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ACOG on Nasdaq

Alpha Cognition Inc.

Alpha Cognition Inc. is a Canadian biological products company based in Vancouver, active since 2017.2 Its shares trade on Nasdaq under the symbol ACOG.2

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Last updated Oct 21, 2026.

Overview

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  • TickerACOG on Nasdaq2
  • IndustryBiological Products, (No Diagnostic Substances)2
  • HeadquartersVancouver, Canada2
  • Incorporated inBritish Columbia, Canada3
  • Business address1452 Hughes Rd., Ste. 200, Grapevine, Tx 760513
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company3
  • Legal formCorporation2
  • LEI254900J4A8UTBGYKPA902
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered address1200 - 750 West Pender Street, V6C 2T8 Vancouver, Canada2
  • Registered withBC Registry Services, BC11414282

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ZUNVEYL with Medicare payors, and developing strategic and clinical partnerships with consultant pharmacists and long-term care pharmacies.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

-221.7%Operating margin5
-202.2%Net margin5
-33.1%Return on equity5
-$20.7MFree cash flow5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product Net brought in 63% of the revenue Alpha Cognition Inc. broke down this way in fiscal 2025.

  1. Product Net$6.8M563%
  2. License$3.4M532%
  3. Licensing$598.4K56%
Products and services by year
Products and services2025
Product Net$6.8M
License$3.4M
Licensing$598.4K

Regions

United States brought in 66% of the revenue Alpha Cognition Inc. broke down this way in fiscal 2025.

  1. United States$6.8M566%
  2. [Canada]$3.4M534%
Regions by year
Regions2025
United States$6.8M
[Canada]$3.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue2¢$603.4K
  • Research and development6¢$1.9M
  • Selling, general and admin92¢$29.1M

Out of $10.2M in revenue.5 The company lost money this year.

Financial statements

Operating income65-$22.7M in 2025+128% since 2023
-$30.0M-$20.0M-$10.0M02023: -$9.9M-$9.9M20232024: -$12.0M-$12.0M2024+21%2025: -$22.7M-$22.7M2025+89%
Net income65-$20.7M in 2025+50% since 2023
-$30.0M-$20.0M-$10.0M02023: -$13.8M-$13.8M20232024: -$14.8M-$14.8M2024+7%2025: -$20.7M-$20.7M2025+40%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Total revenue$10.2M
Cost of product sales, excluding amortization of intangible asset$474.0K
Cost of licensing revenue$1.4M
Amortization of intangible asset$21.5K$79.9K
Research and development$1.9M$3.9M
Selling, general and administrative expenses$29.1M$8.0M
Total operating expenses$32.9M$12.0M
Loss from operations-$22.7M-$12.0M
Interest income$1.9M$161.7K
Grant income$81.1K$463.9K
Gain (loss) on derivative liabilities and conversion of convertible debt$88.2K-$3.2M
Other expenses-$77.8K-$237.0K
Total other income (expenses)$2.0M-$2.8M
Net loss and comprehensive loss-$20.7M-$14.8M
Weighted average stock outstanding, basic (in Shares)17.7M shares7.2M shares
Net loss per share, basic (in Dollars per share)-$1.17-$2.04
Adjusted net loss, diluted-$20.8M-$14.8M
Weighted average stock outstanding, diluted (in Shares)17.7M shares7.2M shares
Net loss per share, diluted (in Dollars per share)-$1.18-$2.04

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Corporate structure

Alpha Cognition 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 Alpha Cognition Inc.

  • MANCHESTER MANAGEMENT CO LLC Filed SCHEDULE 13G on Alpha Cognition Inc., latest Sep 23, 2026 (3 filings since Feb 17, 2026)
  • Opaleye Management Inc. Filed SCHEDULE 13G/A on Alpha Cognition Inc., latest Jul 24, 2026 (9 filings since Oct 3, 2025)
  • Funicular Funds, LP Filed SCHEDULE 13G on Alpha Cognition Inc., latest Feb 19, 2026 (3 filings since Apr 16, 2025)
  • Ikarian Capital, LLC Filed SCHEDULE 13G/A on Alpha Cognition Inc., latest Feb 17, 2026 (2 filings since Feb 14, 2025)
  • AWM Investment Company, Inc. Filed SCHEDULE 13G/A on Alpha Cognition Inc., latest Feb 13, 2026 (3 filings since Feb 13, 2025)
  • Solas Capital Management, LLC Filed SCHEDULE 13G on Alpha Cognition Inc., latest Feb 14, 2025
  • James E. Besser Filed SCHEDULE 13G on Alpha Cognition Inc., latest Jan 31, 2025
  • John Prentiss Havens Filed SC 13D/A on Alpha Cognition Inc., latest Nov 15, 2024 (2 filings since Nov 15, 2024)
  • Alpha Cognition Inc. Vancouver, British Columbia, Canada

