ARVN on Nasdaq

Arvinas (United States)

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through our PROteolysis TArgeting Chimera, or PROTAC, protein degradation platform, we are pioneering the development of a new class of therapeutics designed to harness the body’s ow n natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.”5 It was founded in 2013.1 It is headquartered in New Haven.1 Its shares trade on Nasdaq under the symbol ARVN.1

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Last updated Oct 21, 2026.

Overview

Jan 1, 2013Founded1

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  • TickerARVN on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersNew Haven1
  • Websitearvinas.com
  • Incorporated inDE3
  • Business address395 Winchester Ave, 5 Science Park, New Haven, Ct 065113
  • Filer categoryAccelerated filer3

We are a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through our PROteolysis TArgeting Chimera, or PROTAC, protein degradation platform, we are pioneering the development of a new class of therapeutics designed to harness the body’s ow n natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. We have designed and optimized our proprietary PROTAC Discovery Engine for the discovery of PROTAC therapeutics to address diseases caused by abnormal proteins or aberrant protein expression. We believe that our targeted protein degradation approach is a novel therapeutic modality that may provide distinct advantages over existing therapies and address a broad range of targets, including historically undruggable proteins, in areas of significant unmet n…5 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 2025

-45.1%Operating margin6
-30.8%Net margin6
-0.3%Revenue growth, 20256
-18.6%Return on equity6
0.00×Debt to equity6
-$275.7MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$285.2M
  • Income tax0¢$300.0K

Out of $262.6M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$262.6M in 2025+1335% since 2019
0$100.0M$200.0M$300.0M2019: $18.3M$18.3M20192020: $21.8M$21.8M2020+19%2021: $46.7M$46.7M2021+114%2022: $131.4M$131.4M2022+181%2023: $78.5M$78.5M2023−40%2024: $263.4M$263.4M2024+236%2025: $262.6M$262.6M2025−0%
Operating income91112106-$118.5M in 2025+130% since 2019
-$600.0M-$400.0M-$200.0M02019: -$51.5M-$51.5M20192020: -$120.8M-$120.8M2020+135%2021: -$188.4M-$188.4M2021+56%2022: -$263.2M-$263.2M2022+40%2023: -$401.5M-$401.5M2023+53%2024: -$250.2M-$250.2M2024−38%2025: -$118.5M-$118.5M2025−53%
Net income91112106-$80.8M in 2025+15% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$70.3M-$70.3M20192020: -$119.3M-$119.3M2020+70%2021: -$191.0M-$191.0M2021+60%2022: -$282.5M-$282.5M2022+48%2023: -$367.3M-$367.3M2023+30%2024: -$198.9M-$198.9M2024−46%2025: -$80.8M-$80.8M2025−59%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
Revenue$262.6M$263.4M$78.5M
Research and development$285.2M$348.2M$379.7M
General and administrative$95.9M$165.4M$100.3M
Total operating expenses$381.1M$513.6M$480.0M
Loss from operations-$118.5M-$250.2M-$401.5M
Other expense, net-$400.0K-$2.9M-$1.2M
Interest income, net$38.4M$54.8M$38.8M
Total other income$38.0M$51.9M$37.6M
Net loss before income taxes and loss from equity method investment-$80.5M-$198.3M-$363.9M
Income tax expense-$300.0K-$600.0K-$900.0K
Loss from equity method investment$0$0-$2.5M
Net loss-$80.8M-$198.9M-$367.3M
Net loss per common share - basic (in dollars per share)-$1.14-$2.77-$6.62
Net loss per common share - diluted (in dollars per share)-$1.14-$2.77-$6.62
Weighted-average common shares outstanding - basic (in shares)70.9M shares71.9M shares55.5M shares
Weighted-average common shares outstanding - diluted (in shares)70.9M shares71.9M shares55.5M shares
Unrealized gain on available-for-sale securities$200.0K$4.1M$16.1M
Comprehensive loss-$80.6M-$194.8M-$351.2M

