Private company
89bio, Inc.
In its 2025 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. Our lead product candidate, pegozafermin, a specifically engineered glycoPEGylated analog of fibroblast growth factor 21, is currently being developed for the treatment of metabolic dysfunction-associated steatohepatitis, previously known as nonalcoholic steatohepatitis, and for the treatment of severe hypertriglyceridemia.”3 It is headquartered in San Francisco, California.1
Last updated Oct 21, 2026.
Overview
- IndustryPharmaceutical Preparations1
- HeadquartersSan Francisco, California1
- Incorporated inDE2
- Business address655 Montgomery Street, Suite 1500, San Francisco, Ca 941112
- Filer categoryLarge accelerated filer2
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We are a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. Our lead product candidate, pegozafermin, a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (“FGF21”), is currently being developed for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), previously known as nonalcoholic steatohepatitis, and for the treatment of severe hypertriglyceridemia (“SHTG”).3 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 | $13.7M4 | $21.3M5 | $36.2M6 | $70.3M7 | $80.8M8 | $122.2M8 | $345.0M8 | |
| Operating expenses | $89.7M7 | $102.2M8 | $151.2M8 | $384.7M8 | ||||
| Operating income | -$15.2M4 | -$26.6M5 | -$49.4M6 | -$89.7M7 | -$102.2M8 | -$151.2M8 | -$384.7M8 | |
| Interest | $674.0K7 | $1.9M8 | $4.8M8 | $5.3M8 | ||||
| Income before tax | -$90.3M7 | -$102.0M8 | -$138.3M8 | -$366.4M8 | ||||
| Income tax | $28.0K4 | $218.0K5 | -$59.0K6 | -$147.0K7 | $19.0K8 | $3.9M8 | $692.0K8 | |
| Net income | -$16.2M4 | -$57.4M5 | -$49.5M6 | -$90.1M7 | -$102.0M8 | -$142.2M8 | -$367.1M8 | |
| Earnings per share | -$4.487 | -$2.938 | -$2.008 | -$3.518 | ||||
| Earnings per share (diluted) | -$4.487 | -$2.938 | -$2.008 | -$3.518 | ||||
| Shares (weighted, basic) | 20.1M shares7 | 34.8M shares8 | 71.2M shares8 | 104.7M shares8 | ||||
| Shares (weighted, diluted) | 20.1M shares7 | 34.8M shares8 | 71.2M shares8 | 104.7M shares8 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Cash | $11.2M4 | $93.3M5 | $98.2M6 | $52.4M7 | $55.3M7 | $316.2M8 | $126.1M8 | |
| Current assets | $11.3M4 | $95.3M5 | $210.2M6 | $162.0M11 | $196.1M7 | $593.5M8 | $476.4M8 | |
| Property, plant and equipment | $150.0K11 | $92.0K7 | $46.0K8 | $23.0K8 | ||||
| Total assets | $11.4M4 | $95.6M5 | $211.1M6 | $162.4M11 | $196.8M7 | $596.3M8 | $478.7M8 | |
| Accounts payable | $6.8M11 | $12.5M7 | $8.6M8 | $15.4M8 | ||||
| Short-term debt | $2.5M6 | $07 | $08 | |||||
| Current liabilities | $4.4M4 | $5.6M5 | $8.1M6 | $19.5M11 | $24.6M7 | $29.6M8 | $36.1M8 | |
| Long-term debt | $16.9M11 | $20.2M7 | $24.8M8 | $35.7M8 | ||||
| Total liabilities | $8.1M6 | $36.5M11 | $45.0M7 | $60.0M8 | $77.9M8 | |||
| Retained earnings | -$213.2M11 | -$315.2M7 | -$457.4M8 | -$824.5M8 | ||||
| Shareholders’ equity | -$16.1M5 | $89.9M6 | $203.0M7 | $126.0M8 | $151.8M8 | $536.3M8 | $400.8M8 | |
| Shares outstanding | 611.2K shares4 | 13.8M shares5 | 19.9M shares6 | 20.3M shares11 | 50.6M shares7 | 93.3M shares8 | 119.8M shares8 | 146.0M 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 | -$12.5M4 | -$25.5M5 | -$46.2M6 | -$76.8M7 | -$81.1M8 | -$129.2M8 | -$367.8M8 | |
| Stock-based compensation | $8.7M7 | $10.4M8 | $16.1M8 | $20.6M8 | ||||
| Capital spending | $39.0K4 | $139.0K5 | $126.0K6 | $63.0K7 | $7.0K8 | $4.0K8 | $15.0K8 | |
| Free cash flow | -$12.5M | -$25.6M | -$46.4M | -$76.8M | -$81.1M | -$129.2M | -$367.8M | |
| Cash from investing | $7.2M7 | -$33.9M8 | -$123.0M8 | -$40.9M8 | ||||
| Cash from financing | $23.9M7 | $117.8M8 | $513.1M8 | $218.6M8 |
Corporate structure
89bio, 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 89bio, Inc.
