PMCB on Nasdaq

PharmaCyte Biotech, Inc.

PharmaCyte Biotech, Inc. is an American biological products company based in Las Vegas, incorporated in Nevada.1 Its shares trade on Nasdaq under the symbol PMCB.1

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Last updated Oct 21, 2026.

Overview

$0Revenue, fiscal 20262
-$19.4MNet income, fiscal 20262

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  • TickerPMCB on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersLas Vegas, Nevada1
  • Incorporated inNV3
  • Business address3960 Howard Hughes Parkway, Suite 500, Las Vegas, Nv 891693
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

Conduct a stability study on our final formulated product candidate as well as the cells from our Master Cell Bank (“MCB”);5 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 2026

-58.3%Return on equity2

Financial statements

Revenue678910112$0 in 2026
02019: $0$020192020: $0$020202021: $0$020212022: $0$020222023: $0$020232024: $0$020242025: $0$020252026: $0$02026
Operating income678910112-$6.9M in 2026+67% since 2019
-$10.0M-$7.5M-$5.0M-$2.5M02019: -$4.1M-$4.1M20192020: -$3.8M-$3.8M2020−7%2021: -$3.6M-$3.6M2021−5%2022: -$4.4M-$4.4M2022+21%2023: -$6.5M-$6.5M2023+47%2024: -$8.5M-$8.5M2024+32%2025: -$4.4M-$4.4M2025−49%2026: -$6.9M-$6.9M2026+57%
Net income678910112-$19.4M in 2026+378% since 2019
-$20.0M0$20.0M$40.0M2019: -$4.1M-$4.1M20192020: -$3.8M-$3.8M2020−6%2021: -$3.6M-$3.6M2021−7%2022: -$4.2M-$4.2M2022+19%2023: -$4.3M-$4.3M2023+2%2024: $333.8K$333.8K20242025: $30.7M$30.7M2025+9085%2026: -$19.4M-$19.4M2026

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

Period ending2026-04-302025-04-30
Revenue$0$0
Research and development costs$391.3K$438.4K
Intangible asset impairment$1.5M$0
General and administrative$4.9M$3.9M
Total operating expenses$6.9M$4.4M
Loss from operations-$6.9M-$4.4M
Interest income$733.4K$1.4M
Dividend income$380.7K$0
Change in fair value of warrant liability-$4.7M$10.4M
Change in fair value of derivative liability$1.1M$2.2M
Change in fair value of convertible note receivable Femasys$1.3M$941.0K
Change in fair value of warrant asset Femasys-$2.6M-$2.1M
Change in fair value of investment QCLS-$7.7M$5.1M
Change in fair value of warrant assets QCLS-$1.4M-$2.4M
Gain on related party investment QCLS$2.1M$21.4M
Gain on legal settlement re-fair value of warrants$106.0K$0
Issuance costs Series C convertible preferred stock and warrants-$1.2M$0
Unrealized gain (loss) on marketable securities-$412.3K$66.3K
Loss on legal settlement$0-$2.0M
Loss on issuance of Series C preferred stock-$215.0K$0
Other expense, net-$980-$965
Total other income (expense), net-$12.6M$35.0M
Income tax benefit (expense)$0$0
Net income (loss)-$19.4M$30.7M
Preferred stock dividends-$278.5K-$1.1M
Undistributed income to Series B convertible preferred stock$0-$3.0M
Preferred stock accretion-$3.5M-$3.2M
Net income (loss) attributable to common stockholders-$23.2M$23.4M
Basic income (loss) per share attributable to common stockholders-$2.77$3.19
Diluted income (loss) per share attributable to common stockholders-$2.77$3.19
Weighted average shares outstanding basic8.4M shares7.3M shares
Weighted average shares outstanding diluted8.4M shares7.3M shares

Compare PharmaCyte Biotech, Inc. with another company

Corporate structure

PharmaCyte Biotech, Inc. sits at the top of its group. 6 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of PharmaCyte Biotech, Inc.

