UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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

Commission File Number 001-36075

EVOKE PHARMA, INC.

(Exact name of registrant as specified in its charter)


Delaware		20-8447886
(State or other jurisdiction of incorporation)		(IRS Employer Identification No.)

420 Stevens Avenue, Suite 230, Solana Beach, CA		92075
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (858) 345-1494

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

      
Title of each class

Trading symbol

     Name of each exchange on which registered

     Common Stock, 
par value $0.0001 per share

     EVOK

     The Nasdaq Capital Market

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, a 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 ~~May~~August 1, 2025, the registrant had 1,~~492~~558,~~858~~465 shares of common stock outstanding.

Evoke pharma, inc.

Form 10-Q

TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION	1
Item 1. Financial Statements	1
Condensed Balance Sheets as of March 31, 2025 (Unaudited) and December 31, 2024	1
Condensed Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024	1
Condensed Statements of Operations for the three months ended March 31, 2025 and 2024 (Unaudited)	2
Condensed Statements of Operations for the three and six months ended June 30, 2025 and 2024 (Unaudited)	2
Condensed Statements of Stockholders’ Equity for the three months ended March 31, 2025 and 2024 (Unaudited)	3
Condensed Statements of Stockholders’ Equity for the three and six months ended June 30, 2025 and 2024 (Unaudited)	3
Condensed Statements of Cash Flows for the three months ended March 31, 2025 and 2024 (Unaudited)	4
Condensed Statements of Cash Flows for the six months ended June 30, 2025 and 2024 (Unaudited)	4
Notes to Condensed Financial Statements (Unaudited)	5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3. Quantitative and Qualitative Disclosures about Market Risk	2223
Item 4. Controls and Procedures	2223
PART II. OTHER INFORMATION	24
Item 1. Legal Proceedings	24
Item 1A. Risk Factors	24
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	2425
Item 3. Defaults Upon Senior Securities	2425
Item 4. Mine Safety Disclosures	2425
Item 5. Other Information	2425
Item 6. Exhibits	2526
SIGNATURES	2728

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Evoke Pharma, Inc.

Condensed Balance Sheets

	March 31,			December 31,
	June 30,			December 31,
	2025			2024
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	12,~~624~~059,~~090~~072		$	13,596,600
Accounts receivable, net of allowance for credit losses of $0		2,~~511~~905,~~490~~443			2,420,373
Prepaid expenses		~~523~~288,~~910~~572			731,945
Inventories		~~532~~641,~~145~~872			445,081
Other current assets		3936,~~240~~119			43,898
Total current assets		1615,~~230~~931,~~875~~078			17,237,897
Operating lease right-of-use asset		~~138~~122,~~758~~938			154,184
Deferred offering costs		—			120,614
Other long-term assets		6,312			6,312
Total assets	$	16,~~375~~060,~~945~~328		$	17,519,007
Liabilities and stockholdersʼ equity
Current liabilities:
Accounts payable and accrued expenses	$	23,~~781~~588,~~203~~290		$	2,341,191
Accrued compensation		~~371~~607,~~732~~139			865,650
Operating lease liability		6163,~~625~~769			59,533
Note payable		5,000,000			5,000,000
Accrued interest payable		2,~~236~~361,~~953~~610			2,113,665
Total current liabilities		1011,~~451~~620,~~513~~808			10,380,039
Operating lease liability, net of current portion		8365,~~217~~028			100,958
Total liabilities		1011,~~534~~685,~~730~~836			10,480,997
Commitments and contingencies
Stockholdersʼ equity:
Preferred stock, $0.0001 par value; authorized shares — 5,000,000 as of March 31, 2025 and December 31, 2024; issued and outstanding shares — zero as of March 31, 2025 and December 31, 2024		—			—
Preferred stock, $0.0001 par value; authorized shares — 5,000,000 as of June 30, 2025 and December 31, 2024; issued and outstanding shares — zero as of June 30, 2025 and December 31, 2024		—			—
Common stock, $0.0001 par value; authorized shares — 100,000,000 and 50,000,000 as of March 31, 2025 and December 31, 2024, respectively; issued and outstanding shares — 1,492,858 and 1,486,009 as of March 31, 2025 and December 31, 2024, respectively		149			149
Common stock, $0.0001 par value; authorized shares — 100,000,000 and 50,000,000 as of June 30, 2025 and December 31, 2024, respectively; issued and outstanding shares — 1,492,858 and 1,486,009 as of June 30, 2025 and December 31, 2024, respectively		149			149
Additional paid-in capital		~~135~~136,~~938~~043,~~876~~129			135,829,493
Accumulated deficit		(~~130~~131,~~097~~668,~~810~~786	)		(128,791,632	)
Total stockholdersʼ equity		54,~~841~~374,~~215~~492			7,038,010
Total liabilities and stockholdersʼ equity	$	16,~~375~~060,~~945~~328		$	17,519,007

See accompanying notes to these unaudited condensed financial statements.

Evoke Pharma, Inc.

Condensed Statements of Operations

(Unaudited)

	Three Months Ended March 31,
	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Net product sales	$	3,~~080~~752,~~158~~142		$	12,~~735~~551,~~490~~366		$	6,832,300		$	4,286,856
Operating expenses:
Cost of goods sold		41167,~~613~~679			9241,~~529~~478			209,292			134,007
Research and development		428,~~783~~413			~~4,645~~—			51,196			4,645
Selling, general and administrative		45,~~297~~134,~~505~~902			3,~~139~~733,~~536~~450			9,432,407			6,872,986
Total operating expenses		45,~~381~~310,~~901~~994			3,~~236~~774,~~710~~928			9,692,895			7,011,638
Loss from operations		(1,~~301~~558,~~743~~852	)		(1,~~501~~223,~~220~~562	)		(2,860,595	)		(2,724,782	)
Other income (expense):
Interest income		~~118~~112,~~853~~534			4681,~~058~~001			231,386			127,059
Interest expense		(~~123~~124,~~288~~658	)		(124,~~658~~657	)		(247,945	)		(249,315	)
Total other expense		(412,~~435~~124	)		(7843,~~600~~656	)		(16,559	)		(122,256	)
Net loss	$	(1,~~306~~570,~~178~~976	)	$	(1,~~579~~267,~~820~~218	)	$	(2,877,154	)	$	(2,847,038	)
Net loss per share of common stock, basic and diluted	$	(0.5162	)	$	(20.0993	)	$	(1.13	)	$	(2.69	)
Weighted-average shares used to compute basic and diluted net loss per share		2,~~548~~553,~~684~~174			~~756~~1,~~808~~363,525			2,550,941			1,060,166

See accompanying notes to these unaudited condensed financial statements.

Evoke Pharma, Inc.

Condensed Statements of Stockholders’ Equity (Deficit)

(Unaudited)

					Additional					Total
	Common Stock				Paid-In		Accumulated			Stockholdersʼ
	Shares		Amount		Capital		Deficit			Equity
Balance as of January 1, 2025		1,486,009	$	149	$	135,829,493	$	(128,791,632	)	$	7,038,010
Stock-based compensation expense		—		—		84,384		—			84,384
Issuance of common stock pursuant to the ESPP		6,849		—		24,999		—			24,999
Net loss		—		—		—		(1,306,178	)		(1,306,178	)
Balance as of March 31, 2025		1,492,858	$	149	$	135,938,876	$	(130,097,810	)	$	5,841,215
Stock-based compensation expense		—		—		104,253		—			104,253
Net loss		—		—		—		(1,570,976	)		(1,570,976	)
Balance as of June 30, 2025		1,492,858	$	149	$	136,043,129	$	(131,668,786	)	$	4,374,492

					Additional						Total
	Common Stock				Paid-In			Accumulated			Stockholdersʼ
	Shares		Amount		Capital			Deficit			(Deficit) Equity
Balance as of January 1, 2024		278,558	$	28	$	120,859,873		$	(123,439,438	)	$	(2,579,537	)
Stock-based compensation expense		—		—		254,029			—			254,029
Issuance of common stock, Pre-Funded Warrants, Series A Warrants, Series B Warrants, and Series C Warrants, net of issuance costs		427,886		43		6,172,580			—			6,172,623
Amendment and issuance of common stock and Pre-Funded Warrants from the March 2024 Amendment of Series B Warrants and Series C Warrants, net of issuance costs		9,967		1		1,229,873			—			1,229,874
Net loss		—		—		—			(1,579,820	)		(1,579,820	)
Balance as of March 31, 2024		716,411	$	72	$	128,516,355		$	(125,019,258	)	$	3,497,169
Stock-based compensation expense		—		—		126,578			—			126,578
Issuance of common stock from cashless exercise of Pre-Funded Warrants		18,425		1		(1	)		—			—
Amendment and issuance of Pre-Funded Warrants from exercise of Series B Warrants, net of issuance costs		—		—		308,429			—			308,429
Net loss		—		—		—			(1,267,218	)		(1,267,218	)
Balance as of June 30, 2024		734,836	$	73	$	128,951,361		$	(126,286,476	)	$	2,664,958

See accompanying notes to these unaudited condensed financial statements.

Evoke Pharma, Inc.

Condensed Statements of Cash Flows

(Unaudited)

	Three Months Ended March 31,
	Six Months Ended June 30,
	2025			2024
Operating activities
Net loss	$	(12,~~306~~877,~~178~~154	)	$	(12,~~579~~847,~~820~~038	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		84188,~~384~~637			~~254~~380,~~029~~607
Non-cash interest expense		~~123~~247,~~288~~945			~~124~~249,~~658~~315
Non-cash operating lease expense		1938,~~147~~294			—
Change in operating assets and liabilities:
Accounts receivable		(91485,~~117~~070	)		(~~778~~1,~~833~~329,932	)
Prepaid expenses and other assets		~~333~~571,~~307~~766			~~222~~521,~~045~~961
Inventories		(87196,~~064~~791	)		(~~106~~62,~~936~~925	)
Accounts payable and accrued expenses		~~440~~1,~~012~~247,099			~~343~~586,~~596~~220
Accrued compensation		(~~493~~258,~~918~~511	)		(1898,~~058,129~~213	)
Operating lease liabilities		(1938,~~370~~742	)		—
Net cash used in operating activities		(~~997~~1,~~509~~562,527	)		(23,~~579~~400,~~390~~005	)
Financing activities
Proceeds from February 2024 Offering		—			6,718,211
Payment of February 2024 Offering costs		—			(426,~~292~~293	)
Proceeds from March 2024 Warrant Amendment		—			1,250,800
Proceeds from amendment and exercise of Series B Warrants, net of issuance costs		—			1,546,497
Proceeds from the issuance of common stock pursuant to the ESPP		24,999			—
Net cash provided by financing activities		24,999			7,~~542~~838,~~719~~415
Net (decrease) increase in cash and cash equivalents		(~~972~~1,~~510~~537,528	)		4,~~963~~438,~~329~~410
Cash and cash equivalents at beginning of period		13,596,600			4,739,426
Cash and cash equivalents at end of period	$	12,~~624~~059,~~090~~072		$	9,~~702~~177,~~755~~836
Supplemental disclosure of non-cash investing and financing activities
Offering costs in accounts payable and accrued expenses	$	—		$	20,926
Warrant amendment costs included in accounts payable and accrued expenses	$	—		$	8,190

See accompanying notes to these unaudited condensed financial statements.

