Sign in

OTLK on Nasdaq

Outlook Therapeutics, Inc.

American biological products company based in Iselin, incorporated in Delaware2

In its 2025 annual report the company says: “We are a biopharmaceutical company that has developed ONS-5010/LYTENAVA TM as the first ophthalmic formulation of bevacizumab approved by the European Commission in the European Union, or EU, and the Medicines and Healthcare products Regulatory Agency, or MHRA, in the United Kingdom, or UK, for use in adults for the treatment of wet age-related macular degeneration, or wet AMD.”6 Its shares trade on Nasdaq under the symbol OTLK.2

Price unavailable

Last updated Oct 21, 2026.

Overview

$1.4MRevenue, fiscal 20253
-$62.4MNet income, fiscal 20253

Compare with SAB Biotherapeutics, Inc., Scinai Immunotherapeutics Ltd. or Inhibrx Biosciences, Inc., or pick any stock.

  • TickerOTLK on Nasdaq2
  • IndustryBiological Products, (No Diagnostic Substances)2
  • HeadquartersCranbury, United States2
  • Incorporated inDE4
  • Business address111 S. Wood Avenue, Unit #100, Iselin, Nj 088304
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation2
  • LEI5493007AWUJ6HPMCBH112
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O UNITED CORPORATE SERVICES, INC., 19901 Dover, United States2
  • Registered withDivision of Corporations, Department of State, 58571842

See how the biggest companies compare on our leaderboards

We are a biopharmaceutical company that has developed ONS-5010/LYTENAVA TM as the first ophthalmic formulation of bevacizumab approved by the European Commission in the European Union, or EU, and the Medicines and Healthcare products Regulatory Agency, or MHRA, in the United Kingdom, or UK, for use in adults for the treatment of wet age-related macular degeneration, or wet AMD. In June 2025, we launched directly into the initial markets of Germany and the UK. Additionally, our Biologics License Application, or BLA, is currently under review at the U.S. Food and Drug Administration, or FDA, for the use of ONS-5010/LYTENAVA as a treatment for wet AMD in the United States. If approved by the FDA., our goal is to also launch directly in the United States as the first and only approved ophthalmic bevacizumab for the treatment of wet AMD. In addition to Europe and the United States., we may se…6 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

4.0%Gross margin3
-4744.3%Operating margin3
-4416.2%Net margin3

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue2¢$1.4M
  • Research and development39¢$27.2M
  • Selling, general and admin57¢$39.9M
  • Income tax2¢$1.6M

Out of $1.4M in revenue.3 The company lost money this year.

Financial statements

Revenue783$1.4M in 2025−54% since 2018
0$2.5M$5.0M$7.5M$10.0M2018: $3.1M$3.1M20182019: $8.1M$8.1M2019+164%2025: $1.4M$1.4M2025−83%
Operating income7891011123-$67.1M in 2025+126% since 2018
-$80.0M-$60.0M-$40.0M-$20.0M02018: -$29.6M-$29.6M20182019: -$36.3M-$36.3M2019+22%2020: -$36.8M-$36.8M2020+1%2021: -$51.7M-$51.7M2021+40%2022: -$63.1M-$63.1M2022+22%2023: -$53.1M-$53.1M2023−16%2024: -$71.7M-$71.7M2024+35%2025: -$67.1M-$67.1M2025−6%
Net income7891011123-$62.4M in 2025+107% since 2018
-$80.0M-$60.0M-$40.0M-$20.0M02018: -$30.1M-$30.1M20182019: -$34.5M-$34.5M2019+15%2020: -$35.2M-$35.2M2020+2%2021: -$53.2M-$53.2M2021+51%2022: -$66.1M-$66.1M2022+24%2023: -$59.0M-$59.0M2023−11%2024: -$75.4M-$75.4M2024+28%2025: -$62.4M-$62.4M2025−17%

Every line of the income statement as filed: the last 2 fiscal years, latest first.3

