Filing Analysis
Theriva Biologics, Inc. filed an 8-K to announce the release of its financial results for the quarter ended June 30, 2026. The filing serves as a formal notice that earnings information is being made public via a press release.
📋 Key Facts
- The company issued a press release on August 11, 2026, containing financial information for the quarter ended June 30, 2026.
- The filing includes Exhibit 99.1, which contains the actual earnings data.
- The report was signed by Steven A. Shallcross, CEO and CFO.
Theriva Biologics announced the dosing of the first patient in its VIRAGE2 clinical trial, a proof-of-concept study for VCN-01 in treating metastatic pancreatic ductal adenocarcinoma (PDAC). The trial aims to evaluate if more frequent repeated dosing improves clinical outcomes compared to standard-of-care chemotherapy.
📋 Key Facts
- First patient dosed in the VIRAGE2 clinical trial on August 6, 2026.
- Trial evaluates VCN-01 (zabilugene almadenorepvec) + gemcitabine/nab-paclitaxel chemotherapy for first-line metastatic PDAC.
- Enrollment is expected to be completed in H2 2026.
- Initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027.
- Trial design is based on Phase 2b observations showing improved survival with 2 doses of VCN-01.
Theriva Biologics, Inc. held its 2026 Annual Meeting of Stockholders where shareholders approved several key measures, including an increase in authorized shares and an expansion of the 2020 Stock Incentive Plan.
🚩 Red Flags
- Significant increase in authorized shares and stock incentive plan capacity suggests potential future dilution for existing shareholders.
📋 Key Facts
- Annual Meeting held on August 3, 2026.
- Stockholders approved Amendment No. 4 to the 2020 Stock Incentive Plan, increasing share authority from 4.5 million to 6.5 million shares.
- Stockholders approved an amendment to increase the total number of authorized shares of common stock (Charter Amendment).
- Stockholders approved the issuance of common stock upon the exercise of outstanding warrants.
- BDO USA, P.C. was ratified as the independent registered public accounting firm for the year ending December 31, 2026.
- Four directors were elected: Jeffrey J. Kraws, Steven A. Shallcross, John Monahan, and Jeffrey Wolf.
Theriva Biologics announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the initiation of the VIRAGE2 clinical trial. This Phase IIa trial will evaluate increased dosing frequency of zabilugene almadenorepvec (VCN-01) in combination with standard-of-care chemotherapy for metastatic pancreatic cancer.
📋 Key Facts
- AEMPS (Spain) authorized the VIRAGE2 clinical trial (EUCT: 2026-525566-21-00).
- The trial is a Phase IIa, single-arm, single-center, open-label, proof-of-concept study.
- Objective: Evaluate the feasibility of administering at least 3 doses of VCN-01 every 2 months in combination with gemcitabine/nab-paclitaxel.
- The trial builds on Phase 2b VIRAGE results where 2 doses administered 3 months apart showed improved overall survival and progression-free survival.
Theriva Biologics received positive scientific advice from the EMA's CHMP regarding the Phase 3 clinical trial design for its lead candidate, VCN-01, in treating metastatic pancreatic adenocarcinoma. The regulatory guidance supports a single Phase 3 trial strategy to support a future marketing authorization application.
📋 Key Facts
- Received Scientific Advice from the EMA's Committee for Medicinal Products for Human Use (CHMP) on Dec 29, 2025.
- The advice concerns the design of a Phase 3 trial for VCN-01 in combination with gemcitabine/nab-paclitaxel SoC for metastatic PDAC.
- CHMP agreed with the proposed clinical development strategy involving a single, double-blinded, randomized, placebo-controlled Phase 3 trial.
- The regulator agreed on inclusion/exclusion criteria, primary endpoint (overall survival), and secondary endpoints.
- CHMP recognized the benefit of repeated dosing ('macrocycles') based on positive Phase 2b VIRAGE trial results.
Theriva Biologics failed to convene its Special Meeting of Stockholders on December 15, 2025, due to a lack of quorum. The company must now reschedule the meeting to seek approval for a massive warrant exercise proposal involving up to 16,184,560 shares.
🚩 Red Flags
- Failure to reach quorum at a critical stockholder meeting suggests significant shareholder apathy or active opposition.
- Potential massive dilution: The company is seeking approval for up to 16,184,560 new shares via warrant exercise.
- Ongoing obligation to hold meetings every 60 days creates continuous administrative burden and uncertainty for the stock price.
📋 Key Facts
- Special Meeting held on December 15, 2025, failed to reach a quorum.
