ANVS on NYSE
Annovis Bio, Inc.
In its 2026 annual report the company says: “We are a late-stage clinical drug platform company addressing neurodegeneration, such as Alzheimer’s disease and Parkinson’s disease. We are developing our lead product candidate, buntanetap, which is designed to address AD, PD, and potentially other chronic neurodegenerative diseases.”4 It is headquartered in Berwyn, United States.2 Its shares trade on NYSE under the symbol ANVS.2
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Last updated Oct 21, 2026.
Overview
- TickerANVS on NYSE2
- IndustryPharmaceutical Preparations2
- HeadquartersBerwyn, United States2
- Incorporated inDE3
- Business address101 Lindenwood Drive, Suite 225, Malvern, Pa 193553
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300IFBVI51FN3NJ322
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O CAPITOL CORPORATE SERVICES, INC., 19904 Dover, United States2
- Registered withDivision of Corporations, Department of State, 45406852
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We are a late-stage clinical drug platform company addressing neurodegeneration, such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). We are developing our lead product candidate, buntanetap, which is designed to address AD, PD, and potentially other chronic neurodegenerative diseases. Buntanetap is a synthetically produced small molecule, orally administered, brain penetrant compound. In several studies, buntanetap was observed to inhibit the synthesis of neurotoxic proteins — APP/Aβ (“APP”), tau/phospho-tau (“tau”), α-Synuclein (“αSYN”) and TDP43 — that are some of the main causes of neurodegeneration. High levels of neurotoxic proteins lead to reduced axonal transport, which is responsible for communication between and within nerve cells. When that communication is compromised, the immune system is activated and attacks the nerve cells, eventually killing them. We have o…4 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
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $25.2M | $20.0M |
| General and administrative | $4.5M | $6.7M |
| Total operating expenses | $29.7M | $26.7M |
| Operating loss | -$29.7M | -$26.7M |
| Interest income | $699.1K | $331.8K |
| Other financing costs | -$1.9M | |
| Change in fair value of warrants | $142.0K | $3.6M |
| Total other income, net | $841.1K | $2.1M |
| Net loss | -$28.9M | -$24.6M |
| Basic (dollars per share) | -$1.40 | -$2.02 |
| Diluted (dollars per share) | -$1.40 | -$2.31 |
| Basic | 20.6M shares | 12.2M shares |
| Diluted | 20.6M shares | 12.2M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.5
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $19.5M | $10.6M | |
| Prepaid expenses and other current assets | $1.5M | $3.4M | |
| Total assets | $21.1M | $13.9M | |
| Accounts payable | $2.6M | $2.3M | |
| Accrued expenses | $1.0M | $1.6M | |
| Total current liabilities | $3.6M | $3.9M | |
| Warrant liability | $595.0K | $737.0K | |
| Total liabilities | $4.2M | $4.6M | |
| Common stock - $0.0001 par value, 70,000,000 shares authorized, 27,199,139 and 14,141,521 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $2.7K | $1.4K | |
| Additional paid-in capital | $180.6M | $144.2M | |
| Accumulated deficit | -$163.7M | -$134.8M | |
| Total stockholders' equity | $16.9M | $9.3M | -$7.8M |
| Total liabilities and stockholders' equity | $21.1M | $13.9M | |
| Preferred stock, par value (dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 2.0M shares | 2.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value (dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized | 70.0M shares | 70.0M shares | |
| Common stock, shares issued | 27.2M shares | 14.1M shares | |
| Common stock, shares outstanding | 27.2M shares | 14.1M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $19.5M | $10.6M | |
| Prepaid expenses and other current assets | $1.5M | $3.4M | |
| Total assets | $21.1M | $13.9M | |
| Accounts payable | $2.6M | $2.3M | |
| Accrued expenses | $1.0M | $1.6M | |
| Total current liabilities | $3.6M | $3.9M | |
| Warrant liability | $595.0K | $737.0K | |
| Total liabilities | $4.2M | $4.6M | |
| Common stock - $0.0001 par value, 70,000,000 shares authorized, 27,199,139 and 14,141,521 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $2.7K | $1.4K | |
| Additional paid-in capital | $180.6M | $144.2M | |
| Accumulated deficit | -$163.7M | -$134.8M | |
| Total stockholders' equity | $16.9M | $9.3M | -$7.8M |
| Total liabilities and stockholders' equity | $21.1M | $13.9M | |
| Preferred stock, par value (dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 2.0M shares | 2.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value (dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized | 70.0M shares | 70.0M shares | |
| Common stock, shares issued | 27.2M shares | 14.1M shares | |
| Common stock, shares outstanding | 27.2M shares | 14.1M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$28.9M | -$24.6M |
| Stock-based compensation expense | $1.8M | $3.8M |
| Change in fair value of warrants | -$142.0K | -$3.6M |
| Non-cash other financing costs | $1.8M | |
| Prepaid expenses and other current assets | $1.8M | $1.1M |
| Accounts payable | $284.5K | $1.0M |
| Accrued expenses | -$530.2K | -$1.4M |
| Net cash used in operating activities | -$25.6M | -$21.9M |
| Proceeds from issuance of common stock, warrants, and pre-funded warrants, net | $34.6M | $18.7M |
| Proceeds from exercise of common stock options, net | $2.0K | $0 |
| Proceeds from exercise of warrants | $8.0M | |
| Net cash provided by financing activities | $34.6M | $26.7M |
| Net increase in cash and cash equivalents | $9.0M | $4.8M |
| Reduction in value of warrants related to exercises | $9.3M | |
| Cash paid for financing costs | $50.0K |
No quarter-by-quarter statement was filed.
