Theriva Biologics Files 8-K with Financials
Ticker: TOVX · Form: 8-K · Filed: Oct 14, 2025 · CIK: 894158
| Field | Detail |
|---|---|
| Company | Theriva Biologics, Inc. (TOVX) |
| Form Type | 8-K |
| Filed Date | Oct 14, 2025 |
| Risk Level | low |
| Pages | 5 |
| Reading Time | 6 min |
| Key Dollar Amounts | $0.001 |
| Sentiment | neutral |
Sentiment: neutral
Topics: financial-statements, 8-k, company-history
TL;DR
Theriva Biologics dropped an 8-K, mostly financials. Check it out.
AI Summary
On October 13, 2025, Theriva Biologics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. 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 updated financial information and disclosures for Theriva Biologics, Inc., which is crucial for investors to assess the company's current financial health and operational status.
Risk Assessment
Risk Level: low — This filing is a routine 8-K reporting financial statements and other events, not indicating any immediate significant 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
- October 13, 2025 (date) — Date of earliest event reported
FAQ
What is the primary purpose of this 8-K filing for Theriva Biologics, Inc.?
The primary purpose of this 8-K filing is to report financial statements and exhibits, along with other events and a Regulation FD disclosure, as of October 13, 2025.
What was Theriva Biologics, Inc. previously named?
Theriva Biologics, Inc. was formerly known as Synthetic Biologics, Inc., Adeona Pharmaceuticals, Inc., and PipEx Pharmaceuticals, Inc.
In which state is Theriva Biologics, Inc. incorporated?
Theriva Biologics, Inc. is incorporated in Nevada.
What is the business address of Theriva Biologics, Inc.?
The business address of Theriva Biologics, Inc. is 9605 Medical Center Drive, Suite 270, Rockville, MD 20850.
What is the IRS Employer Identification Number for Theriva Biologics, Inc.?
The IRS Employer Identification Number for Theriva Biologics, Inc. is 13-3808303.
Filing Stats: 1,389 words · 6 min read · ~5 pages · Grade level 6.3 · Accepted 2025-10-14 06:06:16
Key Financial Figures
- $0.001 — ch registered Common stock, par value $0.001 per share TOVX NYSE American Indica
Filing Documents
- tm2528558d1_8k.htm (8-K) — 69KB
- tm2528558d1_ex99-1.htm (EX-99.1) — 15KB
- tm2528558d1_ex99-2.htm (EX-99.2) — 22KB
- tm2528558d1_ex99-1img001.jpg (GRAPHIC) — 5KB
- 0001104659-25-098882.txt ( ) — 289KB
- syn-20251013.xsd (EX-101.SCH) — 3KB
- syn-20251013_lab.xml (EX-101.LAB) — 33KB
- syn-20251013_pre.xml (EX-101.PRE) — 22KB
- tm2528558d1_8k_htm.xml (XML) — 4KB
01. Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure. On October 13, 2025, Theriva Biologics, Inc. (the "Company") issued a press release announcing the presentation on October 20, 2025 of expanded metastatic pancreatic ductal adenocarcinoma (mPDAC) data from the VIRAGE Phase 2b trial (NCT05673811) at the European Society for Medical Oncology (ESMO 2025) Annual Congress. The press release also announced a separate poster presentation on the same day describing previously reported data for SYN-004 (ribaxamase) in allogeneic hematopoietic transplant recipients at Infectious Diseases Week (IDWeek) 2025 Annual Meeting. Results from the VIRAGE Phase 2b trial included in the abstract are set forth below: 112 patients were randomized. Patients in the modified intent to treat (mITT) population received at least 1 dose of gemcitabine/nab-paclitaxel (GA) standard of care chemotherapy (GA, Arm I) or VCN-01 (Arm II). Patients in the full analysis set (FAS) population received at least 1 dose of gemcitabine/nab-paclitaxel standard of care chemotherapy (GA; Arm I) or VCN-01 followed by at least 1 dose of GA (Arm II). mITT FAS Arm I (48) Arm II (53) HR (95% CI) Arm I (48) Arm II (48) HR (95% CI) OS mo. 8.6 10.6 0.69 (0.42-1.12) P =0.196 8.6 10.8 0.57 (0.34-0.96) P =0.055 PS mo. 4.6 5.6 0.63 (0.4-1.0) P =0.047 4.6 7.0 0.55 (0.34-0.88) P =0.011 DoR mo. 5.4 11.2 0.22 (0.08-0.62) P =0.004 5.4 11.2 0.22 (0.08-0.62) P =0.004 ORR 31.3% 35.8% 31.3% 39.6% Definitions -mo. (Months). OS (overall survival). PS or PFS (progression free survival). DoR (duration of response). ORR (objective response rate). HR (hazard ratio). CI (confidence interval). Compared to patients who started GA cycle 4 alone (Arm I), patients who received 2 VCN-01 doses and started GA cycle 4 (Arm II) showed greater improvement in OS (14.8 vs 11.6 months; HR 0.44; 95% CI 0.21 - 0.92; P =0.046) and PFS (11.2 vs 7.4 months; HR 0.48; 95% CI 0.25 - 0.91; P =0
01. Other Events
Item 8.01. Other Events. On October 13, 2025, the Company issued a press release announcing the presentation on October 20, 2025 of expanded metastatic pancreatic ductal adenocarcinoma (mPDAC) data from the VIRAGE Phase 2b trial (NCT05673811) at ESMO 2025. Results from the abstract for the VIRAGE Phase 2b trial are set forth below. 112 patients were randomized. Patients in the modified intent to treat (mITT) population received at least 1 dose of GA (Arm I) or VCN-01 (Arm II). Patients in the full analysis set (FAS) population received at least 1 dose of gemcitabine/nab-paclitaxel standard of care chemotherapy (GA; Arm I) or VCN-01 followed by at least 1 dose of GA (Arm II). mITT FAS Arm I (48) Arm II (53) HR (95% CI) Arm I (48) Arm II (48) HR (95% CI) OS mo. 8.6 10.6 0.69 (0.42-1.12) P =0.196 8.6 10.8 0.57 (0.34-0.96) P =0.055 PS mo. 4.6 5.6 0.63 (0.4-1.0) P =0.047 4.6 7.0 0.55 (0.34-0.88) P =0.011 DoR mo. 5.4 11.2 0.22 (0.08-0.62) P =0.004 5.4 11.2 0.22 (0.08-0.62) P =0.004 ORR 31.3% 35.8% 31.3% 39.6% Definitions: mo.(months). OS (overall survival). PS or PFS (progression free survival). DoR (duration of response). ORR (objective response rate). HR (hazard ratio). CI (confidence interval) Compared to patients who started GA cycle 4 alone (Arm I), patients who received 2 VCN-01 doses and started GA cycle 4 (Arm II) showed greater improvement in OS (14.8 vs 11.6 months; HR 0.44; 95% CI 0.21 - 0.92; P =0.046) and PFS (11.2 vs 7.4 months; HR 0.48; 95% CI 0.25 - 0.91; P =0.017). VCN-01 administration was well tolerated. All VCN- 01-related serious adverse events (n=13) were resolved, the most common being flu-like symptoms (13,2%), transaminase increase (5.7%) and drug-induced liver injury (3.8%). Viral genome analysis confirmed the bioactivity of the second VCN-01 dose. The study met its primary endpoints. Patients receiving VCN-01 + GA had improved OS, PFS and DoR compared to GA stan
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 13, 2025 99.2 Abstract: "VIRAGE trial: randomized Phase IIb, open-label, study of Nab-Paclitaxel and Gemcitabine with/without intravenous VCN-01 in Patients with Metastatic Pancreatic Cancer (mPDAC)" 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 14, 2025 THERIVA BIOLOGICS, INC. By: /s/ Steven A. Shallcross Name: Steven A. Shallcross Title: Chief Executive Officer and Chief Financial Officer