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CGTX on Nasdaq

COGNITION THERAPEUTICS INC

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative diseases and disorders of the central nervous system, or CNS, and retina. Our lead product candidate, zervimesine, also known as CT1812, is an orally delivered, small molecule designed to protect neuronal synapses by preventing the binding of oligomers of pathogenic proteins including β-amyloid, or Aβ and ɑ-synuclein.”3 It is headquartered in Purchase, New York.1 Its shares trade on Nasdaq under the symbol CGTX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerCGTX on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersPurchase, New York1
  • Incorporated inDE2
  • Business address2500 Westchester Ave, Purchase, Ny 105772
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company2

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We are a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative diseases and disorders of the central nervous system, or CNS, and retina. Currently available therapies for these diseases are limited, with many diseases having no approved therapies or treatments. Our goal is to develop disease-modifying treatments for patients with these degenerative disorders.3 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 income45678-$47.8M in 2025+175% since 2020
-$60.0M-$40.0M-$20.0M02020: -$17.4M-$17.4M20202021: -$28.6M-$28.6M2021+64%2022: -$43.6M-$43.6M2022+52%2023: -$50.7M-$50.7M2023+16%2024: -$54.0M-$54.0M2024+6%2025: -$47.8M-$47.8M2025−11%
Net income456789-$23.5M in 2025+200% since 2020
-$40.0M-$30.0M-$20.0M-$10.0M02020: -$7.8M-$7.8M20202021: -$11.7M-$11.7M2021+49%2022: -$21.4M-$21.4M2022+83%2023: -$25.8M-$25.8M2023+21%2024: -$34.0M-$34.0M2024+32%2025: -$23.5M-$23.5M2025−31%

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

Period ending2025-12-312024-12-31
Research and development$37.2M$41.7M
General and administrative$10.6M$12.3M
Total operating expenses$47.8M$54.0M
Loss from operations-$47.8M-$54.0M
Grant income$23.4M$19.5M
Other income, net$919.0K$666.0K
Interest expense-$13.0K-$25.0K
Loss on currency translation from liquidation of subsidiary-$195.0K
Total other income, net$24.3M$20.0M
Net loss-$23.5M-$34.0M
Foreign currency translation adjustment, including reclassifications$195.0K
Total comprehensive loss-$23.5M-$33.8M
Net loss per share, basic (in dollars per share)-$0.32-$0.86
Net loss per share, diluted (in dollars per share)-$0.32-$0.86
Weighted-average common shares outstanding, basic (in shares)72.8M shares39.7M shares
Weighted-average common shares outstanding, diluted (in shares)72.8M shares39.7M shares

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Corporate structure

COGNITION THERAPEUTICS INC sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of COGNITION THERAPEUTICS INC

  • BIOS Memory SPV I, LP Filed SCHEDULE 13D/A on COGNITION THERAPEUTICS INC, latest Sep 23, 2025 (5 filings since Oct 25, 2021)
  • PATHSTONE FAMILY OFFICE, LLC Filed SCHEDULE 13G on COGNITION THERAPEUTICS INC, latest Feb 4, 2025 (2 filings since Jan 19, 2024)
  • Orin Hirschman Filed SC 13G/A on COGNITION THERAPEUTICS INC, latest Feb 7, 2024 (3 filings since Nov 18, 2022)
  • COGNITION THERAPEUTICS INC Purchase, New York

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What COGNITION 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, before depreciation$280.0K8 Dec 31, 2025$1.3M8 Dec 31, 2024−79.1%
Accumulated depreciation$187.0K8 Dec 31, 2025$1.2M8 Dec 31, 2024−83.8%
Property and equipment, net$93.0K8 Dec 31, 2025$181.0K8 Dec 31, 2024−48.6%
Operating-lease assets (leased space)$306.0K8 Dec 31, 2025$498.0K8 Dec 31, 2024−38.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$36.8M8 Dec 31, 2025$25.0M8 Dec 31, 2024+47.2%

Properties, in its own words

Our principal executive offices are located in Purchase, New York where we currently occupy 2,864 square feet of office space under a lease that expires in May of 2029. We lease approximately 5,109 square feet of laboratory and office space located in Pittsburgh, Pennsylvania under leases that expire in June of 2026. We believe that our current facilities are adequate to meet our ongoing needs, and that, if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.

