Theriva Biologics Files 8-K
Ticker: TOVX · Form: 8-K · Filed: May 23, 2024 · CIK: 894158
| Field | Detail |
|---|---|
| Company | Theriva Biologics, Inc. (TOVX) |
| Form Type | 8-K |
| Filed Date | May 23, 2024 |
| Risk Level | low |
| Pages | 2 |
| Reading Time | 3 min |
| Key Dollar Amounts | $0.001 |
| Sentiment | neutral |
Sentiment: neutral
Topics: sec-filing, 8-k, regulatory
TL;DR
Theriva Biologics filed a routine 8-K, no major news.
AI Summary
Theriva Biologics, Inc. filed an 8-K on May 23, 2024, reporting on other events and financial statements. The company, formerly known as Synthetic Biologics, Inc., is incorporated in Nevada and operates in the pharmaceutical preparations sector. The filing does not disclose specific financial figures or material events beyond its routine reporting nature.
Why It Matters
This filing indicates Theriva Biologics is meeting its SEC reporting obligations, which is standard for publicly traded companies. It does not contain new material information that would immediately impact investors.
Risk Assessment
Risk Level: low — The filing is a standard 8-K report and does not contain any new material information, significant financial changes, or strategic announcements that would inherently increase risk.
Key Players & Entities
- Theriva Biologics, Inc. (company) — Registrant
- Synthetic Biologics, Inc. (company) — Former company name
- May 23, 2024 (date) — Date of earliest event reported
FAQ
What is the primary purpose of this 8-K filing for Theriva Biologics, Inc.?
This 8-K filing serves as a Current Report for Theriva Biologics, Inc., covering items related to Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits, as of May 23, 2024.
What was Theriva Biologics, Inc. previously known as?
Theriva Biologics, Inc. was formerly known as Synthetic Biologics, Inc., with a date of name change on March 5, 2012.
In which state is Theriva Biologics, Inc. incorporated?
Theriva Biologics, Inc. is incorporated in Nevada.
What is the Standard Industrial Classification (SIC) code for Theriva Biologics, Inc.?
The Standard Industrial Classification code for Theriva Biologics, Inc. is 2834, which corresponds to Pharmaceutical Preparations.
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.
Filing Stats: 741 words · 3 min read · ~2 pages · Grade level 11.7 · Accepted 2024-05-23 08:20:22
Key Financial Figures
- $0.001 — h registered Common stock, par value $0.001 per share TOVX NYSE American Indica
Filing Documents
- tm2415354d1_8k.htm (8-K) — 27KB
- tm2415354d1_ex99-1.htm (EX-99.1) — 14KB
- tm2415354d1_ex99-1img01.jpg (GRAPHIC) — 12KB
- 0001104659-24-064544.txt ( ) — 235KB
- syn-20240523.xsd (EX-101.SCH) — 3KB
- syn-20240523_lab.xml (EX-101.LAB) — 33KB
- syn-20240523_pre.xml (EX-101.PRE) — 22KB
- tm2415354d1_8k_htm.xml (XML) — 4KB
01. Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure. On May 23, 2024, Theriva Biologics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the Company's ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for treatment of PDAC. 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 "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes "safe harbor" language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are "forward-looking" rather than historical.
01. Other Events
Item 8.01. Other Events. On May 23, 2024, the Company issued a press release announcing that the FDA has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the Company's ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for treatment of PDAC.
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 May 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: May 23, 2024 THERIVA BIOLOGICS, INC. By: /s/ Steven A. Shallcross Name: Steven A. Shallcross Title: Chief Executive Officer and Chief Financial Officer