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 Alpha Cognition 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$39.1K6 Dec 31, 2024$12.4K6 Dec 31, 2023+215.9%
Accumulated depreciation$12.0K6 Dec 31, 2024$10.6K6 Dec 31, 2023+12.6%
Property and equipment, net$328.5K5 Dec 31, 2025$27.1K5 Dec 31, 2024+1113.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$66.0M5 Dec 31, 2025$48.5M5 Dec 31, 2024+36.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$413.0K6 Dec 31, 2024$532.0K6 Dec 31, 2023−22.4%
Finite-lived intangibles, gross$1.2M5 Dec 31, 2025$1.2M5 Dec 31, 20240%
Accumulated amortization$794.2K5 Dec 31, 2025$772.7K5 Dec 31, 2024+2.8%
Finite-lived intangibles, net$391.4K5 Dec 31, 2025$413.0K5 Dec 31, 2024−5.2%

Inventory

ItemLatestA year beforeChange
Inventory, total$5.1M5 Dec 31, 2025$615.1K5 Dec 31, 2024+732.9%
Raw materials$3.7M5 Dec 31, 2025
Work in process$725.5K5 Dec 31, 2025$615.1K5 Dec 31, 2024+17.9%
Finished goods$672.7K5 Dec 31, 2025

Properties, in its own words

The Company does not own or rent any real estate with respect to its corporate head office and laboratory facilities.

Our corporate head office is located at Suite 200 – 1452 Hughes Road, Grapevine, TX, 76051.

Item 2 of the 10-K filed Mar 31, 2026.4

Leadership

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

Chief operating officer

  1. Lauren D'Angelo2024–now
2025
Board members and other officers (7)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorMichael McFadden named Oct 18, 2021 to Nov 18, 202417
  • Executive OfficerJay Rob Yoo named Oct 9, 202418
  • Executive OfficerDon Kalkofen named Feb 28, 2023 to Jan 31, 202419
  • Executive OfficerDenis Kay named Oct 18, 2021 to Feb 28, 202320
  • Executive OfficerJeremy Wright named Oct 18, 202121
  • DirectorJohn Havens named Oct 18, 2021 to Nov 18, 202417
  • DirectorLen Mertz named Oct 18, 2021 to Nov 18, 202417
  • DirectorJohn Rob Havens named Oct 9, 202418
  • DirectorLen Rob Mertz named Oct 9, 202418
  • DirectorRob Bakshi named Oct 18, 2021 to Jan 31, 202419
  • DirectorFrederick Sancilio named Oct 18, 202121
  • DirectorJeremy Mertz named Oct 18, 202121

Former names

  • Neurodyn Cognition Inc.Oct 16, 2015 to Oct 9, 20193

Timeline

  1. Jun 23, 20268-K Executive or director change; Shareholder vote22
  2. May 1, 20268-K Executive or director change23
  3. Apr 20, 20268-K Executive or director change24
  4. Apr 14, 20268-K Entered a material agreement25
  5. Mar 27, 20268-K Regulation FD disclosure26
  6. Mar 26, 20268-K Results of operations27
  7. Feb 23, 20268-K Executive or director change28
  8. Jan 15, 20268-K Executive or director change29
  9. Oct 15, 20258-K Change of auditor30
  10. Oct 14, 20258-K Change of auditor31
  11. Oct 2, 20258-K Entered a material agreement; Other events32
  12. Aug 22, 20258-K Entered a material agreement33
  13. Nov 15, 2017Founded Alpha Cognition Inc. is founded2

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.30) a share, on Nov 13, 2025.34