Evoke Pharma, Inc.

Notes to Condensed Financial Statements

(Unaudited)

1. Organization and Basis of Presentation

Evoke Pharma, Inc. (the “Company”) was incorporated under the laws of the state of Delaware in January 2007. The Company is a specialty pharmaceutical company focused primarily on the development and commercialization of drugs to treat gastroenterological disorders and disease.

Since its inception, the Company has devoted its efforts to developing its sole product, Gimoti® (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The Company launched U.S. commercial sales of Gimoti in October 2020 through its commercial partner Eversana Life Science Services, LLC (“Eversana”).

The Company’s activities are subject to the significant risks and uncertainties associated with any specialty pharmaceutical company that has launched its first commercial product, including market acceptance of the product and the potential need to obtain additional funding for its operations.

Going Concern

The financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations since inception and expects to continue to incur net losses for the foreseeable future until such time, if ever, that it can generate significant revenues from the sale of Gimoti. As of ~~March~~June 3130, 2025 the Company had approximately $12.61 million in cash and cash equivalents. The Company anticipates that it will continue to incur losses from operations due to commercialization activities, including manufacturing Gimoti, conducting the post-marketing commitment single-dose pharmacokinetics (“PK”) clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti, and for other general and administrative costs to support the Company’s operations. Both the Company and Eversana may terminate the commercial services and loan agreement (as described in Note 5. Commercial Services and Loan Agreements with Eversana), pursuant to the Net Profit Quarterly Termination Right (NPQTR) (as defined in Note 5); however, the Company has no intent to terminate the Eversana Agreement. There can be no assurance that Eversana will not exercise its right pursuant to the NPQTR. Should Eversana exercise its right under the NPQTR, the Loan Agreement, as described in Note 5, would also be terminated and the Company would be responsible for repaying the principal and accrued interest on the loan, which was $7.24 million as of ~~March~~June 3130, 2025, within 90 days of the effective date of the termination. In addition, the Company would need to establish a commercial infrastructure in order to continue distributing Gimoti. The timing and costs associated with this are not clear, but the Company believes they would be substantial. As a result, management believes that there is substantial doubt about the Company’s ability to continue as a going concern for one year after the date these financial statements are issued. The financial statements do not include any adjustments that may result from the outcome of this uncertainty.

The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. The Company anticipates that it will be required to raise additional funds through debt, equity or other forms of financing, such as potential collaboration arrangements, to fund future operations and continue as a going concern.

There can be no assurance that additional financing will be available when needed or on acceptable terms. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, and/or suspend or curtail commercialization activities. Any of these actions could materially harm the Company’s business, results of operations, financial condition and future prospects. Because the Company’s business is entirely dependent on the success of Gimoti, if the Company is unable to secure additional financing, successfully commercialize Gimoti or identify and execute on strategic alternatives for Gimoti or the Company, the Company will be required to curtail all of its activities and may be required to liquidate, dissolve or otherwise wind down its operations.

Reverse Stock Split

On May 22, 2024, the Company's stockholders granted the board of directors the authority to effect a reverse stock split of the Company's outstanding common stock. On July 31, 2024, the Company filed an amendment (the “Amendment”) to its amended and restated certificate of incorporation to effectuate a reverse stock split of the Company’s common stock. Pursuant to the Amendment, at the effective time of 12:01 a.m. Eastern Time on August 1, 2024, each twelve (12) shares of the Company’s common stock issued and outstanding was combined into one (1) validly issued, fully paid and non-assessable share of common stock (the “Reverse Stock Split”). The par value and the authorized shares of the Company's common stock were not adjusted as

a result of the Reverse Stock Split. All issued and outstanding common stock, warrants to purchase common stock, options to purchase common stock, per-share data and related information have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.

2. Summary of Significant Accounting Policies

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the condensed financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair ~~presentation~~statement of the Company’s financial position and of the results of operations and cash flows for the periods presented. These financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2025. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The balance sheet at December 31, 2024, has been derived from the audited financial statements at that date.

Risks and Uncertainties

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates, including those related to the valuation of share-based awards, the fair value of warrants and the assessment of its ability to fund its operations for at least the next 12 months from the date of issuance of these condensed financial statements. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that management believes to be reasonable under the circumstances. Estimates are assessed each reporting period and updated to reflect current information. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.

Cash and Cash Equivalents

The Company deposits its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation (“FDIC”). This cash is held in checking, cash sweep, and money market accounts. At times, deposits held may exceed the amount of insurance provided by the FDIC. The Company maintains an insured cash sweep account in which cash from its main operating checking account is invested overnight in highly liquid, short-term investments. The Company considers all highly liquid investments with a maturity date of 90 days or less at the date of purchase to be cash equivalents. The Company has not experienced any losses in its cash and cash equivalents and management believes the Company is not exposed to significant credit risk with respect to such accounts. The Company's cash and cash equivalents are classified as Level 1 inputs within the fair value hierarchy.

Fair Value of Financial Instruments

The carrying amounts of all financial instruments, including accounts receivable and accounts payable and accrued expenses, are considered to be representative of their respective fair values because of the short-term nature of those instruments. The carrying value of the note payable approximates fair value since the debt is due on demand as of ~~March~~June 3130, 2025 and the carrying value is the settlement value, which is a Level 2 input within the fair value hierarchy.

Accounts Receivable and Allowance for Credit Losses

Accounts receivable are recorded net of allowance for credit losses, if any. The Company evaluates its estimate of expected credit losses based on a combination of factors, including historical experience, assessment of specific customer-related risks, review of outstanding invoices, forecasts about the future, and various other assumptions and estimates. The allowance for credit losses was zero as of both ~~March~~June 3130, 2025 and December 31, 2024 and no provision for credit losses was recorded for the three and six months ended ~~March~~June 3130, 2025 and 2024.

Inventories

The Company's inventories consisted of the following as of ~~March~~June 3130, 2025 and December 31, 2024:

	March 31,		December 31,
	June 30,		December 31,
	2025		2024
Raw materials	$	~~157~~294,~~070~~601	$	257,467
Finished goods		~~375~~347,~~075~~271		187,614
Total inventories	$	~~532~~641,~~145~~872	$	445,081

Inventories are stated at the lower of cost (first-in first-out basis) or net realizable value. The Company’s raw materials inventories are held at its third-party suppliers and its finished goods inventories are held on consignment by Eversana. ~~The~~and ~~Company~~distributing ~~records such inventories as consigned inventories~~pharmacies.

Deferred Offering Costs

Deferred offering costs represent legal, accounting, and other direct costs related to future equity financings and are recognized as a non-current asset on the condensed balance sheets. After consummation of the equity financing, the offering costs are recognized as a reduction of proceeds and reclassified to additional paid-in capital on the condensed balance sheet. Should a planned equity financing be abandoned, terminated, or significantly delayed, the deferred offering costs are immediately written off as an administrative expense. As of December 31, 2024, the Company had deferred offering costs of $0.1 million related to the filing of a shelf registration statement in August 2024, which were written off during the first quarter of 2025.

Warrants

The Company accounts for warrants as equity-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in 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 common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, 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 warrants that meet all criteria for equity classification, the warrants are required to be recorded as additional paid-in capital in the condensed balance sheets at the time of issuance. Equity-classified warrants are measured at their estimated fair value on the issuance date using either the Black-Scholes option pricing model or a Monte-Carlo simulation model based on the applicable assumptions, which include the exercise price of the warrants, the Company's stock price and volatility, the expected warrant term, the risk-free interest rate, the expected dividends, and if applicable, the vesting behavior.

Revenue Recognition

At the inception of a collaboration arrangement, the Company first assesses whether the contractual arrangement is within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether the arrangement involves a joint operating activity and involves two (or more) parties that are both active participants in the activity and exposed to significant risks and rewards dependent on the commercial success of such activity. Then the Company determines whether the collaboration arrangement in its entirety represents a contract with a customer as defined by ASC 606, Revenue from Contracts with Customers (“ASC 606”). If only a portion of the collaboration arrangement is potentially with a customer, the Company applies the distinct good or service unit-of-account guidance in ASC 606 to determine whether there is a unit of account that should be accounted for under ASC 606.

The Company has entered into a collaborative arrangement with Eversana for the commercialization and distribution of Gimoti in the United States. Under this arrangement, Eversana is responsible for market access, marketing, distribution, and patient support services, while the Company retains ownership of Gimoti and all legal, regulatory, and manufacturing responsibilities. The Company records sales for Gimoti. The Company reimburses Eversana for its commercialization costs pursuant to an agreed upon budget and a percentage of product profits, if any, which are recorded within selling, general and administrative expenses in the statement of operations. The Company has determined that the underlying patient is the customer and the Company is the principal in its relationship with Eversana based on the indicators of control occurring prior to product transfer to the customer, including risks related to inventory and responsibility for product fulfillment. Payment terms are net 30 from invoice date.

In accordance with ASC 606, the Company recognizes revenue when a customer obtains control of promised goods in an amount that reflects the consideration the Company expects to receive in exchange for the goods provided. Customer control is determined upon the customer’s physical receipt of the product. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: identify the contracts with the customer; identify the performance obligations in the contract; determine the transaction price; allocate the transaction price to the performance obligations in the contract; and recognize revenue when (or as) it satisfies a performance obligation. At contract inception, the Company assesses the goods promised within each contract and determines those that are performance obligations and assesses whether each promised good is distinct. The Company then recognizes as revenue the amount of the transaction price allocated to the respective performance obligation when the customer obtains control of the product.

Product revenues are recognized net of any applicable variable consideration. The Company uses judgment to estimate variable consideration including (i) Medicaid and Medicare program rebates, (ii) sales related adjustments, wherever applicable, including patient support programs, rebates, and other sales related discounts and (iii) co-pay assistance. The Medicaid and Medicare program rebates are determined based on statutory provisions and are estimated based on the expected number of claims and related cost associated with the customer transaction. Medicaid and Medicare rebates of $0.2 million were recorded as accounts payables and accrued expenses in the condensed balance sheets as of both ~~March~~June 3130, 2025 and December 31, 2024.

Co-pay assistance is recorded as an offset to gross revenue at the time revenue from the product sale is recognized based on expected and actual program participation. Co-pay assistance liabilities are estimated using prescribing data available from customers. The Company's analysis also contemplates application of the constraint in accordance with the guidance, under which it determines a significant reversal of revenue would not occur in a future period. If actual results in the future vary from estimates, the Company will adjust these estimates, which could affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance of approximately $0.32 million and $0.1 million as of ~~March~~June 3130, 2025 and December 31, 2024, respectively, are classified as accounts payable and accrued expenses in the condensed balance sheets.