Item 2 of the 10-K filed Mar 26, 2026.3

Leadership

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

Chief executive

  1. Lisa Ricciardi2021–now

President

  1. Lisa Ricciardi2021–now

Chief financial officer

  1. James Michael O'Brien2021–2022
  2. Andrew J. Einhorn2022
  3. John Brendan Doyle2023–now
2025
Board members and other officers (9)

Former names

  • COGNITION THERAPUTICS INCJan 29, 2009 to Dec 28, 20102

Timeline

  1. Aug 6, 20268-K Results of operations23
  2. Jun 24, 20268-K Other events24
  3. Jun 18, 20268-K Shareholder vote25
  4. Jun 4, 20268-K Regulation FD disclosure26
  5. May 21, 20268-K Other events27
  6. May 7, 20268-K Results of operations28
  7. Mar 26, 20268-K Results of operations; Regulation FD disclosure29
  8. Mar 2, 20268-K Other events30
  9. Jan 27, 20268-K Other events31
  10. Dec 18, 20258-K Entered a material agreement; Ended a material agreement32
  11. Nov 6, 20258-K Results of operations33
  12. Sep 15, 20258-K Other events34
  13. Oct 7, 2021New chief executive Lisa Ricciardi becomes CEO11

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.06) a share, on Nov 6, 2025.35

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results23
  2. May 7, 2026Reported quarterly or annual results28
  3. Mar 26, 2026Reported quarterly or annual results29
  4. Nov 6, 2025Reported quarterly or annual results33
  5. Aug 7, 2025Reported quarterly or annual results36
  6. May 7, 2025Reported quarterly or annual results37
  7. Mar 20, 2025Reported quarterly or annual results38
  8. Nov 13, 2024Reported quarterly or annual results39

Drug trials and FDA: coming up

  1. May 31, 2027Phase 2 trial readout expected Phase 2 trial of CT1812 in Early Alzheimer's Disease: primary completion expected May 31, 2027 (ClinicalTrials.gov NCT05531656).40

Drug trials and FDA: recently

  1. Nov 25, 2024Phase 2 trial completed Phase 2 trial of CT1812 in Dementia With Lewy Bodies: primary completion Nov 25, 2024, results posted Mar 12, 2026 (ClinicalTrials.gov NCT05225415).41

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

272 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 71 major events, 117 insider forms, 10 large holders, 54 other. The latest 20:

  1. Aug 7, 202610-Q EDGAR
  2. Aug 6, 20268-K EDGAR
  3. Jun 24, 20268-K EDGAR
  4. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  5. Jun 22, 20264 OWNERSHIP DOCUMENT EDGAR
  6. Jun 22, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Jun 22, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Jun 22, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Jun 18, 20268-K EDGAR
  10. Jun 4, 20268-K EDGAR
  11. May 21, 20268-K EDGAR
  12. May 8, 202610-Q EDGAR
  13. May 7, 20268-K EDGAR
  14. May 4, 20264 OWNERSHIP DOCUMENT EDGAR
  15. Apr 27, 2026ARS EDGAR
  16. Apr 27, 2026DEFA14A EDGAR
  17. Apr 27, 2026DEF 14A EDGAR
  18. Apr 20, 20264 OWNERSHIP DOCUMENT EDGAR
  19. Apr 20, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Apr 20, 20264 OWNERSHIP DOCUMENT EDGAR

