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Theriva Biologics, Inc.

In its 2026 annual report the company says: “We are a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need.”3 It is headquartered in Rockville, Maryland.1 Its shares trade on NYSE under the symbol TOVX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTOVX on NYSE1
  • IndustryPharmaceutical Preparations1
  • HeadquartersRockville, Maryland1
  • Incorporated inNV2
  • Business address9605 Medical Center Drive, Suite 270, Rockville, Md 208502
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We are a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. As a result of the Company’s acquisition of Theriva Biologics, S.L. (“VCN”, formerly named VCN Biosciences, S.L.), in March 2022, as described in more detail below (the “Acquisition”), we transitioned our strategic focus to oncology through the development of VCN’s new oncolytic adenovirus platform designed for intravenous and intravitreal delivery to trigger tumor cell death, to improve access of co-administered cancer therapies to the tumor, and to promote a robust and sustained anti-tumor response by the patient’s immune system. Our lead product candidate, VCN - 01 (zabilugene almadenorepvec), is a clinical stage oncolytic human adenovirus that is modified for tumor - selective replication and to express an enzyme, PH20 hyaluronidase. VCN - 01 …3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Financial statements

Operating income456789-$24.1M in 2025+54% since 2019
-$30.0M-$20.0M-$10.0M02019: -$15.7M-$15.7M20192020: -$10.2M-$10.2M2020−35%2021: -$14.3M-$14.3M2021+40%2022: -$21.6M-$21.6M2022+51%2023: -$21.4M-$21.4M2023−1%2024: -$26.3M-$26.3M2024+23%2025: -$24.1M-$24.1M2025−9%
Net income45679-$23.7M in 2025+55% since 2019
-$30.0M-$20.0M-$10.0M02019: -$15.3M-$15.3M20192020: -$10.0M-$10.0M2020−34%2021: -$14.3M-$14.3M2021+42%2022: -$19.7M-$19.7M2022+38%2023: -$18.3M-$18.3M2023−7%2024: -$25.7M-$25.7M2024+40%2025: -$23.7M-$23.7M2025−7%

Every line of the income statement as filed: the last 2 fiscal years, latest first.9

Period ending2025-12-312024-12-31
General and administrative$15.4M$7.4M
Research and development$8.6M$12.0M
In-process research and development impairment$0$1.3M
Goodwill impairment$5.6M
Total Operating Costs and Expenses$24.1M$26.3M
Loss from Operations-$24.1M-$26.3M
Foreign currency exchange gain (loss)$25.0K-$4.0K
Interest income$287.0K$697.0K
Total Other Income$312.0K$693.0K
Net Loss before income taxes-$23.7M-$25.7M
Net Loss-$23.7M-$25.7M
Less deemed dividend from warrant inducement-$1.5M
Net Loss Attributable to Common Stockholders-$25.2M-$25.7M
Net Loss Per Share - Basic (in dollars per share)-$2.08-$19.03
Net Loss Per Share - Dilutive (in dollars per share)-$2.08-$19.03
Weighted average number of shares outstanding during the period - Basic (in shares)12.1M shares1.3M shares
Weighted average number of shares outstanding during the period - Dilutive (in shares)12.1M shares1.3M shares
Gain (loss) on foreign currency translation$1.9M-$1.2M
Total comprehensive loss-$21.8M-$26.9M

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Corporate structure

Theriva Biologics, 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 Theriva Biologics, Inc.

  • Theriva Biologics, Inc. Rockville, Maryland

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

What it owns

What Theriva Biologics, 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$1.2M9 Dec 31, 2025$1.2M9 Dec 31, 2024−1.4%
Accumulated depreciation$966.0K9 Dec 31, 2025$935.0K9 Dec 31, 2024+3.3%
Property and equipment, net$222.0K9 Dec 31, 2025$270.0K9 Dec 31, 2024−17.8%
Operating-lease assets (leased space)$803.0K9 Dec 31, 2025$1.3M9 Dec 31, 2024−36.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$13.1M9 Dec 31, 2025$11.6M9 Dec 31, 2024+12.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$08 Dec 31, 2024$5.7M9 Dec 31, 2023−100.0%
Intangible assets, net (excluding goodwill)$19.6M9 Dec 31, 2025$17.4M9 Dec 31, 2024+13.0%
Indefinite-lived intangibles (excluding goodwill)$19.8M9 Sep 30, 2024
Finite-lived intangibles, net$19.8M8 Sep 30, 2024

Properties, in its own words

Our corporate headquarters are located at 9605 Medical Center Drive, Suite 270, Rockville, Maryland, where we occupy approximately 10,363 square feet of office space under a lease agreement expiring December 31, 2027, with monthly rent of $28,001. Our Spanish subsidiary Theriva Biologics S.L. (formerly VCN Biosciences S.L.) currently leases approximately 8,611 square feet of office and laboratory space office space from Grifols in Parets de Vallès, Barcelona, Spain with a rent of $27,054 per month. This lease was executed for an initial term beginning in January 2023 until October 2026, with an option to renew for an additional five years.