The Company does not allow product returns. The Company may replace damaged product upon shipment, but such amounts have been immaterial. Cash receipts from sales come directly from the Company’s commercial partner, Eversana, and are typically received in 30 to 60 days after month-end.

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common stock outstanding for the period, without consideration for common stock equivalents. Warrants to purchase shares of the Company’s common stock are included in the calculation of basic net loss per common share if the exercise price of the warrants represents de minimis consideration and is non-substantive in relation to the price paid for the warrant, and if the warrants are immediately exercisable with no further vesting conditions or contingencies associated with them. The 1,060,316 shares of the Company's common stock underlying the Pre-Funded Warrants, Modified Series A Warrants and Modified Series C Warrants described in Note 4, Stockholders’ Equity, are included in the weighted average outstanding common stock in the calculation of basic and diluted net loss per share due to their nominal exercise price. The Company considers Series A Warrants, Series B Warrants, Series C Warrants, and Representatives’ Warrants to be participating securities, because holders of such instruments participate in the event a dividend is paid on common stock. The holders of the Series A Warrants, Series B Warrants, Series C Warrants, and Representatives’ Warrants do not have a contractual obligation to share in the Company’s losses. As such, losses are attributed entirely to common stockholders and for periods in which the Company has reported a net loss, diluted loss per common share is the same as basic loss per common share. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common stock and common stock equivalents outstanding for the period determined using the treasury-stock method.

The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive:

	Three Months Ended March 31,
	Three and Six Months Ended June 30,
	2025		2024
Warrants to purchase common stock		792,731		23,~~641~~266,~~907~~107
Common stock options		~~269~~278,~~930~~343		5154,~~983~~540
Total excluded securities		1,~~062~~071,~~661~~074		23,~~693~~320,~~890~~647

Recent Accounting Pronouncements – Not Yet Adopted

From time to time, new accounting pronouncements are issued by the FASB or other standards setting bodies that are adopted as of the specified effective date. The Company believes the impact of recently issued standards, other than those noted below, and any issued but not yet effective standards will not have a material impact on our financial statements upon adoption.

In December 2023, the FASB issued ASU No. 2023-09 ("ASU 2023-09"), “Improvements to Income Tax Disclosures.” ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024 ~~and for private businesses for annual periods beginning after December 15~~, ~~2025,~~ with early adoption permitted. The Company is currently evaluating the impact of this guidance on its financial statement disclosures.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40) (ASU 2024-03). The amendments in this update require disclosure, in the notes to the financial statements, of specific expense categories present within expense captions presented on the face of the income statement within continuing operations of public business entities. The amendments in this update are effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any and all prior periods presented in the financial statements. The impact of adoption this ASU on the Company’s disclosures is currently being evaluated.

In January 2025, the FASB issued ASU No. 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. The amendment in this update clarifies the effective date of ASU 2024-03, which is that public business entities are required to adopt the guidance in annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. The impact of adoption of this ASU on the Company’s disclosures is currently being evaluated.

In July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted. The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act of 2017, including 100% bonus depreciation, domestic research cost expensing and the business interest expense limitation, among other tax changes. Many of the tax provisions of the OBBBA are designed to accelerate tax deductions, which could lead to lower cash tax payments. The new legislation has multiple effective dates, with certain provisions effective in 2025 and others in the future. While the Company continues to assess the impact of the tax provisions of the OBBBA on its consolidated financial statements, the Company currently believes that the tax provisions of the legislation are not expected to have a material impact on the Company’s statement of operations.

3. Commitments and Contingencies

Leases

In December 2016, the Company entered into an operating lease for office space in Solana Beach, California (the “Initial Lease”). The Initial Lease commenced on January 1, 2017, and as amended, expired on October 31, 2023.

Upon expiration of the Initial Lease, the Company entered into an operating lease for a new office space in Solana Beach, California commencing on November 1, 2023 and expiring on October 31, 2024 (the “Short-Term Lease”). The Short-Term Lease qualified as a short-term lease under ASC 842 and was not recorded on the balance sheet. Operating lease expense for the Short-Term Lease was recognized on a straight-line basis over the lease term as general administrative expense within the statement of operations.

Upon expiration of the Short-Term Lease, the Company entered into an amendment for the same office space in Solana Beach commencing on November 1, 2024 and expiring on March 31, 2027 (the “Current Lease”). As the Current Lease agreement did not include an implicit rate, the Company estimated the incremental borrowing rate of 10% utilized to discount future minimum lease payments based on information available at lease commencement. Operating lease expense for the Current Lease is recognized on a straight-line basis over the lease term. The Company recognized a right-of-use asset obtained in exchange for new lease obligations of $0.2 million upon commencement of the Current Lease. The new lease liability obligation is recorded in operating lease liability and operating lease liability, net of current portion in the balance sheets. As of ~~March~~June 3130, 2025, the remaining lease term was 21.08 years.

The following table summarizes supplemental lease information:

	Three Months Ended March 31,
	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
Lease costs(1)	$	2019,~~107~~147	$	18,~~936~~966	$	39,254	$	37,902
Cash paid for leases	$	19,370	$	18,936
Cash paid for leases(1)	$	19,371	$	18,966	$	38,742	$	37,902

(1)

~~Lease~~During ~~costs~~the three and ~~cash~~six ~~paid~~months ~~for~~ended ~~leases~~June ~~includes $20~~30,~~331~~ ~~and $18~~2024,~~936~~ oflease ~~short-term~~costs ~~lease~~and ~~expense~~cash paid for ~~the~~leases ~~three~~were ~~months~~wholly ~~ended~~attributable ~~March~~to ~~31,~~short-term ~~2025~~leases. ~~and~~For ~~2024,~~all ~~respectively.~~periods ~~Variable~~presented, variable lease costs included in general and administrative expense ~~for three months ended March 31, 2025 and 2024~~ were immaterial.

Future lease payments as of ~~March~~June 3130, 2025 were as follows:

Years Ending December 31,
2025 (Remainder)	$	5839,~~500~~128
2026		80,207
2027		20,551
Total future lease payments		~~159~~139,~~258~~886
Less: imputed interest		(1411,~~416~~089	)
Total lease liability	$	~~144~~128,~~842~~797

4. Stockholders’ Equity

Equity Transactions

February 2024 Offering

In February 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Craig-Hallum Capital Group LLC and Laidlaw & Company (UK) Ltd. (collectively, the “Underwriters”), relating to the issuance and sale of 427,886 common stock units (the “Common Stock Units”) at a public offering price of $8.16 per Common Stock Unit and, to certain investors, 491,221 pre-funded warrant units (the “PFW Units”) at a public offering price of $8.1588 per PFW Unit (the “February 2024 Offering”). Each Common Stock Unit consisted of (i) one share of common stock, (ii) a Series A Warrant to purchase one share of common stock (the “Series A Warrant”), (iii) a Series B Warrant to purchase one share of common stock (the “Series B Warrant”), and (iv) a Series C Warrant to purchase one share of common stock (the “Series C Warrant”). Each PFW Unit consisted of (i) a pre-funded warrant to purchase one share of common stock (the “Pre-Funded Warrants”), (ii) a Series A Warrant, (iii) a Series B Warrant, and (iv) a Series C Warrant. The Company also issued warrants to the Underwriters to purchase up to 45,955 shares of common stock, equal to 5% of the securities sold in the February 2024 Offering (the “Representatives’ Warrants”). The Series A Warrants are fully exercisable and are recognized as a freestanding financial instruments. In accordance with the terms and provisions of the Series C Warrants, the Series C Warrants were not exercisable, in part or in whole, at any time unless the Series B Warrants had been exercised. If Series B Warrants were not exercised before November 13, 2024, the corresponding Series C Warrants were no longer deemed outstanding and could not be exercised. Furthermore, the Series B Warrants and Series C Warrants could not be transferred by the holder without the consent of the Company, and, therefore the Series B Warrants and Series C Warrants were accounted for as a single unit of account.

Net cash proceeds from the February 2024 Offering was $6.2 million after deducting underwriter and offering expenses. The Pre-Funded Warrants, Series A Warrants, Series B Warrants, and Series C Warrants are equity classified and were recognized as additional paid-in capital in the balance sheets. The Representatives’ Warrants were accounted for under ASC 718, Compensation — Stock Compensation, and were recognized as an equity issuance cost at their grant date fair value within additional paid-in capital in the balance sheets.

August 2024 Shelf Registration Statement

On August 29, 2024, the Company filed a universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”), covering the offering of up to $50.0 million of common stock, preferred stock, debt securities, warrants, and/or units, subject to the “Baby Shelf Limitation” which limits the amount that the Company can offer and sell to up to one-third of its public float during any 12-month period so long as our public float remains below $75.0 million. The Shelf Registration Statement was declared effective by the SEC on September 6, 2024.

As of ~~March~~June 3130, 2025, there have been no shares of common stock, preferred stock, debt securities, warrants, and/or units issued under the Shelf Registration Statement.

At The Market Equity Offering

The Company had previously entered into a Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to approximately $1.9 million through Wainwright (the “ATM Offering”). The Shelf Registration Statement included a prospectus covering the offering, issuance and sale of up to approximately $1.9 million of the Company’s common stock from time to time through the ATM Offering (the “ATM Prospectus”). In November 2024, the Company filed a prospectus supplement to amend and supplement the ATM Prospectus to update the amount of shares it is eligible to sell under the “Baby Shelf Limitation” to $3.1 million under the Sales Agreement.

The Company did not issue any shares of common stock pursuant to the ATM Offering during the three months and six months ended ~~March~~June 3130, 2025.

Warrant Amendments

In each of March, June and September 2024, the Company entered into substantially similar amendments with certain holders of its Series B Warrants and Series C Warrants (individually, the “March 2024 Warrant Amendment,” “June 2024 Warrant Amendment,” and the “September 2024 Warrant Amendment,” respectively and collectively, the “Warrant Amendments”). Pursuant to the Warrant Amendments, to the extent a holder exercised its Series B Warrants prior to the exercise deadlines set forth in the respective Warrant Amendment (the “Amendment Exercise Deadline”), the holder’s corresponding Series C Warrants vested and became exercisable for the lesser of (i) three times the number of Series B Warrants exercised by the Holder and (ii) the total number of Series C Warrants outstanding to the holder. Following each Amendment Exercise Deadline, if the holder exercised any remaining Series B Warrants, the remaining Series C Warrants, if any, vested and became exercisable on a one-for-one basis as to the same number of Series B Warrants exercised.

The Warrant Amendments allowed a holder to elect to receive Pre-Funded Warrants upon exercise of Series B Warrants and Series C Warrants in lieu of shares of the Company’s common stock, at a purchase price of $8.1588 per warrant exercised and an exercise price of $0.0012 per Pre-Funded Warrant.