The 272 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

24 open-market trades by officers, directors and large owners since October 2021: 19 buys and 5 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Apr 16, 2026Doyle John BrendanChief Financial OfficerBuy10,000$1.13$11.3KForm 4
Apr 16, 2026Ricciardi LisaCEO & PresidentBuy9,175$1.10$10.1KForm 4
Apr 16, 2026Caggiano AnthonyChief Medical OfficerBuy10,000$1.11$11.1KForm 4
Jan 31, 2025Ricciardi LisaCEO & PresidentBuy38,851$0.77$29.9KForm 4
Mar 14, 2024Ricciardi LisaCEO & PresidentBuy5,700$1.75$10.0KForm 4
Nov 29, 2022RICHSTONE ELLEN BDirectorBuy10,000$2.66$26.6KForm 4
Nov 28, 2022BIOS Fund I QP, LPDirectorBuy16,064$2.65$42.6KForm 4
Nov 28, 2022BIOS Fund III QP, LPDirectorBuy16,064$2.65$42.6KForm 4
Nov 16, 2022BIOS Fund I, LPDirectorBuy71,000$1.40$99.4KForm 4
Nov 16, 2022BIOS Fund III NT, LPDirectorBuy71,000$1.40$99.4KForm 4
Nov 15, 2022BIOS Fund I QP, LPDirectorBuy1,500,000$1.20$1.8MForm 4
Nov 15, 2022Cavu Management, LPDirectorBuy1,500,000$1.20$1.8MForm 4
Nov 15, 2022Ricciardi LisaCEO & PresidentBuy12,000$1.30$15.6KForm 4
Nov 15, 2022Wallace PeggyDirectorBuy12,500$1.20$15.0KForm 4
Oct 13, 2021Wallace PeggyDirectorBuy3,000$12.00$36.0KForm 4
Oct 13, 2021BIOS Memory SPV I, LPDirectorBuy190,000$12.00$2.3MForm 4
Oct 13, 2021BIOS Memory SPV I, LPDirectorSale90$12.00$1.1KForm 4
Oct 13, 2021Fletcher Aaron G.L.DirectorBuy190,000$12.00$2.3MForm 4
Oct 13, 2021Fletcher Aaron G.L.DirectorSale90$12.00$1.1KForm 4
Oct 13, 2021Golden Seeds Cognition Therapeutics LLC10% ownerSale33$12.00$397Form 4

All 24 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
2025Lisa RicciardiPresident and Chief Executive Officer66$651.0K$1.5M45
2025Anthony Caggiano, M.D., Ph.D.Chief Medical Officer$503.0K$927.9K45
2025John DoyleChief Financial Officer$460.6K$866.8K45
2024Lisa RicciardiPresident and Chief Executive Officer66$629.0K$1.5M45
2024Anthony Caggiano, M.D., Ph.D.Chief Medical Officer$486.0K$1.1M45
2024John DoyleChief Financial Officer$445.0K$809.6K45

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$169.7M 2010–2026
Money received by yearMoney received by year, 2010–2026: $169.7M in all. Federal grants $169.7M.$0$20M$40M$60M2010 · Federal grants: $198.4K20102012 · Federal grants: $142.0K20122014 · Federal grants: $699.9K20142015 · Federal grants: $783.4K2016 · Federal grants: $5.5M20162017 · Federal grants: $7.7M2018 · Federal grants: $8.2M20182019 · Federal grants: $11.9M2020 · Federal grants: $31.5M20202021 · Federal grants: $40.6M2022 · Federal grants: $12.4M20222023 · Federal grants: $8.5M2024 · Federal grants: $13.1M20242025 · Federal grants: $12.0M2026 · Federal grants: $16.5M2026
Figures by year
YearFederal grantsTotal
2026$16.5M$16.5M
2025$12.0M$12.0M
2024$13.1M$13.1M
2023$8.5M$8.5M
2022$12.4M$12.4M
2021$40.6M$40.6M
2020$31.5M$31.5M
2019$11.9M$11.9M
2018$8.2M$8.2M
2017$7.7M$7.7M
2016$5.5M$5.5M
2015$783.4K$783.4K
2014$699.9K$699.9K
2012$142.0K$142.0K
2010$198.4K$198.4K

Federal awards

Obligated amounts from USAspending.gov46, by calendar year, 2010–2026, for its registration. Obligations are what agencies committed, not always what was paid out. Contracts pay for goods and services; grants, loans and direct payments are assistance. Loans are charted at the face value of the loans listed here. An award’s amount below is its lifetime total, and some began before the years charted.

