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ATXI on OTC

AVENUE THERAPEUTICS, INC.

AVENUE THERAPEUTICS, INC. is an American pharmaceutical preparations company based in Bay Harbor Islands.2 Its shares trade on OTC under the symbol ATXI.2

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Last updated Oct 21, 2026.

Overview

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  • TickerATXI on OTC2
  • IndustryPharmaceutical Preparations2
  • HeadquartersNew York, United States2
  • Incorporated inDE3
  • Business address1111 Kane Concourse, Suite 301, Bay Harbor Islands, Fl 331543
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300IN52C2XAYTBO532
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O Incorporating Services, Ltd., 19901 Dover, United States2
  • Registered withDivision of Corporations, Department of State, 56897522

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Avenue Therapeutics, Inc. (“Avenue” or the “Company”) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. Our current product candidates are ATX-04, a selective β2-adrenergic agonist for Pompe disease, intravenous tramadol (“IV tramadol”), a schedule IV opioid for the treatment of post-operative acute pain and previously, through November 5, 2025, BAER-101 for the treatment of epilepsy and panic disorders.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

-219.6%Operating margin5
-207.2%Net margin5
-158.8%Return on equity5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development74¢$1.0M
  • Other costs26¢$365.0K
  • Income tax0¢$2.0K

Out of $1.4M in revenue.5 The company lost money this year.

Financial statements

Revenue5$1.4M in 2025
0$500.0K$1.0M$1.5M2024: $0$020242025: $1.4M$1.4M2025
Operating income6789105-$3.1M in 2025−88% since 2019
-$30.0M-$20.0M-$10.0M02019: -$26.3M-$26.3M20192020: -$5.2M-$5.2M2020−80%2021: -$3.7M-$3.7M2021−28%2022: -$8.0M-$8.0M2022+115%2023: -$14.5M-$14.5M2023+81%2024: -$11.3M-$11.3M2024−22%2025: -$3.1M-$3.1M2025−73%
Net income678105-$2.9M in 2025−89% since 2019
-$30.0M-$20.0M-$10.0M02019: -$25.9M-$25.9M20192020: -$5.2M-$5.2M2020−80%2021: -$3.7M-$3.7M2021−28%2022: -$3.6M-$3.6M2022−5%2023: -$10.5M-$10.5M2023+195%2024: -$11.7M-$11.7M2024+11%2025: -$2.9M-$2.9M2025−75%

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

Period ending2025-12-312024-12-31
Other revenue$1.4M$0
Research and development$1.0M$6.6M
General and administrative$3.7M$4.6M
Gain on sale of Baergic-$203.0K$0
Total operating expenses-$4.5M-$11.3M
Loss from operations-$3.1M-$11.3M
Interest income-$121.0K-$176.0K
Loss on common stock warrant liabilities$0$759.0K
Change in fair value of warrant liability-$15.0K-$170.0K
Net loss-$2.9M-$11.7M
Net loss attributable to non-controlling interest-$38.0K-$44.0K
Net loss attributable to common stockholders-$2.9M-$11.7M
Net loss per common share attributable to common stockholders, basic and diluted (in dollars per share)-$0.93-$15.79
Weighted average number of common shares outstanding, basic and diluted (in shares)3.1M shares1.3M shares

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Corporate structure

AVENUE THERAPEUTICS, INC. is part of a group headed by Fortress Biotech. 10 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of AVENUE THERAPEUTICS, INC.