We do not own any real property. We believe that we have adequate space for our anticipated needs and that suitable additional space will be available at commercially reasonable prices as needed.

Item 2 of the 10-K filed Mar 12, 2026.3

Leadership

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

Chief executive

  1. Michael F. Manion2006
  2. Steve H. Kanzer2006–2008
  3. Nicholas Stergis2008
  4. Lyman Max Lyon Jr.2009
  5. James S. Kuo2010–2011
  6. Steven A. Shallcross2017–now

Chair

  1. Steve H. Kanzer2009
  2. James S. Kuo2010–2011

President

  1. Michael F. Manion2006
  2. Charles Bisgaier Phd.2007
  3. Lyman Max Lyon Jr.2009
  4. James S. Kuo2010–2011

Chief financial officer

  1. Charles Evan Ballantyne2012–2015
  2. Steven A. Shallcross2015–now

Chief operating officer

  1. Francis Tufaro2022
2010201520202025
Board members and other officers (15)

Former names

  • Synthetic Biologics, Inc.Mar 12, 2012 to Oct 12, 20222
  • ADEONA PHARMACEUTICALS, INC.Aug 26, 2008 to Feb 17, 20122
  • PIPEX PHARMACEUTICALS, INC.Dec 14, 2006 to Oct 16, 20082
  • SHEFFIELD PHARMACEUTICALS INCSep 10, 1997 to Dec 8, 20062
  • SHEFFIELD MEDICAL TECHNOLOGIES INCMay 7, 1996 to May 14, 19972

Timeline

  1. Aug 11, 20268-K Results of operations37
  2. Aug 6, 20268-K Regulation FD disclosure; Other events38
  3. Aug 4, 20268-K Executive or director change; Shareholder vote39
  4. Jul 7, 20268-K Regulation FD disclosure; Other events40
  5. Jun 11, 20268-K Regulation FD disclosure; Other events41
  6. Jun 5, 20268-K Other events42
  7. May 5, 20268-K Results of operations43
  8. Apr 17, 20268-K Regulation FD disclosure; Other events44
  9. Apr 9, 20268-K Other events45
  10. Mar 23, 20268-K Regulation FD disclosure; Other events46
  11. Mar 12, 20268-K Results of operations47
  12. Feb 18, 20268-K Entered a material agreement; Regulation FD disclosure48
  13. Dec 21, 2017New chief executive Steven A. Shallcross becomes CEO12
  14. Mar 3, 2010New chief executive James S. Kuo becomes CEO13
  15. Aug 3, 2009New chief executive Lyman Max Lyon Jr. becomes CEO14
  16. Jul 14, 2008New chief executive Nicholas Stergis becomes CEO15
  17. Nov 13, 2006New chief executive Steve H. Kanzer becomes CEO17
  18. Aug 11, 2006New chief executive Michael F. Manion becomes CEO16

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/202649

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results37
  2. May 5, 2026Reported quarterly or annual results43
  3. Mar 12, 2026Reported quarterly or annual results47
  4. Nov 12, 2025Reported quarterly or annual results50
  5. Aug 11, 2025Reported quarterly or annual results51
  6. May 14, 2025Reported quarterly or annual results52
  7. Mar 6, 2025Reported quarterly or annual results53
  8. Nov 12, 2024Reported quarterly or annual results54

Drug trials and FDA: coming up

  1. Aug 1, 2027Phase 1/2 trial readout expected Phase 1/2 trial of VCN-01 oncolytic adenovirus (zabilugene almadenorepvec) and Nab-paclitaxel + Gemcitabine in Pancreas Cancer, Metastatic: primary completion expected Aug 1, 2027 (ClinicalTrials.gov NCT07701486).55

Drug trials and FDA: recently

  1. Mar 28, 2025Phase 2 trial completed Phase 2 trial of Nab-paclitaxel, Gemcitabine and others in Pancreatic Adenocarcinoma: primary completion Mar 28, 2025, results posted Oct 8, 2026 (ClinicalTrials.gov NCT05673811).56

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

242 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 103 major events, 29 insider forms, 9 large holders, 3 private raises, 78 other. The latest 20:

