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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 No. 001-38944

Akero Therapeutics, Inc.

(Exact name of registrant as specified in its charter)


Delaware		81-5266573
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

601 Gateway Boulevard, Suite 350

South San Francisco, CA 94080

(650) 487-6488

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

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



Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	AKRO	The Nasdaq Global Select 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 November 3, 2025, the registrant had 82,316,179 shares of common stock, $0.0001 par value per share, outstanding.

Table of Contents

SUMMARY OF THE MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS

Our business is subject to numerous risks and uncertainties, including those described in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q. The principal risks and uncertainties affecting our business includes:

•

We may not complete the pending transaction with Novo Nordisk A/S, a Danish aktieselskab (“Novo”) within the time frame we anticipate or at all, which could have an adverse effect on our business, financial results, and/or operations.

•

While the Merger Agreement (as defined below) is in effect, we are subject to restrictions on our business activities, which may prevent us from pursuing strategic business opportunities and taking other actions we may consider advantageous.

•

The pendency of the transaction with Novo could adversely affect our business, financial results and/or operations, including by adversely affecting business relationships with employees and third parties and by diverting the attention of management from day-to-day operations.

•

In certain instances, the Merger Agreement requires us to pay a termination fee to Novo, which could require us to use available cash that would have otherwise been available for general corporate purposes.

•

We have incurred, and will continue to incur, direct and indirect costs as a result of the pending transaction with Novo.

•

Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, including difficulties in identifying patients with metabolic dysfunction-associated steatohepatitis (“MASH,” formerly known as nonalcoholic steatohepatitis), significant competition for recruiting such patients in clinical trials, and restrictions on patients and investigators related to outbreaks of infectious diseases or public health crises.

•

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

•

Failures or delays in the commencement or completion of, or ambiguous or negative results from our planned clinical trials of our product candidates could result in increased costs to us and could delay, prevent, or limit our ability to generate revenue and continue our business.

•

Clinical development is uncertain and our clinical trials for efruxifermin (“EFX”) and any future product candidates may experience delays, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on our business.

•

We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates.

•

The manufacture of our product candidates is complex and we may encounter difficulties in production. If we or any of our third-party manufacturers encounter such difficulties, or fail to meet rigorously enforced regulatory standards, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.

•

We are heavily dependent on the success of EFX, our only product candidate.

•

If we fail to develop and successfully commercialize other product candidates, our business and future prospects may be harmed and our business will be more vulnerable to any problems that we encounter in developing and commercializing our product candidate.

•

We may develop EFX, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks.

•

If we are not successful in discovering, developing, receiving regulatory approval for and commercializing EFX and any future product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.

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•

We may be required to make significant payments under our license agreement for EFX.

•

The regulatory approval processes of the U.S. Food and Drug Administration (the “FDA”) and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. Our inability to obtain regulatory approval for EFX or any future product candidate would substantially harm our business.

•

Even if we are able to obtain regulatory approvals for our product candidate or any future product candidates, if they exhibit harmful side effects after approval, our regulatory approvals could be revoked or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims.

•

Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which, if violated, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

•

We have incurred significant losses since our inception and we expect to incur losses for the foreseeable future.

•

We currently have a limited operating history, have not generated any revenue to date, and may never become profitable.

•

We will require additional capital to finance our operations, which may not be available to us on acceptable terms, or at all. As a result, we may not complete the development and commercialization of our product candidate or develop any future product candidates.

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		Page
PART I.	FINANCIAL INFORMATION
Item 1.	Condensed Consolidated Financial Statements	7
	Condensed Consolidated Balance Sheets (Unaudited)	7
	Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)	8
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) (Unaudited)	9
	Condensed Consolidated Statements of Cash Flows (Unaudited)	11
	Notes to Unaudited Condensed Consolidated Financial Statements	12
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	28
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	38
Item 4.	Controls and Procedures	38
PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	40
Item 1A.	Risk Factors	40
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	92
Item 3.	Defaults Upon Senior Securities	92
Item 4.	Mine Safety Disclosures	92
Item 5.	Other Information	92
Item 6.	Exhibits	93
Signatures		94