  • INTRACOASTAL CAPITAL, LLC Filed SCHEDULE 13G/A on PharmaCyte Biotech, Inc., latest Feb 13, 2026 (7 filings since Feb 11, 2022)
  • Ayrton Capital LLC Filed SCHEDULE 13G/A on PharmaCyte Biotech, Inc., latest Feb 13, 2025 (3 filings since May 19, 2023)
  • Iroquois Capital Management, LLC Filed SC 13D/A on PharmaCyte Biotech, Inc., latest Jun 16, 2023 (6 filings since Nov 4, 2021)
  • Shay Capital LLC Filed SC 13G/A on PharmaCyte Biotech, Inc., latest Feb 14, 2023 (2 filings since Oct 20, 2022)
  • SABBY MANAGEMENT, LLC Filed SC 13G/A on PharmaCyte Biotech, Inc., latest Jan 10, 2023 (2 filings since Jan 4, 2022)
  • PharmaCyte Biotech, Inc. Las Vegas, Nevada
    • FEMASYS INC Stake · Suwanee, Georgia
    • Q/C TECHNOLOGIES, INC. Stake · New York, New York
    • PharmaCyte Biotech Australia Pty. Ltd. Subsidiary · Australia
    • PharmaCyte Biotech Europe Limited Subsidiary · Ireland
    • Viridis Biotech, Inc. Subsidiary · Nevada, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G; stakes of 5% or more it reported on Schedules 13D and 13G (2 companies). Each entity in the chart links to its source.

What it owns

What PharmaCyte Biotech, 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$18.6M2 Apr 30, 2026$15.2M2 Apr 30, 2025+22.6%
Marketable securities, current$254.0K2 Apr 30, 2026$366.3K2 Apr 30, 2025−30.7%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$02 Apr 30, 2026$1.5M2 Apr 30, 2025−100.0%

Properties, in its own words

Our principal office is located at 3960 Howard Hughes Parkway, Suite 500, Las Vegas, Nevada 89169 and we lease this space on a month-to-month arrangement. This space consists of approximately 100 square feet of office space plus the use of certain shared facilities, such as a lobby, conference rooms, a kitchen and open workspaces. We believe this space will be adequate for our operations for the foreseeable future.

Item 2 of the 10-K filed Jul 29, 2026.5

Leadership

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

Chief executive

  1. Kenneth Waggoner2021
2010201520202025
Board members and other officers (13)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorJoshua N. Silverman named Sep 4, 202528
  • DirectorRobert M. Weinstein named Sep 4, 202528
  • DirectorWalker R. Wayne named Sep 4, 202528

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • PharmaCyte Biotech Australia Pty. Ltd. Australia4
  • PharmaCyte Biotech Europe Limited Ireland4
  • Viridis Biotech, Inc. Nevada, USA4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • NUVILEX, INC.Mar 26, 2009 to Jan 9, 20153
  • EFOODSAFETY COM INCAug 20, 2001 to Mar 17, 20093

Timeline

  1. Apr 2, 20268-K Executive or director change; Shareholder vote29
  2. Dec 5, 20258-K Listing notice or transfer30
  3. Nov 18, 20258-K Financial statements and exhibits31
  4. Oct 31, 20258-K Executive or director change; Shareholder vote32
  5. Sep 5, 20258-K Entered a material agreement; Completed an acquisition or sale; Regulation FD disclosure33
  6. Aug 18, 20258-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure34
  7. Apr 24, 20258-K Shareholder vote35
  8. Feb 26, 20258-K Change of auditor36
  9. May 23, 20248-K Entered a material agreement; Completed an acquisition or sale; Other events37
  10. May 1, 20248-K Shareholder vote38
  11. Nov 24, 20238-K Executive or director change39
  12. Nov 16, 20238-K Entered a material agreement; Other events40
  13. Aug 31, 2021New chief executive Kenneth Waggoner becomes CEO15

Calendar

When it reported results

  1. Jul 11, 2022Reported quarterly or annual results41

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

Filings

166 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 35 major events, 35 insider forms, 20 large holders, 1 private raises, 55 other. The latest 20:

  1. Sep 14, 202610-Q FORM 10-Q FOR JUL 2026 EDGAR
  2. Jul 29, 202610-K FORM 10-K FOR APRIL 2026 EDGAR
  3. Jul 17, 20264/A EDGAR
  4. Jul 17, 20264/A EDGAR
  5. Jul 17, 20264/A EDGAR
  6. Jul 17, 20264/A EDGAR
  7. Apr 2, 20264 EDGAR
  8. Apr 2, 20264 EDGAR
  9. Apr 2, 20264 EDGAR
  10. Apr 2, 20264 EDGAR
  11. Apr 2, 20268-K EDGAR
  12. Mar 17, 202610-Q FORM 10-Q FOR JAN 2026 EDGAR
  13. Mar 9, 2026ARS ANNUAL REPORT EDGAR
  14. Mar 9, 2026DEF 14A DEFINITIVE PROXY STATEMENT EDGAR
  15. Feb 27, 2026PRE 14A PRELIMINARY PROXY STATEMENT EDGAR
  16. Feb 13, 2026SCHEDULE 13G/A EDGAR
  17. Jan 7, 20264 EDGAR
  18. Jan 7, 20264 EDGAR
  19. Dec 18, 202510-Q FORM 10-Q FOR OCT 2025 EDGAR
  20. Dec 15, 2025NT 10-Q EXTENSION EDGAR

The 166 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

6 open-market trades by officers, directors and large owners since October 2021: 6 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 7, 2026Silverman JoshuaCEO and PresidentBuy40,000$0.83$33.2KForm 4
Jan 7, 2026SCHECHTER JONATHANDirectorBuy20,000$0.84$16.8KForm 4
Jan 6, 2026Silverman JoshuaCEO and PresidentBuy30,000$0.79$23.7KForm 4
Jan 6, 2026SCHECHTER JONATHANDirectorBuy20,000$0.79$15.8KForm 4
Jan 5, 2026Silverman JoshuaCEO and PresidentBuy30,000$0.78$23.4KForm 4
Jan 5, 2026SCHECHTER JONATHANDirectorBuy20,000$0.78$15.6KForm 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.

Stakes it holds

PharmaCyte Biotech, Inc. has told the SEC it owns more than 5% of 2 companies, latest first (Schedules 13D and 13G).

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
2025Joshua N. SilvermanChief Executive55$375.0K$520.3K49
2025Carlos A. TrujilloChief Financial$380.0K$482.0K49
2024Officer and President$375.0K$829.6K49
2024Officer$380.0K$636.1K49

Money raised

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

  1. Aug 17, 2025Raised $7 million in a private offering of equity Form D: 12 investors so far 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 27. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Citadel Advisors LLC283,381$218.2K0.0%−76,166
Geode Capital Management, LLC124,247$95.7K0.0%−71,413
Vanguard Capital Management LLC56,778$43.7K0.0%+5,311
Susquehanna International Group, Llp44,853$34.5K0.0%New
Renaissance Technologies LLC37,987$29.2K0.0%−18,513
XTX Topco Ltd34,180$26.3K0.0%−18,182
Northern Trust Corp32,624$25.1K0.0%−2,977
Jane Street Group, LLC30,064$23.1K0.0%+18,534
Schonfeld Strategic Advisors LLC26,926$20.7K0.0%−83
Vanguard Fiduciary Trust Co23,452$18.1K0.0%No change
Equitec Proprietary Markets, LLC22,227$17.1K0.0%No change
Commonwealth Equity Services, LLC20,255$15.6K0.0%+9,942
Tower Research Capital LLC (TRC)4,888$3.8K0.0%−1
UBS Group AG4,142$3.2K0.0%−377
Group One Trading LLC500$3850.0%−1,285
Osaic Holdings, Inc.303$2320.0%+1
Barclays PLC192$1480.0%New
Hrt Financial LP15,451$110.0%−9,290
Sachetta, LLC14$110.0%No change
SBI Securities Co., Ltd.6$50.0%+3
Bfsg, LLC5$40.0%No change
Morgan Stanley2$20.0%+1
Financial Consulate, Inc2$20.0%No change
NewEdge Advisors, LLC2$20.0%No change
Johnson Financial Group, Inc.1$10.0%No change

