4. Fair Value of Financial Assets and Liabilities

Interim Financial Information

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


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

For the quarterly period ended September 30, 2025


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

For the transition period from to

Commission File Number: 001-38503

Iterum Therapeutics plc

(Exact name of registrant as specified in its charter)

     Ireland

     98-1283148

     (State or other jurisdiction of
incorporation or organization)

     (I.R.S. Employer
Identification No.)

25 North Wall Quay,

Dublin 1,

Ireland

(Address of principal executive offices)

Not applicable

(Zip Code)

(+353) 1 903-8354

(Registrant’s telephone number, including area code)

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


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Ordinary Shares, $0.01 par value per share	ITRM	The Nasdaq Stock Market LLC

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

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

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

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 November 13, 2025, the registrant had 52,787,679 ordinary shares, $0.01 par value per share, outstanding.

Table of Contents


		Page
PART I.	FINANCIAL INFORMATION	1
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss	2
	Condensed Consolidated Statements of Cash Flows	3
	Condensed Consolidated Statements of Stockholders' Equity	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	38
Item 4.	Controls and Procedures	38
PART II.	OTHER INFORMATION	39
Item 1.	Legal Proceedings	39
Item 1A.	Risk Factors	39
Item 5.	Other Information	96
Item 6.	Exhibits	97
	Signatures	98

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

•

our use of cash reserves;

•

our ability to continue as a going concern;

•

our ability to manufacture, sell, market and distribute ORLYNVAH™ with EVERSANA Life Science Services, LLC, or EVERSANA, and/or other third-parties, including our ability to build and maintain a sales force for ORLYNVAH™;

•

our ability to regain and maintain compliance with listing requirements of the Nasdaq Capital Market;

•

our ability to raise additional capital from the Nasdaq Capital Market given our limited ordinary shares currently available and authorized for issuance;

•

the design, initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs;

•

our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

•

our ability to advance product candidates into, and successfully complete, clinical trials;

•

the potential advantages of our product candidates;

•

the timing or likelihood of regulatory filings and approvals;

•

the commercialization of our product candidates, if approved;

•

our manufacturing plans;

•

our sales, marketing and distribution capabilities and strategy;

•

the market opportunity for and the potential market acceptance of ORLYNVAH™ for uncomplicated urinary tract infections caused by certain designated microorganisms in adult women who have limited or no alternative oral antibacterial treatment options;

•

market acceptance of any product we successfully commercialize;

•

the pricing, coverage and reimbursement of our product candidates, if approved;

•

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

•

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to defend and enforce any such intellectual property rights;

•

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

•

our expectations regarding how far into the future our cash on hand will fund our ongoing operations;

•

our financial performance;

•

developments relating to our competitors and our industry;

•

the impact of general economic conditions, including inflation and tariffs; and

•

the potential sale, license, or other disposition of our rights to ORLYNVAH™ and results of discussions regarding strategic alternatives.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors” and elsewhere in this Quarterly Report. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and

assumptions, the forward-looking events and circumstances discussed in this Quarterly Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report to conform these statements to new information, actual results or to changes in our expectations, except as required by law.

You should read this Quarterly Report and the documents that we have filed with the Securities and Exchange Commission, as exhibits to this Quarterly Report with the understanding that our actual future results, levels of activity, performance, and events and circumstances may be materially different from what we expect.

This Quarterly Report also contains industry, market and competitive position data from our own internal estimates and research as well as industry and general publications and research surveys and studies conducted by third parties. Industry publications, studies, and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our internal data and estimates are based upon information obtained from trade and business organizations and other contacts in the markets in which we operate and our management’s understanding of industry conditions. While we believe that each of these studies and publications is reliable, we have not independently verified market and industry data from third-party sources. While we believe our internal company research is reliable and the market definitions are appropriate, neither such research nor these definitions have been verified by any independent source. The industry in which we operate is subject to a high degree of uncertainty and risks due to various factors, including those described in the section titled “Risk Factors”.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

iii

SUMMARY OF RISK FACTORS

Below is a summary of the principal factors that make an investment in our ordinary shares speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below in the “Risk Factors” section of this Quarterly Report on Form 10-Q, and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the SEC before making investment decisions regarding our ordinary shares. These risks include the following:

•

We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern. As of September 30, 2025, we had $11.0 million of cash and cash equivalents. Based on our available cash resources, we do not believe that our existing cash and cash equivalents will enable us to fund our operating expenses for the next 12 months from the date of filing of this Quarterly Report on Form 10-Q.

•

We have incurred net losses in each year since our inception and anticipate that we will continue to incur significant losses unless we successfully commercialize our sulopenem program.

•

We will require additional capital to fund our operations including to support the ongoing commercialization of ORLYNVAH™ in the United States and the ongoing clinical development related to our sulopenem program. If we fail to obtain financing when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

•

Changes in and uncertainty surrounding trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect on our reputation, business, financial condition and results of operations.

•

In the event that we are unable to raise sufficient capital to fund our operations and continue to fund the marketing, sale and distribution of ORLYNVAH™ in the United States, our board of directors may determine that a liquidation and dissolution of our business approved by shareholders is the best method to seek to maximize shareholder value. In such an event, the amount of cash available for distribution to our shareholders, if any, will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

•

We are heavily dependent on the success of our sulopenem program including the ongoing commercialization of ORLYNVAH™ in the United States, and our ability to develop, obtain additional marketing approvals for and successfully commercialize oral sulopenem and IV sulopenem in jurisdictions outside the United States and/or for other indications. If we are unable to achieve and sustain profitability, the market value of our ordinary shares will likely decline.

•

While we continue to engage in business development discussions with other companies to sell, license, or otherwise dispose of our rights to sulopenem, on August 20, 2025, we commercially launched ORLYNVAH™ in the United States with our commercialization partner, EVERSANA Life Science Services, LLC (EVERSANA), to serve patients with limited or no treatment options. We are heavily dependent on the success of such commercial launch of ORLYNVAH™ in the United States. Any failure to successfully commercialize ORLYNVAH™, inability to enter a business development transaction satisfactory to our board of directors to sell, license, or otherwise dispose of our rights to sulopenem, or inability to obtain marketing approval for any other product candidates, or significant delays in doing so, will materially harm our business.

•

Serious adverse events or undesirable side effects or other unexpected properties of ORLYNVAH™, sulopenem or any other product candidate may be identified during development or after approval that could delay, prevent or cause the withdrawal of regulatory approval, limit the commercial potential, or result in significant negative consequences following marketing approval.

•

Even though ORLYNVAH™ has obtained regulatory approval in the United States and we may obtain regulatory approval for other product candidates, they may never achieve the market acceptance by physicians, patients, hospitals, third-party payors and others in the medical community that is necessary for commercial success, and the market opportunity may be smaller than we estimate.

•

We currently have a limited commercial organization. If we are unable to expand and maintain sales, marketing and distribution capabilities with our commercialization partner, EVERSANA, enter into sales, marketing and distribution agreements with third parties, or enter into a strategic alternative with a partner that has established commercial capabilities in the United States, the ongoing commercialization of ORLYNVAH™ in the United States may not be successful.

•

We contract with third parties, including ACS Dobfar S.p.A., for the manufacture of preclinical and clinical supplies of ORLYNVAH™ and expect to continue to do so in connection with any future clinical trials and commercialization of our products and product candidates. This reliance on third parties increases the risk that we will not have sufficient quantities

of our products and/or product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

•

We rely heavily on the exclusive license agreement with Pfizer Inc. (Pfizer), for the patent rights and know-how required for the development of sulopenem and to commercialize ORLYNVAH™ and the know-how required to develop the IV formulation of sulopenem. If we fail to comply with our obligations in our agreement with Pfizer, we could lose such rights that are important to our business.