  1. Oct 9, 2026PRE 14A EDGAR
  2. Aug 24, 2026S-8 EDGAR
  3. Aug 11, 202610-Q EDGAR
  4. Aug 11, 20268-K EDGAR
  5. Aug 6, 20268-K EDGAR
  6. Aug 4, 20268-K EDGAR
  7. Jul 7, 20268-K EDGAR
  8. Jun 29, 2026ARS EDGAR
  9. Jun 29, 2026DEF 14A EDGAR
  10. Jun 18, 2026PRE 14A EDGAR
  11. Jun 11, 20268-K EDGAR
  12. Jun 5, 20268-K EDGAR
  13. May 5, 202610-Q EDGAR
  14. May 5, 20268-K EDGAR
  15. Apr 30, 2026DEF 14A EDGAR
  16. Apr 20, 2026PRE 14A EDGAR
  17. Apr 17, 20268-K EDGAR
  18. Apr 9, 20268-K EDGAR
  19. Mar 23, 20268-K EDGAR
  20. Mar 16, 2026DEF 14A EDGAR

The 242 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

7 open-market trades by officers, directors and large owners since October 2021: 7 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 7, 2023SHALLCROSS STEVEN ACEO and CFOBuy14,000$0.69$9.7KForm 4
Jun 6, 2023SHALLCROSS STEVEN ACEO and CFOBuy26,000$0.63$16.4KForm 4
Feb 10, 2023SHALLCROSS STEVEN ACEO and CFOBuy25,000$1.04$26.0KForm 4
Feb 2, 2023SHALLCROSS STEVEN ACEO and CFOBuy25,000$0.94$23.5KForm 4
Jan 25, 2023SHALLCROSS STEVEN ACEO and CFOBuy25,000$0.87$21.8KForm 4
Jan 20, 2023SHALLCROSS STEVEN ACEO and CFOBuy25,000$0.75$18.8KForm 4
Dec 29, 2022SHALLCROSS STEVEN ACEO and CFOBuy100,000$0.44$44.0KForm 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
2025Steven ShallcrossChief Executive Officer and Chief Financial Officer64$667.5K$564
2024Steven ShallcrossChief Executive Officer and Chief Financial Officer64$645.0K$564

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$17.6M 2022–2025
Money received by yearMoney received by year, 2022–2025: $17.6M in all. Private raises (Form D) $17.6M.$0$5M$10M$15M2022 · Private raises (Form D): $4.5M2022202320242025 · Private raises (Form D): $13.1M2025
Figures by year
YearPrivate raises (Form D)Total
2025$13.1M$13.1M
2022$4.5M$4.5M

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. Oct 17, 2025Raised $13.1 million in a private offering of securities65 Form D: 10 investors so far Form D
  2. Jul 29, 2022Raised $3 million in a private offering of equity66 Form D: 1 investor so far Form D
  3. Mar 10, 2022Raised $1.5 million in a private offering of equity67 Form D: 4 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 26. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC486,179$121.5K0.0%+293,775
Jane Street Group, LLC331,922$83.0K0.0%+154,888
Geode Capital Management, LLC294,021$73.6K0.0%−156,242
Vanguard Fiduciary Trust Co241,780$60.4K0.0%No change
Ikarian Capital, LLC112,076$28.0K0.0%No change
Northern Trust Corp82,700$20.7K0.0%New
Renaissance Technologies LLC63,710$15.9K0.0%New
UBS Group AG61,053$15.3K0.0%−164,571
XTX Topco Ltd53,868$13.5K0.0%−40,752
Ground Swell Capital, LLC35,292$8.8K0.0%New
Boothbay Fund Management, LLC27,646$6.9K0.0%No change
Susquehanna International Group, Llp24,064$6.0K0.0%New
Morgan Stanley20,299$5.1K0.0%−3,303
Two Sigma Securities, LLC19,748$4.9K0.0%−85,493
Two Sigma Investments, LP15,456$3.9K0.0%+15
Schwarz Dygos Wheeler Investment Advisors LLC15,000$3.8K0.0%No change
BlackRock, Inc.7,504$1.9K0.0%No change
Osaic Holdings, Inc.441$1100.0%+433
SBI Securities Co., Ltd.358$900.0%+227
Northwestern Mutual Wealth Management Co100$250.0%New
Virtu Financial LLC87,138$220.0%−166,080
IFP Advisors, Inc11$30.0%No change
Barclays PLC3$10.0%New
NFSG Corp5$10.0%No change
Danske Bank A/s1$00.0%No change

