy. Income Taxes

The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. The difference between the financial statement and tax basis of assets and liabilities is determined annually. Deferred income tax assets and liabilities are computed for those differences that have future tax consequences using the currently enacted tax laws and rates that apply to the years in which they are expected to affect taxable income. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense.

The Company uses a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate. The Company’s policy is to record interest and penalties related to income taxes as part of the tax provision. Returns for tax years beginning with those filed for the period ended December 31, 2018 are open to federal and state tax examination.

yz. Recent Accounting Pronouncements

In November 2024, the FASB issued Subtopic 220-40 "Disaggregation of Income Statement Expenses", which requires an entity to disclose, on an annual and interim basis, disaggregated information about certain income statement expense line items in a tabular format in the notes to the financial statements. The standard will be effective for annual reporting periods beginning after December 15, 2026 and for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. We are currently evaluating the potential effect that the updated standard will have on our financial statement disclosures.

In December 2023, the FASB issued Topics 740 "Improvements to Income Tax Disclosures" to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. This guidance is effective for our annual periods beginning January 1, 2025, with early adoption permitted. We are currently evaluating the potential effect that the updated standard will have on our financial statement disclosures.

3. Fair Value Measurements and Marketable Securities Available-for-Sale

The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:

Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).

Level 3 — Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.

The following table presents information about the Company’s marketable securities and the Warrant liability as of ~~March~~June 3130, 2025 and December 31, 2024, measured at fair value on a recurring basis, and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value. The Company’s Warrant liabilities are included within the Level 1 and Level 3 fair value hierarchy. The fair value of the Consideration, Public and Forward Purchase Warrants is determined using the closing price of the warrants on the NYSE market. The fair value of the Private Placement Warrants is determined using the Black-Scholes option pricing formula. The primary unobservable input utilized in determining the fair value of the Private Warrants is the expected volatility. The expected volatility was estimated considering observable Public Warrant pricing, the Company's own historical volatility and the volatility of guideline public companies. There have not been any transfers between the levels during the periods.

	March 31, 2025
	Total		Level 1		Level 2		Level 3
	(In thousands)
Financial assets:
Cash equivalents:
Money market funds	$	14,830	$	14,830	$	—	$	—
Corporate bonds		1,073		—		1,073		—
		15,903		14,830		1,073		—
Marketable securities:
Certificate of deposits		9,802		—		9,802		—
Commercial paper		11,224		—		11,224		—
U.S. government and government agency securities		329,777		—		329,777		—
Corporate bonds		62,896		—		62,896		—
		413,699		—		413,699		—
Total financial assets:	$	429,602	$	14,830	$	414,772	$	—
Financial liabilities:
Warrants	$	2,804	$	2,726	$	—	$	78

Debt

As of June 30, 2025, the estimated fair value of our debt approximated the carrying amount. The fair value of the debt was estimated for disclosure purposes only and was determined based on other inputs that are observable, and thus categorized as Level 2 in the fair value hierarchy.

Liability Related to Revenue Interest Financing Agreement

The Company will use the prospective method to account for changes in the effective interest rate arising from changes in the estimates of the revenue stream from the royalties and will update the effective interest rate on a quarterly basis. The Company will indicate that the carrying amount of the liability related to revenue interest financing agreement is based on management's estimate of the future royalties to be paid over the life of the arrangement using an imputed rate of interest, which are considered Level 3.


	June 30, 2025
	Total		Level 1		Level 2		Level 3
	(In thousands)
Financial assets:
Cash equivalents:
Money market funds	$	198,989	$	198,989	$	—	$	—
		198,989		198,989		—		—
Marketable securities:
Certificate of deposits		1,964		—		1,964		—
Commercial paper		7,494		—		7,494		—
U.S. government and government agency securities		303,978		—		303,978		—
Corporate bonds		46,316		—		46,316		—
		359,752		—		359,752		—
Total financial assets:	$	558,741	$	198,989	$	359,752	$	—

Financial liabilities:
Warrants	$	2,350	$	2,299	$	—	$	51


	December 31, 2024
	Total		Level 1		Level 2		Level 3
	(In thousands)
Financial assets:
Cash equivalents:
Money market funds	$	11,549	$	11,549	$	—	$	—
		11,549		11,549		—		—
Marketable securities:
Certificate of deposits		12,642		—		12,642		—
Commercial paper		18,227		—		18,227		—
U.S. government and government agency securities		355,170		—		355,170		—
Corporate bonds		80,930		—		80,930		—
		466,969		—		466,969		—
Total financial assets:	$	478,518	$	11,549	$	466,969	$	—

Financial liabilities:
Warrants	$	2,053	$	1,959	$	—	$	94

Marketable securities consist primarily of U.S. government and government agency, certificate of deposits, commercial paper, corporate bond and municipal securities ("Debt Securities"). Based on the Company’s intentions regarding its marketable securities, all Debt Securities are classified as available-for-sale and are carried at fair value based on the price that would be received upon sale of the security.

The following table provides the amortized cost, aggregate fair value, and unrealized gains (losses) of marketable securities as of ~~March~~June 3130, 2025 and December 31, 2024:


	June 30, 2025
	Amortized Cost		Unrealized Gains		Unrealized Losses			Fair Value
	(In thousands)
Cash equivalents:
Money market funds	$	198,989	$	—	$	—		$	198,989
		198,989		—		—			198,989
Marketable securities:
Certificate of deposits		1,964		—		—			1,964
Commercial paper		7,491		3		—			7,494
U.S. government and government agency securities		304,738		210		(970	)		303,978
Corporate bonds		46,241		123		(48	)		46,316
		360,434		336		(1,018	)		359,752
	$	559,423	$	336	$	(1,018	)	$	558,741

	March 31, 2025
	AmortizedCost		Unrealized Gains		Unrealized Losses			Fair Value
	(In thousands)
Cash equivalents:
Money market funds	$	14,830	$	—	$	—		$	14,830
Corporate bonds		1,073		—		—			1,073
		15,903		—		—			15,903
Marketable securities:
Certificate of deposits		9,797		5		—			9,802
Commercial paper		11,212		12		—			11,224
U.S. government and government agency securities		330,289		289		(801	)		329,777
Corporate bonds		62,857		124		(85	)		62,896
		414,155		430		(886	)		413,699
	$	430,058	$	430	$	(886	)	$	429,602


	December 31, 2024
	Amortized Cost		Unrealized Gains		Unrealized Losses			Fair Value
	(In thousands)
Cash equivalents:
Money market funds	$	11,549	$	—	$	—		$	11,549
		11,549		—		—			11,549
Marketable securities:
Certificate of deposits		12,628		14		—			12,642
Commercial paper		18,200		27		—			18,227
U.S. government and government agency securities		355,214		436		(480	)		355,170
Corporate bonds		80,891		119		(80	)		80,930
		466,933		596		(560	)		466,969
	$	478,482	$	596	$	(560	)	$	478,518

For the three months ended March 31, 2025 and 2024, there were no unrealized gains or losses on equity securities. The activity related to the net gains (losses) on marketable securities included in other income (expense) on the consolidated statements of operations and comprehensive loss were as follows (in thousands):15

	Three months ended March 31,
	2025		2024
Net realized gains (losses) on available-for-sale securities were as follows:
Realized gains from sales of available-for-sale securities	$	3	$	1
Realized losses from sales of available-for-sale securities		—		—
Total losses on marketable securities	$	3	$	1

For the three and six months ended June 30, 2025 and 2024, there were no unrealized gains or losses on equity securities. The activity related to the net gains (losses) on marketable securities included in other income (expense) on the consolidated statements of operations and comprehensive loss were as follows (in thousands):

The following tables provide marketable securities with continuous unrealized losses for less than 12 months and 12 months or greater and the related fair values as of March 31, 2025 and December 31, 2024 were as follows:


	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Net realized gains (losses) on available-for-sale securities were as follows:
Realized gains from sales of available-for-sale securities	$	—		$	1		$	3		$	1
Realized losses from sales of available-for-sale securities		(1	)		(8	)		(1	)		(7	)
Total (losses) gain on marketable securities	$	(1	)	$	(7	)	$	2		$	(6	)

	March 31, 2025
	Less than 12 Months					12 Months or Greater					Total		Total
	Fair Value		Unrealized Losses			Fair Value		Unrealized Losses			Fair Value		Unrealized Losses
	(In thousands)
U.S. government and government agency securities	$	171,761	$	(793	)	$	989	$	(8	)	$	172,750	$	(801	)
Corporate bonds		15,081		(31	)		4,937		(54	)		20,018		(85	)
	$	186,842	$	(824	)	$	5,926	$	(62	)	$	192,768	$	(886	)

The following tables provide marketable securities with continuous unrealized losses for less than 12 months and 12 months or greater and the related fair values as of June 30, 2025 and December 31, 2024 were as follows:


	June 30, 2025
	Less than 12 Months					12 Months or Greater				Total		Total
	Fair Value		Unrealized Losses			Fair Value		Unrealized Losses		Fair Value		Unrealized Losses
	(In thousands)
Certificate of deposits	$	1,097	$	—		$	—	$	—	$	1,097	$	—
Commercial paper		2,459		—			—		—		2,459		—
U.S. government and government agency securities		174,384		(970	)		—		—		174,384		(970	)
Corporate bonds		10,163		(48	)		—		—		10,163		(48	)
	$	188,103	$	(1,018	)	$	—	$	—	$	188,103	$	(1,018	)

	December 31, 2024
	Less than 12 Months					12 Months or Greater					Total		Total
	Fair Value		Unrealized Losses			Fair Value		Unrealized Losses			Fair Value		Unrealized Losses
	(In thousands)
U.S. government and government agency securities	$	111,021	$	(398	)	$	45,099	$	(82	)	$	156,120	$	(480	)
Certificate of deposits	$	243	$	—		$	—	$	—		$	243	$	—
U.S. government and government agency securities		111,021		(398	)		45,099		(82	)		156,120		(480	)
Corporate bonds		20,659		(33	)		9,911		(47	)		30,570		(80	)
	$	131,~~680~~923	$	(431	)	$	55,010	$	(129	)	$	186,~~690~~933	$	(560	)

Unrealized losses from the marketable securities are primarily attributable to changes in interest rates and represent temporary impairments due to general market factors. The Company has not recognized an allowance for expected credit losses related to available-for-sale investments as the Company has not identified any unrealized losses for these investments attributable to credit factors during the three and six months ended ~~March~~June 3130, 2025. As of ~~March~~June 3130, 2025, the Company does not intend to sell these securities nor does the Company believe that it will be required to sell these securities before the recovery of their amortized cost basis.

Maturity information based on fair value is as follows as of ~~March~~June 3130, 2025:

Within one year

After one yearthrough five years

Total

(In thousands)

Certificate of deposits

91,~~802~~964

—

91,~~802~~964

Commercial paper

117,~~224~~494

—

117,~~224~~494

U.S. government and government agency securities

~~244~~222,~~844~~711

8481,~~933~~267

~~329~~303,~~777~~978

Corporate bonds

3532,~~702~~587

2713,~~194~~729

6246,~~896~~316

~~301~~264,~~572~~756

~~112~~94,~~127~~996

~~413~~359,~~699~~752

4. ~~Collaboration~~Revenue ~~and License Agreements~~Recognition

The Company enters into collaborative arrangements for the research and development, and commercialization of drug products and drug candidates. To date, these collaborative arrangements have included out-licensing of and options to out-license in-licensed compounds to other parties. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost reimbursement arrangements and royalty payments.16

The Company revenues by geographic region, based on the patient’s location for the three and six months ended June 30, 2025 and 2024 are summarized as follows (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
United States	$	1,238	$	—	$	1,238	$	—
China		3,354		1,095		6,254		1,095
Japan		241		340		425		340
Total revenues	$	4,833	$	1,435	$	7,917	$	1,435

Net Product Revenue

Product revenue, net was approximately $1.2 million for the three months ended June 30, 2025 from the U.S. sales of IBTROZI. We began shipping IBTROZI to our U.S. customers in June 2025.

Collaboration and License Agreements Revenue

In-Licensing Arrangements with Daiichi Sankyo Company Ltd. ("DS")

The Company has in-licensed the rights to develop, manufacture and, ~~if approved,~~ commercialize multiple development stage drug candidates globally or in specific territories. The development milestone payments are recognized when the achievement of the associated milestone becomes probable and estimable and have been expensed before regulatory approval has been obtained. ToIn ~~date~~December 2024, a $2 million development milestone payment has been capitalized as an intangible asset upon regulatory approval in China. We reached two milestones in 2024, and the resulting $6 million in development milestone payments owed was paid to DS in March 2025. In June 2025, an $8 million milestone payment to DS is owed upon regulatory approval in the U.S. This milestone payment has been capitalized as an intangible asset.

Out-Licensing Arrangements

The Company's revenue related to its out-licensing collaborative agreements consist of product revenue, upfront license fees, royalty revenue and research and development services revenue from its collaboration agreements with Innovent Biologics Co. Ltd. ("Innovent") and Nippon Kayaku Co., Ltd. ("NK") for ~~Taletrectinib~~ taletrectinib (also known as "AB-106").

The following table summarizes total revenue recognized for the three months ended March 31, 2025 (in thousands):

	Three Months Ended
	March 31, 2025
Revenue
Product revenue		779
Royalty revenue		249
Research and development service revenue		2,056
Total	$	3,084

There was no revenue for the three months ended March 31, 2024 since the acquisition of AnHeart completed in the second quarter of 2024.

Collaboration and License Agreement with Innovent

In May 2021, AnHeart entered into an agreement with Innovent, granting Innovent a sub-licensable, royalty-bearing, exclusive right and license to commercialize AB-106 in the People's Republic of China and Taiwan (the "Innovent Territory"). AnHeart is responsible for funding ongoing clinical trials of AB-106, regulatory submissions after development with Innovent responsible for commercialization ~~upon regulatory approvals~~. ~~They also granted Innovent the option to obtain a license to commercialize AB-329 once they provide proof of concept behind the compound in a region in the Innovent Territory (the "Innovent Option").~~ Under the agreement, AnHeart received a non-refundable upfront cash payment, $12.0 million for achievement of certain regulatory approval milestones, and is eligible to receive up to $17.0 million upon achievement of additional regulatory milestones, up to $105.0 million upon achievement of commercial milestones, and tiered percentage royalties ranging from mid-teen to low-twenties on annual net sales of taletrectinib in the Innovent Territory subject to certain adjustments.

For the three and six months ended ~~March~~June 3130, 2025, the Company recognized research and development service revenue of $12.92 million and $4.1 million, sales of products ~~revenue~~supply of $0.89 million and $1.7 million, and royalties of $0.2 million and $0.5 million, respectively, under the Innovent agreement. As of ~~March~~June 3130, 2025, the accounts receivable of Innovent was $01.32 million.

Collaboration and License Agreement with NK

In October 2023, AnHeart entered into an agreement with NK, granting NK a sub-licensable, royalty-bearing, exclusive right and license to commercialize AB-106 in Japan (the "NK Territory"). AnHeart is responsible for funding ongoing clinical trials of AB-106 in the NK Territory, with NK responsible for funding regulatory submissions in the NK Territory. The Company also granted NK a sub-licensable, royalty-bearing, exclusive right and license to research, develop and commercialize any new indications of AB-106 in the NK Territory ("NK New Indication Right"). Under the agreement, AnHeart received a non-refundable upfront cash payment and is eligible to receive $25.0 million upon achievement of a regulatory milestone, up to $35.0 million upon achievement of commercial milestones, and a lower-mid double digit percentage royalty on net sales of taletrectinib in the NK Territory.

~~The Company recognized research and development service revenue of $0.2 million for the three months ended March 31, 2025. As of March 31, 2025, the accounts receivable of NK was $0.1 million.~~ 17

The Company recognized research and development service revenue of $0.2 million and $0.4 million, respectively, for the three and six months ended June 30, 2025. As of June 30, 2025, the accounts receivable of NK was $0.1 million.

Contract assets and contract liabilities

When the Company satisfies its performance obligations by providing services to a customer before the customer pays consideration and before payment is due, the Company recognizes its rights to consideration as a contract asset.

The Company did not recognize any contract assets as of ~~March~~June 3130, 2025.

