Theriva Biologics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

$TOVX
Biotechnology: Pharmaceutical Preparations
Health Care
Get the next $TOVX alert in real time by email
false 0000894158 0000894158 2024-10-16 2024-10-16 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 16, 2024

 

THERIVA BIOLOGICS, INC.

(Exact name of registrant as specified in its charter)

 

Nevada   001-12584   13-3808303
(State or other jurisdiction of
incorporation)
  (Commission File No.)   (IRS Employer Identification
No.)

 

9605 Medical Center Drive, Suite 270

Rockville, Maryland 20850

(Address of principal executive offices and zip code)

 

(301) 417-4364

Registrant’s telephone number, including area code

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
¨ Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)
   
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on
which registered
Common stock, par value $0.001 per share TOVX NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

Item 7.01. Regulation FD Disclosure.

 

On October 16, 2024, Theriva Biologics, Inc. (the “Company”) issued a press release announcing that the European Commission has adopted the European Medicines Agency (“EMA”) recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, the Company’s systemic, selective, stroma-degrading oncolytic adenovirus, for the treatment of retinoblastoma.

 

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.

 

Item 8.01. Other Events. 

 

On October 16, 2024, the Company issued a press release announcing that the European Commission has adopted the EMA recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, the Company’s systemic, selective, stroma-degrading oncolytic adenovirus, for the treatment of retinoblastoma.

 

Item 9.01. Financial Statements and Exhibits.

 

(d)   Exhibits.

 

Exhibit
Number
  Description
99.1   Press Release issued by Theriva Biologics, Inc., dated October 16, 2024
104   Cover Page Interactive Data File (embedded within the XBRL document)

 

 

 

 

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 16, 2024 THERIVA BIOLOGICS, INC.
   
  By: /s/ Steven A. Shallcross
    Name: Steven A. Shallcross
    Title: Chief Executive Officer and Chief Financial Officer

 

 

 

Get the next $TOVX alert in real time by email

Chat with this insight

Save time and jump to the most important pieces.

Recent Analyst Ratings for
$TOVX

DatePrice TargetRatingAnalyst
More analyst ratings

$TOVX
Press Releases

Fastest customizable press release news feed in the world

See more
  • Theriva™ Biologics Announces U.S. FDA Guidance on Design of Phase 3 Study of VCN-01 for the Treatment of Metastatic Pancreatic Cancer

    ROCKVILLE, Md., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE:TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the outcomes of a recent Type D meeting with the U.S. Food and Drug Administration (FDA) to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC). The Company recently announced the completion of target enrollment into the multinational VIRAGE Phase 2b clinical study evaluating intravenous VCN-01 in combinatio

    $TOVX
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Theriva™ Biologics Reports Third Quarter 2024 Operational Highlights and Financial Results

    Target patient enrollment of 92 evaluable patients achieved in the VIRAGE Phase 2b clinical trial of VCN-01 in patients with metastatic pancreatic ductal adenocarcinoma Manufacturing funding awarded by the Spanish Government's National Knowledge Transfer Program Data and Safety Monitoring Committee Review of Phase 1b/2a SYN-004 in allogeneic hematopoietic cell transplant recipients recommends expansion to Cohort 3 Orphan Medicinal Product Designation granted by the European Commission to VCN-01 for the treatment of retinoblastoma Rare Pediatric Disease Designation granted by the FDA for the treatment of retinoblastoma Placed Second in International Competit

    $TOVX
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Theriva Biologics Selected as Finalist in International Competition for Merck KGaA's EMEA Advance Biotech Grant

    ROCKVILLE, Md., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE:TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced selection as one of five finalists for Merck KGaA's EMEA Advance Biotech Grant. Finalists for the grant will present to a six-judge panel from Merck's Emerging Biotech group during BIO Europe 2024 in Stockholm, Sweden. Manel Cascalló, PhD., General Director - EU Subsidiary, Theriva Biologics, will present an overview of VCN-01, currently being studied in a Phase 2b clinical trial in first-line metastatic pancreatic cancer in combination with standard-of-care

    $TOVX
    Biotechnology: Pharmaceutical Preparations
    Health Care

$TOVX
SEC Filings

See more

$TOVX
Leadership Updates

Live Leadership Updates

See more
  • Theriva Biologics Announces Appointment of Ramon Alemany, Ph.D., to Senior Vice President of Discovery

    -Appointment expected to aid advancement of Theriva's discovery program and strengthen collaboration with the Institut Catala d'Oncologia (ICO) and the Biomedical Research Institute of Bellvitge (IDIBELL)- ROCKVILLE, Md., May 23, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE:TOVX), ("Theriva" or the "Company"), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the appointment of Dr. Ramon Alemany as Senior Vice President of Discovery, effective immediately. Dr. Alemany will oversee Theriva's discovery and development pipeline and will continue to serve as Chair of the Scientific Advisory Board. D

    $TOVX
    Biotechnology: Pharmaceutical Preparations
    Health Care

$TOVX
Financials

Live finance-specific insights

See more
  • Theriva™ Biologics Reports Full-Year 2023 Operational Highlights and Financial Results

    – The independent data monitoring committee (IDMC) recommended the continuation of VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma (PDAC), with no safety concerns raised - - VIRAGE remains on track to complete enrollment in the first half of 2024- - As of December 31, 2023, Theriva Biologics reports $23.2 million in cash, which is expected to provide runway into the first quarter of 2025 - - Conference call and webcast to be held on Monday, March 25 at 8:30 a.m. ET - ROCKVILLE, Md., March 25, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE:TOVX), a diversified clinical-stage company developing ther

    $TOVX
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Theriva™ Biologics to Host Conference Call and Webcast to Discuss Full Year 2023 Operational Highlights and Financial Results

    ROCKVILLE, Md., March 19, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE:TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that it plans to host a conference call on Monday, March 25, 2024, at 8:30 a.m. ET to discuss its financial results for the full year ended December 31, 2023 and provide a corporate update. Individuals may participate in the live call via telephone by dialing 1-877-451-6152 (domestic) or 1-201-389-0879 (international) and using the conference ID: 13744453. Participants are asked to dial-in 15 minutes before the start of the call to register. Investors and th

    $TOVX
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Theriva™ Biologics Reports Third Quarter 2023 Operational Highlights and Financial Results

    - VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma remains on track to complete enrollment in the first half of 2024; multiple patients have received second doses of VCN-01, which continues to be well tolerated with a safety profile consistent with prior clinical trials - - Presented survival outcomes data from the Phase 1 investigator-sponsored study evaluating VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck at the European Society for Medical Oncology (ESMO) Congress 2023 - - Data from the Phase 1 investigator-sponsored stu

    $TOVX
    Biotechnology: Pharmaceutical Preparations
    Health Care

$TOVX
Large Ownership Changes

This live feed shows all institutional transactions in real time.

See more