- Deep Track Capital, LP Filed SCHEDULE 13G/A on 89bio, Inc., latest Feb 13, 2026 (6 filings since Jul 6, 2022)
- Pentwater Capital Management LP Filed SCHEDULE 13G on 89bio, Inc., latest Nov 14, 2025
- MONTANOVA CAPITAL, LLC Filed SCHEDULE 13G/A on 89bio, Inc., latest Nov 13, 2025 (6 filings since Oct 30, 2023)
- RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13D/A on 89bio, Inc., latest Nov 3, 2025 (11 filings since Jul 6, 2022)
- Adage Capital Management, L.P. Filed SCHEDULE 13D/A on 89bio, Inc., latest Oct 31, 2025 (2 filings since Oct 3, 2025)
- Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on 89bio, Inc., latest Oct 7, 2025 (9 filings since Feb 14, 2023)
- VANGUARD GROUP INC Filed SCHEDULE 13G on 89bio, Inc., latest Jul 29, 2025
- RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on 89bio, Inc., latest May 15, 2025 (3 filings since Feb 14, 2024)
- BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G/A on 89bio, Inc., latest Feb 14, 2025 (5 filings since Jul 11, 2022)
- BlackRock Filed SC 13G/A on 89bio, Inc., latest Nov 8, 2024 (3 filings since Jan 29, 2024)
- State Street Corporation Filed SC 13G/A on 89bio, Inc., latest Oct 17, 2024 (2 filings since Jan 24, 2024)
- Cormorant Asset Management, LP Filed SC 13G/A on 89bio, Inc., latest Feb 14, 2024 (2 filings since Dec 29, 2022)
- 89bio, Inc. San Francisco, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What 89bio, 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 | $23.0K8 Dec 31, 2024 | $46.0K8 Dec 31, 2023 | −50.0% |
| Operating-lease assets (leased space) | $1.6M8 Dec 31, 2024 | $2.3M8 Dec 31, 2023 | −31.4% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $126.1M8 Dec 31, 2024 | $316.2M8 Dec 31, 2023 | −60.1% |
| Marketable securities, current | $313.9M8 Dec 31, 2024 | $262.7M8 Dec 31, 2023 | +19.5% |
| Debt securities available for sale | $378.4M8 Dec 31, 2024 | $361.3M7 Dec 31, 2023 | +4.7% |
Properties, in its own words
Our corporate headquarters is located in San Francisco, California, and consists of 17,616 square feet of office space under a lease that expires in March 2027. We believe that our current space is adequate for our needs. We also believe we will be able to obtain additional space, as needed, on commercially reasonable terms.