- The meeting was intended to seek stockholder approval for the issuance of up to 16,184,560 common stock shares via 'New Warrants'.
- The warrants were issued under an Inducement Agreement dated October 16, 2025, with institutional investors.
- Per the Inducement Agreement, the company is now obligated to call a new meeting and must continue calling meetings every 60 days until approval is obtained or warrants expire.
Theriva Biologics, Inc. filed an 8-K to announce the release of its financial results for the quarter ended September 30, 2025. The filing serves as a formal notification that financial information was made public via press release.
📋 Key Facts
- Report date: November 12, 2025
- Reporting period: Quarter ended September 30, 2025
- The company issued a press release containing financial results (Exhibit 99.1)
- Information provided under Item 2.02 is not considered 'filed' for purposes of Section 18 of the Exchange Act.
Theriva Biologics, Inc. has filed a prospectus supplement to its existing S-3 registration statement to facilitate the 'at-the-market' (ATM) offering of up to $2,894,225 in common stock through A.G.P./Alliance Global Partners.
🚩 Red Flags
- Potential dilution for existing shareholders through the issuance of new common stock.
- ATM offerings are often used by micro-cap companies to raise immediate working capital, which can signal a need for liquidity.
📋 Key Facts
- Offering amount: Up to $2,894,225 of common stock.
- Sales Agent: A.G.P./Alliance Global Partners.
- Commission rate: Up to 3.0% of the gross sales price per share sold.
- Mechanism: At-the-market (ATM) offering under Rule 415(a)(4).
- Registration Statement: Form S-3, originally declared effective on September 25, 2024.
Theriva Biologics, Inc. has filed a prospectus supplement to its existing S-3 registration statement for an 'at the market' (ATM) offering of common stock. The offering seeks to raise up to $4,019,597 through A.G.P./Alliance Global Partners.
🚩 Red Flags
- Potential dilution for existing shareholders through the issuance of new common stock.
- ATM offerings are often used by micro-cap companies to raise immediate working capital, which can signal a need for liquidity.
📋 Key Facts
- The company is offering up to $4,019,597 in common stock.
- The offering is being conducted via an 'at the market' (ATM) issuance under a Sales Agreement with A.G.P./Alliance Global Partners.
- The Sales Agent will receive a commission of up to 3.0% of the gross sales price per share sold.
- The registration statement was originally declared effective on September 25, 2024.
Theriva Biologics, Inc. announced the presentation of data from its VIRAGE Phase 2b trial regarding expanded metastatic pancreatic ductal adenocarcinoma (mPDAC) at the ESMO 2025 Annual Congress.
📋 Key Facts
- Data presented concerns the VIRAGE Phase 2b trial (NCT05673811).
- The clinical focus is on expanded metastatic pancreatic ductal adenocarcinoma (mPDAC).
- Presentation occurred at a mini oral session at the European Society for Medical Oncology (ESMO) 2025 Annual Congress.
- Data was presented on October 20, 2025.
Theriva Biologics entered into a warrant inducement agreement to raise approximately $4.4 million in gross proceeds by allowing existing warrant holders to exercise at a reduced price of $0.54 per share. In exchange, the company is issuing new warrants representing 200% of the underlying shares, leading to significant potential dilution.
🚩 Red Flags
- Significant potential dilution: Issuing new warrants for 200% of the number of shares underlying existing warrants.
- Warrant Inducement: Reducing exercise price to entice holders, often a sign of liquidity pressure.
- High transaction cost: AGP to receive a 7.0% cash fee on gross proceeds ($308,000).
- Restrictive covenants: Company cannot issue common stock or file registration statements for 45 days (with some exceptions).
📋 Key Facts
- Entered into Inducement Agreement on October 16, 2025; closed October 17, 2025.
- Existing warrants (September and May series) exercised at a reduced price of $0.54 per share.
- Gross proceeds from exercise: approximately $4.4 million.
- Issuance of New Warrants to purchase up to 16,184,560 shares of Common Stock (200% of existing underlying shares).
- New warrants have a 5-year term and require stockholder approval for exercise.
- Company agreed to file a Resale Registration Statement within 30 days.
Theriva Biologics announced expanded Phase 2b trial data for its VCN-01 therapy in metastatic pancreatic ductal adenocarcinoma (mPDAC), which met primary endpoints. The company will present these findings at the ESMO 2025 Annual Congress on October 20, 2025.
🚩 Red Flags
- Clinical trial data is subject to regulatory scrutiny and may not guarantee future commercial success or FDA approval.