•

If we are unable to obtain and maintain patent protection or other intellectual property rights for ORLYNVAH™ or our other technology and product candidates, or if the scope of the patent protection or intellectual property rights we obtain is not sufficiently broad, we may not be able to continue to commercialize ORLYNVAH™ or develop and commercialize any other product candidates or technology or otherwise compete effectively in our markets.

•

The price of our ordinary shares has been volatile and could be subject to volatility related or unrelated to our operations and our shareholders’ investment in us could suffer a decline in value.

•

The volatility of our shares and shareholder base may hinder or prevent us from engaging in beneficial corporate initiatives. Our shareholder base is comprised of a large number of retail (or non-institutional) investors, which creates more volatility since shares change hands frequently. As a result, there can be a significant turnover of shareholders between the record date and the meeting date which makes it harder to get shareholders to vote. While we make every effort to engage retail investors, such efforts can be expensive, and the frequent turnover creates logistical issues for obtaining shareholder approval. Further, retail investors tend to be less likely to vote in comparison to institutional investors. Failure to secure sufficient votes may impede our ability to move forward with initiatives that are intended to grow the business and create shareholder value or prevent us from engaging in such initiatives at all.

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

ITERUM THERAPEUTICS PLC

Condensed Consolidated Balance Sheets

(In thousands except share and per share data)

(Unaudited)


	September 30,			December 31,
	2025			2024
Assets
Current assets:
Cash and cash equivalents	$	11,002		$	24,125
Accounts receivable		448			—
Inventory		1,149			—
Income taxes receivable		—			48
Prepaid expenses and other current assets		1,128			614
Total current assets		13,727			24,787
Intangible asset, net		18,710			19,746
Property and equipment, net		18			23
Restricted cash		29			34
Other assets		19			5
Total assets	$	32,503		$	44,595
Liabilities and Shareholders’ Deficit
Current liabilities:
Accounts payable	$	577		$	251
Accrued expenses		5,216			2,651
Exchangeable notes		—			14,463
Royalty-linked notes		281			—
Income taxes payable		24			—
Other current liabilities		332			240
Total current liabilities	$	6,430		$	17,605
Pfizer promissory note		21,215			20,300
Royalty-linked notes		12,239			10,771
Total liabilities	$	39,884		$	48,676
Commitments and contingencies (Note 17)
Shareholders’ deficit
Undesignated preferred shares, $0.01 par value per share: 100,000,000 shares authorized at September 30, 2025 and December 31, 2024; no shares issued at September 30, 2025 and December 31, 2024		—			—
Ordinary shares, $0.01 par value per share: 80,000,000 shares authorized at September 30, 2025 and December 31, 2024, 48,991,860 shares issued at September 30, 2025; 31,534,233 shares issued at December 31, 2024		490			315
Additional paid-in capital		498,580			481,676
Accumulated deficit		(506,451	)		(486,072	)
Total shareholders' deficit		(7,381	)		(4,081	)
Total liabilities and shareholders’ deficit	$	32,503		$	44,595

The accompanying notes are an integral part of these condensed consolidated financial statements.

ITERUM THERAPEUTICS PLC

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2025			2024			2025			2024
Product Revenue, net	$	390		$	—		$	390		$	—

Costs and expenses:
Cost of sales		(20	)		—			(20	)		—
Amortization of intangible asset		(349	)		—			(1,036	)		—
Research and development		(1,261	)		(3,107	)		(2,852	)		(9,159	)
Selling, general and administrative		(6,491	)		(1,780	)		(13,452	)		(5,867	)
Total operating expenses		(8,121	)		(4,887	)		(17,360	)		(15,026	)
Operating loss		(7,731	)		(4,887	)		(16,970	)		(15,026	)
Interest expense, net		(441	)		(590	)		(1,291	)		(1,648	)
Adjustments to fair value of derivatives		(673	)		(433	)		(1,807	)		(1,226	)
Other expense, net		(2	)		(48	)		(60	)		(77	)
Total other expense		(1,116	)		(1,071	)		(3,158	)		(2,951	)
Loss before income taxes		(8,847	)		(5,958	)		(20,128	)		(17,977	)
Income tax expense		(132	)		(136	)		(251	)		(215	)
Net loss	$	(8,979	)	$	(6,094	)	$	(20,379	)	$	(18,192	)
Net loss per share – basic and diluted	$	(0.20	)	$	(0.30	)	$	(0.51	)	$	(1.05	)
Weighted average ordinary shares outstanding – basic and diluted		45,801,927			20,044,270			39,975,269			17,352,918
Statements of Comprehensive Loss
Net loss	$	(8,979	)	$	(6,094	)	$	(20,379	)	$	(18,192	)
Other comprehensive income:
Unrealized loss on marketable securities		—			3			—			1
Comprehensive loss	$	(8,979	)	$	(6,091	)	$	(20,379	)	$	(18,191	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

ITERUM THERAPEUTICS PLC

Condensed Consolidated Statements of Cash Flows

(In thousands, except share and per share data)

(Unaudited)


	Nine Months Ended September 30,
	2025			2024
Cash flows from operating activities:
Net loss	$	(20,379	)	$	(18,192	)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation		19			23
Amortization of intangible asset		1,036			—
Share-based compensation expense		170			274
Interest on short-term investments		—			1
Amortization of debt discount and deferred financing costs		194			1,713
Interest on exchangeable notes - non-cash		88			542
Financing transaction costs included in financing activities		—			1,977
Interest on promissory note - non-cash		1,415			—
Adjustments to fair value of derivatives		1,807			1,226
Other		1,820			1,233
Changes in operating assets and liabilities:
Accounts receivable		(448	)		—
Prepaid expenses and other current assets		(2,196	)		(2,575	)
Inventory		(1,149	)		—
Accounts payable		326			(4,161	)
Accrued expenses		2,642			(4,270	)
Income taxes		(35	)		(4	)
Other liabilities		(568	)		(301	)
Net cash used in operating activities		(15,258	)		(22,514	)
Cash flows from investing activities:
Purchases of property and equipment		(14	)		(2	)
Purchases of short-term investments		—			(12,390	)
Proceeds from sale of short-term investments		—			29,500
Net cash (used in) / provided by investing activities		(14	)		17,108
Cash flows from financing activities:
Repayment of exchangeable notes		(14,745	)		—
Proceeds from issuance of ordinary shares, net of transaction costs		16,909			12,814
Net cash provided by financing activities		2,164			12,814
Effect of exchange rates on cash and cash equivalents		(20	)		(73	)
Net (decrease) / increase in cash, cash equivalents and restricted cash		(13,128	)		7,335
Cash, cash equivalents and restricted cash, at beginning of period		24,159			6,105
Cash, cash equivalents and restricted cash, at end of period	$	11,031		$	13,440
Supplemental Disclosure of Cash Flow Information:
Income taxes paid - U.S.	$	120		$	220

The accompanying notes are an integral part of these condensed consolidated financial statements.