Period ending2025-09-302024-09-30
Revenues, net$1.4M
Cost of revenues$1.4M
Gross profit$57.2K
Research and development$27.2M$41.8M
Selling, general and administrative$39.9M$29.9M
Loss from operations-$67.1M-$71.7M
Loss on equity method investment$141.0K$100.7K
Interest income-$89.7K-$906.1K
Interest expense$283.1K$3.2M
Loss from change in fair value of promissory notes$6.1M$2.5M
Warrant related expenses (Note 10)$37.5M
Warrant inducement expenses (Note 10)$33.5M
Gain from change in fair value of warrant liability-$43.0M-$38.6M
Loss before income taxes-$64.0M-$75.4M
Income tax (benefit) expense-$1.6M$2.8K
Net loss-$62.4M-$75.4M
Net loss per share of common stock, basic (in dollars per share)-$1.79-$4.06
Net loss per share of common stock, diluted (in dollars per share)-$1.79-$4.06
Weighted average shares outstanding, basic (in shares)34.8M shares18.5M shares
Weighted average shares outstanding, diluted (in shares)34.8M shares18.5M shares

Compare Outlook Therapeutics, Inc. with another company

Corporate structure

Outlook Therapeutics, Inc. sits at the top of its group. 4 entities, 4 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Outlook Therapeutics, Inc.

  • Outlook Therapeutics, Inc. Cranbury, New Jersey, United States
    • Outlook Therapeutics CH GmbH Subsidiary · Switzerland
    • Outlook Therapeutics Limited (dormant subsidiary) Subsidiary · United Kingdom
    • Outlook Therapeutics NL B.V. Subsidiary · Netherlands

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 Outlook Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Operating-lease assets (leased space)$225.5K3 Sep 30, 2025$274.6K3 Sep 30, 2024−17.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$8.1M3 Sep 30, 2025$14.9M3 Sep 30, 2024−45.9%
Stakes in other companies (equity method)$552.2K3 Sep 30, 2025$693.2K3 Sep 30, 2024−20.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$3.3M3 Sep 30, 2025
Raw materials$2.4M3 Sep 30, 2025
Work in process$958.5K3 Sep 30, 2025
Finished goods$29.6K3 Sep 30, 2025

Properties, in its own words

Our headquarters are located in Iselin, New Jersey where we occupy approximately 3,726 square feet of office space under a lease that expires in April 30, 2029. In March 2021, we entered into a three-year term corporate office lease for our former corporate headquarters in Iselin, New Jersey that ended on April 30, 2024.

Item 2 of the 10-K filed Dec 19, 2025.6

Leadership

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

Chief executive

  1. Pankaj Mohan2016–2018
  2. Lawrence A. Kenyon2018–2021
  3. C. Russell Trenary Iii.2021–2024
  4. Robert Charles Jahr2025–now

President

  1. Pankaj Mohan2016–2018
  2. C. Russell Trenary Iii.2021–2024

Chief financial officer

  1. Lawrence A. Kenyon2016–2026
  2. Kevin Michael Lundquist2026–now

Chief operating officer

  1. Terry Dagnon2018–2022
20202025
Board members and other officers (28)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Outlook Therapeutics CH GmbH Switzerland5
  • Outlook Therapeutics DE GmbH Germany5
  • Outlook Therapeutics Limited Republic of Ireland5
  • Outlook Therapeutics Limited (dormant subsidiary) England and Wales5
  • Outlook Therapeutics NL B.V. Netherlands5
  • Outlook Therapeutics Pty Ltd Australia5

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

Former names

  • Oncobiologics, Inc.Aug 10, 2015 to Nov 13, 20184

Timeline

  1. Sep 30, 20268-K Listing notice or transfer46
  2. Sep 18, 20268-K Other events47
  3. Aug 27, 20268-K Executive or director change48
  4. Aug 14, 20268-K Results of operations49
  5. Aug 14, 20268-K Other events50
  6. Aug 12, 20268-K Results of operations; Other events51
  7. Jul 24, 20268-K Executive or director change52
  8. Jul 24, 20268-K Other events53
  9. Jul 16, 20268-K Bylaws or fiscal year changed; Shareholder vote54
  10. Jun 26, 20268-K Listing notice or transfer55
  11. Jun 16, 20268-K Other events56
  12. Jun 1, 20268-K Other events57
  13. Jul 9, 2025New chief executive Robert Charles Jahr becomes CEO15
  14. Jul 8, 2021New chief executive C. Russell Trenary Iii. becomes CEO16
  15. Aug 3, 2018New chief executive Lawrence A. Kenyon becomes CEO17
  16. May 12, 2016New chief executive Pankaj Mohan becomes CEO18
  17. Oct 22, 2015Founded Outlook Therapeutics, Inc. is founded2