When a customer pays consideration before the Company provide services, the Company records its obligation as a contract liability. The Company expects to recognize all of this balance as revenue as research and development services are provided over the next 4 years.

The contract liabilities of the Company as of ~~March~~June 3130, 2025 isare listed in the table below.

	March 31, 2025
	June 30, 2025
	(In thousands)
Research and development service revenue		2422,~~383~~184

The Company recognized $24.15 million of revenue for the ~~three~~six months ended ~~March~~June 3130, 2025 that was included in the contract liability balance at December 31, 2024.

The balance of contract liabilities as of ~~March~~June 3130, 2025 represents the transaction price allocated to the remaining performance obligations. The contract liability of $109.87 million is expected to be recognized within one year and the rest in the following ~~three~~five years.

The costs incurred to fulfill customer contracts were capitalized and amortized to cost of revenue on a systematic basis that is consistent with the transfer of research and development services to the customer to which the asset relates. For the three months ended ~~March~~June 3130, 2025, $2.0 million of costs incurred to fulfill customer contracts were capitalized and expensed in the same period. There were no balances related to the costs incurred to fulfill customer contracts as of ~~March~~June 3130, 2025.

5. ~~Borrowing~~Borrowings

16In 2020, AnHeart entered into loan agreements with Bank of Hangzhou to obtain short-term borrowings to supplement its working capital. As of June 30, 2025, the outstanding balance net of repayments was $5.6 million. For the six months ended June 30, 2025, the Company has drawn down $5.6 million and repaid $5.6 million. The fixed interest rate of the outstanding borrowings was 3.50% per annum.

InOn ~~2020~~April 4, 2023, AnHeart entered into ~~loan~~a ~~agreements~~Loan and Security Agreement with Shanghai Pudong Development Bank ofin ~~Hangzhou~~Silicon Valley for up to ~~obtain~~40.0 ~~short-~~million RMB or equivalent in optional currency USD term ~~borrowings~~loans to("SSVB ~~supplement~~Loan"). ~~its~~The SSVB Loan consists of a short-term working capital. Asloan of ~~March~~20 31million RMB, which matured on April 4, 2024, and a long-term loan of 20 million RMB, which matured on April 4, 2025, ~~the~~at which time all outstanding ~~balance~~balances ~~net~~were due. Draws on the line of ~~repayments~~credit ~~was~~for ~~$5.5~~the ~~million.~~short-term ~~For~~loans are payable on the ~~three~~maturity ~~months~~date ~~ended~~of ~~March~~the 31SSVB Loan. As of June 30, 2025, there ~~were~~was no ~~borrowings~~outstanding orline ~~repayments~~of credit balance. ~~The~~For ~~fixed~~the ~~interest~~six ~~rate~~months ofended ~~these~~June ~~borrowings~~30, is2025, ~~3.5%~~the toCompany 4repaid $0.~~05%~~7 ~~per annum~~million.

~~On April 4, 2023, AnHeart entered into a~~ Loan ~~and Security~~ Agreement ("2023 SSVB Agreement") with Shanghai Pudong Development Bank in Silicon Valley for up to 40.0 million RMB or equivalent in optional currency USD term loans ("SSVB Loan"). The SSVB Loan consists of a short-term working capital loan of 20 million RMB, which matured on April 4, 2024, and a long-term loan of 20 million RMB, which matures on April 4, 2025, at which time all outstanding balances are due. Draws on the line of credit for the short-term loans are payable on the maturity date of the SSVB Loan. Draws on the line of credit for the long-term loans are payable in equal installments monthly over the shorter of 24 months or from the date the draw took place till the SSVB loan matures. Outstanding balances will bear interest at a fixed rate of 4.25%. As of March 31, 2025, the outstanding line of credit balance net of repayments was $0.2 million. For the three months ended March 31, 2025, the Company repaid $0.5 million.

On March 3, 2025, ~~we announced~~ (the ~~closing~~“Closing ofDate”), athe ~~non-dilutive~~Company ~~financing~~entered ofinto upa to $~~250~~100.0 million ~~from~~senior ~~Sagard.~~secured ~~The~~loan ~~financing~~agreement ~~is comprised of a $150.0 million~~ (the ~~"Investment~~“Loan ~~Amount"~~Agreement”), ~~synthetic royalty financing agreement~~ with Sagard ~~Healthcare~~Holdings ~~Partners~~Manager LP (~~Delaware~~“Sagard”) IIas LPadministrative agent, and athe ~~$100.0~~lenders ~~million~~party ~~senior secured term loan with Sagard Holdings Manager LP~~thereto. The ~~Investment Amount and a~~ $50.0 million tranche of the term loan ~~will~~was be funded ~~conditioned~~on ~~upon~~June 25, 2025, following FDA’s approval of ~~taletrectinib on or prior to September 30, 2025~~IBTROZI. The second tranche of $50 million of the term loan will be available at our option until June 30, 2026, asbecause ~~long as~~ we have achieved first U.S. commercial sale of ~~taletrectinib~~IBTROZI.

The senior secured loans under the Loan Agreement (the “Loans”) mature on September 30, 2030 and bear interest at a variable annual rate equal to the secured overnight financing rate (subject to a 4.00% floor) plus a margin of 6.00%, payable quarterly. The Company will be required to pay a funding fee equal to a low single-digit percentage of each tranche, upon, and subject to, funding of such tranche, and an exit fee equal to a nominal percentage of each tranche upon repayment of such tranche.

The Company may voluntarily prepay the Loans at any time subject to a prepayment premium which, until the second anniversary of the initial funding date, is equal to the amount of interest that would have been paid up to, but not including, the second anniversary of such date, plus 3.00% of the principal amount of the Loans being repaid. Thereafter, the prepayment premium equals 3.00% of the principal amount of the Loans being repaid and is reduced over time until the fourth anniversary date, after which no prepayment premium is required. The Company is required to make mandatory prepayments of the Loans with net cash proceeds from certain asset sales or insurance proceeds or condemnation awards, in each case, subject to certain exceptions and reinvestment rights.

The obligations of the Company under the Loan Agreement are guaranteed by certain of its existing subsidiaries and are required to be guaranteed by subsequently acquired or organized subsidiaries, subject to certain exceptions (collectively, the “Guarantors”). The obligations of the Company under the Loan Agreement and the related guarantees thereunder are secured, subject to customary permitted liens and other agreed upon exceptions, by (i) a pledge of all of the equity interests of the Company’s and the Guarantors’ direct subsidiaries, and (ii) a perfected security interest in substantially all of the Company’s and the Guarantors’ tangible and intangible assets.

The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions. In addition, the Loan Agreement contains a financial covenant requiring that the Company maintain not less than $25 million of cash and certain cash equivalent investments. Failure of the Company to comply with the financial covenant will result in an event of default, subject to certain cure rights of the Company other than under certain specified circumstances.

The Loan Agreement contains events of default which are customary for financings of this type, in certain circumstances subject to customary cure periods. Following an event of default and any cure period, if applicable, Sagard will have the right upon notice to terminate any undrawn commitments and may accelerate all amounts outstanding under the Loan Agreement, in addition to other remedies available to it as a secured creditor of the Company.

Future Minimum Payments

The following table presents future minimum payments, including interest and the end of term charge, under the Loan Agreement as of June 30, 2025:


	June 30, 2025
	(In thousands)
2025 (remaining 6 months)	$	2,637
2026		5,230
2027		5,230
2028		5,244
2029		5,230
Thereafter		54,162
Total		77,733
Less: imputed interest		(27,483	)
Less: unamortized debt discount and issuance costs		(3,276	)
Total loan agreement	$	46,974

Revenue Interest Financing Agreement

On the Closing Date, the Company also entered into a Revenue Interest Financing Agreement (the “Financing Agreement”) with Sagard Healthcare Partners (Delaware) II LP (the “Investor”), pursuant to which the Investor paid the Company $150 million (the “Investment Amount”) on June 25, 2025, following the FDA’s approval of IBTROZI. In exchange for the Investment Amount, the Company has agreed to make tiered royalty payments to the Investor (the “Payments”) on U.S. net sales of IBTROZI equal to 5.5% of annual U.S. net sales up to $600 million and 3.0% of annual U.S. net sales between $600 million and $1 billion. The Company will retain all annual U.S. net sales above $1 billion. The obligation to make the Payments will cease upon the earliest occurrence of total Payments reaching 1.6 times of the Investment Amount by the calendar quarter ending on June 30, 2031, 1.75 times of the Investment Amount by the calendar quarter ending on June 30, 2034, or 2.0 times of the Investment Amount thereafter.

The Company is required to make a true up payment to the Investor to the extent the Investor has not received Payments equaling at least 100% of the Investment Amount by February 1, 2043 in an amount equal to any such shortfall.

The Company’s obligations under the Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions and subject to an intercreditor agreement with Sagard, by a perfected security interest in (i) accounts receivable arising from U.S. net sales of IBTROZI and (ii) intellectual property, product registrations and regulatory approvals related to commercialization of IBTROZI in the United States.

The Company has the right, but not the obligation (the “Call Option”), to buy out the Investor’s interest in the Payments at a repurchase price (the “Put/Call Price”) equal to (a) on or prior to the second anniversary of the Closing Date, an amount equal to 140% of the Investment Amount, less all Payments made to the applicable repurchase date, (b) after the second anniversary but on or prior to August 1, 2031, an amount equal to 160% of the Investment Amount, less all Payments made to the applicable repurchase date, (c) after August 1, 2031 but on or prior to August 1, 2034, an amount equal to 175% of the Investment Amount, less all Payments made to the

applicable repurchase date, and (d) after August 1, 2034, an amount equal to 200% of the Investment Amount, less all Payments made to the applicable repurchase date.

The Financing Agreement contains customary representations and warranties and certain restrictions on the Company’s ability to incur indebtedness and grant liens on intellectual property, product registrations and regulatory approvals related to commercialization and development of taletrectinib in the United States. In addition, the Financing Agreement provides that if certain events (“Put Option Events”) occur, including certain bankruptcy events, non-payment of Payments, a change of control, expiration or termination of certain intellectual property rights or marketing authorization, an out-license or sale of all of the rights in and to taletrectinib in the United States and (subject to applicable cure periods) non-compliance with the covenants in the Financing Agreement, the Investor may require the Company to repurchase its interests in the Payments at the Put/Call Price.

The Financing Agreement will be accounted for as debt at the time the funding occurs and at amortized cost using the effective interest method. The Company will use the prospective method to account for changes in the effective interest rate arising from changes in the estimates of the revenue stream from the royalties.

The following table shows the activity within the liability related to the Finance Agreement during the three months ended June 30, 2025:


	Liabilities Related to Finance Agreement
	(in thousands)
Carrying value of liability related to Finance Agreement at June 25, 2025	$	150,000
Issuance costs		(4,674	)
Non-cash interest expense		266
Amortization of issuance costs		11
Carrying value of liability related to Finance Agreement at June 30, 2025	$	145,603

6. Leases

Our principal executive offices are located in New York, New York, where we lease approximately 7,900 square feet of office space under a lease that terminates in 2027, with an option for us to extend the lease for an additional five years which is not reasonably assured of exercise, and in San Francisco, where we lease approximately 19,418 square feet of office space that terminates in 2029. We also occupy office space located in Burlington, Massachusetts, where we lease approximately 2,235 square feet of office space under a lease that terminates in 2027, as well as a total of approximately 1,735 square meters of office space in the People’s Republic of China, in the cities of Beijing, Guangzhou, Hangzhou and Shanghai, under leases that terminate in 2025 through 2029.

Operating lease expense was $0.9 million and $0.5 million for the three months ended ~~March~~June 3130, 2025 and 2024, respectively, and $1.8 million and $1.0 million for the six months ended June 30, 2025 and 2024, respectively. Expense related to variable leases was not significant for the three and six months ended ~~March~~June 3130, 2025 and 2024. Operating cash flows for the ~~three~~six months ended ~~March~~June 3130, 2025 and 2024 included $01.74 million and $01.51 million for operating leases, respectively.

The following table presents the future minimum lease analysis of the Company's operating lease liabilities showing the aggregate lease payments as of ~~March~~June 3130, 2025.

	March 31, 2025
	June 30, 2025
	(In thousands)
2025 (remaining 9 months)	$	1,761
2025 (remaining 6 months)	$	1,083
2026		2,~~081~~131
2027		1,~~352~~377
2028		1,~~214~~216
2029		~~205~~160
Total undiscounted lease payments		65,~~613~~967
Less: imputed interest		(~~885~~760	)
Total operating lease liabilities	$	5,~~728~~207

~~The weighted average incremental borrowing rate used to determine the operating lease liabilities was 8.75%. The Company's weighted average remaining lease term was 3.03 years as of March 31, 2025.~~20

The weighted average incremental borrowing rate used to determine the operating lease liabilities was 8.91%. The Company's weighted average remaining lease term was 3.04 years as of June 30, 2025.

7. Net Loss per Share

Basic loss per share is computed by dividing net loss by the weighted-average number of shares of Class A and Class B Common Stock outstanding. Diluted loss per share reflects the potential dilution that could occur if the stock options to issue Common Stock were exercised. The Company had a net loss in all periods presented thus the dilutive net loss per common share is the same as the basic net loss per common share as the effect of any options or conversions is anti-dilutive.

The earnings per share amounts are the same for the different classes of Common Stock because the holders of each class are legally entitled to equal per share distributions whether through dividends or liquidation.

The following securities outstanding at ~~March~~June 3130, 2025 and 2024 have been excluded from the calculation of weighted average shares outstanding:


	As of June 30,
	2025		2024
Warrants		8,681,182		8,681,182
Class A Common Stock options		77,654,180		52,692,948
Restricted stock units		129,257		2,161,352
Convertible preferred stock		—		85,120,200

	Three Months Ended March 31,
	2025		2024
Warrants		8,681,182		5,787,462
Class A Common Stock options		77,442,787		38,224,240
Restricted stock units		1,394,353		—

8. Accumulated Other Comprehensive Income (Loss)

The following table presents a rollforward of the changes in accumulated other comprehensive income (losses) for the ~~three~~six months ended ~~March~~June 3130, 2025 and 2024, which is all attributable to unrealized gains (losses) on available-for-sale securities. All amounts are net of tax.

	2025			2024
Balance at beginning of period	$	573		$	181
Unrealized loss		(490	)		(1,349	)
Unrealized losses		(716	)		(1,601	)
Amount reclassified for realized gain on marketable securities		(32	)		(16	)
Currency translation adjustment		~~465~~(182	)		—148
Balance at end of period	$	~~545~~(327	)	$	(1,~~169~~266	)

9. Stock-Based Compensation

The 2021 Equity Incentive Plan

In March 2019, the Company adopted the 2019 Equity Incentive Plan or (“2019 Plan”), which provided for the grant of options, stock appreciation rights, restricted stock, and other stock awards. In January 2021, our board of directors adopted the 2021 Equity Incentive Plan (the “2021 Plan”). The 2021 Plan was approved by our stockholders in February 2021 and became effective immediately upon the Closing Date of the Merger. Shares available for future issuance under the 2019 Plan were canceled.

Awards. The 2021 Plan provides for the grant of incentive stock options (“ISOs”), within the meaning of Section 422 of the Code to employees, including employees of any parent or subsidiary, and for the grant of nonstatutory stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to employees, directors and consultants, including employees and consultants of our affiliates.

Authorized Shares. The maximum number of shares of Class A Common Stock reserved for issuance upon adoption of the 2021 Plan was 50,684,047 shares of Class A Common Stock. The number of shares of Class A Common Stock reserved for issuance under the 2021 Plan will automatically increase on January 1 of each year, starting on January 1, 2022 through January 1, 2031, in an amount equal to (1) 4.0% of the total number of shares of Class A Common Stock and Class B Common Stock outstanding or issuable upon conversion or exercise of outstanding instruments on December 31 of the preceding year, or (2) a lesser number of shares of Class A Common Stock determined by our board of directors prior to the date of the increase. The maximum number of shares of Class A Common Stock that may be issued on the exercise of ISOs under the 2021 Plan is three times the number of shares available for issuance upon the 2021 Plan becoming effective or 152,052,141 shares.