Item 2 of the 10-K filed Feb 27, 2025.3
Leadership
Who has led 89bio, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerRohan Palekar Nov 8, 2019 to now12
- Chief financial officerRyan Martins Nov 8, 2019 to now13
- Chief operating officerFrancis Willard Sarena Aug 7, 2024 to now14
- Chief operating officerRam Waisbourd Mar 16, 2020 to Nov 18, 202015
Board members and other officers (17)
- Chief Medical OfficerHarry H. Mansbach Nov 8, 2019 to now16
- OfficerQuoc Le-Nguyen Nov 8, 2019 to now17
- OfficerRam Waisbourd Nov 8, 2019 to Feb 22, 202218
- Board memberMartin Babler Apr 23, 2024 to now19
- Board memberCharles McWherter Aug 7, 2024 to now20
- Board memberEdward Morrow Atkinson Iii. Mar 1, 2022 to now21
- Board memberKathleen Laporte Nov 3, 2021 to now22
- Board memberSteven Altschuler Mar 25, 2020 to now23
- Board memberLota S. Zoth Jun 4, 2020 to now24
- Board memberAnat Naschitz Nov 8, 2019 to Apr 19, 202125
- Board memberDerek Dirocco Nov 8, 2019 to now26
- Board memberGregory Grunberg Nov 8, 2019 to Feb 13, 202327
- Board memberPeter Kolchinsky Nov 8, 2019 to now28
- Board memberRajeev M. Shah Nov 8, 2019 to now28
- Board memberRohan Palekar Nov 8, 2019 to now12
- Board memberTomer Kariv Nov 8, 2019 to Nov 13, 201929
- Board memberIsrael Gp L.p. Orbimed Ii. Nov 13, 2019 to Sep 23, 202030
Timeline
- Oct 30, 20258-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer31
- Sep 18, 20258-K Entered a material agreement; Other events32
- Aug 7, 20258-K Results of operations33
- May 30, 20258-K Shareholder vote34
- May 1, 20258-K Results of operations35
- Apr 9, 20258-K Regulation FD disclosure36
- Feb 27, 20258-K Results of operations37
- Feb 4, 20258-K Executive or director change38
- Jan 29, 20258-K Entered a material agreement39
- Jan 13, 20258-K Results of operations; Other events40
- Dec 16, 20248-K Executive or director change41
- Nov 14, 20248-K Entered a material agreement42
- Nov 8, 2019New chief executive Rohan Palekar becomes CEO12
Calendar
When it reported results
- Aug 7, 2025Reported quarterly or annual results33
- May 1, 2025Reported quarterly or annual results35
- Feb 27, 2025Reported quarterly or annual results37
- Jan 13, 2025Reported quarterly or annual results40
- Nov 7, 2024Reported quarterly or annual results43
- Aug 5, 2024Reported quarterly or annual results44
- May 9, 2024Reported quarterly or annual results45
- Feb 29, 2024Reported quarterly or annual results46
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
380 filings to the SEC since October 2021: 4 annual reports, 12 quarterly reports, 51 major events, 185 insider forms, 64 large holders, 64 other. The latest 20:
- Feb 13, 2026SCHEDULE 13G/A EDGAR
- Nov 19, 2025EFFECT EDGAR
- Nov 14, 2025SCHEDULE 13G/A EDGAR
- Nov 14, 2025SCHEDULE 13G EDGAR
- Nov 13, 2025SCHEDULE 13G/A EDGAR
- Nov 10, 202515-12G EDGAR
- Nov 3, 2025SCHEDULE 13D/A EDGAR
- Nov 3, 20254 EDGAR
- Oct 31, 2025SCHEDULE 13D/A EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
- Oct 30, 20254 EDGAR
The 380 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
41 open-market trades by officers, directors and large owners since October 2021: 16 buys and 25 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jul 15, 2025 | Le-Nguyen QuocSee Remarks | Sale | 10,461 | $11.02 | $115.3K | Form 4 |