When it reported results

  1. Mar 26, 2026Reported quarterly or annual results27
  2. Aug 13, 2024Reported quarterly or annual results35

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

Filings

207 filings to the SEC since October 2021: 2 annual reports, 7 quarterly reports, 29 major events, 60 insider forms, 24 large holders, 10 private raises, 75 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Sep 28, 20264 EDGAR
  3. Sep 23, 2026SCHEDULE 13G EDGAR
  4. Sep 16, 20264 EDGAR
  5. Aug 24, 20264 EDGAR
  6. Aug 13, 202610-Q QUARTERLY REPORT EDGAR
  7. Aug 4, 20264 EDGAR
  8. Jul 28, 20264 EDGAR
  9. Jul 24, 2026SCHEDULE 13G/A EDGAR
  10. Jul 24, 20264 EDGAR
  11. Jun 29, 2026SCHEDULE 13G/A EDGAR
  12. Jun 29, 20264 EDGAR
  13. Jun 23, 20268-K CURRENT REPORT EDGAR
  14. Jun 15, 20264 EDGAR
  15. Jun 11, 20264 EDGAR
  16. Jun 9, 20264 EDGAR
  17. May 29, 20264 EDGAR
  18. May 22, 2026SCHEDULE 13G/A EDGAR
  19. May 22, 20264 EDGAR
  20. May 19, 20264 EDGAR

The 207 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

54 open-market trades by officers, directors and large owners since October 2021: 53 buys and 1 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 25, 2026Opaleye Management Inc.10% ownerBuy13,426$8.47$113.7KForm 4
Sep 24, 2026Opaleye Management Inc.10% ownerBuy18,337$8.57$157.1KForm 4
Sep 16, 2026Opaleye Management Inc.10% ownerBuy80,170$8.51$682.4KForm 4
Sep 15, 2026Opaleye Management Inc.10% ownerBuy3,375$8.54$28.8KForm 4
Sep 14, 2026Opaleye Management Inc.10% ownerBuy40,373$8.70$351.2KForm 4
Aug 21, 2026Wills Robert JamesDirectorBuy10,000$9.62$96.2KForm 4
Aug 3, 2026Opaleye Management Inc.10% ownerBuy50,000$8.00$400.0KForm 4
Jul 31, 2026Opaleye Management Inc.10% ownerBuy2,900$7.92$23.0KForm 4
Jul 24, 2026Opaleye Management Inc.10% ownerBuy130$7.90$1.0KForm 4
Jul 23, 2026Opaleye Management Inc.10% ownerBuy49,849$7.80$388.8KForm 4
Jul 22, 2026Opaleye Management Inc.10% ownerBuy150,237$7.83$1.2MForm 4
Jun 26, 2026Opaleye Management Inc.10% ownerBuy152,336$6.40$975.0KForm 4
Jun 25, 2026Opaleye Management Inc.10% ownerBuy197$6.50$1.3KForm 4
Jun 15, 2026Opaleye Management Inc.10% ownerBuy4,550$5.99$27.3KForm 4
Jun 12, 2026Opaleye Management Inc.10% ownerBuy273$5.93$1.6KForm 4
Jun 11, 2026Opaleye Management Inc.10% ownerBuy2,862$5.91$16.9KForm 4
Jun 10, 2026Opaleye Management Inc.10% ownerBuy5,872$5.99$35.2KForm 4
Jun 9, 2026Opaleye Management Inc.10% ownerBuy24,856$5.98$148.6KForm 4
Jun 5, 2026Opaleye Management Inc.10% ownerBuy10,054$5.83$58.6KForm 4
May 29, 2026Opaleye Management Inc.10% ownerBuy70,577$5.90$416.4KForm 4

All 54 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
2025Michael McFadden58$625.0K$3.6M44
2025Lauren D’Angelo47$500.0K$2.4M44
2025Henry Du48$285.0K$464.5K44
2024Chief Executive Officer$500.0K$943.7K44
2024Chief Commercial Officer and Chief Operating Officer$420.0K$797.7K44
2024Interim Chief Financial Officer$54.4K$363.6K44