ITERUM THERAPEUTICS PLC

Condensed Consolidated Statements of Stockholders' Deficit

(In thousands, except share and per share data)

(Unaudited)


	Ordinary Shares				Additional					Accumulated Other
	Shares		Amount		Paid in Capital		Accumulated Deficit			Comprehensive Income (Loss)		Total
Balance at June 30, 2025		42,131,328	$	421	$	493,164	$	(497,472	)	$	—		(3,887	)
Issuance of ordinary shares, net		6,860,532		69		5,363		—			—		5,432
Share-based compensation expense		—		—		53		—			—		53
Net loss		—		—		—		(8,979	)		—		(8,979	)
Balance at September 30, 2025		48,991,860	$	490	$	498,580	$	(506,451	)	$	—	$	(7,381	)

	Ordinary Shares				Additional					Accumulated Other
	Shares		Amount		Paid in Capital		Accumulated Deficit			Comprehensive Income (Loss)		Total
Balance at December 31, 2024		31,534,233	$	315	$	481,676	$	(486,072	)	$	—	$	(4,081	)
Issuance of ordinary shares, net		17,431,145		175		16,702		—			—		16,877
Exercise of warrants for ordinary shares		26,482		—		32		—			—		32
Share-based compensation expense		—		—		170		—			—		170
Net loss		—		—		—		(20,379	)		—		(20,379	)
Balance at September 30, 2025		48,991,860	$	490	$	498,580	$	(506,451	)	$	—	$	(7,381	)


	Ordinary Shares				Additional					Accumulated Other
	Shares		Amount		Paid in Capital		Accumulated Deficit			Comprehensive Income (Loss)			Total
Balance at June 30, 2024		16,584,029	$	166	$	462,318	$	(473,396	)	$	(1	)	$	(10,913	)
Issuance of ordinary shares, net		6,121,965		61		2,651		—			—			2,712
Issue of warrants for ordinary shares, net		—		—		2,718		—			—			2,718
Share-based compensation expense		—		—		67		—			—			67
Net loss		—		—		—		(6,094	)		—			(6,094	)
Unrealized gain on available-for-sale securities		—		—		—		—			3			3
Balance at September 30, 2024		22,705,994	$	227	$	467,754	$	(479,490	)	$	2		$	(11,507	)

	Ordinary Shares				Additional					Accumulated Other
	Shares		Amount		Paid in Capital		Accumulated Deficit			Comprehensive Income (Loss)			Total
Balance at December 31, 2023		13,499,003	$	135	$	454,759	$	(461,298	)	$	1		$	(6,403	)
Issuance of ordinary shares, net		9,177,847		92		9,974		—			—			10,066
Issue of warrants for ordinary shares, net		—		—		2,718		—			—			2,718
Exercise of share options		29,144		—		29		—			—			29
Share-based compensation expense		—		—		274		—			—			274
Net loss		—		—		—		(18,192	)		—			(18,192	)
Unrealized gain on available-for-sale securities		—		—		—		—			1			1
Balance at September 30, 2024		22,705,994	$	227	$	467,754	$	(479,490	)	$	2		$	(11,507	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

1. Basis of Presentation

Description of Business

Iterum Therapeutics plc (the Company) was incorporated under the laws of the Republic of Ireland in June 2015 as a limited company and re-registered as a public limited company on March 20, 2018. The Company maintains its registered office at 25 North Wall Quay, Dublin 1, D01 H104, Ireland. The Company commenced operations in November 2015. The Company licensed global rights to its novel anti-infective compound, sulopenem, from Pfizer Inc. (Pfizer). The Company is dedicated to maximizing the commercial potential of ORLYNVAH™ (sulopenem etzadroxil and probenecid), the first oral branded penem available in the United States and potentially the first and only oral and intravenous (IV) branded penem available globally and is focused on delivering differentiated anti-infectives aimed at combating the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. The Company is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. In October 2024, the Company received approval from the United Sates Food and Drug Administration (FDA) of its New Drug Application for ORLYNVAH™ (oral sulopenem) for the treatment of uUTIs caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options. The Company commercially launched ORLYNVAH™ into the community market in the United Sates in August 2025 and expects modest sales in 2025 during the early stages of its commercialization efforts.

The Company is continuing to build its commercial capabilities and infrastructure to continue to support the launch of ORLYNVAH™ in the United States. In June 2025, the Company's subsidiary, Iterum Therapeutics US Limited (ITUS), entered into a Product Commercialization Agreement (the EVERSANA Agreement) with EVERSANA Life Science Services, LLC (EVERSANA) for the commercialization of ORLYNVAHTM. Pursuant to the EVERSANA Agreement, EVERSANA provides sales and commercial operations services to ITUS in the United States, as well as the provision of marketing, logistics, channel management, regulatory, medical affairs and other services related to the commercialization of ORLYNVAHTM in the United States.

Liquidity and Going Concern

Since inception, the Company has devoted substantially all of its efforts to research and development, recruiting management and technical staff, raising capital, and conducting pre-commercialization and commercialization activities. The Company began commercial operations in August 2025 and therefore has limited net product sales. The Company has financed its operations through the issuance of ordinary and convertible preferred shares, debt raised under a financing arrangement with Silicon Valley Bank (SVB) including the Paycheck Protection Program loan (PPP loan), a sub-award from the Trustees of Boston University under the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) program and the proceeds of a private placement (Private Placement) and subsequent rights offering (the 2020 Rights Offering) pursuant to which its wholly owned subsidiary, Iterum Therapeutics Bermuda Limited (Iterum Bermuda) issued and sold approximately $51,808 aggregate principal amount of 6.500% Exchangeable Senior Subordinated Notes (Exchangeable Notes) and $104 aggregate principal amount of Limited Recourse Royalty-Linked Subordinated Notes (the RLNs and, together with the Exchangeable Notes, the Securities), which Securities were sold in units consisting of an Exchangeable Note in the original principal amount of $1,000 and 50 RLNs (the Units). Beginning on January 21, 2021 through January 31, 2025, certain noteholders of $40,691 aggregate principal amount of Exchangeable Notes completed a non-cash exchange of their notes, including accrued and unpaid interest of $3,071, for an aggregate of 3,760,155 of the Company’s ordinary shares. On January 31, 2025, the Exchangeable Notes matured and Iterum Bermuda repaid in full to the holders thereof an aggregate principal amount of $11,117 together with accrued interest of $3,628.

The Company is subject to risks and uncertainties common to early-stage companies in the pharmaceutical industry, including, but not limited to, the ability to secure additional capital to fund operations, failure to successfully develop and commercialize its product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology and compliance with government regulations.

Even with receipt of FDA approval and the commercial launch of ORLYNVAHTM, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and include the accounts of the Company and its subsidiaries.

The Company filed a universal shelf registration statement on Form S-3 with the Securities and Exchange Commission (SEC), which was declared effective on October 17, 2022 (File No. 333-267795), and pursuant to which the Company registered for sale up to $100,000 of any combination of debt securities, ordinary shares, preferred shares, subscription rights, purchase contracts, units and/or warrants from time to time and at prices and on terms that the Company may determine. On October 7, 2022, the Company entered into a sales agreement with HC Wainwright (the Sales Agreement), as agent, pursuant to which it could offer and sell ordinary shares, nominal value $0.01 per ordinary share (the ordinary shares) for aggregate gross sales proceeds of up to $16,000 (subject to the availability of ordinary shares), from time to time through HC Wainwright by any method permitted that is deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the Securities Act). On

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

December 10, 2024, the Company filed a prospectus supplement with the SEC pursuant to which it may offer and sell ordinary shares having an aggregate offering price of up to an additional $25,000 through HC Wainwright pursuant to the Sales Agreement.

