Theriva Biologics Files 8-K with Financials

TL;DR

Theriva Biologics dropped an 8-K with financials and other disclosures. Check it out.

AI Summary

On April 22, 2024, Theriva Biologics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, and also includes a Regulation FD Disclosure and Other Events. Theriva Biologics, Inc. was formerly known as Synthetic Biologics, Inc. and ADEONA PHARMACEUTICALS, INC.

Why It Matters

This filing provides updated financial information and disclosures for Theriva Biologics, Inc., which is important for investors to assess the company's current financial health and any material events.

Risk Assessment

Risk Level: low — This is a routine filing of financial statements and disclosures, not indicating any immediate operational or financial distress.

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 22, 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

• tm2412300d1_8k.htm (8-K) — 36KB
• tm2412300d1_ex99-1.htm (EX-99.1) — 17KB
• tm2412300d1_ex99-2.htm (EX-99.2) — 6KB
• image_005.jpg (GRAPHIC) — 141KB
• tm2412300d1_ex99-1img001.jpg (GRAPHIC) — 13KB
• 0001104659-24-050037.txt ( ) — 450KB
• syn-20240422.xsd (EX-101.SCH) — 3KB
• syn-20240422_lab.xml (EX-101.LAB) — 33KB
• syn-20240422_pre.xml (EX-101.PRE) — 22KB
• tm2412300d1_8k_htm.xml (XML) — 4KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On April 22, 2024, Theriva Biologics, Inc. (the "Company") issued a press release announcing the presentation of preclinical data demonstrating enhanced anti-tumor effects in human pancreatic cancer xenograft-bearing mice treated with lead product candidate VCN-01 and liposomal irinotecan. These data support the potential synergy of VCN-01 and first-line pancreatic cancer chemotherapy regimens, and will be featured in a poster presentation at the American Society for Cell and Gene Therapy (the "ASGCT")) 27 th Annual Meeting on May 10, 2024. Key takeaways include: Overview: The combination of VCN-01 + topoisomerase I (topo1) inhibitors, such as liposomal irinotecan, has a tolerable toxicity profile and may improve the efficacy in the treatment of human pancreatic cancer. In vitro: Viral protein expression was increased in human pancreatic cancer cell lines when they were exposed to topo1 inhibiting chemotherapeutics, irinotecan, its active metabolite, SN-38, and topotecan. In vivo: Synergy of VCN-01 plus liposomal irinotecan was observed in animals bearing subcutaneous human pancreatic tumors. o In human pancreatic mouse xenograft models, treatment with VCN-01 at a dose of 4x10 10 vp or liposomal irinotecan alone (at both the 10 mg/kg and 5 mg/kg doses) resulted in significant tumor growth inhibition compared to saline. o Combination therapy with VCN-01 + liposomal irinotecan at either dose displayed significantly reduced tumor growth compared to each treatment alone. o qPCR analyses performed on tumors collected at end of study confirmed the presence of viral genomes, indicating ongoing transcriptional activity of VCN-01, which is consistent with viral replication for several days after administration. The full abstract for the poster presentation has been released by the ASGCT. A copy of the abstract titled "Enhanced Anti-Tumor Efficacy of Combination Therapy with the Oncolytic Adenovirus, VCN-01, and Liposomal I

01. Other Events

Item 8.01. Other Events. On April 22, 2024, the Company issued a press release announcing the presentation of preclinical data demonstrating enhanced anti-tumor effects in a human pancreatic mouse xenograft treated with lead product candidate, VCN-01 and liposomal irinotecan. These data support the potential synergy of VCN-01 and first-line pancreatic cancer chemotherapy regimens Key takeaways include: Overview: The combination of VCN-01 + topo1 inhibitors, such as liposomal irinotecan, has a tolerable toxicity profile and may improve the efficacy in the treatment of human pancreatic cancer. In vitro: Viral protein expression was increased in human pancreatic cancer cell lines when they were exposed to topoisomerase I (topo1) inhibiting chemotherapeutics, irinotecan, its active metabolite, SN-38, and topotecan. In vivo: Synergy of VCN-01 plus liposomal irinotecan was observed in animals bearing subcutaneous human pancreatic tumors. o In human pancreatic mouse xenograft models, treatment with VCN-01 at a dose of 4x10 10 vp or liposomal irinotecan alone (at both the 10 mg/kg and 5 mg/kg doses) resulted in significant tumor growth inhibition compared to saline. o Combination therapy with VCN-01 + liposomal irinotecan at either dose displayed significantly reduced tumor growth compared to each treatment alone. o qPCR analyses performed on tumors collected at end of study confirmed the presence of viral genomes, indicating ongoing transcriptional activity of VCN-01, which is consistent with viral replication for several days after administration. The full abstract for the poster presentation has been released by the ASGCT. The poster will be presented at the ASGCT 27 th Annual Meeting on May 10, 2024

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description 99.1 99.2 Press Release issued by Theriva Biologics, Inc., dated April 22, 2024 Abstract titled "Enhanced Anti-Tumor Efficacy of Combination Therapy with the Oncolytic Adenovirus, VCN-01, and Liposomal Irinotecan in a Human Pancreatic Mouse Xenograft ." 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 22, 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