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ALDX on Nasdaq

Aldeyra Therapeutics, Inc.

In its 2026 annual report the company says: “Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. Our approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity.”6 It is headquartered in Wilmington, United States.2 Its shares trade on Nasdaq under the symbol ALDX.2

$0.76 down 0.03 (3.67%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

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  • TickerALDX on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersWilmington, United States2
  • Incorporated inDE4
  • Business address23 Bradford Street, Suite 1, Concord, Ma 017424
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation2
  • LEI529900HGKY864E4Y90142
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o CORPORATION SERVICE COMPANY, 251 LITTLE FALLS DRIVE, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 38421572

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Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. Our approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our product candidates include RASP (reactive aldehyde species) modulators ADX-248, ADX-246, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated diseases. Our late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.6 From its latest annual report

Financials

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

Financial statements

Operating income789101112-$35.3M in 2025−44% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$63.1M-$63.1M20192020: -$36.4M-$36.4M2020−42%2021: -$56.2M-$56.2M2021+54%2022: -$62.7M-$62.7M2022+11%2023: -$42.8M-$42.8M2023−32%2024: -$60.1M-$60.1M2024+40%2025: -$35.3M-$35.3M2025−41%
Net income789101112-$33.8M in 2025−44% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$60.8M-$60.8M20192020: -$37.6M-$37.6M2020−38%2021: -$57.8M-$57.8M2021+54%2022: -$62.0M-$62.0M2022+7%2023: -$37.5M-$37.5M2023−39%2024: -$55.9M-$55.9M2024+49%2025: -$33.8M-$33.8M2025−39%

Every line of the income statement as filed: the last 2 fiscal years, latest first.12

Period ending2025-12-312024-12-31
Research and development$25.7M$48.2M
General and administrative$9.6M$11.9M
Loss from operations-$35.3M-$60.1M
Interest income$3.3M$6.2M
Interest expense-$1.9M-$1.9M
Total other income, net$1.4M$4.3M
Net loss-$33.8M-$55.9M
Net loss per share - basic-$0.56-$0.94
Net loss per share - diluted-$0.56-$0.94
Weighted average common shares outstanding - basic60.1M shares59.5M shares
Weighted average common shares outstanding - diluted60.1M shares59.5M shares

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Corporate structure

Aldeyra Therapeutics, Inc. sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Aldeyra Therapeutics, Inc.

  • Aldeyra Therapeutics, Inc. Wilmington, Delaware, United States
    • Helio Vision Germany GmbH Subsidiary · Germany

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 Aldeyra 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
Property and equipment, net$011 Dec 31, 2024$5.8K11 Dec 31, 2023−100.0%
Operating-lease assets (leased space)$275.9K12 Dec 31, 2025$267.0K12 Dec 31, 2024+3.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$70.0M12 Dec 31, 2025$54.5M12 Dec 31, 2024+28.5%
Marketable securities, current$012 Dec 31, 2025$46.6M12 Dec 31, 2024−100.0%

Properties, in its own words

Our offices are located in Lexington, Massachusetts. As of December 31, 2025, we lease approximately 9,351 square feet of office space pursuant to a lease that expires in December 2026. Management believes that this office space is suitable and adequate to meet our anticipated near-term needs. We anticipate that following the expiration of the lease, additional or alternative space will be available at commercially reasonable terms.

Item 2 of the 10-K filed Feb 27, 2026.6

Leadership

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

Chief executive

  1. Todd C. Brady2014–now

President

  1. Todd C. Brady2014–now

Chief financial officer

  1. Stephen J. Tulipano2014–2018
  2. Joshua Reed2018–2022

Chief operating officer

  1. Scott Young2014–2016
201520202025
Board members and other officers (14)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Helio Vision Germany GmbH Germany5

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

Former names

  • Aldexa Therapeutics, Inc.Jan 3, 2013 to Mar 4, 20144
  • Neuron Systems IncOct 6, 2005 to Aug 1, 20084

Timeline

  1. Sep 29, 20268-K Regulation FD disclosure; Other events32
  2. Jul 30, 20268-K Entered a material agreement33
  3. Jul 15, 20268-K Other events34
  4. Jun 10, 20268-K Executive or director change; Shareholder vote; Regulation FD disclosure35
  5. May 1, 20268-K Regulation FD disclosure36
  6. Apr 20, 20268-K Executive or director change37
  7. Apr 1, 20268-K Other events38
  8. Mar 17, 20268-K Regulation FD disclosure; Other events39
  9. Dec 31, 20258-K Executive or director change40
  10. Dec 16, 20258-K Regulation FD disclosure; Other events41
  11. Nov 13, 20258-K Regulation FD disclosure; Other events42
  12. Oct 28, 20258-K Other events43
  13. May 1, 2014New chief executive Todd C. Brady becomes CEO15