Compare Arvinas (United States) with another company

Corporate structure

Arvinas (United States) sits at the top of its group. 5 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Arvinas (United States)

  • D. E. SHAW & CO, L.P. Filed SCHEDULE 13G/A on Arvinas (United States), latest Aug 14, 2026 (2 filings since Nov 14, 2025)
  • VANGUARD PORTFOLIO MANAGEMENT LLC Filed SCHEDULE 13G on Arvinas (United States), latest Apr 28, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Arvinas (United States), latest Mar 26, 2026 (6 filings since Feb 9, 2022)
  • CITADEL ADVISORS LLC Filed SCHEDULE 13G/A on Arvinas (United States), latest Nov 14, 2025 (3 filings since Jan 30, 2025)
  • Logos Global Management LP Filed SCHEDULE 13D/A on Arvinas (United States), latest Oct 15, 2025 (3 filings since Jun 16, 2025)
  • PRICE T ROWE ASSOCIATES INC /MD/ Filed SCHEDULE 13G/A on Arvinas (United States), latest Aug 14, 2025 (5 filings since Feb 14, 2022)
  • EcoR1 Capital, LLC Filed SCHEDULE 13G/A on Arvinas (United States), latest May 15, 2025 (4 filings since May 16, 2022)
  • BlackRock Filed SCHEDULE 13G/A on Arvinas (United States), latest Apr 17, 2025 (6 filings since Feb 3, 2022)
  • RTW INVESTMENTS, LP Filed SC 13G/A on Arvinas (United States), latest Nov 14, 2024 (2 filings since Feb 14, 2024)
  • Avidity Partners Management LP Filed SC 13G/A on Arvinas (United States), latest Feb 13, 2024 (3 filings since Jun 16, 2022)
  • FMR LLC Filed SC 13G/A on Arvinas (United States), latest Dec 11, 2023 (3 filings since Feb 9, 2022)
  • New Leaf Ventures III, L.P. Filed SC 13G/A on Arvinas (United States), latest Feb 11, 2022
  • Arvinas (United States) New Haven
    • Arvinas Androgen Receptor, Inc. Subsidiary · Delaware, United States
    • Arvinas Estrogen Receptor, Inc. Subsidiary · Delaware, United States
    • Arvinas Operations, Inc. Subsidiary · Delaware, United States
    • Arvinas Winchester, Inc. Subsidiary · Delaware, 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 Arvinas (United States) 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$33.4M6 Dec 31, 2025$32.6M6 Dec 31, 2024+2.5%
Accumulated depreciation$28.2M6 Dec 31, 2025$25.6M6 Dec 31, 2024+10.2%
Property and equipment, net$5.2M6 Dec 31, 2025$7.0M6 Dec 31, 2024−25.7%
Operating-lease assets (leased space)$8.2M6 Dec 31, 2025$9.0M6 Dec 31, 2024−8.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$142.9M6 Dec 31, 2025$100.5M6 Dec 31, 2024+42.2%
Marketable securities, current$542.5M6 Dec 31, 2025$938.9M6 Dec 31, 2024−42.2%
Stakes in other companies (equity method)$06 Dec 31, 2025$010 Dec 31, 2024

Properties, in its own words

As of December 31, 2025, we leased approximately 73,500 square feet of office and laboratory space in New Haven, Connecticut under leases, as amended, that expire in December 2029. We believe that our facilities are sufficient to meet our current needs and that suitable additional or alternative space will be available as and when needed on commercially reasonable terms for any future growth.

Item 2 of the 10-K filed Feb 24, 2026.5

Leadership

Who has led Arvinas (United States), and when. Pick a name to see everywhere that person has worked.