Calendar

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results49
  2. Aug 12, 2026Reported quarterly or annual results51
  3. May 18, 2026Reported quarterly or annual results58
  4. May 13, 2026Reported quarterly or annual results59
  5. Feb 17, 2026Reported quarterly or annual results60
  6. Dec 19, 2025Reported quarterly or annual results61
  7. Aug 14, 2025Reported quarterly or annual results62
  8. May 15, 2025Reported quarterly or annual results63

Drug trials and FDA: recently

  1. Jul 24, 2026FDA approval FDA approved Lytenava (bevacizumab-vikg), a new molecular entity (BLA 761320).64
  2. Nov 7, 2024Phase 3 trial completed Phase 3 trial of bevacizumab and ranibizumab in Neovascular Age-related Macular Degeneration: primary completion Nov 7, 2024, results posted Jun 30, 2026 (ClinicalTrials.gov NCT06190093).65

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

360 filings to the SEC since October 2021: 8 annual reports, 15 quarterly reports, 95 major events, 123 insider forms, 36 large holders, 6 private raises, 77 other. The latest 20:

  1. Oct 13, 2026SCHEDULE 13G EDGAR
  2. Sep 30, 20268-K EDGAR
  3. Sep 18, 20268-K EDGAR
  4. Sep 2, 20264 EDGAR
  5. Sep 2, 20263 EDGAR
  6. Aug 27, 20268-K EDGAR
  7. Aug 19, 2026SCHEDULE 13G EDGAR
  8. Aug 18, 202610-Q EDGAR
  9. Aug 17, 2026NT 10-Q EDGAR
  10. Aug 14, 20264 PRIMARY DOCUMENT EDGAR
  11. Aug 14, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Aug 14, 20268-K EDGAR
  13. Aug 14, 2026424B5 EDGAR
  14. Aug 14, 20268-K EDGAR
  15. Aug 14, 2026SCHEDULE 13D/A EDGAR
  16. Aug 14, 20264 EDGAR
  17. Aug 12, 2026424B5 EDGAR
  18. Aug 12, 20268-K EDGAR
  19. Jul 29, 20264 PRIMARY DOCUMENT EDGAR
  20. Jul 24, 20268-K EDGAR

The 360 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

42 open-market trades by officers, directors and large owners since October 2021: 37 buys and 5 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 14, 2026KENYON LAWRENCE AChief Financial OfficerBuy101,010Form 4
Aug 14, 2026Jahr Robert CharlesChief Executive OfficerBuy151,515Form 4
Aug 12, 2026Sukhtian Ghiath M.DirectorBuy2,525,252$0.99$2.5MForm 4
Jul 29, 2026Sukhtian Faisal GhiathDirectorBuy95,398$1.05$100.2KForm 4
Jun 2, 2026Haddadin Yezan MuntherDirectorBuy29,000$0.83$24.1KForm 4
May 28, 2026GMS Ventures & InvestmentsDirectorBuy8,539,709$0.59$5.0MForm 4
May 27, 2026Sukhtian Faisal GhiathDirectorBuy122,174$0.41$50.1KForm 4
May 26, 2026Haddadin Yezan MuntherDirectorBuy34,000$0.44$15.0KForm 4
May 26, 2026THURMAN RANDY HDirectorBuy5,000$0.43$2.1KForm 4
May 26, 2026HILZINGER KURT JDirectorBuy400,000$0.44$176.0KForm 4
Sep 26, 2024KENYON LAWRENCE AChief Financial OfficerBuy5,000$5.69$28.4KForm 4
Apr 15, 2024Syntone Ventures LLC10% ownerBuy714,286Form 4
Mar 28, 2024Haddadin Yezan MuntherDirectorBuy1,882$11.82$22.2KForm 4
Mar 7, 2024Evanson JeffCHIEF COMMERCIAL OFFICERBuy62,484$0.42$26.2KForm 4
Apr 20, 2023Dagnon TerryChief Operations OfficerSale520,000$1.14$592.8KForm 4
Jan 20, 2023Evanson JeffCHIEF COMMERCIAL OFFICERSale267,000$1.11$296.4KForm 4
Jan 19, 2023Evanson JeffCHIEF COMMERCIAL OFFICERSale103,255$1.22$126.0KForm 4
Jan 18, 2023Evanson JeffCHIEF COMMERCIAL OFFICERSale33,738$1.25$42.2KForm 4
Jan 17, 2023Evanson JeffCHIEF COMMERCIAL OFFICERSale27,162$1.31$35.6KForm 4
Oct 7, 2022Sukhtian Faisal GhiathDirectorBuy30,000$1.29$38.7KForm 4

All 42 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.