📋 Key Facts
- VIRAGE Phase 2b trial met primary endpoints for OS, PFS, and DoR in mPDAC patients.
- In the FAS population (Arm II: VCN-01 + GA), Overall Survival (OS) was 10.8 months vs 8.6 months in Arm I (GA alone).
- Progression-Free Survival (PFS) improved to 7.0 months in Arm II vs 4.6 months in Arm I (HR 0.55; P=0.011).
- Duration of Response (DoR) was 11.2 months for Arm II vs 5.4 months for Arm I (HR 0.22; P=0.004).
- VCN-01 administration was reported as well tolerated, with serious adverse events resolving in all 13 cases.
- Data presentation scheduled for October 20, 2025, at ESMO 2025.
Theriva Biologics presented preclinical data for its VCN-12 oncolytic adenovirus at the 32nd Annual Congress of the European Society of Gene & Cell Therapy. The data suggests improved efficacy and stroma degradation compared to their lead candidate, VCN-01.
📋 Key Facts
- Presented preclinical data for VCN-12 (part of VCN-X discovery program) on October 8, 2025.
- VCN-12 incorporates bee hyaluronidase and parasporin-2 to increase stroma degradation and tumor cell lysis.
- In vitro studies showed increased cell killing compared to lead candidate VCN-01.
- Animal studies in immunocompetent hamsters showed significant reduction in pancreatic tumor growth and complete regression in 2 of 9 hamsters.
- VCN-12 demonstrated a persistent immune response that prevented new tumor establishment in responders 43 days post-treatment.
Theriva Biologics issued a press release regarding preclinical data presentations for its VCN-12 and VCN-01 programs. The filing highlights scientific advancements in oncolytic adenovirus development and intracranial administration studies.
📋 Key Facts
- Presented preclinical data for VCN-12 (next generation oncolytic adenovirus) at the 32nd Annual Congress of the European Society of Gene & Cell Therapy.
- Announced publication of results from a preclinical study evaluating intracranial administration of VCN-01.
- VCN-01 study was conducted by collaborators at the University of Navarra to support brain tumor treatment development.
Theriva Biologics announced a significant restructuring plan involving a 32% workforce reduction to refocus on business development and clinical trials for its lead candidate, VCN-01. The company expects to incur $520,000 in severance charges but aims to extend its cash runway into Q2 2026 through annual savings of approximately $2.0 million.
🚩 Red Flags
- Significant workforce reduction (32%) often indicates severe liquidity constraints or a desperate need to preserve cash.
- Cash runway only extends to Q2 2026, indicating the company will likely require further financing within the next 6-9 months.
- Restructuring charges and cost-cutting measures are typical precursors to distressed financial positions in micro-cap biotech.
📋 Key Facts
- Workforce reduction of approximately seven employees, representing ~32% of the global workforce, implemented on September 30, 2025.
- Estimated restructuring charges of ~$520,000 to be incurred in Q4 2025.
- Anticipated annual savings of ~$2.0 million in compensation and benefits.
- Goal is to extend cash runway into the second quarter (Q2) of 2026.
- Strategic pivot toward business development, licensing, and clinical trials for VCN-01 in PDAC and retinoblastoma.
Theriva Biologics, Inc. reported the results of its 2025 Annual Meeting of Stockholders held on August 29, 2025. Key outcomes included the election of four directors and the approval of an amendment to increase the share pool for the 2020 Stock Incentive Plan.
🚩 Red Flags
- Significant increase in authorized shares under the Stock Incentive Plan (80% increase from 2.5M to 4.5M), which may lead to future dilution of existing shareholders.
📋 Key Facts
- Annual Meeting held on August 29, 2025.
- Stockholders approved Amendment No. 3 to the 2020 Stock Incentive Plan, increasing authorized shares under the plan from 2,500,000 to 4,500,000.
- Four directors were elected: Jeffrey J. Kraws, Steven A. Shallcross, John Monahan, and Jeffrey Wolf.
- BDO USA, P.C. was ratified as the independent registered public accounting firm for the year ending December 31, 2025.
- Stockholders approved executive compensation on an advisory basis.
- Stockholders approved a three-year frequency for future advisory votes on executive compensation.
Theriva Biologics, Inc. filed an 8-K to announce the release of financial information for the quarter ended June 30, 2025. The filing serves as a formal notification of the earnings press release issued on August 11, 2025.
📋 Key Facts
- The company released financial results for the fiscal quarter ending June 30, 2025.
- The announcement was made via a press release dated August 11, 2025.
