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

TL;DR

Theriva Biologics dropped an 8-K on Oct 3rd covering Reg FD and other events. Check it out.

AI Summary

On October 3, 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, formerly known as Synthetic Biologics, Inc., is incorporated in Nevada and headquartered in Rockville, MD.

Why It Matters

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

Risk Assessment

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

Key Players & Entities

• Theriva Biologics, Inc. (company) — Registrant
• Synthetic Biologics, Inc. (company) — Former company name
• October 3, 2024 (date) — Date of earliest event reported
• Nevada (jurisdiction) — State of incorporation
• Rockville, MD (location) — Business address

FAQ

Key Financial Figures

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

Filing Documents

• tm2425487d1_8k.htm (8-K) — 34KB
• tm2425487d1_ex99-1.htm (EX-99.1) — 20KB
• image_001.jpg (GRAPHIC) — 4KB
• image_002.jpg (GRAPHIC) — 4KB
• image_003.jpg (GRAPHIC) — 4KB
• image_004.jpg (GRAPHIC) — 4KB
• 0001104659-24-105634.txt ( ) — 254KB
• syn-20241003.xsd (EX-101.SCH) — 3KB
• syn-20241003_lab.xml (EX-101.LAB) — 33KB
• syn-20241003_pre.xml (EX-101.PRE) — 22KB
• tm2425487d1_8k_htm.xml (XML) — 4KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On October 3, 2024, Theriva Biologics, Inc. (the "Company") issued a press release announcing a positive outcome from the Data and Safety Monitoring Committee ("DSMC") review of results from the second Cohort of the Company's Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant ("HCT") recipients for the prevention of acute graft-versus-host-disease. Based on a review of the safety and pharmacokinetic data, the DSMC has recommended that the study may proceed to enroll Cohort 3 in which study drug (SYN-004 or Placebo) will be administered in combination with the IV beta-lactam antibiotic cefepime. The Company is pursuing additional funding to enable the conduct of the third cohort The Phase 1b/2a study is on-going and remains blinded; however, key findings from blinded data for Cohort 2 are included below: Adverse events ("AEs") and serious adverse events ("SAEs") observed in Cohort 2 were typical of those observed in allo-HCT patients and no AEs or SAEs were determined by the investigators to be related to study drug treatment. o A total of 15 SAEs were reported among 10 patients, with the most common SAE being infections and infestations, including sepsis. o No patients died within the 30-day follow-up period after the last dose of study drug; 1 patient died 95 days and another 211 days after the last dose of study drug due to cancer relapse and pneumonia respectively (not related to study drug). Consistent with the findings from Cohort 1 and previous studies of SYN-004 in healthy volunteers, no patient blood samples were positive for SYN-004 at any timepoint. The pharmacokinetics of piperacillin, which can be metabolized by SYN-004, were as expected for this patient population. The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be "fil

01. Other Events

Item 8.01. Other Events. On October 3, 2024, the Company issued a press release announcing a positive outcome from the DSMC review of results from the second Cohort of the Company's Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant recipients for the prevention of acute graft-versus-host-disease.. Based on a review of the safety and pharmacokinetic data, the DSMC has recommended that the study may proceed to enroll Cohort 3 in which study drug (SYN-004 or Placebo) will be administered in combination with the IV beta-lactam antibiotic cefepime. The Company is pursuing additional funding to enable the conduct of the third cohort The Phase 1b/2a study is on-going and remains blinded; however, key findings from blinded data for Cohort 2 are included below: Adverse events ("AEs") and serious adverse events ("SAEs") observed in Cohort 2 were typical of those observed in allo-HCT patients and no AEs or SAEs were determined by the investigators to be related to study drug treatment. o A total of 15 SAEs were reported among 10 patients, with the most common SAE being infections and infestations, including sepsis. o No patients died within the 30-day follow-up period after the last dose of study drug; 1 patient died 95 days and another 211 days after the last dose of study drug due to cancer relapse and pneumonia respectively (not related to study drug). Consistent with the findings from Cohort 1 and previous studies of SYN-004 in healthy volunteers, no patient blood samples were positive for SYN-004 at any timepoint. The pharmacokinetics of piperacillin, which can be metabolized by SYN-004, were as expected for this patient population.

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 October 3, 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: October 3, 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