  • Ikarian Capital, LLC Filed SCHEDULE 13G/A on AVENUE THERAPEUTICS, INC., latest Feb 17, 2026 (2 filings since Feb 14, 2025)
  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on AVENUE THERAPEUTICS, INC., latest Feb 14, 2025 (2 filings since Nov 14, 2024)
  • Robert L. Davidow Filed SC 13G/A on AVENUE THERAPEUTICS, INC., latest May 2, 2024 (3 filings since Nov 28, 2023)
  • SABBY MANAGEMENT, LLC Filed SC 13G/A on AVENUE THERAPEUTICS, INC., latest Jan 2, 2024 (2 filings since Jan 4, 2023)
  • CVI Investments, Inc. Filed SC 13G/A on AVENUE THERAPEUTICS, INC., latest Feb 14, 2023 (2 filings since Oct 17, 2022)
  • Nantahala Capital Management, LLC Filed SC 13G/A on AVENUE THERAPEUTICS, INC., latest Dec 14, 2022 (2 filings since Feb 14, 2022)
  • InvaGen Pharmaceuticals, Inc. Filed SC 13D/A on AVENUE THERAPEUTICS, INC., latest Oct 19, 2022 (2 filings since Jul 28, 2022)
  • INTRACOASTAL CAPITAL, LLC Filed SC 13G on AVENUE THERAPEUTICS, INC., latest Oct 17, 2022
  • VANGUARD GROUP INC Filed SC 13G/A on AVENUE THERAPEUTICS, INC., latest Feb 9, 2022
  • VANGUARD INDEX FUNDS Filed SC 13G/A on AVENUE THERAPEUTICS, INC., latest Feb 9, 2022
  • Fortress Biotech New York, New York, United States
    • AVENUE THERAPEUTICS, INC. New York, New York, United States
    • ● Aevitas Therapeutics, Inc. Subsidiary · Delaware, United States
    • ● Cellvation, Inc. Subsidiary · Delaware, United States
    • ● Cyprium Therapeutics, Inc. Subsidiary · Delaware, United States
    • ● Helocyte, Inc. Subsidiary · Delaware, United States
    • ● Journey Medical Corporation Subsidiary · Delaware, United States
    • ● Mustang Bio, Inc. Subsidiary · Delaware, United States
    • ● Oncogenuity, Inc. Subsidiary · Delaware, United States
    • ● Urica Therapeutics, Inc. Subsidiary · Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What AVENUE THERAPEUTICS, INC. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$2.9M5 Dec 31, 2025$2.6M5 Dec 31, 2024+10.1%

Properties, in its own words

Our corporate and executive office is located at 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154. We are not currently under a lease agreement at 1111 Kane Concourse, but we are provided access to this space by Fortress at no cost to us. We believe that our existing facilities are adequate to meet our current requirements. We do not own any real property.

Item 2 of the 10-K filed Mar 30, 2026.4

Leadership

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

Chief executive

  1. Lucy Lu2017–2021
  2. Alexandra Maclean2022–now

President

  1. Lucy Lu2017–2021

Chief financial officer

  1. Joseph Walter Vazzano2019–2021
20202025
Board members and other officers (15)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerDavid A. Jin named Feb 14, 202330
  • Executive OfficerMichael A. Ryan, M.S. named Feb 14, 202330
  • Executive OfficerScott A. Reines, M.D., Ph.D. named Feb 14, 202330
  • DirectorJay A. Kranzler, M.D., Ph.D. named Feb 14, 202330

Timeline

  1. Feb 23, 20268-K Entered a material agreement; Other events31
  2. Dec 31, 20258-K Shareholder vote32
  3. Nov 18, 20258-K Director nominations; Other events33
  4. Nov 12, 20258-K Entered a material agreement; Executive or director change; Other events34
  5. Apr 30, 20258-K Entered a material agreement; Ended a material agreement; Completed an acquisition or sale35
  6. Mar 17, 20258-K Listing notice or transfer36
  7. Mar 7, 20258-K Other events37
  8. Nov 29, 20248-K Listing notice or transfer38
  9. Nov 14, 20248-K Results of operations39
  10. Sep 27, 20248-K Executive or director change40
  11. Aug 9, 20248-K Results of operations41
  12. Jun 26, 20248-K Executive or director change; Shareholder vote42
  13. Aug 3, 2022New chief executive Alexandra Maclean becomes CEO13
  14. Aug 18, 2017New chief executive Lucy Lu becomes CEO14
  15. Feb 9, 2015Founded AVENUE THERAPEUTICS, INC. is founded2

Calendar

When it reported results

  1. Nov 14, 2024Reported quarterly or annual results39
  2. Aug 9, 2024Reported quarterly or annual results41
  3. May 15, 2024Reported quarterly or annual results43
  4. Mar 18, 2024Reported quarterly or annual results44
  5. Nov 13, 2023Reported quarterly or annual results45
  6. Aug 10, 2023Reported quarterly or annual results46
  7. May 12, 2023Reported quarterly or annual results47
  8. Mar 30, 2023Reported quarterly or annual results48