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Oct 21, 2024Filed a private offering of securities Form D: $346,944 offered in all Form D
  2. Sep 24, 2024Raised $4.5 million in a private offering of securities Form D: $11.1 million offered in all Form D
  3. Jan 24, 2024Raised $2.8 million in a private offering of equity Form D: $6.8 million offered in all Form D
  4. Dec 22, 2023Raised $1.8 million in a private offering of equity Form D: $4.2 million offered in all Form D
  5. Nov 8, 2023Raised $1 million in a private offering of equity Form D: $1.7 million offered in all Form D
  6. Oct 16, 2023Raised $343,999 in a private offering of equity Form D: $586,361 offered in all Form D
  7. Aug 31, 2023Raised $1.3 million in a private offering of equity Form D: $2.1 million offered in all Form D
  8. Mar 15, 2023Raised $1.3 million in a private offering of equity Form D: $3.3 million offered in all Form D
  9. Feb 16, 2023Raised $1.8 million in a private offering of equity Form D: $4.7 million offered in all Form D
  10. Oct 1, 2021Raised $424,983 in a private offering of equity Form D: $920,796 offered in all Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 26. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Opaleye Management Inc.2,895,467$20.9M1.9%+333,517
Solas Capital Management, LLC1,924,617$13.9M7.4%No change
AWM Investment Company, Inc.1,672,168$12.1M1.0%No change
Cable Car Capital, LP1,382,339$10.0M0.2%No change
Ikarian Capital, LLC836,259$6.0M1.0%−220,000
Sphera Funds Management Ltd.545,816$3.9M0.6%−21,800
Alyeska Investment Group, L.P.365,000$2.6M0.0%No change
Aristides Capital LLC218,510$1.6M0.4%No change
Cantor Fitzgerald, L. P.217,836$1.6M0.0%+29,205
Boothbay Fund Management, LLC189,148$1.4M0.0%−67,245
Citadel Advisors LLC97,546$704.3K0.0%+7,957
Villere St Denis J & Co LLC71,158$513.8K0.1%No change
Tudor Investment Corp Et Al61,596$444.7K0.0%No change
Act Capital Management, LLC51,500$371.8K0.2%No change
Berkshire Asset Management Llc/pa19,824$143.1K0.0%No change
Two Sigma Investments, LP18,832$136.0K0.0%+2,946
Geode Capital Management, LLC11,992$86.6K0.0%No change
Raymond James Financial Inc10,000$72.2K0.0%No change
National Bank Of Canada /fi/5,292$37.7K0.0%No change
UBS Group AG1,456$10.5K0.0%+1,018
Allworth Financial LP750$5.4K0.0%No change
Jones Financial Companies Lllp250$1.6K0.0%+150
Morgan Stanley200$1.4K0.0%New
Steward Partners Investment Advisory, LLC200$1.4K0.0%No change
Royal Bank Of Canada122$1.0K0.0%−557

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

SEC filer profile

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

  • Name on EDGARAlpha Cognition Inc.1
  • CIK0001655923
  • Employer ID (EIN)00-00000004
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inBritish Columbia4
  • 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 address1452 Hughes Rd., Ste. 200, Grapevine, TX 760511
  • Phone(858) 344-43751
  • Shares outstanding21,777,868 as of Aug 13, 20268
  • Public float$149.5M as of Jun 30, 20254
  • AuditorCBIZ CPAs P.C., New York, New York PCAOB ID 199; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceOct 16, 20151
  • Filings214 in all: 4 (48), 8-K (26), D (17), CORRESP (12), SCHEDULE 13G/A (12), 3 (11), SCHEDULE 13G (10), UPLOAD (9)1
    All 34 form types

    424B3 (8), EFFECT (8), S-1/A (8), 10-Q (7), S-1 (4), 8-K/A (3), DEFA14A (3), S-3 (3), 10-K (2), 424B5 (2), DEF 14A (2), DRS (2), DRS/A (2), POS AM (2), S-8 (2), 3/A (1), 424B2 (1), 424B4 (1), 8-A12B (1), CERT (1), DRSLTR (1), POS EX (1), S-1MEF (1), S-8 POS (1), SC 13D (1), SC 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Jun 23, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, no par valueACOGNasdaq

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Alpha Cognition Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 69 risks under these headings, as written.4