| Apr 15, 2025 | Le-Nguyen QuocSee Remarks | Sale | 15,329 | $5.95 | $91.2K | Form 4 |
| Jan 30, 2025 | Kolchinsky PeterDirector | Buy | 5,714,285 | $8.75 | $50.0M | Form 4 |
| Jan 22, 2025 | McWherter CharlesDirector | Buy | 10,000 | $6.71 | $67.1K | Form 4 |
| Jan 21, 2025 | McWherter CharlesDirector | Buy | 5,000 | $6.55 | $32.8K | Form 4 |
| Jan 15, 2025 | Le-Nguyen QuocSee Remarks | Sale | 10,963 | $6.49 | $71.2K | Form 4 |
| Dec 6, 2024 | PALEKAR ROHANChief Executive Officer | Buy | 5,000 | $7.89 | $39.5K | Form 4 |
| Dec 5, 2024 | McWherter CharlesDirector | Buy | 10,000 | $8.00 | $80.0K | Form 4 |
| Nov 22, 2024 | PALEKAR ROHANChief Executive Officer | Buy | 10,000 | $8.35 | $83.5K | Form 4 |
| Oct 30, 2024 | Le-Nguyen QuocSee Remarks | Sale | 27,955 | $8.12 | $227.0K | Form 4 |
| Apr 1, 2024 | PALEKAR ROHANChief Executive Officer | Sale | 52,718 | $10.91 | $575.2K | Form 4 |
| Mar 4, 2024 | Kolchinsky PeterDirector | Buy | 1,350,000 | $15.35 | $20.7M | Form 4 |
| Feb 26, 2024 | PALEKAR ROHANChief Executive Officer | Sale | 4,477 | $10.76 | $48.2K | Form 4 |
| Dec 29, 2023 | PALEKAR ROHANChief Executive Officer | Sale | 50,000 | $11.20 | $560.0K | Form 4 |
| Jul 17, 2023 | LAPORTE KATHLEENDirector | Sale | 12,500 | $18.80 | $235.0K | Form 4 |
| Jun 5, 2023 | PALEKAR ROHANChief Executive Officer | Sale | 15,000 | $20.00 | $300.0K | Form 4 |
| Jun 1, 2023 | Atkinson Edward Morrow IIIDirector | Sale | 6,250 | $17.91 | $111.9K | Form 4 |
| May 9, 2023 | Le-Nguyen QuocSee Remarks | Sale | 13,683 | $18.11 | $247.8K | Form 4 |
| Apr 4, 2023 | Martins RyanChief Financial Officer | Sale | 8,721 | $14.95 | $130.4K | Form 4 |
| Mar 28, 2023 | Hayden Michael RDirector | Buy | 61,538 | $16.15 | $993.8K | Form 4 |
All 41 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.
- Deep Track Capital, LPSCHEDULE 13G/A, 6 filings Jul 6, 2022 to Feb 13, 202647
- Pentwater Capital Management LPSCHEDULE 13G, 1 filing Nov 14, 202548
- MONTANOVA CAPITAL, LLCSCHEDULE 13G/A, 6 filings Oct 30, 2023 to Nov 13, 202549
- RA CAPITAL MANAGEMENT, L.P.SCHEDULE 13D/A, 11 filings Jul 6, 2022 to Nov 3, 202550
- Adage Capital Management, L.P.SCHEDULE 13D/A, 2 filings Oct 3, 2025 to Oct 31, 202551
- Janus Henderson Group Ltd.SCHEDULE 13G/A, 9 filings Feb 14, 2023 to Oct 7, 202552
- VANGUARD GROUP INCSCHEDULE 13G, 1 filing Jul 29, 202553
- RTW INVESTMENTS, LPSCHEDULE 13G/A, 3 filings Feb 14, 2024 to May 15, 202554
- BIOTECHNOLOGY VALUE FUND L PSCHEDULE 13G/A, 5 filings Jul 11, 2022 to Feb 14, 202555
- BlackRockSC 13G/A, 3 filings Jan 29, 2024 to Nov 8, 202456
- State Street CorporationSC 13G/A, 2 filings Jan 24, 2024 to Oct 17, 202457
- Cormorant Asset Management, LPSC 13G/A, 2 filings Dec 29, 2022 to Feb 14, 202458
- ADAGE CAPITAL PARTNERS GP, L.L.C.SC 13G/A, 3 filings Aug 12, 2022 to Feb 7, 202459
- ORBIMED ADVISORS LLCSC 13D/A, 3 filings Jul 5, 2022 to Mar 24, 202360
- GREAT POINT PARTNERS LLCSC 13G/A, 2 filings Jul 8, 2022 to Feb 14, 202361
- Longitude Capital Partners III, LLCSC 13D/A, 2 filings Feb 7, 2022 to Feb 14, 202362
- Wellington Management CompanySC 13G/A, 2 filings Jan 10, 2022 to Jun 10, 202263
- Ran NussbaumSC 13G/A, 1 filing Feb 14, 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 | Rohan Palekar | 59 | $646.0K | $7.6M65 |
| 2024 | Hank Mansbach | 60 | $507.2K | $3.7M65 |