Board members and other officers (20)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Arvinas Androgen Receptor, Inc. Delaware4
  • Arvinas Estrogen Receptor, Inc. Delaware4
  • Arvinas Operations, Inc. Delaware4
  • Arvinas Winchester, Inc. Delaware4

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

Former names

  • ARVINAS INC.Jul 20, 2018 to Oct 10, 20183
  • ARVINAS HOLDING COMPANY, LLCOct 23, 2015 to Sep 28, 20183

Timeline

  1. Aug 4, 20268-K Results of operations38
  2. Jun 25, 20268-K Shareholder vote39
  3. Jun 22, 20268-K Executive or director change40
  4. Jun 16, 20268-K Other events41
  5. Jun 2, 20268-K Regulation FD disclosure; Other events42
  6. May 12, 20268-K Entered a material agreement; Regulation FD disclosure43
  7. May 12, 20268-K Results of operations44
  8. May 1, 20268-K Regulation FD disclosure; Other events45
  9. Mar 18, 20268-K Regulation FD disclosure; Other events46
  10. Feb 24, 20268-K Results of operations47
  11. Feb 18, 2026New chief executive Randy Teel becomes CEO15
  12. Feb 12, 20268-K Executive or director change48
  13. Dec 8, 20258-K Regulation FD disclosure; Other events49
  14. Sep 26, 2018New chief executive John G. Houston becomes CEO16
  15. Jan 1, 2013Founded Founded1

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.48) a share, on Nov 5, 2025.50

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results38
  2. May 12, 2026Reported quarterly or annual results44
  3. Feb 24, 2026Reported quarterly or annual results47
  4. Nov 5, 2025Reported quarterly or annual results51
  5. Aug 6, 2025Reported quarterly or annual results52
  6. May 1, 2025Reported quarterly or annual results53
  7. Feb 11, 2025Reported quarterly or annual results54
  8. Oct 30, 2024Reported quarterly or annual results55

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

329 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 78 major events, 134 insider forms, 40 large holders, 57 other. The latest 20:

  1. Sep 28, 2026S-8 EDGAR
  2. Sep 22, 2026144 EDGAR
  3. Sep 9, 2026144 EDGAR
  4. Sep 4, 2026144 EDGAR
  5. Aug 31, 2026S-8 EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 4, 2026144 EDGAR
  8. Aug 4, 202610-Q EDGAR
  9. Aug 4, 20268-K EDGAR
  10. Jul 9, 2026144 EDGAR
  11. Jun 26, 20264 EDGAR
  12. Jun 26, 20264 EDGAR
  13. Jun 26, 20264 EDGAR
  14. Jun 26, 20264 EDGAR
  15. Jun 26, 20264 EDGAR
  16. Jun 26, 20264 EDGAR
  17. Jun 25, 20268-K EDGAR
  18. Jun 24, 20264 EDGAR
  19. Jun 23, 2026144 EDGAR
  20. Jun 22, 20268-K EDGAR

The 329 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

61 open-market trades by officers, directors and large owners since October 2021: 2 buys and 59 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 24, 2026Saik AndrewChief Financial OfficerSale5,696$8.16$46.5KForm 4
Jun 17, 2026Cacace Angela MChief Scientific OfficerSale2,576$7.60$19.6KForm 4
May 21, 2026Teel RandyPresident and CEOSale2,209$9.04$20.0KForm 4
May 11, 2026Saik AndrewChief Financial OfficerSale11,139$9.94$110.7KForm 4
May 11, 2026Loomis David KVP, Chief Accounting OfficerSale1,919$9.94$19.1KForm 4
May 11, 2026Cacace Angela MChief Scientific OfficerSale9,657$9.94$96.0KForm 4
May 11, 2026Berkowitz NoahChief Medical OfficerSale11,108$9.94$110.4KForm 4
May 11, 2026Teel RandyPresident and CEOSale9,657$9.94$96.0KForm 4
Mar 18, 2026Berkowitz NoahChief Medical OfficerSale6,435$11.10$71.4KForm 4
Mar 6, 2026Morrison BriggsDirectorBuy20,000$13.40$268.0KForm 4
Feb 27, 2026Houston John GDirectorSale35,297$13.21$466.2KForm 4
Feb 23, 2026Loomis David KVP, Chief Accounting OfficerSale1,108$12.16$13.5KForm 4
Feb 23, 2026Cacace Angela MChief Scientific OfficerSale3,609$12.16$43.9KForm 4
Feb 23, 2026Teel RandyPresident and CEOSale4,786$12.16$58.2KForm 4
Feb 13, 2026Teel RandyPresident and CEOSale4,403$11.89$52.4KForm 4
Feb 13, 2026Saik AndrewChief Financial OfficerSale5,134$11.89$61.0KForm 4
Feb 13, 2026Cacace Angela MChief Scientific OfficerSale4,592$11.89$54.6KForm 4
Feb 13, 2026Berkowitz NoahChief Medical OfficerSale5,685$11.89$67.6KForm 4
Feb 13, 2026Loomis David KVP, Chief Accounting OfficerSale1,016$11.89$12.1KForm 4
Nov 7, 2025Loomis David KVP, Chief Accounting OfficerSale230$9.89$2.3KForm 4