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, among other things, statements about:

•

the proposed Merger (as defined below) with Novo;

•

the success, cost and timing of our product development activities and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;

•

our ability to successfully enroll, conduct and complete the three parallel, randomized, placebo-controlled, global clinical trials of our Phase 3 SYNCHRONY program, including our ability to reach agreement with the FDA and other regulatory authorities on clinical trial designs

•

the impact of geopolitical tensions, such as the increasing conflict in the Middle East, including between India and Pakistan, on clinical trial sites, such as those in India, Israel and Turkey where clinical sites have been activated to participate in our Phase 3 SYNCHRONY program;

•

our ability to maintain our expected timeline for reporting primary endpoint results of the Phase 3 program called SYNCHRONY, which is comprised of three ongoing clinical trials (Outcomes, Histology, and Real-World);

•

the potential for another pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, to disrupt our business plans, product development activities, ongoing clinical trials, including the timing and enrollment of patients, the health of our employees and the strength of our supply chain;

•

our ability to advance any product candidate into or successfully complete any clinical trial;

•

our ability to successfully manufacture our product candidates for future clinical trials or for commercial use, if approved;

•

the potential for our identified research priorities to advance our technologies;

•

our ability to obtain and, if obtained, maintain regulatory approval of EFX or any future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate;

•

the ability to license additional intellectual property relating to any future product candidates and to comply with our existing license agreement;

•

our ability to commercialize our products in light of the intellectual property rights of others;

•

the success of competing therapies that are or become available;

•

our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;

•

the commercialization of our product candidates, if approved;

•

our plans to research, develop and commercialize our product candidates;

•

our ability to attract collaborators with development, regulatory and commercialization expertise;

•

future agreements with third parties in connection with the commercialization of our product candidates and any other approved product;

•

the size and growth potential of the markets for our product candidates, and our ability to serve those markets;

•

the rate and degree of market acceptance of our product candidates, if approved;

•

regulatory developments in the United States and foreign countries;

•

our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

•

our ability to attract and retain key scientific or management personnel;

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•

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

•

the impact of unstable global economic and geopolitical conditions, including trade restrictions such as sanctions, tariffs, reciprocal and retaliatory tariffs, and other tariff-related measures; regulatory requirements, legal actions, or enforcement; and inflation rates on our business, financial condition and results of operation;

•

the impact of laws and regulations; and

•

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q, particularly in the “Risk Factors” section, that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or into which we may enter.

You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed or incorporated by reference as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

NOTE REGARDING TRADEMARKS

Akero Therapeutics, Inc. is the owner of the AKERO trademark, as well as certain other trademarks, including design versions of some of these trademarks. The symbols ™ and ® are not used in connection with the presentation of these trademarks in this report and their absence does not indicate a lack of trademark rights. Certain other trademarks used in this report are the property of third-party trademark owners and may be presented with or without trademark references.

All brand names or trademarks appearing in this report are the property of their respective owners. Unless the context requires otherwise, references in this report to “Akero,” the “Company,” “we,” “us,” and “our” refer to Akero Therapeutics, Inc. and its subsidiary.

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PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

Akero Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)


	September 30, 2025			December 31, 2024
ASSETS
Current assets:
Cash and cash equivalents	$	176,032		$	340,238
Short-term marketable securities		561,794			402,840
Prepaid expenses and other current assets		16,709			27,302
Total current assets		754,535			770,380
Long-term marketable securities		250,490			54,751
Right of use asset		552			755
Total assets	$	1,005,577		$	825,886
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	20,399		$	9,027
Accrued expenses and other current liabilities		27,252			30,727
Total current liabilities		47,651			39,754
Loan payable, noncurrent		—			35,297
Warrant liability		—			194
Operating lease liability, noncurrent		289			529
Total liabilities		47,940			75,774
Commitments and contingencies (Note 12)
Stockholders’ equity:
Common stock, $0.0001 par value, 150,000,000 shares authorized as of September 30, 2025 and December 31, 2024; 80,149,218 and 72,383,013 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively		8			7
Additional paid-in capital		2,004,755			1,575,313
Accumulated other comprehensive income		1,826			948
Accumulated deficit		(1,048,952	)		(826,156	)
Total stockholders’ equity		957,637			750,112
Total liabilities and stockholders’ equity	$	1,005,577		$	825,886

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

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Akero Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Operating expenses:
Research and development	$	78,883		$	72,232		$	217,704		$	178,204
General and administrative		11,353			9,471			34,287			29,194
Total operating expenses		90,236			81,703			251,991			207,398
Loss from operations		(90,236	)		(81,703	)		(251,991	)		(207,398	)
Interest expense		(1,092	)		(1,246	)		(3,418	)		(3,468	)
Loss on Extinguishment of Loan Payable		(1,557	)		—			(1,557	)		—
Interest and other income, net		11,319			10,244			34,170			28,830
Net loss		(81,566	)		(72,705	)		(222,796	)		(182,036	)
Net unrealized gain on marketable securities		838			2,364			878			1,833
Comprehensive loss	$	(80,728	)	$	(70,341	)	$	(221,918	)	$	(180,203	)
Net loss per common share, basic and diluted	$	(0.99	)	$	(1.05	)	$	(2.76	)	$	(2.76	)
Weighted-average number of shares used in computing net loss per common share, basic and diluted		82,008,267			69,442,136			80,807,705			65,982,798

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

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Akero Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(In thousands, except share amounts)

(Unaudited)


					Additional		Accumulated Other						Total
	Common Stock				Paid-In-		Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Capital		Gain (Loss)			Deficit			Equity (Deficit)
Balances at December 31, 2023		55,754,445	$	6	$	1,109,126	$	270		$	(574,096	)	$	535,306
Exercise of stock options		233,321		—		1,769		—			—			1,769
Common stock issued for vested restricted stock units		10,663		—		—		—			—			—
Vested warrants issued pursuant to loan agreement		—		—		431		—			—			431
Issuance of common stock pursuant to At-The-Market (“ATM”) offering, net of issuance costs		500,000		—		10,604		—			—			10,604
Issuance of common stock pursuant to a follow-on offering, net of issuance costs		12,650,000		1		344,437		—			—			344,438
Stock-based compensation expense		—		—		7,398		—			—			7,398
Net unrealized loss on marketable securities		—		—		—		(349	)		—			(349	)
Net loss		—		—		—		—			(53,344	)		(53,344	)
Balances at March 31, 2024		69,148,429		7		1,473,765		(79	)		(627,440	)		846,253
Exercise of stock options		334		—		3		—			—			3
Common stock issued for vested restricted stock units		40,661		—		—		—			—			—
Issuance of common stock pursuant to ESPP purchases		16,244		—		324		—			—			324
Stock-based compensation expense		—		—		7,656		—			—			7,656
Net unrealized loss on marketable securities		—		—		—		(182	)		—			(182	)
Net loss		—		—		—		—			(55,987	)		(55,987	)
Balances at June 30, 2024		69,205,668		7		1,481,748		(261	)		(683,427	)		798,067
Exercise of stock options		367,615		—		3,131		—			—			3,131
Common stock issued for vested restricted stock units		41,304		—		—		—			—			—
Stock-based compensation expense		—		—		7,468		—			—			7,468
Net unrealized gain on marketable securities		—		—		—		2,364			—			2,364
Net loss		—		—		—		—			(72,705	)		(72,705	)
Balances at September 30, 2024		69,614,587	$	7	$	1,492,347	$	2,103		$	(756,132	)	$	738,325

Balances at December 31, 2024		72,383,013	$	7	$	1,575,313	$	948		$	(826,156	)	$	750,112
Exercise of stock options		438,460		—		7,396		—			—			7,396
Common stock issued for vested restricted stock units		40,789		—		—		—			—			—
Issuance of common stock and accompanying pre-funded warrants in a follow-on offering, net of issuance costs		6,427,170		1		377,780		—			—			377,781
Issuance of common stock pursuant to ATM offering, net of issuance costs		380,488		—		10,361		—			—			10,361
Stock-based compensation expense		—		—		8,784		—			—			8,784
Net unrealized gain on marketable securities		—		—		—		137			—			137
Net loss		—		—		—		—			(70,725	)		(70,725	)
Balances at March 31, 2025		79,669,920		8		1,979,634		1,085			(896,881	)		1,083,846
Exercise of stock options		160,301		—		3,062		—			—			3,062
Common stock issued for vested restricted stock units		69,787		—		—		—			—			—
Issuance of common stock pursuant to ESPP purchases		19,195		—		458		—			—			458
Stock-based compensation expense		—		—		9,055		—			—			9,055
Net unrealized (loss) on marketable securities		—		—		—		(97	)					(97	)
Net loss		—		—		—		—			(70,505	)		(70,505	)
Balances at June 30, 2025		79,919,203		8		1,992,209		988			(967,386	)		1,025,819

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Akero Therapeutics, Inc.

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) (continued)

(In thousands, except share amounts)

(Unaudited)


Exercise of stock options	177,573		—		3,285		—		—			3,285
Common stock issued for vested restricted stock units	52,442		—		—		—		—			—
Stock-based compensation expense	—		—		9,261		—		—			9,261
Net unrealized gain on marketable securities	—		—		—		838		—			838
Net loss	—		—		—		—		(81,566	)		(81,566	)
Balances at September 30, 2025	80,149,218	$	8	$	2,004,755	$	1,826	$	(1,048,952	)	$	957,637

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

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Akero Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)


	Nine Months Ended September 30,
	2025			2024
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(222,796	)	$		(182,036	)
Adjustments to reconcile net loss to net cash used in operating activities:					.
Stock-based compensation expense		27,100				22,522
Depreciation		—				3
Non-cash lease expense		203				188
Net amortization of premiums and discounts on marketable securities		(7,752	)			(10,106	)
Amortization of debt issuance costs and discount		543				433
Loss on extinguishment of loan payable		1,557				—
Fair value change in warrant liability		(194	)			526
Unrealized foreign exchange gain and loss		—				67
Acquired in-process research and development expense		—				999
Changes in operating assets and liabilities:
Prepaid expenses and other assets		10,593				(19,495	)
Accounts payable		11,379				18,118
Accrued expenses and other current liabilities		(3,500	)			5,955
Operating lease liability		(214	)			(191	)
Net cash (used in) operating activities		(183,081	)			(163,017	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of short-term and long-term marketable securities		(732,473	)			(436,316	)
Proceeds from maturities of short-term marketable securities		386,411				312,335
Purchase of in-process research and development		—				(999	)
Net cash (used in) investing activities		(346,062	)			(124,980	)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from the exercise of stock options		13,742				4,903
Proceeds from the issuance of common stock pursuant to employee stock purchase plan purchases		458				324
Proceeds from the issuance of common stock and pre-funded warrants in a follow-on public offering		378,350				—
Proceeds from the issuance of common stock in a follow-on public offering		—				344,839
Proceeds from the issuance of common stock pursuant to the ATM offering		10,361				10,604
Proceeds from loan payable		—				10,000
Repayment of loan payable		(37,398	)			—
Payment of debt and equity issuance costs		(576	)			(815	)
Net cash provided by financing activities		364,937				369,855
Net (decrease) increase in cash and cash equivalents		(164,206	)			81,858
Cash and cash equivalents at the beginning of the period		340,238				234,207
Cash and cash equivalents at the end of the period	$	176,032		$		316,065

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Cash paid for interest	$	3,216		$		2,948

NON-CASH INVESTING AND FINANCING INFORMATION:
Change in net unrealizable gain on marketable securities	$	878		$		1,833
Warrant liability costs reclassified to additional paid-in equity on vested warrants issued	$	—		$		431
Debt and equity issuance costs included in accounts payable and accrued expenses and other current liabilities	$	—		$		15

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

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Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

Nature of the business and basis of presentation

Akero Therapeutics, Inc., together with its wholly owned subsidiary Akero Securities Corporation (“Akero” or the “Company”), is a clinical-stage company dedicated to developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis, or MASH, formerly known as non-alcoholic steatohepatitis, or NASH. MASH is a severe form of metabolic dysfunction-associated steatotic liver disease, or MASLD, formerly known as nonalcoholic fatty liver disease, or NAFLD, characterized by inflammation and fibrosis in the liver that can progress to cirrhosis, liver failure, cancer and death. The Company’s lead product candidate, efruxifermin, or EFX, is an analog of fibroblast growth factor 21, or FGF21, which is an endogenously expressed hormone that protects against cellular stress and regulates metabolism of lipids, carbohydrates and proteins throughout the body. The Company has an ongoing, global Phase 3 program called SYNCHRONY, which is comprised of three clinical trials (Outcomes, Histology, and Real-World) with an expected total enrollment of about 3,500 patients, which is designed to support applications for marketing approval for patients with pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) due to MASH. The SYNCHRONY program builds on two biopsy-based Phase 2b trials in corresponding patient populations, with a combined total of over 300 patients treated for up to 96 weeks. Based on statistically significant fibrosis regression and MASH resolution among patients with either biopsy-confirmed pre-cirrhotic MASH (F2-F3) or compensated cirrhosis (F4) due to MASH, the Company believes EFX has the potential, if approved, to be an important medicine for treating MASH.

The Company is subject to risks and uncertainties common to mid-stage companies in the biotechnology industry, including, but not limited to, completion and success of clinical testing, preparation for a potential commercial launch of EFX, if approved, development by competitors of new technological innovations, compliance with governmental regulations, dependence on key personnel and protection of proprietary technology and the ability to secure additional capital to fund operations. EFX will require extensive clinical testing prior to regulatory approval and commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

Agreement and Plan of Merger

On October 9, 2025, the Company announced it entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Novo and NN Invest Sub, Inc, a Delaware corporation and a direct or indirect wholly owned subsidiary of Novo (“Merger Sub”), providing for the merger of Merger Sub with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly owned subsidiary of Novo (see Note 14).

Basis of presentation

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 after elimination of all intercompany accounts and transactions. All adjustments necessary for the fair presentation of the Company’s condensed consolidated financial statements for the periods presented have been reflected.

Liquidity

In accordance with Accounting Standards Update (“ASU”) No. 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 certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued.

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Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

Since its initial public offering (“IPO”) in June 2019, the Company has raised capital primarily through the sale of its common stock in follow-on public offerings, registered direct offerings and At-the-Market (“ATM”) offerings. The Company has incurred recurring losses since its inception, including net losses of $222,796 and $182,036 for the nine months ended September 30, 2025 and 2024, respectively, and net losses of $252,060 and $151,759 for the years ended December 31, 2024 and 2023, respectively. In addition, as of September 30, 2025, the Company had an accumulated deficit of $1,048,952. The Company expects to continue to generate operating losses for the foreseeable future. As of November 7, 2025, the issuance date of these condensed consolidated financial statements, the Company expects that its existing cash, cash equivalents, short-term and long-term marketable securities of $988,316 as of September 30, 2025, will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these condensed consolidated financial statements. If the Merger is not consummated, the Company expects that it will require additional funding to complete the clinical development of EFX, commercialize EFX, if it receives regulatory approval, and pursue in-licenses or acquisitions of other product candidates.

If the Merger is not consummated and the Company is unable to obtain additional funding, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all.

Summary of significant accounting policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements and the notes thereto in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 28, 2025. Except as reflected below, there were no changes to the Company’s significant accounting policies as described in the Annual Report on Form 10-K. Reflected in this note are updates to accounting policies, including the impact of the adoption of new policies.

Unaudited interim financial statements

The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in accordance with GAAP for interim financial reporting and as required by Regulation S-X, Rule 10-01. The unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2025 and 2024 are unaudited. The results for the three and nine months ended September 30, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025, any other interim periods, or any future year or period.

Use of estimates

The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the recognition of research and development expenses, stock-based compensation expense, warrant liabilities and the valuation allowance for deferred tax assets. 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 when there

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Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.

Concentrations of credit risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term and long-term marketable securities. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash investments in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. At September 30, 2025, all of the Company’s cash, cash equivalents, short-term and long-term investments were held at three accredited financial institutions.

Recently Adopted Accounting Pronouncements

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. Under ASU No. 2023-09, entities are required to uniformly classify and present greater disaggregation of information in the rate reconciliation and income taxes paid. ASU No. 2023-09 is intended to benefit investors by improving the transparency and decision usefulness of income tax disclosures. The new standard is effective for annual periods beginning after December 15, 2024. The Company adopted the ASU No. 2023-09 effective January 1, 2025. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures.

Recently Issued Accounting Standards Not Yet Adopted

In November 2024 and January 2025, the FASB issued ASU No. 2024-03 and ASU No. 2025-01, Comprehensive Income - Expense Disaggregation Disclosures, which will improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses in commonly presented expense captions such as cost of sales, selling, general and administrative, and research and development. The amendments are effective for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted for annual financial statements that have not yet been issued or made available. The amendments should be applied on either (1) prospectively to financial statements issued for reporting periods after the effective date or (2) retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the provisions of the amendments and the effect on its future condensed consolidated financial statements.

3. Fair value measurements

Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the

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Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

•

Level 1—Quoted prices in active markets for identical assets or liabilities.

•

Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

•

Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The following is a summary of the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2025 and December 31, 2024:


	September 30, 2025
	Total		Level 1		Level 2		Level 3
Money market funds	$	140,729	$	140,729		—		—
U.S. Treasury securities		545,474		545,474		—		—
U.S. Government agency securities		54,774		—		54,774		—
Commercial paper		29,969		—		29,969		—
Corporate debt securities		202,033		—		202,033		—
Total assets	$	972,979	$	686,203	$	286,776	$	—

	December 31, 2024
	Total		Level 1		Level 2		Level 3
Money market funds	$	314,092	$	314,092	$	—	$	—
U.S. Treasury securities		248,885		248,885		—		—
U.S. Government agency securities		60,691		—		60,691		—
Commercial paper		34,544		—		34,544		—
Corporate debt securities		113,471		—		113,471		—
Total assets	$	771,683	$	562,977	$	208,706	$	—

Warrant liabilities	$	194	$	—	$	—	$	194
Total liabilities	$	194	$	—	$	—	$	194

Level 2 assets were valued by the Company using quoted prices in active markets for similar securities.

The carrying values of the Company’s prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. During the nine months ended September 30, 2025 and the twelve months ended December 31, 2024, there were no transfers between Level 1, Level 2 and Level 3.

The value of the Loan Payable approximated its fair value as of December 31, 2024 and was classified as a Level 3 liability as of that date. The Company estimated the fair value of the warrant liabilities as of December 31, 2024 using the Black-Scholes model based on key assumption and inputs (see Note 6). The Company utilized a probability assessment to estimate the likelihood of vesting for the remaining Loan Agreement warrants and allocated the probability of occurrence percentage to the fair value calculated.

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Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

4. Short and long-term marketable securities

The following is a summary of short-term and long-term marketable securities as of September 30, 2025 and December 31, 2024:


	September 30, 2025
	Amortized cost		Gross unrealized gains		Gross unrealized losses			Credit losses		Fair value
Money market funds	$	140,729		—		—		$	—	$	140,729
U.S. Treasury securities		544,143		1,342		(12	)		—		545,473
U.S. Government agency securities		54,748		27		—			—		54,775
Commercial paper		29,969		1		—			—		29,970
Corporate debt securities		201,564		468		—			—		202,032
Total	$	971,153	$	1,838	$	(12	)	$	—	$	972,979

Cash equivalents										$	160,695
Short-term marketable securities											561,794
Long-term marketable securities											250,490
Total										$	972,979

	December 31, 2024
	Amortized cost		Gross unrealized gains		Gross unrealized losses			Credit losses		Fair value
Money market funds	$	314,092	$	—	$	—		$	—	$	314,092
U.S. Treasury securities		248,202		738		(55	)		—		248,885
U.S. Government agency securities		60,596		95		—			—		60,691
Commercial paper		34,500		45		(1	)		—		34,544
Corporate debt securities		113,346		141		(16	)		—		113,471
Total	$	770,736	$	1,019	$	(72	)	$	—	$	771,683

Cash equivalents										$	314,092
Short-term marketable securities											402,840
Long-term marketable securities											54,751
Total										$	771,683

The following table presents the contractual maturities of the Company’s short-term and long-term marketable securities as of September 30, 2025 and December 31, 2024.


	September 30, 2025		December 31, 2024
Due within one year	$	561,794	$	402,840
Due after one year through two years		250,490		54,751
Total	$	812,284	$	457,591

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Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

5. Accrued expenses and other current liabilities

The following is a summary of accrued expenses and other current liabilities as of September 30, 2025 and December 31, 2024:


	September 30, 2025		December 31, 2024
Accrued external research and development expenses	$	21,401	$	28,925
Accrued employee compensation and benefits		4,976		1,171
Short-term lease liability and other		875		631
Total	$	27,252	$	30,727

6. Loan Payable and Warrant Liability

On June 15, 2022, the Company entered into the Loan Agreement with Hercules Capital, Inc. (“Hercules”), which was subsequently amended on June 7, 2023 and February 28, 2024, for an aggregate principal amount of $150,000 (“Term Loan”). Pursuant to the amended Loan Agreement, the Term Loan was available to the Company in five tranches, subject to certain terms and conditions.

Under the terms of the Loan Agreement, the Company received $10,000 upon closing, $15,000 was borrowed in March 2023 and an additional $10,000 was borrowed in connection with the second amendment on February 28, 2024 (the “Tranche I and Tranche II Commitments”). On September 23, 2025, the Company terminated the Term Loan and repaid the total $35,000 borrowings. The Company recorded a Loss on Extinguishment of Note Payable of $1,557 in connection with the repayment.

The Loan Agreement required the Company to issue warrants to Hercules to purchase shares of the Company’s common stock, par value $0.0001 per share (“common stock”). Warrants to purchase a total of 64,257 shares of common stock were issued to Hercules in connection with the borrowings under the Term Loan, which remain outstanding as of September 30, 2025 (see Note 7). The Company is not obligated to issue any additional warrants to Hercules.

7. Stockholder’s equity (deficit)

Common stock

As of September 30, 2025 and December 31, 2024, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 150,000,000 shares of $0.0001 par value common stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. The holders of common stock, voting exclusively and as a separate class, have the exclusive right to vote for the election of directors of the Company. Common stockholders are entitled to receive dividends, as may be declared by the board of directors. Through September 30, 2025, no cash dividends had been declared or paid.

In March 2023, the Company entered into a sales agreement with Jefferies LLC (the “Sales Agreement”) activating an At-The-Market (“ATM”) facility. Pursuant to the Sales Agreement, the Company filed a prospectus supplement on March 17, 2023, under which the Company may offer and sell shares of common stock, having an aggregate value of up to $200,000. In April and May 2023, the Company sold 3,006,052 shares of common stock under the Sales Agreement, at an average price of $42.38 per share, and received net proceeds of $123,824, after deducting sales agent commissions and issuance costs of approximately $3,578. In February 2024, the Company sold an additional

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Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

500,000 shares of common stock under the Sales Agreement, at an average price of $21.75 per share, and received net proceeds of $10,604, after deducting sales agent commissions and issuance costs of approximately $271.

On May 16, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, (“Jefferies”), as a representative of the several underwriters, pursuant to which the Company agreed to issue and sell 5,238,500 shares of the Company’s common stock at $42.00 per share in a registered direct offering pursuant to the Company’s effective shelf registration statement on Form S-3ASR and a related prospectus supplement filed with the SEC. The offering closed on May 16, 2023. The Company received net proceeds of $210,956, after deducting underwriters commissions and offering costs incurred by the Company of approximately $9,061.

On March 8, 2024, the Company completed a follow-on public offering at which time the Company issued 12,650,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,650,000 additional shares of common stock, at a public offering price of $29.00 per share. The Company received $344,838 net of underwriting discounts and commissions of $22,011, but before deducting offering costs incurred by the Company of approximately $401.

On May 10, 2024, the Company entered into an amendment to the Sales Agreement (“Amended Sales Agreement”) to increase the aggregate offering price of the shares of the Company’s common stock by an additional $200,000. In accordance with the terms of the Amended Sales Agreement, the Company may now offer and sell shares of its common stock having an aggregate offering price of up to $261,723 from time to time.

In November and December 2024, the Company sold 2,249,907 shares of common stock under the Amended Sales Agreement, at an average price of $30.83 per share, and received gross proceeds of $69,373 before deducting sales agent commissions and issuance costs of approximately $1,734. In January 2025, the Company sold an additional 380,488 shares of common stock under the Amended Sales Agreement, at an average price of $27.93 for gross proceeds of $10,627 and before deducting sales agent commissions of approximately $266.

In January 2025, the Company sold 6,427,170 shares of the its common stock at a public offering price of $48.00 per share, and in lieu of common stock to certain investors, pre-funded warrants to purchase 1,958,247 shares of common stock at a public offering price of $47.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant. The pre-funded warrants do not have an expiration date and are exercisable at any time. The pre-funded warrants are classified within stockholders' equity on the Company’s condensed consolidated balance sheet as of September 30, 2025. The Company received net proceeds of $378,350, after deducting underwriting discounts and commission of $24,150, but before deducting offering costs incurred by the Company of approximately $569. The Company may receive nominal proceeds, if any, from the exercise of the prefunded warrants. There were no pre-funded warrants exercised during the nine months ended September 30, 2025.

As of September 30, 2025 and December 31, 2024, there were 80,149,218 and 72,383,013 shares of common stock issued and outstanding, respectively.

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Akero Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(Amounts in thousands, except share and per share data)

The following shares of common stock were reserved for issuance as follows:


	September 30, 2025		December 31, 2024
Options outstanding under the 2018 Stock Option and Grant Plan		387,036		577,089
Options outstanding under the 2019 Stock Option and Incentive Plan		6,963,148		6,983,360
Unvested restricted stock units outstanding under the 2019 Stock Option and Incentive Plan		725,304		715,306
Warrants to purchase common stock associated with Loan Agreement		64,257		64,257
Pre-funded warrants sold in a public offering in January 2025		1,958,247		—
Options available for future grant		4,094,979		1,938,688
Warrants available for future grant to Hercules		—		211,137
Common stock available for ATM program		9,092,586		9,473,074
2019 Employee Stock Purchase Plan		2,365,270		1,973,662
Total		25,650,827		21,936,573

Undesignated preferred stock

The Company’s fourth amended and restated certificate of incorporation authorizes the Company to issue up to 10,000,000 shares of undesignated preferred stock, par value $0.0001 per share. There were no undesignated preferred shares issued or outstanding as of September 30, 2025.

Warrants Associated with Loan Agreement

In connection with the Loan Agreement with Hercules (see Note 6), the Company was obligated to issue warrants to purchase shares of the Company’s common stock. Warrants to purchase a total of 64,257 shares of common stock were issued to Hercules in connection with the borrowings under the Term Loan, which remain outstanding as of September 30, 2025. The Company recorded the warrants at their relative fair value of $227 as of the date of issuance in the shareholders equity category of the balance sheet. The Company is not obligated to issue any additional warrants to Hercules.

SUMMARY OF THE MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

Agreement and Plan of Merger

Basis of presentation

Liquidity

Use of estimates

Concentrations of credit risk

4. Short and long-term marketable securities

5. Accrued expenses and other current liabilities

6. Loan Payable and Warrant Liability

7. Stockholder’s equity (deficit)

Common stock

Undesignated preferred stock

Warrants Associated with Loan Agreement

8. Stock-based awards

2019 Stock option and incentive plan

Akero Therapeutics, Inc. 10-Q