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CRVO on Nasdaq

CervoMed Inc.

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company developing treatments for age-related brain disorders. Our lead drug candidate, neflamapimod, is an investigational, orally administered small-molecule drug that readily crosses the blood brain barrier and selectively inhibits the enzyme p38α, a key driver of neuroinflammation and synaptic dysfunction.”3 It is headquartered in Boston, Massachusetts.1 Its shares trade on Nasdaq under the symbol CRVO.1

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Last updated Oct 21, 2026.

Overview

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  • TickerCRVO on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoston, Massachusetts1
  • Incorporated inDE2
  • Business address20 Park Plaza, Suite 424, Boston, Ma 021162
  • Filer categoryNon-accelerated filer, Smaller reporting company2

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We are a clinical-stage biotechnology company developing treatments for age-related brain disorders. Our lead drug candidate, neflamapimod, is an investigational, orally administered small-molecule drug that readily crosses the blood brain barrier and selectively inhibits the enzyme p38α, a key driver of neuroinflammation and synaptic dysfunction. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of DLB, our lead indication, as well as nfvPPA, RAS, and ALS.3 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

-706.2%Operating margin4
-673.1%Net margin4
-58.9%Revenue growth, 20254
-148.0%Return on equity4

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$21.8M

Out of $4.0M in revenue.4 The company lost money this year.

Financial statements

Revenue564$4.0M in 2025
0$2.5M$5.0M$7.5M$10.0M2022: $0$020222023: $7.1M$7.1M20232024: $9.7M$9.7M2024+36%2025: $4.0M$4.0M2025−59%
Operating income789564-$28.3M in 2025+145% since 2019
-$30.0M-$20.0M-$10.0M02019: -$11.6M-$11.6M20192020: -$16.0M-$16.0M2020+38%2021: -$24.7M-$24.7M2021+54%2022: -$3.5M-$3.5M2022−86%2023: -$7.8M-$7.8M2023+125%2024: -$18.2M-$18.2M2024+133%2025: -$28.3M-$28.3M2025+55%
Net income789564-$27.0M in 2025+129% since 2019
-$30.0M-$20.0M-$10.0M02019: -$11.8M-$11.8M20192020: -$14.2M-$14.2M2020+20%2021: -$24.1M-$24.1M2021+70%2022: -$5.8M-$5.8M2022−76%2023: -$2.2M-$2.2M2023−63%2024: -$16.3M-$16.3M2024+650%2025: -$27.0M-$27.0M2025+66%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Grant revenue$4.0M$9.7M
Research and development$21.8M$18.8M
General and administrative$10.5M$9.2M
Total operating expenses$32.3M$28.0M
Loss from operations-$28.3M-$18.2M
Other expense-$8.3K-$991
Interest income$1.3M$1.9M
Total other income, net$1.3M$1.9M
Net loss-$27.0M-$16.3M
Net loss per share of common stock, basic and diluted (in dollars per share)-$2.98-$2.02
Weighted average shares outstanding, basic and diluted (in shares)9.0M shares8.1M shares
Net unrealized (loss) gain on marketable securities-$50.4K$56.2K
Total comprehensive loss-$27.0M-$16.2M

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Corporate structure

CervoMed 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 CervoMed Inc.

  • CervoMed Inc. Boston, Massachusetts

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

What it owns

What CervoMed 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.

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$8.2M4 Dec 31, 2025$9.0M4 Dec 31, 2024−8.5%
Marketable securities, current$12.6M4 Dec 31, 2025$29.9M4 Dec 31, 2024−57.8%
Debt securities available for sale$12.6M4 Dec 31, 2025$29.9M4 Dec 31, 2024−57.8%

Properties, in its own words

We currently have a short-term lease for office space in Boston, Massachusetts which we use for our corporate offices. In addition, we previously had a short-term agreement to utilize membership-based co-working space in Charlottesville, Virginia, which was terminated in the first quarter of 2024. Rent expense related to our short-term agreements was approximately $57,112 and $34,692 for the years ended December 31, 2025 and 2024, respectively.

We believe the space is adequate to meet our near-term needs.