On August 9, 2024, the Company completed a rights offering (the 2024 Rights Offering) in which it sold an aggregate of 6,121,965 units (2024 Units) at a subscription price of $1.21 per whole 2024 Unit, consisting of (a) one ordinary share, (b) a warrant to purchase 0.50 ordinary shares, at an exercise price of $1.21 per whole ordinary share from the date of issuance through its expiration one year from the date of issuance (the 1-year warrants) and (c) a warrant to purchase one ordinary share, at an exercise price of $1.21 per whole ordinary share from the date of issuance through its expiration five years from the date of issuance (the 5-year warrants and, together with the 1-year warrants, the warrants). The Company's net proceeds from the 2024 Rights Offering, after deducting dealer-manager fees and other offering expenses payable by the Company, were $5,430. The warrants are exercisable upon issuance at a price of $1.21 per ordinary share. The 1-year warrants expired on August 9, 2025 and the 5-year warrants will expire on August 9, 2029.

The Company filed a universal shelf registration statement on Form S-3 with the SEC, which was declared effective on February 19, 2025 (File No. 333-284774), and pursuant to which the Company registered for sale up to $150,000 of any combination of debt securities, ordinary shares, preferred shares, subscription rights, purchase contracts, units and/or warrants from time to time and at prices and on terms that the Company may determine.

On April 28, 2025, the Company entered into a securities purchase agreement with an institutional investor (the April 2025 Registered Direct Offering) pursuant to which it issued and sold an aggregate of (i) 3,040,000 ordinary shares, at a purchase price of $0.90 per ordinary share, and (ii) pre-funded warrants to purchase up to an aggregate of 2,515,556 ordinary shares at a purchase price of $0.89 per pre-funded warrant. The Company's net proceeds from the April 2025 Registered Direct Offering, after deducting placement agent fees and offering expenses payable by the Company were $4,177. Upon closing, the pre-funded warrants became exercisable immediately at an exercise price of $0.01 per ordinary share, subject to adjustment in certain circumstances, and expire when exercised in full, subject to certain conditions. As of September 30, 2025, all pre-funded warrants issued in connection with the April 28, 2025 Offering had been exercised.

In accordance with Accounting Standards Update (ASU) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year of the date of issue of these quarterly condensed consolidated financial statements.

The Company has funded its operations to date primarily with proceeds from the sale of preferred shares and ordinary shares, warrants, debt raised under its financing arrangement with SVB including the PPP loan (both of which have been repaid), payments received under the CARB-X program, proceeds from the Private Placement and 2020 Rights Offering and product sales. The Company has incurred operating losses since inception, including net losses of $20,379 and $18,192 for the nine months ended September 30, 2025 and 2024, respectively, and a net loss of $24,774 for the year ended December 31, 2024. The Company had an accumulated deficit of $506,451 as of September 30, 2025 and expects to continue to incur net losses for the foreseeable future. The Company’s future cash flows are dependent on key variables such as its ability to achieve its revenue growth from sales of ORLYNVAH™ in the United States and its ability to secure additional sources of funding in the form of public or private financing of debt or equity or collaboration agreements. Based on its available cash and cash equivalents, including amounts raised under the Sales Agreement with H.C. Wainwright & Co. LLC (HC Wainwright), as agent, subsequent to September 30, 2025 (see Note 19 – Subsequent Events), the Company does not have cash on hand to fund its current operations and capital expenditure requirements for the next 12 months from the date of this Quarterly Report on Form 10-Q. This condition raises substantial doubt about the Company’s ability to continue as a going concern for one year from the date these condensed consolidated financial statements are issued.

The Company's ability to continue as a going concern is dependent on its ability to obtain additional funding to support its business objectives, including achieving its revenue growth rate from sales of ORLYNVAH™ in the United States. The Company has limited experience with and has not yet demonstrated an ability to successfully commercialize a product. Management expects that, in order to obtain additional funding for its operations and commercialization activities, it will need to raise funding through the possible sale of the Company’s equity or debt through additional public or private financings. Although management plans to obtain additional funding to finance its operations, and has successfully raised capital in the past, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all.

If the Company is unable to obtain funding, it could be forced to significantly delay, scale back or discontinue the development and commercialization of its sulopenem program, or otherwise change its strategy, which could adversely affect its business prospects, or the Company may be unable to continue operations. Based on the Company’s operating losses since inception, the expectation of continued operating losses for the foreseeable future, and the need to raise additional capital to finance its future operations, management has concluded there is substantial doubt about the Company’s ability to continue as a going concern within one year from the date these condensed consolidated financial statements are issued.

The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the condensed consolidated financial statements have been prepared on a basis that assumes

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

The condensed consolidated balance sheet at December 31, 2024 was derived from audited financial statements, but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2025 and for the three and nine months ended September 30, 2025 and 2024 have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the 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 February 7, 2025. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2025, and results of operations for the three and nine months ended September 30, 2025 and 2024, and cash flows for the nine months ended September 30, 2025 and 2024 have been made. The results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2025.

2. Summary of Significant Accounting Policies

There have been no material changes in the Company’s significant accounting policies described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In August 2025, ORLYNVAH™ was launched in the United States and the Company began recording net product revenue, cost of goods sold and related accounts receivable. New accounting policies have been described below.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, the reported amounts of expenses during the reporting period and the assessment of the Company’s ability to continue as a going concern. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the valuation of the RLNs and the accounting for revenue allowances. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Actual results could differ materially from those estimates.

Specifically, management has estimated variables used to calculate the discounted cash flow analysis (DCF) to value the RLN liability (see Note 4 – Fair Value of Financial Assets and Liabilities) and made estimates in the accounting for revenue allowances (see Note 3 – Revenue).

Cash and Cash Equivalents

The Company’s cash and cash equivalents consist of cash balances and highly liquid investments with maturities of three months or less at the date of purchase. Accounts held at United States financial institutions are insured by the Federal Deposit Insurance Corporation up to $250, while accounts held at Irish financial institutions are insured under the Deposit Guarantee Scheme up to $117 (€100).

Cash accounts with any type of restriction are classified as restricted cash. If restrictions are expected to be lifted in the next twelve months, the restricted cash account is classified as current. Included within restricted cash on the Company’s condensed consolidated balance sheet is $15 and $17 as of September 30, 2025 and December 31, 2024, respectively, relating to the warrants issued on June 5, 2020 pursuant to the securities purchase agreement (June 3, 2020 SPA) from the June 3, 2020 registered direct offering (June 3, 2020 Offering), $4 and $6 as of September 30, 2025 and December 31, 2024, respectively, relating to the warrants issued on July 2, 2020 pursuant to the securities purchase agreement (June 30, 2020 SPA) from the June 30, 2020 registered direct offering (June 30, 2020 Offering) and $10 and $11 as of September 30, 2025 and December 31, 2024, respectively, relating to warrants issued in the underwritten offering in October 2020 (October 2020 Offering). On the closing date of each of the registered direct offerings on June 3, 2020 (June 3, 2020 Offering) and June 30, 2020 (June 30, 2020 Offering) and the underwritten offering in the October 2020 Offering, each investor deposited $0.01 per warrant issued being the nominal value of the underlying ordinary share represented by each warrant. This amount will be held in trust by the Company pending a decision by the relevant investor to exercise the warrant by means of a “cashless exercise” pursuant to the terms of the warrant, in which case the $0.01 will be used to pay up the nominal value of the ordinary share issued pursuant to the warrant. Upon the exercise of the warrants other than by means of a

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

"cashless exercise", the amount held in trust will be returned to the relevant investor in accordance with the terms of the applicable purchase agreement or prospectus.