Corporate structure
Annovis Bio, 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 Annovis Bio, Inc.
- Empery Asset Management, LP Filed SCHEDULE 13G/A on Annovis Bio, Inc., latest Oct 15, 2026 (2 filings since Jul 29, 2026)
- HIGHBRIDGE CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Annovis Bio, Inc., latest Aug 14, 2026
- CVI Investments, Inc. Filed SCHEDULE 13G/A on Annovis Bio, Inc., latest May 12, 2025 (2 filings since Feb 10, 2025)
- Orin Hirschman Filed SC 13G/A on Annovis Bio, Inc., latest Nov 28, 2023 (2 filings since Nov 8, 2023)
- Annovis Bio, Inc. Berwyn, Pennsylvania, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Annovis Bio, 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $19.5M5 Dec 31, 2025 | $10.6M5 Dec 31, 2024 | +85.1% |
Properties, in its own words
Our offices are in Malvern, Pennsylvania, where we have leased and have access to approximately 1,500 square feet of office space pursuant to a short-term lease agreement. We believe that our facilities are adequate to meet our current needs.
Item 2 of the 10-K filed Mar 13, 2026.4
Leadership
Who has led Annovis Bio, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerMaria-Luisa Maccecchini Jan 29, 2020 to now14
- PresidentMaria-Luisa Maccecchini Jan 29, 2020 to now14
- Chief financial officerHenry Hagopian Iii. Aug 31, 2022 to Nov 22, 202315
- Chief financial officerJeffrey B. McGroarty Jan 29, 2020 to Jan 5, 202216
Board members and other officers (7)
- Vice President, FinanceAndrew Walsh May 16, 2025 to now17
- Board memberReid McCarthy Apr 19, 2021 to now18
- Board memberClaudine Bruck Jan 29, 2020 to now19
- Board memberMaria-Luisa Maccecchini Jan 29, 2020 to now14
- Board memberMark K. White Jan 29, 2020 to Jul 3, 202420
- Board memberMichael B. Hoffman Jan 29, 2020 to now21
- Board memberRobert M. Whelan Jr. Jan 29, 2020 to Jul 6, 202022
Former names
- QR Pharma, Inc.Jan 15, 2010 to Mar 15, 20193
Timeline
- Aug 14, 20268-K Results of operations23
- Jul 10, 20268-K Other events24
- Jun 17, 20268-K Shareholder vote25
- May 20, 20268-K Entered a material agreement; Regulation FD disclosure26
- May 15, 20268-K Results of operations27
- Apr 10, 20268-K Entered a material agreement; Regulation FD disclosure28
- Mar 25, 20268-K Executive or director change29
- Mar 16, 20268-K Results of operations30
- Feb 12, 20268-K Regulation FD disclosure31
- Jan 28, 20268-K Regulation FD disclosure32
- Nov 13, 20258-K Results of operations33
- Oct 28, 20258-K Entered a material agreement; Other events34
- Jan 29, 2020New chief executive Maria-Luisa Maccecchini becomes CEO14
- Apr 29, 2008Founded Annovis Bio, Inc. is founded2
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.37) a share, on Nov 12, 2025.35
When it reported results
- Aug 14, 2026Reported quarterly or annual results23