The Employee Stock Purchase Plan

In January 2021, our board of directors adopted the 2021 Employee Stock Purchase Plan (the “ESPP”). The ESPP was approved by our stockholders in February 2021 and became effective immediately upon the Closing Date of the Merger.

Share Reserve. The maximum number of shares of Class A Common Stock reserved for issuance upon the adoption of the 2021 ESPP was 4,750,354 shares of Class A Common Stock. The number of shares of Class A Common Stock reserved for issuance under the 2021 ESPP will automatically increase on January 1st of each year, beginning on January 1, 2022 and continuing through and including January 1, 2031, by 1.0% of the total number of shares of Class A Common Stock and Class B Common Stock outstanding or issuable upon conversion or exercise of outstanding instruments on December 31st of the preceding calendar year or such lesser number of shares of Class A Common Stock as determined by our board of directors. Shares subject to purchase rights granted under the 2021 ESPP that terminate without having been exercised in full will not reduce the number of shares available for issuance under the 2021 ESPP.

The stock-based compensation expense included in the Company’s condensed statement of operations and comprehensive loss for the three and six months ended ~~March~~June 3130, 2025 and 2024 is as follows (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
Research and development	$	5,151	$	4,190	$	8,562	$	6,482
General and administrative		6,880		5,379		11,323		8,128
	$	12,031	$	9,569	$	19,885	$	14,610

	Three Months Ended March 31,
	2025		2024
Research and development	$	3,411	$	2,292
General and administrative		4,443		2,749
	$	7,854	$	5,041

The following table summarizes stock option activity under the 2019 Plan, 2021 Plan and assumed options in the AnHeart acquisition for the six months ended June 30, 2025.

The following table summarizes stock option activity under the 2019 Plan, 2021 Plan and assumed options in the AnHeart acquisition for the three months ended March 31, 2025.


	Shares
Outstanding at December 31, 2024		57,729,709
Granted		24,304,015
Exercised		(2,808,239	)
Forfeited or canceled		(1,571,305	)
Outstanding at June 30, 2025		77,654,180
Exercisable at June 30, 2025		29,550,511

	Shares
Outstanding at December 31, 2024		57,729,709
Granted		21,970,600
Exercised		(2,002,388	)
Forfeited		(255,134	)
Outstanding at March 31, 2025		77,442,787
Exercisable at March 31, 2025		27,048,262

The weighted average exercise price of all outstanding options as of June 30, 2025 was $2.73 per share.

The ~~weighted~~following ~~average~~table ~~exercise~~summarizes ~~price~~the ofactivity ~~all~~for ~~outstanding~~the ~~options~~restricted asstock ofunits ~~March~~for ~~31,~~the ~~2025~~six ~~was~~months ~~$2.73~~ended ~~per~~June ~~share~~30, 2025.

The following table summarizes the activity for the restricted stock units for the three months ended March 31, 2025.


	Restricted Stock Units
Non-vested at December 31, 2024		1,420,131
Granted		—
Vested		(1,290,874	)
Forfeited or canceled		—
Non-vested at June 30, 2025		129,257

	Restricted Stock
	Units
Non-vested at December 31, 2024		1,420,131
Granted		—
Vested		(25,778	)
Forfeited or canceled		—
Non-vested at March 31, 2025		1,394,353

10. Warrants

Following the Merger, there were 5,787,472 warrants to purchase Common Stock outstanding, consisting of 4,791,639 Public Warrants, 162,500 Private Placement Warrants and 833,333 Forward Purchase Warrants. Each whole warrant entitles the registered holder to purchase one share of our Class A Common Stock at a price of $11.50 per share. Pursuant to the warrant agreement, a warrant holder may exercise its warrants only for a whole number of shares of our Class A Common Stock.

Following the Acquisition of AnHeart, the Company issued 2,893,720 Consideration Warrants. The Consideration Warrants ~~were restricted with respect to the exercise and transfer thereof until receipt of such stockholder approval and otherwise~~ have terms identical to those of the Company’s outstanding Public Warrants. ~~The Consideration Warrants are no longer restricted with respect to the exercise and transfer thereof based on the stockholder approval obtained at the Annual Meeting.~~

At ~~March~~June 3130, 2025, there were an aggregate of 8,681,182 warrants outstanding.

The Company concluded that the Consideration Warrants, Public Warrants, Private Warrants and Forward Purchase Warrants do not meet the conditions to be classified in equity. The warrants were recorded at fair value with subsequent changes in fair value reflected in earnings (see Note 3). The change in fair value resulted in a loss of $0.8 million during the three months ended March 31, 2025.22

The Company concluded that the Consideration Warrants, Public Warrants, Private Warrants and Forward Purchase Warrants do not meet the conditions to be classified in equity. The warrants were recorded at fair value with subsequent changes in fair value reflected in earnings (see Note 3). The change in fair value resulted in a loss of $0.3 million during the six months ended June 30, 2025.

The fair value of Consideration, Public and Forward Purchase Warrants is determined using the closing price of the warrants on the NYSE market and the related Warrant liability is included in Level 1 fair value measurements. The Company utilizes the Black-Scholes option pricing formula to determine the fair value of the Private Warrants at each reporting period, with changes in fair value recognized in the statement of operations. The estimated fair value of the warrant liability for the Private Warrants is determined using Level 3 inputs. Inherent in a binomial options pricing model are assumptions related to expected share-price volatility, expected life, risk-free interest rate and dividend yield. The annualized volatility of the Warrant was based on a calibration to the publicly traded warrant price as of the valuation date. The risk-free interest rate was estimated using linear interpolation assuming a term consistent with the time until the warrants expire, and yield information was based on U.S. Treasury Constant Maturities. The expected life of the warrants is assumed to be equivalent to their remaining contractual term. The dividend rate is based on the historical rate, which the Company anticipates remaining at zero.

The aforementioned warrant liabilities are not subject to qualified hedge accounting.

19There were no transfers between Levels 1, 2 or 3 during the period ended June 30, 2025.

There were no transfers between Levels 1, 2 or 3 during the period ended March 31, 2025.

The following table provides quantitative assumptions regarding Level 3 fair value measurements:

	March 31, 2025			December 31, 2024
	June 30, 2025			December 31, 2024
Stock price	$	1.7695		$	2.66
Strike price	$	11.50		$	11.50
Term (in years)		0.96			1.1
Volatility		~~191~~183.45	%		137.5	%
Risk-free rate		4.12	%		4.1	%
Dividend yield		0.0	%		0.0	%

The Company determined the following fair values for the outstanding warrants (in thousands):

	March 31,2025
	June 30,2025
Public Warrants	$	1,~~533~~293
Private Placement Warrants		7851
Forward Purchase Warrants		~~267~~225
Consideration Warrants		~~926~~781
Total	$	2,~~804~~350

The following presents changes in liabilities classified in Level 3 of the fair value hierarchy for the ~~three~~six months ended ~~March~~June 3130, 2025 (in thousands):

	Three Months Ended
	Six Months Ended
	March 31, 2025
	June 30, 2025
Beginning balance	$	94
Change in fair value of Private Warrants liability recognized in earnings		(1643	)
Ending balance	$	7851

11. Commitments and Contingencies

Commitments

The Company has standby letters of credit with banks in the aggregate amount of $0.9 million which serve as security for the New York and San Francisco spaces operating leases. The standby letters of credit automatically renew annually.

Contingencies

From time to time, the Company is involved in routine litigation that arises in the ordinary course of business. There are no pending significant legal proceedings to which the Company is a party, for which management believes the ultimate outcome would have a material adverse effect on the Company’s financial position.

2012. Subsequent Event

On July 30, 2025, Tim Patterson filed a derivative complaint (Tim Patterson, derivatively on behalf of Nuvation Bio, Inc. v. David Hung, et al. Index No. 654535/2025) (the “Action”) in the Supreme Court of the State of New York for the County of New York on behalf of Nuvation Bio against our seven current directors and one former director (the “Individual Defendants”). The Action asserts claims against the Individual Defendants for allegedly breaching their fiduciary duties to us by awarding our directors excessive compensation between 2021 and 2024 and seeks restitution from the Individual Defendants, changes to our director compensation policies and practices, and attorneys’ fees and other costs of suit. We and the Individual Defendants have not yet responded to the filing of the Action. Due to the inherent uncertainties of litigation, the Company cannot reasonably predict at this time the timing or outcomes of these matters or estimate the amount of losses, or range of losses, if any, or their effect, if any, on its condensed consolidated financial statements.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis provide information which our management believes is relevant to an assessment and understanding of our consolidated results of operations and financial condition. You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and notes thereto included elsewhere in this report. In addition to historical financial information, this discussion contains forward-looking statements based upon our current expectations that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the section titled “Item 1A. Risk Factors.”

Overview

We are a global commercial-stage oncology company focused on tackling some of the toughest challenges in cancer treatment bywith the goal of developing therapies that create a profound, positive impact on patients’ lives. We were founded in 2018 by our chief executive officer, David Hung, M.D., who founded Medivation, Inc. and led its successful development of oncology drugs Xtandi® and talazoparib (now marketed as Talzenna®), leading to its $14.3 billion sale to Pfizer Inc. (“Pfizer”) in 2016. We leverage our team’s extensive expertise in medicinal chemistry, preclinical development, drug development, business development, manufacturing, and commercialization to pursue oncology targets validated by strong clinical or preclinical data and develop novel small molecules that improve the activity and overcome the liabilities of currently marketed drugs.

~~Our~~We ~~most~~commercially ~~advanced~~launched ~~product~~IBTROZI ~~candidate,~~in ~~taletrectinib,~~the isU.S. anin ~~oral,~~June ~~potent~~2025, ~~central~~following ~~nervous~~its ~~system-active,~~approval ~~selective,~~by ~~next-generation~~the ~~c-ros~~U.S. ~~oncogene~~Food 1and Drug Administration (“~~ROS1~~FDA”) ~~inhibitor~~on ~~specifically~~June ~~designed~~11, 2025 for the treatment of adult patients with locally advanced or metastatic ROS1-positive (“ROS1+”) non-small cell lung cancer ("“NSCLC"”). Taletrectinib ishas ~~being~~also ~~evaluated~~been approved in China for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC inwho ~~two~~either ~~Phase~~have 2or ~~single-arm~~have ~~pivotal~~not ~~studies:~~previously ~~TRUST-I~~been treated with ROS1 TKIs and is being commercialized in China, ~~and~~by ~~TRUST-II,~~our apartner ~~global~~Innovent ~~study~~Biologics (Suzhou) Co. Ltd. (“Innovent”) under the brand name DOVBLERON®. Taletrectinib has been granted Orphan Drug Designation by the U.S. ~~Food and Drug Administration (“~~FDA”) for the treatment of patients with ROS1+ NSCLC and other NSCLC indications, and was previously granted Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (~~"NMPA") for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC. Based on pooled results of the TRUST-I and TRUST-II studies, we submitted a New Drug Application (~~“~~NDA~~NMPA”) for ~~taletrectinib to~~ the ~~U.S. FDA in October 2024 for the~~ treatment of patients with advanced ROS1+ NSCLC (line agnostic, full approval). On December 22, 2024, the FDA accepted the NDA for Priority Review and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of June 23, 2025. In China, taletrectinib has been approved for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC ~~who either have or have not previously been treated with ROS1 TKIs, and is being commercialized in China by our partner Innovent Biologics (Suzhou) Co~~. ~~Ltd. (“Innovent”).~~ In March 2025, our commercialization partner in Japan, Nippon Kayaku Co., Ltd., completed submission of a Marketing Authorization Application (“MAA”) for taletrectinib for advanced ROS1+ NSCLC to Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”).

InOur ~~addition to taletrectinib, our~~ clinical-stage pipeline includes differentiated, novel oncology product candidates that have been generated from our proprietary drug discovery and development programs or acquired through business development activities:

•

~~Safusidenib~~Taletrectinib iscontinues ato ~~novel,~~be ~~oral,~~evaluated ~~potent,~~for ~~brain~~the ~~penetrant,~~treatment ~~targeted inhibitor~~ of ~~mutant~~patients ~~isocitrate~~with ~~dehydrogenase~~advanced 1ROS1+ ~~("mIDH1").~~NSCLC ~~Safusidenib is being evaluated~~ in atwo Phase 2 ~~study in patients with diffuse IDH1~~single-~~mutant~~arm ~~glioma. We expect to provide an update on the~~ pivotal ~~study~~studies: ~~design~~TRUST-I ~~for the safusidenib program~~ in ~~the~~China, ~~second~~and ~~half~~TRUST-II, ofa ~~2025~~global study.

•

Safusidenib is a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 ("mIDH1"). We recently published an updated trial design of the randomized phase 2 study of safusidenib in diffuse IDH1-mutant glioma, which will now evaluate maintenance treatment with safusidenib against placebo in high grade IDH1-mutant glioma. Discussion with the FDA regarding registration-enabling trials of safusidenib are ongoing and we plan to provide additional updates in the second half of 2025.

•

NUV-1511 is our first clinical-stage drug-drug conjugate ("DDC"), which fuses a targeting agent to a widely used chemotherapy agent. NUV-1511 is being evaluated in a Phase 1/2 study in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. FDA labeling, human epidermal growth factor receptor 2-negative ("HER2-") metastatic breast cancer, metastatic castration-resistant prostate cancer (“mCRPC”), advanced pancreatic cancer, and platinum-resistant ovarian cancer ("PROC"). We expect to provide an update from the Phase 1/2 dose escalation study of NUV-1511 in the second half of 2025.

•

NUV-868 is a BD2-selective, oral, small molecule bromodomain and extra-terminal ("BET") inhibitor that inhibits BRD4. As previously announced, we are evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.

Recent Developments

•

In ~~January~~April 2025, ~~China’s~~pooled ~~NMPA~~data ~~approved~~from ~~taletrectinib~~our ~~for~~pivotal ~~the~~Phase ~~treatment~~2 ofTRUST-I ~~adult~~and ~~patients~~TRUST-II ~~with~~studies ~~locally~~of ~~advanced~~taletrectinib orwas ~~metastatic~~published ~~ROS1+~~in ~~NSCLC~~the ~~who~~Journal ~~either~~of ~~have~~Clinical orOncology ~~have~~(Perol, ~~not~~et ~~been~~al., ~~previously treated with ROS1 TKIs~~2025).

•

In ~~March~~June 2025, wethe ~~announced that we secured up to $250~~U.~~0 million in non-dilutive financing from Sagard Healthcare Partners~~S. WeFood ~~will receive $150.0 million in royalty interest financing~~ and ~~$50.0~~Drug ~~million~~Administration inhas ~~debt~~approved ~~upon~~IBTROZI ~~U.S.~~for ~~FDA~~the ~~approval~~treatment of ~~taletrectinib~~adult bypatients ~~September 30, 2025,~~ with ~~access~~locally toadvanced anor ~~additional~~metastatic ~~$50.0~~ROS1+ ~~million in debt at the Company’s option after first commercial sale of taletrectinib~~NSCLC.

2125

•

In ~~March~~June 2025, ~~our~~taletrectinib ~~commercialization~~(IBTROZI) ~~partner~~was added as a Preferred Agent in ~~Japan,~~the ~~Nippon~~latest ~~Kayaku~~National ~~Co.,~~Comprehensive ~~Ltd~~Cancer Network Clinical Practice Guidelines ® ("NCCN Guidelines") in Oncology. Specifically, ~~completed~~the ~~submission~~NCCN ofGuidelines now include taletrectinib (IBTROZI) as a ~~MAA~~Preferred Agent for ~~taletrectinib~~both ~~for~~first-line ~~advanced~~and subsequent therapy for ROS1+ NSCLC, toincluding ~~Japan’s~~specific ~~PMDA~~recommendations for those with brain metastases and resistance mutations.

•

In ~~March~~June 2025, weunder ~~entered~~our ~~into~~non-dilutive afinancing ~~commercial~~agreements ~~supply agreement~~ with ~~Asymchem~~Sagard ~~Laboratories~~Healthcare ~~(Tianjin) Co.~~Partners, ~~Ltd.~~we ~~for~~received ~~the~~$150.0 ~~supply~~million ofin ~~taletrectinib~~royalty ~~drug~~interest ~~substance,~~financing and a$50.0 ~~commercial~~million ~~supply~~in ~~agreement~~debt ~~with~~and ~~Asymchem~~have ~~Life~~access ~~Science~~to ~~(Tianjin)~~an ~~Co.,~~additional ~~Ltd~~$50.0 ~~for~~million in debt at the ~~supply~~Company’s ofoption ~~taletrectinib~~until ~~drug~~June ~~product~~2026.