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

SEC filer profile

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

  • Name on EDGARPharmaCyte Biotech, Inc.1
  • CIK0001157075
  • Employer ID (EIN)62-17721515
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company5
  • Incorporated inNevada5
  • Fiscal year endsApril 301
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address3960 Howard Hughes Parkway, Suite 500, Las Vegas, NV 891691
  • Phone(917) 595.28501
  • Shares outstanding10,735,649 as of Sep 11, 202614
  • Public float$6.3M as of Oct 31, 20255
  • AuditorCBIZ CPAs P.C, Morristown, New Jersey PCAOB ID 199; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceAug 20, 20011
  • Filings471 in all: 8-K (103), 10-Q (56), UPLOAD (29), CORRESP (26), 4 (25), 3 (19), 10-K (18), 10QSB (16)1
    All 50 form types

    NT 10-K (15), NT 10-Q (14), 10-Q/A (11), 8-K/A (9), 10-K/A (7), DEF 14A (7), DEFA14A (7), SC 13G/A (7), 10KSB (6), 424B5 (6), EFFECT (6), S-3 (6), SC 13D/A (6), 10QSB/A (5), PRE 14A (5), SC 13G (5), 4/A (4), D (4), DFAN14A (4), S-3/A (4), SB-2/A (4), SC 13D (4), SCHEDULE 13G/A (4), 424B3 (3), ARS (3), S-8 (3), S-8 POS (3), CT ORDER (2), SB-2 (2), 10KSB/A (1), 424B2 (1), 425 (1), 8-A12B (1), CERT (1), NTN 10K (1), NTN 10Q (1), PREC14A (1), S-3MEF (1), SC TO-I (1), SC TO-I/A (1), SCHEDULE 13D/A (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Jul 29, 2026
    Quarterly report (10-Q) Sep 14, 2026
    Proxy statement (DEF 14A) Mar 9, 2026
    Latest 8-K (8-K) Apr 2, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, Par Value $0.0001 Per SharePMCBNasdaq

From the cover page of the 10-K filed Jul 29, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks PharmaCyte Biotech, Inc. names in Item 1A of its 10-K filed Jul 29, 2026: 73 risks under these headings, as written.5