Net cash proceeds from the March Warrant Amendment, the June Warrant Amendment, and the September 2024 Warrant Amendment were $1.2 million, $0.3 million and $0.4 million, respectively, after deducting underwriter commissions and offering expenses. The Warrant Amendments were entered into to encourage the exercise of Series B Warrants in order to obtain capital to meet the Minimum Stockholders’ Equity Requirement as more fully discussed in Note 1. Organization and Basis of Presentation. The Warrant Amendments neither changed the number of shares of common stock underlying each series of warrants nor its equity classification. The incremental change in fair value from the Warrant Amendments was accounted for as equity issuance costs and recognized within additional paid-in capital in the balance sheets.

September 2024 Exercise Price Warrant Amendment

In September 2024, the Company also entered into an amendment with certain holders of its Series A Warrants, Series B Warrants and Series C Warrants (the “September 2024 Exercise Price Warrant Amendment”). Pursuant to the September 2024 Exercise Price Warrant Amendment, such holders who agreed to pay a non-refundable up-front payment of $3.99 per Series A Warrant or Series C Warrant prior to September 30, 2024 deadline (as defined in the September 2024 Exercise Price Amendment) had the exercise price reduced for each of the Series A Warrants and Series C Warrants from $8.16 to $0.01 (such Series A Warrants and Series C Warrants modified to have a reduced exercise price referred to as the “Modified Series A Warrants” and “Modified Series C Warrants”). To the extent such holder did not elect to modify all outstanding Series A Warrants and Series C Warrants, the remaining Series A Warrants and Series C Warrants held by each holder retained an exercise price of $8.16 per Series A Warrant or Series C Warrant.

Net cash proceeds from the September 2024 Exercise Price Warrant Amendment were $2.5 million after deducting underwriter and offering expenses. The September 2024 Exercise Price Warrant Amendment was entered to encourage the modification of Series A Warrants and Series C Warrants in order to obtain capital to meet the Minimum Stockholders’ Equity Requirement. The September 2024 Exercise Price Warrant Amendment neither changed the number of shares of Common Stock underlying each series of warrants nor its equity classification. The incremental change in fair value from the September 2024 Exercise Price Warrant Amendment was an equity issuance cost and was recognized within additional paid-in capital in the balance sheets.

In connection with the September 2024 Exercise Price Warrant Amendment, the Company entered into a letter agreement, dated September 27, 2024 (the “Letter Agreement”), with certain affiliates of Nantahala Capital Management, LLC (collectively, “Nantahala”), pursuant to which, subject to certain limitations, the Company provided Nantahala the right to appoint (or cause to be nominated) (i) one member of the Company’s board of directors (the “Board”) and one member of each Board committee so long as Nantahala, together with its affiliates, beneficially owns at least 5.0% of the Company’s outstanding shares of common stock and (ii) two members of the Board so long as Nantahala, together with its affiliates, beneficially owns at least 15.0% of the Company’s outstanding shares of common stock, subject to certain exceptions.

Warrants

Each of the outstanding warrants is convertible on a one-for-one basis into the Company’s common stock and are fully exercisable as of ~~March~~June 3130, 2025. The following table is a summary of the Company’s warrants outstanding as of ~~March~~June 3130, 2025:



	Number of
	Warrants Outstanding		Exercise Price		Initial Exercise Date	Expiration Date
Pre-Funded Warrants		528,609	$	0.0012	February 13, 2024	Until Exercised in Full
Series A Warrants		354,022	$	8.16	February 13, 2024	February 13, 2029
Modified Series A Warrants(1)		281,080	$	0.01	February 13, 2024	February 13, 2029
Series C Warrants		392,754	$	8.16	February 13, 2024	February 13, 2029
Modified Series C Warrants(1)		250,627	$	0.01	February 13, 2024	February 13, 2029
Representativesʼ Warrants		45,955	$	13.47	August 13, 2024	February 13, 2029
Total warrants		1,853,047

__________________

(1)

The Modified Series A Warrants and Modified Series C Warrants represent Series A Warrants and Series C Warrants, respectively, modified under the September 2024 Exercise Price Warrant Amendment.

Stock-Based Compensation

Stock Options

In January 2025, the number of shares of common stock available for issuance under the 2013 Equity Incentive Award Plan (the “2013 Plan”) was increased by 89,161 shares as a result of the automatic increase provision in the 2013 Plan. Stock-based compensation expense includes charges related to stock option grants. The Company measures stock-based compensation expense based on the grant date fair value of any awards granted to its employees. Such expense is recognized over the period of time that employees provide service and earn rights to the awards.

During the ~~three~~six months ended ~~March~~June 3130, 2025 and 2024, the Company granted stock options to purchase ~~143~~152,~~915~~328 and 6,352 shares of the Company’s common stock~~. During the three months ended March 31~~, ~~2024, no options were granted~~respectively.

The following assumptions were used in estimating the grant date fair value of options issued during the three and six months ended ~~March~~June 3130, 2025 and 2024:

Risk free interest rate	4.38-4.39%
	Three Months Ended June 30,		Six Months Ended June 30,
Expected option term (in years)	5.8 - 6.0
	2025	2024	2025	2024
Volatility of common stock	99% - 107.3%
Risk free interest rate	4.18%	4.46%	4.18%-4.39%	4.46%
Expected dividend yield	0.0%
Expected option term (in years)	5.5	5.5	5.5-6.0	5.5
Volatility of common stock	99.98%	107.11%	99.0%- 107.3%	107.11%
Expected dividend yield	0.0%	0.0%	0.0%	0.0%

Employee Stock Purchase Plan

Stock-based compensation expense also includes charges related to common stock issued under the Amended and Restated 2013 Employee Stock Purchase Plan (the “ESPP”). The Company allows eligible employees to purchase shares of the Company’s common stock through payroll deductions at a price equal to 85% of the lesser of the fair market value of the Company’s common stock on the first trading day of the offering period or on the applicable purchase date. The offering period is determined by the compensation committee and may be up to 27 months long. Current offering periods commence on each of September 1 and March 1 during the term. Purchase dates will be set for the last trading day in each six-month period and will occur on each of August 31 and February 28 (unless such days are not trading days). In January 2025, the number of shares of common stock available for issuance under the ESPP was increased by 14,860 shares as a result of the automatic increase provision in the ESPP. During the third quarter of 2024, an offering period was initiated. During the ~~three~~six months ended ~~March~~June 3130, 2025, there were 6,849 shares of common stock issued pursuant to the Company’s ESPP, for gross proceeds of approximately $25,000.

During the ~~three~~six months ended ~~March~~June 3130, 2024, no employees participated in the ESPP plan and as such, no ESPP awards were valued using the Black-Scholes option pricing-model. The estimated fair value of each ESPP award granted was determined on

the date of purchase using the Black-Scholes option-pricing valuation model with the following assumptions for the ~~three~~six months ended ~~March~~June 3130, 2025,:


Risk free interest rate		4.3%
Expected option term (in years)		0.5
Volatility of common stock		91.5%
Expected dividend yield		0.0%

The Company recognized stock-based compensation expense as follows:

	Three Months Ended March 31,
	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
Research and development	$	~~4,373~~—	$	~~1,215~~—	$	4,373	$	1,215
Selling, general and administrative		80104,~~011~~253		~~252~~126,~~814~~578		184,264		379,392
Total stock-based compensation expense	$	84104,~~384~~253	$	~~254~~126,~~029~~578	$	188,637	$	380,607

	Three Months Ended March 31,
	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
Stock options	$	7793,~~638~~335	$	~~254~~126,~~029~~578	$	170,973	$	380,607
ESPP		610,~~746~~918		—		17,664		—
Total stock-based compensation expense	$	84104,~~384~~253	$	~~254~~126,~~029~~578	$	188,637	$	380,607

As of ~~March~~June 3130, 2025, there was approximately $0.98 million of unrecognized compensation costs related to outstanding options, which are expected to be recognized over a weighted-average period of 2.8 years.

As of ~~March~~June 3130, 2025, there was approximately $187,000 of unrecognized compensation costs related to the ESPP, which are expected to be recognized over a weighted-average period of 0.42 years.

5. Commercial Services and Loan Agreements with Eversana

On January 21, 2020, the Company entered into a commercial services agreement (as amended, the “Eversana Agreement”) with Eversana for the commercialization of Gimoti. Pursuant to the Eversana Agreement, Eversana commercializes and distributes Gimoti in the United States. Eversana also manages the marketing of Gimoti to targeted health care providers, as well as the sales and distribution of Gimoti in the United States.

Under the terms of the Eversana Agreement, the Company maintains ownership of the Gimoti NDA, as well as legal, regulatory, and manufacturing responsibilities for Gimoti. Eversana utilizes its internal sales organization, along with other commercial functions, for market access, marketing, distribution and other related patient support services. The Company records sales for Gimoti and retain more than 80% of net product profits once both parties’ costs are reimbursed. For the three months ended ~~March~~June 3130, 2025 and 2024, approximately $23.62 million and $12.2 million of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. For the six months ended June 30, 2025 and 2024, approximately $5.8 million and $3.6 million of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. As of ~~March~~June 3130, 2025, unreimbursed commercialization costs to Eversana were approximately $7779.58 million. Such costs will generally be payable only as net product profits are recognized or upon certain termination events. Eversana receives reimbursement of its commercialization costs pursuant to an agreed upon budget and a percentage of product profits in the mid-to-high teens. Net product profits are the net sales (as defined in the Eversana Agreement) of Gimoti, less (i) reimbursed commercialization costs, (ii) manufacturing and administrative costs set at a fixed percentage of net sales, and (iii) third party royalties. During the term of the Eversana Agreement, Eversana agreed to not market, promote, or sell a competing product in the United States.

On February 1, 2022, the Eversana Agreement was amended to extend the term from June 19, 2025 (five years from the date the Food & Drug Administration approved the Gimoti new drug application) to December 31, 2026, unless terminated earlier pursuant to its terms (the “Eversana Amendment”). The Eversana Amendment also increased the percentage of net product profit retained by the Company and increased the proportion of costs that are reimbursed to Eversana to the extent Eversana has accumulated unreimbursed costs.

Upon expiration or termination of the agreement, the Company will retain all profits from product sales and assume all corresponding commercialization responsibilities. ~~Within 30 days after each of the first three annual anniversaries of commercial launch, either party may terminate the agreement if net sales of Gimoti do not meet certain annual thresholds.~~ Either party may terminate the agreement: for the material breach of the other party, subject to a 60-day cure period; in the event an insolvency, petition of the other party is pending for more than 60 days; upon 30 days written notice to the other party if Gimoti is subject to a safety recall; the other party is in breach of certain regulatory compliance representations under the Eversana Agreement; if the Company discontinues the development or

~~Company discontinues the development or~~ production of Gimoti; if the net profit is negative for any two consecutive calendar quarters (the “Net Profit Quarterly Termination Right”) beginning with the measurement date of June 30, 2023; or if there is a change in applicable laws that makes operation of the services as contemplated under the agreement illegal or commercially impractical. Either party may also terminate the Eversana Agreement upon a change of control of the Company’s ownership.