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

SEC filer profile

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

  • Name on EDGARTheriva Biologics, Inc.1
  • CIK0000894158
  • Employer ID (EIN)13-38083033
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inNevada3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address9605 Medical Center Drive, Suite 270, Rockville, MD 208501
  • Phone(734) 332-78001
  • Shares outstanding45,892,668 as of Aug 7, 202611
  • Public float$3.9M as of Jun 30, 20253
  • AuditorBDO USA, P.C, Raleigh, North Carolina PCAOB ID 243; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceMay 7, 19961
  • Filings1,034 in all: 8-K (353), 4 (133), 10-Q (75), DEF 14A (33), CORRESP (31), 424B3 (29), 424B5 (29), UPLOAD (26)1
    All 51 form types

    SC 13G/A (25), EFFECT (24), 10-K (23), PRE 14A (23), 3 (21), SC 13D/A (21), S-3 (20), SC 13G (20), 10QSB (16), S-8 (15), DEFA14A (14), 8-K/A (11), SC 13D (10), CT ORDER (7), S-3/A (7), D (6), S-1/A (6), 10KSB (5), ARS (5), S-1 (4), 10-K/A (3), 10-Q/A (3), 10KSB/A (3), DEFR14A (3), NT 10-K (3), POS AM (3), 10-K405 (2), 4/A (2), DEF 14C (2), PRE 14C (2), S-8 POS (2), SCHEDULE 13G (2), SCHEDULE 13G/A (2), 424B2 (1), 424B4 (1), 8-A12B (1), AW (1), CERTAMX (1), FWP (1), POS EX (1), PRER14A (1), SB-2 (1), SB-2/A (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Jun 29, 2026
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
Common StockTOVXNYSE

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

Risk factors and legal proceedings

The risks Theriva Biologics, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 61 risks under these headings, as written.3