| 2024 | QuocLe-Nguyen | 57 | $480.0K | $3.7M65 |
| 2024 | Ryan Martins | 48 | $455.7K | $3.4M65 |
| 2024 | Francis Sarena | 54 | $204.5K | $2.7M65 |
| 2023 | Chief Executive Officer | $611.1K | $5.6M65 | |
| 2023 | Chief Medical Officer | $483.0K | $2.5M65 | |
| 2023 | Chief Technical Operations Officer | $455.0K | $2.5M65 | |
| 2022 | Chief Executive Officer | $587.6K | $3.1M65 | |
| 2022 | Chief Medical Officer | $465.0K | $1.5M65 | |
| 2022 | Chief Technical Operations Officer | $435.0K | $1.5M65 |
SEC filer profile
How 89bio, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGAR89bio, Inc.1
- CIK0001785173
- Employer ID (EIN)36-49468443
- Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address655 Montgomery Street, Suite 1500, San Francisco, CA 941111
- Phone(415) 432-92701
- Shares outstanding148,308,250 as of Jul 31, 202510
- Public float$722.4M as of Jun 28, 20243
- AuditorKPMG LLP, San Francisco, California, USA PCAOB ID 185; it also attests to the company’s internal control over financial reporting3
- On EDGAR sinceAug 16, 20191
- Filings559 in all: 4 (241), 8-K (71), SC 13G/A (23), 3 (20), SC 13D/A (20), 10-Q (18), CORRESP (14), SC 13G (13)1
All 50 form types
SCHEDULE 13G/A (12), 144 (11), 424B5 (11), S-8 (7), S-8 POS (7), UPLOAD (7), 10-K (6), DEF 14A (6), DEFA14A (6), EFFECT (6), SCHEDULE 13D/A (4), 424B4 (3), 8-K/A (3), ARS (3), DRS (3), S-1 (3), SC 13D (3), SC14D9C (3), SCHEDULE 13G (3), FWP (2), POSASR (2), S-1MEF (2), S-3 (2), S-3ASR (2), SC 14D9/A (2), SC TO-C (2), SC TO-T/A (2), SEC STAFF LETTER (2), 15-12G (1), 25-NSE (1), 8-A12B (1), CERT (1), DRS/A (1), DRSLTR (1), NT 10-K (1), POS AM (1), PRE 14A (1), S-1/A (1), S-3/A (1), SC 14D9 (1), SC TO-T (1), SCHEDULE 13D (1)
- Latest filingsAnnual report (10-K) Feb 27, 2025
Quarterly report (10-Q) Aug 8, 2025
Proxy statement (DEF 14A) Apr 15, 2025
Latest 8-K (8-K) Oct 30, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common stock, par value $0.001 per share | ETNB | Nasdaq Global Market |
From the cover page of the 10-K filed Feb 27, 2025 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks 89bio, Inc. names in Item 1A of its 10-K filed Feb 27, 2025: 56 risks under these headings, as written.3
- Risks Related to Our Business and Industry
- We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred net losses since our inception, we expect to incur significant and increasing operating losses and we may never be profitable. Our stock is a highly speculative investment.
- Our business depends on the success of pegozafermin, our only product candidate under clinical development, which has not completed a pivotal trial. If we are unable to obtain regulatory approval for and successfully commercialize pegozafermin or other future product candidates, or we experience significant delays in doing so, our business will be materially harmed.
- Clinical drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes, and the results of prior preclinical or clinical trials are not necessarily predictive of our future results.
- We will require substantial 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 pegozafermin or develop new product candidates.
- If we experience delays in clinical testing, our commercial prospects will be adversely affected, our costs may increase and our business may be harmed.