Item 2 of the 10-K filed Mar 13, 2026.3

Leadership

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

Chief executive

  1. Paul Feller2010
  2. Stephen M. Simes2014
  3. David G. Kalergis2016–2020
  4. John J. Alam2023–now

Chair

  1. Paul Feller2008
  2. Sol J. Barer2013–2014
  3. David G. Kalergis2016–2020

President

  1. Yael Schwartz2013–2014
  2. David Sherris2014
  3. John J. Alam2023–now

Chief financial officer

  1. Philip B. Donenberg2014
  2. William Karl Hornung2018–2022
  3. John William Tanner2023–2024
  4. William Robert Elder2024–now
2010201520202025
Board members and other officers (46)

Former names

  • Diffusion Pharmaceuticals Inc.Jan 15, 2016 to Aug 14, 20232
  • RestorGenex CorpMar 10, 2014 to Jan 14, 20162
  • Stratus Media Group, IncJul 30, 2008 to Mar 7, 20142
  • FERIS INTERNATIONAL, INC.Mar 14, 2008 to Jul 16, 20082
  • TITAN MOTORCYCLE CO OF AMERICA INCNov 16, 1998 to Feb 22, 20082

Timeline

  1. Oct 14, 20268-K Regulation FD disclosure64
  2. Oct 13, 20268-K Regulation FD disclosure; Other events65
  3. Oct 9, 20268-K Regulation FD disclosure66
  4. Sep 28, 20268-K Regulation FD disclosure; Other events67
  5. Sep 10, 20268-K Regulation FD disclosure; Other events68
  6. Aug 10, 20268-K Results of operations69
  7. Aug 4, 20268-K Regulation FD disclosure; Other events70
  8. Jul 14, 20268-K Regulation FD disclosure; Other events71
  9. Jul 9, 20268-K Regulation FD disclosure; Other events72
  10. Jun 22, 20268-K Entered a material agreement; Unregistered sale of shares; Other events73
  11. Jun 22, 20268-K Regulation FD disclosure; Other events74
  12. Jun 18, 20268-K Other events75
  13. Aug 23, 2023New chief executive John J. Alam becomes CEO12
  14. Jan 13, 2016New chief executive David G. Kalergis becomes CEO13
  15. Mar 12, 2014New chief executive Stephen M. Simes becomes CEO14
  16. Apr 15, 2010New chief executive Paul Feller becomes CEO15

Calendar

Coming up

  1. Nov 6, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.84) a share, on Nov 7, 2025.76

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results69
  2. May 18, 2026Reported quarterly or annual results77
  3. Mar 17, 2026Reported quarterly or annual results78
  4. Nov 10, 2025Reported quarterly or annual results79
  5. Aug 11, 2025Reported quarterly or annual results80
  6. May 12, 2025Reported quarterly or annual results81
  7. Mar 18, 2025Reported quarterly or annual results82
  8. Nov 13, 2024Reported quarterly or annual results83

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

Filings

353 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 115 major events, 110 insider forms, 24 large holders, 84 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Oct 13, 20268-K EDGAR
  3. Oct 9, 20268-K EDGAR
  4. Sep 28, 20268-K EDGAR
  5. Sep 10, 20268-K EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 14, 2026SCHEDULE 13G EDGAR
  9. Aug 14, 2026SCHEDULE 13G EDGAR
  10. Aug 10, 20268-K EDGAR
  11. Aug 7, 2026S-8 EDGAR
  12. Aug 7, 202610-Q EDGAR
  13. Aug 4, 20268-K EDGAR
  14. Jul 14, 20268-K EDGAR
  15. Jul 10, 2026EFFECT EDGAR
  16. Jul 10, 2026424B3 EDGAR
  17. Jul 9, 20268-K EDGAR
  18. Jul 8, 2026SCHEDULE 13G/A EDGAR
  19. Jul 6, 2026S-3 EDGAR
  20. Jun 26, 2026SCHEDULE 13G EDGAR