  • Because of the following factors, as well as other factors affecting our financial condition and operating results, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.
  • RISKS RELATED TO OUR FINANCIAL POSITION AND CAPITAL REQUIREMENTS
  • Our auditor’s report on our consolidated financial statements contains an explanatory paragraph regarding our ability to continue as a going concern.
  • We will need to raise additional capital to operate our business and our failure to obtain funding when needed may force us to delay, reduce or eliminate certain of our development programs or commercialization efforts.
  • We expect to continue to incur significant operating and capital expenditures and we will need additional funds to support our operations, and such funding may not be available to us on acceptable terms, or at all, which would force us to delay, reduce or suspend our research and development programs and other operations or commercialization efforts.
  • The actual amount of funds we will need to operate is subject to many factors, some of which are beyond our control.
  • We currently have a limited operating history as an oncology company, no products approved for commercial sale, have no significant source of revenue and may never generate significant revenue.
  • Although we currently believe that our internal controls are effective, we have identified material weaknesses in our internal controls in the past, and we cannot provide assurances that additional material weaknesses will not occur in the future
  • We expect to seek to raise additional capital in the future, which may be dilutive to stockholders or impose operational restrictions.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
  • If our acquired intangible assets become impaired in the future as was the case in 2024, we may be required to record a significant charge to earnings.
  • A prolonged U.S. federal government shutdown could materially and adversely affect our business and operations.
The other 50 risks
  • Federal budget and debt-ceiling disputes may adversely affect capital markets and our financing activities.
  • RISKS RELATED TO OUR BUSINESS
  • Prior to 2022, we had not conducted any research and development activities directed to cancer diagnosis, treatment or prevention and there can be no assurance that we will successfully be able to do so.
  • In the past OVs have experienced certain safety and efficacy challenges.
  • Our research and development efforts may not result in commercially successful products and technologies, which may limit our ability to achieve profitability.
  • We have in the past, and may continue to seek to, form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
  • We rely on licenses to use various technologies that are material to our business and we may not be able to retain rights licensed to us by others to commercialize key products and may not be able to establish or maintain the relationships we need to develop, manufacture, and market our products.
  • We may incur additional expenses in connection with our licenses and collaboration arrangements and our development of our product candidates.
  • Developments by competitors may render our products or technologies obsolete or non-competitive.
  • We may seek to selectively establish collaborations, and, if we are unable to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • If the parties we depend on for supplying substance raw materials for our product candidates and certain manufacturing-related services do not timely supply these products and services in sufficient quality or quantity, or if current drug supply becomes unusable, it may delay or impair our ability to develop, manufacture and market our product candidates.
  • For our clinical trials of VCN-01 (zabilugene almadenorepvec), we have or will administer our product candidate, VCN-01, in combination with other cancer drugs. Any problems obtaining these co-administered drugs could result in a delay or interruption in our clinical trials.
  • If third-party vendors, upon whom we rely to conduct our preclinical studies or clinical trials, do not perform or fail to comply with strict regulations, these studies or trials may be delayed, terminated, or fail, or we could incur significant additional expenses, which could materially harm our business.
  • We may fail to retain or recruit necessary personnel, and we may be unable to secure the services of consultants.
  • Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, 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 and timelines.
  • Global health crises may adversely affect our planned operations.
  • Business disruptions could seriously harm our future revenue and financial condition and increase costs and expenses.
  • Unfavorable U.S. or global economic conditions could adversely affect our business, financial condition or results of operations.
  • Changes to trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect on our reputation, business, financial condition and results of operations.
  • We rely extensively on our information technology systems, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.
  • Our business and operations would suffer in the event of computer system failures.
  • Any failure to maintain the security of information relating to our patients, customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise, could expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm our reputation.
  • We may face particular data protection, data security and privacy risks in connection with the European Union’s Global Data Protection Regulation and other privacy regulations.
  • REGULATORY RISKS
  • If we do not obtain the necessary regulatory approvals in the U.S. and/or other countries we will not be able to develop or sell our product candidates.
  • Clinical trials are very expensive, time-consuming, and difficult to design and implement.
  • The results of our clinical trials may not support our product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily predictive of future results.
  • Difficulties enrolling patients in our clinical trials or delays in enrollment are expected to result in our clinical development activities being delayed or otherwise adversely affected.
  • Patients who are administered our product candidates may experience unexpected side effects or other safety risks that could cause a halt in their clinical development, preclude approval of our product candidates or limit their commercial potential.
  • It is possible that we may not be able to obtain or maintain orphan drug designation or exclusivity for our drug candidates, which could limit the potential profitability of our product candidates.
  • Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidate and, even if we obtain FDA approval, we may not receive marketing approval, marketing exclusivity or other expected benefits.
  • Although we have obtained rare pediatric disease designation for VCN-01 (zabilugene almadenorepvec) for the treatment of retinoblastoma, we may not be eligible to receive a priority review voucher in the event the FDA determines we no longer meet the criteria for designation, revokes the designation or FDA approval of a BLA for VCN-01 for retinoblastoma does not occur prior to September 30, 2029.
  • Our product candidates, if approved for sale, may not gain acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenues.
  • We depend on third parties, including researchers and sublicensees, who are not under our control. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to seek or obtain regulatory approval for or commercialize our product candidates.
  • We currently have no marketing, sales or distribution organization and have no experience in marketing products as a company. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.
  • Reimbursement may not be available for our product candidates, which would impede sales.
  • Healthcare reform measures could hinder or prevent our product candidates’ commercial success.
  • If we fail to comply with state and federal healthcare regulatory laws, we could face substantial penalties, damages, fines, disgorgement, exclusion from participation in governmental healthcare programs, and the curtailment of operations, any of which could harm our business.
  • If we obtain approval to commercialize our clinical product candidates outside of the United States, a variety of risks associated with international operations could harm our business.
  • If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
  • We and our subsidiaries are subject to U.S. and foreign tax laws, and changes to such tax laws or differing interpretation of those laws by the relevant governmental authorities could adversely affect our business and operating results.
  • INTELLECTUAL PROPERTY RISKS
  • We rely on patents, patent applications, trade secrets and various regulatory exclusivities to protect some of our product candidates and our ability to compete may be limited or eliminated if we are not able to protect our products.
  • We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, as well as costs associated with lawsuits.
  • If we infringe the rights of others, we could be prevented from selling products or forced to pay damages.
  • We enjoy restricted geographical protection with respect to certain patents.
  • We may become subject to claims challenging inventorship or ownership of our patents and other intellectual property.
  • RISKS RELATING TO OUR SECURITIES
  • We cannot assure you that our Common Stock will be liquid or that it will remain listed on the NYSE American.
  • The market price of our Common Stock has been and may continue to be volatile and adversely affected by various factors.
  • Our Charter and bylaws and Nevada law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.
  • We do not intend to pay dividends in the foreseeable future on our Common Stock.
  • Resales of our Common Stock in the public market by our stockholders may cause the market price of our common stock to fall.
  • The shares of Common Stock offered under our current ATM Sales Agreement may be sold in “at the market” offerings, and investors who buy shares at different times will likely pay different prices.

Legal proceedings

From time to time we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, operating results, financial condition or cash flows. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.3

Sources

The numbers on this page point here. Each one links to the record it came from.

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