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$97.9M 2022–2024
Money received by yearMoney received by year, 2022–2024: $97.9M in all. Private raises (Form D) $97.9M.$0$20M$40M$60M$80M2022 · Private raises (Form D): $32.9M202220232024 · Private raises (Form D): $65.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$65.0M$65.0M
2022$32.9M$32.9M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Apr 23, 2026Filed a private offering of equity78 Form D: $5 million offered in all Form D
  2. Jan 17, 2025Filed a private offering of equity79 Form D: $32 million offered in all Form D
  3. Apr 15, 2024Raised $5 million in a private offering of equity80 Form D: $13.3 million offered in all Form D
  4. Mar 18, 2024Raised $60 million in a private offering of equity81 Form D: $159 million offered in all Form D
  5. Dec 28, 2022Raised $31.8 million in a private offering of debt82 Form D: 1 investor so far Form D
  6. Dec 28, 2022Raised $1 million in a private offering of securities83 Form D: 1 investor so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 69. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC4,376,872$7.0M0.0%+2,409,712
Perceptive Advisors LLC3,139,216$5.0M0.1%New
Marshall Wace, Llp1,987,578$3.2M0.0%New
BlackRock, Inc.1,668,579$2.7M0.0%+1,191,108
Jane Street Group, LLC1,425,270$2.3M0.0%New
Geode Capital Management, LLC1,245,868$2.0M0.0%+642,262
Susquehanna International Group, Llp968,190$1.5M0.0%+834,106
Vanguard Fiduciary Trust Co661,664$1.1M0.0%+485,135
Gilpin Wealth Management, LLC555,000$882.5K0.6%−45,162
State Street Corp539,802$858.3K0.0%+376,700
Cantor Fitzgerald, L. P.450,000$715.5K0.0%New
Sanctuary Advisors, LLC344,529$547.8K0.0%New
Raymond James Financial Inc332,051$528.0K0.0%+305,000
Group One Trading LLC246,428$391.8K0.0%+132,727
Northern Trust Corp237,561$377.7K0.0%+170,171
Simplex Trading, LLC205,013$326.0K0.0%+72,347
LPL Financial LLC184,942$294.1K0.0%+151,315
UBS Group AG152,215$242.0K0.0%+19,146
Deutsche Bank Ag\130,700$207.8K0.0%New
Wealth Management Partners, LLC118,170$187.9K0.0%New
Jefferies Financial Group Inc.62,500$99.4K0.0%New
Millennium Management LLC57,839$92.0K0.0%New
Tower Research Capital LLC (TRC)57,391$91.3K0.0%+42,586
Royal Fund Management, LLC47,200$75.0K0.0%New
Scotia Capital Inc.46,300$73.6K0.0%New

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

SEC filer profile

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

  • Name on EDGAROutlook Therapeutics, Inc.1
  • CIK0001649989
  • Employer ID (EIN)38-39827046
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsSeptember 301
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address111 S. Wood Avenue, Unit #100, Iselin, NJ 088301
  • Phone60961939901
  • Shares outstanding243,447,554 as of Aug 14, 202614
  • Public float$26.9M as of Mar 31, 20256
  • AuditorKPMG LLP, Philadelphia, Pennsylvania PCAOB ID 185; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceAug 10, 20151
  • Filings833 in all: 4 (266), 8-K (176), 10-Q (32), 3 (32), 424B3 (32), CORRESP (28), SC 13D/A (23), EFFECT (22)1
    All 46 form types