All 61 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
2025Former President and$706.2K$6.5M69
2025Chief Medical Officer$552.4K$3.6M69
2025Chief Financial Officer$542.1K$3.4M69
2025Chief Scientific Officer$500.8K$3.3M69
2025Former President of$152.6K$903.4K69
2024Chief Executive Officer$684.0K$12.7M69
2024Research and$367.9K$4.2M69
2024and Treasurer$272.6K$3.5M69
2023Chief Executive Officer$657.7K$7.6M69
2023Development$466.9K$2.7M69

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
BlackRock, Inc.7,609,123$63.2M0.0%+811,539
Vanguard Portfolio Management LLC4,123,399$34.3M0.0%+233,771
D. E. Shaw & Co., Inc.3,495,153$29.0M0.0%−143,414
Pfizer Inc3,457,815$27.7M16.2%No change
Armistice Capital, LLC2,796,000$23.2M0.6%+818,000
Vanguard Capital Management LLC2,714,163$22.6M0.0%+24,801
Two Sigma Investments, LP2,573,447$21.4M0.0%+741,333
State Street Corp2,196,872$18.3M0.0%+368,400
Nextech Invest Ltd.1,122,713$17.1M0.8%+583,319
Geode Capital Management, LLC1,667,265$13.9M0.0%+110,158
Qube Research & Technologies Ltd1,592,276$13.2M0.0%+390,641
Jacobs Levy Equity Management, Inc1,412,643$11.7M0.0%−28,878
Federated Hermes, Inc.1,356,032$11.3M0.0%+215,317
Hillsdale Investment Management Inc.750,900$6.2M0.1%New
TCG Crossover Management, LLC707,098$5.9M0.1%−1,680,363
Dimensional Fund Advisors LP654,909$5.4M0.0%+169,145
Goldman Sachs Group Inc640,811$5.3M0.0%−116,064
Citadel Advisors LLC620,973$5.2M0.0%−560,015
Northern Trust Corp615,296$5.1M0.0%+94,341
Aqr Capital Management LLC601,873$5.0M0.0%+316,755
Nantahala Capital Management, LLC600,000$5.0M0.2%+300,000
Kennedy Capital Management LLC589,238$4.9M0.1%+36,597
Arbiter Partners Capital Management LLC589,188$4.9M1.4%New
Millennium Management LLC574,011$4.8M0.0%−2,341
Charles Schwab Investment Management Inc542,174$4.5M0.0%+17,000

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

SEC filer profile

How Arvinas (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARARVINAS, INC.2
  • CIK0001655759
  • Employer ID (EIN)47-25661205
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address395 Winchester Ave, 5 Science Park, New Haven, CT 065112
  • Phone203-535-14562
  • Shares outstanding65,386,191 as of Jul 31, 202614
  • Public float$469.0M as of Jun 30, 20255
  • AuditorDeloitte & Touche LLP, Boston, Massachusetts PCAOB ID 34; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceOct 23, 20152
  • Filings599 in all: 4 (243), 8-K (114), 3 (36), SC 13G/A (30), 144 (29), 10-Q (24), SC 13G (17), S-8 (13)2
    All 37 form types