In April 2025, pooled data from our pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib was published in the Journal of Clinical Oncology (Perol, et al., 2024).

Financial Overview

Since our inception in 2018, we have focused substantially all of our resources on conducting research and development activities, including drug discovery, preclinical studies, clinical trials, establishing and maintaining our intellectual property portfolio, developing our manufacturing network and managing the manufacture of clinical and research material, hiring personnel, raising capital and providing general and administrative support for these operations. Our revenue related to its out-licensing collaborative agreements consists of product revenue, upfront license fees, royalty revenue and research and development services revenue from its collaboration agreements. We have funded our operations to date primarily from the issuance and sale of our common and preferred stock, including through the Merger and a Private Investment in Public Equity ("PIPE") financing in connection with the Merger.

We have incurred net losses in each year since inception. As of ~~March~~June 3130, 2025, we had an accumulated deficit of $~~964~~1,023.0 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations as well as a charge related to the acquisition of an in-process research and development asset. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:

•

advance product candidates through clinical trials;

•

pursue regulatory approval of product candidates;

•

operate as a public company;

•

continue our preclinical programs and clinical development efforts;

•

continue research activities for the discovery of new product candidates; and

•

manufacture supplies for our preclinical studies and clinical trials.

In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory, tax-related, director and officer insurance, investor relations and other expenses that we did not incur as a private company. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the public or private sale of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. If we raise funds through strategic collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our platform technology, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our Common Stock. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability.

On March 3, 2025, we announced the closing of a non-dilutive financing of up to $250.0 million from Sagard. The financing is comprised of a $150.0 million synthetic royalty financing and a $100.0 million senior secured term loan. The $150 million from the synthetic royalty financing and the first $50.0 million tranche of the term loan ~~will~~was be funded ~~conditioned~~on June 25, 2025 upon FDA’s approval of ~~taletrectinib on or prior to September 30, 2025~~IBTROZI. The transaction will support the U.S. launch of ~~taletrectinib~~IBTROZI and general corporate purposes.

Components of Results of Operations

Revenues

We ~~enter~~Prior ~~into~~to ~~collaborative~~our ~~arrangements~~commercialization ~~for~~of ~~the~~IBTROZI, ~~research~~substantially ~~and~~all ~~development~~of our revenues were generated from payments under prior collaboration agreements, and ~~commercialization~~milestones, ofroyalties ~~drug~~and ~~products~~other ~~and~~revenues ~~drug~~from ~~candidates~~our licensing arrangements. To date, these collaborative arrangements have included out-licensing of and options to out-license in-licensed compounds to other parties. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost reimbursement arrangements and royalty payments. Our revenue related to its out-licensing collaborative agreements consists of product revenue, upfront license fees, royalty revenue and research and development services revenue from its collaboration agreements.

include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost reimbursement arrangements and royalty payments. Our revenue related to its out-licensing collaborative agreements consists of product revenue, upfront license fees, royalty revenue and research and development services revenue from its collaboration agreements.

We receive payments from our customers based on billing terms established in the contract. Up-front payments and fees are recorded as contract liabilities (e.g., deferred revenue) upon receipt or when due until we perform our obligations under the arrangement. In the event of an early termination of a collaboration agreement, any contract liabilities would be recognized in the period in which all our obligations under the agreement have been fulfilled.

Research and Development Expenses

Research and development expenses include:

•

expenses incurred under agreements with third-party contract organizations, and consultants;

•

costs related to production of drug substance, including fees paid to contract manufacturers;

•

laboratory and vendor expenses related to the execution of preclinical trials; and

•

employee-related expenses, which include salaries, benefits and stock-based compensation.

We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks and estimates of services performed using information and data provided to us by our vendors and third-party service providers. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and as services are performed. We expense in-process research and development projects acquired as part of asset acquisitions that have no alternative future use.

We expect our research and development expenses to increase for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, as our product candidates advance into later stages of development, and as we begin to conduct clinical trials. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist of personnel-related costs, facilities costs, depreciation and amortization expenses and professional services expenses, including legal, human resources, audit and accounting services. Personnel-related costs consist of salaries, benefits and stock-based compensation. Facilities costs consist of rent and maintenance of facilities. We anticipate increased expenses related to compliance with the rules and regulations of the SEC, NYSE, insurance premiums, investor relations activities and other administrative and professional services.

Other Income (Expense), Net

Other income (expense) consists of change in fair value of warrant liabilities, interest earned on our cash equivalents and investments, interest expense, advisory expense related to our investments and realized gains and losses on marketable securities.

2327

Results of Operations for The Three and Six Months Ended ~~March~~June 3130, 2025 and 2024

Revenues

Our revenues consist of product revenue, net and revenues related to ~~its~~our out-licensing collaborative and license agreements ~~consist~~consists of ~~product revenue,~~ upfront license fees, royalty revenue, products supply and research and development services revenue ~~from its collaboration agreements~~.

The following table summarizes total revenue recognized for the three and six months ended ~~March~~June 3130, 2025 and 2024 (in thousands):

	Three Months Ended
	Three Months Ended June 30,				Six Months Ended June 30,
	March 31, 2025
	2025		2024		2025		2024
Revenue
Revenues:
Product revenue		779
Product revenue, net	$	1,238	$	—	$	1,238	$	—
Royalty revenue		249
Collaboration and license agreements revenue		3,595		1,435		6,679		1,435
Research and development service revenue		2,056
Total revenues	$	4,833	$	1,435	$	7,917	$	1,435
Total	$	3,084

~~There~~Product ~~was no revenue for the three months ended March 31~~Revenue, ~~2024 since the acquisition of AnHeart completed in the second quarter of 2024.~~Net

On June 11, 2025, we announced that the FDA approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (“NSCLC”). To date, our only source of product revenue has been from the U.S. sales of IBTROZI. We began shipping IBTROZI to our U.S. customers in June 2025. Product revenue, net from U.S. sales of IBTROZI was approximately $1.2 million for the three months ended June 30, 2025.

Collaboration and License Agreements Revenue

Collaboration and license agreement increased by $2.2 million for the three months ended June 30, 2025 compared to 2024. The increase was primarily due to a $0.9 million increase in products supply, $0.2 million increase in royalty revenue and a $1.1 million increase in research and development service revenue under the collaboration agreement with Innovent.

Collaboration and license agreement increased by $5.2 million for the six months ended June 30, 2025 compared to 2024. The increase was primarily due to a $1.7 million increase in products supply, $0.5 million increase in royalty revenue and a $3.0 million increase in research and development service revenue under the collaboration agreement with Innovent.

Operating Expenses

	Three Months Ended March 31,				Increase /
	Three Months Ended June 30,							Six Months Ended June 30,
	2025		2024		~~(Decrease)~~Change			2025		2024		Change
(In thousands)	~~(In thousands)~~
Operating expenses:
Research and development	$	2427,~~601~~362	$	1229,~~842~~247	$	11(1,~~759~~885	)	$	51,963	$	42,089	$	9,874
Selling, general and administrative		35,393		7,357		28,036
Acquired in-process research and development		—		425,070		(425,070	)		—		425,070		(425,070	)
Total operating expenses		59,994		20,199		39,795
Selling, general and administrative		38,484		16,156		22,328			73,877		23,513		50,364
Total operating expenses	$	65,846	$	470,473	$	(404,627	)	$	125,840	$	490,672	$	(364,832	)

Research and Development Expenses

Research and development expenses ~~increased~~decreased by $111.89 million for the three months ended ~~March~~June 3130, 2025 compared to 2024. The ~~increase~~decrease was ~~primarily~~ due to a $64.23 million ~~increase~~decrease in ~~personnel~~third-~~related~~party costs ~~driven~~as bythe prior period included costs for the ~~acquisition~~preparation of ~~AnHeart~~a asNew ~~well~~Drug asApplication ~~stock-based~~(NDA) ~~compensation~~for ~~and~~taletrectinib ~~other~~for ~~benefits~~submission to the U.S. FDA and a $01.8 million decrease due to a shift of manufacturing activities toward commercial drug production, offset by a $3.2 million increase in ~~amortization~~salaries ofand ~~assembled~~other ~~workforce~~benefits driven by the increase in headcount and $51.40 million increase in ~~third-party~~stock ~~costs~~compensation primarily related to ~~clinical~~one-time ~~trial~~charge ~~expense~~ for the vesting of performance-based awards upon receiving U.S. FDA approval of taletrectinib.

Research and development expenses increased by $9.9 million for the six months ended June 30, 2025 compared to 2024. The increase was primarily due to a $10.0 million increase in salaries and other benefits driven by the increase in headcount and $2.1 million increase in stock compensation primarily related to one-time charge for the vesting of performance-based awards upon receiving U.S. FDA approval of taletrectinib, $0.1 million increase in amortization of assembled workforce, $1.1 million increase in third-party costs

related to clinical trial expense for taletrectinib offset by $3.4 million decrease due to a shift of manufacturing activities toward commercial drug production.

Acquired In-process Research and Development Expenses

On April 9, 2024, as a result of the acquisition of AnHeart, we recorded a $425.1 million charge representing an acquired in-process research and development asset with no alternative future use in acquired in-process research and development expenses.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by $2822.03 million for the three months ended ~~March~~June 3130, 2025, compared to 2024. The increase was due to a $10.79 million increase in sales and marketing expenses, a $10.3 million increase in personnel-related costs as a result of the ~~acquisition~~increase ofin ~~AnHeart~~headcount, a $121.25 million increase in ~~sales~~stock ~~and~~compensation ~~marketing~~primarily ~~expenses,~~related ~~$1.4~~to ~~million~~one-time ~~increase~~charge infor ~~professional~~the ~~fees~~vesting of performance-based awards upon receiving U.S. FDA approval of taletrectinib, a $0.59 million increase in ~~occupancy~~other expenses, ~~$1.1~~as ~~million~~a ~~increase~~result inof ~~legal~~systems ~~fees~~built to prepare for the commercial launch of taletrectinib, and a $0.24 million increase in ~~foreign~~occupancy ~~currency~~expenses ~~impact~~offset ~~and~~by $2.0.6 million ~~increase~~decrease in ~~other~~professional ~~expenses~~fees, as a ~~result~~$0.5 ofmillion ~~the~~decrease ~~integration~~in oflegal ~~AnHeart~~fees ~~offset~~and bya $0.16 million decrease in ~~taxes~~foreign currency impact.

Selling, general and administrative expenses increased by $50.4 million for the six months ended June 30, 2025, compared to 2024. The increase was due to a $19.3 million increase in personnel-related costs as a result of the increase in headcount, a $3.2 million increase in stock compensation primarily related to one-time charge for the vesting of performance-based awards upon receiving U.S. FDA approval of taletrectinib, $23.1 million increase in sales and marketing expenses, $2.8 million increase in other expenses as a result of systems built to prepare for the commercial launch of taletrectinib, $0.8 million increase in professional fees, a $0.9 million increase in occupancy expenses and a $0.6 million increase in legal fees offset by $0.3 million decrease in foreign currency impact.

Other Income (Expense), Net

The following table presents a breakdown of our other income (expense):

	Three Months Ended March 31,
	Three Months Ended June 30,									Six Months Ended June 30,
	2025			2024			Change			2025			2024			Change
(In thousands)
Other income (expense):
Interest income	$	54,~~321~~780		$	7,~~130~~144		$	(12,~~809~~364	)	$	10,101		$	14,274		$	(4,173	)
Interest expense		(54421	)		—(132	)		(54289	)		(475	)		(132	)		(343	)
Investment advisory fees		(~~203~~182	)		(~~265~~247	)		6265			(385	)		(512	)		127
Change in fair value of warrant liability		~~(751~~454	)		(1,~~459~~135	)		~~708~~(681	)		(297	)		(324	)		27
Realized gain on marketable securities		3			1			2
Realized (loss) gain on marketable securities		(1	)		(7	)		6			2			(6	)		8
Other income		1,452			—			1,452
Net loss on disposal of fixed assets		(34	)		—			(34	)		(34	)		—			(34	)
Total other income (expense), net	$	5,768		$	5,407		$	361
Other (expense) income		(14	)		—			(14	)		1,438			—			1,438
Total other income (expense), net	$	4,582		$	7,893		$	(3,311	)	$	10,350		$	13,300		$	(2,950	)

24Other income (expense), net decreased by $3.3 million for the three months ended June 30, 2025 compared to 2024 primarily related to a decrease in interest income from investments of $2.4 million primarily due to lower treasury yield, a $0.7 million decrease in the change in fair value of warrant liability, a $0.3 million increase in interest expense offset by a $0.1 million decrease in investment advisory fees.

Other income (expense), net ~~increased~~decreased by $03.40 million for the ~~three~~six months ended ~~March~~June 3130, 2025 compared to 2024 primarily related to a ~~$1.5~~decrease ~~million increase~~ in ~~other~~interest income ~~due~~from toinvestments ~~government~~of ~~subsidy income, a~~ $04.72 million ~~increase~~primarily indue ~~the~~to ~~change~~lower intreasury ~~fair~~yield ~~value~~and ~~of warrant liability,~~ a $0.13 million ~~decrease~~increase in ~~investment~~interest ~~advisory~~expense ~~fees~~ offset by ~~decrease~~a ~~in interest income from investments of~~ $1.85 million ~~primarily~~increase in other income due to ~~lower~~government ~~treasury~~subsidy ~~yield~~income and a $0.1 million ~~increase~~decrease in ~~interest~~investment ~~expense~~advisory fees.

Liquidity, Capital Resources and Plan of Operations

From inception through ~~March~~June 3130, 2025, our operations have been financed primarily by the sale and issuance of Series A preferred stock and Common Stock, including through the Merger and the PIPE Investment. As of ~~March~~June 3130, 2025, we had $~~461~~607.7 million in cash, cash equivalents and marketable securities and an accumulated deficit of $~~964~~1,023.0 million.

Our primary use of cash is to fund operating expenses, which consist of research and development expenses related to our clinical-stage product candidates and preclinical programs, and to a lesser extent, general and administrative expenses. Cash used to ~~fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.~~

On March 3, 2025, we announced the closing of a non-dilutive financing of up to $250.0 million from Sagard. The financing is comprised of a $150.0 million (the "Investment Amount") synthetic royalty financing agreement with Sagard Healthcare Partners (Delaware) II LP (the “RIF Agreement”) and a $100.0 million senior secured term loan with Sagard Holdings Manager LP (the “Loan Agreement”). The Investment Amount and a $50.0 million tranche of the term loan will be funded conditioned upon FDA’s approval of taletrectinib on or prior to September 30, 2025. The second tranche of $50 million of the term loan will be available at our option until June 30, 2026, as long as we have achieved first U.S. commercial sale of taletrectinib.29

~~Under~~fund ~~the~~operating ~~RIF~~expenses ~~Agreement,~~is inimpacted exchange for the Investment Amount, we have agreed to make tiered royalty payments to Sagard on U.S. net sales of taletrectinib equal to 5.5% of annual U.S. net sales up to $600 million and 3.0% of annual U.S. net sales between $600 million and $1 billion. We will retain all annual U.S. net sales above $1 billion. Our obligation to make the royalty payments will cease upon the earliest occurrence of total royalty payments reaching 1.6 times of the Investment Amount by the ~~calendar~~timing ~~quarter ending on June 30, 2031, 1.75 times~~ of ~~the~~when ~~Investment Amount by the calendar quarter ending on June 30, 2034, or 2.0 times of the Investment Amount thereafter. To the extent~~ we ~~have~~pay ~~not~~these ~~made royalty payments totaling at least 100% of the Investment Amount by February 1~~expenses, ~~2043,~~as wereflected ~~will be required to make a true up payment~~ in ~~an amount equal to such shortfall (~~the ~~“True Up Payment”). In addition, if certain events occur, including certain bankruptcy events, non-payment of Payments, a~~ change ~~of control, expiration or termination of certain intellectual property rights or marketing authorization, an out-license or sale of all of the rights~~ in ~~and~~our to taletrectinib in the United States and (subject to applicable cure periods) non-compliance with the covenants in the RIF Agreement, we may be required to repurchase the synthetical royalty financing at a repurchase price ranging from 1.4 to 2.0 times of the Investment Amount, depending on the time of such event, less all royalty payments we made by then under the Loan Agreement, the term loan will bear interest at the secured overnight financing rate ("SOFR") plus a margin of 6.00%, subject to a 4.00% SOFR floor. There are no scheduled amortization payments associated with the term loan, with all outstanding ~~principal~~accounts ~~due~~payable ~~at maturity. The transaction will support the U.S. commercial launch of taletrectinib~~ and ~~general~~accrued ~~corporate purposes~~expenses.