  • In addition, you should carefully consider these risks when you read “forward-looking” statements elsewhere in this Report. These are statements that relate to our expectations for future events and time periods. Generally, the words “anticipate,” “expect,” “intend,” and similar expressions identify forward-looking statements. Forward-looking statements involve risks and uncertainties, and future events and circumstances could differ significantly from those anticipated in the forward-looking statements.
  • Forward-Looking Statements and Associated Risks
  • Risks Related to Our Financial Position, FDA Clinical Hold, Need for Additional Capital and Overall Business
  • We are a biotechnology company with limited resources, a limited operating history, and no products approved for clinical trials or commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.
  • As a result of the clinical hold that has been placed on our IND by the FDA, it has taken and may continue to take considerable time and expense to respond to the FDA and no assurance can be given that the FDA will remove the clinical hold in which case our business and prospects will likely suffer material adverse consequences.
  • U.S. government shutdowns, reductions in FDA staffing and funding, or other disruptions to FDA operations could further delay the lifting of the clinical hold on our IND and materially harm our business.
  • We contract with Austrianova for the manufacture of our product candidates for preclinical studies and clinical trials, if allowed to proceed, and expect to continue to do so for commercialization. This reliance on Austrianova increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • If we are unable to successfully raise additional capital, our future clinical trials and product development could be limited, and our long-term viability may be threatened.
  • Due to the significant resources required for the development of our programs, and depending on our ability to access capital, we must prioritize development of certain product candidates. We may expend our limited resources on programs that do not yield a successful product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We currently have no commercial revenue and may never become profitable.
  • We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.
  • Our future revenues are unpredictable which causes potential fluctuations in operating results.
The other 62 risks
  • We may be unable to adequately protect our information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure.
  • Risks Related to Regulatory Matters
  • If we are unable to obtain, or if there are delays in obtaining, required approval from the applicable regulatory agencies, we will not be able to commercialize our product candidates and our ability to generate revenue will be materially impaired.
  • If allowed to proceed with our clinical development programs, we intend to conduct clinical trials for certain of our product candidates at sites outside of the U.S., and the U.S. regulatory agencies may not accept data from trials conducted in such locations.
  • Our plan to first pursue a clinical trial before a pivotal Phase 3 trial will likely result in additional costs to us and resultant delays in the FDA review process and any future commercialization and marketing if regulatory approval is obtained.
  • Development of a biologic involves a lengthy and expensive process with an uncertain outcome. We may incur additional costs or experience delays in completing or be unable to complete the development and commercialization of our product candidates.
  • We are seeking FDA approval to commence clinical trials in the U.S. of certain of our product candidates based on clinical data that was obtained in trials conducted outside the U.S., and it is possible that the FDA may not accept data from trials conducted in such locations or conducted nearly 20 years ago.
  • Results in previous clinical trials of our encapsulated live cell and ifosfamide combination for pancreatic cancer may not be replicated in future clinical trials which could result in development delays or a failure to obtain marketing approval.
  • The review processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable. If we are unable to obtain approval for our drug candidates from applicable regulatory authorities, we will not be able to market and sell those drug candidates in those countries or regions and our business could be substantially harmed.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, we may not achieve our clinical development timeline and our receipt of necessary regulatory approvals could be delayed or prevented.
  • We may request priority review for our product candidates in the future. FDA may not grant priority review for any of our product candidates. Moreover, even if FDA designated such products for priority review, that designation may not lead to a faster regulatory review or approval process and, in any event, does not assure regulatory approval of the product.
  • In some instances, we believe we may be able to secure approval from FDA to use accelerated development pathways. If we are unable to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate which could increase the expense of obtaining and delay the receipt of necessary marketing approvals.
  • We currently have Orphan Drug designation for our product candidate for the treatment of pancreatic cancer, and may seek Orphan Drug designation for additional product candidates, and we may be unsuccessful in obtaining or maintaining such designations.
  • A Fast Track by the FDA or similar designation by another regulatory agency, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
  • A Breakthrough Therapy designation by the FDA or similar designation by another regulatory agency, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
  • Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.
  • Any product candidate for which we obtain marketing approval will be subject to extensive post-marketing regulatory requirements and could be subject to post-marketing restrictions or withdrawal from the market. We may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of our product candidates are approved.
  • Biologics carry unique risks and uncertainties, which could have a negative impact on future results of operations.
  • Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, substantial civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Recently enacted and future legislation could increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
  • Even if we are able to commercialize any of our drug candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business.
  • Risks Related to the Commercialization of Our Product Candidates
  • Serious adverse events or undesirable side effects or other unexpected properties of our encapsulated live cell plus ifosfamide product candidate or any of our other product candidates may be identified during development that could delay or prevent the product candidates’ marketing approval.
  • Even if one of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third party payors and others in the medical community necessary for commercial success and the market opportunity for the product candidate may be smaller than we anticipated.
  • If any of our product candidates receives marketing approval and we or others later discover that the therapy is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the therapy could be compromised.
  • If we are unable to establish sales, marketing and distribution capabilities or enter acceptable sales, marketing and distribution arrangements with third parties, we may not be successful in commercializing any product candidate that we develop when a product candidate is approved.
  • Risks Related to Our Dependence on Third Parties
  • We rely heavily on third parties to conduct our preclinical studies and plan to rely on third parties to conduct our clinical trials, assuming they are allowed to proceed, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such studies and trials.
  • Future preclinical and clinical development collaborations may be important to us. If we are unable to maintain these collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • We rely on Prof. Günzburg and Dr. Salmons for the development of our product candidates. If they decide to terminate their relationship with us, we may not be successful in the development of our product candidates.
  • The manufacture of our product candidates is complex, and difficulties may be encountered in production. If such difficulties are encountered or failure to meet regulatory standards occurs, our ability to provide supply of our product candidates for clinical trials, if allowed to proceed, or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
  • Risks Related to our Intellectual Property
  • We may not be able to protect our intellectual property rights throughout the world.
  • Our intellectual property and data and market exclusivity may not be sufficient to block others from commercializing identical or competing products.
  • If we are unable to obtain and maintain intellectual property protection for our technology and product candidates, or if the scope of the intellectual property 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.
  • If we do not obtain patent and/or data exclusivity for our product candidates, our business may be materially harmed.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • If we breach any of our license or collaboration agreements, it could compromise our development and commercialization efforts for our product candidates.
  • 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.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • We may not be successful in obtaining or maintaining necessary rights for its development pipeline through acquisitions and licenses from third parties.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • 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.
  • Any trademarks we have obtained or may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Risks Related to Our Business Model and Operations
  • Development of brand awareness is critical to our success.
  • Rapid advances in artificial intelligence by our competitors and third parties may place us at a competitive disadvantage, and the use of AI technologies by our employees, consultants, or service providers could expose us to additional risks.
  • Any weakness in our internal controls could have a material adverse effect on us.
  • The insurance coverage and reimbursement status of newly approved products are uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
  • Our employees, consultants and independent contractors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could subject us to significant liability and harm our reputation.
  • Our transactions and relationships outside the U.S. will be subject to the FCPA and similar anti-bribery and anti-corruption laws.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • We incur increased costs because of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.
  • You may experience future dilution as a result of future equity offerings.
  • We are not currently in compliance with the continued listing requirements for Nasdaq, and if we are unable to regain compliance, our common stock could be delisted from Nasdaq or another nationally recognized stock exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
  • Nasdaq’s recently adopted minimum Market Value of Listed Securities requirement of $5 million could result in the suspension and delisting of our common stock from Nasdaq.
  • Our outstanding Series C Convertible Preferred Stock has dividend, liquidation, redemption, anti-dilution and voting rights that are senior to, or could dilute, the rights of holders of our common stock, and we may issue additional shares of preferred stock, which may limit your rights as a holder of our common stock.
  • We may experience volatility in our stock price, which may adversely affect the trading price of our common stock.
  • The price of our common stock is volatile, which substantially increases the risk that our investors may not be able to sell their shares at or above the price that the investors have paid for their shares.
  • We have no plans to pay dividends in the foreseeable future, and investors may not expect a dividend as a return of or on any investment in us.
  • We are a “smaller reporting company” under the Commission’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.
  • As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act.
  • We face risks related to owning securities issued by other public companies.
  • Our ownership of securities of other companies creates a risk that we will be categorized as an investment company that is subject to registration under the Investment Company Act of 1940 (the “1940 Act”). If we are deemed to be an investment company under the 1940 Act, we may be required to institute burdensome compliance requirements and our activities may be restricted, which may make it difficult for us to continue operating our business.
  • Risks Related to Employee and Tax Matters, Managing Growth and Macroeconomic Conditions
  • We have experienced significant management changes which could increase our control risks and have a material adverse effect on our ability to do business and our results of operations.

