Full Press Release Details
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 Competition for
Merck KGaA's EMEA Advance Biotech Grant
ROCKVILLE, Md., November 12, 2024 (GLOBE NEWSWIRE) - Theriva
Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases
in areas of high unmet need, today reported financial results for the third quarter ended September 30, 2024, and provided a corporate
"We are very pleased to have completed enrollment in VIRAGE,
our Phase 2b trial in metastatic pancreatic ductal adenocarcinoma (PDAC) during the third quarter. Considering the tremendous need for
new therapies to treat pancreatic cancer, we have initiated discussions with regulatory agencies to explore the potential expansion of
the VIRAGE Phase 2b study into a registrational Phase 3 trial early next year, taking advantage of both Orphan Drug and Fast Track designations.
The novel mechanism of action of VCN-01 provides a unique opportunity to expand the treatment landscape in hard-to treat-cancers such
as PDAC and retinoblastoma and deliver new interventions that may significantly improve outcomes for patients, " said Steven A.
Shallcross, Chief Executive Officer of Theriva Biologics. "With funding from the Spanish Government and a small capital raise, we
are in a position to advance our proprietary suspension cell line towards larger scale manufacturing of VCN-01 for Phase 3 and commercial
Recent Program Highlights and Anticipated Milestones:
Pancreatic Ductal Adenocarcinoma (PDAC):
SYN-004 (ribaxamase):
Third Quarter Ended September 30, 2024 Financial Results
General and administrative expenses increased
to $2.3 million for the three months ended September 30, 2024, from $212,000 for the three months ended September 30, 2023. This increase
of 986% is primarily related to a $1.5 million decrease in contingent consideration during the three months ended September 30, 2023,
resulting in a reduction of prior period expenses and a $0.5 million increase in contingent consideration during the three months ended
September 30, 2024. Additionally, there was a decrease in investor relations expenses, Theriva S.L. expenses, and lower director
and officer insurance, offset by increased audit and registration fees. The charge related to stock-based compensation expense was $118,000
for the three months ended September 30, 2024, compared to $95,000 for the three months ended September 30, 2023.
Research and development expenses decreased to
$2.7 million for the three months ended September 30, 2024, from approximately $4.0 million for the three months ended September 30, 2023.
This decrease of 32% is primarily the result of lower clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in
PDAC, lower expenses related to our Phase 1a clinical trial of SYN-020 which has completed, and lower expenses to our Phase 1b/2a clinical
trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. We anticipate research and development expense to increase as we continue
our VIRAGE Phase 2 clinical trial of VCN-01 and plan for our Phase 3 clinical trial of VCN-01 in PDAC, advance our VCN-01 program in retinoblastoma,
expand GMP manufacturing activities for VCN-01, and continue supporting our other preclinical and discovery initiatives. The charge related
to stock-based compensation expense was $59,000 for the three months ended September 30, 2024, compared to $40,000 related to stock-based
compensation expense for the three months ended September 30, 2023.
During the three months ended September 30, 2024,
we experienced a sustained decline in the quoted market price of our Common Stock and we deemed this to be a triggering event for impairment.
We performed an interim impairment analysis using the "Income approach" that requires significant judgments, including primarily
the estimation of future development costs, the probability of success in various phases of our development programs, potential post-launch
cash flows and a risk-adjusted weighted average cost of capital. We concluded that the in-process R&D with a carrying value of $19.8
million was written down to its estimated fair value of $18.6 million and an impairment charge of $1.3 million was recorded, and goodwill
with a carrying value of $1.5 million was written down to its estimated fair value of zero and an impairment charge of $1.5 million was
recorded during the quarter. The decrease in the valuation was primarily driven by an increase in the discount rate which was impacted
by an increase in the company specific risk premium, and not by material changes to the clinical and administrative operations of the
Other income was $161,000 for the three months
ended September 30, 2024 compared to other income of $388,000 for the three months ended September 30, 2023. Other income for the three
months ended September 30, 2024 is primarily comprised of interest income of $158,000 and an exchange gain of $3,000. Other income for
the three months ended September 30, 2023 is primarily comprised of interest income of $382,000 and an exchange gain of $6,000.
Cash and cash equivalents totaled $16.4 million as of September 30,
2024, compared to $23.2 million as of December 31, 2023.
About Theriva Biologics, Inc.
Theriva Biologics (NYSE American: TOVX), is a diversified clinical-stage
company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a
new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve
access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient's
immune system. The Company's lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively
within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer
treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal
(GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci)
and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients;
and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and
intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics' website at www.therivabio.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such
as "may," "should," "potential," "continue," "expects," "anticipates,"
"intends," "plans," "believes," "estimates," and similar expressions, and include statements
regarding the novel mechanism of action of VCN-01 providing a unique opportunity to expand the treatment landscape in hard-to treat-cancers
such as PDAC and retinoblastoma and deliver new interventions that may significantly improve outcomes for patients; being in a position
to advance the Company's proprietary suspension cell line towards larger scale manufacturing of VCN-01 for Phase 3 and commercial
use; the potential expansion of the VIRAGE Phase 2b study into a Phase 3 registrational trial; the Company being eligible to receive
a Priority Review Voucher for VCN-01 for the treatment of retinoblastoma; and identifying sources of funding for SYN-004 to
undertake Cohort 3,. Important factors that could cause actual results to differ materially from current expectations include, among
others, the Company's and VCN's ability to reach clinical milestones when anticipated, including the ability generate clinical
data that establishes VCN-01 may lead to improved clinical outcomes for patients with PDAC and other solid cancers; the Company's
and VCN's product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results;
the ability to complete clinical trials on time and achieve the desired results and benefits; the ability to obtain regulatory approval
for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the
Company's and VCN's ability to promote or commercialize their product candidates for the specific indications, acceptance
of product candidates in the marketplace and the successful development, marketing or sale of the Company's and VCN's products,
developments by competitors that render such products obsolete or non-competitive, the Company's and VCN's ability to maintain
license agreements, the continued maintenance and growth of the Company's and VCN's patent estate, the ability to continue
to remain well financed and other factors described in the Company's Annual Report on Form 10-K for the year ended December 31,
2023 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information
in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking
statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
LifeSci Advisors, LLC
Condensed Consolidated Balance Sheet