Largest grants

  1. Jun 1, 2020$80.7M from National Institutes of Health: Aging Research47 To COGNITION THERAPEUTICS, INC. Award R01AG065248
  2. Sep 15, 2018$30.5M from National Institutes of Health: Aging Research48 To COGNITION THERAPEUTICS, INC. Award R01AG058660
  3. May 15, 2021$29.5M from National Institutes of Health: Aging Research49 To COGNITION THERAPEUTICS, INC. Award R01AG071643
  4. Jul 1, 2019$5.4M from National Institutes of Health: Aging Research50 To COGNITION THERAPEUTICS, INC. Award RF1AG058710
  5. Sep 15, 2017$4.7M from National Institutes of Health: Aging Research51 To COGNITION THERAPEUTICS, INC. Award RF1AG057553
  6. Sep 30, 2017$2.4M from National Institutes of Health: Aging Research52 To COGNITION THERAPEUTICS, INC. Award RF1AG057780
  7. Sep 15, 2016$2.4M from National Institutes of Health: Aging Research53 To COGNITION THERAPEUTICS, INC. Award RF1AG051593
  8. Aug 15, 2016$2.4M from National Institutes of Health: Aging Research54 To COGNITION THERAPEUTICS, INC. Award RF1AG054176

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 66. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BIOS Capital Management, LP6,000,000$6.9M16.6%No change
DAVENPORT & Co LLC4,259,511$4.9M0.0%+1,366,703
Vanguard Capital Management LLC3,438,775$4.0M0.0%+436,988
BlackRock, Inc.1,261,993$1.5M0.0%+293,631
Chescapmanager LLC997,029$1.1M0.1%No change
Geode Capital Management, LLC910,006$1.0M0.0%−10,202
Renaissance Technologies LLC693,288$797.3K0.0%−423,848
Hilton Capital Management, LLC548,950$631.3K0.0%No change
Vanguard Fiduciary Trust Co508,220$584.5K0.0%+44,536
CM Management, LLC450,000$517.5K0.3%+50,000
Dauntless Investment Group, LLC371,701$427.5K0.7%−59,299
Sigma Planning Corp362,265$416.6K0.0%+24,500
State Street Corp348,983$401.3K0.0%+34,500
Tocqueville Asset Management L.P.320,500$368.6K0.0%+125,500
UBS Group AG218,536$251.3K0.0%+141,663
American Financial Group Inc205,000$235.8K0.1%No change
Northern Trust Corp178,202$204.9K0.0%+9,516
Voss Capital, LP175,000$201.2K0.0%−25,000
Texas Capital Bank Wealth Management Services Inc143,296$164.8K0.0%+20,000
Charles Schwab Investment Management Inc84,940$97.7K0.0%No change
XTX Topco Ltd78,471$90.2K0.0%−117,332
Corient Private Wealth LP78,226$90.0K0.0%+6,114
McAdam, LLC64,553$74.2K0.0%−5,400
Fca Corp /tx52,536$60.4K0.0%No change
Raymond James Financial Inc50,850$58.5K0.0%+3,350

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

SEC filer profile

How COGNITION 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 EDGARCOGNITION THERAPEUTICS INC1
  • CIK0001455365
  • Employer ID (EIN)13-43653593
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address2500 Westchester Ave, Purchase, NY 105771
  • Phone412-481-22101
  • Shares outstanding95,093,746 as of Aug 4, 20269
  • Public float$18.2M as of Jun 30, 20253
  • AuditorErnst & Young LLP, Philadelphia, PA PCAOB ID 423
  • On EDGAR sinceJan 29, 20091
  • Filings300 in all: 4 (91), 8-K (71), 3 (16), 10-Q (15), CORRESP (11), 4/A (8), D (8), 424B5 (7)1
    All 34 form types