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.13) a share, on Nov 5, 2025.44

When it reported results

  1. May 4, 2023Reported quarterly or annual results45
  2. Mar 9, 2023Reported quarterly or annual results46
  3. Nov 10, 2022Reported quarterly or annual results47
  4. Aug 5, 2022Reported quarterly or annual results48
  5. May 5, 2022Reported quarterly or annual results49
  6. Mar 17, 2022Reported quarterly or annual results50
  7. Oct 28, 2021Reported quarterly or annual results51

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

Filings

223 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 68 major events, 80 insider forms, 21 large holders, 32 other. The latest 20:

  1. Sep 29, 20268-K EDGAR
  2. Aug 12, 2026SCHEDULE 13G EDGAR
  3. Aug 6, 202610-Q EDGAR
  4. Jul 30, 20268-K EDGAR
  5. Jul 27, 2026SCHEDULE 13G/A EDGAR
  6. Jul 15, 20268-K EDGAR
  7. Jun 11, 20264 EDGAR
  8. Jun 11, 20264 EDGAR
  9. Jun 11, 20264 EDGAR
  10. Jun 11, 20264 EDGAR
  11. Jun 11, 20264 EDGAR
  12. Jun 11, 20264 EDGAR
  13. Jun 11, 20264 EDGAR
  14. Jun 11, 20263 EDGAR
  15. Jun 10, 20268-K EDGAR
  16. Jun 5, 20264 EDGAR
  17. May 15, 2026SCHEDULE 13G/A EDGAR
  18. May 7, 202610-Q EDGAR
  19. May 1, 20268-K EDGAR
  20. Apr 27, 2026ARS EDGAR

The 223 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

35 open-market trades by officers, directors and large owners since October 2021: 22 buys and 13 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 3, 2026Brady Todd CPresident and CEOBuy250,000$1.67$417.5KForm 4
Mar 19, 2026DOUGLAS RICHARDDirectorBuy70,000$1.40$98.0KForm 4
Mar 18, 2026Alfieri MichaelPrincipal Financial OfficerBuy5,000$1.42$7.1KForm 4
Aug 13, 2025Alfieri MichaelPrincipal Financial OfficerBuy2,500$5.30$13.2KForm 4
Aug 11, 2025Machatha StephenChief Development OfficerSale22,073$5.15$113.7KForm 4
Apr 3, 2025PERCEPTIVE LIFE SCIENCES MASTER FUND LTD10% ownerSale3,400,000$1.42$4.8MForm 4
Aug 12, 2024Machatha StephenChief Development OfficerSale16,041$4.74$76.0KForm 4
Aug 12, 2024Greenberg BruceSee RemarksSale10,834$4.74$51.4KForm 4
Apr 5, 2024EDELMAN JOSEPH10% ownerBuy37,712$4.74$178.8KForm 4
Apr 4, 2024EDELMAN JOSEPH10% ownerBuy140,281$4.67$655.1KForm 4
Apr 3, 2024PERCEPTIVE LIFE SCIENCES MASTER FUND LTD10% ownerBuy309,847$4.09$1.3MForm 4
Apr 2, 2024PERCEPTIVE LIFE SCIENCES MASTER FUND LTD10% ownerBuy186,051$3.44$640.0KForm 4
Apr 1, 2024PERCEPTIVE LIFE SCIENCES MASTER FUND LTD10% ownerBuy8,374$3.25$27.2KForm 4
Mar 12, 2024Machatha StephenChief Development OfficerSale11,537$3.16$36.5KForm 4
Mar 12, 2024Machatha StephenChief Development OfficerSale11,537$3.16$36.5KForm 4
Mar 12, 2024Brady Todd CPresident and CEOSale85,324$3.05$260.2KForm 4
Mar 11, 2024Greenberg BruceSee RemarksSale13,201$3.41$45.0KForm 4
Mar 11, 2024Greenberg BruceSee RemarksSale13,201$3.41$45.0KForm 4
Mar 11, 2024Machatha StephenChief Development OfficerSale18,231$3.41$62.2KForm 4
Mar 11, 2024Brady Todd CPresident and CEOSale97,914$3.27$320.2KForm 4