Accounts Receivable

Accounts receivable are recorded net of any estimated expected credit losses. The Company's measurement of expected credit losses is based on relevant information about past events, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. No allowance for credit losses was recorded as of September 30, 2025.

Concentration of Credit Risk

Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company has most of its cash and cash equivalents at three accredited financial institutions in the United States and Ireland, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

The Company is also subject to credit risk related to its trade accounts receivable from product sales. ORLYNVAH™ is distributed primarily through a single retail pharmacy. The Company extends credit to its customer in the normal course of business after evaluating their overall financial condition, and subsequently through payment history and other factors.

Inventory

Inventory is stated at the lower of cost and net realizable value and consists of raw materials, work-in-progress and finished goods (see Note 5 – Inventory for further details). The Company began capitalizing inventory costs following FDA approval of ORLYNVAH™ on October 25, 2024. Inventory is valued on a first-in, first-out basis. The Company periodically reviews inventory for expiry and obsolescence and writes it down accordingly, if necessary. Prior to FDA approval of ORLYNVAH™, the Company expensed all inventory-related costs, including costs incurred for clinical development, to research and development costs in the period in which such costs were incurred.

Revenue Recognition

The Company’s revenue consists of product sales of ORLYNVAH™. See Note 3 – Revenue for more detail on product revenue.

The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. At contract inception, the Company assesses the goods or services promised within each contract, determines whether each promised good or service is distinct and identifies those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Cost of Goods Sold

Cost of goods sold consists primarily of direct and indirect costs related to the manufacture of ORLYNVAH™ for commercial sale, including third-party manufacturing costs, raw material and component costs, packaging services, distribution fees and royalties to Pfizer on product sales. Prior to the FDA approval of ORLYNVAH™ in October 2024, costs incurred for the manufacture of ORLYNVAH™ were recorded as research and development expenses and therefore are not included in cost of goods sold. As a result, the cost of goods sold related to ORLYNVAH™ will initially reflect a lower average per unit cost of materials, as previously expensed inventory is utilized and sold to customers.

Net Loss Per Ordinary Share

Basic and diluted net loss per ordinary share is determined by dividing net loss attributable to ordinary shareholders by the weighted-average ordinary shares outstanding during the period in accordance with Accounting Standard Codification (ASC) 260, Earnings per Share. For the periods presented, the following ordinary shares underlying the options, warrants and the Exchangeable Notes have been excluded from the calculation because they would be anti-dilutive.

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)


	Three and Nine Months Ended
	September 30, 2025		September 30, 2024
Options to purchase ordinary shares		940,664		913,988
Warrants		5,906,416		9,663,125
Exchangeable Notes		—		2,541,786
Total		6,847,080		13,118,899

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

On October 9, 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative (ASU 2023-06), which incorporates several disclosures and presentation requirements currently residing in SEC Regulations S-X and S-K. For entities subject to the existing SEC disclosure requirements, including those preparing for sale or issuance of securities, the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. For all other entities, the amendments will be effective two years later, with early adoption permitted. ASU 2023-06 is not expected to have a material impact on the consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which enhances the annual income tax disclosures for the effective tax rate reconciliation and income taxes paid. The amendments are effective for public business entities, for annual periods beginning after December 15, 2024 and for annual periods beginning after December 15, 2025 for all other entities. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The ASU applies on a prospective basis to annual financial statements for periods beginning after the effective date. However, retrospective application in all prior periods presented is permitted. The Company is assessing what impact ASU 2023-09 will have on the consolidated financial statements.

On November 4, 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (ASU 2024-03), which requires new disclosures to disaggregate prescribed natural expenses underlying any income statement caption. ASU 2024-03 is effective for annual periods in fiscal years beginning after December 15, 2026, and interim periods thereafter. Early adoption is permitted. ASU 2024-03 applies on a prospective basis for periods beginning after the effective date. However, retrospective application to any or all prior periods presented is permitted. The Company is currently assessing the impact ASU 2024-03 will have on the consolidated financial statements and disclosures.

On November 26, 2024, the FASB issued ASU 2024-04, Debt—Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments (ASU 2024-04), which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion. ASU 2024-04 is effective for all entities for annual and interim periods in fiscal years beginning after December 15, 2025. Early adoption is permitted for all entities that have adopted the amendments in ASU 2020-06. ASU 2024-04 is not expected to have a material impact on the consolidated financial statements.

On January 6, 2025, the FASB issued ASU 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date (ASU 2025-01), which amends the effective date of ASU 2024-03 to clarify that all public business entities are required to adopt the guidance in annual periods after December 15, 2026, and interim periods in fiscal years beginning after December 15, 2027.

On July 30, 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets (ASU 2025-05), which provides certain entities with an additional practical expedient and an accounting policy election for estimating expected credit losses on current accounts receivable and current contract assets arising from revenue transactions under ASC 606. This ASU is effective for all entities for annual and interim periods in fiscal years beginning after December 15, 2025. Early adoption is permitted for all entities. ASU 2025-05 is not expected to have a material impact on the consolidated financial statements.

3. Revenue

The Company’s revenue consists of product sales of ORLYNVAH™. ORLYNVAH™ was approved by the FDA in October 2024, and the Company began generating product revenue from sales of ORLYNVAH™ in August 2025. The Company uses a third

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

party logistics provider to fulfill orders of ORLYNVAH™ to the Company’s customers. The third party logistics provider performs services for the Company that include warehousing, distribution, order and accounts receivable management, and data management.

Product revenue is recorded with each sale at the transaction price, net of reserves for variable components, including but not limited to distribution service fees, prompt pay discounts, chargebacks, rebates, co-payment assistance and product returns, as applicable, which are collectively referred to as “Gross-to-Net Adjustments”. Estimates for Gross-to-Net Adjustments are reassessed each reporting period, and adjustments are recorded on a cumulative catch-up basis, which would affect product revenue and net income in the period of adjustment. Accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Accounts Receivable and Allowance policy in Note 2 – Summary of Significant Accounting Policies.

The Company utilizes the expected value method when estimating the amount of variable consideration to include in the transaction price with respect to each of the foregoing variable components. Variable consideration is included in the transaction price only to the extent it is probable that a significant revenue reversal will not occur when the uncertainty associated with the variable consideration is resolved.

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain Gross-to-Net Adjustments. The specific considerations that the Company uses in estimating the amounts related to Gross-to-Net Adjustments are as follows:

Distribution Service Fees. The Company pays distribution service fees to its retail pharmacy. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company considers these fees to be separate from the customer’s purchase of the product and, therefore, they are recorded in other current liabilities on the condensed consolidated balance sheets.

Prompt Pay Discounts. The Company incentivizes on time invoice payments through prompt pay discounts. Prompt pay discounts are typically taken by customers, so an estimate of the discount is recorded at the time of sale based on the purchased amount. Prompt pay discount estimates are recorded as contra accounts receivable on the condensed consolidated balance sheets.

Chargebacks. Certain government entities and covered entities (e.g. Veterans Administration, 340B covered entities) can purchase the product at a price discounted below WAC. The difference between the government or covered entity purchase price and WAC will be charged back to the Company. The Company estimates the amount of chargebacks based on the expected number of claims and the related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the condensed consolidated balance sheets.

Rebates. The Company provides commercial rebates to pharmacy benefit managers and managed care organizations and is subject to mandatory discount obligations under the Medicare, Medicaid, and Tricare programs. The rebate amounts for these programs are determined by contractual arrangements or statutory requirements. Rebates are owed after the product has been dispensed to a patient and the Company has been invoiced. The Company estimates the amount in rebates based on the expected number of claims and the related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the condensed consolidated balance sheets.