~~Based~~On ~~upon~~March ~~our~~3, ~~current operating plan~~2025, we ~~believe~~announced ~~that~~the ~~our~~closing ~~existing~~of ~~cash,~~a ~~cash~~non-dilutive ~~equivalents~~financing of up to $250.0 million from Sagard. The financing is comprised of a $150.0 million (the "Investment Amount") synthetic royalty financing agreement with Sagard Healthcare Partners (Delaware) II LP (the “RIF Agreement”) and ~~marketable~~a ~~securities~~$100.0 asmillion senior secured term loan with Sagard Holdings Manager LP (the “Loan Agreement”). The Investment Amount and a $50.0 million tranche of ~~March~~the 31term loan was funded on June 25, 2025, ~~will~~following ~~enable~~FDA’s usapproval toof ~~fund~~IBTROZI. ~~our~~The ~~operating~~second ~~expenses~~tranche ~~and~~of ~~capital~~$50 ~~expenditure~~million ~~requirements~~of ~~through~~the term loan will be available at ~~least~~our ~~the~~option ~~next~~until 12June ~~months~~30, 2026, because we have achieved first U.S. commercial sale of IBTROZI.

WeUnder ~~expect~~the toRIF ~~incur~~Agreement, ~~substantial~~in ~~expenses~~exchange infor the ~~foreseeable~~Investment ~~future~~Amount, ~~for~~we ~~the~~have ~~development~~agreed ~~and~~to ~~potential~~make ~~commercialization~~tiered royalty payments to Sagard on U.S. net sales of ~~our~~IBTROZI ~~product~~equal ~~candidates~~to 5.5% of annual U.S. net sales up to $600 million and ~~ongoing~~3.0% ~~internal~~of ~~research~~annual U.S. net sales between $600 million and ~~development~~$1 ~~programs~~billion. We Atwill ~~this~~retain ~~time,~~all weannual ~~cannot~~U.S. ~~reasonably~~net ~~estimate~~sales above $1 billion. Our obligation to make the ~~nature,~~royalty ~~timing~~payments orwill ~~aggregate~~cease ~~amount~~upon the earliest occurrence of ~~costs~~total ~~for~~royalty ~~our~~payments ~~development~~reaching 1.6 times of the Investment Amount by the calendar quarter ending on June 30, ~~potential~~2031, ~~commercialization~~1.75 times of the Investment Amount by the calendar quarter ending on June 30, ~~and~~2034, ~~internal~~or ~~research~~2.0 ~~and~~times ~~development~~of ~~programs~~the Investment Amount thereafter. ~~However~~To the extent we have not made royalty payments totaling at least 100% of the Investment Amount by February 1, 2043, we will be required to make a true up payment in ~~order~~an amount equal to ~~complete~~such ~~our~~shortfall ~~current~~(the ~~and~~“True ~~future~~Up ~~preclinical~~Payment”). ~~studies~~In ~~and~~addition, ~~clinical~~if ~~trials~~certain events occur, including certain bankruptcy events, non-payment of Payments, a change of control, expiration or termination of certain intellectual property rights or marketing authorization, an out-license or sale of all of the rights in and to ~~complete~~IBTROZI in the ~~process~~United ofStates ~~obtaining~~and ~~regulatory~~(subject ~~approval~~to ~~for~~applicable ~~our~~cure ~~product~~periods) ~~candidates~~non-compliance with the covenants in the RIF Agreement, aswe ~~well~~may asbe required to ~~build~~repurchase the ~~sales~~synthetical royalty financing at a repurchase price ranging from 1.4 to 2.0 times of the Investment Amount, ~~marketing~~depending ~~and~~on ~~distribution~~the ~~infrastructure~~time ~~that~~of such event, less all royalty payments we ~~believe~~made by then under the Loan Agreement, the term loan will bebear ~~necessary~~interest toat ~~commercialize~~the ~~our~~secured ~~product~~overnight ~~candidates~~financing rate ("SOFR") plus a margin of 6.00%, ifsubject ~~approved~~to a 4.00% SOFR floor. There are no scheduled amortization payments associated with the term loan, wewith ~~may~~all ~~require~~outstanding ~~substantial~~principal ~~additional~~due ~~funding~~at inmaturity. The transaction will support the ~~future~~U.S. commercial launch of IBTROZI and general corporate purposes.

Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities as of June 30, 2025, will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months.

We expect to incur substantial expenses in the foreseeable future for the development and commercialization of our product candidates and ongoing internal research and development programs. At this time, we cannot reasonably estimate the nature, timing or aggregate amount of costs for our development, commercialization, and internal research and development programs. However, in order to complete our current and future preclinical studies and clinical trials, and to complete the process of obtaining regulatory approval for our product candidates, as well as to commercialize our product candidates, we may require substantial additional funding in the future.

Cash Flows

The following table summarizes our cash flows for the periods indicated:

	Three Months Ended March 31,
	Six Months Ended June 30,
	2025			2024
	(In thousands)
Cash used in operating activities	$	(4290,~~627~~805	)	$	(1553,~~702~~026	)
Cash provided by investing activities		54109,~~182~~058			741,~~542~~815
Cash provided by financing activities		~~548~~193,971			212,769
Effect of foreign exchange rate changes on cash and cash equivalents		~~151~~23			—78
Net decrease in cash and cash equivalents		12,254			(8,139	)
Net increase (decrease) in cash and cash equivalents	$	212,247		$	(8,364	)

Operating Activities

In 2025, cash used in operating activities of $4290.68 million was attributable to a net loss of $53112.2 million offset by a net change of $2.79 million in our net operating assets and liabilities and non-cash charges of $718.95 million. The change in operating assets and liabilities was primarily due to a $1210.30 million decrease in accounts receivable, $416.21 million increase in accounts payable, ~~and~~$8.0 million increase in intangible assets, $0.1 million decrease in other non-current assets, ~~offset by~~ $8.98 million decrease in accrued expenses, $24.35 million decrease in contract liabilities, $1.20 million increase in prepaid expenses and other current assets, $0.6 million increase in inventory and $10.54 million increase in interest receivable on marketable securities. The non-cash charges consisted primarily of stock-based compensation of $719.9 million, changes in fair value of warrant liability of $0.83 million, $0.37 million of depreciation and amortization, $0.23 million of lease expense, ~~and~~ $0.23 million ofin ~~foreign~~interest ~~currency~~expense ~~transaction gain~~ offset by amortization of premium on marketable securities of $12.58 million and $0.2 million of foreign currency transaction gain.

In 2024, cash used in operating activities of $15.7 million was attributable to a net loss of $14.8 million, a net change of $4.6 million in our net operating assets and liabilities offset by non-cash charges of $3.7 million. The change in operating assets and liabilities was primarily due to a $5.3 million increase in prepaid expenses and other current assets, $0.6 million increase in interest receivable on marketable securities, $0.5 million increase in other non-current assets offset by $1.5 increase in accrued expenses and $0.3 million increase in accounts payable. The non-cash charges consisted primarily of stock-based compensation of $5.0 million and changes in fair value of warrant liability of $1.5 million offset by amortization of premium on marketable securities of $2.8 million. 30

In 2024, cash used in operating activities of $53.0 million was attributable to a net loss of $477.3 million, a net change of $10.7 million in our net operating assets and liabilities offset by non-cash charges of $435.0 million. The change in operating assets and liabilities was primarily due to a $4.0 decrease in accrued expenses, $2.8 million decrease in accounts payable, $1.7 million increase in prepaid expenses and other current assets, $1.4 million decrease in contract liabilities, $0.2 million increase in interest receivable on marketable securities, $0.5 million increase in other non-current assets and $0.1 million increase in accounts receivable. The non-cash charges consisted primarily of $425.1 million of acquired in-process research and development, stock-based compensation of $14.6 million and changes in fair value of warrant liability of $0.3 million, $0.3 million of depreciation and amortization offset by amortization of premium on marketable securities of $5.2 million and $0.1 million of non cash lease expense.

Investing Activities

In 2025, cash provided by investing activities of $54109.21 million was related to the $~~115~~251.07 million of proceeds from the sale of marketable securities offset by purchase of marketable securities of $60142.74 million and $0.12 million purchase of property and equipment.

In 2024, cash provided by investing activities of $741.58 million was related to the $251.3 million of proceeds from the sale of marketable securities, $19.8 cash acquired from the acquisition of AnHeart, offset by purchase of marketable securities of $~~128~~221.59 million ~~offset~~and by $~~136~~7.04 million of ~~proceeds~~transaction ~~from~~costs related to the ~~sale~~acquisition of ~~marketable securities~~AnHeart.

Financing Activities

In 2025, cash provided by financing activities of $0194.60 million was related to the $1150.0 million proceeds from the RIF Agreement, $48.9 million proceeds from the Loan Agreement, $1.9 million proceeds from exercise of options and $0.5 million of proceeds from issuance of Common Stock under the Employee Stock Purchase Plan offset by $6.6 million payment of debt issuance costs and $0.57 million of debt repayments.

In 2024, cash provided by financing activities of $212.8 ~~thousand~~million was related to the $2.0 million proceeds from exercise of options and $0.1 million of proceeds from issuance of Common Stock under the Employee Stock Purchase Plan, $7.0 million of proceeds from borrowings offset by $6.3 million of debt repayments.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an on-going basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable in the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions.

While our significant accounting policies are described in the notes to our consolidated financial statements, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results.

Revenue Recognition

We apply ASC Topic 606, "Revenue from Contracts with Customers" ("ASC 606") to account for our revenue transactions. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the five-step model. We only apply the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606 at contract inception, we review the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct. We recognize as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied. Accounts receivable represent amounts invoiced and revenues recognized prior to invoicing when we have satisfied our performance obligation and have the unconditional right to payment.

Product revenue, net

information regarding changes in applicable regulations and guidelines that would impact the amount of the actual rebates, our expectations regarding future utilization rates and channel inventory data. We review the adequacy of our provisions for sales deductions on a quarterly basis. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that adjustment is appropriate and to reflect actual experience. The most significant items deducted from gross product sales where we exercise judgment are rebates, sales returns and chargebacks.

Collaborative Arrangement

In November 2018, the FASB issued Topic 808, "Collaborative Arrangements" ("ASC 808"): Clarifying the Interaction between ASC 808 and ASC 606. This update clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer and precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. We adopted this standard for all periods presented. We enter into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates. We assessed and determined that none of the collaboration agreements entered into during the periods presented were within the scope of ASC 808, as all of the agreements did not involve active participation by both parties in a joint research activity, and therefore did not qualify as collaborative arrangements under ASC 808. We have determined that all the elements of the above collaborations are reflective of a vendor-customer relationship and therefore within the scope of ASC 606. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, we perform the five-step model under ASC 606 noted above. We recognize revenue to depict the transfer of control of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to receive in exchange for those goods or services. Our collaborative arrangements may contain more than one unit of account, or performance obligation, including grants of licenses to intellectual property rights, agreements to provide research and development services and other deliverables. The collaborative arrangements do not include a right of return for any deliverable. As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. In developing the stand-alone selling price for a performance obligation, we consider competitor pricing for a similar or identical product, market awareness of and perception of the product, expected product life and current market trends. In general, the consideration allocated to each performance obligation is recognized when the respective obligation is satisfied either by delivering a good or providing a service, limited to the consideration that is not constrained. Non-refundable payments received before all of the relevant criteria for revenue recognition are satisfied are recorded as contract liabilities.

Licenses of intellectual property

If a license to our intellectual property is determined to be distinct from the other promises or performance obligations identified in the contract, we recognize revenue from the portion of the transaction price allocated to the license at a point in time, when the license is transferred to the customer and the customer is able to benefit from the license.

Research and development services

Customer options

A customer's right to choose, at its discretion, to make a payment for additional goods or services is generally considered an option. If we are not presently obligated to provide and does not have a right to consideration for delivering additional goods or services, the item is considered an option. We evaluate the customer options for material rights, such as the ability to acquire additional goods or services for free or a discount. Optional future services that reflect their standalone selling prices do not provide the customer with a material right and, therefore, are not considered performance obligations and are accounted for as separate contracts. The optional future services do not include a material right to be accounted for as performance obligations.

Milestone payments

Our collaboration agreements include development and regulatory milestones. We evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. We evaluate factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our control or the licensee's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, we re-evaluate the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.

Royalties

For sales-based royalties, including milestone payments based on the level of sales, we determine whether the sole or predominant item to which the royalties relate is a license. When the license is the sole or predominant item to which the sales-based royalty relates, we recognize revenue at the later of: (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). For the three and six months ended ~~March~~June 3130, 2025, the Company has recognized $0.2 million and $0.5 million, respectively, sales-based royalty revenue resulting from the Company's collaboration agreements.

In the event of an early termination of a collaboration agreement, any contract liabilities would be recognized in the period in which all our obligations under the agreement have been fulfilled. For a complete discussion of accounting for revenue, see the section titled "Collaboration and License Agreements" in Note 5 to our consolidated financial statements appearing elsewhere in this report.

Interest-bearing loans and borrowings

Acquisition of assets and businesses

Our consolidated financial statements include the operations of acquired businesses after the completion of the acquisitions. We account for acquired businesses using the acquisition method of accounting, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date and that the fair value of acquired in-process research and development be recorded on the balance sheet. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill. When we acquire net assets that do not constitute a business, as defined in accounting principles generally accepted in the United States of America (“GAAP”), no goodwill is recognized and acquired in-process research and development is expensed in acquired in-process research and development expenses. Contingent consideration in a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Fair value is generally estimated by using a probability-weighted discounted cash flow approach. Any liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved.

Research and Development Expenses

Warrant Liability

We account for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the company’s own ordinary shares, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as a liability at their fair value on the date of issuance and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The fair value of Consideration, Public, and Forward Purchase Warrants was determined using the closing price of the publicly traded warrants on the NYSE market. The fair value of the Private Placement Warrants was estimated using a Black-Scholes option pricing model (see Note 3).

Stock-Based Compensation Expense

We estimate the fair value of our stock-based awards to employees and non-employees that are based on a service condition only using the Black-Scholes option-pricing model, which is impacted by our Common Stock price as well as other variables including, but not limited to, expected term that options will remain outstanding, expected Common Stock price volatility over the term of the option awards, risk-free interest rates and expected dividends.

We determine the fair value of stock-based awards that are based on both a service condition and achievement of the first to occur of a market or performance condition using a Monte Carlo simulation.

The fair value of a stock-based award is recognized over the period during which a recipient is required to provide services in exchange for the award, known as the requisite service period (usually the vesting period) on a straight-line basis. Stock-based compensation expense is recognized based on the fair value determined on the date of grant and is reduced for forfeitures as they occur.

Estimating the fair value of stock-based awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of variables. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require significant analysis and judgment to develop.

Expected Term—We have opted to use the “simplified method” for estimating the expected term of options whose vesting is based on service condition only, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option (generally 10 years).

Expected Volatility—Due to our limited operating history and a lack of company specific historical and implied volatility data, we have based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded.

Risk-Free Interest Rate—The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of our stock options at the time of the grant.

Expected Dividend—We have not issued any dividends in our history and do not expect to issue dividends over the life of the options and therefore have estimated the dividend yield to be zero.

We will continue to use judgment in evaluating the expected volatility, and interest rates utilized for our stock-based compensation expense calculations on a prospective basis.