- May 15, 2026Reported quarterly or annual results27
- Mar 16, 2026Reported quarterly or annual results30
- Nov 13, 2025Reported quarterly or annual results33
- Aug 12, 2025Reported quarterly or annual results36
- May 13, 2025Reported quarterly or annual results37
- Mar 21, 2025Reported quarterly or annual results38
- Nov 12, 2024Reported quarterly or annual results39
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
209 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 70 major events, 64 insider forms, 7 large holders, 1 private raises, 47 other. The latest 20:
- Oct 15, 2026SCHEDULE 13G/A EDGAR
- Oct 7, 2026DEFA14A EDGAR
- Sep 11, 2026DEF 14A EDGAR
- Aug 25, 2026PRE 14A EDGAR
- Aug 14, 202610-Q EDGAR
- Aug 14, 20268-K EDGAR
- Aug 14, 2026SCHEDULE 13G EDGAR
- Jul 29, 2026SCHEDULE 13G EDGAR
- Jul 10, 20268-K EDGAR
- Jun 17, 20268-K EDGAR
- May 21, 20264 OWNERSHIP DOCUMENT EDGAR
- May 20, 20268-K EDGAR
- May 20, 2026424B5 EDGAR
- May 19, 2026424B5 EDGAR
- May 15, 202610-Q EDGAR
- May 15, 20268-K EDGAR
- Apr 30, 2026DEFA14A EDGAR
- Apr 30, 2026DEF 14A EDGAR
- Apr 10, 20268-K EDGAR
- Apr 9, 2026424B5 EDGAR
The 209 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
12 open-market trades by officers, directors and large owners since October 2021: 12 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| May 20, 2026 | Hoffman Michael BDirector | Buy | 76,344 | $1.87 | $142.8K | Form 4 |
| Apr 2, 2026 | Hoffman Michael BDirector | Buy | 713,800 | $2.10 | $1.5M | Form 4 |
| Dec 8, 2025 | Hoffman Michael BDirector | Buy | 45,000 | $4.31 | $193.8K | Form 4 |
| Nov 24, 2025 | Hoffman Michael BDirector | Buy | 39,200 | $4.08 | $159.9K | Form 4 |
| Nov 24, 2025 | Hoffman Michael BDirector | Buy | 39,200 | $4.08 | $159.9K | Form 4 |
| Nov 21, 2025 | Hoffman Michael BDirector | Buy | 20,000 | $3.50 | $69.9K | Form 4 |
| Nov 14, 2025 | Hoffman Michael BDirector | Buy | 15,000 | $2.11 | $31.6K | Form 4 |
| Oct 28, 2025 | Maccecchini Maria-LuisaPresident & CEO | Buy | 97,561 | $2.05 | $200.0K | Form 4 |
| Oct 28, 2025 | Hoffman Michael BDirector | Buy | 975,610 | $2.05 | $2.0M | Form 4 |
| Oct 12, 2021 | White Mark K.Director | Buy | 5,000 | $27.40 | $137.0K | Form 4 |
| Oct 11, 2021 | Bruck ClaudineDirector | Buy | 181 | $27.66 | $5.0K | Form 4 |
| Oct 11, 2021 | Maccecchini Maria-LuisaPresident & CEO | Buy | 18,000 | $27.61 | $497.0K | Form 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.
- Empery Asset Management, LPSCHEDULE 13G/A, 2 filings Jul 29, 2026 to Oct 15, 202640
- HIGHBRIDGE CAPITAL MANAGEMENT LLCSCHEDULE 13G, 1 filing Aug 14, 202641
- CVI Investments, Inc.SCHEDULE 13G/A, 2 filings Feb 10, 2025 to May 12, 202542
- Orin HirschmanSC 13G/A, 2 filings Nov 8, 2023 to Nov 28, 202343
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.