The Company's net profits were negative for the two preceding calendar quarters as of ~~March~~June 3130, 2025, and therefore, Eversana or the Company could have exercised the Net Profit Quarterly Termination Right (“NPQTR”) during the 60-day period after quarter-end. Since the note payable and accrued interest payable could be accelerated by Eversana by terminating the Eversana Agreement as of ~~March~~June 3130, 2025, those payments were recorded as current liabilities as of ~~March~~June 3130, 2025. Each party continues to have the option to exercise the NPQTR for the 60-day period following the end of future quarters so long as the net profit under the Eversana Agreement remains negative for consecutive quarters. In the event the Company initiates such termination, the Company shall pay to Eversana a one-time payment equal to all of Eversana’s unreimbursed costs plus a portion of Eversana’s commercialization costs incurred in the 12 months prior to termination. Such payment amount would be reduced by the amount of previously reimbursed commercialization costs and profit split paid for the related prior twelve-month period and any revenue which occurred prior to the termination yet to be collected. If Eversana terminates the agreement due to an uncured material breach by the Company, or if the Company terminates the Eversana Agreement in certain circumstances, including pursuant to the NPQTR, the Company has agreed to reimburse Eversana for its unreimbursed commercialization costs for the prior twelve-month period and certain other costs. In addition, Eversana may terminate the Eversana Agreement if the Company withdraws Gimoti from the market for more than 90 days. If Eversana terminates the Eversana Agreement for convenience, the Company is under no obligation to reimburse Eversana for unreimbursed commercialization costs.

In the event the Company initiates such termination, the Company shall pay to Eversana a one-time payment equal to all of Eversana’s unreimbursed cost plus a portion of Eversana’s commercialization costs incurred in the 12 months prior to termination. Such payment amount would be reduced by the amount of previously reimbursed commercialization costs and profit split paid for the related prior twelve-month period and any revenue which occurred prior to the termination yet to be collected. If Eversana terminates the agreement due to an uncured material breach by the Company, or if the Company terminates the Eversana Agreement in certain circumstances, including pursuant to the NPQTR, the Company has agreed to reimburse Eversana for its unreimbursed commercialization costs for the prior twelve-month period and certain other costs. In addition, Eversana may terminate the Eversana Agreement if the Company withdraws Gimoti from the market for more than 90 days. If Eversana terminates the Eversana Agreement for convenience, the Company is under no obligation to reimburse Eversana for unreimbursed commercialization costs.

In connection with the Eversana Agreement, the Company and Eversana have entered into the Eversana Credit Facility, pursuant to which Eversana has agreed to provide a revolving Credit Facility of up to $5.0 million to the Company upon FDA approval of the Gimoti NDA under certain customary conditions. The Eversana Credit Facility terminates on December 31, 2026, unless terminated earlier pursuant to its terms. The Eversana Credit Facility is secured by all of the Company’s personal property other than the Company’s intellectual property. Under the terms of the Eversana Credit Facility, the Company cannot grant an interest in the Company’s intellectual property to any other person. Each loan under the Eversana Credit Facility will bear interest at an annual rate equal to 10.0%, with such interest due at the end of the loan term. In 2020, the Company borrowed $5.0 million under the Eversana Credit Facility.

The Company may prepay any amounts borrowed under the Eversana Credit Facility at any time without penalty or premium. The maturity date of all amounts, including interest, borrowed under the Eversana Credit Facility will be 90 days after the expiration or earlier termination of the Eversana Agreement. The Eversana Credit Facility also includes events of default, the occurrence and continuation of which provide Eversana with the right to exercise remedies against the Company and the collateral securing the loans under the Eversana Credit Facility, including the Company’s cash. These events of default include, among other things, the Company’s failure to pay any amounts due under the Eversana Credit Facility, an uncured material breach of the representations, warranties and other obligations under the Eversana Credit Facility, the occurrence of insolvency events and the occurrence of a change in control.

6. Segment Information

Operating segments are defined as components of an enterprise for which separate financial information is regularly evaluated by the chief operating decision maker (“CODM”), which is the Company’s Chief Executive Officer, in deciding how to allocate resources and assess performance. The Company’s CODM evaluates the Company’s financial information including budget-versus-actual results and cash projections on an aggregate basis when assessing performance for allocating financial and personnel resources. The Company is not organized by market and is managed and operated as one business.

The Company identifies its operating segments based on its business activities. The Company operates within a single operating segment being the development and commercialization of pharmaceutical products. The development and commercialization of pharmaceutical products segment generates revenues in the United States. The Company’s administrative functions including finance, business development and procurement, support the development and commercialization of pharmaceutical products segment. The Company operates primarily in one geographic area, being the United States. The CODM allocates resources (inclusive of both capital and personnel) based upon the Company’s net loss, which is utilized to monitor budget-to-actual variances on a monthly basis.

The accounting policies of the development and commercialization of pharmaceutical products segment are the same as those described in Note 2. Summary of Significant Accounting Policies. All Company assets are in the United States. The measure of segment assets is reported on the balance sheets as total assets. The Company does not have intra-entity sales or transfers.

The Company has no transactions denominated in foreign currencies nor any tangible or intangible property for which isit recognizes depreciation or amortization and depreciating assets are not part of the CODMs evaluation or decision-making process.

The following table summarizes the Company’s financial data for its development and commercialization of pharmaceutical products segment:

	Three Months Ended March 31,
	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Net product sales	$	3,~~080~~752,~~158~~142		$	12,~~735~~551,~~490~~366		$	6,832,300		$	4,286,856
Less:
Cost of goods sold		(41167,~~613~~679	)		(9241,~~529~~478	)		(209,292	)		(134,007	)
Eversana profit sharing		(23,~~618~~188,~~135~~997	)		(12,~~475~~168,~~261~~661	)		(5,807,132	)		(3,643,922	)
Employee expenses		(~~638~~631,~~099~~795	)		(~~696~~561,~~801~~171	)		(1,269,894	)		(1,257,973	)
Professional fees		(~~704~~927,~~629~~215	)		(~~503~~624,~~717~~038	)		(1,631,844	)		(1,127,755	)
Stock-based compensation		(84104,~~384~~253	)		(~~254~~126,~~029~~578	)		(188,637	)		(380,607	)
Sales and marketing expenses		(~~188~~172,~~668~~885	)		(~~163~~203,~~797~~294	)		(361,553	)		(367,091	)
Other operating expenses(1)		(~~106~~118,~~373~~170	)		(5049,~~576~~708	)		(224,543	)		(100,283	)
Interest income		~~118~~112,~~853~~534			4681,~~058~~001			231,386			127,059
Interest expense (non-cash)		(~~123~~124,~~288~~658	)		(124,~~658~~657	)		(247,945	)		(249,315	)
Total segment costs loss and net loss	$	(1,~~306~~570,~~178~~976	)	$	(1,~~579~~267,~~820~~218	)	$	(2,877,154	)	$	(2,847,038	)

________________

(1) Includes ongoing product development costs, occupancy costs (including rent and utilities), administrative costs, travel and business taxes.

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

The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto for the fiscal year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 13, 2025. Past operating results are not necessarily indicative of results that may occur in future periods.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, commercial activities to be conducted by Eversana Life Science Services, LLC, or Eversana, the pricing and reimbursement for Gimoti®™ (metoclopramide) nasal spray, future prescribing trends for Gimoti, future regulatory developments, research and development costs, the timing and likelihood of commercial success, the potential to develop future product candidates, plans and objectives of management for future operations, continued compliance with Nasdaq listing requirements and future results of current and anticipated products, are forward-looking statements. These statements 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 statement. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. Although we believe the expectations reflected in these forward-looking statements are reasonable, such statements are inherently subject to risk and we can give no assurances that our expectations will prove to be correct. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form 10-Q completely. As a result of many factors, including without limitation those set forth under “Risk Factors” under Item 1A of Part II below, and elsewhere in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements. Except as required by applicable law, we undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes. For all forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

We use our registered trademark, EVOKE PHARMA, and other trademarks, including GIMOTI, in this Quarterly Report on Form 10-Q. This Quarterly Report on Form 10-Q also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this Quarterly Report on Form 10-Q appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and tradenames.

Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Evoke,” “we,” “us” and “our” refer to Evoke Pharma, Inc.

Overview

We are a specialty pharmaceutical company focused primarily on the development and commercialization of drugs to treat gastrointestinal, or GI, disorders and diseases. Since our inception, we have devoted our efforts to developing our sole product, Gimoti (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. In June 2020, we received approval from the U.S. Food and Drug Administration, or FDA, for our 505(b)(2) New Drug Application, or NDA, for Gimoti. We launched commercial sales of Gimoti in the United States in October 2020 through our commercial partner Eversana.

Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which food in an individual’s stomach takes too long to empty resulting in a variety of serious GI symptoms and systemic metabolic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. In May 2023, we reported results from a study conducted by Eversana which showed diabetic gastroparesis patients taking Gimoti had significantly fewer physician office visits, emergency department visits, and inpatient hospitalizations compared to patients taking oral metoclopramide. This overall lower health resource utilization reduced patient and payor costs by approximately $15,000 during a six-month time period for patients taking Gimoti compared to patients taking oral metoclopramide.

In January 2020, we entered into a commercial services agreement with Eversana, or the Eversana Agreement, for the commercialization of Gimoti. Pursuant to the Eversana Agreement, Eversana commercializes and distributes Gimoti in the United

States. Eversana also manages the marketing of Gimoti to targeted health care providers, as well as the sales and distribution of Gimoti in the United States. Eversana also provided a $5 million revolving credit facility, or the Eversana Credit Facility, that became available upon FDA approval of the Gimoti NDA. In 2020, we borrowed $5 million under the Eversana Credit Facility, which expires on December 31, 2026, unless terminated earlier pursuant to its terms.

We have primarily funded our operations through the sale of our convertible preferred stock prior to our initial public offering in September 2013, borrowings from loans, and the sale of shares of our common stock, warrants, and pre-funded warrants in public offerings. We launched commercial sales of Gimoti in late October 2020 with Eversana and, to date, have generated modest sales.

We have incurred losses in each year since our inception. These operating losses resulted from expenses incurred in connection with advancing Gimoti through development activities, pre-commercial and commercialization activities, and other general and administrative costs associated with our operations. We expect to continue to incur operating losses until revenues from sales of Gimoti exceed our expenses, if ever. We may never become profitable, or if we do, we may not be able to sustain profitability on a recurring basis.

