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OCGN on Nasdaq

Ocugen

Logo: ocugen.com4

Ocugen is a biopharmaceutical company based in Malvern.1 Its shares trade on Nasdaq under the symbol OCGN.1

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Last updated Oct 21, 2026.

Overview

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  • TickerOCGN on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersMalvern1
  • Websiteocugen.com
  • Incorporated inDE5
  • Business address11 Great Valley Parkway, Malvern, Pa 193555
  • Filer categoryNon-accelerated filer, Smaller reporting company5
  • Legal formCorporation3
  • LEI549300JVNUI9CXWJLR093
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 41903503

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Ocugen is aiming to redefine the future of vision through game-changing gene therapies with the potential to address significant, unmet medical needs. Our First-in-class, breakthrough modifier gene therapy platform presents a potential paradigm shift in treating inherited retinal diseases and blindness diseases affecting millions across the globe.7 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

-1425.7%Operating margin8
-1537.4%Net margin8
8.8%Revenue growth, 20258
-$57.1MFree cash flow8

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$39.8M

Out of $4.4M in revenue.8 The company lost money this year.

Financial statements

Revenue910118$4.4M in 2025
0$2.0M$4.0M$6.0M$8.0M2019: $0$020192020: $43.0K$43.0K20202021: $0$020212022: $2.5M$2.5M20222023: $6.0M$6.0M2023+143%2024: $4.1M$4.1M2024−33%2025: $4.4M$4.4M2025+9%
Operating income91210118-$62.9M in 2025+344% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$14.2M-$14.2M20192020: -$21.3M-$21.3M2020+50%2021: -$58.0M-$58.0M2021+173%2022: -$89.1M-$89.1M2022+53%2023: -$65.5M-$65.5M2023−26%2024: -$54.8M-$54.8M2024−16%2025: -$62.9M-$62.9M2025+15%
Net income91210118-$67.8M in 2025+235% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$20.2M-$20.2M20192020: -$21.8M-$21.8M2020+8%2021: -$58.4M-$58.4M2021+167%2022: -$86.8M-$86.8M2022+49%2023: -$63.1M-$63.1M2023−27%2024: -$54.1M-$54.1M2024−14%2025: -$67.8M-$67.8M2025+26%

Every line of the income statement as filed: the last 2 fiscal years, latest first.8

Period ending2025-12-312024-12-31
Total revenue$4.4M$4.1M
Research and development$39.8M$32.1M
General and administrative$27.6M$26.7M
Total operating expenses$67.3M$58.8M
Loss from operations-$62.9M-$54.8M
Interest income$922.0K$1.3M
Interest expense-$5.2M-$688.0K
Other (expense) income, net-$664.0K$140.0K
Total other (expense) income-$4.9M$703.0K
Net loss-$67.8M-$54.1M
Foreign currency translation adjustment$13.0K$28.0K
Comprehensive loss-$67.8M-$54.0M

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Corporate structure

Ocugen sits at the top of its group. 6 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Ocugen

  • Ocugen Waltham, Massachusetts, United States
    • Histogenics Securities Corporation Subsidiary · Massachusetts, United States
    • Ocugen Canada Ltd. Subsidiary · Canada
    • Ocugen India Private Limited Subsidiary · India
    • Ocugen OpCo, Inc. Subsidiary · Delaware, United States
    • OrthoCellix, Inc. Subsidiary · Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 Ocugen 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$19.9M8 Dec 31, 2025$19.7M8 Dec 31, 2024+1.0%
Accumulated depreciation$5.5M8 Dec 31, 2025$3.2M8 Dec 31, 2024+74.5%
Property and equipment, net$14.4M8 Dec 31, 2025$16.6M8 Dec 31, 2024−13.1%
Operating-lease assets (leased space)$4.1M8 Dec 31, 2025$3.6M8 Dec 31, 2024+13.3%

Properties, in its own words

Our properties are located in Malvern, Pennsylvania and other locations, including our corporate headquarters, which consist of approximately 28,488 square feet of leased office space, and our current GMP facility, which consists of approximately 16,401 square feet of laboratory and future manufacturing space. Our corporate headquarters has a lease term of approximately seven years and includes options to extend the lease for up to 10 years, which we have not elected to account for since it is not reasonably certain that we will exercise such option. Our current GMP facility has a lease term of seven years and includes an option to extend the lease for up to five years, which we have elected to account for since it is reasonably certain that we will exercise such option. We lease three other general use facilities within the United States, which have initial terms of two to three years and contain no option to extend. The Company also has leases in Canada and India which have terms of four to five years and contain no option to extend. We believe that our existing facilities are adequate 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 4, 2026.7

Leadership

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

Chief executive

  1. Adam Gridley2014–2018
  2. Shankar Musunuri2019–now

President

  1. Adam Gridley2014–2018

Chief financial officer

  1. Kevin McArdle2014–2015
  2. Jonathan I. Lieber2015–2018
  3. Sanjay Subramanian2019–2022
  4. Quan Anh Vu2023
  5. Treerita Essalima Johnson-Greene2026–now
201520202025
Board members and other officers (34)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Histogenics Securities Corporation Massachusetts6
  • Ocugen Canada Ltd. Canada6
  • Ocugen India Private Limited India6
  • Ocugen Limited Ireland6
  • Ocugen OpCo, Inc. Delaware6
  • OrthoCellix, Inc. Delaware6

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

Former names

  • HISTOGENICS CORPAug 7, 2006 to Sep 26, 20195

Timeline

  1. Oct 15, 20268-K Entered a material agreement; Regulation FD disclosure; Other events54
  2. Oct 15, 20268-K Regulation FD disclosure55
  3. Oct 6, 20268-K Shareholder vote56
  4. Sep 23, 20268-K Shareholder vote57
  5. Sep 8, 20268-K Regulation FD disclosure; Other events58
  6. Aug 6, 20268-K Results of operations59
  7. Jul 13, 20268-K Other events60
  8. Jun 11, 20268-K Shareholder vote; Other events61
  9. Jun 3, 20268-K Executive or director change62
  10. May 14, 20268-K New debt or obligation; Unregistered sale of shares; Regulation FD disclosure63
  11. May 14, 20268-K Executive or director change; Other events64
  12. May 7, 20268-K Entered a material agreement; Ended a material agreement; Results of operations65
  13. Dec 13, 2019New chief executive Shankar Musunuri becomes CEO16
  14. Dec 2, 2014New chief executive Adam Gridley becomes CEO17
  15. Jul 14, 2006Founded Ocugen is founded3

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.07) a share, on Nov 5, 2025.66

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results59
  2. May 7, 2026Reported quarterly or annual results65
  3. May 5, 2026Reported quarterly or annual results67
  4. May 4, 2026Reported quarterly or annual results68
  5. Mar 4, 2026Reported quarterly or annual results69
  6. Nov 5, 2025Reported quarterly or annual results70
  7. Aug 1, 2025Reported quarterly or annual results71
  8. May 9, 2025Reported quarterly or annual results72

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

Filings

364 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 137 major events, 108 insider forms, 25 large holders, 73 other. The latest 20:

  1. Oct 15, 20268-K EDGAR
  2. Oct 15, 20268-K EDGAR
  3. Oct 13, 20264 EDGAR
  4. Oct 9, 2026144 EDGAR
  5. Oct 6, 20268-K EDGAR
  6. Sep 23, 20268-K EDGAR
  7. Sep 11, 20264 EDGAR
  8. Sep 9, 2026144 EDGAR
  9. Sep 8, 20268-K EDGAR
  10. Aug 14, 2026DEFA14A EDGAR
  11. Aug 13, 2026SCHEDULE 13G/A EDGAR
  12. Aug 7, 2026SCHEDULE 13G EDGAR
  13. Aug 6, 202610-Q EDGAR
  14. Aug 6, 20268-K EDGAR
  15. Jul 30, 2026DEFA14A DEFA 14A EDGAR
  16. Jul 30, 2026DEF 14A EDGAR
  17. Jul 29, 2026SCHEDULE 13G EDGAR
  18. Jul 20, 2026PRE 14A EDGAR
  19. Jul 13, 20268-K EDGAR
  20. Jun 17, 20264 EDGAR