Co-payment Program. The Company offers co-payment assistance programs to commercially insured patients whose insurance requires a co-payment to be made when filling their prescription. The Company estimates the amount of co-payment assistance based on the expected volume and the average buy down rate associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Co-payment program estimates are recorded as other current liabilities on the condensed consolidated balance sheets.

Product Returns. Customers have the right to return damaged product, product that is within six months or less of the labeled expiration date, or product that is past the expiration date by no more than twelve months. ORLYNVAH™ was commercially launched in August 2025 and due to the lack of historical sales and returns data, the Company used professional judgment and industry data to estimate returns. As time passes and historical data becomes available, the Company will use historical sales and returns data to estimate future product returns. No reserve for potential product returns was deemed necessary at September 30, 2025.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

The carrying amounts reported in the condensed consolidated balance sheets for accounts receivable, inventory, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities approximate their fair value based on the short-term maturity of these instruments.

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

The following table presents information about the Company’s RLNs, promissory note to Pfizer (the Promissory Note) and Exchangeable Notes and indicates the fair value hierarchy of the valuation inputs utilized to determine the approximate fair value:


September 30, 2025	Book		Approximate
Current Liabilities	Value		Fair Value		Level 1		Level 2		Level 3
Royalty-linked notes
Short-term royalty-linked notes	$	281	$	281	$	—	$	—	$	281
Total current liabilities	$	281	$	281	$	—	$	—	$	281

Long-term Liabilities
Promissory Note
Long-term promissory note	$	21,215	$	21,619	$	—	$	21,619	$	—
Revenue Futures
Royalty-linked notes		12,239		12,239		—		—		12,239
Total long-term liabilities	$	33,454	$	33,858	$		$	21,619	$	12,239

December 31, 2024	Book		Approximate
Current Liabilities	Value		Fair Value		Level 1		Level 2		Level 3
Exchangeable Notes
Short-term exchangeable notes	$	14,463	$	14,444	$	—	$	14,444	$	—
Total current liabilities	$	14,463	$	14,444	$	—	$	14,444	$	—

Long-term Liabilities
Promissory Note
Long-term promissory note	$	20,300	$	20,412	$	—	$	20,412	$	—
Revenue Futures
Royalty-linked notes		10,771		10,771		—		—		10,771
Total long-term liabilities	$	31,071	$	31,183	$	—	$	20,412	$	10,771

The fair value of the Promissory Note was determined using DCF analysis using the effective interest rate calculated following the modification of the original license agreement with Pfizer for the worldwide exclusive rights to research, develop, manufacture and commercialize sulopenem (Pfizer License), which represents a Level 2 basis of fair value measurement (see Note 11 – Debt).

The fair value of Exchangeable Notes was determined using DCF analysis using the fixed interest rate outlined in the indenture governing the Exchangeable Notes (Exchangeable Notes Indenture), without consideration of transaction costs, which represents a Level 2 basis of fair value measurement.

The Level 3 liabilities held as of September 30, 2025 consist of a separate financial instrument that was issued as part of the Units, the RLNs (see Note 12 – Royalty-Linked Notes).

At any time on or after January 21, 2021 through January 31, 2025, subject to specified limitations, the Exchangeable Notes were exchangeable for the Company’s ordinary shares, cash or a combination of ordinary shares and cash. Beginning on January 21, 2021 to January 31, 2025, certain noteholders of $40,691 aggregate principal amount of Exchangeable Notes completed a non-cash exchange of their notes for an aggregate of 3,760,155 of the Company’s ordinary shares, which included accrued and unpaid interest relating to such notes. On January 31, 2025, the Exchangeable Notes matured and Iterum Bermuda repaid to the holders thereof an aggregate principal amount of $11,117 together with accrued interest of $3,628.

The RLN liability is carried at fair value on the condensed consolidated balance sheet (see Note 12 – Royalty-Linked Notes). The total fair value of $12,520 was determined using DCF analysis, without consideration of transaction costs, which represents a Level 3 basis of fair value measurement. The key inputs to valuing the RLNs were the terms of the indenture governing the RLNs (the RLN Indenture), the expected cash flows to be received by holders of the RLNs based on management’s revenue forecasts of U.S. sulopenem sales and a risk-adjusted discount rate to derive the net present value of expected cash flows. The RLNs will be subject to a maximum return amount, including all principal and payments and certain default interest in respect of uncurable defaults, of $160.00 (or 4,000 times the principal amount of such note). The discount rate applied to the model was 22%. Fair value measurements are highly sensitive to changes in these inputs and significant changes in these inputs could result in a significantly higher or lower fair value.

There have been no transfers of assets or liabilities between the fair value measurement levels.

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

5. Inventory


	September 30, 2025		December 31, 2024
Raw materials	$	95	$	—
Work-in-progress		106		—
Finished Goods		948		—
	$	1,149	$	—

Inventory is stated at the lower of cost and net realizable value and consists of raw materials, work-in-progress and finished goods. The Company began capitalizing inventory costs following FDA approval of ORLYNVAH™ in October 2024, and inventory production commenced in February 2025. The Company has not recorded any inventory write-downs for the nine months ended September 30, 2025. No allowance for excess, damaged, and obsolete inventory was recorded at September 30, 2025. The Company currently uses a limited number of third-party contract manufacturing organizations to produce its inventory.

6. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:


	September 30, 2025		December 31, 2024
Other prepaid assets	$	434	$	138
Prepaid insurance		404		389
Prepaid research and development expenses		192		4
Research and development tax credit receivable		98		18
Right of use assets, net		—		65
Total	$	1,128	$	614

7. Intangible Asset, net

Intangible asset and related accumulated amortization are as follows:


	September 30, 2025			December 31, 2024
Gross intangible asset	$	20,000		$	20,000
Less: accumulated amortization		(1,290	)		(254	)
	$	18,710		$	19,746

On November 18, 2015, the Company and Iterum Therapeutics International Limited (ITIL), a wholly owned subsidiary of the Company, entered into the Pfizer License. Under the Pfizer License, ITIL agreed to make certain regulatory and sales payments, including a regulatory milestone payment of $20,000 to Pfizer upon approval of ORLYNVAH™ by the FDA for commercial sale in the United States. On October 25, 2024, the Company received FDA approval for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections in adult women who have limited or no alternative oral antibacterial treatment options, and the regulatory milestone payment was capitalized on that date. The milestone payment is being amortized over a period of 14.4 years based on the patent life of ORLYNVAH™. The Company deferred this payment for a two-year period, at an annual rate of eight percent on a daily compounded basis until paid in full, which was amended and restated on May 13, 2025 for an additional three-year deferral period, at an annual rate of ten percent for the extended deferral period, beginning on October 26, 2026, as permitted pursuant to the terms of the Pfizer License.

Amortization expense for the nine months ended September 30, 2025 was $1,036.

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

The estimated future amortization related to intangible assets included on the condensed consolidated balance sheet as of September 30, 2025 for the following five fiscal years and thereafter were as follows:


Due in 12 month period ending Sept 30,
2026	$	1,389
2027		1,389
2028		1,389
2029		1,389
2030		1,389
Thereafter		11,765
	$	18,710

8. Property and Equipment, net

Property and equipment and related accumulated depreciation are as follows:


	September 30, 2025			December 31, 2024
Leasehold improvements	$	—		$	148
Furniture and fixtures		—			120
Computer equipment		109			95
		109			363
Less: accumulated depreciation		(91	)		(340	)
	$	18		$	23

Depreciation expense was $19 and $23 for the nine months ended September 30, 2025 and 2024, respectively. In addition, accumulated depreciation decreased by $148 due to the removal of fully depreciated leasehold improvements and $120 due to the removal of fully depreciated furniture and fixtures during the nine months ended September 30, 2025 and $5 due to the removal of fully depreciated computer equipment during the nine months ended September 30, 2024.

