Full Press Release Details
Theriva Biologics Reports Second Quarter
2024 Operational Highlights and Financial Results
- VIRAGE, the Phase 2b clinical trial of VCN-01
in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma (PDAC), is expected to complete enrollment in the third
- Received Fast Track Designation (FTD) Granted
by the U.S. Food and Drug Administration (FDA) for VCN-01 for the treatment of metastatic pancreatic adenocarcinoma-
- Received Rare Pediatric Disease Designation
(RPDD) Granted by the U.S. Food and Drug Administration (FDA) for VCN-01 for the treatment of children with retinoblastoma-
- As of June 30, 2024, Theriva Biologics reports
$16.6 million in cash, which is expected to provide runway into the second quarter of 2025-
Rockville, MD, August 13, 2024 -
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 second quarter ended June 30, 2024, and provided
"We remain on track to complete enrollment for VIRAGE, our Phase
2b trial in metastatic PDAC during the third quarter and are pleased with the FDA's decision to grant FTD to VCN-01, highlighting
the urgent need for new options to treat this deadly disease," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.
"Our lead oncolytic virus (OV) product candidate, VCN-01 is uniquely designed for co-administration with chemotherapy and/or immunotherapy
to enhance tumor access by these agents and elicit a persistent antitumor immune response. The ongoing VIRAGE trial is evaluating VCN-01
in combination with standard-of-care chemotherapy, gemcitabine/nab-paclitaxel, as a first line therapy to enable the earliest possible
use in metastatic PDAC. We look forward to building upon the compelling clinical data from Phase 1 studies that underscores VCN-01's
multiple modes of action and potential to overcome historical challenges around systemic OV administration. Beyond PDAC, we continue to
pursue opportunities that maximize the therapeutic potential of VCN-01. To that end, we are excited by the grant of RPDD to VCN-01 for
the treatment of children with retinoblastoma. We will continue to build a portfolio of potentially improved therapeutic combinations
as part of our broader strategy to address unmet needs for difficult to treat cancers. Additionally, we have taken steps to further rationalized
our burn, which will allow us to extend our cash runway by an additional quarter and bring us closer to the completion and data readout
of the VIRAGE trial."
Recent Program Highlights and Anticipated
Pancreatic Ductal Adenocarcinoma (PDAC):
SYN-004 (ribaxamase):
Second Quarter Ended June 30, 2024 Financial Results
General and administrative expenses decreased
to $1.5 million for the three months ended June 30, 2024, from $2.7 million for the three months ended June 30, 2023. This decrease of
45% is primarily comprised of the decrease in employee compensation costs, consulting fees, audit fees, lower director and officer insurance,
and a decrease in fair value of the contingent consideration adjustment, offset by increased investor relation costs. The charge related
to stock-based compensation expense was $114,000 for the three months ended June 30, 2024, compared to $106,000 for the three months ended
Research and development expenses decreased
to $3.0 million for the three months ended June 30, 2024, from approximately $3.1 million for the three months ended June 30, 2023.
This decrease of 6% is primarily the result of lower clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01
in PDAC and lower expenses related to our Phase 1a clinical trial of SYN-020 which has completed, offset by increased 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 enrollment in our VIRAGE Phase 2 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 $58,000 for the three months ended June 30, 2024, compared
to $40,000 related to stock-based compensation expense for the three months ended June 30, 2023.
During the quarter ended June 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. The Company
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 its development programs, potential post-launch
cash flows and a risk-adjusted weighted average cost of capital. We concluded that the IPR&D was not impaired as of June 30, 2024,
however, goodwill with a carrying value of $5.5 million was written down to its estimated fair value of $1.5 million and an impairment
charge of $4.0 million was recorded during the quarter ended June 30, 2024. 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 business.
income was $172,000 for the three months ended June 30, 2024 compared to other income of $377,000 for the three months ended June 30,
2023. Other income for the three months ended June 30, 2024 is primarily comprised of interest income of $173,000 and an exchange loss
of $1,000. Other income for the three months ended June 30, 2023 is primarily comprised of interest income of $381,000 and exchange loss
Cash and cash equivalents totaled $16.6 million as of June 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 remaining on track to complete enrollment for VIRAGE Phase 2b trial of VCN-01 in combination with chemotherapy for metastatic PDAC during the third
quarter; VCN-01 being uniquely designed for co-administration with chemotherapy and/or immunotherapy to enhance tumor access and elicit
a persistent antitumor immune response; the cash providing runway into the second quarter of 2025, building upon the clinical data from
Phase 1 studies that underscores VCN-01's multiple modes of action; the potential to overcome historical challenges around systemic
OV administration, continuing to pursue opportunities that maximize the therapeutic potential of VCN-01; continuing to build a portfolio
of potentially improved therapeutic combinations as part of the Company's broader strategy to address unmet needs for difficult
to treat cancers; further rationalized burn, which will allow the Company to extend its cash runway by an additional quarter and bring
it closer to the completion and data readout of the VIRAGE trial , the PDAC trial enrolling 92 evaluable patients across sites in the
U.S. and Spain, and completion of enrollment in the third quarter of 2024; the Company being eligible to receive a Priority Review Voucher:
and, enrollment into the third cohort commencing in the second half of 2024 contingent on adequate funding. 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 to continue to enroll patients as planned and the completion of
enrollment in VIRAGE in the third quarter of 2024, generating 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 the cash providing a runway into the second quarter
of 2025, 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