Recent Accounting Pronouncements

For information about recent accounting pronouncements, see the sections titled “Significant Accounting Policies—Recent Accounting Pronouncements” in Note 2 to our consolidated financial statements for the three months ended ~~March~~June 3130, 2025 appearing elsewhere in this report.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Interest Rate Risk

We had cash and investments of $~~461~~607.7 million as of ~~March~~June 3130, 2025, consisting of cash, money market funds, government securities, and corporate bonds. To date, fluctuations in interest income have not been significant.

We do not enter into investments for trading or speculative purposes and have not used any derivative financial instruments to manage our interest rate risk exposure. We have not been exposed to, nor do we anticipate being exposed to, material risks due to changes in interest rates.

Foreign Currency Risk

Our expenses are generally denominated in U.S. dollars. A 10% increase or decrease in current exchange rates would not have a material effect on our financial results.

Item 4. Controls and Procedures.

Disclosure Controls and Procedures

Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) as of ~~March~~June 3130, 2025. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures were effective as of ~~March~~June 3130, 2025.

Changes in Internal Control Over Financial Reporting

There have not been any changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

3034

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

~~None~~On July 30, 2025, Tim Patterson filed a derivative complaint (Tim Patterson, derivatively on behalf of Nuvation Bio, Inc. v. David Hung, et al. Index No. 654535/2025) (the “Action”) in the Supreme Court of the State of New York for the County of New York on behalf of Nuvation Bio against our seven current directors and one former director (the “Individual Defendants”). The Action asserts claims against the Individual Defendants for allegedly breaching their fiduciary duties to us by awarding our directors excessive compensation between 2021 and 2024 and seeks restitution from the Individual Defendants, changes to our director compensation policies and practices, and attorneys’ fees and other costs of suit. We and the Individual Defendants have not yet responded to the filing of the Action.

Item 1A. Risk Factors.

Summary of Risk Factors

Below is a summary of material factors that make an investment in our securities speculative or risky. Importantly, this summary does not address all of the risks and uncertainties that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found in the section below. The below summary is qualified in its entirety by that more complete discussion of such risks and uncertainties. You should consider carefully the risks and uncertainties described below as part of your evaluation of an investment in our securities:

•

Our ~~clinical~~near-~~stage~~term ~~product~~prospects ~~candidates~~are assignificantly ~~well~~dependent ason ~~our~~the ~~other~~commercialization ~~pipeline~~of ~~assets will require significant further investment and regulatory approvals prior to commercialization~~IBTROZI. ~~The~~If ~~FDA recently accepted for priority review the NDA for taletrectinib and~~ we ~~will~~are ~~need~~unable to ~~obtain~~successfully ~~regulatory~~commercialize ~~approval~~IBTROZI, ~~manufacture~~our ~~sufficient~~ability ~~commercial~~to ~~supply, build a U.S. commercial organization, and make other substantial investments before we~~ generate ~~any~~meaningful ~~revenues~~revenue ~~from~~or ~~product~~achieve ~~sales.~~profitability ~~Even~~will ~~so,~~be wematerially ~~may~~and ~~never~~adversely ~~achieve or maintain profitability~~affected.

•

WeThe ~~will~~successful ~~need~~commercialization ~~substantial~~of ~~funding~~IBTROZI toand ~~pursue~~ our ~~business~~other ~~objectives.~~product Ifcandidates wewill ~~are~~depend ~~unable~~in topart ~~raise capital when needed or~~ on ~~favorable~~the ~~terms,~~extent orto ~~receive~~which ~~significant~~governmental ~~revenues~~authorities ~~from~~and ~~the~~health ~~sales~~insurers ofestablish ~~our~~adequate ~~product~~coverage, wereimbursement ~~could~~levels beand ~~forced~~pricing topolicies. ~~delay,~~Failure ~~reduce~~to obtain or ~~terminate~~maintain ~~our~~adequate ~~product~~coverage ~~development,~~and ~~other~~reimbursement ~~operations~~for IBTROZI or ~~commercialization~~our ~~efforts.~~other ~~Additionally~~product candidates, ~~raising~~if ~~additional~~approved, ~~capital~~could ~~may~~limit ~~cause~~our ~~dilution~~ability to ~~our~~market ~~stockholders,~~those ~~restrict~~products ~~our~~and ~~operations~~decrease orour ~~require~~ability us to ~~relinquish~~generate ~~proprietary rights~~revenue.

•

IfIBTROZI wemay dofail ~~not~~to ~~obtain~~achieve ~~regulatory~~the ~~approval~~degree ~~for~~of ~~and~~market ~~successfully~~acceptance ~~commercialize~~by ~~our~~physicians, ~~product~~patients, ~~candidates~~third-party inpayors ~~one~~and orothers ~~more~~in ~~indications~~the ormedical wecommunity ~~experience~~necessary ~~significant~~for ~~delays~~commercial insuccess. ~~doing~~The ~~so,~~market weopportunity ~~may~~for ~~never~~IBTROZI ~~generate~~could ~~any~~also ~~revenue~~be orsmaller ~~become~~than ~~profitable~~we believe.

•

~~Our~~If ~~level~~competitors ofdevelop ~~indebtedness~~products, ~~and~~product ~~debt~~candidates ~~service~~or ~~obligations~~technologies ~~could~~that ~~adversely~~are ~~affect~~superior ~~our~~to ~~financial~~or ~~condition~~more ~~and~~cost-effective ~~make~~than IBTROZI, it ~~more~~would ~~difficult~~significantly ~~for~~impact usthe todevelopment ~~fund~~and ~~our~~commercial ~~operations~~viability of IBTROZI, which would severely and ~~impose~~adversely ~~numerous~~affect ~~other~~our ~~obligations~~financial results, business and ~~restrictions~~business ~~that~~prospects, ~~will~~and ~~limit~~the ~~our~~future ~~operational~~of ~~flexibility~~IBTROZI, and might cause us to cease operations.

•

~~Our~~We ~~approach~~rely toon ~~the~~a ~~discovery~~select ~~and~~network ~~development~~ of ~~product~~third-party ~~candidates~~distributors, ~~based~~specialty onpharmacies ~~our~~and ~~Drug-Drug~~other ~~Conjugate~~vendors ~~platform~~to isdistribute ~~unproven~~IBTROZI ~~and~~in isthe ~~based on novel technology~~U.S., and weany dofailure ~~not~~by ~~know~~such ~~whether~~distributors, wespecialty ~~will~~pharmacies beand ~~able~~vendors tocould ~~develop~~adversely ~~any~~affect ~~products~~our ofrevenues, ~~commercial~~financial ~~value~~condition, or ifresults ~~competing technological approaches will limit the commercial value~~ of ~~our product candidates or render our platform obsolete~~operations.

•

~~Clinical~~If ~~trials~~we ~~are~~or ~~very~~others ~~expensive,~~later ~~time-consuming~~discover ~~and~~that ~~difficult~~IBTROZI toor ~~design~~any ~~and~~of ~~implement,~~our ~~and~~future ~~involve~~approved ~~uncertain~~product ~~outcomes.~~candidates ~~Furthermore,~~is ~~results~~less ofeffective ~~earlier~~than ~~preclinical~~previously ~~studies~~believed ~~and~~or ~~clinical~~causes ~~trials~~undesirable ~~may~~side effects that were not bepreviously ~~predictive~~identified, ofour ~~results~~ability ofto ~~future~~market ~~preclinical~~such ~~studies~~drug orcould ~~clinical~~be ~~trials~~compromised.

•

WeOur ~~may~~regulatory ~~encounter~~approval ~~substantial~~for ~~delays~~IBTROZI in ~~our~~the ~~preclinical~~U.S. ~~studies~~for oradvanced ~~clinical~~ROS1+ ~~trials~~NSCLC oris subject to post-marketing requirements and commitments, and we may be subject to penalties or product withdrawal if we fail to ~~demonstrate~~comply ~~safety~~with these regulatory requirements and ~~efficacy~~commitments, toor ~~the~~if ~~satisfaction~~we ofexperience ~~applicable~~unanticipated problems with IBTROZI. If we are unable to maintain regulatory ~~authorities~~approval for IBTROZI, our business and business prospects would be severely affected.

•

If ~~any~~we ofdo ~~our~~not ~~product~~obtain ~~candidates~~regulatory ~~receives marketing~~ approval for and ~~we,~~successfully orcommercialize ~~others,~~additional ~~later~~product ~~discover~~candidates ~~that the drug is less effective than previously believed~~ or ~~causes~~we experience ~~undesirable~~significant ~~side~~delays ~~effects~~in ~~that~~doing ~~were not previously identified~~so, ~~our~~we ~~ability~~may toincur ~~market~~significant ~~the drug could be compromised~~loses.

•

Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors and customers will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, health information privacy and security laws and other healthcare laws and regulations including comparable foreign healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

•

We do not have our own manufacturing capabilities and failure by us to maintain a manufacturing supply chain to appropriately and adequately supply IBTROZI for commercial and future clinical uses would adversely affect our ability

to commercialize IBTROZI and/or result in a further delay in or cessation of clinical trials, and our business and business prospects could be severely harmed. This is also the case for our future product candidates.

•

We will need substantial funding to pursue our business objectives. If we are unable to to raise capital if and when needed or on favorable terms, or receive significant revenues from the sales of our products, we could be forced to delay, reduce or terminate our product development, other operations or commercialization efforts.

•

Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations.

•

We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.

•

WeClinical ~~have~~trials ~~never~~are ~~commercialized~~very aexpensive, ~~product~~time-consuming ~~candidate~~and difficult to design and weimplement, ~~may~~and ~~lack~~involve ~~the~~uncertain ~~necessary~~outcomes. ~~expertise~~Furthermore, ~~personnel~~results ~~and~~of ~~resources~~earlier topreclinical ~~successfully~~studies ~~commercialize~~and ~~any~~clinical oftrials ~~our~~may ~~products~~not ~~that~~be ~~receive~~predictive ~~regulatory~~of ~~approval~~results onof ~~our~~future ~~own~~preclinical studies or ~~together~~clinical ~~with collaborators~~trials.

•

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

•

~~Even~~Our ifapproach weto ~~obtain~~the ~~regulatory~~discovery ~~approval~~and ~~for~~development ~~our~~of product candidates based on our Drug-Drug Conjugate platform is unproven, ~~they~~and we do not know whether we will ~~remain~~be ~~subject~~able to ~~ongoing~~develop ~~regulatory~~any ~~oversight.~~products of commercial value, or if competing technological approaches will limit the commercial value of our product candidates or render our platform obsolete.

•

including equivalent foreign laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Following our recent Acquisition of AnHeart, we may have difficulty integrating AnHeart’s business, operations and employees, including those based in China. This may cause disruption to ongoing business, divert the attention of management, and the process of combining the companies may cost more and take longer than originally anticipated.

We rely on third parties to perform the chemistry work associated with our drug discovery and preclinical activities and to conduct our preclinical studies and future clinical trials, and our business could be substantially harmed if these third parties cease performing services or perform in an unsatisfactory manner.

•

We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of taletrectinib, safusidenib, NUV-1511, NUV-868 and our other current and future product candidates.

If we are not able to maintain existing collaborations or establish new collaborations, we may have to alter some of our future development and commercialization plans.

If we are unable to obtain, maintain, protect and enforce sufficient patent and other intellectual property rights for our product candidates and technology, or if the scope of patent and other intellectual property rights obtained is not sufficiently broad, we may not be able to compete effectively in our market.

•

Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.

•

We may become involved in lawsuits to protect or enforce our patents or other intellectual property or defend ourselves against third party that would claim we infringe their intellectual property rights, which could be expensive, time-consuming and unsuccessful,. ~~and~~Issued ~~issued~~ patents covering our technology and product candidates could be found invalid or unenforceable if challenged.

•

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business.

Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

Our business, operations and clinical development plans and timelines and supply chain could be adversely affected by the effects of health epidemics, on the manufacturing, clinical trial and other business activities performed by us or by third parties with whom we conduct business, including our contract manufacturing organizations ("CMOs"), contract research organizations ("CROs"), shippers and others.

•

Our future success depends on our ability to retain Dr. Hung and our other key employees, consultants and advisors and to attract, retain and motivate qualified personnel.

•

The dual-class structure of our Common Stock has the effect of concentrating voting power with our Chief Executive Officer, which limits other stockholders’ ability to influence the outcome of important transactions, including a change in control.

Risks Related to Commercialization of IBTROZI

Our near-term prospects are significantly dependent on the commercialization of IBTROZI. If we are unable to successfully commercialize IBTROZI, our ability to generate meaningful revenue or achieve profitability will be materially and adversely affected.

In June 2025, we received FDA approval to commercialize IBTROZI in the U.S. for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC, and we initiated a commercial launch of IBTROZI in the U.S. in that indication. IBTROZI is our only product approved for marketing by the FDA, and our ability to generate revenue from product sales and achieve profitability is mostly dependent on our ability to successfully commercialize IBTROZI in the U.S. We may not be able to successfully commercialize IBTROZI for a number of reasons, including:

•

we may not be able to establish or demonstrate in the medical community the safety and efficacy of IBTROZI and its potential advantages over existing treatments;

•

physicians may be reluctant to prescribe IBTROZI until longer-term efficacy and safety data exists;

•

the length of time that patients who are prescribed IBTROZI remain on treatment may be shorter than we anticipate;

•

our limited historical experience in marketing, selling and distributing IBTROZI;

•

our ability to access or reach prescribers;

•

the reimbursement and coverage policies of government and private payors such as Medicare, Medicaid, insurance companies, health maintenance organizations and other plan administrators;

•

our ability to influence testing and appropriate patient identification processes within accounts;

•

the relative price of IBTROZI as compared to alternative treatment options;

•

the relatively low incidence and prevalence of patients in IBTROZI’s approved indication, including the reliability of our market and sales estimates;

•

future competitive or other market factors that may adversely affect the commercial potential of IBTROZI;

•

we may not be able to obtain and maintain regulatory approvals for taletrectinib in any other jurisdictions or for any other indications;

•

changed or increased regulatory restrictions;

•

changes to the label for IBTROZI that could restrict how we market and sell IBTROZI, including adverse events observed in ongoing and future studies of taletrectinib such as TRUST-I and TRUST-II;

•

the capabilities of third-party manufacturers may adversely affect the success of our commercialization of IBTROZI; and

•

we may not be able to maintain adequate commercial supplies of IBTROZI to meet demand.

Moreover, successful commercialization of IBTROZI may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all. If we are unable to successfully commercialize IBTROZI, our ability to generate meaningful revenue from product sales and achieve profitability will be materially and adversely affected, which in turn would severely and adversely affect our financial results, business and business prospects.

We have limited experience as a commercial company and our sales, marketing, and distribution of IBTROZI may be unsuccessful or less successful than anticipated.

As a company, we have limited experience in selling and marketing or commercializing an approved drug product in the U.S., and no such experience outside of the U.S. The success of our U.S. commercialization efforts is subject to, among other things, managing our internal sales, marketing, and distribution capabilities and our ability to navigate the significant expenses and risks involved with the management of such capabilities. For example, our commercial launch of IBTROZI in the U.S. may not continue as planned or anticipated, which may require us to, among others, adjust or amend our commercialization plan and incur significant expenses. If we are unsuccessful in accomplishing our objectives or if our commercialization efforts do not continue as planned, we may not be able to successfully commercialize IBTROZI, we may require significant additional capital and financial resources, we may not become profitable, and we may not be able to compete against more established companies in our industry, any of which would severely and adversely affect our financial results, business and business prospects.

Given our limited experience in marketing and selling IBTROZI in the U.S., our initial estimate of the size of the required sales force may be materially more or less than the size of the sales force actually required to effectively commercialize IBTROZI. As such, we may be required to hire substantially more sales representatives and medical support liaisons to adequately support the commercialization of IBTROZI, or we may incur excess costs as a result of hiring more sales representatives and medical support liaisons than necessary.

If the market opportunities for IBTROZI are smaller than we believe, our revenue may be adversely affected, and our business may suffer.

We are commercializing IBTROZI in advanced ROS1+ NSCLC, and the addressable patient population in advanced ROS1+ NSCLC is based on our estimates. These estimates, which have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations and market research, may prove to be incorrect. Further, new information from us or others may change the estimated incidence or prevalence of patients with advanced ROS1+ NSCLC. We may be unable to successfully identify patients and achieve a significant market share in IBTROZI’s approved indication.