    424B5 (21), UPLOAD (19), D (13), DEF 14A (13), S-8 (12), S-3 (11), SC 13G (11), SC 13G/A (11), 10-K (10), PRE 14A (9), S-1/A (9), SCHEDULE 13G/A (9), 10-K/A (6), DEFA14A (6), POS AM (6), S-1 (6), 4/A (5), SCHEDULE 13D/A (5), SCHEDULE 13G (5), ARS (4), FWP (4), 25-NSE (3), SC 13D (3), 3/A (2), 424B4 (2), CERTNAS (2), CT ORDER (2), DRS (2), DRS/A (2), 8-A12B (1), 8-A12B/A (1), 8-K/A (1), DRSLTR (1), NT 10-Q (1), POS EX (1), PRER14A (1), S-1MEF (1), SEC STAFF ACTION (1)

  • Latest filingsAnnual report (10-K) Dec 19, 2025
    Quarterly report (10-Q) Aug 18, 2026
    Proxy statement (DEF 14A) Jun 1, 2026
    Latest 8-K (8-K) Sep 30, 2026

Securities registered for trading

ClassSymbolExchange
Common StockOTLKThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Dec 19, 2025 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Outlook Therapeutics, Inc. names in Item 1A of its 10-K filed Dec 19, 2025: 73 risks under these headings, as written.6