- The filing includes Exhibit 99.1 containing the specific financial details.
Theriva Biologics, Inc. announced the date for its 2025 Annual General Meeting of Shareholders and established revised deadlines for stockholder proposals.
📋 Key Facts
- The 2025 Annual Meeting is scheduled for August 29, 2025.
- The record date for determining stockholders entitled to vote is July 8, 2025.
- Stockholder proposals under Rule 14a-8 must be received by the Company by July 5, 2025, to be included in proxy materials.
- Revised deadlines were necessitated because the meeting date is more than 30 days prior to the anniversary of the 2024 Annual Meeting.
Theriva Biologics, Inc. has filed a prospectus supplement to its existing S-3 registration statement to facilitate the 'at-the-market' (ATM) offering of up to $2,534,352 in common stock through A.G.P./Alliance Global Partners.
🚩 Red Flags
- Dilutive event: The offering will result in the issuance of new common stock, diluting existing shareholders.
- Small offering size relative to typical micro-cap operations suggests potential liquidity/cash runway management needs.
📋 Key Facts
- Offering amount: Up to $2,534,352 of common stock.
- Sales Agent: A.G.P./Alliance Global Partners.
- Pricing method: At-the-market (ATM) offering via Rule 415(a)(4).
- Commission rate: Up to 3.0% of the gross sales price per share sold.
- Registration Statement: Form S-3 originally declared effective on September 25, 2024.
Theriva Biologics announced a poster presentation of Phase 1 study results for its oncolytic virus VCN-01 at the 2025 ASCO annual meeting. The data focuses on safety and efficacy in patients with refractory retinoblastoma.
🚩 Red Flags
- None identified in this filing.
📋 Key Facts
- Phase 1 dose-escalation study of VCN-01 in refractory retinoblastoma patients presented at ASCO 2025.
- VCN-01 was reported as well tolerated; most frequent adverse events were Grade 1 or 2 uveitis.
- No dose-limiting toxicities or ocular/systemic toxicities ≥ Grade 3 were observed.
- Clinical efficacy noted: 4 patients showed unequivocal improvement in vitreous seed density and enucleation was avoided in 3 patients to date.
- Immunohistochemical analysis showed selective VCN-01 replication in retinoblastoma cells without healthy tissue involvement.
Theriva Biologics, Inc. filed an 8-K to announce the release of its quarterly results for the period ended March 31, 2025.
📋 Key Facts
- The filing is a standard announcement of quarterly earnings (Results of Operations and Financial Condition).
- Reporting date: May 14, 2025.
- Period covered: Quarter ended March 31, 2025.
Theriva Biologics, Inc. completed a public offering of common stock and warrants on May 8, 2025, raising approximately $7.5 million in gross proceeds. The offering includes significant warrant coverage that will result in substantial potential dilution for existing shareholders.
🚩 Red Flags
- Significant potential dilution: The number of warrant shares (approx. 11.6M) significantly exceeds the current outstanding common stock (4.77M).
- High warrant coverage: Total potential shares upon exercise/conversion represent a massive increase in share count.
- Restrictive covenants: The purchase agreement includes 'standstill' style restrictions on future equity offerings, limiting management's flexibility to raise capital via ATM programs for several months.
📋 Key Facts
- Gross proceeds from the offering: ~$7.5 million.
- Securities issued: 1,990,900 shares of common stock, up to 4,827,280 pre-funded warrant shares, and up to 6,818,180 common warrant shares.
- Combined offering price for shares and warrants: $1.10 per unit.
- Pre-Funded Warrants are immediately exercisable at $0.001 per share.
- Common Warrants have an exercise price of $1.10 and expire in 5 years.
- Placement Agent (A.G.P./Alliance Global Partners) to receive a 7.0% aggregate fee plus up to $100,000 in expenses.
- The company has imposed restrictions on future equity issuances/ATM offerings for 90 days to 6 months depending on the circumstances.
Theriva Biologics announced positive topline results from its Phase 2b VIRAGE clinical trial for VCN-01 in treating metastatic pancreatic cancer. The data showed improvements in median overall survival (OS) and progression-free survival (PFS) when VCN-01 was used in combination with standard-of-care chemotherapy.
🚩 Red Flags
- The p-value for the primary endpoint of Overall Survival (p=0.0546) narrowly missed the traditional threshold for statistical significance (< 0.05), though it is clinically meaningful.
- Clinical trial results are subject to regulatory interpretation and may not guarantee FDA approval.
