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AVIR on Nasdaq

Atea Pharmaceuticals, Inc.

American pharmaceutical preparations company, incorporated in Massachusetts1

In its 2026 annual report the company says: “We are a late-stage clinical biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biochemistry and virology to discover, develop and commercialize novel, orally administered antivirals to treat serious viral diseases.”4 It is headquartered in Boston, Massachusetts.1 Its shares trade on Nasdaq under the symbol AVIR.1

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Last updated Oct 21, 2026.

Overview

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  • TickerAVIR on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoston, Massachusetts1
  • Incorporated inMA2
  • Business address225 Franklin Street, Suite 2100, Boston, Ma 021102
  • Filer categoryNon-accelerated filer, Smaller reporting company2

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We are a late-stage clinical biopharmaceutical company leveraging our deep understanding of antiviral drug development, medicinal chemistry, biochemistry and virology to discover, develop and commercialize novel, orally administered antivirals to treat serious viral diseases. Our current product candidate pipeline includes the regimen of bemnifosbuvir and ruzasvir which we believe has the potential to improve the current standard of care (“SOC”) for the treatment of patients with hepatitis C virus (“HCV”) infection and AT-587 which we believe has the potential to be the first direct-acting antiviral (“DAA”) for the treatment of patients, particularly immunocompromised patients, with chronic hepatitis E virus (“HEV”) infection.4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2021

39.4%Operating margin5
34.5%Net margin5
622.5%Revenue growth, 20215
17.1%Return on equity6
-$87.0MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2021

  • Research and development48¢$167.2M
  • Other costs13¢$45.6M
  • Income tax5¢$17.4M
  • Profit34¢$121.2M

Out of $351.4M in revenue.5

Financial statements

Revenue5$351.4M in 2021+622% since 2020
0$100.0M$200.0M$300.0M$400.0M2020: $48.6M$48.6M20202021: $351.4M$351.4M2021+622%
Operating income75$138.4M in 2021
-$50.0M0$50.0M$100.0M$150.0M2019: -$14.6M-$14.6M20192020: -$11.0M-$11.0M2020−24%2021: $138.4M$138.4M2021
Net income75$121.2M in 2021
-$50.0M0$50.0M$100.0M$150.0M2019: -$14.0M-$14.0M20192020: -$10.9M-$10.9M2020−22%2021: $121.2M$121.2M2021

Every line of the income statement as filed: the last 2 fiscal years, latest first.10

Period ending2025-12-312024-12-31
Research and development$148.0M$144.1M
General and administrative$32.9M$48.8M
Total operating expenses$180.9M$192.9M
Loss from operations-$180.9M-$192.9M
Interest income and other, net$16.4M$25.5M
Loss before income taxes-$164.5M-$167.5M
Income tax benefit (expense)$6.2M-$925.0K
Net loss-$158.3M-$168.4M
Unrealized (loss) gain on available-for-sale investments-$59.0K$26.0K
Comprehensive loss-$158.4M-$168.4M
Net loss per share - basic-$1.94-$2.00
Net loss per share - diluted-$1.94-$2.00
Weighted-average number of common shares - basic81.5M shares84.3M shares
Weighted-average number of common shares - diluted81.5M shares84.3M shares

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Corporate structure

Atea Pharmaceuticals, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Atea Pharmaceuticals, Inc.

  • TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Atea Pharmaceuticals, Inc., latest Oct 6, 2026
  • FMR LLC Filed SCHEDULE 13G/A on Atea Pharmaceuticals, Inc., latest May 6, 2026 (8 filings since Feb 9, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Atea Pharmaceuticals, Inc., latest Mar 26, 2026 (4 filings since Feb 9, 2022)
  • BML Investment Partners, L.P. Filed SCHEDULE 13G on Atea Pharmaceuticals, Inc., latest Feb 9, 2026 (5 filings since Oct 2, 2023)
  • Jean-Pierre Sommadossi Filed SCHEDULE 13G/A on Atea Pharmaceuticals, Inc., latest May 14, 2025 (4 filings since Feb 10, 2022)
  • BlackRock Filed SCHEDULE 13G/A on Atea Pharmaceuticals, Inc., latest Apr 23, 2025 (5 filings since Feb 4, 2022)
  • Radoff Bradley Louis Filed SCHEDULE 13D/A on Atea Pharmaceuticals, Inc., latest Apr 17, 2025 (3 filings since Mar 4, 2025)
  • EcoR1 Capital, LLC Filed SCHEDULE 13G/A on Atea Pharmaceuticals, Inc., latest Feb 14, 2025 (7 filings since Dec 10, 2021)
  • TANG CAPITAL PARTNERS LP Filed SC 13D/A on Atea Pharmaceuticals, Inc., latest Nov 28, 2023 (2 filings since May 22, 2023)
  • Morningside Venture Investments Ltd Filed SC 13G/A on Atea Pharmaceuticals, Inc., latest Feb 16, 2022
  • Cormorant Asset Management, LP Filed SC 13G/A on Atea Pharmaceuticals, Inc., latest Feb 14, 2022
  • RA CAPITAL MANAGEMENT, L.P. Filed SC 13G/A on Atea Pharmaceuticals, Inc., latest Feb 14, 2022
  • Atea Pharmaceuticals, Inc. Boston, Massachusetts
    • Atea Pharmaceuticals Securities Corporation Subsidiary · Massachusetts, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Atea Pharmaceuticals, 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

ItemLatestA year beforeChange
Property and equipment, before depreciation$2.0M10 Dec 31, 2025$2.0M10 Dec 31, 20240%
Accumulated depreciation$1.5M10 Dec 31, 2025$1.1M10 Dec 31, 2024+37.6%
Property and equipment, net$457.0K10 Dec 31, 2025$873.0K10 Dec 31, 2024−47.7%
Operating-lease assets (leased space)$634.0K10 Dec 31, 2025$1.2M10 Dec 31, 2024−49.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$95.7M10 Dec 31, 2025$64.7M10 Dec 31, 2024+47.9%
Marketable securities, current$206.1M10 Dec 31, 2025$390.0M10 Dec 31, 2024−47.2%
Marketable securities, non-current$012 Dec 31, 2024$012 Dec 31, 2023
Debt securities available for sale$206.1M10 Dec 31, 2025$390.0M10 Dec 31, 2024−47.2%

Properties, in its own words

Our principal office is located at 225 Franklin Street, Boston, Massachusetts, where we lease 17,544 square feet of office space. We lease this space under a sublease agreement, with the term January 1, 2022 through December 31, 2026. We believe that our facilities are sufficient to meet our current needs and that suitable additional space will be available as and when needed.

Item 2 of the 10-K filed Mar 5, 2026.4

Leadership

Who has led Atea Pharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Jean-Pierre Sommadossi2020–now

Chair

  1. Jean-Pierre Sommadossi2020–now

President

  1. Jean-Pierre Sommadossi2020–now
2025
Board members and other officers (15)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Atea Pharmaceuticals Securities Corporation Massachusetts3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Aug 12, 20268-K Results of operations29
  2. Jun 22, 20268-K Shareholder vote30
  3. May 12, 20268-K Results of operations31
  4. Mar 5, 20268-K Results of operations32
  5. Jan 8, 20268-K Results of operations33
  6. Nov 12, 20258-K Results of operations34
  7. Aug 7, 20258-K Results of operations35
  8. Jun 20, 20258-K Shareholder vote36
  9. May 12, 20258-K Results of operations37
  10. Apr 17, 20258-K Entered a material agreement; Results of operations; Executive or director change38
  11. Apr 1, 20258-K Other events39
  12. Mar 24, 20258-K Other events40
  13. Oct 29, 2020New chief executive Jean-Pierre Sommadossi becomes CEO13

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.53) a share, on Nov 12, 2025.41

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results29
  2. May 12, 2026Reported quarterly or annual results31
  3. Mar 5, 2026Reported quarterly or annual results32
  4. Jan 8, 2026Reported quarterly or annual results33
  5. Nov 12, 2025Reported quarterly or annual results34
  6. Aug 7, 2025Reported quarterly or annual results35
  7. May 12, 2025Reported quarterly or annual results37
  8. Apr 17, 2025Reported quarterly or annual results38