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

Filings

234 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 70 major events, 38 insider forms, 25 large holders, 1 private raises, 80 other. The latest 20:

  1. Aug 7, 202610-Q EDGAR
  2. May 8, 202610-Q EDGAR
  3. Mar 30, 202610-K EDGAR
  4. Feb 23, 20268-K EDGAR
  5. Feb 17, 2026SCHEDULE 13G/A EDGAR
  6. Jan 6, 20264 EDGAR
  7. Jan 6, 2026SCHEDULE 13D/A EDGAR
  8. Dec 31, 20258-K EDGAR
  9. Dec 16, 2025EFFECT EDGAR
  10. Dec 15, 2025POS AM EDGAR
  11. Dec 15, 2025RW EDGAR
  12. Dec 5, 2025DEF 14A EDGAR
  13. Nov 18, 20258-K EDGAR
  14. Nov 13, 202510-Q EDGAR
  15. Nov 12, 20258-K EDGAR
  16. Aug 14, 202510-Q EDGAR
  17. Jul 18, 202525-NSE EDGAR
  18. May 15, 202510-Q EDGAR
  19. Apr 30, 20258-K EDGAR
  20. Apr 2, 20254 EDGAR

The 234 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

8 open-market trades by officers, directors and large owners since October 2021: 4 buys and 4 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 2, 2024Herskowitz NeilDirectorSale23$2.00$46Form 4
Nov 5, 2024KRANZLER JAY DDirectorSale61$2.24$137Form 4
Sep 30, 2024KRANZLER JAY DDirectorBuy497$2.50$1.2KForm 4
Sep 27, 2024KRANZLER JAY DDirectorBuy3$2.40$7Form 4
Dec 11, 2023Davidow Robert L10% ownerSale617,000$0.14$86.6KForm 4
Sep 8, 2023ROSENWALD LINDSAY A MDDirectorBuy348,675$0.72$251.0KForm 4
Sep 8, 2023Fortress Biotech, Inc.10% ownerBuy418,410$0.72$301.3KForm 4
Oct 11, 2022InvaGen Pharmaceuticals, Inc.10% ownerSale388,888$7.71$3.0MForm 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
2024Alexandra MacLean58$420.0K$840.1K60
2024David Jin35$155.3K60
2023Chief Executive Officer$400.0K$1.2M60
2023Interim Chief Financial Officer and Chief Operating Officer$260.0K60

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$242.5K 2023–2023
Money received by yearMoney received by year, 2023–2023: $242.5K in all. Private raises (Form D) $242.5K.$0$100K$200K$300K2023 · Private raises (Form D): $242.5K2023
Figures by year
YearPrivate raises (Form D)Total
2023$242.5K$242.5K

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.

  1. Jan 27, 2023Raised $242,537 in a private offering of securities30 Form D: 1 investor so far Form D

SEC filer profile

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

  • Name on EDGARAVENUE THERAPEUTICS, INC.1
  • CIK0001644963
  • Employer ID (EIN)47-41132754
  • 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 address1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 331541
  • Phone781-652-45001
  • Shares outstanding3,294,967 as of Aug 4, 202611
  • Public float$571.9K as of Jun 30, 20254
  • AuditorKPMG LLP, New York, NY PCAOB ID 185; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceDec 30, 20151
  • Filings423 in all: 8-K (119), 4 (74), 10-Q (29), CORRESP (28), 3 (21), UPLOAD (15), EFFECT (11), 10-K (9)1
    All 44 form types

    SC 13G (9), SC 13G/A (9), DEF 14A (8), DEFA14A (8), SC 13D/A (8), S-1/A (7), S-3 (7), 424B5 (6), 10-12G/A (4), 424B3 (4), S-1 (4), S-8 (4), DEF 14C (3), FWP (3), PRE 14C (3), SCHEDULE 13D/A (3), 10-12G (2), 424B4 (2), D (2), PRE 14A (2), RW (2), SC 13D (2), SCHEDULE 13G/A (2), 25-NSE (1), 4/A (1), 424B2 (1), 8-A12B (1), CERTNAS (1), CT ORDER (1), DEFM14A (1), DRS (1), POS AM (1), PREM14A (1), S-1MEF (1), S-3/A (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 30, 2026
    Quarterly report (10-Q) Aug 7, 2026
    Proxy statement (DEF 14A) Dec 5, 2025
    Latest 8-K (8-K) Feb 23, 2026