📋 Key Facts
- VIRAGE Phase 2b trial evaluated VCN-01 + gemcitabine/nab-paclitaxel vs. SoC alone for metastatic PDAC.
- Median Overall Survival (OS) was 10.8 months in the VCN-01 arm vs. 8.6 months in the SoC control arm (HR = 0.57).
- Median Progression Free Survival (PFS) improved to 7.0 months vs. 4.6 months (HR = 0.55, p=0.0105).
- Median Duration of Response (DoR) doubled in the VCN-01 arm to 11.2 months vs. 5.4 months in control (HR = 0.22).
- Subgroup analysis suggests a second dose of VCN-01 may provide additional benefit, with median OS reaching 14.8 months in the two-dose subgroup.
- Adverse events (pyrexia, flu-like illness, vomiting, nausea) were reported as transient and reversible.
Theriva Biologics announced positive results from a second Independent Data Monitoring Committee (IDMC) review of its VIRAGE Phase 2b clinical trial. The review confirmed that VCN-01 is well tolerated when combined with standard chemotherapy for metastatic pancreatic cancer, with adverse events being transient and reversible.
📋 Key Facts
- Second IDMC review completed for the VIRAGE Phase 2b clinical trial (metastatic PDAC).
- VCN-01 was found to be well tolerated in combination with gemcitabine/nab-paclitaxel.
- Adverse events (AEs) such as pyrexia, flu-like illness, vomiting, nausea, and elevated transaminases were reported as transient and reversible.
- The frequency and grade of AEs decreased after the second dose (day 92) compared to the first dose (day 1).
- IDMC noted that the AE profile is consistent with expectations for oncolytic virus administration in this patient population.
Theriva Biologics, Inc. issued an 8-K to announce the release of financial information for its fiscal year ended December 31, 2024.
📋 Key Facts
- The filing is a standard announcement of results of operations and financial condition (Item 2.02).
- Financial information pertains to the fiscal year ending December 31, 2024.
- A press release containing the detailed financial data was issued on March 6, 2025.
Theriva Biologics announced the results of a Type D meeting with the FDA regarding its lead clinical candidate, VCN-01, for the treatment of pancreatic adenocarcinoma (PDAC). The FDA advised against expanding the current Phase 2b study into a Phase 3 trial, recommending instead a stand-alone Phase 3 study.
🚩 Red Flags
- Clinical pathway change: The FDA's recommendation to pivot from expanding the current trial to a new stand-alone Phase 3 study may imply increased capital requirements and longer timelines for drug approval.
📋 Key Facts
- FDA Type D meeting held to discuss Phase 3 design for VCN-01 in combination with standard-of-care chemotherapy.
- FDA advised against expanding the ongoing VIRAGE Phase 2b study into a Phase 3 study.
- Optimal path identified by FDA: conduct a stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel.
- FDA agreed with proposed design and noted that adding additional chemotherapy would complicate analysis.
- The VIRAGE Phase 2b study has completed target enrollment.
Theriva Biologics, Inc. filed an 8-K to announce the release of its financial results for the quarter ended September 30, 2024.
📋 Key Facts
- The filing is a standard disclosure of quarterly results under Item 2.02.
- Reporting period: Quarter ended September 30, 2024.
- Filing date: November 12, 2024.
- The company issued a press release (Exhibit 99.1) containing the financial information.
Theriva Biologics, Inc. reported the results of its 2024 Annual Meeting of Stockholders, which included significant shareholder approvals for increasing authorized share counts and amending the company's stock incentive plan.
🚩 Red Flags
- Massive increase in authorized share count (from 14M to 350M) suggests significant potential for future dilution through equity offerings.
- Significant expansion of the Stock Incentive Plan (nearly 9x increase) indicates substantial upcoming dilution via employee/director compensation.
📋 Key Facts
- Stockholders approved Amendment No. 2 to the 2020 Stock Incentive Plan, increasing the share limit from 280,000 to 2,500,000 shares.
- Stockholders approved an amendment to the Articles of Incorporation to increase authorized common stock from 14,000,000 to 350,000,000 shares.
- Four directors (Jeffrey J. Kraws, Steven A. Shallcross, John Monahan, and Jeffrey Wolf) were elected to the Board.
- BDO USA, P.C. was ratified as the independent registered public accounting firm for the fiscal year ending December 31, 2024.
- The company filed a Certificate of Change in Nevada effective November 1, 2024, to reflect the increase in authorized shares.