The 353 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

18 open-market trades by officers, directors and large owners since October 2021: 17 buys and 1 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 11, 2026BOGER JOSHUA SDirectorBuy955,414$3.14$3.0MForm 4
Nov 18, 2025Winton MatthewChief Commercial and BusinessBuy1,500$7.95$11.9KForm 4
Nov 18, 2025ELDER WILLIAM ROBERTCFO, GC & SecretaryBuy2,500$8.32$20.8KForm 4
Nov 17, 2025Winton MatthewChief Commercial and BusinessBuy3,500$8.43$29.5KForm 4
Nov 17, 2025Gregoire SylvieDirectorBuy21,600$8.46$182.7KForm 4
Nov 17, 2025ELDER WILLIAM ROBERTCFO, GC & SecretaryBuy1,000$8.45$8.4KForm 4
Nov 17, 2025ALAM JOHN JCEO & PresidentBuy21,600$8.46$182.7KForm 4
Nov 14, 2025Gregoire SylvieDirectorBuy3,400$7.56$25.7KForm 4
Nov 14, 2025ALAM JOHN JCEO & PresidentBuy3,400$7.56$25.7KForm 4
Nov 14, 2025Winton MatthewChief Commercial and BusinessBuy10,000$7.57$75.7KForm 4
Nov 13, 2025Gregoire SylvieDirectorBuy4,447$7.51$33.4KForm 4
Nov 13, 2025ALAM JOHN JCEO & PresidentBuy4,447$7.51$33.4KForm 4
Nov 12, 2025Gregoire SylvieDirectorBuy5,553$7.35$40.8KForm 4
Nov 12, 2025ELDER WILLIAM ROBERTCFO, GC & SecretaryBuy3,500$7.44$26.0KForm 4
Nov 12, 2025ALAM JOHN JCEO & PresidentBuy5,553$7.35$40.8KForm 4
May 14, 2025ELDER WILLIAM ROBERTCFO, GC & SecretaryBuy4,233$8.46$35.8KForm 4
Aug 27, 2024ELDER WILLIAM ROBERTCFO, GC & SecretaryBuy1,000$18.16$18.2KForm 4
Feb 26, 2024BOGER JOSHUA SDirectorSale36Form 4

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
2025John AlamMD64$614.8K$1.0M94
2025Robert J. CobuzziJr., PhD$238.6K$917.5K94
2025William Elder42$467.1K$686.3K94
2025Kelly BlackburnMHA$436.6K$652.5K94
2024President & Chief Executive Officer$538.5K$1.0M94
2024Former Chief Operating Officer$465.8K$813.2K94
2024Chief Financial OfficerGeneral Counsel & Corporate Secretary$406.5K$651.7K94

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 37. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Woodline Partners LP688,987$2.1M0.0%New
Vanguard Capital Management LLC316,202$980.2K0.0%No change
Sabby Management, LLC248,880$771.5K6.4%New
Geode Capital Management, LLC66,923$207.5K0.0%−7,448
BlackRock, Inc.53,845$166.9K0.0%+2,185
Byrne Asset Management LLC51,250$158.9K0.1%+36,550
Citizens Financial Group Inc/ri37,477$116.2K0.0%No change
Vanguard Fiduciary Trust Co36,151$112.1K0.0%No change
Jane Street Group, LLC32,231$99.9K0.0%+13,985
Thompson Davis & Co., Inc.29,750$92.2K0.1%+19,750
Savvy Advisors, Inc.25,922$80.4K0.0%No change
State Street Corp20,527$63.6K0.0%No change
Cetera Investment Advisers19,622$60.8K0.0%−7,715
Summit Financial, LLC18,140$56.2K0.0%New
Russell Investments Group, Ltd.15,363$47.6K0.0%−727
Northern Trust Corp13,318$41.3K0.0%−16,726
Morgan Stanley12,699$39.4K0.0%−727,193
HighTower Advisors, LLC11,919$36.9K0.0%+654
Fmr LLC10,538$32.7K0.0%−502
NFSG Corp3,000$9.3K0.0%No change
Vanguard Global Advisers, LLC2,597$8.1K0.0%No change
Tower Research Capital LLC (TRC)2,173$6.7K0.0%−5
Federation des caisses Desjardins du Quebec1,700$5.3K0.0%No change
Hoey Investments, Inc1,080$3.3K0.0%No change
UBS Group AG992$3.1K0.0%−4,247