  • You should consider carefully the risks and uncertainties described below, together with all of the other information in this Annual Report on Form 10-K. If any of the following risks are realized, our business, financial condition, results of operations and prospects could be adversely affected. The risks described below are not the only risks facing our company. Risks and uncertainties not currently known to us or that we currently deem to be immaterial also may adversely affect our business, financial condition, results of operations and/or prospects.
  • Risks Related to Our Financial Condition and Capital Requirements
  • We have incurred significant losses and negative cash flows from operations since our inception and expect to continue to incur significant losses and negative cash flows from operations for at least the next 12 months.
  • We have not generated material revenue from any product sales and may never be profitable.
  • There is substantial doubt about our ability to continue as a going concern. We will need to raise substantial additional funding to complete the development of ONS-5010/LYTENAVA outside the EU and UK and support our operations until we are able to generate sufficient revenue from the sales of ONS-5010/LYTENAVA in the EU and UK. This additional funding may not be available on acceptable terms or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
  • Raising additional capital, including modifications to our existing convertible securities, may cause dilution to our securityholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • We are obligated to repay a minimum of $3,000,000 of the outstanding balance of the March 2025 Note each calendar quarter starting with the second calendar quarter of 2025, subject to adjustments for conversions by Avondale and the payment of an exit fee of 7.5%, or the Quarterly Debt Reduction Obligations. Any amount converted by Avondale during a given calendar quarter in excess of the Quarterly Debt Reduction Obligations will be credited toward meeting the Quarterly Debt Reduction Obligations for the next quarter or quarters.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • We are highly dependent on the success of ONS-5010/LYTENAVA, our only product that has been approved in the EU and UK. If ONS-5010/LYTENAVA does not receive regulatory approval outside the EU and UK, or is not successfully commercialized, our business may be harmed.
  • Due to our limited resources and access to capital, we have, and will continue to need to, prioritize development of certain product candidates; and these decisions may prove to have been wrong and may harm our business.
  • Clinical drug development is a lengthy and expensive process and we may encounter substantial delays in our clinical trials or may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
  • The results of previous clinical trials may not be predictive of future results, and the results of our current and planned clinical trials may not satisfy the requirements of the FDA, EMA and the European Commission or other comparable foreign regulatory authorities.
The other 63 risks
  • ONS-5010/LYTENAVA and any future product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if granted.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates, and our existing insurance coverage may not be sufficient to satisfy any liability that may arise.
  • Failure to obtain regulatory approval in any targeted jurisdiction would prevent us from marketing our products to a larger patient population and reduce our commercial opportunities.
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
  • The development and commercialization of pharmaceutical products is subject to extensive regulation, and we may not obtain regulatory approvals for ONS-5010/LYTENAVA outside of the EU or UK or in any other indications for which we plan to develop the product, or any future product candidates, on a timely basis or at all.
  • Disruptions at the FDA and other government agencies caused by shutdowns or funding shortages 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.
  • Any delays in the commencement or completion, or termination or suspension, of our planned or future clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
  • Any delays in the commencement or completion, or termination or suspension, of our planned or future clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects. Before we can initiate clinical trials in the United States in any distinct indication, we must submit the results of preclinical and/or other studies to the FDA along with other information, including information about chemistry, manufacturing and controls and our proposed clinical trial protocol, as part of an IND or similar regulatory filing.
  • If we experience delays or difficulties in enrolling patients in our planned clinical trials, our receipt of necessary regulatory approvals of ONS-5010/LYTENAVA outside the EU and UK could be delayed or prevented.
  • Adverse side effects or other safety risks associated with ONS-5010/LYTENAVA or any future product candidate could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon further development, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • Interim, “top-line” and preliminary results from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Risks Related to Commercialization of Our Product Candidates
  • We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced or more effective than ours. Other products may be approved and successfully commercialized before ours, which may adversely affect our financial condition and our ability to successfully commercialize our product candidates.
  • The commercial success of any current or future product candidate will depend upon the degree of market acceptance by physicians, patients, third-party payors and others in the medical community.
  • Although ONS-5010/LYTENAVA is approved in the EU and the UK, off-label repackaging of Avastin at compounding pharmacies may continue, which could have a material adverse effect on our business and financial condition.
  • We currently have no marketing and sales organization. If we are unable to establish and maintain sales and marketing capabilities in jurisdictions for which we choose to retain commercialization rights, we may be unable to generate any revenue.
  • We may need to enter into alliances with other companies that can provide capabilities and funds for the development and commercialization of product candidates. If we are unsuccessful in forming or maintaining these alliances on favorable terms, our business could be harmed.
  • The third-party coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
  • Off-label use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, and/or subject us to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any product.
  • The affected populations for ONS-5010/LYTENAVA or any of our other future product candidates may be smaller than we or third parties currently project, which may affect the addressable markets for our product candidates.
  • If the launch of ONS-5010/LYTENAVA or any of our other future product candidates is further delayed or unsuccessful, or if sales of our marketed products do not meet the levels currently expected, we may face costs related to excess inventory or unused capacity at our manufacturing facilities and at the facilities of third parties or our collaborators.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third parties to conduct our preclinical and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for ONS-5010/LYTENAVA outside the EU and UK, or for any other of our product candidates, or commercialize ONS-5010/LYTENAVA or any other of our product candidates and our business could be harmed.
  • Because we may rely on third parties, some of which are or may be sole source vendors for manufacturing and supply of our drug candidates for preclinical and clinical development materials and commercial supplies, our supply may become limited or interrupted or may not be of satisfactory quantity or quality. Our business could be harmed if our current contract manufacturer is unable to manufacture our product candidates at the necessary quantity or quality levels for preclinical, clinical and commercial supply.
  • Any adverse developments affecting the manufacture of ONS-5010/LYTENAVA could substantially increase our costs and limit supply for such product candidate.
  • We depend on third parties for the commercialization of ONS-5010/LYTENAVA in the EU and UK, and may depend on third parties for the commercialization of ONS-5010/LYTENAVA in the United States, if approved. Failure to commercialize in the relevant markets could harm our business and operating results.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • We currently engage single source suppliers for clinical trial services and multiple source suppliers for future drug substance manufacturing, fill-finish manufacturing and product testing of ONS-5010/LYTENAVA. The loss of any of these suppliers, or any future single source suppliers, could harm our business.
  • Risks Related to Intellectual Property
  • If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed. Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • So called “submarine” patents may be granted to our competitors that may significantly alter our launch timing expectations, reduce our projected market size, cause us to modify our product or process or block us from the market altogether.
  • We may not identify relevant patents or may incorrectly interpret the relevance, scope or expiration of a patent, which might adversely affect our ability to develop and market our products.
  • We may become involved in lawsuits to protect or enforce any future patents, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • If we are unable to obtain and maintain effective patent rights for ONS-5010/LYTENAVA or any future product candidates, we may not be able to prevent competitors from using technologies we consider important in the development and commercialization of ONS-5010/LYTENAVA or any future product candidates, resulting in loss of any potential competitive advantage our patents may have otherwise afforded us.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submissions, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • If we are unable to maintain effective proprietary rights for ONS-5010/LYTENAVA or our product candidates or any future product candidates, we may not be able to compete effectively in our markets.
  • We may be subject to claims challenging the inventorship of our patent filings and other intellectual property.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • We may not be successful in obtaining or maintaining necessary rights to ONS-5010/LYTENAVA or our product candidates through acquisitions and in-licenses.
  • Risks Related to Our Business Operations
  • Our business could be materially and adversely affected in the future by the effects of disease outbreaks, epidemics and pandemics.
  • Unfavorable global economic and political conditions could adversely affect our business, financial condition or results of operations.
  • We may not be successful in our efforts to identify, develop or commercialize additional product candidates.
  • We are highly dependent on the services of our key executives and personnel, and if we are not able to retain these members of our management or recruit additional management, clinical and scientific personnel, our business will suffer.
  • Healthcare legislative reform measures and other regulatory reforms may harm our business and results of operations.
  • At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
  • We are subject, directly and indirectly, to foreign, federal, and state healthcare laws and regulations, including fraud and abuse, false claims, physician payment transparency and health information privacy and security laws. If we are unable to comply or have not fully complied with such laws, we could face substantial penalties.
  • The international aspects of our business expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
  • 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 harm our business.
  • Acquisitions or joint ventures could disrupt our business, cause dilution to our stockholders and otherwise harm our business.
  • We may pursue the development of our product candidates in combination with other approved therapeutics. If the FDA or a comparable foreign regulatory authority revokes approval of any such therapeutic, or if safety, efficacy, manufacturing or supply issues arise with any therapeutic that we use in combination with one of our product candidates in the future, we may be unable to further develop and/or market our product candidate or we may experience significant regulatory delays or supply shortages, and our business could be materially harmed.
  • Our employees, independent contractors, consultants, collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • Our business activities will be subject to the Foreign Corrupt Practices Act and similar anti-bribery and anti-corruption laws.
  • We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.
  • If our information technology systems or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
  • Risks Related to Ownership of Our Securities
  • The trading price of our securities is likely to be volatile, and purchasers of our securities could incur substantial losses.
  • GMS Ventures beneficially owns a significant percentage of our common stock and has the right to designate members to our board of directors and is able to exert significant control over matters subject to stockholder approval, which could prevent new investors from influencing significant corporate decisions.
  • Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
  • If securities or industry analysts do not publish research, or publish unfavorable research, about our business, the market price of our securities and trading volume could decline.
  • We are a “smaller reporting company” and, because we have opted to use the reduced reporting requirements available to us, certain investors may find investing in our securities less attractive.
  • We are a “smaller reporting company” under the SEC’s disclosure rules, meaning that we have either: (i) a public float of less than $250 million; or (ii) annual revenues of less than $100 million during the most recently completed fiscal year; and no public float; or a public float of less than $700 million.
  • We have and will continue to incur significant costs and demands upon management as a result of complying with the laws and regulations affecting public companies in the United States, which may harm our operating results.
  • Future sales and issuances of our common stock or rights to purchase securities, including pursuant to our equity incentive plans or exercise of warrants, could result in additional dilution of the percentage ownership of our stockholders and could cause the market price of our securities to fall.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