Theriva Biologics announced that the European Medicines Agency (EMA) has recommended granting orphan medicinal product designation to its lead clinical candidate, VCN-01, for the treatment of retinoblastoma.
📋 Key Facts
- Date of announcement: October 16, 2024
- Regulatory body: European Commission/European Medicines Agency (EMA)
- Candidate name: VCN-01 (oncolytic adenovirus)
- Indication: Retinoblastoma
- Designation type: Orphan medicinal product designation
Theriva Biologics announced positive DSMC results for its Phase 1b/2a trial of SYN-004, recommending the study proceed to Cohort 3. However, the company explicitly noted it is currently pursuing additional funding to finance this next phase.
🚩 Red Flags
- Company explicitly stated it is 'pursuing additional funding' to enable the conduct of Cohort 3, indicating potential liquidity constraints or upcoming dilution.
📋 Key Facts
- DSMC recommended proceeding to Cohort 3 for SYN-004 (ribaxamase) in HCT recipients.
- Cohort 3 will involve administration of study drug or placebo in combination with cefepime.
- No Adverse Events (AEs) or Serious Adverse Events (SAEs) were determined by investigators to be related to the study drug.
- 15 SAEs reported among 10 patients, primarily infections/sepsis, but deemed typical for allo-HCT patients and unrelated to the drug.
- Pharmacokinetics of piperacillin were as expected in this patient population.
Theriva Biologics, Inc. completed a public offering of common stock and warrants on September 27, 2024, raising approximately $2.5 million in gross proceeds. The offering includes pre-funded warrants and common warrants that will lead to significant future dilution.
🚩 Red Flags
- Significant potential dilution from the issuance of over 1.9 million warrants/pre-funded warrants relative to current outstanding shares.
- The offering price ($1.75) is relatively low, suggesting a need for immediate liquidity.
- Restrictive covenants in the Purchase Agreement prevent certain equity offerings for up to 6 months.
📋 Key Facts
- Offering closed on September 27, 2024.
- Gross proceeds of approximately $2.5 million before fees.
- Offered 918,600 shares of common stock at $1.75 per share (combined with warrants).
- Issued 510,000 Pre-Funded Warrants exercisable at $0.0001 per share.
- Issued Common Warrants for up to 1,428,600 shares with an exercise price of $2.00 per share.
- Placement Agent (A.G.P./Alliance Global Partners) charged a 7.0% fee plus up to $100,000 in expenses.
- Post-offering common stock outstanding: 2,272,462 shares (assuming no warrant exercise).
Theriva Biologics announced the completion of patient enrollment for its VIRAGE Phase 2b clinical trial evaluating VCN-01 in combination with chemotherapy for metastatic pancreatic cancer. The company also intends to conduct several investor presentations in the coming weeks.
📋 Key Facts
- Achieved target enrollment of 92 evaluable patients in the VIRAGE Phase 2b clinical trial.
- The trial evaluates VCN-01 plus standard-of-care (SoC) chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC).
- VCN-01 has received FDA Orphan Drug Designation and Fast Track Designation for PDAC.
- Phase 1 data previously showed an overall response rate of 83% in a small cohort (n=6) with median progression-free survival of 6.3 months.
- Total of 142 patients have been administered VCN-01 across all indications to date.
Theriva Biologics announced a €2.28 million funding award from the Spanish government's National Knowledge Transfer Program for its THERICEL project. The funding includes a €1.33 million unsecured loan to the company and a €0.95 million grant to Universitat Autònoma de Barcelona (UAB) to advance viral therapy manufacturing platforms.
🚩 Red Flags
- The funding is structured as an unsecured loan rather than a pure grant, creating a future repayment obligation.
📋 Key Facts
- Total award amount: €2.28 million from Spain's Ministry of Science, Innovation & Universities.
- Company component: Receives an unsecured loan of €1.33 million as a lump sum in Q4 2024.
- Loan terms: 4.015% interest rate; repayment over 7 years starting three years from the award date.
- Partner component: UAB receives a €0.95 million grant paid in annual installments over 3 years.
- Purpose: To advance the THERICEL suspension cell platform for clinical manufacture of adenovirus and AAV therapies.
Theriva Biologics, Inc. announced the conversion of all remaining Series C and Series D Convertible Preferred Stock into common stock as of September 6, 2024.
🚩 Red Flags
- Conversion price of $30.50 is significantly higher than typical micro-cap trading prices (suggests potential dilution if market price is lower, though total share count increase here is minimal).
📋 Key Facts
- Conversion date: September 6, 2024
- Series C Conversion: 4,138 shares converted to 1,086 common shares at $30.50 per share.