All 35 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
2025Todd C. BradyM.D., Ph.D.$700.0K$4.7M59
2025Stephen G. MachathaPh.D..$400.0K$1.5M59
2025Michael Alfieri61$246.0K59
2024President and Chief Executive Officer$591.6K$3.9M59
2024Chief Development Officer$392.3K$1.7M59
2024Principal Financial Officer and Principal Accounting Officer$111.7K59

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
Knoll Capital Management, LLC5,475,516$11.7M6.5%No change
Aqr Capital Management LLC3,751,558$8.0M0.0%+921,683
Kingdon Capital Management, L.l.c.2,652,315$5.6M0.8%+500,000
Vanguard Capital Management LLC2,361,796$5.0M0.0%−1,946
D. E. Shaw & Co., Inc.1,940,338$4.1M0.0%+536,348
Marshall Wace, Llp1,506,974$3.2M0.0%+1,377,281
683 Capital Management, LLC1,450,000$3.1M0.3%−50,000
Jane Street Group, LLC1,375,115$2.9M0.0%+406,224
BlackRock, Inc.1,257,243$2.7M0.0%−2,506,644
Qube Research & Technologies Ltd1,128,803$2.4M0.0%+1,041,725
Ardsley Advisory Partners LP975,000$2.1M0.2%+25,000
Renaissance Technologies LLC882,000$1.9M0.0%+18,813
Vanguard Portfolio Management LLC794,863$1.7M0.0%−12,915
Goldman Sachs Group Inc725,444$1.5M0.0%+182,298
Jacobs Levy Equity Management, Inc646,840$1.4M0.0%−149,976
Morgan Stanley608,321$1.3M0.0%+89,679
Geode Capital Management, LLC596,029$1.3M0.0%−655,623
Dimensional Fund Advisors LP529,083$1.1M0.0%−95,087
Arrowstreet Capital, Limited Partnership421,178$897.1K0.0%New
Cantor Fitzgerald, L. P.400,000$852.0K0.0%New
Citadel Advisors LLC379,144$807.6K0.0%+112,804
Millennium Management LLC360,350$767.5K0.0%−634,893
UBS Group AG301,940$643.1K0.0%−235,629
Vanguard Fiduciary Trust Co298,242$635.3K0.0%−40,379
XTX Topco Ltd254,777$542.7K0.0%+179,611

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

SEC filer profile

How Aldeyra 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 EDGARAldeyra Therapeutics, Inc.1
  • CIK0001341235
  • Employer ID (EIN)20-19681976
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address23 Bradford Street, Suite 1, Concord, MA 017421
  • Phone781-761-49041
  • Shares outstanding60,326,421 as of Aug 4, 202614
  • Public float$231.9M as of Jun 30, 20256
  • AuditorBDO USA, P.C., Boston, Massachusetts PCAOB ID 243; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceOct 6, 20051
  • Filings646 in all: 4 (191), 8-K (176), 10-Q (38), SC 13G/A (32), 3 (24), SC 13G (18), 424B5 (15), S-8 (15)1
    All 37 form types

    CORRESP (14), 10-K (12), DEF 14A (12), DEFA14A (11), EFFECT (10), UPLOAD (8), 144 (7), S-1/A (7), SCHEDULE 13G/A (7), 4/A (6), POS AM (6), ARS (4), D (4), S-1 (4), S-3 (4), FWP (3), 10-K/A (2), 424B1 (2), 424B4 (2), CT ORDER (2), REGDEX (2), 8-A12B (1), 8-A12B/A (1), 8-K/A (1), CERTNAS (1), DRS (1), DRS/A (1), S-8 POS (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Feb 27, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareALDXThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 27, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Aldeyra Therapeutics, Inc. names in Item 1A of its 10-K filed Feb 27, 2026: 75 risks under these headings, as written.6