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

SEC filer profile

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

  • Name on EDGARCervoMed Inc.1
  • CIK0001053691
  • Employer ID (EIN)30-06450323
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address20 Park Plaza, Suite 424, Boston, MA 021161
  • Phone(617) 744-44001
  • Shares outstanding15,119,096 as of Aug 6, 202611
  • Public float$39.9M as of Jun 30, 20253
  • AuditorRSM US LLP, Boston, Massachusetts PCAOB ID 49; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJun 16, 19981
  • Filings999 in all: 8-K (290), 4 (186), 10-Q (59), 3 (53), CORRESP (36), UPLOAD (30), 424B3 (25), 10-K (18)1
    All 63 form types

    NT 10-Q (18), EFFECT (17), DEF 14A (16), SC 13G (16), DEFA14A (13), S-8 (13), SC 13D (11), SC 13G/A (11), 425 (10), PRE 14A (10), S-1/A (10), S-3 (10), D (9), NT 10-K (9), SCHEDULE 13G/A (9), 10-K/A (8), 4/A (8), 424B5 (8), 8-K/A (8), S-1 (8), 10-Q/A (7), 10QSB (7), 3/A (6), PRE 14C (5), SCHEDULE 13G (5), 10KSB (4), DEF 14C (4), ARS (3), SC 13D/A (3), 10SB12G/A (2), 424B4 (2), FWP (2), POS AM (2), PREC14A (2), PRER14A (2), PRRN14A (2), S-3/A (2), S-4/A (2), SEC STAFF LETTER (2), 10KSB/A (1), 10QSB/A (1), 10SB12G (1), 424B2 (1), 8-A12B (1), 8-A12G (1), CERTNAS (1), DEFC14A (1), DEFR14C (1), DEFS14A (1), DFAN14A (1), PRER14C (1), PRES14A (1), S-4 (1), SC 14F1 (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 13, 2026
    Quarterly report (10-Q) Aug 7, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareCRVONASDAQ

From the cover page of the 10-K filed Mar 13, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks CervoMed Inc. names in Item 1A of its 10-K filed Mar 13, 2026: 75 risks under these headings, as written.3

  • Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital
  • We are a clinical stage biopharmaceutical company and have incurred significant losses since our inception. We expect our net losses to continue for the foreseeable future. We are not currently profitable and may never achieve or sustain profitability. We are unable to predict the extent of future losses or when we might become profitable, if ever. This raises substantial doubt regarding our ability to continue as a going concern.
  • We will require additional capital to fund our operations. If we fail to obtain necessary financing on acceptable terms, or at all, we may not be able to complete the development and commercialization of neflamapimod.
  • We currently do not have, and may never have, any products that generate significant revenues.
  • We may be required to make significant payments to Vertex in connection with our license agreement.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our business may be impacted by macroeconomic conditions, including fears concerning the financial services industry, inflation, volatility in interest rates and volatile market conditions, and other uncertainties beyond our control.
  • Certain regulatory limitations may affect our ability to consummate future financings.
  • We could be subject to audit and repayment of the NIA Grant.
  • Risks Related to Our Product Development and Regulatory Approval
  • We are heavily dependent on the success of our lead product candidate, neflamapimod, which is still under clinical development. If neflamapimod does not receive regulatory approval or is not successfully commercialized, our business will be materially harmed.
  • The development and commercialization of drug products is subject to extensive regulation, and the regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable. There is no guarantee that our planned clinical trials for neflamapimod to treat patients with DLB, or in any other indications that we may pursue, will be successful. If we are ultimately unable to obtain regulatory approval for neflamapimod on a timely basis, or at all, our business will be substantially harmed.
The other 64 risks
  • Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of neflamapimod or any other product candidates we may develop or acquire.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • We have concentrated our recent research and development efforts on the treatment of DLB, a disease that has seen limited success in drug development. The ability to successfully develop drugs for DLB and other age-related brain disorders is extremely difficult and is subject to a number of unique challenges. In addition, our rationale for neflamapimod in the treatment of DLB is based on a scientific understanding of the disease that may be wrong.
  • Clinical results observed in our Phase 1, Phase 2 and open-label clinical trials, including the 16-week Extension phase data from the RewinD-LB Trial, evaluating neflamapimod are not regulatory evidence of drug safety or efficacy.
  • Enrollment and retention of participants in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
  • Results of nonclinical studies, early clinical trials, and analyses of open-label results, including the Extension Phase results from the RewinD-LB Trial, may not be indicative of results obtained in later large, well-controlled, randomized clinical trials. In addition, preliminary, topline and interim data from our clinical trials that we may announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Regulatory authorities, including the FDA, may not accept data from clinical trials conducted outside of their jurisdiction.
  • Safety issues with neflamapimod or with any other product candidate we may develop or acquire in the future, or with product candidates or approved products of third parties that are similar to our product candidates, could give rise to delays in the regulatory approval process, restrictions on labeling or product withdrawal after approval, if any, or may otherwise cause us to modify or supplement our clinical development program.
  • We may be unable to obtain regulatory approval in the US or foreign jurisdictions and, as a result, be unable to commercialize our product candidates and our ability to generate revenue will be materially impaired.
  • If we seek to enter into collaborative arrangements or strategic alliances for our drug candidates, but fails to enter into and maintain successful relationships, we may have to reduce or delay our drug development activities or increase our expenditures.
  • If we are unable to take full advantage of regulatory programs designed to expedite drug development or provide other incentives, our development programs may be adversely impacted.
  • The FDA granted orphan drug designation for neflamapimod for certain indications, which might not provide the intended benefit thereof.
  • We rely on third parties to conduct, supervise and monitor our clinical trials. If those third parties do not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, our business will be harmed.
  • Our reliance on third parties for the production of neflamapimod may result in delays in our clinical trials or regulatory approvals and may impair the development and ultimate commercialization of neflamapimod, which would adversely impact our business and financial position.
  • If we change the manufacturers of our product candidates, we may be required to conduct comparability studies evaluating the manufacturing processes of the product candidates and incur other costs related to the technology transfer.
  • Risks Related to Our Intellectual Property
  • If we do not adequately protect our proprietary rights, we may not be able to compete effectively.
  • There is currently no composition of matter patent protection that covers neflamapimod.
  • If we fail to comply with our obligations under our existing license agreement with Vertex, or with any future intellectual property licenses with third parties, we could lose license rights that are important to our business.
  • We may become subject to third parties’ claims alleging infringement of their patents and proprietary rights, or we may need to become involved in lawsuits to protect or enforce our patents, either of which could be costly and time consuming, potentially delay or prevent the development and commercialization of ours product candidates, or put our patents and other proprietary rights at risk.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop, manufacture and market our product candidates.
  • We may be involved in lawsuits to protect or enforce our patents or other intellectual property or the intellectual property of our licensors, which could be expensive, time-consuming, and unsuccessful.
  • Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We enjoy only limited geographical protection with respect to certain patents, and we may not be able to protect our intellectual property rights throughout the world.
  • The lives of our patents may not be sufficient to effectively protect our products and business.
  • Intellectual property discovered or developed through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a manufacturing preference for US-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-US manufacturers.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • 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 non-compliance with these requirements.
  • Risks Related to Commercialization