- If we encounter difficulties in enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- We have relied on, and expect to continue to rely on, third-party manufacturers and vendors to produce and release pegozafermin or any future product candidates. Any failure by a third-party to produce and release acceptable product candidates for us pursuant to our specifications and regulatory standards may delay or impair our ability to initiate or complete our clinical trials, obtain and maintain regulatory approvals or commercialize approved products.
- Pegozafermin and any future product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or limit the commercial profile of an approved label.
- We are developing pegozafermin for the treatment of MASH and SHTG. The requirements for approval of pegozafermin by the FDA and comparable foreign regulatory authorities may be difficult to predict and may change over time, which makes it difficult to predict the timing and costs of the clinical development.
- Lack of efficacy, adverse events or undesirable side effects may emerge in clinical trials conducted by third parties developing FGF product candidates, which could adversely affect our stock price, our ability to attract additional capital and our development program.
- Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
The other 45 risks
- The manufacture of biologic products is complex and we are subject to many manufacturing risks, any of which could substantially increase our costs and limit supply of our products.
- We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.
- Unstable market and economic conditions, inflation, fluctuations in interest rates, natural disasters, public health crises, political crises, geopolitical events, such as the crisis in Ukraine and Israel, or other macroeconomic conditions, may have serious adverse consequences on our business and financial condition.
- The Loan Agreement contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay any outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation.
- We may encounter difficulties in managing our growth, which could adversely affect our operations.
- 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.
- We rely on third parties for certain aspects of our product candidate development process and we may not be able to obtain and maintain the third-party relationships that are necessary to develop, commercialize and manufacture some or all of our product candidates. If these third parties do not successfully perform and comply with regulatory requirements, we may not be able to successfully complete clinical development, obtain regulatory approval, or commercialize our product candidates and our business could be substantially harmed.
- Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
- If we fail to develop and commercialize additional product candidates, we may be unable to grow our business.
- We may use our limited financial and human resources to pursue a particular research program or product candidate that is ultimately unsuccessful or less successful than other programs or product candidates that we may have forgone or delayed.
- We may seek to establish commercial collaborations for our product candidates, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
- We may not be successful in our efforts to identify, in-license or acquire, discover, develop or commercialize additional product candidates.
- Our international operations may expose us to business, regulatory, political, operational, financial, pricing and reimbursement risks associated with doing business outside of the United States.
- Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
- Our employees, contractors, vendors, principal investigators, consultants and future partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- If the market opportunities for our approved product candidates, if any, are smaller than we expect, it could materially and adversely affect our financial condition and results of operation.
- Risks Related to Regulatory Approvals
- Pegozafermin has not received regulatory approval. If we are unable to obtain regulatory approvals to market pegozafermin or any future product candidates, our business will be adversely affected.
- Even if we are able to obtain regulatory approvals for pegozafermin or any future product candidate, 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.
- 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 pegozafermin or any future product candidates would substantially harm our business.
- We have received Breakthrough Therapy designation for pegozafermin in MASH from the FDA and PRIME designation for pegozafermin in MASH from the EMA, but such designation may not actually lead to a faster development or regulatory review or approval process, and does not increase the likelihood that pegozafermin will receive marketing approval. In addition, we may seek Breakthrough Therapy, Fast Track or PRIME designation for other indications or future product candidates, but we might not receive such designation.
- We conduct clinical trials for pegozafermin at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.
- Disruptions at the FDA and other government agencies could negatively affect the review of our regulatory submissions, which could negatively impact our business.
- Even if pegozafermin or any future product candidate receives regulatory approval, it may still face future development and regulatory difficulties.
- We expect the product candidates we develop will be regulated as biologics, and therefore they may be subject to competition sooner than anticipated.
- Current and future legislation may increase the difficulty and cost for us, and any collaborators, to obtain marketing approval of and commercialize our drug candidates and affect the prices we, or they, may obtain.
- 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.
- Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
- Risks Related to Intellectual Property
- Our success depends upon our ability to obtain and maintain intellectual property protection for our products and technologies.
- We may not be able to protect our intellectual property rights throughout the world.