Drug trials and FDA: coming up

  1. Dec 2026Phase 3 trial readout expected Phase 3 trial of Bemnifosbuvir-Ruzasvir and Sofosbuvir-Velpatasvir in HEPATITIS C VIRUS CHRONIC INFECTION: primary completion expected Dec 2026 (ClinicalTrials.gov NCT07037277).42

Drug trials and FDA: recently

  1. Dec 9, 2024Phase 2 trial completed Phase 2 trial of Bemnifosbuvir and Ruzasvir in Chronic Hepatitis C Virus: primary completion Dec 9, 2024, results posted Oct 21, 2025 (ClinicalTrials.gov NCT05904470).43

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

218 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 34 major events, 82 insider forms, 42 large holders, 40 other. The latest 20:

  1. Oct 6, 2026SCHEDULE 13G EDGAR
  2. Aug 12, 202610-Q EDGAR
  3. Aug 12, 20268-K EDGAR
  4. Jun 23, 20264 EDGAR
  5. Jun 23, 20264 EDGAR
  6. Jun 23, 20264 EDGAR
  7. Jun 23, 20264 EDGAR
  8. Jun 23, 20264 EDGAR
  9. Jun 23, 20264 EDGAR
  10. Jun 23, 20264 EDGAR
  11. Jun 23, 20264 EDGAR
  12. Jun 22, 20268-K EDGAR
  13. May 21, 20264/A EDGAR
  14. May 20, 20264 EDGAR
  15. May 12, 202610-Q EDGAR
  16. May 12, 20268-K EDGAR
  17. May 6, 2026SCHEDULE 13G/A EDGAR
  18. Apr 27, 2026DEFA14A EDGAR
  19. Apr 27, 2026DEF 14A EDGAR
  20. Mar 26, 2026SCHEDULE 13G/A EDGAR

The 218 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

21 open-market trades by officers, directors and large owners since October 2021: 7 buys and 14 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 18, 2026Murphy Polly A.DirectorBuy6,100$4.17$25.4KForm 4
May 18, 2025Murphy Polly A.DirectorBuy6,100$4.17$25.4KForm 4
Jan 16, 2025BERGER FRANKLIN MDirectorBuy10,000$3.36$33.6KForm 4
Jan 16, 2025BERGER FRANKLIN MDirectorBuy10,000$3.36$33.6KForm 4
Jan 15, 2025BERGER FRANKLIN MDirectorBuy15,000$3.19$47.9KForm 4
Jan 15, 2025BERGER FRANKLIN MDirectorBuy15,000$3.19$47.9KForm 4
Dec 10, 2024BERGER FRANKLIN MDirectorSale359,606$2.85$1.0MForm 4
Sep 19, 2024Sommadossi Jean-PierrePresident, CEO, and ChairmanSale1,841$4.00$7.4KForm 4
Sep 18, 2024Sommadossi Jean-PierrePresident, CEO, and ChairmanSale22,187$4.03$89.4KForm 4
Sep 17, 2024Sommadossi Jean-PierrePresident, CEO, and ChairmanSale33,941$4.05$137.5KForm 4
Jun 20, 2024Polsky BruceDirectorSale17,544$3.49$61.2KForm 4
Jun 5, 2024Sommadossi Jean-PierrePresident, CEO, and ChairmanSale1,006$4.00$4.0KForm 4
Feb 1, 2024Corcoran AndreaSee RemarksSale15,843$3.84$60.8KForm 4
Feb 1, 2024Sommadossi Jean-PierrePresident, CEO, and ChairmanSale56,910$3.85$219.1KForm 4
Feb 1, 2024Horga Maria ArantxaChief Medical OfficerSale15,870$3.84$60.9KForm 4
Feb 1, 2024Foster WayneEVP, Chief Accounting OfficerSale12,477$3.84$47.9KForm 4
Feb 1, 2024Vavricka JohnChief Commercial OfficerSale11,819$3.84$45.4KForm 4
Feb 1, 2024Hammond Janet MJChief Development OfficerSale14,029$3.84$53.9KForm 4
Nov 14, 2022BERGER FRANKLIN MDirectorSale16,166$5.16$83.4KForm 4
Nov 11, 2022BERGER FRANKLIN MDirectorSale25,500$5.15$131.3KForm 4

All 21 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.

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.