As of ~~March~~June 3130, 2025, we had cash and cash equivalents of approximately $12.61 million. Current cash on hand is intended to fund commercialization activities for Gimoti, including manufacturing Gimoti, conducting the post-marketing commitment single-dose pharmacokinetics, or PK, clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti and any additional development activities should we seek additional indications, protecting our intellectual property portfolio and for other general and administrative costs to support our operations. We believe, based on our current operating plan, excluding any potential early repayment of the Eversana Credit Facility, that our existing cash and cash equivalents as of ~~March~~June 3130, 2025, as well as cash flows from future net sales of Gimoti, will be sufficient to fund our operations into the ~~second~~third quarter of 2026. However, should Eversana terminate the Eversana Agreement under the NPQTR (as defined in Note 1. Organization and Basis of Presentation to our financial statements), repayment of the Eversana Credit Facility, in addition to our other ongoing obligations, would raise substantial doubt about our ability to continue as a going concern. As such, we have concluded there is substantial doubt about our ability to continue as a going concern as our existing cash on hand as of ~~March~~June 3130, 2025, is not sufficient to fund our operations 12 months from the issuance of this Quarterly Report on Form 10-Q. This period could be further shortened if future net sales of Gimoti are less than expected or if there are any significant increases in planned spending on commercialization activities, including for marketing and manufacturing of Gimoti, and our selling, general and administrative costs to support operations, including as a result of any termination of the Eversana Agreement. We anticipate that we will be required to raise additional funds in order to continue as a going concern. Because our business is entirely dependent on the success of Gimoti, if we are unable to secure additional financing or identify and execute on other development or strategic alternatives for Gimoti or our company, we will be required to curtail all of our activities and may be required to liquidate, dissolve or otherwise wind down our operations. Any of these events could result in a complete loss of your investment in our securities.

Nasdaq Listing and Reverse Stock Split

On May 24, 2023, we received a written notice from Nasdaq indicating that, based on our stockholders’ equity of $2.1 million as of March 31, 2023, as reported in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, we were not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1) (“Minimum Stockholders’ Equity Requirement”). As required by Nasdaq, we submitted our plan to regain compliance with the Minimum Stockholders’ Equity Requirement and, following a hearing before the Nasdaq Hearings Panel (the “Panel”), and several quarters in which we demonstrated continued compliance with the Minimum Stockholders’ Equity Requirements, we were notified on June 4, 2024, that the Panel determined that we had regained compliance with the Minimum Stockholders’ Equity Requirement. Pursuant to Nasdaq Listing Rule 5815(d)(4)(A), we ~~will~~were be subject to a discretionary panel monitor through June 4, 2025. On ~~If,~~June ~~within that one-year monitoring period~~20, ~~we fail to maintain compliance with any Nasdaq continued listing requirement~~2025, ~~the Listing Qualifications Staff (the “Staff”) of Nasdaq will issue a Delist Determination Letter, and~~ we ~~will~~received ~~have an opportunity to request~~ a ~~new~~letter ~~hearing~~from ~~with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable. Notwithstanding~~ Nasdaq ~~Listing~~indicating ~~Rule~~that ~~5810(c)(2),~~ we ~~will~~had ~~not~~regained ~~be permitted to provide the Staff with a plan of~~ compliance with ~~respect to any deficiency that arises during~~ the ~~one-year~~Minimum ~~monitoring~~Stockholder’s ~~period,~~Equity Requirements and ~~the~~were ~~Staff~~no ~~will~~longer ~~not~~under bea ~~permitted~~panel ~~to grant additional time for us to regain compliance with respect to any deficiency~~monitor.

On February 21, 2024, we received a letter from Nasdaq indicating that, for the last thirty consecutive business days, the bid price for our common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).

In May 2024, our stockholders granted our board of directors the authority to effect a reverse stock split of our outstanding common stock. In order to regain compliance with the Minimum Bid Price Requirement by August 19, 2024, on July 31, 2024, we filed an amendment (the “Amendment”) to our amended and restated certificate of incorporation to effectuate a reverse stock split of our common stock. Pursuant to the Amendment, at the effective time of 12:01 a.m. Eastern Time on August 1, 2024, each twelve (12) shares of our common stock issued and outstanding was combined into one (1) validly issued, fully paid and non-assessable share of common stock (the “Reverse Stock Split”). The par value and the authorized shares of our common stock were not adjusted as a result of the Reverse Stock Split. All of our issued and outstanding common stock, warrants to purchase common stock, options to purchase common stock, per-share data and related information have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.

of the Reverse Stock Split. All of our issued and outstanding common stock, warrants to purchase common stock, options to purchase common stock, per-share data and related information have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.

On August 15, 2024, we received a letter from Nasdaq stating we had regained compliance with the Minimum Bid Price Requirement and the minimum bid price matter was closed.

Recent Developments

One Big Beautiful Bill Act

On July 4, 2025, President Trump signed into law the legislation commonly referred to as the One Big Beautiful Bill Act (“OBBBA”). The OBBBA includes various provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The OBBBA has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. We are currently assessing its impact on our consolidated financial statements and will recognize the income tax effects in the consolidated financial statements beginning in the period in which the OBBBA was signed into law.

Financial Operations Overview

Revenue Recognition

Our ability to generate revenue and become profitable depends on our ability to successfully commercialize Gimoti, which we launched in the United States through prescription in October 2020 through our commercial partner Eversana. If we or Eversana fail to successfully grow sales of Gimoti, we may never generate significant revenues and our results of operations and financial position will be adversely affected.

In accordance with Accounting Standards Codification, or ASC, 606, Revenue from Contracts with Customers, we recognize revenue when a customer obtains control of promised goods in an amount that reflects the consideration we expect to receive in exchange for the goods provided. Customer control is determined upon the customer’s physical receipt of the product. To determine revenue recognition for arrangements within the scope of ASC 606, we perform the following five steps: identify the contracts with the customer; identify the performance obligations in the contract; determine the transaction price; allocate the transaction price to the performance obligations in the contract; and recognize revenue when (or as) it satisfies a performance obligation. At contract inception, we assess the goods promised within each contract and determine those that are performance obligations and assess whether each promised good is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the customer obtains control of the product.

Product revenues are recorded net of sales-related adjustments, wherever applicable, including patient support programs, rebates, and other sales related discounts. We use judgment to estimate variable consideration. We are subject to rebates under Medicaid and Medicare programs. The rebates for these programs are determined based on statutory provisions. We estimate Medicaid and Medicare rebates based on the expected number of claims and related cost associated with the customer transaction.

We also make estimates about co-payment assistance to commercially insured patients meeting certain eligibility requirements, as well as to uninsured patients. Co-payment assistance is recorded as an offset to gross revenue at the time revenue from the product sale is recognized based on expected and actual program participation. Co-pay liabilities are estimated using prescribing data available from customers. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities for Medicare and Medicaid rebates, as well as co-pay assistance, are classified as accounts payable and accrued expenses in the balance sheets.

Sales of Gimoti Metrics

Gimoti prescriptions, prescribers, and other revenue metrics continue to increase. Net product sales during the quarter ended ~~March~~June 3130, 2025 were approximately $3.17 million which is a $10.37 million increase compared to net product sales for the quarter ended March 31, ~~2024~~2025. ASPN Pharmacy, or ASPN, serves as the non-dispensing pharmacy hub for Gimoti. ASPN offers a seamless path for processing and filling prescriptions, helps patients understand coverage and identify available savings opportunities, and facilitates communications between providers and payors. ASPN improves the proportion of prescriptions covered by insurance payors through increased patient communication and electronic automation of processes and speed of communication. We ~~added~~continue ~~several~~to add new dispensing pharmacies to ~~our pharmacy platform during~~ the ~~year~~ASPN ~~ended December 31~~platform, ~~2024,~~ which has allowed for better insurance coverages by mitigating geographic and pharmacy benefit manager restrictions to filling prescriptions, and plan to continue this expansion throughout 2025. Adding dispensing pharmacies has also added redundancy and capacity to fill prescriptions and reduced reliance on ~~having~~any aone ~~single~~of our dispensing pharmacy ~~partner~~partners. ASPN continues to process inbound prescriptions at a pace that is showing improved patient capture and conversion to reimbursed fills by insurers, and reduced reliance on savings programs.

There were approximately 1,~~793~~960 new inbound prescriptions into the ASPN reimbursement center during the quarter ended ~~March~~June 3130, 2025, which is a 259.3% increase compared to the quarter ended March 31, ~~2024~~2025. Patients who have an opportunity to refill the product (that is, patients who have completed their first fill and have additional refills on their prescription) received a refill approximately ~~70% of the time. We believe some patients choose not to refill their prescriptions due to remission of symptoms. Cumulatively, new prescribers increased 9.6% during the quarter ended March 31, 2025.~~

The ASPN team accesses the Medicare and Medicaid systems to facilitate product reimbursement submissions for patients seeking treatment. For the three months ended March 31, 2025, these government programs made up approximately 31% of the filled prescriptions for Gimoti. From the commercial launch of Gimoti through March 31, 2025, the majority of patients have been between

~~the~~70% ~~ages~~ of 31the ~~and~~time. 65We ~~years~~believe ~~old.~~some ~~The~~patients ~~vast~~choose ~~majority~~not ofto ~~patients~~refill ~~are~~their ~~female~~prescriptions ~~and~~due ~~were~~to ~~being~~remission ~~treated~~of bysymptoms. aCumulatively, ~~gastroenterologist~~new orprescribers aincreased ~~nurse~~9.0% ~~practitioner~~during orthe ~~physician~~quarter ~~assistant~~ended onJune ~~their~~30, ~~staff~~2025.

The ASPN team conducts benefit verification and facilitates the prior authorization process across all payer types for patients prescribed Gimoti. For the six months ended June 30, 2025, these government programs made up approximately 30% of the filled prescriptions for Gimoti. From the commercial launch of Gimoti through June 30, 2025, the majority of patients have been between the ages of 31 and 65 years old. The vast majority of patients are female and were being treated by a gastroenterologist or a nurse practitioner or physician assistant on their staff.

Key Opinion Leaders, or KOLs, have presented data regarding the safety profile for Gimoti and we expect KOLs will present additional data in the future. Data presented at the May 2024 Digestive Disease Week indicated a far lower incidence of tardive dyskinesia, or TD, than previously published. This retrospective data was generated from a U.S. based database covering over 270 million patient lives. The outcome showed a 0.12% incidence of TD for gastroparesis patients taking any form of metoclopramide for any diagnosis.