The 364 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

36 open-market trades by officers, directors and large owners since October 2021: 4 buys and 32 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 9, 2026Musunuri ShankarChief Executive OfficerSale525,991$1.12$589.1KForm 4
Jun 15, 2026Johnson-Greene Treerita EssalimaChief Financial OfficerBuy21,000$1.23$25.8KForm 4
Nov 26, 2024Fernandes PrabhavathiDirectorBuy10,000$0.91$9.1KForm 4
Nov 22, 2024Castillo KirstenDirectorBuy25,000$0.91$22.8KForm 4
Jun 14, 2023Zhang JungeDirectorBuy200,278$0.50$100.1KForm 4
Feb 16, 2023Musunuri ShankarChief Executive OfficerSale100,000$1.08$108.0KForm 4
Jan 17, 2023Musunuri ShankarChief Executive OfficerSale100,000$1.28$128.0KForm 4
Dec 16, 2022Musunuri ShankarChief Executive OfficerSale95,809$1.43$137.0KForm 4
Oct 14, 2022Musunuri ShankarChief Executive OfficerSale100,000$1.66$166.0KForm 4
Oct 6, 2022Kumar RameshDirectorSale4,500$1.83$8.2KForm 4
Aug 11, 2022Castillo KirstenDirectorSale42,000$2.91$122.2KForm 4
Jul 18, 2022Kumar RameshDirectorSale7,500$2.57$19.3KForm 4
Jul 14, 2022Musunuri ShankarChief Executive OfficerSale150,000$2.72$408.0KForm 4
May 13, 2022Musunuri ShankarChief Executive OfficerSale125,000$1.92$240.0KForm 4
Apr 18, 2022Kumar RameshDirectorSale7,500$2.83$21.2KForm 4
Mar 16, 2022Musunuri ShankarChief Executive OfficerSale81,823$2.65$216.8KForm 4
Feb 14, 2022Musunuri ShankarChief Executive OfficerSale90,000$3.74$336.6KForm 4
Jan 18, 2022Kumar RameshDirectorSale7,500$4.07$30.5KForm 4
Dec 16, 2021Musunuri ShankarChief Executive OfficerSale115,000$5.22$600.3KForm 4
Nov 16, 2021Musunuri ShankarChief Executive OfficerSale115,000$8.04$924.6KForm 4

All 36 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.

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.27,002,933$41.3M0.0%+19,697,954
State Street Corp21,469,307$32.8M0.0%+11,799,116
Vanguard Capital Management LLC14,372,598$22.0M0.0%+568,487
Millennium Management LLC13,943,252$21.3M0.0%+216,060
Geode Capital Management, LLC8,871,013$13.6M0.0%+4,643,909
Rtw Investments, LP6,666,666$10.2M0.1%No change
UBS Group AG5,177,508$7.9M0.0%−2,102,812
Ikarian Capital, LLC3,962,972$6.1M1.0%No change
GMT Capital Corp3,505,398$5.4M0.3%No change
Marshall Wace, Llp3,410,257$5.2M0.0%−4,642,093
Vanguard Portfolio Management LLC3,329,446$5.1M0.0%+2,393,647
Hennion & Walsh Asset Management, Inc.2,830,397$4.3M0.1%+1,553,672
Northern Trust Corp2,747,562$4.2M0.0%+2,033,826
Vanguard Fiduciary Trust Co2,367,144$3.6M0.0%+366,041
Two Sigma Investments, LP2,230,179$3.4M0.0%−21,103
Qube Research & Technologies Ltd2,203,407$3.4M0.0%−1,569,659
Bank Of America Corp /de/1,990,636$3.0M0.0%+816,456
Boothbay Fund Management, LLC1,097,742$1.7M0.0%No change
Charles Schwab Investment Management Inc1,042,537$1.6M0.0%+830,443
Goldman Sachs Group Inc1,020,894$1.6M0.0%−106,512
Susquehanna International Group, Llp1,020,479$1.6M0.0%+250,930
Nuveen, LLC823,461$1.3M0.0%New
Bank of New York Mellon Corp808,835$1.2M0.0%+722,717
Citadel Advisors LLC783,322$1.2M0.0%−2,025,835
Citigroup Inc548,591$839.3K0.0%+405,432