Securities registered for trading

ClassSymbolExchange
ATXI

From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks AVENUE THERAPEUTICS, INC. names in Item 1A of its 10-K filed Mar 30, 2026: 65 risks under these headings, as written.4

  • We have terminated our license agreement for AJ201 with AnnJi and disposed of our equity interest in Baergic and rights to BAER‑101, resulting in the loss of two of our primary product candidates. As a result, our product pipeline is limited and our prospects depend heavily on our ability to identify and develop new product candidates, and on the success of third parties over whom we have no control.
  • We currently have no drug products for sale, but we are developing two drug product candidates, ATX-04 and IV tramadol. We are dependent on the success of our current or future product candidates and cannot guarantee that these product candidates will receive regulatory approval or be successfully commercialized.
  • We may not receive regulatory approval for our current or future product candidates, or their approvals may be delayed, which would have a material adverse effect on our business and financial condition.
  • If serious adverse or unacceptable side effects are identified during the development of our current or future product candidates, we may need to abandon or limit our development of some of our current or future product candidates.
  • We may not be able to manage our business effectively if we are unable to attract and retain key personnel.
  • Our employees, consultants, or third-party partners may engage in misconduct or other improper activities, including those that result in noncompliance with certain regulatory standards and requirements, which could have a material adverse effect on 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 harm our business.
  • The use of artificial intelligence in the healthcare industry and challenges with properly managing its use could adversely affect our business.
  • We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • Certain of our directors currently serve, and in the past, certain officers and directors have served, in similar roles with our parent company, affiliates, related parties, and other parties with whom we transact business; ongoing and future relationships and transactions between these parties could result in conflicts of interest.
  • We have incurred significant losses since our inception. We expect to incur losses for the foreseeable future, and may never achieve or maintain profitability.
  • Our operating history makes it difficult to evaluate our business and prospects.
The other 53 risks
  • There is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.
  • We do not have any products that are approved for commercial sale and therefore do not expect to generate any revenues from product sales in the foreseeable future, if ever.
  • We will require substantial additional funding, which may not be available to us on acceptable terms, or at all. If we fail to raise the necessary additional capital, we may have to delay, reduce, or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish proprietary rights.
  • The delisting of our common stock from the Nasdaq Capital Market may continue to adversely affect the liquidity and trading price of our common stock and our ability to raise additional capital.
  • The OTC Pink Open Market is a thinly traded market lacking in liquidity, which could make it difficult for our stockholders to sell their shares of common stock and/or for us to raise additional funding.
  • Our stock price and trading volume on the OTC Pink Open Market is subject to price volatility unrelated to us or our operations, which could depress the market price of our common stock and result in rapid and substantial losses for our stockholders, who may lose all or part of their investment.
  • Our common stock may be considered a “penny stock” and, therefore, may be subject to certain rules that make it difficult for brokers, dealers, or investors to sell the shares.
  • The market for penny stocks has experienced numerous frauds and abuses, which could adversely impact investors in our common stock.
  • Volatility in our common stock price may subject us to securities litigation.
  • If any of our current or future product candidates are approved and our contract manufacturers fail to produce the products in the volumes that we require on a timely basis, to produce the products according to the applicable quality standards and requirements, or to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the commercialization of that product candidate, if approved, lose potential revenues, or be unable to meet market demand.
  • We rely, and expect to continue to rely, on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or complying with applicable regulatory requirements.
  • We contract with third parties for the manufacture of our product candidates for preclinical and clinical testing and expect to continue to do so for potential commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our current or future product candidates or products for which we obtain regulatory approval or such quantities at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts.
  • We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate, unreliable, or unacceptable to regulatory authorities.
  • The making, use, sale, importation, exportation, and distribution of controlled substances are subject to regulation by state, federal, and foreign law enforcement and other regulatory agencies.
  • If the DEA decides to reschedule tramadol from a Schedule IV controlled substance to a more restrictive Schedule, IV tramadol could lose its competitive advantage associated with having less burdensome regulatory requirements, and our related clinical development and regulatory approval could be delayed or prevented and, if approved, we could be subject to additional security requirements and quota system controls.
  • We may not receive regulatory approval for IV tramadol, or our approval may be significantly delayed due to scientific or regulatory reasons.
  • Even if one or more of our current or future product candidates receives regulatory approval, which may not occur, it will remain subject to substantial regulatory scrutiny.