At the May 2023 Digestive Disease Week conference, a head-to-head (oral v. nasal metoclopramide), real world evidence data in 514 patients was presented. Compared to patients in the oral metoclopramide cohort, patients taking Gimoti experienced fewer visits to a physician’s office and emergency room (60% reduction), and had fewer inpatient admissions (68% reduction) compared to oral metoclopramide. To our knowledge, this study is the first such head-to-head data ever to be presented regarding the product and a clear support for improved outcomes for patients using Gimoti. This data was further validated in October 2023 at the American College of Gastroenterology conference, when the related cost data was presented at a plenary session showing a $15,000 savings for those patients taking Gimoti compared to oral metoclopramide over the six-month period following initiation of therapy. In October 2024 during the American College of Gastroenterology meeting, additional data related to the comparative study between Gimoti and oral metoclopramide showed a similar benefit for persons also taking GLP-1 treatments. This continues to be an area of interest for gastroenterologists who are more frequently seeing patients with delayed gastric emptying accompanying GLP-1 following initiation of therapy. These data have recently been provided to our commercialization field force to inform physicians and payers of the potential benefits seen in these real-world trials.

Research and Development Expenses

We expense all research and development expenses as they are incurred. Research and development expenses primarily include:

•

clinical and regulatory-related costs;

•

expenses incurred under agreements with contract research organizations, or CROs;

•

manufacturing and stability testing costs and related supplies and materials used in clinical trials; and

•

employee-related expenses, including salaries, benefits, travel and stock-based compensation expense.

All of our research and development expenses to date have been incurred in connection with the development of Gimoti. Since FDA approval of Gimoti in June 2020, research and development costs have decreased and shifted to commercialization and selling costs. We are waiting for feedback from the FDA related to the design of an FDA post-marketing commitment single-dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti to accommodate patients that may require further dosage adjustments. We are unable to estimate with any certainty the costs we will incur related to this trial, or the regulatory review of such lower dosage of Gimoti, though such costs may be significant and will substantially increase research and development expenses once this trial is initiated. We may also incur additional costs to the extent we pursue additional clinical trials to expand the indication of Gimoti. Clinical development timelines, the probability of success and development costs can differ materially from expectations.

The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:

•

per subject trial costs;

•

the number of sites included in the trials;

•

the length of time required to enroll eligible subjects;

•

the number of subjects that participate in the trials;

•

the number of doses that subjects receive;

•

the cost of comparative agents used in trials;

•

the drop-out or discontinuation rates of subjects;

•

potential additional safety monitoring or other studies requested by regulatory agencies; and

•

the duration of patient follow-up.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation. Other selling, general and administrative expenses include professional fees for accounting, tax, patent costs, legal services, insurance, facility costs and costs associated with being a publicly-traded company, including fees associated with investor relations and directors’ and officers’ liability insurance premiums. We expect that selling, general and administrative expenses will increase in the future as we continue to progress with the commercialization of Gimoti and we reimburse Eversana from the net profits attained from the sales of Gimoti.

Other Developments

The United States has enacted, and continues to consider, a range of trade-related measures, including tariffs, export controls, and other policies. These actions, as well as retaliatory tariffs imposed by other countries on U.S. exports, have led to significant volatility and uncertainty in global markets. Although we are actively monitoring the tariff developments and analyzing the potential impacts, we currently do not expect them to have a material impact on our business or results of operations.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these financial statements requires us 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 condensed financial statements, as well as the reported expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ materially from these estimates under different assumptions or conditions.

There have been no new or significant changes to our critical accounting policies and estimates discussed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025.

Results of Operations

Comparison of Three Months Ended ~~March~~June 3130, 2025 and 2024

The following table summarizes the results of our operations:

	Three Months Ended March 31,
	Three Months Ended June 30,
	2025		2024		$ Change			% Change
Net product sales	$	3,~~080~~752,~~158~~142	$	12,~~735~~551,~~490~~366	$	1,~~344~~200,~~668~~776			7747	%
Cost of goods sold	$	41167,~~613~~679	$	9241,~~529~~478	$	~~(50~~126,~~916~~201	)		~~-55~~304	%
Research and development expenses	$	428,~~783~~413	$	~~4,645~~—	$	388,~~138~~413			~~821~~100	%
Selling, general and administrative expenses	$	45,~~297~~134,~~505~~902	$	3,~~139~~733,~~536~~450	$	1,~~157~~401,~~969~~452			3738	%

Net Product Sales. Net product sales for the three months ended ~~March~~June 3130, 2025 compared to the three months ended ~~March~~June 3130, 2024 increased by approximately $1.32 million. The increase in product sales during 2025 is due to the increased conversion rate due to the expanded pharmacy network, a greater number of physicians within larger gastroenterology teams prescribing Gimoti after first-physician adoption and patients re-filling prescriptions at a higher rate.

Cost of Goods Sold. Cost of goods sold for the three months ended ~~March~~June 3130, 2025 compared to the three months ended ~~March~~June 3130, 2024 ~~decreased~~increased by approximately $51126,000. The ~~decrease~~increase in costs of goods sold during 2025 is primarily due to timing of stability testing on commercial product batches. ~~which was partially offset by an overall increase in sales and related costs~~

Research and Development Expenses. Research and development expenses for the three months ended ~~March~~June 3130, 2025 compared to the three months ended ~~March~~June 3130, 2024 increased by approximately $388,000 due to miscellaneous product development costs.

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the three months ended ~~March~~June 3130, 2025 compared to the three months ended ~~March~~June 3130, 2024 increased by approximately $1.24 million primarily due to an increase of $1.20 million in marketing and Eversana profit sharing amounts as a direct result of an increase in net product sales, ~~and~~an increase of 0.3

~~$0.2~~ million in professional fees ~~primarily as a result of expensing the deferred offering costs associated with the filing of a shelf registration statement in August 2024~~ and a $0.1 million increase in product liability insurance and other costs associated with being a public company. ~~These increases were partially offset by a decrease of $0.3 million in wages, taxes and employee insurance, including a $0.2 million decrease in stock-based compensation expense.~~

Comparison of Six Months Ended June 30, 2025 and 2024

The following table summarizes the results of our operations:


	Six Months Ended June 30,
	2025		2024		$ Change		% Change
Net product sales	$	6,832,300	$	4,286,856	$	2,545,444		59	%
Cost of goods sold	$	209,292	$	134,007	$	75,285		56	%
Research and development expenses	$	51,196	$	4,645	$	46,551		1002	%
Selling, general and administrative expenses	$	9,432,407	$	6,872,986	$	2,559,421		37	%

Net Product Sales. Net product sales for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 increased by approximately $2.5 million. The increase in product sales during 2025 is due to the increased conversion rate due to the expanded pharmacy network, a greater number of physicians within larger gastroenterology teams prescribing Gimoti after first-physician adoption and patients re-filling prescriptions at a higher rate.

Cost of Goods Sold. Cost of goods sold for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 increased by approximately $0.1 million. The increase in costs of goods sold during 2025 is primarily due to timing of stability testing on commercial product batches.

Research and Development Expenses. Research and development expenses for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 increased by approximately $47,000 due to miscellaneous product development costs.

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 increased by approximately $2.6 million primarily due to an increase of $2.2 million in marketing and Eversana profit sharing amounts as a direct result of an increase in net product sales, an increase of $ 0.4 million in professional fees and a $0.2 million increase in product liability insurance and other costs associated with being a public company. These increases were partially offset by a $0.2 million decrease in stock-based compensation expense.

Liquidity and Capital Resources

Since our inception in 2007, we have funded our operations primarily from the sale of equity securities and borrowings under loan and security agreements.

In connection with the Eversana Agreement, we entered into the Eversana Credit Facility, pursuant to which Eversana agreed to provide a revolving credit facility of up to $5.0 million to us upon FDA approval of the Gimoti NDA, as well as certain other customary conditions. The Eversana Credit Facility terminates on December 31, 2026, unless terminated earlier pursuant to its terms. The Eversana Credit Facility is secured by all of our personal property other than our intellectual property. Under the terms of the Eversana Credit Facility, we cannot grant an interest in our intellectual property to any other person. Each loan under the Eversana Credit Facility will bear interest at an annual rate equal to 10.0%, with such interest due at the end of the loan term. In 2020, we borrowed $5.0 million from the Eversana Credit Facility.

As of ~~March~~June 3130, 2025, we had approximately $12.61 million in cash and cash equivalents. We anticipate that we will continue to incur losses from operations due to commercialization activities, including manufacturing Gimoti, conducting the post-marketing commitment single-dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti, and for other general and administrative costs to support our operations. Both we and Eversana may terminate the commercial services agreement (as described in Note 5. Commercial Services and Loan Agreements with Eversana), pursuant to the NPQTR (as defined in Note 5); however, we have no intent to terminate the Eversana Agreement. There can be no assurance that Eversana will not exercise its right pursuant to the NPQTR. Should Eversana exercise its right under the NPQTR, the Loan Agreement (as described in Note 5) would also be terminated and we would be responsible for repaying the principal and accrued interest on the loan, which was $7.24 million as of ~~March~~June 3130, 2025, within 90 days of the effective date of the termination. In addition, we would need to establish a commercial infrastructure in order to continue distributing Gimoti. The timing and costs associated with this are not clear, but we believe they would be substantial. As a result, management believes that there is substantial doubt about its ability to continue as a going concern for one year after the date these financial statements are issued. This would materially and adversely affect our near-term liquidity needs and cash runway. We anticipate we will be required to raise additional funds in order to continue as a going concern. Because our business is entirely dependent on the success of Gimoti, if we are unable to secure additional financing or identify and execute on other development or strategic alternatives for Gimoti or our company, we will be required to curtail all of our activities and may be required to liquidate, dissolve or otherwise wind down our operations. Any of these events could result in a complete loss of your investment in our securities.

There is no assurance that other financing will be available when needed to allow us to continue as a going concern. The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.

Sources and Uses of Our Cash

The following table summarizes our cash flows:

	Three Months Ended March 31,
	Six Months Ended June 30,
	2025			2024			$ Change
Net cash used in operating activities	$	(~~997~~1,~~509~~562,527	)	$	(23,~~579~~400,~~390~~005	)	$	1,~~581~~837,~~881~~478
Net cash provided by financing activities	$	24,999		$	7,~~542~~838,~~719~~415		$	(7,~~517~~813,~~720~~416	)
Net (decrease) increase in cash and cash equivalents	$	(~~972~~1,~~510~~537,528	)	$	4,~~963~~438,~~329~~410		$	(5,~~935~~975,~~839~~938	)

Operating Activities. The primary use of our cash has been to fund our clinical research, prepare our NDA, manufacture Gimoti, commercial sales of Gimoti, and other general operations. The cash used in operating activities during the ~~three~~six months ended ~~March~~June 3130, 2025 and 2024 was primarily related to commercialization activities for Gimoti and other general operational activities. We expect that cash used in operating activities during the remainder of 2025 will be in-line with cash used during similar periods in 2024 because growing sales are expected to offset commercialization activities, including manufacturing Gimoti~~, and the planned post-marketing commitment to conduct a single-dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti~~.