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

Members of Congress who traded it

2 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Nov 8, 2022Christopher L. Jacobs, HouseSale$1,001 - $15,000+152.4%Report
Jun 16, 2022Christopher L. Jacobs, HouseBuy$15,001 - $50,000−168.8%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

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

  • Name on EDGAROcugen, Inc.2
  • CIK0001372299
  • Employer ID (EIN)04-35223157
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company7
  • Incorporated inDelaware7
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address11 Great Valley Parkway, Malvern, PA 193552
  • Phone484-328-47012
  • Shares outstanding339,110,401 as of Jul 31, 202614
  • Public float$279.2M as of Jun 30, 20257
  • AuditorPricewaterhouseCoopers LLP, Philadelphia, Pennsylvania PCAOB ID 238; no auditor attestation of internal control over financial reporting7
  • On EDGAR sinceAug 7, 20062
  • Filings890 in all: 8-K (277), 4 (241), 3 (44), 10-Q (35), DEFA14A (33), 425 (22), SC 13G/A (22), 424B5 (18)2
    All 55 form types

    CORRESP (16), DEF 14A (15), SC 13G (15), S-8 (14), UPLOAD (13), 10-K (12), EFFECT (9), SC 13D/A (8), PRE 14A (7), S-3 (7), D (6), SCHEDULE 13G (6), 144 (5), 424B3 (5), DRS/A (5), 8-K/A (4), ARS (4), CT ORDER (4), S-1/A (4), SCHEDULE 13G/A (4), SC 13D (3), 10-K/A (2), 3/A (2), PRER14A (2), REGDEX (2), S-4/A (2), SEC STAFF LETTER (2), 10-Q/A (1), 4/A (1), 424B4 (1), 424B7 (1), 8-A12B (1), 8-A12G (1), CERTNAS (1), D/A (1), DEFR14A (1), DRS (1), FWP (1), NT 10-K (1), NT 10-Q (1), POS AM (1), POSASR (1), RW (1), S-1 (1), S-3/A (1), S-3ASR (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 4, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Jul 30, 2026
    Latest 8-K (8-K) Oct 15, 2026

Securities registered for trading

ClassSymbolExchange
Common StockOCGNThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 4, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks Ocugen names in Item 1A of its 10-K filed Mar 4, 2026: 72 risks under these headings, as written.7