- Private raises (Form D) $1.1M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2023 | $1.1M | $1.1M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 60. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Annovis Bio, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARAnnovis Bio, Inc.1
- CIK0001477845
- Employer ID (EIN)26-25404214
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address101 Lindenwood Drive, Suite 225, Malvern, PA 193551
- Phone484-875-31921
- Shares outstanding42,606,152 as of Aug 14, 202613
- Public float$36.1M as of Jun 30, 20254
- AuditorErnst & Young LLP, Philadelphia, Pennsylvania PCAOB ID 42; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceJan 15, 20101
- Filings307 in all: 8-K (81), 4 (72), 10-Q (20), 424B5 (15), CORRESP (10), 3 (9), DEFA14A (9), UPLOAD (9)1
All 37 form types
4/A (8), D (8), DEF 14A (8), 10-K (7), S-1/A (6), 424B4 (3), ARS (3), EFFECT (3), SC 13G (3), SC 13G/A (3), SCHEDULE 13G (3), 8-A12B (2), CERT (2), D/A (2), DRSLTR (2), FWP (2), PRE 14A (2), S-3 (2), S-8 (2), SCHEDULE 13G/A (2), 144 (1), 25 (1), 5 (1), DRS (1), DRS/A (1), S-1 (1), S-1MEF (1), S-3/A (1), SC 13D (1)
- Latest filingsAnnual report (10-K) Mar 13, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Sep 11, 2026
Latest 8-K (8-K) Aug 14, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | ANVS | New York Stock Exchange |
From the cover page of the 10-K filed Mar 13, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Annovis Bio, Inc. names in Item 1A of its 10-K filed Mar 13, 2026: 72 risks under these headings, as written.4
- Risks Related to Our Financial Position and Need for Additional Capital
- Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern, if we are unable to obtain additional financings.
- The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025, contains an explanatory paragraph relating to our ability to continue as a going concern.
- We have incurred significant net losses since inception and anticipate that we will continue to incur net losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability.
- We will require substantial additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of buntanetap.
- Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
- We have limited operating history and no history of commercializing pharmaceutical products.
- As we continue to build our business, we expect our financial condition and operating results may fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, reliance should not be placed upon the results of any particular quarterly or annual period as indications of future operating performance.
- Our ability to use our tax net operating losses is uncertain.
- Inflation could adversely affect our business and results of operations.
- Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
- Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval
The other 62 risks
- We are heavily dependent on the success of buntanetap, our most advanced product candidate, which is still under clinical development, and if this drug does not receive regulatory approval or is not successfully commercialized, our business will be materially harmed.
- If we are not successful in discovering, developing and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
- Business disruptions could harm our ability to complete or could materially delay our clinical trials, as well as cause disruptions to the FDA and other governmental authorities.
- Clinical trials are expensive, time-consuming and difficult to design and implement, and involve an uncertain outcome.
- The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for buntanetap or any other product candidates, our business will be substantially harmed.
- We have concentrated our research and development efforts on the treatment of AD and PD, diseases that have seen limited success in drug development. Further, buntanetap is based on a new approach to treating AD and PD, which makes it difficult to predict the time and cost of development and subsequent obtaining of regulatory approval.
- Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
- We may develop buntanetap and future product candidates for use in combination with other therapies, which could expose us to additional regulatory risks.
- Enrollment and retention of patients 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 preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials.
- Interim “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are further subject to audit and verification procedures that could result in material changes in the final data. Furthermore, undue reliance on interim analyses may be detrimental to our long-term clinical development plans, which could harm our business, operating results, prospects or financial condition.
- Our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
- The market opportunities for buntanetap or any other product candidates, if approved, may be smaller than we anticipate, which could adversely affect our business, financial condition and results of operations.
- We have never obtained marketing approval for a product candidate, and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates. Further, even if marketing approval is obtained, we have no experience as a company in commercializing products.
- Even if we obtain FDA approval for buntanetap or any other product candidates in the United States, we may never obtain approval for or commercialize buntanetap or any other product candidates in any other jurisdiction, which would limit our ability to realize their full market potential.
- Even if we obtain regulatory approval for buntanetap or any product candidates, we will still face extensive and ongoing regulatory requirements and obligations and any product candidates, if approved, may face future development and regulatory difficulties.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
- We may seek a Breakthrough Therapy designation for buntanetap from the FDA in PD and AD. However, we might not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process.
- Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit, delay or cease commercialization of any products that we may develop.
- Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities.
- Risks Related to Commercialization
- We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
- The successful commercialization of buntanetap and any other product candidates we develop 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 products and decrease our ability to generate revenue.
- Even if buntanetap or any product candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success, which would adversely affect our business.
- If we are unable to establish sales, marketing and distribution capabilities, we may not be successful in commercializing buntanetap, if approved.
- A variety of risks associated with operating internationally could materially adversely affect our business.