Legal proceedings

On November 3, 2023, a securities class action lawsuit was filed against us and certain of our officers in the United States District Court for the District of New Jersey. The class action complaint alleges violations of the Exchange Act in connection with allegedly false and misleading statements made by us related to our BLA during the period from August 3, 2021 through August 29, 2023. The complaint alleges, among other things, that we violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose that there was an alleged lack of evidence supporting ONS-5010/LYTENAVA as a treatment for wet AMD and that we and/or our manufacturing partner had deficient CMC controls for ONS-5010/LYTENAVA, which remained unresolved at the time our BLA was re-submitted to the FDA and, as a result, the FDA was unlikely to approve our BLA, and that our stock price dropped when such information was disclosed. The plaintiffs in the class action complaint seek damages and interest, and an award of reasonable costs, including attorneys’ fees. The defendants’ motion to dismiss the second amended complaint is currently pending before the court.

The opening of Item 3, Legal Proceedings.6

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
    SEC EDGAROther events
  48. 48
  49. 49
  50. 50
    SEC EDGAROther events
  51. 51
  52. 52
  53. 53
    SEC EDGAROther events
  54. 54
  55. 55
  56. 56
    SEC EDGAROther events
  57. 57
    SEC EDGAROther events
  58. 58
  59. 59
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68
  69. 69
  70. 70
  71. 71
  72. 72
  73. 73
  74. 74
  75. 75
  76. 76
  77. 77
  78. 78
  79. 79
  80. 80
  81. 81
  82. 82
  83. 83