    DEFA14A (9), 10-K (8), DEF 14A (8), SCHEDULE 13G/A (8), CORRESP (7), 424B5 (6), UPLOAD (6), ARS (4), CT ORDER (4), 4/A (3), D (3), EFFECT (3), S-3ASR (3), SCHEDULE 13G (3), 424B3 (2), S-3 (2), SCHEDULE 13D/A (2), 3/A (1), 424B4 (1), 5 (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), S-1/A (1), S-1MEF (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Feb 24, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Aug 4, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.001 per shareARVNThe Nasdaq Global Select Market

From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Arvinas (United States) names in Item 1A of its 10-K filed Feb 24, 2026: 70 risks under these headings, as written.5

  • Risks Related to Our Financial Position and Need For Additional Capital
  • We have incurred significant losses since our inception. We expect to incur expenses and operating losses over at least the next several years and may never achieve or maintain profitability.
  • We have never generated revenue from product sales and may never be profitable.
  • We will need substantial additional funding to continue our operations. If we are unable to raise capital when needed, we may be required to delay, limit, reduce or terminate our research or product development programs or future commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our limited operating history may make it difficult for our stockholders to evaluate the success of our business to date and to assess our future viability.
  • Our cost savings plan and the associated workforce reductions implemented in April 2025 and September 2025 may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.
  • Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
  • In the future, we might not be able to utilize a significant portion of any net operating loss carryforwards and research and development tax credit carryforwards we may have.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • Our approach to the discovery and development of product candidates based on our PROTAC technology platform is unproven, which makes it difficult to predict the time, cost of development and likelihood of successfully developing any products.
  • We do not have any product candidates that have been approved for commercialization. If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
The other 60 risks
  • Drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • If SAEs, undesirable side effects, or unexpected characteristics are identified during the development of any product candidates we may develop, we may need to abandon or limit our further clinical development of those product candidates.
  • Positive data from preclinical or early clinical studies of our product candidates are not necessarily predictive of the results of later clinical studies and any future clinical trials of our product candidates. If we cannot replicate the positive data from our preclinical or early clinical studies of our product candidates in our future clinical trials, we will be unable to successfully develop, obtain regulatory approval for and commercialize our product candidates.
  • Interim top-line 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.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary marketing approvals could be delayed or prevented.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We are developing and plan to continue to develop our product candidates in combination with other drugs. If the FDA or similar regulatory authorities outside of the United States do not approve these other drugs, or revoke their approval of such drugs, or if safety, efficacy, manufacturing or supply issues arise with the drugs we choose to evaluate in combination with our product candidates, we may be unable to obtain approval of or market our products.
  • We have conducted, and may in the future conduct, clinical trials for product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.
  • We may not be successful in our efforts to identify or discover additional potential product candidates.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • Risks Related to Dependence on Third Parties
  • We have an ongoing collaboration with Pfizer related to vepdegestrant, but have announced that we and Pfizer have agreed to jointly select a third party for the commercialization and potential future development of vepdegestrant. If our collaboration with Pfizer or another party is not successful, we may not be able to capitalize on the market potential of vepdegestrant.
  • We currently depend, and expect to continue to depend, on collaborations, license arrangements, and other strategic alliances with third parties for the research, development, and the potential future commercialization of certain of the product candidates we may develop. If any such collaborations are not successful, we may not be able to capitalize on the market potential of those product candidates.
  • We may seek to establish additional collaborations or out-license the development of our product candidates. If we are not able to establish collaborations or enter into these out-licenses on commercially reasonable terms, we may have to alter our business development plans or product development and commercialization plans.
  • We rely and expect to continue to rely on third parties, including CROs, to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
  • We rely on third-party CMOs or CDMOs for the manufacture and testing of both drug substance and finished drug product for our product candidates for preclinical testing and clinical trials and expect to continue to do so for commercialization. This reliance on third parties may increase the risk that we will
  • not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
  • Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns, leadership changes and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development programs and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  • Risks Related to the Commercialization of Our Product Candidates
  • Even if any of our product candidates 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 we are unable to establish sales and marketing capabilities, we may not be successful in commercializing our product candidates if and when they are approved.