- We rely on a license from Teva and a sublicense from ratiopharm to patents and know-how related to glycoPEGylation technology that are used in the development, manufacture and commercialization of pegozafermin. Any termination or loss of significant rights, including the right to glycoPEGylation technology,
- or breach, under these agreements or any future license agreement related to our product candidates, would materially and adversely affect our ability to continue the development and commercialization of the related product candidates.
- We may be unable to obtain intellectual property rights or technology necessary to develop and commercialize pegozafermin and any future product candidates.
- 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.
- Risks Related to Ownership of Our Common Stock
- The price of our common stock may be volatile and fluctuate significantly and results announced by us and our collaborators or competitors could cause our stock price to decline, and you may lose all or part of your investment.
- Sales of our common stock, or the perception that such sales may occur, or issuance of shares of our common stock upon exercise of warrants could depress the price of our common stock.
- Raising additional capital may cause dilution to existing stockholders, restrict our operations or require us to relinquish rights to our technologies.
- We may issue warrants in the future, and hedging activity by investors in such warrants could depress the trading price of our common stock.
- General Risk Factors
- Our directors, executive officers and current holders of 5% or more of our capital stock have substantial control over our company, which could limit your ability to influence the outcome of matters subject to stockholder approval, including a change of control.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud. If we are unable to maintain effective internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our stock may decrease.
- Our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could prevent a third party from acquiring us (even if an acquisition would benefit our stockholders), may limit the ability of our stockholders to replace our management and limit the price that investors might be willing to pay for shares of our common stock.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States will be the exclusive forum for substantially all
- disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- Our ability to use our net operating loss carryforwards and other tax attributes may be limited. If we are required to pay any tax assessment, it could impact our net operating loss carryforwards, as well as our results of operations and financial condition.
- Litigation costs and the outcome of litigation could have a material adverse effect on our business.
Legal proceedings
We are currently not a party to any material legal proceedings. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors, and there can be no assurances that favorable outcomes will be obtained.
The opening of Item 3, Legal Proceedings.3
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGAR89bio, Inc. filings on SEC EDGAR
- 2SEC EDGAR89bio, Inc. filings on SEC EDGAR
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- 4SEC EDGAR89bio, Inc. 10-K for fiscal 2018
- 5SEC EDGAR89bio, Inc. 10-K for fiscal 2019
- 6SEC EDGAR89bio, Inc. 10-K for fiscal 2020
- 7SEC EDGAR89bio, Inc. 10-K for fiscal 2021
- 8SEC EDGAR89bio, Inc. 10-K for fiscal 2022
- 9SEC EDGAR89bio, Inc. 10-Q for fiscal 2025
- 10SEC EDGAR89bio, Inc. 10-Q for fiscal 2025
- 11SEC EDGAR89bio, Inc. 10-K for fiscal 2021
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- 17SEC EDGARQuoc Le-Nguyen, Officer
- 18SEC EDGARRam Waisbourd, Officer
- 19SEC EDGARMartin Babler, Board member
- 20SEC EDGARCharles McWherter, Board member
- 21
- 22SEC EDGARKathleen Laporte, Board member
- 23SEC EDGARSteven Altschuler, Board member
- 24SEC EDGARLota S. Zoth, Board member
- 25SEC EDGARAnat Naschitz, Board member
- 26SEC EDGARDerek Dirocco, Board member
- 27SEC EDGARGregory Grunberg, Board member
- 28SEC EDGARPeter Kolchinsky, Board member
- 29SEC EDGARTomer Kariv, Board member
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- 31
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- 33SEC EDGARResults of operations
- 34SEC EDGARShareholder vote
- 35SEC EDGARResults of operations
- 36SEC EDGARRegulation FD disclosure
- 37SEC EDGARResults of operations
- 38SEC EDGARExecutive or director change
- 39SEC EDGAREntered a material agreement
- 40SEC EDGARResults of operations; Other events
- 41SEC EDGARExecutive or director change
- 42SEC EDGAREntered a material agreement
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- 45
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- 49
- 50
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- 56SEC EDGARBlackRock SC 13G/A on 89bio, Inc.
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- 64SEC EDGARRan Nussbaum SC 13G/A on 89bio, Inc.
- 65