  • Risks Related to Commercialization and Manufacturing
  • Risks Related to Our Financial Position
  • Risks Related to Our Business Development
  • Risks Related to Our Industry
  • Risks Related to Our Intellectual Property
  • Risks Related to Government Regulation
  • Risks Related to Employee Matters and Growth Management
  • Risks Related to Our Common Stock
  • General Risk Factors
  • ZUNVEYL oral tablet formulation 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 ZUNVEYL 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.
The other 66 risks
  • We are subject to certain supply chain risks inherent in manufacturing our lead product, ZUNVEYL, and future products with respect to Taiwan. Risks including periodic foreign economic downturns and political instability, which may adversely affect our ability to obtain materials and conduct business in Taiwan.
  • Our product candidates have not previously been manufactured on a commercial scale, and there are risks associated with scaling up manufacturing to commercial scale. In particular, we are working on developing a larger scale manufacturing process that is more efficient and cost-effective to commercialize our potential products, which may not be successful.
  • The manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, could be delayed or prevented.
  • The successful commercialization of ZUNVEYL and our other product candidates which may obtain approval 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 a small, newly formed 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 ZUNVEYL or our other product candidates, if approved, effectively in the United States and foreign jurisdictions or generate product revenue.
  • Risks Related to Our Financial Condition
  • We are a commercial biopharmaceutical company with one product approved for commercial sale and have incurred significant losses since our inception. We expect to incur significant losses for the foreseeable future and our costs may increase substantially in the foreseeable future.
  • Our ability to continue to generate revenue and achieve profitability depends significantly on our ability to achieve commercial success with ZUNVEYL oral tablet formulation, our one FDA approved product, and continued development and commercialization of our other product candidates, if approved.
  • We have a limited operating history and no prior 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 capital to meet our financial obligations and to pursue our business objectives, including the continued commercialization of ZUNVEYL oral tablet formulation. If we are unable to raise capital when needed, we could be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.
  • We expect to be exposed to fluctuations in currency exchange rates, which could adversely affect our results of operations.
  • Our business is heavily dependent on the commercial success of ZUNVEYL oral tablet formulation, our only FDA approved product, and the development and commercialization of any future product candidates that we may develop or acquire.
  • We may not successfully expand our pipeline of product candidates. If we are not successful in identifying, developing, in-licensing, acquiring or/and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
  • We have initially concentrated our research and development efforts on the treatment of Alzheimer’s Disease, a disease that has seen limited success in drug development.
  • ZUNVEYL remains subject to regulatory oversight.
  • For our other product candidates, we may encounter substantial delays in our preclinical studies, clinical trials and obtaining NDA approval or may not be able to conduct or complete our preclinical studies or clinical trials or receive NDA approval on the timelines we expect, if at all.
  • The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or other comparable foreign regulatory authorities.
  • 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.
  • Use of our therapeutic candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a therapeutic candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.
  • 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 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.
  • We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may have been more profitable or for which there could have been a greater likelihood of success.
  • 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.
  • Significant disruptions of our information technology systems, breaches of data security and other incidents could materially adversely affect our business, results of operations and financial condition.
  • We identified material weaknesses in our internal control over financial reporting which are in the process of being remediated, and if we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired.
  • Risk related to Our Industry
  • Research and development of pharmaceuticals is lengthy and inherently risky. We cannot give any assurance that our future product candidates will receive regulatory approval.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns 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.
  • 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.
  • 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.
  • We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may 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.
  • Our success depends on our ability to obtain and maintain patent protection for our technology and product candidates including our lead product, ZUNVEYL formerly known as ALPHA-1062. If such protection is not obtained, the scope of the patent protection obtained is not sufficiently broad, or we lose such protection, 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, which may harm our business.
  • 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 ZUNVEYL can be challenged by third parties.
  • One of our patent listings in the Orange Book has an inadvertent inaccuracy which may subject us to administrative proceedings before the FDA or litigation claims.
  • 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, ZUNVEYL.
  • 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.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline.
  • Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
  • 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.
  • 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 protect our product including our lead product, ZUNVEYL.
  • 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, resulting in harm to our business and competitive position.
  • 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 that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • 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.
  • We have not yet registered our trademarks in certain jurisdictions. Failure to secure those registrations could adversely affect our business.
  • The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable.
  • The FDA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • Even following our regulatory approval of ZUNVEYL or for a future product candidate, our products will remain subject to regulatory scrutiny.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • 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.
  • 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.
  • 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 our business may rely, which could negatively impact our business.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
  • 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.
  • We will need to increase the size of our organization, and we may experience difficulties in managing growth.
  • Our success is dependent on our ability to attract and retain highly qualified management and other clinical and scientific personnel.
  • 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.
  • If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval.
  • 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.

Legal proceedings

From time to time, we are involved in various legal proceedings arising from the normal course of business activities. We are not currently a party to any material legal proceedings nor are we aware of any such legal proceedings contemplated by government agencies. However, from time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business

The opening of Item 3, Legal Proceedings.4

Sources

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