Financing Activities. During the ~~three~~six months ended ~~March~~June 3130, 2025, cash provided by financing activities was $24,999 due to the issuance of 6,849 shares of common stock pursuant to our employee stock purchase plan. No shares were issued during the ~~three~~six months ended ~~March~~June 3130, 2024. During ~~three~~six months ended ~~March~~June 3130, 2024, cash provided by financing activities was $7.58 million primarily due to the sale of 437,853 shares of common stock at $8.16 per share and 683,475 Pre-Funded Warrants at $8.1588 per share.

primarily due to the sale of 437,853 shares of common stock at $8.16 per share and 642,626 Pre-Funded Warrants at $8.1588 per share.

Capital Resource Requirements

On October 16, 2024, we entered into the Seventh Amendment to our existing office lease agreement. The Seventh Amendment extends the term of the lease from October 31, 2024 to March 31, 2027. The Seventh Amendment provides for an initial monthly base rent of approximately $6,500, with stated escalation clauses each November first through the lease term. We are also responsible for common area maintenance costs associated with the leased space.

The amount and timing of our future funding requirements will depend on many factors, including but not limited to:

•

the costs of commercialization activities, including costs associated with commercial manufacturing;

•

the commercial success of Gimoti, including competition with well-established products approved earlier by FDA, including oral and intravenous forms of metoclopramide, the same active ingredient in the nasal spray for Gimoti;

•

our ability to manufacture sufficient quantities of Gimoti to meet demand, including whether our contract manufacturers, suppliers, and/or consultants are able to meet appropriate timelines;

•

the progress and costs of the post-marketing commitment to conduct a single-dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti and the costs of any additional clinical trials we may pursue to expand the indication of Gimoti;

•

our ability to obtain, maintain and enforce our patents and other intellectual property rights, and the costs incurred to do so;

•

the terms and timing of any collaborative, licensing, co-promotion or other arrangements that we may establish; and

•

costs associated with any other product candidates that we may develop, in-license or acquire.

We expect to continue to incur expenses as we:

•

continue the commercial activities for Gimoti;

•

manufacture Gimoti;

•

conduct the post-marketing commitment single-dose PK clinical trial of Gimoti and any additional development activities should we seek additional indications;

•

maintain, expand and protect our intellectual property portfolio; and

•

continue to fund the accounting, legal, insurance and other costs associated with being a public company.

Item 3. Quantitative and Qualitative Disclosure about Market Risk

As a smaller reporting company, we are not required to provide the information required by this Item.

Item 4. Controls and Procedures

Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the timelines specified in the SEC’s rules and forms, 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. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

As required by SEC Rule 13a-15(b), as of ~~March~~ 31June 30, 2025, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as of the end of the period covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025.

participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as of the end of the period covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2025.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) of the Exchange Act during the quarter ended ~~March~~June 3130, 2025, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

None.

Item 1A. Risk Factors

There have been no material changes to the risk factors included in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the SEC on March 13, 2025 and in “Part II, Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with the SEC on May 13, 2025, other than the following:

~~Changes~~Enacted toand ~~United~~future ~~States~~legislation ~~tariff~~may increase the difficulty and ~~import/export~~cost ~~regulations~~for ~~may~~us ~~have~~to acommercialize ~~negative~~Gimoti ~~effect~~and onaffect usthe prices we may obtain.

~~The~~In ~~United States has enacted, and continues to consider, a range of trade-related measures, including tariffs, export controls, and other policies. The President of~~ the United States ~~has~~and ~~directed~~some ~~agencies~~foreign ~~to reassess key aspects of U.S. trade policy~~jurisdictions, ~~and~~ there ~~has~~have been ~~ongoing debate and uncertainty surrounding potential changes to trade agreements~~, ~~tariff structures,~~ and ~~foreign~~we ~~investment~~expect ~~regulations.~~there ~~Shifts~~will in trade policy—whether through legislation, executive action, or international negotiation—could alter the global trade landscape and affect supply chains, pricing, and demand for goods and services. These developments, or the perception that such changes may occur, have and could continue to ~~have~~be, a ~~material~~number ~~adverse~~of ~~effect~~legislative ~~on global economic conditions, contribute to volatility in financial markets,~~ and ~~disrupt~~regulatory ~~international~~changes ~~trade, including trade between the United States~~ and ~~its~~proposed ~~key~~changes ~~partners.~~regarding ~~We currently depend on third-party contract manufacturers for starting materials,~~ the ~~final~~healthcare ~~drug~~system ~~substance~~that ~~and~~could ~~nasal~~restrict ~~spray~~or ~~delivery~~regulate ~~device for Gimoti, including Cosma located in Italy as the sole~~post-~~source~~approval ~~supplier~~activities ~~of metoclopramide,~~ and ~~Thermo~~affect ~~Fisher~~our ~~Scientific~~ability ~~Inc. located in France, as the sole manufacturer of Gimoti. As a result of these tariff and trade developments, we could experience a negative impact~~ to ~~our~~profitably ~~costs~~sell ~~for~~ Gimoti ~~from our third-party manufacturers, or may experience supply chain disruptions~~. ~~Any~~ ~~of these factors could adversely affect our business, financial condition and results of operations.~~

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We are not sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the commercialization of Gimoti, if any, may be.

In 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, was signed into law. The ACA was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. The ACA, among other things, increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively; modified the AMP definition under the MDRP for drugs that are inhaled, infused, instilled, implanted, or injected; imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified federal government programs, and increased the number of entities eligible for discounts under the 340B program.

Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA without specifically ruling on the constitutionality of the ACA.

There have been a number of recent regulatory and legislative initiatives designed to encourage generic competition for pharmaceutical products, including expedited review procedures for generic manufacturers and incentives designed to spur generic competition of branded drugs. In particular, FDA and Federal Trade Commission, or FTC, have been focused on brand companies’ denial of drug supply to potential generic competitors for testing. In December 2019, the Creating and Restoring Equal Access to Equivalent Samples Act (the “CREATES Act”) was enacted, which provides a legislatively defined private right of action under which eligible product developers can bring suit against companies who refuse to sell sufficient quantities of their branded products on commercially reasonable, market-based terms to support such eligible product developers’ marketing applications. We cannot currently predict the specific outcome or impact on our business of such regulatory and legislative initiatives. However, it is our policy, which is in compliance with the CREATES Act, to evaluate requests for samples of our branded products, and to provide samples in response to bona fide requests from qualified third parties, including generic manufacturers, subject to specified conditions.

In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers, which went into effect on April 1, 2013, and due to subsequent legislative amendments, will remain in effect through the first six months of 2032, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, unless additional Congressional action is taken. The American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. In addition, on March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory cap on the Medicaid drug rebate, beginning January 1, 2024. The rebate was previously capped at 100% of a drug's AMP.

The cost of prescription pharmaceuticals in the United States has been the subject of considerable discussion. There have been several Congressional inquiries and proposed and enacted legislation designed to, among other things, reform government program reimbursement methodologies. Most recently, on August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize

price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (which began in 2025). The IRA permits the Secretary of the Department of Health and Human Services (HHS) to implement many of those provisions through guidance, as opposed to regulation, for the initial years. CMS has published the negotiated prices for the initial ten drugs, which will first be effective in 2026, and the list of the subsequent 15 drugs that will be subject to negotiation, although the Medicare drug price negotiation program is currently subject to legal challenges. While the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.

In addition, the One Big Beautiful Bill Act, which was enacted in July 2025, imposes significant reductions in the funding of the Medicaid program. Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, which could adversely affect our sales of Gimoti.

In the coming years, additional legislative and regulatory changes could be made to governmental health programs that could significantly impact pharmaceutical companies and the success of our product.

Individual states in the United States have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, marketing cost disclosure, drug price increase disclosure and other transparency measures, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing. Some states have enacted legislation creating so-called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states, while some states are also seeking to implement general, across the board price caps for pharmaceuticals, or are seeking to regulate drug distribution. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. Furthermore, there has been increased interest by third party payors and governmental authorities in reference pricing systems and publication of discounts and list prices. These reforms could reduce the ultimate demand for our products, if approved, or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.

These laws and the regulations and policies implementing them, as well as other healthcare reform measures that may be adopted in the future, may have a material adverse effect on our industry generally and on our ability to successfully develop and commercialize our products. We expect that these healthcare reform measures that may be adopted in the future could result in more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our future product candidates, if approved.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

During the three months ended MarchJune 3130, 2025, none of our officers or directors adopted, modified or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any non Rule 10b5-1 trading arrangement.

2425

Item 6. Exhibits

Index to Exhibits

ExhibitNumber	Description of Exhibit	Form	File Number	Date of Filing	Exhibit Number	Filed Herewith
3.1	Amended and Restated Certificate of Incorporation of the Company	8-K	001-36075	9/30/2013	3.1
3.2	Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Company	8-K	001-36075	5/20/2022	3.1
3.3	Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Company	10-Q	001-36075	8/13/2024	3.3
3.4	Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Company	8-K	001-36075	8/1/2024	3.1
3.5	Amended and Restated Bylaws of the Company	8-K	001-36075	9/30/2013	3.2
4.1	Form of Pre-Funded Warrant	S-1/A	333-275443	12/15/2023	4.2
4.2	Form of Series A Warrant	S-1/A	333-275443	1/11/2024	4.3
4.3	Form of Series B Warrant	S-1/A	333-275443	1/11/2024	4.4
4.4	Form of Series C Warrant	S-1/A	333-275443	1/11/2024	4.5
4.5	Form of Representative Warrant	S-1/A	333-275443	2/14/2024	4.1
4.6	Form of Warrant Amendment	8-K	001-36075	3/25/2024	4.1
4.7	Form of Warrant Amendment	8-K	001-36075	6/20/2024	4.1
4.8	Form of Exercise Price Warrant Amendment	8-K	001-36075	9/27/2024	4.1
4.9	Form of Series C Vesting Warrant Amendment	8-K	001-36075	9/27/2024	4.2
10.1	Amended and Restated Non-Employee Director Compensation Policy					X
31.1	Certification of Principal Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934					X
31.2	Certification of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934					X
32.1*	Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002					X
32.2*	Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002					X
101.INS	Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document					X

ExhibitNumber

Description of Exhibit

Form

File Number

Date of Filing

Exhibit Number

Filed Herewith

File because its XBRL tags are embedded within the inline XBRL document

104

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

* This certification is being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

     Exhibit
Number

     Description of Exhibit

     Form

     File Number

     Date of Filing

     Exhibit Number

     Filed Herewith

     104

     Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

     X

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	Evoke Pharma, Inc.
Date: May 13, 2025	By:	/s/ Matthew J. D'Onofrio
Date: August 14, 2025	By:	/s/ Matthew J. D'Onofrio
		Matthew J. D’OnofrioChief Executive Officer(Principal Executive Officer)

	Evoke Pharma, Inc.
Date: May 13, 2025	By:	/s/ Mark Kowieski
Date: August 14, 2025	By:	/s/ Mark Kowieski
		Mark KowieskiChief Financial Officer(Principal Financial and Accounting Officer)

2728

Filing Compare · Evoke Pharma Inc