- Risks Related to Our Dependence on Third Parties
- Our employees and independent contractors, including principal investigators, CROs, consultants, vendors, and any third parties we may engage in connection with development and commercialization, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
- We currently rely on third-party contract manufacturing organizations (“CMOs”) for the production of clinical supply of buntanetap and intend to rely on CMOs for the production of commercial supply of buntanetap, if approved. Our dependence on CMOs may impair the development and commercialization of the drug, which would adversely impact our business and financial position.
- We currently rely and in the future intend to 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, it may harm our business.
- Risks Related to Healthcare Laws and Other Legal Compliance Matters
- Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set.
- 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.
- Any clinical trial programs we conduct or research collaborations we enter into in the EEA may subject us to the General Data Protection Regulation.
- 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 could face criminal liability and other serious consequences for violations, which could harm our business.
- We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities.
- Recent U.S. tax legislation may materially adversely affect our financial condition, results of operations and cash flows.
- Risks Related to Our Intellectual Property
- If we are unable to obtain, maintain and enforce patent or other intellectual property protection for buntanetap, Posiphen Form B or any future product candidates or technology or if the scope of the patent protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, our ability to successfully commercialize buntanetap, Posiphen Form B, or any future product candidates may be adversely affected and we may not be able to compete effectively in our markets.
- If we are unable to obtain additional patent protection to prolong the patent life of our product candidates, we may not be able to continue development of our product candidates.
- Our patents may be challenged in courts, in patent offices or before other administrative bodies which could result in the invalidation, narrowing or unenforceability of our patents and our patent portfolio, along with the unpredictable nature of patent prosecution, may not provide us with sufficient rights to similarly challenge other parties or exclude others from commercializing products similar or identical to ours.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- 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, which could be costly, time-consuming, delay or prevent the development and commercialization of our 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.
- Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- 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.
- 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.
- If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and under similar legislation in foreign countries, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed.
- Intellectual property rights do not address all potential threats to our competitive advantage.
- 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.
- We have not yet registered our trademarks in the United States or other jurisdictions. Failure to secure such registrations could adversely affect our business.
- 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.
- In response to an inability to enforce our patent rights, or in the event of successful litigation against us by third parties, or in the normal course of future business operations, we may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties or claims asserting ownership of what we regard as our own intellectual property.
- Our proprietary information may be lost, or we may suffer security breaches.
- Risks Related to Our Employees, Managing Our Growth and Our Operations
- Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.
- We expect to expand our development, regulatory, and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
- We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.
- We may seek to enter into collaborations, license agreements and other similar arrangements in the future, and may not be successful in doing so.
- Our business and operations would suffer in the event of failures involving our information technology systems, or those of any of our service providers.
- Disruption, failure or cybersecurity breaches affecting or targeting computers and infrastructure used by us or our business partners may adversely impact our business and operations.
- The cash and cash equivalents that we use to meet our working capital and operating expense needs are held in deposit accounts at two financial institutions. If one or both financial institutions fail, our deposit accounts could be adversely affected due to the loss of or delay in obtaining access to all or a portion of our uninsured funds.
- Risks Related to Our Common Stock
- The market price of our common stock has been volatile and fluctuated substantially in the past and may continue to experience volatility and substantial fluctuations in the future, which could result in substantial losses for purchasers of our common stock.
- Our failure to regain the NYSE’s continued listing requirements could result in a delisting of our common stock.
- We have been subject to securities class action litigation in the past and could be subject to such litigation in the future.
- Our directors, executive officers and certain stockholders own a significant percentage of our common stock and, if they choose to act together, will be able to exert significant control over matters subject to stockholder approval.
Legal proceedings
From time to time, we may become subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceedings against us that we believe could have a material adverse effect on our business, operating results or financial condition.
The opening of Item 3, Legal Proceedings.4
Sources
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- 18SEC EDGARReid McCarthy, Board member
- 19SEC EDGARClaudine Bruck, Board member
- 20SEC EDGARMark K. White, Board member
- 21SEC EDGARMichael B. Hoffman, Board member
- 22SEC EDGARRobert M. Whelan Jr., Board member
- 23SEC EDGARResults of operations
- 24SEC EDGAROther events
- 25SEC EDGARShareholder vote
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- 27SEC EDGARResults of operations
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- 29SEC EDGARExecutive or director change
- 30SEC EDGARResults of operations
- 31SEC EDGARRegulation FD disclosure
- 32SEC EDGARRegulation FD disclosure
- 33SEC EDGARResults of operations
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- 35NasdaqNasdaq calendar
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