YearExecutiveAgeSalaryTotal pay
2025Jean-Pierre SommadossiPhD70$703.5K$3.4M56
2025Janet HammondMD, PhD66$590.9K$1.8M56
2025Andrea Corcoran63$549.5K$1.7M56
2025Maria Arantxa HorgaMD57$523.6K$1.6M56
2025John Vavricka62$443.2K$1.2M56
2024PresidentChief Executive Officer$703.5K$4.2M56
2024Chief Development Officer$573.7K$2.2M56
2024Chief Financial Officer,$533.5K$1.9M56
2024Chief Medical Officer$508.4K$1.9M56
2024Chief Commercial Officer$430.3K$1.4M56
2023and Chairman of the Board$683.0K$5.9M56
2023Chief Development Officer$557.0K$2.1M56
2023Executive Vice PresidentLegal$518.0K$2.0M56
2023Chief Medical Officer$493.6K$1.8M56
2023Chief Commercial Officer$417.7K$1.5M56

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Fmr LLC12,004,064$55.8M0.0%+53,292
BlackRock, Inc.8,720,077$40.5M0.0%+284,640
BML Capital Management, LLC6,952,330$32.3M18.5%−106,327
Tang Capital Management LLC4,814,700$22.4M1.0%No change
Vanguard Capital Management LLC2,964,862$13.8M0.0%−281,262
Bain Capital Life Sciences Investors, LLC2,075,639$9.7M0.6%−284,999
Geode Capital Management, LLC1,958,435$9.1M0.0%+210,729
State Street Corp1,652,399$7.7M0.0%−42,236
Two Sigma Investments, LP1,506,697$7.0M0.0%−357,467
Dimensional Fund Advisors LP1,299,515$6.0M0.0%+44,031
Renaissance Technologies LLC1,131,200$5.3M0.0%−35,200
Rosalind Advisors, Inc.1,070,550$5.0M1.9%−101,305
Jpmorgan Chase & Co945,918$4.4M0.0%+5,761
Northern Trust Corp755,239$3.5M0.0%+170,214
Morgan Stanley719,514$3.3M0.0%−11,506
Vanguard Portfolio Management LLC630,185$2.9M0.0%+72,606
Charles Schwab Investment Management Inc610,607$2.8M0.0%+13,898
Goldman Sachs Group Inc530,856$2.5M0.0%−57,607
Vanguard Fiduciary Trust Co469,801$2.2M0.0%−14,904
CM Management, LLC355,000$1.7M1.0%No change
Barclays PLC348,653$1.6M0.0%+187,707
D. E. Shaw & Co., Inc.345,186$1.6M0.0%−34,128
Banque Pictet & Cie Sa345,077$1.6M0.0%No change
Millennium Management LLC304,611$1.4M0.0%−45,321
Nuveen, LLC284,283$1.3M0.0%+41,180

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Atea Pharmaceuticals, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARAtea Pharmaceuticals, Inc.1
  • CIK0001593899
  • Employer ID (EIN)46-05748694
  • Filer statusNon-accelerated filer not an emerging growth company; 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 address225 Franklin Street, Suite 2100, Boston, MA 021101
  • Phone(857) 284-88911
  • Shares outstanding80,204,699 as of Aug 10, 20269
  • Public float$262.6M as of Jun 30, 20254
  • AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceDec 11, 20131
  • Filings313 in all: 4 (106), 8-K (41), SC 13G/A (25), 3 (19), 10-Q (18), DEFA14A (13), 144 (12), SC 13G (10)1
    All 39 form types

    SCHEDULE 13G/A (7), 10-K (6), DEF 14A (6), CORRESP (4), D (4), EFFECT (3), SC 13D/A (3), UPLOAD (3), 4/A (2), D/A (2), POS AM (2), S-1/A (2), S-8 (2), SC 13D (2), SCHEDULE 13D (2), SCHEDULE 13D/A (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 424B4 (1), 8-A12B (1), ARS (1), CERT (1), DFAN14A (1), DRS (1), DRS/A (1), DRSLTR (1), POSASR (1), S-1 (1), S-1MEF (1), S-3 (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Aug 12, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareAVIRThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Atea Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Mar 5, 2026: 74 risks under these headings, as written.4