- Series D Conversion: 100,000 shares converted to 26,230 common shares at $30.50 per share.
- Total new common shares issued: 27,316 shares.
- Resulting status: No Series C or Series D Convertible Preferred Stock remains outstanding.
Theriva Biologics, Inc. has implemented a 1-for-25 reverse stock split effective August 26, 2024. The action was taken specifically to maintain compliance with the NYSE American per share price requirements.
🚩 Red Flags
- Reverse stock split (typically indicates significant downward pressure on share price or delisting risk).
- Explicitly stated purpose is to meet NYSE American per share price requirements, indicating a struggle to maintain minimum listing standards.
📋 Key Facts
- Reverse stock split ratio is 1:25 (one new share for every 25 old shares).
- Effective date of the split: August 26, 2024, at 12:01 a.m. ET.
- Outstanding shares reduced from 25,131,230 to approximately 1,005,249 shares.
- The split was executed via a Certificate of Change filed in Nevada.
- No fractional shares will be issued; stockholders with fractions will be rounded up to the nearest whole share.
Theriva Biologics, Inc. has approved a 1-for-25 reverse stock split to maintain compliance with NYSE American listing requirements regarding minimum share price.
🚩 Red Flags
- Reverse stock split is being executed specifically to avoid delisting from the NYSE American due to per share price requirements.
- Significant reduction in total outstanding shares (approx. 96% reduction).
📋 Key Facts
- Reverse stock split ratio: 1-for-25.
- Effective date: Expected at 12:01 a.m. ET on August 26, 2024.
- Share count reduction: Outstanding shares expected to decrease from 25,131,230 to approximately 1,005,249.
- Fractional shares will be rounded up to the nearest whole share; no cash in lieu of fractional shares will be paid.
- The trading symbol remains 'TOVX' and a new CUSIP (87164U 508) has been assigned.
Theriva Biologics, Inc. filed an 8-K to announce the release of its financial results for the quarter ended June 30, 2024.
📋 Key Facts
- The filing is a standard announcement of quarterly earnings (Item 2.02).
- Financial information pertains to the quarter ended June 30, 2024.
- The report was filed on August 13, 2024.
Theriva Biologics announced that the FDA granted Rare Pediatric Drug Designation (RPDD) for its lead candidate, VCN-01, for treating retinoblastoma. Additionally, a holder of Series C Convertible Preferred Stock converted 135,431 shares into 888,072 shares of common stock.
🚩 Red Flags
- Significant dilution potential due to the conversion of Series C Preferred Stock into a large block of common stock (888,072 shares).
📋 Key Facts
- FDA granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma on July 30, 2024.
- VCN-01 is a systemic, selective, stroma-degrading oncolytic adenovirus.
- The company previously received orphan drug designation for VCN-01 for the same indication.
- Series C Convertible Preferred Stock conversion: 135,431 preferred shares converted into 888,072 common shares.
- Conversion price was set at $1.22 per share.
Theriva Biologics announced that the FDA has granted Fast Track Designation (FTD) to its lead clinical candidate, VCN-01, for use in combination with chemotherapy to treat metastatic pancreatic adenocarcinoma. This follows a previous Orphan Drug Designation for the same candidate.
📋 Key Facts
- FDA granted Fast Track Designation (FTD) to VCN-01 in combination with gemcitabine and nab-paclitaxel.
- Target indication: metastatic pancreatic adenocarcinoma (PDAC).
- The drug is currently being evaluated in the VIRAGE Phase 2b multinational clinical study.
- VCN-01 previously received Orphan Drug Designation for PDAC treatment.
Theriva Biologics, Inc. announced the conversion of 135,431 shares of Series C Convertible Preferred Stock into 888,072 shares of common stock.
🚩 Red Flags
- Potential dilution for existing common shareholders due to the issuance of 888,072 new shares.
📋 Key Facts
- Conversion date: May 13, 2024
- Shares converted: 135,431 shares of Series C Convertible Preferred Stock
- Common stock issued: 888,072 shares
- Conversion price: $1.22 per share
Theriva Biologics, Inc. filed an 8-K to announce the release of its financial results for the quarter ended March 31, 2024.
📋 Key Facts
- The filing is a standard announcement of quarterly financial results (Item 2.02).
- Financial information pertains to the fiscal quarter ending March 31, 2024.
- The company issued a press release on May 7, 2024, which is incorporated by reference as Exhibit 99.1.