    UPLOAD (7), S-8 (6), 10-K (5), DEF 14A (5), DEFA14A (5), EFFECT (5), ARS (4), D/A (4), S-1/A (4), 424B4 (3), S-3 (3), SC 13D/A (3), 3/A (2), DRS (2), S-1 (2), SC 13G (2), SC 13G/A (2), 8-A12B (1), CERT (1), DRS/A (1), DRSLTR (1), REGDEX (1), S-1MEF (1), SC 13D (1), SCHEDULE 13D/A (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 7, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

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

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks COGNITION THERAPEUTICS INC names in Item 1A of its 10-K filed Mar 26, 2026: 73 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Capital Needs
  • We are a clinical-stage biopharmaceutical company with no products approved for commercial sale and have incurred significant losses since our inception in 2007. We expect to incur significant losses over the foreseeable future and may never achieve or maintain profitability.
  • We have completed, Phase 2 clinical trials, but have no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
  • We will need substantial additional capital to meet our financial obligations in the future and to pursue our business objectives. If we are unable to raise capital when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy.
  • The economic environment may make it difficult to raise capital on acceptable terms or at all.
  • To date, we have partially relied on non-dilutive grants to cover certain of our capital requirements for our clinical trials, and we may fail to continue to receive non-dilutive funding.
  • We could be subject to audit and repayment of our non-dilutive NIA Grants.
  • Due to the significant resources required for the development of our product candidates, we must prioritize development of certain product candidates and/or certain disease indications. We may expend our limited resources on candidates or indications that do not yield a successful product and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.
  • Risks Related to Discovery, Development and Regulatory Approval of Our Product Candidates
  • Our business is heavily dependent on the successful development, regulatory approval and commercialization of zervimesine and any future product candidates that we may develop or acquire.
  • We may not successfully expand our pipeline of product candidates, including by pursuing additional indications for zervimesine or by in-licensing or acquiring additional product candidates for other diseases.
The other 63 risks
  • Research and development of pharmaceuticals is inherently risky. We cannot give any assurance that any of our product candidates will receive regulatory approval.
  • We may encounter substantial delays in our preclinical studies and clinical trials or may not be able to conduct or complete our preclinical studies or clinical trials on the timelines we expect, if at all.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Our product candidates may cause undesirable and unforeseen side effects or have other properties that could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • Preclinical and clinical development involves a lengthy and expensive process with an uncertain outcome, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results. We have not tested any of our product candidates in pivotal clinical trials and our product candidates may not have favorable results in future clinical trials.
  • Interim “top-line” and preliminary data from studies or 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.
  • We have initially concentrated our research and development efforts on the treatment of AD and DLB, diseases that have seen limited success in drug development.
  • We have never conducted pivotal clinical trials, and we may be unable to do so for any product candidates we may develop.
  • A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • A Fast Track designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.
  • Changes in funding for, or disruptions to the staffing and operations of the FDA and other government agencies 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.
  • We have conducted, and in the future plan to conduct, clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • If we are not successful in identifying, developing and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
  • Even if the product candidates that we develop receive regulatory approval in the United States or another jurisdiction, they may never receive approval in other jurisdictions, which would limit market opportunities for our product candidates and adversely affect our business.
  • Risks Related to Our Business and Industry
  • We are heavily dependent on the success of zervimesine, our lead product candidate, which is still under clinical development, and if zervimesine does not receive regulatory approval or is not successfully commercialized, our business may be harmed.
  • We will need to increase the size of our organization, and we may experience difficulties in managing growth.
  • If we fail to attract and retain senior management and key scientific personnel, our business may be materially and adversely affected.
  • 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.
  • We may explore strategic collaborations that may never materialize or may fail.
  • We may seek to grow our business through acquisitions of complementary businesses, and the failure to manage acquisitions, or the failure to integrate them with our existing business, could harm our financial condition and operating results.
  • Significant disruptions of information technology systems and infrastructure, data breaches and other cybersecurity incidents could materially adversely affect our business, results of operations and financial condition.