9. Leases

The Company did not hold any operating leases at September 30, 2025 and previously held operating leases for office premises and a printer.

Operating lease expenses were recognized on a straight-line basis over the lease term. The Company recognized $0 and $65 of operating lease costs for right-of-use assets during the three and nine months ended September 30, 2025 respectively, and $101 and $299 of operating lease costs for right-of-use assets during the three and nine months ended September 30, 2024, respectively. The Company recognized $22 and $32 of rental expense on short-term leases during the three and nine months ended September 30, 2025, respectively. No rental expense was recognized on short-term leases during the three and nine months ended September 30, 2024.

Information related to the Company’s right-of-use assets and related lease liabilities is as follows:


	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2025		September 30, 2024		September 30, 2025		September 30, 2024
Cash paid for operating lease liabilities	$	—	$	101	$	68	$	301


	September 30, 2025			December 31, 2024
Weighted-average remaining lease term	0.09 years			0.39 years
Weighted-average discount rate		10.0	%		11.5	%

There were no right-of-use assets and lease liabilities at September 30, 2025. Right-of-use assets and lease liabilities for the Company’s operating leases were recorded in the condensed consolidated balance sheet as follows at December 31, 2024, representing

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

the Company’s right to use the underlying asset for the lease term (Prepaid expenses and other current assets) and the Company’s obligation to make lease payments (Other current liabilities):


	December 31, 2024
Prepaid expenses and other current assets	$	65

Other current liabilities	$	67

10. Accrued Expenses

Accrued expenses consist of the following:


	September 30, 2025		December 31, 2024
Accrued commercial expenses	$	2,865	$	—
Accrued manufacturing expenses		1,228		1,148
Accrued payroll and bonus expenses		882		1,138
Accrued other expenses		241		365
Total	$	5,216	$	2,651

11. Debt

2025 Exchangeable Notes

On January 21, 2020, the Company completed a Private Placement pursuant to which its wholly owned subsidiary, Iterum Bermuda issued and sold $51,588 aggregate principal amount of Exchangeable Notes and $103 aggregate principal amount of RLNs to a group of accredited investors. On September 8, 2020, the Company completed a rights offering (the 2020 Rights Offering) pursuant to which Iterum Bermuda issued and sold $220 aggregate principal amount of Exchangeable Notes and $0.5 aggregate principal amount of RLNs, to existing shareholders. The Securities were sold in Units with each Unit consisting of an Exchangeable Note in the original principal amount of $1,000 and 50 RLNs. The Units were sold at a price of $1,000 per Unit.

At any time on or after January 21, 2021, subject to specified limitations, the Exchangeable Notes were exchangeable for the Company’s ordinary shares, cash or a combination of ordinary shares and cash. Any accrued and unpaid interest being exchanged was calculated to include all interest accrued on the Exchangeable Notes being exchanged to, but excluding, the exchange settlement date. Beginning on January 21, 2021 through January 31, 2025, certain noteholders of $40,691 in aggregate principal amount of Exchangeable Notes completed a non-cash exchange of their notes, including accrued and unpaid interest of $3,071, for an aggregate of 3,760,155 of the Company’s ordinary shares. On January 31, 2025, the Exchangeable Notes matured and Iterum Bermuda repaid in full to the holders thereof an aggregate principal amount of $11,117 together with accrued interest of $3,628.

The Company did not recognize any interest expense related to the Exchangeable Notes during the three months ended September 30, 2025 and recognized $88 of interest expense related to the Exchangeable Notes during the nine months ended September 30, 2025 and the Company recognized $181 and $542 of interest expense related to the Exchangeable Notes during the three and nine months ended September 30, 2024, respectively. The Company did not recognize any amortization of debt discounts and deferred financing costs during the three months ended September 30, 2025 and recognized $194 related to the amortization of the debt discounts and deferred financing costs during the nine months ended September 30, 2025, and $575 and $1,713 related to the amortization of the debt discounts and deferred financing costs during the three and nine months ended September 30, 2024, respectively. These amounts are recorded in interest expense, net in the condensed consolidated statements of operations and comprehensive loss.

Pfizer Promissory Note

On November 18, 2015, the Company and ITIL entered into the Pfizer License. Under the Pfizer License, ITIL agreed to make certain regulatory and sales milestone payments, including a regulatory milestone payment of $20,000 to Pfizer upon approval of oral sulopenem for commercial sale in the United States by the FDA. On October 25, 2024, the Company received FDA approval for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

On October 28, 2024, the Company notified Pfizer that it was electing to defer payment of the milestone payment for two years, or until October 25, 2026 (the Deferral Period), and delivered the Promissory Note issued by ITIL in the amount of the milestone payment to Pfizer, as permitted pursuant to the terms of the Pfizer License. The Promissory Note bears interest at an annual rate of eight percent (8.0%) on a daily compounded basis until paid in full and matures on October 25, 2026. ITIL has the right to prepay the unpaid principal balance of the Promissory Note together with accrued and unpaid interest at any time without premium or penalty. Pursuant to the terms of the Promissory Note, ITIL may (i) assign the Promissory Note to an affiliate of ITIL; (ii) designate one of its affiliates to perform its obligations thereunder; or (iii) assign the Promissory Note in the event of a change of control, provided that in the case of clauses (i) and (ii) ITIL is not relieved of any liability thereunder. Pursuant to the terms of the Pfizer License, if a change of control of ITIL or the Company occurs during the Deferral Period, Pfizer may, in its sole discretion and at its sole option, declare the milestone payment to be immediately due and payable together with all interest accrued under the Promissory Note. The Company has guaranteed all of the amounts payable by ITIL under the terms of the Pfizer License, including the amounts owed under the Promissory Note, pursuant to the guarantee entered into by and among ITIL, the Company and Pfizer on November 18, 2015 in connection with the Pfizer License.

On May 13, 2025, the Company and ITIL entered into an amended and restated promissory note (the A&R Note) and a letter agreement relating to the A&R Note and amending the Pfizer License Agreement in connection therewith (the Letter Agreement). The A&R Note extends the Deferral Period by an additional three years, or until October 25, 2029 (the Extended Deferral Period). In connection with the extension to the Deferral Period, ITIL agreed in the A&R Note to increase the annual rate of interest from eight percent (8%) to ten percent (10%) on a daily compounded basis during the Extended Deferral Period, beginning on October 26, 2026. The Company evaluated the A&R Note and the Letter Agreement under ASC 470 and determined that it should be accounted for as a debt modification as the cash flows under the amended terms do not differ by at least 10% from the cash flows under the original agreement. Accordingly, no gain or loss was recorded relating to the modification.

The Company recognized $562 and $1,415 of interest expense related to the Pfizer Promissory Note during the three and nine months ended September 30, 2025, respectively.