  • We have no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability.
  • Our business operations are subject to applicable healthcare laws and regulations. If neflamapimod is approved, we will also be subject to stringent regulation and ongoing regulatory obligations and restrictions, which could delay our marketing and commercialization activities and also expose us to penalties if we fail to comply with applicable regulations.
  • Even if neflamapimod or any other product candidate we develop receives marketing approval, we may fail to achieve the level of acceptance necessary for commercial success.
  • If the market opportunity for any product candidate that we develop is smaller than we believe, our revenue may be adversely affected and our business may suffer.
  • We face substantial competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing neflamapimod, if approved.
  • Consumers may sue us for product liability, which could result in substantial liabilities that exceed our available resources and damage our reputation.
  • Any product candidate for which we obtain marketing approval will be subject to extensive post-marketing regulatory requirements and could be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experiences unanticipated problems with our products, when and if any of them are approved.
  • Risks Related to Our Securities
  • Our stock price may be volatile, there may be limited liquidity in the trading market for our common stock, and the market price of our common stock may drop in the future.
  • Ownership of our common stock is highly concentrated among our officers and directors, which may prevent our stockholders from influencing significant corporate decisions and may result in perceived conflicts of interest that could cause us stock price to decline.
  • Future sales of shares by existing stockholders could cause our stock price to decline.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports about us, our business, or our market, our stock price and trading volume could decline.
  • If we cannot continue to satisfy the Nasdaq Capital Market continued listing standards and other Nasdaq rules, our common stock could be delisted, which could harm our business, the trading price of our common stock, our ability to raise additional capital and the liquidity of the market for our common stock.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management.
  • Our certificate of incorporation designates the state courts in the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against us and our directors, officers and employees.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.
  • General Risks Related to Our Business and Operations
  • AI presents risks and challenges that can impact our business including by posing security risks to confidential information, proprietary information, and personal data, as well as emerging, unknown business risks.
  • The development and use of AI presents risks and challenges that can impact our business, including by posing security risks to our confidential information, proprietary information, and personal data and could give rise to legal and/or regulatory actions, damage our reputation, or otherwise materially harm our business.
  • Our future success depends in large part on our ability to retain our key employees, as well as our ability to attract, train and motivate additional qualified personnel. We may also encounter difficulties in managing our growth, which could disrupt our operations.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Our IT systems, or those of our vendors, collaborators or other contractors or consultants, may fail or suffer security incidents, loss of data and other disruptions, which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • Our business may be affected from time to time by government investigations and litigation with third parties, including our ongoing matter with Paul Feller.
  • Our business is, or may in the future become, subject to complex and evolving US and foreign laws and regulations relating to privacy and data protection. These laws and regulations are subject to change and uncertain interpretation, and our actual or perceived failure to comply with such obligations could result in liability or reputational harm and could harm our business.
  • Past or future transactions resulting in an ownership change under Section 382 may subject our NOL carryforwards and certain other tax attributes to limitation.
  • We incur costs and demands upon management as a result of complying with the laws, rules and regulations affecting public companies.
  • Our business activities may be subject to the FCPA and similar anti-bribery and anti-corruption laws.
  • Our employees, independent contractors, consultants, vendors and future commercial partners, if any, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of ours business may rely, which could negatively impact our business.
  • US federal income tax reform or other changes in applicable tax law could adversely affect our business and financial condition.
  • We face risks associated with increased geopolitical uncertainty, including as a result of evolving domestic and foreign tariff policies.
  • Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  • Epidemics, pandemics or other public health crises, including COVID-19, could adversely affect our business.
  • Political uncertainty may have an adverse impact on our operating performance and results of operations.
  • We hold our cash and cash equivalents that we use to meet our working capital needs in deposit accounts that could be adversely affected if the financial institutions holding such funds fail.
  • Certain stockholders could attempt to influence changes within our Company which could adversely affect our operations, financial condition and the value of our common stock.

Legal proceedings

The information in Note 8, Commitments and Contingencies — Legal Proceedings to our consolidated financial statements included in, Part II — Item 8 — Financial Statements and Supplementary Data of this Annual Report is incorporated herein by reference.

In addition, from time to time, we are subject to various pending or threatened legal actions and proceedings, including those that arise in the ordinary course of its business, which may include employment matters, breach of contract disputes and stockholder litigation. Such actions and proceedings are subject to many uncertainties and to outcomes that are not predictable with assurance and that may not be known for extended periods of time. We record a liability in our consolidated financial statements for costs related to claims, including future legal costs, settlements and judgments, when we have assessed that a loss is probable and an amount can be reasonably estimated. If the reasonable estimate of a probable loss is a range, we record the most probable estimate of the loss or the minimum amount when no amount within the range is a better estimate than any other amount. We disclose a contingent liability even if the liability is not probable or the amount is not estimable, or both, if there is a reasonable possibility that a material loss may have been incurred. In the opinion of management, as of the date hereof, the amount of liability, if any, with respect to these matters, individually or in the aggregate, will not materially affect our consolidated results of operations, financial position or cash flows.

The opening of Item 3, Legal Proceedings.3

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