  • Risks Related to Our Financial Position and Capital Requirements
  • We have incurred significant losses and negative cash flows from operations since our inception. We may incur losses over the next several years and may never achieve or maintain profitability. These factors raise substantial doubt about our ability to continue as a going concern absent obtaining significant additional funding.
  • We have no history of commercializing pharmaceutical products, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts.
  • Due to our limited resources and access to capital, we must, and have in the past decided to, prioritize development of certain product candidates over other potential product candidates. These decisions may prove to have been wrong and may adversely affect our ability to develop our own programs, our attractiveness as a commercial partner and may ultimately have an impact on our commercial success.
  • We will need additional capital in order to enable us to successfully develop our product candidates, and such funding may not be available on acceptable terms, or at all. Raising additional capital may cause dilution to stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
  • The terms of our Loan and Security Agreement with Avenue Capital Management II, L.P. and the lenders listed therein as well as our loan agreement (the "EB-5 Loan Agreement") with EB-5 Life Sciences, L.P. ("EB-5 Life Sciences") require us to meet certain operating covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
  • Our management has broad discretion in the use of the net proceeds from our capital raises, including our November 2024 debt financing transaction, and may not use these proceeds effectively.
  • Our ability to utilize our tax net operating losses is uncertain.
  • We may be subject to future changes in tax legislation or exposure to additional tax liabilities that may adversely affect our financial condition, results of operations, and cash flows.
  • Risks Related to Our Business and the Development of Our Product Candidates
  • We are substantially dependent on the success of our product candidates. We cannot guarantee that our product candidates will successfully complete development, receive regulatory approval, or be successfully commercialized.
The other 62 risks
  • Our product candidates generated from our modifier gene therapy platform are based on a novel technology and face an uncertain regulatory environment, which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable. 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 as expected, and our ability to generate revenue will be materially impaired.
  • The development and manufacture of biologics is a complex process and entails particular risks.
  • OCU400 has received RMAT and ODDs from the FDA, as well as ATMP and OMPD designations from the EMA. OCU410ST has received RPDD and ODD from the FDA and ATMP and OMPD from the EMA, OCU410 has received ATMP designation from the EMA. However, there is no guarantee that we will be able to maintain these designations, receive these designations for any of our other product candidates, or receive or maintain any corresponding benefits, including periods of exclusivity.
  • The FDA may determine that our product candidates have undesirable side effects that could delay or prevent their regulatory approval or commercialization. If such side effects are identified during the development of our product candidates, we may need to abandon our development of such product candidates.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our completion of clinical trials and receipt of necessary regulatory approvals could be delayed or prevented.
  • Data from preclinical studies and early-stage clinical trials and "top-line", initial or preliminary data from our clinical trials may not be predictive of success in later clinical trials.
  • We conduct portions of our clinical trials for product candidates at sites outside the United States, and the FDA may not accept data from clinical trials conducted in foreign locations.
  • Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.
  • We may be subject to fines, penalties, injunctions, or other enforcement actions if we are determined to be promoting the use of our products, if approved, for unapproved or “off-label” uses, resulting in damage to our reputation and business.
  • Even if our product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense.
  • We will need to obtain FDA approval of any proposed product names, and any failure or delay associated with such approval may adversely affect our business.
  • Geopolitical events and conditions could adversely affect our business, financial condition and operating results.
  • Specifically, changes in the economic, political, legal and social conditions and policies of the Chinese government or in relations between China and the United States may materially and adversely affect our business, financial condition, results of operations, access to capital, and the market price of our common stock.
  • The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
  • Risks Related to the Commercialization of Our Product Candidates
  • We have no prior experience in the marketing, sale, and distribution of biotechnology products and there can be no assurance that our product candidates, if approved, will be successfully commercialized.
  • If we obtain approval to commercialize our product candidates outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
  • If we are unable to establish effective marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may be unable to generate product revenues.
  • We face significant competition from other pharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations. Our operating results will suffer if we fail to compete effectively.
  • If our product candidates for which we receive approval do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
  • If the market opportunities for our product candidates are smaller than we believe, our revenue may be adversely affected, and our business may suffer.
  • If third-party payors do not reimburse patients for our products candidates, if approved, or if reimbursement levels are set too low for us to sell our product candidates at a profit, our ability to successfully commercialize our product candidates, if approved, and our results of operations will be harmed.
  • As an organization, we have limited experience in the development, manufacturing, distribution, or commercialization of a vaccine candidate.
  • Due to the end of the COVID-19 public health emergency and decline in vaccination rates, the demand for any COVID-19 vaccine product candidate we develop may decrease significantly.
