Theriva Biologics Files 8-K: Regulation FD, Other Events

TL;DR

Theriva Biologics filed an 8-K on 4/23 for Reg FD and other events. Formerly Synthetic Biologics.

AI Summary

On April 23, 2024, Theriva Biologics, Inc. filed an 8-K report detailing a Regulation FD Disclosure and Other Events. The filing also includes financial statements and exhibits. Theriva Biologics, Inc. was formerly known as Synthetic Biologics, Inc., Adeona Pharmaceuticals, Inc., and Pipex Pharmaceuticals, Inc.

Why It Matters

This 8-K filing provides important updates and disclosures for Theriva Biologics, Inc., which may impact investor understanding of the company's current status and regulatory compliance.

Risk Assessment

Risk Level: low — This filing is a routine 8-K report and does not appear to contain significant negative news or events.

Key Players & Entities

• Theriva Biologics, Inc. (company) — Registrant
• Synthetic Biologics, Inc. (company) — Former company name
• Adeona Pharmaceuticals, Inc. (company) — Former company name
• Pipex Pharmaceuticals, Inc. (company) — Former company name
• April 23, 2024 (date) — Date of earliest event reported

FAQ

Key Financial Figures

• $0.001 — ch registered Common stock, par value $0.001 per share TOVX NYSE American Indica

Filing Documents

• tm2412300d2_8k.htm (8-K) — 32KB
• tm2412300d2_ex99-1.htm (EX-99.1) — 16KB
• image_001.jpg (GRAPHIC) — 4KB
• image_002.jpg (GRAPHIC) — 4KB
• image_003.jpg (GRAPHIC) — 4KB
• 0001104659-24-050307.txt ( ) — 242KB
• syn-20240423.xsd (EX-101.SCH) — 3KB
• syn-20240423_lab.xml (EX-101.LAB) — 33KB
• syn-20240423_pre.xml (EX-101.PRE) — 22KB
• tm2412300d2_8k_htm.xml (XML) — 4KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On April 23, 2024, Theriva Biologics, Inc. (the "Company") issued a press release announcing positive topline data from the investigator sponsored Phase 1 Trial of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma. Safety and clinical outcomes support the therapeutic potential of VCN-01 in retinoblastoma and emphasize VCN-01's potential for use in diverse cancer. The Monitoring Committee determined that the trial results were positive, and therefore, the Company will receive an exclusive, worldwide license, and related patents from Sant Joan de Du-Barcelona Children's Hospital for the treatment of pediatric patients with advanced retinoblastoma. Key Takeaways: Patients received two intravitreal injections of VCN-01, 14 days apart, at a dose of either 2 x 10 9 vp/eye (n=1) or 2 x 10 10 vp/eye (n=8). The data for 9 evaluable patients were reviewed by the study Monitoring Committee who agreed that the trial had a positive outcome: Safety : VCN-01 was well tolerated after intravitreal administration at the 2 doses and the most frequently reported treatment-related adverse events were Grade 1 or 2. There were no dose limiting toxicities and no ocular or systemic toxicities equal to or greater than Grade 3 during the evaluation period. o Some degree of ocular inflammation and associated turbidity was observed after VCN-01 injection. Inflammation was managed, and vitreous haze improved in some cases, by local and systemic administration of anti-inflammatory drugs. Antitumor effects: intravitreal VCN-01 demonstrated promising antitumor activity and did not appear to change the retinal function. o Four patients presented a response characterized by unequivocal improvement in vitreous seed density. o Eye enucleation was avoided in 3 patients to date, one of whom has retained their eye after 4 years of follow-up.

01. Other Events

Item 8.01. Other Events. On April 23, 2024, the Company issued a press release announcing positive topline data from the investigator sponsored Phase 1 Trial of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma. Safety and clinical outcomes support the therapeutic potential of VCN-01 in retinoblastoma and emphasize VCN-01's potential for use in diverse cancer. The Monitoring Committee determined that the trial results were positive, and therefore, the Company will receive an exclusive, worldwide license, and related patents from Sant Joan de Du-Barcelona Children's Hospital for the treatment of pediatric patients with advanced retinoblastoma. Key Takeaways: Patients received two intravitreal injections of VCN-01, 14 days apart, at a dose of either 2 x 10 9 vp/eye (n=1) or 2 x 10 10 vp/eye (n=8). The data for 9 evaluable patients were reviewed by the study Monitoring Committee who agreed that the trial had a positive outcome: Safety : VCN-01 was well tolerated after intravitreal administration at the 2 doses and the most frequently reported treatment-related adverse events were Grade 1 or 2. There were no dose limiting toxicities and no ocular or systemic toxicities equal to or greater than Grade 3 during the evaluation period. o Some degree of ocular inflammation and associated turbidity was observed after VCN-01 injection. Inflammation was managed, and vitreous haze improved in some cases, by local and systemic administration of anti-inflammatory drugs. Antitumor effects: intravitreal VCN-01 demonstrated promising antitumor activity and did not appear to change the retinal function. o Four patients presented a response characterized by unequivocal improvement in vitreous seed density. o Eye enucleation was avoided in 3 patients to date, one of whom has retained their eye after 4 years of follow-up.

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description 99.1 Press Release issued by Theriva Biologics, Inc., dated April 23, 2024 104 Cover Page Interactive Data File (embedded within the XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: April 23, 2024 THERIVA BIOLOGICS, INC. By: /s/ Steven A. Shallcross Name: Steven A. Shallcross Title: Chief Executive Officer and Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR