Private company
Akero Therapeutics, Inc.
American pharmaceutical preparations company based in San Francisco2
In its 2025 annual report the company says: “We are 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.”4
Last updated Oct 21, 2026.
Overview
- IndustryPharmaceutical Preparations2
- HeadquartersSan Francisco, United States2
- Incorporated inDE3
- Business address601 Gateway Boulevard, Suite 350, South San Francisco, Ca 940803
- Filer categoryLarge accelerated filer3
- Legal formCorporation2
- LEI549300SI3KG74LBE29552
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressc/o The Corporation Trust Company, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 62945432
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We are 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. Our 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. We have initiated a Phase 3 program called SYNCHRONY, which is …4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Research and development | $11.9M5 | $37.0M6 | $64.9M6 | $81.8M7 | $85.3M8 | $141.8M8 | $247.5M8 | |
| Operating income | -$13.8M5 | -$45.7M6 | -$80.2M6 | -$100.9M7 | -$115.2M8 | -$172.9M8 | -$285.4M8 | |
| Interest | $739.0K8 | $3.1M8 | $4.7M8 | |||||
| Income tax | $24.0K6 | |||||||
| Net income | -$81.7M9 | -$43.8M6 | -$79.2M10 | -$100.8M7 | -$112.0M8 | -$151.8M11 | -$252.1M11 | |
| Earnings per share | -$2.897 | -$2.878 | -$2.898 | -$3.758 | ||||
| Earnings per share (diluted) | -$2.906 | -$2.526 | -$2.897 | -$2.878 | -$2.898 | -$3.758 | ||
| Shares (weighted, basic) | 34.8M shares7 | 39.0M shares8 | 52.6M shares8 | 67.1M shares8 | ||||
| Shares (weighted, diluted) | 34.8M shares7 | 39.0M shares8 | 52.6M shares8 | 67.1M shares8 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Cash | $76.0M5 | $64.8M13 | $187.2M6 | $150.5M14 | $249.8M7 | $234.2M8 | $340.2M8 | |
| Current assets | $77.1M5 | $138.0M13 | $271.3M6 | $193.6M14 | $355.2M7 | $560.0M8 | $770.4M8 | |
| Property, plant and equipment | $90.0K14 | $47.0K7 | $18.0K8 | |||||
| Total assets | $77.2M5 | $138.1M13 | $273.3M6 | $195.5M14 | $356.6M7 | $580.3M8 | $825.9M8 | |
| Accounts payable | $6.7M14 | $8.0M7 | $7.0M8 | $9.0M8 | ||||
| Current liabilities | $2.3M5 | $9.4M13 | $13.1M6 | $25.1M14 | $19.1M7 | $19.1M8 | $39.8M8 | |
| Total liabilities | $2.3M5 | $9.4M13 | $14.6M6 | $26.4M14 | $30.0M7 | $45.0M8 | $75.8M8 | |
| Retained earnings | -$310.3M14 | -$422.3M7 | -$574.1M8 | -$826.2M8 | ||||
| Shareholders’ equity | -$49.9M6 | $128.7M6 | $258.7M7 | $169.1M8 | $326.6M8 | $535.3M8 | $750.1M8 | |
| Shares outstanding | 239.0K shares5 | 28.6M shares13 | 34.7M shares6 | 34.9M shares14 | 46.9M shares7 | 55.8M shares8 | 72.4M shares8 | 79.6M shares8 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Cash from operations | -$4.6M5 | -$35.6M6 | -$70.8M6 | -$79.7M7 | -$92.5M8 | -$145.4M8 | -$230.1M8 | |
| Stock-based compensation | $10.1M7 | $23.2M8 | $21.5M8 | $29.7M8 | ||||
| Capital spending | $148.0K6 | |||||||
| Free cash flow | -$71.0M | |||||||
| Cash from investing | $42.3M7 | -$63.8M8 | -$223.6M8 | -$109.7M8 | ||||
| Cash from financing | $602.0K7 | $255.6M8 | $353.3M8 | $445.8M8 | ||||
| Dividend per share | $0.005 | $0.0013 | $0.006 | $0.0014 | $0.007 | $0.008 |
Corporate structure
Akero Therapeutics, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Akero Therapeutics, Inc.
- Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Akero Therapeutics, Inc., latest Feb 17, 2026 (10 filings since Feb 10, 2022)
- RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on Akero Therapeutics, Inc., latest Feb 17, 2026 (5 filings since Feb 14, 2024)
- Deep Track Capital, LP Filed SCHEDULE 13G/A on Akero Therapeutics, Inc., latest Feb 13, 2026 (2 filings since Oct 7, 2025)
- Wellington Management Company Filed SCHEDULE 13G/A on Akero Therapeutics, Inc., latest Feb 10, 2026 (9 filings since Feb 4, 2022)
- PRICE T ROWE ASSOCIATES INC /MD/ Filed SCHEDULE 13G/A on Akero Therapeutics, Inc., latest Nov 14, 2025 (4 filings since Feb 14, 2023)
- GENERAL ATLANTIC, L.P. Filed SCHEDULE 13G/A on Akero Therapeutics, Inc., latest May 15, 2025 (2 filings since Mar 15, 2024)
- ALKEON CAPITAL MANAGEMENT LLC Filed SC 13G/A on Akero Therapeutics, Inc., latest Nov 13, 2024 (4 filings since Feb 14, 2022)
- State Street Corporation Filed SC 13G/A on Akero Therapeutics, Inc., latest Oct 17, 2024 (3 filings since Feb 3, 2023)
- BAKER BROS. ADVISORS LP Filed SC 13G/A on Akero Therapeutics, Inc., latest Feb 14, 2024 (2 filings since Feb 14, 2023)
- Pfizer Filed SC 13G/A on Akero Therapeutics, Inc., latest Feb 14, 2024 (2 filings since Jun 28, 2022)
- Redmile Group, LLC Filed SC 13G/A on Akero Therapeutics, Inc., latest Feb 14, 2024 (3 filings since Feb 14, 2022)
- Avidity Partners Management LP Filed SC 13G/A on Akero Therapeutics, Inc., latest Feb 13, 2024 (3 filings since Sep 16, 2022)
- Akero Therapeutics, Inc. San Francisco, California, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Akero Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, net | $18.0K8 Dec 31, 2023 | $47.0K7 Dec 31, 2022 | −61.7% |
| Operating-lease assets (leased space) | $755.0K8 Dec 31, 2024 | $1.0M8 Dec 31, 2023 | −25.1% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $340.2M8 Dec 31, 2024 | $234.2M8 Dec 31, 2023 | +45.3% |
| Marketable securities, current | $402.8M8 Dec 31, 2024 | $315.8M8 Dec 31, 2023 | +27.6% |
| Marketable securities, non-current | $54.8M8 Dec 31, 2024 | $19.3M8 Dec 31, 2023 | +183.9% |
| Debt securities available for sale | $771.7M8 Dec 31, 2024 | $542.0M8 Dec 31, 2023 | +42.4% |
Properties, in its own words
We lease office space where our corporate headquarters are located, which consists of 6,647 square feet located at 601 Gateway Boulevard, South San Francisco, California. We believe our current office space is sufficient to meet our office needs until the expiration of the lease in July 2027.
Item 2 of the 10-K filed Feb 28, 2025.4
Leadership
Who has led Akero Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerAndrew Cheng Jun 19, 2019 to now15
- PresidentAndrew Cheng Jun 19, 2019 to now15
- Chief financial officerWilliam Richard White Jun 19, 2019 to now16
Board members and other officers (13)
- Chief Technology OfficerScott A. Gangloff May 1, 2024 to now17
- OfficerPatrick Lamy Jan 11, 2023 to now18
- Chief Development OfficerCatriona Yale Jun 19, 2019 to now19
- Chief Scientific OfficerTimothy Rolph Jun 19, 2019 to now20
- Board memberChou Judy Jul 14, 2021 to now21
- Board memberTomas J. Heyman Jun 11, 2020 to now22
- Board memberAaron Royston Jun 19, 2019 to Jun 25, 201923
- Board memberAndrew Cheng Jun 19, 2019 to now15
- Board memberG. Walmsley Graham Jun 19, 2019 to now24
- Board memberJane Henderson Jun 19, 2019 to now25
- Board memberKevin Bitterman Jun 19, 2019 to Jun 3, 202126
- Board memberMark T. Iwicki Jun 19, 2019 to now27
- Board memberSeth Loring Harrison Jun 19, 2019 to now28
Timeline
- Dec 9, 20258-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer29
- Dec 3, 20258-K Shareholder vote; Other events30
- Oct 9, 20258-K Entered a material agreement; Bylaws or fiscal year changed; Other events31
- Sep 29, 20258-K Ended a material agreement32
- Aug 8, 20258-K Results of operations33
- Jun 4, 20258-K Shareholder vote34
- May 12, 20258-K Results of operations35
- Feb 28, 20258-K Results of operations36
- Jan 30, 20258-K Entered a material agreement37
- Jan 27, 20258-K Results of operations; Regulation FD disclosure; Other events38
- Nov 8, 20248-K Results of operations39
- Aug 9, 20248-K Results of operations40
- Jun 19, 2019New chief executive Andrew Cheng becomes CEO15
- Jan 24, 2017Founded Akero Therapeutics, Inc. is founded2
Calendar
When it reported results
- Aug 8, 2025Reported quarterly or annual results33
- May 12, 2025Reported quarterly or annual results35
- Feb 28, 2025Reported quarterly or annual results36
- Jan 27, 2025Reported quarterly or annual results38
- Nov 8, 2024Reported quarterly or annual results39
- Aug 9, 2024Reported quarterly or annual results40
- May 10, 2024Reported quarterly or annual results41
- Feb 29, 2024Reported quarterly or annual results42
Drug trials and FDA: recently
- Mar 3, 2026Phase 3 trial completed Phase 3 trial of Efruxifermin in NASH/MASH: primary completion Mar 3, 2026, no results posted yet (ClinicalTrials.gov NCT06161571).43
- Dec 15, 2023Phase 2 trial completed Phase 2 trial of EFX in NASH - Nonalcoholic Steatohepatitis: primary completion Dec 15, 2023, results posted Jul 21, 2026 (ClinicalTrials.gov NCT05039450).44
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar
Filings
517 filings to the SEC since October 2021: 5 annual reports, 13 quarterly reports, 41 major events, 309 insider forms, 66 large holders, 83 other. The latest 20:
- Feb 17, 2026SCHEDULE 13G/A EDGAR
- Feb 17, 2026SCHEDULE 13G/A EDGAR
- Feb 13, 2026SCHEDULE 13G/A EDGAR
- Feb 10, 2026SCHEDULE 13G/A EDGAR
- Dec 19, 202515-12G EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 20254 EDGAR
- Dec 9, 2025S-8 POS EDGAR
The 517 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
226 open-market trades by officers, directors and large owners since October 2021: 14 buys and 212 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Oct 10, 2025 | Cheng AndrewPresident and CEO | Sale | 30,000 | $53.98 | $1.6M | Form 4 |
| Oct 7, 2025 | Rolph TimothyChief Scientific Officer | Sale | 12,500 | $46.08 | $576.0K | Form 4 |
| Oct 1, 2025 | Young JonathanChief Operating Officer | Sale | 12,500 | $47.75 | $596.9K | Form 4 |
| Sep 11, 2025 | Young JonathanChief Operating Officer | Sale | 586 | $43.02 | $25.2K | Form 4 |
| Sep 11, 2025 | Yale CatrionaChief Development Officer | Sale | 659 | $43.02 | $28.4K | Form 4 |
| Sep 11, 2025 | White William RichardChief Financial Officer | Sale | 659 | $43.02 | $28.4K | Form 4 |
| Sep 11, 2025 | Rolph TimothyChief Scientific Officer | Sale | 553 | $43.02 | $23.8K | Form 4 |
| Sep 11, 2025 | Cheng AndrewPresident and CEO | Sale | 1,796 | $43.02 | $77.3K | Form 4 |
| Sep 10, 2025 | Cheng AndrewPresident and CEO | Sale | 30,000 | $43.24 | $1.3M | Form 4 |
| Sep 8, 2025 | Rolph TimothyChief Scientific Officer | Sale | 12,500 | $44.17 | $552.1K | Form 4 |
| Sep 2, 2025 | Young JonathanChief Operating Officer | Sale | 12,500 | $46.09 | $576.1K | Form 4 |
| Aug 12, 2025 | Young JonathanChief Operating Officer | Sale | 12,500 | $47.78 | $597.3K | Form 4 |
| Aug 12, 2025 | Henderson JaneDirector | Sale | 3,000 | $47.46 | $142.4K | Form 4 |
| Aug 11, 2025 | Cheng AndrewPresident and CEO | Sale | 30,000 | $48.59 | $1.5M | Form 4 |
| Aug 5, 2025 | Rolph TimothyChief Scientific Officer | Sale | 12,500 | $49.30 | $616.3K | Form 4 |
| Jul 16, 2025 | Yale CatrionaChief Development Officer | Sale | 10,000 | $52.95 | $529.5K | Form 4 |
| Jul 10, 2025 | Cheng AndrewPresident and CEO | Sale | 30,000 | $51.16 | $1.5M | Form 4 |
| Jul 7, 2025 | Rolph TimothyChief Scientific Officer | Sale | 12,500 | $51.09 | $638.6K | Form 4 |
| Jul 1, 2025 | Lamy PatrickSee Remarks | Sale | 2,000 | $52.88 | $105.8K | Form 4 |
| Jun 20, 2025 | Lamy PatrickSee Remarks | Sale | 875 | $54.59 | $47.8K | Form 4 |
All 226 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Janus Henderson Group Ltd.SCHEDULE 13G/A, 10 filings Feb 10, 2022 to Feb 17, 202645
- RTW INVESTMENTS, LPSCHEDULE 13G/A, 5 filings Feb 14, 2024 to Feb 17, 202646
- Deep Track Capital, LPSCHEDULE 13G/A, 2 filings Oct 7, 2025 to Feb 13, 202647
- Wellington Management CompanySCHEDULE 13G/A, 9 filings Feb 4, 2022 to Feb 10, 202648
- PRICE T ROWE ASSOCIATES INC /MD/SCHEDULE 13G/A, 4 filings Feb 14, 2023 to Nov 14, 202549
- GENERAL ATLANTIC, L.P.SCHEDULE 13G/A, 2 filings Mar 15, 2024 to May 15, 202550
- ALKEON CAPITAL MANAGEMENT LLCSC 13G/A, 4 filings Feb 14, 2022 to Nov 13, 202451
- State Street CorporationSC 13G/A, 3 filings Feb 3, 2023 to Oct 17, 202452
- BAKER BROS. ADVISORS LPSC 13G/A, 2 filings Feb 14, 2023 to Feb 14, 202453
- PfizerSC 13G/A, 2 filings Jun 28, 2022 to Feb 14, 202454
- Redmile Group, LLCSC 13G/A, 3 filings Feb 14, 2022 to Feb 14, 202455
- Avidity Partners Management LPSC 13G/A, 3 filings Sep 16, 2022 to Feb 13, 202456
- VANGUARD GROUP INCSC 13G, 1 filing Feb 13, 202457
- ADAGE CAPITAL PARTNERS GP, L.L.C.SC 13G/A, 2 filings Apr 10, 2023 to Feb 7, 202458
- BlackRockSC 13G/A, 4 filings Feb 4, 2022 to Jan 26, 202459
- Skorpios TrustSC 13G/A, 2 filings Dec 5, 2022 to Sep 12, 202360
- Atlas Venture Fund XI, L.P.SC 13G/A, 2 filings Feb 11, 2022 to Feb 14, 202361
- Point72 Asset Management, L.P.SC 13G/A, 3 filings Dec 13, 2021 to Feb 14, 202362
- Goldman SachsSC 13G/A, 2 filings Feb 8, 2022 to Feb 7, 202363
- venBio Global Strategic Fund II L.P.SC 13D/A, 1 filing Sep 15, 202264
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | Andrew ChengM.D. Ph.D. (PEO) | $686.0K | $10.5M65 | |
| 2024 | Scott Gangloff | 51 | $313.6K | $6.1M65 |
| 2024 | William WhiteJ.D. (PFO) | 52 | $510.0K | $3.1M65 |
| 2024 | Catriona Yale | 53 | $494.0K | $3.0M65 |
| 2024 | Jonathan YoungJ.D., Ph.D. | $490.0K | $3.0M65 | |
| 2023 | President and Chief Executive Officer | $660.0K | $8.8M65 | |
| 2023 | Chief Financial Officer | $475.0K | $4.3M65 | |
| 2023 | Chief Development Officer | $475.0K | $3.4M65 | |
| 2023 | Chief Operating Officer | $471.0K | $3.4M65 | |
| 2022 | President and Chief Executive Officer | $624.0K | $10.4M65 | |
| 2022 | Chief Financial Officer | $452.0K | $4.1M65 | |
| 2022 | Chief Operating Officer | $449.0K | $4.1M65 | |
| 2022 | Chief Development Officer | $444.0K | $4.1M65 |
SEC filer profile
How Akero Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARAkero Therapeutics, Inc.1
- CIK0001744659
- Employer ID (EIN)81-52665734
- Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address601 Gateway Boulevard, Suite 350, South San Francisco, CA 940801
- Phone650-487-64881
- Shares outstanding82,316,179 as of Nov 3, 202511
- Public float$1.6T as of Jun 30, 20244
- AuditorDeloitte & Touche LLP, Morristown, NJ PCAOB ID 34; it also attests to the company’s internal control over financial reporting4
- On EDGAR sinceDec 18, 20181
- Filings734 in all: 4 (398), 8-K (74), 144 (46), SC 13G/A (37), SC 13G (25), 3 (22), 10-Q (20), SCHEDULE 13G/A (14)1
All 45 form types
424B5 (9), S-8 (7), S-8 POS (7), SC 13D/A (7), 10-K (6), 4/A (6), DEF 14A (6), CORRESP (5), ARS (3), DEFA14A (3), UPLOAD (3), 424B4 (2), DRS (2), DRS/A (2), DRSLTR (2), EFFECT (2), S-1 (2), S-1MEF (2), S-3ASR (2), SC 13D (2), SCHEDULE 13G (2), 10-K/A (1), 15-12G (1), 25-NSE (1), 8-A12B (1), 8-K/A (1), CERT (1), CT ORDER (1), D (1), DEFM14A (1), FWP (1), POSASR (1), PRE 14A (1), PREM14A (1), RW (1), S-1/A (1), S-3 (1)
- Latest filingsAnnual report (10-K) Feb 28, 2025
Quarterly report (10-Q) Nov 7, 2025
Proxy statement (DEF 14A) Apr 28, 2025
Latest 8-K (8-K) Dec 9, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | AKRO | Nasdaq |
From the cover page of the 10-K filed Feb 28, 2025 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Akero Therapeutics, Inc. names in Item 1A of its 10-K filed Feb 28, 2025: 72 risks under these headings, as written.4
- Risks Related to the Clinical Development and Manufacturing of our Product Candidate
- 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 MASH, 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 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 subject to many manufacturing risks, any of which could substantially increase our costs, delay clinical programs and limit supply of our product candidates.
- We contract with third parties for the manufacture of EFX and the delivery device utilized for EFX and expect to continue to do so for future clinical trials and for commercialization of EFX as well as for any future product candidates. This reliance on third parties increases the risk that we will not have sufficient quantities of EFX, or the delivery devices utilized for EFX, or any future product candidates or medicines or that such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- Risks Related to Our Business, Industry and Intellectual Property
- We are heavily dependent on the success of EFX, our only product candidate.
The other 62 risks
- We have expended and will continue to expend our limited resources to pursue a particular therapeutic candidate or indication, such as our focus on developing EFX for the treatment of MASH, and may fail to capitalize on therapeutic candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- 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.
- We may be required to make significant payments under our license agreement for EFX.
- If we breach our license agreement with Amgen related to EFX, we could lose the ability to continue the development and commercialization of EFX.
- We may seek to establish collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
- We must attract and retain highly skilled employees in order to succeed. If we are not able to retain our current senior management team and our scientific advisors or continue to attract and retain qualified scientific, technical and business personnel, our business will suffer.
- Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- We may encounter difficulties in managing our growth, which could adversely affect our operations.
- Our success depends upon our ability to obtain and maintain intellectual property protection for our products and technologies. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
- Patent terms may be inadequate to protect our competitive position on our product candidate or any future product candidates for an adequate amount of time.
- We may not be able to protect our intellectual property rights throughout the world.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may be unable to obtain intellectual property rights or technology necessary to develop and commercialize EFX or any future product candidates.
- Our inability to protect our confidential information and trade secrets would harm our business and competitive position.
- We may become involved in lawsuits or other proceedings to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of our business.
- Third parties may initiate legal proceedings against us alleging that we infringe their intellectual property rights or we may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated a third party’s intellectual property, or claiming ownership of what we regard as our own intellectual property.
- Intellectual property rights do not necessarily address all potential threats.
- Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
- Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidate or any future product candidates.
- Risks Related to Government Regulation
- We have limited experience in conducting clinical trials and have never obtained approval for any product candidates, and may be unable to do so successfully.
- The regulatory approval processes of 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.
- The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
- Additional time may be required to obtain regulatory approval for our product candidates because they are combination products.
- While we intend to seek designations for our product candidates with the FDA and comparable other regulatory authorities that are intended to confer benefits such as a faster development process or an accelerated regulatory pathway, there can be no assurance that we will successfully obtain such designations. In addition, even if one or more of our product candidates are granted such designations, we may not be able to realize the intended benefits of such designations.
- We may seek priority review designation for one or more of our product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.
- Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing EFX or any future product candidates outside the United States.
- 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.
- Even if our current product candidate or any future product candidates receive regulatory approval, they will remain subject to extensive regulatory scrutiny and may still face future development and regulatory difficulties.
- The advancement of healthcare reform may negatively impact our ability to profitably sell our product candidate or any future product candidates, if approved.
- 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.
- Failure to comply with health, data protection, and national security laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.
- Artificial intelligence presents risks and challenges that can impact our business, including by posing security risks to our confidential information, proprietary information and personal data.
- Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
- Healthcare insurance coverage and reimbursement may be limited or unavailable for our product candidate, if approved, which could make it difficult for us to sell our product candidate or other therapies profitably.
- Our activities in the United States subject us to various laws relating to foreign investment and the export of certain technologies, and our failure to comply with these laws or adequately monitor the compliance of our suppliers and others we do business with could subject us to substantial fines, penalties and even injunctions, the imposition of which on us could have a material adverse effect on the success of our business.
- We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
- Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key personnel, and substantial changes in leadership, personnel, and policy could prevent new or existing product candidates from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Risks Related to Our Financial Condition and Need for Additional Capital
- 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.
- Risks Related to Our Indebtedness
- Our operating activities may be restricted as a result of covenants related to our term loan obligation, which we may be required to repay in an event of default, which could have a materially adverse effect on our business.
- Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations.
- Risks Related to Commercialization and Market Acceptance
- Even if we commercialize EFX or any future product candidates, if approved, these products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could harm our business.
- If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize future product candidates, and our ability to generate revenue will be materially impaired.
- Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
- If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved.
- Our product candidate or any future product candidates may not achieve adequate market acceptance among physicians, patients, third-party payors and others in the medical community necessary for commercial success.
- Risks Related to Our Operations
- We incur significant costs and expend significant time and effort, as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives and corporate governance practices.
- If we fail to maintain an effective system of internal controls over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
- If our information technology systems or those of third parties upon which we rely, or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm and other adverse consequences.
- We use and generate materials that may expose us to material liability.
- General Risk Factors
- Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
- Our business is affected by macroeconomic conditions, including rising inflation, interest rates, supply chain constraints and significant political, trade, or regulatory developments.
- Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and its financial condition and results of operations.
- We are a “large accelerated filer” as defined by the SEC, and the reduced disclosure requirements previously available to us no longer apply.
- The market price of our stock may be volatile, and you could lose all or part of your investment. Because of potential volatility in our trading price and trading volume, we may incur significant costs from class action securities litigation.
- We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Legal proceedings
From time to time, we may be involved in lawsuits, claims, investigations and proceedings, consisting of intellectual property, commercial, employment and other matters which arise in the ordinary course of business. On April 26, 2024, a purported stockholder of the Company filed a lawsuit, captioned Klobus v. Akero Therapeutics, Inc., No. 3:24-cv-02534 (N.D. Cal.), in the U.S. District Court for the Northern District of California against the Company and three of its officers. The suit purports to be filed on behalf of a class of stockholders who purchased or otherwise acquired Company common stock between September 13, 2022, and October 9, 2023. The suit asserts claims under the Exchange Act for alleged misstatements and omissions regarding the Company’s Phase 2b SYMMETRY study. The complaint seeks damages in an unspecified amount. The court appointed lead plaintiffs and lead counsel on August 2,
2024. Lead Plaintiffs filed an amended complaint on September 24, 2024. On November 18, 2024, Defendants filed a motion to dismiss, Lead Plaintiffs filed an Opposition on January 13, 2025, and Defendants filed a Reply on February 21, 2025. A hearing on Defendants’ motion to dismiss is currently scheduled for March 11, 2025. Due to the early stage of this matter, it is not possible to determine the probability or amount of potential related costs. The Company intends to vigorously defend against the lawsuit.
The opening of Item 3, Legal Proceedings.4
Sources
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- 18SEC EDGARPatrick Lamy, Officer
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- 21SEC EDGARChou Judy, Board member
- 22SEC EDGARTomas J. Heyman, Board member
- 23SEC EDGARAaron Royston, Board member
- 24SEC EDGARG. Walmsley Graham, Board member
- 25SEC EDGARJane Henderson, Board member
- 26SEC EDGARKevin Bitterman, Board member
- 27SEC EDGARMark T. Iwicki, Board member
- 28SEC EDGARSeth Loring Harrison, Board member
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- 30SEC EDGARShareholder vote; Other events
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- 32SEC EDGAREnded a material agreement
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- 34SEC EDGARShareholder vote
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