  • Risks Related to Our Financial Condition and Capital Requirements
  • We have a limited operating history and no history of successfully developing or commercializing any approved antiviral products, which may make it difficult to evaluate the success of our business to date and to assess the prospects for our future viability.
  • We have incurred significant operating expenses since inception and expect to incur significant additional operating expenses for the foreseeable future. We have no products that have generated any commercial revenue. We expect to incur operating losses in 2026 and for the foreseeable future.
  • We may require substantial additional financing, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
  • We may engage in strategic collaborations or other transactions that could disrupt our business, cause dilution to our stockholders, reduce our financial resources, and subject us to other risks.
  • We have not generated any revenue from product sales and may not be able to achieve profitability.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
  • Our ability to use our net operating loss carryforwards and other tax attributes to offset taxable income may be subject to certain limitations.
  • We may delay, suspend or terminate the development of a product candidate at any time if we believe the perceived market or commercial opportunity does not justify further investment or for other strategic business, financial or other reasons, which could materially harm our business and adversely affect our stock price.
  • Risks Related to the Discovery, Development, Preclinical and Clinical Testing, Manufacturing and Regulatory Approval of Our Product Candidates
  • Our business is highly dependent on the success of our lead product candidate, the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV, which will require significant additional clinical testing, including successful completion of Phase 3 clinical testing, before we can seek regulatory approval and potentially launch commercial sales. If this product candidate fails in clinical development, does not receive regulatory approval or is not successfully commercialized, or is significantly delayed in doing so, our business will be harmed.
  • The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, expensive, time-consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business will be seriously harmed.
The other 63 risks
  • Clinical development, including enrollment of patients in clinical trials, is an expensive, lengthy and uncertain process. We may encounter substantial delays and costs in our clinical trials or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.
  • We are developing certain of our product candidates in combination with other therapies, which exposes us to additional risks.
  • Our product candidates may be associated with serious adverse events (“SAEs”), undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • If we encounter difficulties enrolling and retaining enrolled patients in our clinical trials and having patients comply with the clinical trial protocol, our clinical development activities could be delayed or otherwise adversely affected.
  • A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
  • We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our product candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign locations.
  • 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.
  • We may not be successful in our efforts to identify and successfully develop additional product candidates.
  • We may focus on potential product candidates that may prove to be unsuccessful and we may have to forego opportunities to develop other product candidates that may prove to be more successful.
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us or any future collaboration partners from obtaining approvals for the commercialization of any product candidate we develop.
  • Even if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the US, which would limit our ability to realize their full market potential.
  • Even if a current or future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • If the market opportunities for our product candidates are smaller than we believe they are or any approval we obtain is based on a narrower definition of the patient population, our business may suffer.
  • Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
  • Our business and operations may suffer in the event of information technology system failures, cyberattacks, or deficiencies, which could materially affect our results.
  • Risks Related to Healthcare Laws and Other Legal Compliance Matters
  • We are subject to extensive and costly government regulation.
  • Enacted and future legislation and policies may increase the difficulty and cost for us to commercialize our product candidates and could adversely affect our business.
  • Enacted and future legislation and policies may increase the difficulty and cost for us to obtain marketing approval of our product candidates and could adversely affect our business.
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny and post-marketing requirements.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Our business operations and current and future relationships with clinical trial investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • We are subject to governmental regulation and other legal obligations, particularly related to privacy, data protection and information security, and we are subject to consumer protection laws that regulate our marketing practices and prohibit unfair or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business.
  • We face potential liability related to the privacy of health information we obtain from clinical trials sponsored by us.
  • Our business may be affected by the evolving regulatory framework relating to the use of AI.
  • We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities.
  • We and our employees are increasingly utilizing social media tools as a means of communication both internally and externally.
  • Risks Related to Commercialization
  • Developments by competitors may render our products or technologies obsolete or non-competitive or may reduce the size of our markets.
  • For the treatment of HCV, we will face significant competition from approved and authorized oral treatments. The approved HCV drugs are well-established products and are widely-accepted by physicians, patients and third-party payors. For other diseases that we may target, we may face competition from drugs approved for treatment of such diseases as well as other treatments in development.