Principal Payments on Outstanding Debt

Scheduled principal payments on outstanding debt, including principal amounts owed to RLN holders (see Note 12 – Royalty-Linked Notes), as of September 30, 2025, for the following five fiscal years and thereafter were as follows:


Year Ending Sept 30,
2026	$	—
2027		—
2028		—
2029		20,000
2030		—
Thereafter		45
Total	$	20,045

12. Royalty-Linked Notes

Liability Related to Sale of Future Royalties

On January 21, 2020, as part of the Private Placement, the Company issued 2,579,400 RLNs to a group of accredited investors. On September 8, 2020, as part of the 2020 Rights Offering, the Company issued 11,000 RLNs to existing shareholders. The RLNs will entitle the holders thereof to payments, at the applicable payment rate, based solely on a percentage of the Company’s net revenues from U.S. sales of specified sulopenem products earned through December 31, 2045, but will not entitle the holders thereof to any payments unless the Company earns net revenues on such approved sulopenem product. If any portion of the principal amount of the outstanding RLNs, equal to $0.04 per RLN, has not been paid as of the end date on December 31, 2045, Iterum Bermuda must pay the unpaid portion of the principal amount. The RLNs will earn default interest if the Company breaches certain obligations under the RLN Indenture (but do not otherwise bear interest) and will be subject to a maximum return amount, including all principal and payments and certain default interest in respect of uncurable defaults, of $160.00 (or 4,000 times the principal amount of such note). The RLNs will be redeemable at the Company’s option, subject to the terms of the RLN Indenture.

In accordance with exceptions allowed under ASC 815-10, Derivatives and Hedging (ASC 815), this transaction was initially accounted for as a debt liability under ASC 470, Debt. Subsequent to the listing of the RLNs on the Bermuda Stock Exchange in January 2021, the RLNs are accounted for as a derivative and are remeasured to fair value at each reporting date. In accordance with ASC 815, the fair value of the RLNs is determined using DCF analysis, without consideration of transaction costs, which represents a Level 3 basis of fair value measurement. Fair value measurements are highly sensitive to changes in inputs and significant changes to

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

inputs can result in a significantly higher or lower fair value. The Company periodically assesses the revenue forecasts of the specified sulopenem products and the related payments. The Company has no obligation to pay any amount to the noteholders until the net revenue of the specified products are earned.

The balance of the RLNs at each reporting date is as follows:


	September 30, 2025
Total liability related to the sale of future royalties, on inception	$	10,990
Liability related to the sale of future royalties, arising from the 2020 Rights Offering		51
Amortization of discount and debt issuance costs		3,666
Adjustments to fair value		(2,129	)
Repayments		(58	)
Total liability related to the sale of future royalties at Sept 30, 2025	$	12,520
Current Portion		281
Long-term Portion	$	12,239

	December 31, 2024
Total liability related to the sale of future royalties, on inception	$	10,990
Liability related to the sale of future royalties, arising from the 2020 Rights Offering		51
Amortization of discount and debt issuance costs		3,666
Adjustments to fair value		(3,936	)
Total liability related to the sale of future royalties at December 31, 2024	$	10,771
Current Portion		—
Long-term Portion	$	10,771

13. Segment Reporting

In accordance with FASB ASC Topic 280, Segment Reporting, the Company has determined that it operates as a single business segment, which is the development and commercialization of innovative treatments for drug resistant bacterial infections. The financial results of the Company’s operations are managed and reported to the Chief Executive Officer, Chief Financial Officer and Chief Commercial Officer, who together are considered the Company’s chief operating decision maker (CODM), on a consolidated basis. The CODM assesses performance and allocates resources based on the Company’s condensed consolidated statements of operations and key components and processes of the Company’s operations are managed centrally. Segment asset information is not used by the CODM to allocate resources.

As a single reportable segment entity, the Company’s segment performance measure is net income / (loss) attributable to shareholders. Significant segment expenses, as provided to the CODM, are presented below:


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2025			2024			2025			2024
Product Revenue, net	$	390		$	—		$	390		$	—
Segment cost of sales		(20	)		—			(20	)		—
Amortization of intangible asset (a)		—			—			—			—
Segment research and development (b) (c)		(1,244	)		(3,077	)		(2,795	)		(8,998	)
Segment selling, general and administration (b) (c)		(6,449	)		(1,734	)		(13,320	)		(5,731	)
Share-based compensation expense (see Note 15)		(53	)		(68	)		(170	)		(274	)
Depreciation and amortization		(355	)		(8	)		(1,055	)		(23	)
Operating loss	$	(7,731	)	$	(4,887	)	$	(16,970	)	$	(15,026	)

Amortization expense of $349 and $1,036 related to the Pfizer Intangible Asset has been excluded for the three and nine months ended September 30, 2025, respectively, and included within depreciation and amortization.

Share-based payment expense of $15 and $50 related to research and development and $38 and $120 related to general and administration have been excluded for the three and nine months ended September 30, 2025, respectively, and included within share-based compensation expense. Share-based payment expense of $25 and $147 related to research and

ITERUM THERAPEUTICS PLC

Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share data)

development and $43 and $127 related to general and administration have been excluded for the three and nine months ended September 30, 2024, respectively, and included within share-based compensation expense.

Depreciation expense of $2 and $7 related to research and development and $4 and $12 related to general and administration have been excluded for the three and nine months ended September 30, 2025, respectively, and included within depreciation and amortization. Depreciation expense of $5 and $14 related to research and development and $3 and $9 related to general and administration have been excluded for the three and nine months ended September 30, 2024, respectively, and included within depreciation and amortization.

Interest Expense, Net


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2025			2024			2025			2024
Interest income	$	121		$	166		$	406		$	607
Interest expense		(562	)		(756	)		(1,697	)		(2,255	)
Interest expense, net	$	(441	)	$	(590	)	$	(1,291	)	$	(1,648	)

Long-Lived Assets

The distribution of long-lived assets by geographical area was as follows:


Long-lived assets	September 30, 2025		December 31, 2024
Ireland	$	18,736	$	19,759
U.S.		11		15
Total	$	18,747	$	19,774

14. Shareholders’ Equity

The Company’s capital structure consists of ordinary shares and undesignated preferred shares. Under Irish law, the Company is prohibited from allotting shares without consideration. Accordingly, at least the nominal value of the shares issued underlying any warrant, pre-funded warrant, restricted share award, restricted share unit, performance share award, bonus share or any other share-based grant must be paid pursuant to the Irish Companies Act 2014 (Irish Companies Act).

Ordinary Shares

On April 28, 2025, the Company entered into a securities purchase agreement with an institutional investor pursuant to which it issued and sold an aggregate of (i) 3,040,000 ordinary shares, at a purchase price of $0.90 per ordinary share, and (ii) pre-funded warrants to purchase up to an aggregate of 2,515,556 ordinary shares at a purchase price of $0.89 per pre-funded warrant. The Company’s gross proceeds from the April 2025 Registered Direct Offering were $5,000 and net proceeds were $4,177 after deducting placement agent fees and offering expenses payable by the Company. Upon closing, the pre-funded warrants became exercisable immediately at an exercise price of $0.01 per ordinary share, subject to adjustment in certain circumstances, and will expire when exercised in full, subject to certain conditions. As of September 30, 2025, all pre-funded warrants issued in connection with the April 28, 2025 Offering had been exercised.

On August 9, 2024, the Company completed the 2024 Rights Offering in which it sold an aggregate of 6,121,965 2024 Units. Aggregate gross proceeds to the Company from the 2024 Rights Offering were $7,408 and net proceeds were $5,430 after deducting fees payable to the dealer-manager and other offering expenses payable by the Company.

At the Company’s annual general meeting of shareholders on May 3, 2023, the Company’s shareholders approved an increase of 60,000,000 ordinary shares of $0.01 par value each to the number of authorized ordinary shares and the Company’s Articles of Association were amended accordingly. The Company has authorized ordinary shares of 80,000,000

Iterum Therapeutics plc 10-Q