Theriva Biologics entered into Amendment No. 2 to its At-The-Market (ATM) sales agreement with A.G.P./Alliance Global Partners and simultaneously terminated B. Riley Securities, Inc. as a party to the same agreement.
🚩 Red Flags
- Continued use of ATM offerings suggests ongoing need for liquidity/capital raising.
📋 Key Facts
- Entered into Amendment No. 2 to the Amended and Restated Sales Agreement on May 2, 2024.
- The agreement allows the Company to sell common stock through A.G.P./Alliance Global Partners via an 'at the market' offering.
- B. Riley Securities, Inc. was removed from the Sales Agreement effective May 1, 2024, by mutual agreement.
- Sales will be conducted under a current or newly filed Form S-3 registration statement.
Theriva Biologics announced positive topline Phase 1 trial data for VCN-01 in pediatric patients with refractory retinoblastoma. As a result of these clinical outcomes, the company will receive an exclusive worldwide license and related patents from Sant Joan de Déu-Barcelona Children’s Hospital.
🚩 Red Flags
- Observed ocular inflammation and turbidity post-injection (managed with anti-inflammatories).
📋 Key Facts
- Phase 1 Trial results for intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were positive.
- 9 evaluable patients were included in the study (n=1 at 2x10^9 vp/eye; n=8 at 2x10^10 vp/eye).
- Safety profile: No dose-limiting toxicities or Grade 3+ ocular/systemic toxicities reported.
- Clinical outcome: 4 patients showed unequivocal improvement in vitreous seed density; enucleation avoided in 3 patients to date.
- The company will receive an exclusive, worldwide license and related patents from Sant Joan de Déu-Barcelona Children’s Hospital.
Theriva Biologics announced preclinical data demonstrating synergistic anti-tumor effects when combining its lead product candidate, VCN-01, with liposomal irinotecan in pancreatic cancer mouse models. The company plans to present these findings at the ASGCT 27th Annual Meeting on May 10, 2024.
📋 Key Facts
- Preclinical data shows enhanced viral protein expression in human pancreatic cancer cell lines when exposed to topo1 inhibitors like irinotecan.
- In vivo mouse xenograft models showed significant tumor growth inhibition for VCN-01 alone and liposomal irinotecan alone.
- Combination therapy (VCN-01 + liposomal irinotecan) demonstrated significantly reduced tumor growth compared to monotherapies.
- qPCR analysis confirmed ongoing transcriptional activity of VCN-01 in tumors, suggesting viral replication for several days post-administration.
Theriva Biologics, Inc. announced its intention to conduct several investor presentations over the coming weeks. The company provided a corporate presentation as an exhibit under Regulation FD disclosure.
📋 Key Facts
- The Company will be making multiple investor presentations in the weeks following April 16, 2024.
- A corporate presentation dated April 2024 was furnished as Exhibit 99.1.
- Information provided under Item 7.01 is not considered 'filed' for purposes of Section 18 or liability under Sections 11 and 12(a)(2).
- The filing includes safe harbor language regarding forward-looking statements.
Theriva Biologics, Inc. issued an 8-K to announce the release of its financial results for the fiscal year ended December 31, 2023.
📋 Key Facts
- The filing is a standard announcement of year-end financial results (Item 2.02).
- Financial information pertains to the fiscal year ending December 31, 2023.
- The report was filed on March 25, 2024.
Theriva Biologics announced that an Independent Data Monitoring Committee (IDMC) recommended continuing enrollment for its Phase 2b VIRAGE clinical trial. The committee found no safety concerns and confirmed the feasibility of repeated systemic dosing of VCN-01.
📋 Key Facts
- The IDMC recommended continuation of enrollment in the VIRAGE Phase 2b trial without protocol changes.
- The trial evaluates VCN-01 combined with gemcitabine/nab-paclitaxel for metastatic pancreatic ductal adenocarcinoma (PDAC).
- Clinical data showed no new safety concerns or additional toxicities from second doses of VCN-01.
- Enrollment is on track to complete in the first half of 2024.
- Trial sites are active across 6 locations in the U.S. and 9 locations in Spain.
Theriva Biologics, Inc. announced its intention to conduct several investor presentations over the coming weeks. The company provided a corporate presentation as an exhibit to facilitate these communications.
📋 Key Facts
- The company will be making multiple presentations to investors starting in January 2024.
- A corporate presentation dated January 2024 was furnished as Exhibit 99.1.
- Information provided under Item 7.01 is not considered 'filed' for purposes of Section 18 or liability under Sections 11 and 12(a)(2) of the Securities Act.