  • We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.
  • Our current and future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
  • Regulatory approval for any approved product is limited by the FDA to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.
  • If the FDA does not conclude that a product candidate satisfies the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for such product candidate under Section 505(b)(2) are not as we expect, the approval pathway for the product candidate will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
  • Changes in U.S. government policy, regulation, enforcement priorities, and funding decisions could adversely affect our business, financial condition and results of operations.
  • Any products for which we receive approval may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which could harm our business.
  • Public concern regarding the safety of opioid drug products such as IV tramadol could delay or limit our ability to obtain regulatory approval for this product candidate, result in the inclusion of serious risk information in our labeling, negatively impact market performance, or require us to undertake other activities that may entail additional costs.
  • If we experience delays or difficulties in the enrollment of patients in any future clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • We expect intense competition for our current or future product candidates, and new products may emerge that provide different or better therapeutic alternatives for our targeted indications.
  • We face substantial competition from other pharmaceutical and biotechnology companies, many of which have significantly greater resources than we do.
  • If the government or third-party payors fail to provide adequate coverage and payment rates for our current or future product candidates, if approved, or if hospitals choose to use therapies that are less expensive, our potential revenue and prospects for profitability will be limited.
  • If none of our current or future product candidates, if approved, achieves broad market acceptance, the potential revenues that we generate from sales will be limited.
  • If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our current or future product candidates, if approved, we may not be successful in commercializing such product candidates if and when they are approved.
  • We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for our current or future product candidates and may have to limit their commercialization, if approved.
  • If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
  • The patent rights that we have in-licensed covering the infusion time and pharmacokinetics, or “PK”, profile for IV tramadol are limited to a specific IV formulation of centrally acting synthetic opioid analgesic, and our market opportunity for this product candidate may be limited by the lack of patent protection for the active ingredient itself and other formulations that may be developed by competitors.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming, and unsuccessful.
  • We may become involved in other types of legal proceedings related to our intellectual property that could result in the invalidation or unenforceability of our patents and could be expensive and time consuming, regardless of the outcome.
  • If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in any litigation would harm our business.
  • 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.
  • If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
  • To the extent we operate in foreign jurisdictions, we may be exposed to increased risk associated with the potential theft of technology and intellectual property.
  • We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Our results of operations and liquidity needs could be materially negatively affected by unfavorable global economic, political and market conditions, including geopolitical conflicts, trade restrictions, tariffs, economic downturn and other macroeconomic factors.
  • We will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
  • Our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity.
  • The occurrence of a catastrophic disaster could damage our facilities beyond insurance limits or we could lose key data which could cause us to curtail or cease operations.
  • We may become involved in securities class action litigation that could divert management’s attention and harm our business.
  • Changes in tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition, or results of operations.
  • Fortress controls a voting majority of our common stock.
  • Fortress has the right to receive a significant grant of shares of our common stock annually, which would result in the dilution of your holdings of common stock upon each grant, which could reduce their value.
  • We might have received better terms from unaffiliated third parties than the terms we receive in our agreements with Fortress.
  • The ownership by our executive officers and some of our directors of equity securities of Fortress and/or rights to acquire equity securities of Fortress might create, or appear to create, conflicts of interest.
  • Fortress’ current or future financial obligations and arrangements, or an event of default thereon, may change the ownership dynamic of us by Fortress.

Legal proceedings

To our knowledge, there are no material legal proceedings pending against us, other than routine actions and administrative proceedings, and other actions we have deemed not material and not expected to have, individually or in the aggregate, a material adverse effect on our financial condition, results of operations, or cash flows. In the ordinary course of business, however, the Company may be subject to both insured and uninsured litigation. Suits and claims may be brought against the Company by customers, suppliers, partners, and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, negligence and other matters, and seeking resulting alleged damages.

The opening of Item 3, Legal Proceedings.4

Sources

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    SEC EDGAROther events
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