  • Risks Related to Our Dependence on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials we may initiate, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with regulatory requirements.
  • If we encounter difficulties in negotiating commercial manufacturing and supply agreements with third-party manufacturers and suppliers of our product candidates or any product components, our ability to commercialize our product candidates, if approved, would be impaired.
  • If the manufacturers upon whom we rely on fail to produce our product candidates or product components pursuant to the terms of contractual arrangements with us or fail to comply with stringent regulations applicable to biotechnology manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates, if approved, and may lose potential revenues.
  • We or our third-party manufacturers may also encounter shortages in the materials necessary to produce our product candidates in the quantities needed for our clinical trials or, if our product candidates are approved, in sufficient quantities for commercialization.
  • The number of available, qualified third-party manufactures is limited, and if we are compelled to locate an alternative manufacturing partner, our product development activities and commercialization could be delayed and additional expense would be incurred.
  • We may seek to collaborate with third parties for the development or commercialization of our product candidates. We may not be successful in establishing or maintaining collaborative relationships, any of which could adversely affect our ability to develop and commercialize our product candidates.
  • Should we desire to pursue a collaboration agreement but are not able to establish collaborations, we may have to alter our development and commercialization plans and our business could be adversely affected.
  • Risks Related to Legal and Compliance Matters
  • We are currently, and may in the future be, subject to securities litigation, which is expensive and could divert management attention.
  • If we fail to comply with federal and state healthcare laws, including fraud, abuse, and health and other information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, and prospects could be adversely affected.
  • Healthcare legislative or regulatory reform measures may have a negative impact on our business and results of operations.
  • Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.
  • Our employees, independent contractors, consultants, commercial partners, principal investigators, or CDMOs 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.
  • 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, or be precluded from developing, manufacturing, and selling certain products outside the United States, which could adversely affect our business, results of operations, and financial condition.
  • Risks Related to Our Intellectual Property
  • As with all patent prosecution, there is no guarantee of obtaining and maintaining patent protection for our technology and product candidates. In addition, there is no guarantee that the scope of the patent protection obtained is sufficiently broad or enforceable, to prevent our competitors from developing and commercializing technology and products similar or identical to ours. Furthermore, our ability to successfully commercialize our technology and product candidates may be impaired due to circumstances that may be out of our control.
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • If we are not able to obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, our business may be materially harmed.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming, and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating, or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • Obtaining and maintaining 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.
  • Certain aspects of our product candidates are protected by patents exclusively licensed from other companies or institutions. If these licensors terminate their agreements with us or fail to maintain or enforce the underlying patents or licenses thereto, or we otherwise lose our rights to these patents, our competitive position and our market share in the markets for any of our licensed and approved products will be harmed.
  • Some intellectual property which we own or have licensed may have been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for United States industry. Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements and limit our ability to contract with non-United States manufacturers.
  • If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • We may be subject to claims by third parties asserting misappropriation of their intellectual property or claiming ownership of what we regard as our own intellectual property.
  • Intellectual property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Risks Related to Our Common Stock
  • We have issued a substantial number of warrants and equity awards from our equity plans which are exercisable into shares of our common stock which could result in substantial dilution to the ownership interests of our existing stockholders.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock.
  • Sales of a substantial number of common stock by our stockholders in the public market could cause our stock price to fall.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Our sixth amended and restated certificate of incorporation, as amended, provides that the Court of Chancery of the State of Delaware is 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 failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.
  • The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses.
  • If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.
  • General Risk Factors
  • Our future success depends on our ability to retain key executives and to attract, retain, and motivate qualified personnel.
  • We expect to expand our development, regulatory, and manufacturing capabilities and potentially implement sales, marketing, and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

Legal proceedings

From time to time, we are subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Although the results of litigation and claims cannot be predicted with certainty, as of the date of this Annual Report, we do not believe we are party to any claim or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

For a discussion of legal proceedings, see Note 16 in the notes to the consolidated financial statements included elsewhere in this Annual Report. This discussion is incorporated herein by reference.

The opening of Item 3, Legal Proceedings.7

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