Legal proceedings

From time to time, we are subject to legal proceedings and claims, either asserted or unasserted, that arise in the ordinary course of business. While the outcome of pending claims cannot be predicted with certainty, we do not believe that the outcome of any potential claims will have a material adverse effect on our financial condition or operating results.

On May 16, 2025, we entered into a settlement and release agreement (“Settlement Agreement”) with H.C. Wainwright & Co., LLC relating to a complaint filed on December 4, 2023, alleging a breach of contract. The Settlement Agreement resolved fully all differences, disputes or claims without admitting any liability, fault or wrongdoing on the part of all parties. The Settlement Agreement required us to pay $1.55 million, comprised of an initial payment of $1.25 million and twelve equal payments of $25,000 beginning on the one-month anniversary of the initial payment. On May 16, 2025, we also issued warrants “(First Warrant Issuance”) to purchase 343,183 shares of our common stock with an exercise price of $4.00 per share with a term of five years from the issuance date. On July 29, 2025, we issued additional warrants (“Additional Warrants”) to purchase 313,067 shares of our common stock with an exercise price of $4.00 per share with a term of five years from the issuance date. The exercise price of the First Warrant Issuance and the Additional Warrants were repriced at $0.9516 per share.

To our knowledge, there are no other material legal proceedings pending against us or any material litigation against any of our officers or directors in their capacity as such, and no such litigation is contemplated by any governmental authorities.

The opening of Item 3, Legal Proceedings.5

Sources

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