Our market opportunity may also be limited by the pricing, reimbursement and access we are able to achieve for IBTROZI, the quality and expiration of our intellectual property rights and regulatory exclusivity, duration of IBTROZI treatment in advanced ROS1+ NSCLC and future competitor treatments that enter the market. If any of our estimates prove to be inaccurate, the market opportunities

for IBTROZI that we or any potential future collaborative partners develop could be significantly diminished, which would have a material adverse impact on our business and business prospects, and would adversely affect our ability to achieve profitability.

IBTROZI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

If IBTROZI does not achieve an adequate level of acceptance, we may not generate significant product revenues and we may never become profitable. For example, current approved immunotherapies, and other cancer treatments like chemotherapy and radiation therapy, are well established in the medical community, and doctors may continue to rely on these therapies. The degree of market acceptance of IBTROZI will depend on a number of factors, including:

•

the ability of IBTROZI to treat advanced ROS1+ NSCLC, as compared with other available drugs, treatments or therapies;

•

the prevalence and severity of any adverse side effects associated with our product candidates;

•

the label and promotional claims allowed by the FDA for IBTROZI and any limitations or warnings about the prevalence or severity of any side effects;

•

limitations or warnings contained in the labeling approved for our product candidates by the FDA or comparable foreign regulatory authorities;

•

availability of alternative treatments;

•

the size of the target patient population, and the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

•

the effectiveness of sales, marketing and distribution support for IBTROZI;

•

the ability of the third-party distributors and specialty pharmacies we contract with to process prescriptions and dispense IBTROZI and the processes required to place orders with such distributors and specialty pharmacies;

•

the pricing and cost effectiveness of IBTROZI, both in absolute terms and relative to alternative treatments;

•

the extent to which IBTROZI is approved for inclusion on formularies in hospitals and managed care organizations;

•

our ability to obtain sufficient third-party coverage and adequate reimbursement; and

•

the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors, including governmental authorities.

The successful commercialization of IBTROZI and our other product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain adequate coverage and reimbursement for IBTROZI or our other product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.

The availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid in the U.S., comparable foreign healthcare programs, private health insurers and other third-party payors are essential for most patients to be able to afford products such IBTROZI. Our ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations will have an effect on our ability to successfully commercialize IBTROZI and our product candidates, if approved, and, if desired, attract collaboration partners to invest in the development of our product candidates. Coverage under certain government programs, such as Medicare, Medicaid, the 340B drug pricing program and TRICARE, or comparable foreign healthcare programs, may not be available for IBTROZI and certain of our product candidates, if approved. Assuming we obtain coverage for a given product by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the U.S., the European Union, China or elsewhere will be available for any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

Third-party payors increasingly are challenging prices charged for pharmaceutical products and services, and many third-party payors may refuse to provide coverage and reimbursement for particular drugs when an equivalent generic drug, biosimilar or a less expensive therapy is available. It is possible that a third-party payor may consider our product candidates and other therapies as substitutable and only offer to reimburse patients for the less expensive product. Even if we show improved efficacy or improved convenience of administration with our product candidates, pricing of existing drugs may limit the amount we will be able to charge for our product candidates. These payors may deny or revoke the reimbursement status of a given product or establish prices for new or existing marketed products at levels that are too low to enable us to realize an appropriate return on our investment in product development. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on products that we may develop.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the U.S., third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered. The Medicare and Medicaid programs increasingly are used as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors may require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.

Taletrectinib is also approved in China for the treatment of advanced ROS1+ NSCLC and sold under the brand name DOVBLREON. In China, the Ministry of Human Resources and Social Security of China or provincial or local human resources and social security authorities, together with other government authorities, review the inclusion or removal of drugs from China’s National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance, or the National Reimbursement Drug List (“NRDL”), or provincial or local medical insurance catalogues for the National Medical Insurance Program regularly, and the tier under which a drug will be classified, both of which affect the amounts reimbursable to program participants for their purchases of those drugs. There can be no assurance that taletrectinib or any of our product candidates, if approved, will be included in the NRDL. Products included in the NRDL have been typically generic and essential drugs. Innovative drugs similar to taletrectinib have historically been more limited on their inclusion in the NRDL due to the affordability of the government’s Basic Medical Insurance, although this has been changing in recent years. Obtaining and maintaining reimbursement status is time-consuming and costly. No uniform policy for coverage and reimbursement for products exists among third-party payors in the U.S. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases at short notice, and we believe that changes in these rules and regulations are likely.

Moreover, increasing efforts by governmental and third-party payors in the U.S. and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. We expect to experience pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. The continuing efforts of the government, insurance companies, managed care organizations and other payors of health care services to contain or reduce costs of health care may adversely affect:

•

the demand for any products for which we may obtain regulatory approval;

•

our ability to set a price that we believe is fair for our products;

•

our ability to obtain coverage and reimbursement approval for a product;

•

our ability to generate revenues and achieve or maintain profitability; and

•

the level of taxes that we are required to pay.

In addition, in case a drug product needs companion diagnostics, then companion diagnostic tests require coverage and reimbursement separate and apart from the coverage and reimbursement for the pharmaceutical or biological product. Similar challenges to obtaining coverage and reimbursement, applicable to pharmaceutical or biological products, will apply to companion diagnostics.

We rely on a select network of third-party distributors, specialty pharmacies and other vendors to distribute IBTROZI in the U.S., and any failure by such distributors, specialty pharmacies and vendors could adversely affect our revenues, financial condition, or results of operations.

We rely on a select network of third-party distributors, specialty pharmacies and other vendors to distribute IBTROZI in the U.S., and the financial failure of any of these parties could adversely affect our revenues, financial condition or results of operations. We rely on such distributors and specialty pharmacies to effectively distribute IBTROZI in a timely manner, provide certain patient support services, manage prescription intake, collect accurate patient and inventory data and collect payments from payors. While we have entered into agreements with each of these parties, they may not perform as agreed, our strategic priorities may change or they may terminate their agreements with us. Further, an inability by our distributors or specialty pharmacies to meet our patients’ needs may lead to reputational harm or patient loss. In the event that such network fails to properly meet our or our patients’ needs, we may need to partner with other distributors, specialty pharmacies or vendors to replace or supplement our current network and there is no guarantee that we will be able to do so on commercially reasonable terms or at all.

If competitors develop products, product candidates or technologies that are superior to or more cost-effective than IBTROZI, it would significantly impact the development and commercial viability of IBTROZI, which would severely and adversely affect our financial results, business and business prospects, and the future of IBTROZI, and might cause us to cease operations.

The pharmaceutical and biotechnology industries are characterized by intense and dynamic competition with rapidly advancing technologies and a strong emphasis on proprietary products. IBTROZI competes with other products and therapies that currently exist, are being developed or will in the future be developed, some of which we may not currently be aware of.

Competitors may develop more commercially desirable or affordable products than IBTROZI. Competitors have developed, or are in the process of developing, technologies that are, or in the future may be, competitive to IBTROZI. Some of these products may have an entirely different approach or means of accomplishing therapeutic effects similar or superior to those that may be demonstrated by IBTROZI. Competitors may develop products that are safer, more effective, or less costly than IBTROZI, or more convenient to administer to patients and, therefore, present a serious competitive threat to IBTROZI. In addition, competitors may price their products below what we may determine to be an acceptable price for IBTROZI, may receive better third-party payor coverage and/or reimbursement, or may be more cost-effective than IBTROZI. Such competitive products or activities by competitors may render IBTROZI obsolete, which may cause us to cease any further development or future commercialization of IBTROZI, which would severely and adversely affect our financial results, business and business prospects, and the future of IBTROZI.

If we are unable to enter into agreements with third parties to sell and market taletrectinib in jurisdictions outside of the U.S. or our partnered territories, we will be unable to successfully commercialize taletrectinib if and when it is approved in such jurisdictions.

We have out-licensed commercial rights to taletrectinib to Innovent in mainland China, Hong Kong, Macau and Taiwan, and to NK in Japan. In the future, we may choose to build a focused sales and marketing infrastructure to sell, or participate in sales activities with our collaborators for, taletrectinib in territories outside of the U.S. and territories subject to existing partnerships, or for our other product candidates if and when they are approved.

There are risks involved with both establishing our own sales and marketing capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time-consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our product candidates on our own include:

•

our inability to recruit and retain adequate numbers of effective sales and marketing personnel;

•

the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing any future product candidates;

•

the lack of complementary products offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

•

unforeseen costs and expenses associated with creating an independent sales and marketing organization.

If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenues or the profitability of these product revenues to us are likely to be lower than if we were to market and sell any products that we develop ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that are favorable to us. In entering into third-party marketing or distribution arrangements, any revenue we receive will depend upon the efforts of the third parties and we cannot assure you that such third parties will establish adequate sales and distribution capabilities or devote the necessary resources and attention to sell and market our product candidates effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.

Failure by us to maintain a manufacturing supply chain to appropriately and adequately supply IBTROZI for commercial and future clinical uses would adversely affect our ability to commercialize IBTROZI and/or result in a further delay in or cessation of clinical trials, and our business and business prospects could be severely harmed.

The manufacture of IBTROZI must comply with applicable regulatory standards for commercial uses and current and potential future clinical trials. The process of manufacturing IBTROZI is complex and subject to several risks, including:

•

the ability to consistently manufacture sufficient yields with acceptable quality control and quality assurance to meet market demand for our commercialization of IBTROZI, as well as the needs for continuing clinical trials;

•

our ability to maintain existing commercial supply agreements and to establish additional or alternative supply agreements if necessary, including our ability to successfully transfer manufacturing technology and attain regulatory approval at any such additional or alternative suppliers;

•

reliance on third-party manufacturers and suppliers, whose efforts we do not control;

•

supply chain issues, including the timely availability of product raw materials, drug substance, and drug product and other supplies, any of which may be impacted by a number of factors, including the effects of macroeconomic or other global conditions;

•

shortage of qualified personnel at any of our third-party suppliers; and

•

regulatory acceptance and continued compliance with regulatory requirements, which vary in each country.

As a result of these and other risks, we may be unable to maintain a manufacturing infrastructure and supply chain capable of providing IBTROZI for clinical and commercial use, which would delay or adversely affect our IBTROZI commercialization efforts; result in lost sales; delay or result in a cessation of our current or potential future clinical trials; delay or preclude potential future regulatory approvals of IBTROZI in other jurisdictions or indications; and could cause financial and reputational harm.

Risks Related to the Regulatory Approval of IBTROZI

We may be unable to maintain regulatory approval for IBTROZI in the U.S. or other jurisdictions, which would severely and adversely affect our business and business prospects.

IBTROZI has been approved in the U.S. and in China (sold under the brand name DOVBLREON) for the treatment of advanced ROS1+ NSCLC. Approved products are subject to extensive and ongoing regulatory requirements for manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, sampling and record-keeping. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current Good Manufacturing Practice (“cGMP”), regulations and GCPs, for any clinical trials that we conduct post-approval, all of which may result in significant expense and limit our ability to commercialize such products. In addition, any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory authorities as reflected in the product’s approved labeling. If we receive marketing approval for any future product candidates we may develop, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label. However, if we are found to have promoted such off-label uses, we may become subject to significant liability.

The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. For example, the U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper decision could result in additional legal challenges to regulations and decisions issued by federal agencies, including the FDA, on which we rely. Any such legal challenges, if successful, could have a material impact on our business. Additionally, the Loper decision may result in increased regulatory uncertainty, inconsistent judicial interpretations, and other impacts to the agency rulemaking process, any of which could adversely impact our business and operations. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability. Moreover, if there are changes in the application of legislation or regulatory policies, or if problems are discovered with a product or our manufacture of a product, or if we or one of our distributors, licensees or co-marketers fails to comply with regulatory requirements, the regulators could take various actions. These include:

•

issuing warnings or untitled letters;

•

seeking an injunction or imposing civil or criminal penalties or monetary fines;

•

suspension or imposition of restrictions on operations, including product manufacturing;

•

seizure or detention of products, refusal to permit the import or export of products or request that we initiate a product recall;

•

suspension, variation or withdrawal of our marketing authorizations;

•

suspension of any ongoing clinical trials;

•

refusal to approve pending applications or supplements to applications submitted by us; or

•

requiring us to conduct additional clinical trials, change our product labeling or submit additional applications for marketing authorization.

If any of these events occur, our ability to sell our approved products may be impaired, and we may incur substantial additional expense to comply with regulatory requirements, which could harm our business, financial condition, results of operations and prospects.

Our regulatory approvals for taletrectinib in the U.S. and China for advanced ROS1+ NSCLC are subject to certain post-marketing requirements and/or commitments, and we may be subject to penalties or product withdrawal if we fail to comply with these regulatory requirements and commitments or if we experience unanticipated problems with taletrectinib.

Our regulatory approval for IBTROZI in the U.S. in advanced ROS1+ NSCLC is subject to post-marketing requirements and commitments, including:

•

a pediatric study;

•

a multicenter trial to further characterize known serious risks by evaluating taletrectinib 400 mg daily taken with standard meals, in patients with advanced or metastatic ROS1+ NSCLC;

•

a hepatic impairment clinical trial to determine a safe and appropriate dosage of taletrectinib in patients with moderate and severe hepatic impairment;

•

clinical drug interaction studies to evaluate the effect of taletrectinib on pharmacokinetics of certain sensitive CYP and transport substrates;

•

a clinical trial to evaluate and inform on instructions for taking taletrectinib with H2-receptor antagonists;

•

complete TRUST-I and TRUST-II studies, including updated duration of response; and

•

an analytical and clinical validation study to support the development of a companion diagnostic.

Our regulatory approval for taletrectinib in China (sold under the brand name DOVBLERON) in advanced ROS1+ NSCLC is subject to a post-marketing requirement to establish the clinical benefit of the drug in a confirmatory clinical trial.

Failure to comply with these post-marketing requirements and commitments or any other regulatory requirements, or later discovery of previously unknown problems with taletrectinib, or our manufacturers, or manufacturing processes for taletrectinib, may result in actions that could severely and adversely affect our business, such as:

•

restrictions on taletrectinib manufacturing, distribution or use;

•

restrictions on labeling or marketing;

•

additional post-marketing requirements or commitments; warning letters, withdrawal of taletrectinib from the market;

•

product recalls;

•

suspension or termination of ongoing clinical trials of taletrectinib in other indications;

•

significant civil, criminal and administrative penalties, including fines, restitutions or disgorgement of profits or revenues;

•

refusal to permit the import or export of taletrectinib;

•

product seizure or detentions; injunctions or the imposition of civil or criminal penalties; and

•

adverse publicity.

If we or others later discover that IBTROZI or any of our future approved product candidates is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market such approved drug could be compromised.

Clinical trials of our product candidates are conducted in carefully defined subsets of patients who have agreed to enter into clinical trials. Consequently, it is possible that our clinical trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects. If we, or others, discover that IBTROZI or any of our future approved product candidates are less effective than previously believed, or cause undesirable side effects, a number of potentially significant negative consequences could result, including:

•

withdrawal, variation, suspension or limitation by regulatory authorities of approvals of such product;

•

product candidate is approved under 21 CFR 314 (Subpart H, accelerated approval) or we receive a conditional marketing authorization but required confirmatory trials may fail to verify clinical benefit or we may fail to fulfill requirements of the conditional marketing authorization;

•

seizure of the product by regulatory authorities;

•

recall of the product;

•

restrictions on the marketing of the product or the manufacturing process for any component thereof;

•

requirement by regulatory authorities of additional warnings on the label, such as a “black box” warning or contraindication;

•

requirements that we implement a REMS, or comparable foreign strategies, or create a medication guide outlining the risks of such side effects for distribution to patients;

•

commitment to expensive additional safety studies prior to approval or post-marketing studies required by regulatory authorities of such product;

•

adverse impact on the product’s competitiveness;

•

initiation of regulatory investigations and government enforcement actions;

•

initiation of legal action against us to hold us liable for harm caused to patients; and

•

harm to our reputation and resulting harm to physician or patient acceptance of our products.

Any of these events could prevent us from achieving or maintaining market acceptance of IBTROZI or any of our future approved product candidates, and could harm our business, financial condition, results of operations and prospects.