  • Risks Related to the Potential Development and Commercialization of Reproxalap and our Product Candidates
  • Our business is dependent in large part on the successful commercialization of reproxalap, if approved. If we are unable to successfully obtain marketing approval for reproxalap or experience significant delays in doing so, or if, after obtaining marketing approvals, we or our strategic partners fail to successfully commercialize these product candidates, our business will be materially harmed.
  • To generate revenue, we will depend on FDA approval and successful commercialization of reproxalap. Our success in obtaining regulatory approval of reproxalap from the FDA depends on whether we successfully address the issues raised by the FDA in the reproxalap Complete Response Letters, and our ability to address any issues the FDA may raise in the future. If we are unable to successfully obtain FDA approval, or FDA approval is delayed or limited, our ability to generate revenue will be significantly delayed.
  • The FDA’s shift toward “radical transparency,” including plans to release future complete response letters promptly after they are issued to sponsors, could have an adverse impact on our business and adversely affect our commercial prospects.
  • If the AbbVie Option is not exercised by AbbVie and we remain responsible for funding further development and commercialization of reproxalap, we may be unable to raise the additional capital required to further develop and commercialize reproxalap or enter into a collaboration agreement with another pharmaceutical company with equivalent or comparable terms, or at all.
  • If the AbbVie Option is exercised and the Collaboration Agreement is executed, then pursuant to the terms of the Collaboration Agreement, we would work closely with AbbVie to execute a commercialization plan for reproxalap in the United States, and the commercialization plan may never achieve desired outcomes.
  • If we fail to develop and commercialize other product candidates, we may be unable to grow our business.
  • Any termination or suspension of, or delays in the commencement or completion of, our clinical trials could result in increased costs to us, delay or limit our ability to generate revenue, and adversely affect our commercial prospects.
  • Reproxalap and our other product candidates are subject to extensive regulation, compliance with which is costly and time consuming, and such regulation may cause unanticipated delays, or prevent the receipt of the required approvals to commercialize our product candidates.
  • Because the Company has no experience in commercializing pharmaceutical products, there is a limited amount of information about us upon which to evaluate our product candidates and business prospects.
  • We may not be successful in our efforts to identify or discover additional potential product candidates, or our decisions to prioritize the development of certain product candidates over others may later prove wrong.
  • The results of preclinical studies and earlier clinical trials are not always predictive of future results. Any product candidate we or any of our future development partners advance into clinical trials may not have favorable results in later clinical trials, if any, or receive regulatory approval.
The other 63 risks
  • Because we are developing novel product candidates for the treatment of diseases in a manner which there is little clinical drug development experience and, in some cases, are designing adaptive trials or using new endpoints or methodologies, the regulatory pathways for approval are not well defined, and, as a result, there is greater risk that our clinical trials will not result in our desired outcomes or require additional trials.
  • Because some of our product candidates are, to our knowledge, new chemical entities, it is difficult to predict the time and cost of development and our ability to successfully complete clinical development of these product candidates and obtain the necessary regulatory approvals for commercialization.
  • We may not be able to qualify for or obtain various designations from regulators that would have the potential to expedite the review process of one or more of our product candidates, and even if we do receive one or more of such designations there is no guarantee that they will ultimately expedite the process, or aid in our obtaining marketing approval or provide market exclusivity.
  • To preserve trial integrity, clinical data from the initial parts of adaptive clinical trials may not be disclosed.
  • We may find it difficult to enroll patients in our clinical trials or identify patients during commercialization (if our products are approved by regulatory agencies) for product candidates addressing orphan or rare diseases.
  • Any product candidate we or any of our future development partners advance into clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent regulatory approval or commercialization or limit commercial potential.
  • Even if we obtain marketing approval for reproxalap or any other product candidate, approved product candidates could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any are approved.
  • Even if we receive regulatory approval for reproxalap or any other product candidate, we or are partners, if any, still may not be able to successfully commercialize, and the revenue that we generate from its sales, if any, could be limited.
  • If the market opportunities for reproxalap and our other product candidates are smaller than we believe they are, and if we are not able to successfully identify patients and achieve significant market share, our revenue may be adversely affected, and our business may suffer.
  • Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates profitably.
  • We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our products.
  • Issues with product quality could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products.
  • If our competitors develop treatments for the target indications of our product candidates that are approved more quickly than ours, marketed more successfully, or demonstrated to be safer or more effective than our product candidates, our commercial opportunity will be reduced or eliminated.
  • If we are unable to enter into agreements with third parties to market, sell, and distribute our product candidates, we may be unable to generate any revenue.
  • If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our product candidates appropriate periods of data or market exclusivity before approving generic versions of our product candidates, the sales of our product candidates could be adversely affected.
  • The FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels; government shutdowns; ability to hire and retain key personnel; and statutory, regulatory, and policy changes.
  • We face uncertainty regarding potential regulatory developments that may adversely affect our business.
  • Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing and commercializing our products abroad and may limit our ability to generate revenue from product sales.
  • Risks Related to our Financial Position and Capital Requirements
  • We have incurred significant operating losses since inception, and we expect to incur significant losses over the next several years. We may never become profitable or, if achieved, be able to sustain profitability.
  • We will require substantial additional financing, and a failure to obtain the necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, other operations or commercialization efforts.
  • Our quarterly operating results may fluctuate significantly.
  • Raising additional capital may cause dilution to stockholders, restrict our operations, or require us to relinquish rights to its technologies or product candidates.
  • We may allocate our cash, cash equivalents, and marketable securities in ways that you or other stockholders may not approve.
  • The terms of our secured debt facility 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 ability to use net operating loss carryforwards and tax credit carryforwards to offset future taxable income may be limited as a result of transactions involving our common stock.
  • Changes in tax laws and the implementation of tax laws could adversely affect us.
  • Governments may impose price controls, which may adversely affect our future profitability.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • Global economic conditions may have an adverse effect on our business.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits. Adverse developments affecting financial institutions, companies in the financial services industry or the financial services industry generally, such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity.
  • If we engage in an acquisition, reorganization, or business combination, we will incur a variety of risks that could adversely affect our business operations or our stockholders.
  • Risks Related to our Reliance on Third Parties
  • We rely and will continue to rely on outsourcing arrangements for many of our activities, including clinical development, commercial readiness preparations, and supply of reproxalap and our other product candidates.
  • We rely on third parties to conduct our clinical trials. If any third-party does not meet our deadlines or otherwise conduct the trials as required and in accordance with regulations, our clinical development programs could be delayed or unsuccessful and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates when expected, or at all.
  • Some of our product candidates may be studied in clinical trials co-sponsored by organizations or agencies other than us, or in investigator-initiated clinical trials, which means we have minimal or no control over the conduct of such trials.
  • We rely completely on third parties to supply drug substance and manufacture drug product for our clinical trials and preclinical studies. We intend to rely on other third parties to produce commercial supplies of product candidates, and our dependence on third parties could adversely impact our business.
  • We may not be successful in establishing and maintaining development, commercial, or other strategic partnerships, which could adversely affect our ability to develop and commercialize product candidates.
  • We may not realize the benefits of our current or future strategic alliances.
  • Our internal computer systems, or those of our development partners, third-party clinical research organizations, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subject to change, including due to judicial challenges.
  • Risks Relating to Our Intellectual Property
  • Our success depends on our and our licensors' ability to protect our intellectual property and our proprietary technologies.
  • Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • Our issued patents could be found invalid or unenforceable if challenged in court.
  • We may fail to comply with any of our obligations under existing or future agreements pursuant to which we license or acquire rights or technology, which could result in the loss of rights or technology that are material to our business.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees, consultants, or agents have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • If we do not obtain protection under the Hatch-Waxman Amendments by extending the patent terms and obtaining data exclusivity for our product candidate, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We and the third parties with whom we work are increasingly utilizing social media tools as a means of communication both internally and externally, and noncompliance with applicable requirements, policies, or contracts due to social media use or negative posts or comments could have an adverse effect on our business.
  • Risks Related to Employee Matters and Managing Growth
  • We are highly dependent on the services of our senior management team and certain key consultants.
  • If we fail to attract and retain senior management, we may be unable to successfully develop or commercialize our product candidates.
  • In order to commercialize the product candidates not subject to existing partnership agreements, we will need to substantially grow the size of our organization. We may encounter difficulties in managing our growth and expanding our operations successfully.
  • Risks Related to Other Legal or Regulatory Matters
  • We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, 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, significant fines and penalties,
  • disruptions of our business operations, reputational harm, loss of revenue or profits, loss of customers or sales, and other adverse business consequences.
  • Current and future legislation may increase the difficulty and cost for us to obtain regulatory and marketing approval of and commercialize our product candidates, alone or with others, and may affect the prices we may obtain.
  • Our operations and relationships with actual and potential customers, providers, and third-party payors will be subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose us to penalties including criminal sanctions, civil penalties, exclusions from government programs, contractual damages, and reputational harm, and could diminish our future profits and earnings.
  • If we market products in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal penalties.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of reproxalap or our other product candidates.
  • We and our development partners, third-party manufacturers, and suppliers use biological materials and may use hazardous materials, and any claims relating to improper handling, storage, or disposal of these materials could be time consuming or costly.
  • We and any of our future development partners will be required to report to regulatory authorities if any of our approved products cause or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm 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, or other remedial measures and legal expenses, any of which could adversely affect our business, results of operations and financial condition.
  • Our employees, independent contractors, vendors, principal investigators, contract research organizations (CROs), and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards, regulatory requirements, and insider trading.

Legal proceedings

From time to time, we may become subject to litigation and claims arising in the ordinary course of business. The Company is not currently a party to any material legal proceedings that we expect to have any material adverse effect on our business, financial condition or results of operation.

The opening of Item 3, Legal Proceedings.6

Sources

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