  • Even if we are able to commercialize any product candidates, the products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for our technology and products or if the scope of the patent 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 commercialize our technology and products may be impaired, and we may not be able to compete effectively in our market.
  • Changes in patent laws or patent jurisprudence could diminish the value of our patents in general, thereby impairing our ability to protect our product candidates.
  • We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors, or other intellectual property, which could be expensive, time-consuming and unsuccessful.
  • We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms or at all.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • If we fail to comply with our obligations in our current and future intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
  • We may be subject to claims by third parties asserting that our employees, consultants, contractors or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent offices, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • If we are not able to obtain patent term extensions in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for our product candidates, our business may be impaired.
  • We only have limited geographical protection with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Regulatory Approval and Marketing of Our Product Candidates, Our Industry and Other Legal and Compliance Matters
  • The regulatory approval process of the FDA is lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed.
  • 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 from obtaining approvals for the commercialization of any or all of our product candidates. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed outside of the United States and may limit our ability to generate revenue from product sales.
  • We may seek certain designations for our product candidates, including Breakthrough Therapy, Fast Track and Priority Review, designations in the United States, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory oversight.
  • The FDA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Our relationships with health care providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other health care laws and regulations, which could expose us to civil, criminal and administrative sanctions, contractual damages, reputational harm and diminished future profits and earnings.
  • If the FDA or comparable foreign regulatory authorities approve generic versions of any of our future drug products that receive marketing approval through the NDA pathway, or such authorities do not grant such future products appropriate periods of data exclusivity before approving generic versions of our products, our sales could be adversely affected.
  • Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and our failure or the failure of our collaborators, CROs, CDMOs, contractors, consultants and other third parties to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • Current and future legislation may increase the difficulty and cost for us and any collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain.
  • The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our drug products, if and when approved.
  • We are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, which could adversely affect our business, results of operations and financial condition.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could significantly harm our business.
  • Social media platforms and AI-based platforms present new risks and challenges to our business.
  • Risks Related to Employee Matters and Managing Growth
  • Our future success depends on our ability to retain key employees, consultants and advisors, as well as our ability to attract, train, retain and motivate qualified personnel.
  • Our internal computer systems and those of our collaborators, CROs, CDMOs, contractors, consultants and other third parties are vulnerable to cyber attacks, cyber intrusions and security breaches, which could not only materially disrupt our business operations and result in the loss of confidential information, but could also damage the integrity of our clinical trials, impact our regulatory filings, compromise our ability to protect our intellectual property, and subject us to regulatory actions that could result in significant fines or other penalties.
  • Our employees, independent contractors, vendors, principal investigators, CROs, CMOs, CDMOs, and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, privacy laws and insider trading laws, which could materially harm our business.
  • Risks Related to Our Common Stock
  • The price of our common stock is volatile and may fluctuate substantially, which could result in the loss of all or part of our stockholders’ investment.
  • We may be subject to securities litigation, which is expensive and could divert management attention.
  • Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to significantly influence or control all matters submitted to stockholders for approval.
  • Provisions in our organizational documents and under Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
  • If a significant portion of our total outstanding shares are sold into the market, the market price of our common stock could drop significantly, even if our business is doing well.
  • We will continue to incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time to any new compliance initiatives and corporate governance practices.
  • Because we have never paid and do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, and any cash expended via our share repurchase program, will be our stockholders’ sole source of gain.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings arising in the ordinary course of business and regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors. We are not currently a party to any material litigation or legal proceedings.

The opening of Item 3, Legal Proceedings.5

Sources

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