Risks Related to Our Financial Position and Need for Additional Capital

~~Except~~We ~~in China where taletrectinib is being commercialized by our partner Innovent, our product candidates~~ are ~~all in development. As a result, we are~~ unable to predict if or when we will ~~successfully develop or commercialize our product candidates, and to~~ generate significant revenue or profits.

~~Our~~We ~~clinical-stage~~are ~~product~~incurring ~~candidates~~and ashave ~~well~~incurred asnet ~~our~~losses ~~other~~every ~~pipeline~~year ~~assets~~since ~~will~~our ~~require~~operations ~~significant~~began ~~further~~in ~~investment~~2018. ~~and~~Losses ~~regulatory~~have ~~approvals~~resulted ~~prior~~principally tofrom ~~commercialization.~~costs ~~Our~~incurred ~~product~~in ~~candidates~~connection ~~will~~with ~~require~~our ~~additional~~research ~~clinical~~and development activities, ~~management~~and offrom ~~clinical~~general and administrative costs associated with our operations. Although we have recently begun to commercialize IBTROZI, ~~preclinical~~our revenue and ~~manufacturing~~profit ~~activities,~~potential ~~obtaining~~is ~~regulatory~~unproven ~~approval,~~and ~~obtaining~~our ~~manufacturing~~very ~~supply,~~limited ~~build~~operating ~~out~~history ofas a commercial ~~organization,~~company ~~substantial~~makes ~~investment~~our ~~and~~future ~~significant~~operating ~~marketing~~results ~~efforts,~~difficult ~~before~~to predict. If we do not generate ~~any~~significant ~~revenues~~revenue from ~~product~~commercial sales. Weof ~~are~~IBTROZI, ~~not~~or ~~permitted~~if towe ~~market~~experience unforeseen events or ~~promote~~choose ~~any~~to ofmake other investments in our ~~product~~business, ~~candidates~~we ~~before~~may continue to experience negative cash flow as we ~~receive~~fund ~~regulatory~~our ~~approval~~operations ~~from~~and clinical development activities and research programs, and continue with the ~~FDA~~commercialization orof ~~comparable~~IBTROZI. ~~foreign~~We ~~regulatory~~will ~~authorities~~need to generate significant revenues to achieve consistent future profitability, and we may never ~~receive~~achieve ~~such~~consistent ~~regulatory~~future ~~approval~~profitability. ~~for~~Even ~~any~~if we do become profitable in the future, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to achieve consistent future profitability could negatively impact the market price of our ~~product~~common ~~candidates~~stock and our ability to sustain operations.

~~The~~Our ~~FDA~~clinical-stage ~~accepted~~product ~~for~~candidates ~~priority~~as ~~review~~well as our ~~NDA~~other ~~for~~pipeline ~~taletrectinib~~assets ~~for~~will ~~the~~require ~~treatment~~significant offurther ~~advanced~~investment ~~ROS1+~~and ~~NSCLC~~regulatory ~~with~~approvals aprior ~~target~~to ~~PDUFA~~commercialization. ~~date~~Our ofproduct ~~June~~candidates 23will require additional clinical development, ~~2025.~~management ~~However~~of clinical, wepreclinical ~~have~~and ~~not~~manufacturing ~~previously~~activities, ~~submitted~~obtaining anregulatory ~~NDA~~approval, toobtaining ~~the~~manufacturing ~~FDA~~supply, ~~for~~build ~~any~~out ~~product~~of ~~candidate~~additional commercial infrastructure, substantial investment and significant marketing efforts, before we ~~cannot~~generate beany ~~certain~~revenues ~~that~~from product sales. We are not permitted to market or promote any of our product candidates ~~will~~before we receive regulatory approval~~. Our~~ ~~other~~from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our clinical-stage product candidates, ~~include~~including safusidenib, which is in a Phase 2 study, and NUV-1511, which is in a Phase 1 study. ~~Our~~We anticipate incurring significant costs associated with launching and commercializing our current and future product candidates, including as a result of payment obligations under the Taletrectinib In-License Agreement, the Safusidenib In-License Agreement, our revenue interest financing agreement with Sagard Healthcare Partners (Delaware) II LP (the “RIF Agreement”), and our credit agreement and guaranty with Sagard Holdings Manager LP (the “Loan Agreement”). Furthermore, if the markets for patient subsets that we are targeting are not as significant as we estimate, we may not ~~receive~~generate significant revenues from sales of such products. Our revenues will also depend, in part, upon our current collaborators’ and future collaborators’ ability to obtain regulatory approval and successfully commercialize our product candidates in their respective territories. We would continue to bear the risk that the FDA or similar foreign regulatory authorities such as the European Medicines Agency (“EMA”), the U.K. Medicines & Healthcare Products Regulatory Agency (“MHRA”) or the National Medical Product Administration of China (“NMPA”), could revoke approval, or that safety, efficacy, manufacturing or supply issues could arise that negatively impact product sales.

approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our product candidates, we may not be able to continue our operations.

Even if we successfully obtain regulatory approvals to market one or more of our product candidates, we anticipate incurring significant costs associated with launching and commercializing our current and future product candidates, including as a result of payment obligations under the Taletrectinib In-License Agreement, the Safusidenib In-License Agreement, our revenue interest financing agreement with Sagard Healthcare Partners (Delaware) II LP (the “RIF Agreement”), and our credit agreement and guaranty with Sagard Holdings Manager LP (the “Loan Agreement”). Furthermore, if the markets for patient subsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products. Our revenues will also depend, in part, upon our current collaborators’ and future collaborators’ ability to obtain regulatory approval and successfully commercialize our product candidates in their respective territories. We would continue to bear the risk that the FDA or similar foreign regulatory authorities such as the European Medicines Agency (“EMA”), the U.K. Medicines & Healthcare Products Regulatory Agency (“MHRA”) or the National Medical Product Administration of China (“NMPA”), could revoke approval, or that safety, efficacy, manufacturing or supply issues could arise that negatively impact product sales.

Even if we generate sufficient revenue to achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease our value and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in value also could cause you to lose all or part of your investment.

We will need substantial funding to pursue our business objectives. If we are unable to ~~raise~~receive ~~capital~~significant ~~when~~revenues ~~needed~~from orthe onsales ~~favorable~~of ~~terms,~~our product or ~~receive~~if ~~significant~~we ~~revenues~~are ~~from~~unable ~~the~~to ~~sales~~raise ofcapital ~~our~~if ~~product~~and when needed or on favorable terms, we could be forced to delay, reduce or terminate our product development, other operations or commercialization efforts.

~~Identifying~~Successful ~~and~~drug ~~developing~~development ~~potential product candidates~~ and ~~conducting~~commercialization ~~preclinical~~requires ~~studies~~significant ~~and~~amounts ~~clinical~~of trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and begin selling any approved productscapital. We expect our expenses to increase in connection with our ongoing activities, particularly as we conduct our ongoing and planned ~~preclinical~~commercialization ~~studies~~efforts ~~and~~for ~~clinical trials~~IBTROZI, ~~initiate~~and ~~additional clinical trials for~~ our ~~product~~development ~~candidates~~ and ~~seek~~ regulatory approval ~~for~~efforts ~~our~~with ~~current~~respect ~~product~~to ~~candidates~~our current and ~~any~~ future product candidates ~~we may develop~~. Our expenses could increase beyond our current expectations if the FDA, or comparable foreign regulatory authorities, require us to perform clinical trials and other studies in addition to those that we currently anticipate. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we will be forced to delay, reduce or terminate our research and development programs or ~~future~~ commercialization efforts.

As of ~~March~~June 3130, 2025, we had $~~461~~607.7 million in cash and investments, and an accumulated deficit of $~~964~~1,023.0 million. Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations for at least the next 12 months. This estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect. Changes may occur beyond our control that would cause us to consume our available capital before that time, including changes in and progress of our development activities and changes in regulation. Our future capital requirements will depend on many factors, including:

•

the level of demand for IBTROZI;

•

the extent to which coverage and reimbursement for IBTROZI is available from government and health administration authorities, private health insurers, managed care programs and other third-party payors;

•

changes in the amount of deductions from gross sales, including government-mandated rebates, chargebacks and discounts that can vary because of changes to the government discount percentage, including increases in the government discount percentage resulting from price increases we may take in the future, or due to different levels of utilization by entities entitled to government rebates and discounts and changes in patient demographics;

•

increases in the scope of eligibility for customers to purchase IBTROZI at the discounted government price or to obtain government-mandated rebates on purchases of IBTROZI;

•

changes in our cost of sales;

•

the timing, cost and level of investment in our sales and marketing efforts to support IBTROZI sales;

•

the timing and level of royalty payments under the RIF Agreement and Loan Agreement with Sagard;

•

the scope, rate of progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our product candidates;

•

the number and development requirements of product candidates that we may pursue, and other indications for our current product candidates that we may pursue;

•

the costs, timing and outcome of regulatory review of our product candidates;

•

the scope and costs of manufacturing development and commercial manufacturing activities;

•

the cost associated with commercializing any approved product candidates;

•

the cost and timing of developing our ability to establish sales and marketing capabilities, if any;

•

the costs of preparing, filing and prosecuting patent applications, maintaining, enforcing and protecting our intellectual property rights, defending intellectual property-related claims and obtaining licenses to third-party intellectual property;

•

our ability to establish and maintain collaborations on favorable terms, if at all; and

•

the extent to which we acquire or in-license other product candidates and technologies and associated intellectual property, and payments required under such acquisitions or in-licenses.

33We will require additional revenues or capital to complete our planned clinical development programs for our clinical stage product candidates as well as our preclinical product candidates to obtain regulatory approval. Any additional capital raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our current and future product candidates, if approved.

WeIn addition, we cannot guarantee that future financing will ~~require~~be ~~additional~~available ~~capital~~on a timely basis, in sufficient amounts or on terms acceptable to ~~complete~~us, ~~our~~if ~~planned~~at ~~clinical~~all. ~~development~~Moreover, ~~programs~~the ~~for~~terms ~~our~~of ~~clinical~~any ~~stage~~financing ~~product~~may ~~candidates~~adversely asaffect ~~well~~the asholdings ~~our~~or ~~preclinical~~the ~~product~~rights ~~candidates~~of toour ~~obtain~~stockholders ~~regulatory~~and ~~approval.~~our ~~Any~~issuance of additional ~~capital~~securities, ~~raising~~whether ~~efforts~~equity ~~may~~or ~~divert~~debt, ~~our~~or ~~management~~the ~~from~~market ~~their~~perception ~~day-~~that such issuances are likely to~~-day~~ ~~activities~~occur, ~~which~~could ~~may~~cause ~~adversely~~the ~~affect~~market price of our ~~ability~~Common Stock to ~~develop~~decline. ~~and~~If ~~commercialize~~we are unable to obtain funding on a timely basis on acceptable terms, we may be required to delay, reduce or terminate one or more of our ~~current~~research and ~~future~~development programs or the commercialization of IBTROZI or any of our other product candidates, if approved. This could harm our business and could potentially cause us to cease operations.

In addition, we cannot guarantee that future financing will be available on a timely basis, in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and our issuance of additional securities, whether equity or debt, or the market perception that such issuances are likely to occur, could cause the market price of our Common Stock to decline. If we are unable to obtain funding on a timely basis on acceptable terms, we may be required to delay, reduce or terminate one or more of our research and development programs or the commercialization of any product candidates that may be approved. This could harm our business and could potentially cause us to cease operations.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish proprietary rights.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, reduce or terminate our product development or future commercialization efforts or grant rights to third parties to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.

New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could affect the tax treatment of our earnings. Any new taxes could adversely affect our business operations, and our business and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us, which could require us to pay additional taxes on a prospective or retroactive basis, as well as penalties, interest and other costs, including compliance costs. ~~The~~Legislation ~~Tax~~referred ~~Cuts~~to ~~and~~as ~~Jobs~~the One Big Beautiful Bill Act (the “OBBBA”) enacted in ~~2017~~2025, (the ~~“Tax~~Inflation Reduction Act”) enacted in 2022, the Coronavirus Aid, Relief, and Economic Security Act enacted in 2020, and the ~~Inflation~~Tax ~~Reduction~~Cuts and Jobs Act enacted in ~~2022~~2017 (the “Tax Act”) made many significant changes to the U.S. tax laws. For example, ~~effective~~for ~~January~~tax 1years beginning after December 31, ~~2022~~2024, the ~~Tax~~OBBBA ~~Act~~restores ~~eliminated~~ the ~~option~~tax todeductibility ~~deduct~~of domestic research and development expenses ~~for tax purposes~~ in the year incurred, ~~and~~which ~~instead~~expenses ~~requires~~had ~~taxpayers~~been required under the Tax Act to ~~capitalize~~be capitalized and subsequently ~~amortize~~amortized ~~such expenses~~ over five years. ~~for~~The ~~research~~OBBBA ~~activities~~did ~~conducted~~not inchange the ~~United~~tax ~~States~~treatment ~~and~~of ~~over~~expenses 15incurred ~~years~~in ~~for~~ research and development activities conducted outside the United States., ~~Although~~which ~~there~~expenses ~~have~~continue ~~been~~to ~~legislative~~be ~~proposals~~required to ~~repeal~~be orcapitalized ~~defer~~and ~~the~~amortized ~~capitalization~~over ~~requirement~~15 toyears. ~~later~~We ~~years,~~are ~~there~~evaluating ~~can~~the bepotential noimpacts ~~assurance~~this ~~that~~and ~~the~~other ~~provision~~changes ~~will~~under bethe ~~repealed~~OBBBA ormay ~~otherwise~~have ~~modified~~on our business. Future guidance from the Internal Revenue Service and other tax authorities with respect to any such legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation or sunset in future years. In addition, it is uncertain if and to what extent various states will conform to federal tax laws. Future tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.

In addition, our tax obligations and effective tax rate could increase, including as a result of the base erosion and profit shifting (“BEPS”) project that is being led by the Organization for Economic Co-operation and Development (“OECD”), and other initiatives led by the OECD. For example, the OECD is leading work on proposals, commonly referred to as “BEPS 2.0”, which to the extent implemented, would make important changes to the international tax system. These proposals are based on two “pillars”, involving the reallocation of taxing rights in respect of certain multinational enterprises above a fixed profit margin to the jurisdictions in which they carry on business (referred to as “Pillar One”) and imposing a minimum effective corporate tax rate on certain multinational enterprises (referred to as “Pillar Two”). A number of countries have enacted, or are in the process of enacting, core elements of the Pillar Two rules. Based on our current understanding of the minimum revenue thresholds, we currently expect to be outside the scope of both the Pillar One and Pillar Two proposals but could fall within their scope in the future. We are monitoring developments and evaluating the potential impacts these new rules may have on our business.

Our ability to use our net operating loss carryforwards and certain other tax attributes to offset taxable income or taxes may be limited.

As of December 31, 2024, we had federal and state net operating loss (“NOL”) carryforwards of $194.3 million and $270.3 million, respectively. Under current law, federal NOLs incurred in taxable years beginning after December 31, 2017 may be carried forward indefinitely, but such federal NOL carryforwards are permitted to be used in any taxable year to offset only up to 80% of taxable income in such year.

Separately, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Internal Revenue Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which generally is defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes, such as research tax credits, to offset its post-change income or taxes may be limited. The completion of the 2021 merger of Nuvation Bio Inc. and Panacea Acquisition Corp., together with private placements and other transactions that have occurred since our inception, may have triggered such an ownership change pursuant to Section 382. We have not completed a Section 382 analysis, and therefore, there can be no assurances that our NOL carryforwards are not already limited. We also may experience ownership changes as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. As a result, if we earn net taxable income, our ability to use our pre-change NOL carryforwards to offset U.S. federal taxable income may be subject to limitations, which potentially could result in increased future tax liability to us. If an ownership change occurs and our ability to use our net operating loss carryforwards is materially limited, this could harm our future operating results by effectively increasing our future tax obligations. In addition, due to changes in laws and regulations, including changes proposed or implemented by the current or a future U.S. presidential administration, such as alternative minimum taxes, or other unforeseen reasons, our existing net operating los

Filing Compare · Nuvation Bio Inc.