  • The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue.
  • If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing any of our product candidates, if approved, and we may not be able to generate any product revenue.
  • Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
  • Risks Related to Manufacturing and our Dependence on Third Parties
  • Our third-party manufacturers may be unable to successfully scale up manufacturing of our product candidates in sufficient quality and quantity in a timely manner, if at all, which may impair the clinical advancement and commercialization of our product candidates.
  • We do not have multiple sources of supply for all of the components used in our product candidates, nor long-term supply contracts, and certain of our suppliers are critical to our production. If we were to lose a critical supplier, it could have a material adverse effect on our ability to complete the development of our product candidates and our efforts to manufacture products for commercialization, if approved. If we obtain regulatory approval and seek to commercialize any approved product we will need to expand the number of manufacturers supplying components of such approved product.
  • We rely on third parties to conduct our preclinical studies and clinical trials. Any failure by a third-party to conduct the clinical trials according to GCPs and in a timely manner may delay or prevent our ability to seek or obtain regulatory approval for or commercialize our product candidates.
  • We currently expect that we may collaborate with third parties in connection with the commercialization of our product candidates, if approved. We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize our product candidates successfully, if at all.
  • Data provided by collaborators and others upon which we rely that have not been independently verified could turn out to be false, misleading or incomplete.
  • Our employees and independent contractors, including principal investigators, CROs, consultants, vendors and any third parties we may engage in connection with research, development, regulatory, manufacturing, quality assurance and other pharmaceutical functions and commercialization may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
  • If our CMOs and CROs use hazardous materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Risks Related to Intellectual Property
  • If we are unable to obtain, maintain, enforce and adequately protect our intellectual property rights with respect to our technology and product candidates, or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected.
  • Third-party claims of intellectual property infringement, misappropriation or other violation may result in substantial costs or prevent or delay our development and commercialization efforts.
  • A number of companies and universities file and obtain patents in the same area as our product candidates, and these patent filings could be asserted against us, which may affect our business, and if successful, could lead to expensive litigation, affect the profitability of our products and/or prohibit the sale of a product or its use.
  • Our products are subject to The Drug Price Competition and Patent Term Restoration Act of 1984, as amended (also referred to as the Hatch-Waxman Act), in the US, that can increase the risk of litigation with generic companies trying to sell our products, and may cause us to lose patent protection.
  • A number of pharmaceutical companies have been the subject of intense review by the FTC or a corresponding agency in another country based on how they have conducted or settled drug patent litigation, and certain reviews have led to an allegation of an antitrust violation, sometimes resulting in a fine or loss of rights. We cannot be sure that we would also not be subject to such a
  • review or that the result of the review would be favorable to us, which could result in a fine or penalty.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
  • The Hatch-Waxman Act in the US provides for the opportunity to seek a patent term extension on one selected patent for each of our products, and the length of that patent term extension, if at all, is subject to review and approval by the USPTO and the FDA.
  • If we are unable to obtain licenses from third parties on commercially reasonable terms or at all, or fail to comply with our obligations under such agreements, our business could be harmed.
  • Litigation and adversarial proceedings are expensive, time-consuming and if unsuccessful, can adversely affect our ability to sell our products when commercialized.
  • Changes in patent laws and enforcement by courts and other authorities in the US and other jurisdictions may impact our ability to protect our patents.
  • 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 not be able to enforce our intellectual property rights throughout the world.
  • We rely on our ability to stop others from competing by enforcing our patents, however some jurisdictions may require us to grant licenses to third parties. Such compulsory licenses could be extended to include some of our product candidates, which may limit our potential revenue opportunities.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties, that our employees have wrongfully used or disclosed alleged trade secrets of their former employers, or asserting ownership of what we regard as our own intellectual property.
  • Our proprietary rights may not adequately protect our technologies and product candidates, and intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Risks Related to Employee Matters, Managing Operations and Other Risks Related to Our Business
  • We may be unable to realize expected benefits from our cost reduction efforts and our business might be adversely affected.
  • Our future success depends upon our ability to retain officers, directors and key employees and attract, retain and motivate qualified personnel.
  • We rely on consultants, advisors and third parties for the performance of critical aspects of our business operations.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
  • Our business could face adverse consequences as a result of the actions of activist shareholders.
  • Risks Related to Our Common Stock

Legal proceedings

We are not subject to any material legal proceedings.

The opening of Item 3, Legal Proceedings.4

Sources

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