Full Press Release Details
Theriva Biologics Reports Full-Year 2024
Operational Highlights and Financial Results
- Enrollment completed in VIRAGE Phase 2b
clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC); topline data expected in Q2 2025 -
- VCN-01 development bolstered by FDA award of Fast
Track designation for the treatment of PDAC and Rare Pediatric Disease designation for retinoblastoma -
- Received guidance from the FDA and EMA
on Phase 3 pivotal trial design for VCN-01 in combination with standard-of-care chemotherapy for metastatic PDAC -
-- As of December 31, 2024, Theriva
Biologics reports $11.6 million in cash, which is expected to provide runway into Q3 2025 -
ROCKVILLE, MD., March 6, 2025 (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 full-year ended December 31, 2024, and provided a corporate update.
"We are very pleased with our clinical and regulatory achievements
in 2024," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "The VIRAGE Phase 2b clinical trial of
our unique, stroma-degrading, oncolytic virus VCN-01in metastatic PDAC is nearing a topline data readout. Should this trial be successful,
our interactions with regulatory agencies in the USA and Europe have provided us with clear direction on the path forward to a potential
pivotal trial for VCN-01 in this indication. As PDAC incidence increases worldwide, the need for new therapies to treat this deadly disease
is even more urgent."
Recent Program Highlights and Anticipated Milestones:
Pancreatic Ductal Adenocarcinoma (PDAC):
In September 2024, we were awarded manufacturing funding from the
Spanish government's National Knowledge Transfer Program. Theriva Biologics and the Universitat Aut noma de Barcelona (UAB)
were awarded a total of 2.28 million (approximately $2.54 million), of which the Company received a loan of 1.33 million
(approximately $1.48 million) on January 17, 2025, which shall be repaid over 7 years commencing three years
from the date of award and UAB will receive a grant of 0.95 million (approximately $1.06 million) dedicated to the THERICEL project
and paid in annual installments over the next 3 years. The THERICEL project is intended to establish the viability of using Theriva's
proprietary A549 suspension cells for the clinical manufacture of adenoviral and AAV therapies.
In 2024, we recognized a tax credit receivable and offsetting deferred
R&D tax credit of $1.8 million from the Spanish government for reimbursement of certain expenses incurred in research and development
Full-Year Ended December 31, 2024 Financial Results
General and administrative expenses increased
to $7.4 million for the year ended December 31, 2024, from $7.1 million for the year ended December 31, 2023. This increase of 4% is primarily
comprised of the contingent consideration adjustment of $700,000 in the current year compared to a decrease of $660,000 in the prior,
year having a cumulative impact to general and administration expenses of $1.4 million, offset by a decrease in compensation costs, consulting
fees, and lower director and officer insurance. The charge relating to stock-based compensation expense was $438,000 for the year ended
December 31, 2024, compared to $388,000 for the year ended December 31, 2023.
Research and development expenses decreased to
$12.0 million for the year ended December 31, 2024, from $14.3 million for the year ended December 31, 2023. This decrease of 16% 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, decreased expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic
HCT recipients, and the recognition of the research and development tax credit, offset by increased expenses related to the Phase 1 trial
of intravitreal VCN-01 in patients with retinoblastoma. We anticipate research and development expense to increase as we complete 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 scale-up manufacturing activities for VCN-01, and continue supporting our other preclinical and discovery initiatives. Research
and development expenses also include a charge relating to non-cash stock-based compensation expense of $233,000 for the year ended December
31, 2024, compared to $165,000 for the year ended December 31, 2023.
Other income was $693,000 for the year ended December
31, 2024, compared to other income of $1,442,000 for the year ended December 31, 2023. Other income for the year ended December 31, 2024
is primarily comprised of interest income of $697,000 and an exchange loss of $4,000. Other income for the year ended December 31, 2023
is primarily comprised of interest income of $1,439,000 offset by an exchange gain of $3,000.
Cash and cash equivalents totaled $11.6 million as of December 31,
2024, compared to $23.2 million as of December 31, 2023.
The audited financial statements for the year ended December 31, 2024
included in the Company's Annual Report on Form 10-K contain an audit opinion from the Company's independent registered public
accounting firm that includes an explanatory paragraph related to the Company's ability to continue as a going concern.
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 topline data expected in Q2 2025; cash runway into Q3 2025;the outcomes of a second Data Monitoring Committee review of safety
data from the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma expected in Q2 2025 ; having clear
direction on the path forward to a potential pivotal trial for VCN-01 in PDAC should the VIRAGE Phase 2b trial be successful; the potential
pivotal Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy gemcitabine/nab-paclitaxel
for the treatment of metastatic PDAC; an End-of-Phase 2 meeting with the FDA to discuss the proposed Phase 3 study being requested before
the end of 2025; preparing the clinical study report from the investigator sponsored Phase 1 trial of intravitreal VCN-01 in pediatric
patients with refractory retinoblastoma conducted at Sant Joan de D u-Barcelona Children's Hospital; continuing discussions
with key opinion leaders for developing a potential pivotal trial protocol for retinoblastoma; obtaining grant funding or finding a licensee
or partner for the SYN-004 development program; the THERICEL project establishing the viability of using Theriva's proprietary A549
suspension cells for the clinical manufacture of adenoviral and AAV therapies; anticipated increase in research and development expense
as the Company completes its VIRAGE Phase 2 clinical trial of VCN-01 and plans for its Phase 3 clinical trial of VCN-01 in PDAC, advances
its VCN-01 program in retinoblastoma, expands GMP scale-up manufacturing activities for VCN-01, and continues supporting its other preclinical
and discovery initiatives. Important factors that could cause actual results to differ materially from current expectations include, among
others, the topline data being positive for the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma ;
Company's ability to effectively design the pivotol trial for VCN-01 in PDAC; the Company's and VCN's ability to reach
clinical milestones when anticipated, including the ability to continue to enroll patients as planned, generating positive clinical data
when anticipated (including from the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma) 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 Company's ability
to complete clinical trials on time and achieve the desired results and benefits; the Company's 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; the ability to find licensees and grant funding for the SYN-004 development program and other factors described
in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and its other filings with the SEC, including