  • Failure to comply with health and data protection laws and regulations could lead to government enforcement actions and civil or criminal penalties, private litigation or adverse publicity and could negatively affect our operating results and business.
  • The use of new and evolving technologies, such as artificial intelligence, in our business may result in risks and challenges that can impact our business, including by posing security and other risks to our confidential and/or proprietary information, including personal information.
  • Our employees and independent contractors, including principal investigators, consultants, any future commercial collaborators, service providers and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • Environmental, social and governance matters may impact our business and reputation.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for our technology and product candidates including our lead product candidate, zervimesine, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Patent terms may be inadequate to protect our competitive position on our product candidates including our lead product candidate, zervimesine, for an adequate amount of time.
  • If we do not obtain protection under the Hatch-Waxman Amendments by obtaining data exclusivity, our business may be harmed.
  • The validity, scope and enforceability of any patents listed in the Orange Book that cover our product candidates including our lead product candidate zervimesine can be challenged by third parties.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate patents or other proprietary rights, may delay or prevent the development and commercialization of any of our product candidates including our lead product candidate, zervimesine.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might harm our ability to develop and market our products.
  • We may become involved in lawsuits to protect or enforce our patents or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protects our product including our lead product candidate, zervimesine.
  • We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
  • 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 may be subject to claims that our employees, consultants, independent contractors or we have wrongfully used or disclosed confidential information of their former employers or other third parties.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities, and have a harmful effect on the success of our business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Any trademarks we have obtained or may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Risks Related to Commercialization, Manufacturing and Reliance on Third Parties
  • Even if our current or future product candidates obtain regulatory approval, they may fail to achieve the broad degree of adoption and use by physicians, patients, hospitals, healthcare payors and others in the medical community necessary for commercial success.
  • The market opportunities for zervimesine, if approved, may be smaller than we anticipate.
  • We rely on third-party suppliers to manufacture our product candidates, and we intend to rely on third parties to produce commercial supplies of any approved product. The loss of these suppliers, or their failure to comply with applicable regulatory requirements or to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business, financial condition, results of operations and prospects.
  • Our product candidates have never been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale. In particular, we will need to develop a larger scale manufacturing process that is more efficient and cost-effective to commercialize our potential products, which may not be successful.
  • We rely on third parties in the conduct of all of our clinical trials. If these third parties do not successfully carry out their contractual duties, fail to comply with applicable regulatory requirements or meet expected deadlines, we may be unable to obtain regulatory approval for our product candidates.
  • We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.
  • The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those drugs and decrease our ability to generate revenue.
  • We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell our product candidates, if approved, effectively in the United States and foreign jurisdictions or generate product revenue.
  • Risks Related to Government Regulation
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
  • Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates.
  • If we develop a small molecule product candidate that obtains regulatory approval, additional competitors could enter the market with generic versions of such drugs, which may result in a material decline in sales of affected products.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Changes in tax laws and regulations may have a material adverse effect on our business, financial condition and results of operations.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.
  • 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 Our Common Stock
  • Our stock price may be volatile, and you may not be able to resell shares of our common stock at or above the price you paid.

Legal proceedings

We are not aware of any pending legal actions that would, if determined aversely to us, have a material adverse effect on our business and operations.

We may, from time to time, become involved in disputes and proceedings arising in the ordinary course of business. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if not resolved, could be time-consuming and result in costly litigation. There can be no assurance that an adverse result in any future proceeding would not have a potentially material adverse effect on our business, results of operations, and financial condition.

The opening of Item 3, Legal Proceedings.3

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