Full Press Release Details
Theriva Biologics Reports Second Quarter
2023 Operational Highlights and Financial Results
- Initiated dosing at U.S. sites for VIRAGE,
the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for Pancreatic Ductal Adenocarcinoma
-Second doses of intravenous VCN-01 administered
to patients in Spain and were well tolerated with a safety profile consistent with prior clinical trials -
-VIRAGE remains on track to complete enrollment
in the first quarter of 2024-
- VCN-01 granted Orphan Drug Designation by
the U.S. FDA for the treatment of pancreatic cancer -
- Ramon Alemany, Ph.D., appointed as Senior
Vice President of Discovery, strengthening the collaboration with the Institut Catala d'Oncologia (ICO) and the Biomedical Research
Institute of Bellvitge (IDIBELL)-
-As of June 30, 2023, Theriva Biologics reports
$34.2 million in cash, which is expected to provide runway into the fourth quarter of 2024-
-Conference call and webcast to be held on Tuesday,
August 8th at 8:30 a.m. ET -
Rockville, MD, August 8, 2023 - 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, 2023, and provided a corporate update.
"We are pleased by the continued progress in the first half of
2023 and look forward to executing on key priorities for our a systemically administered oncolytic adenovirus and lead program, VCN-01,
in key indications and therapeutic combinations," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Notably,
we have initiated dosing at U.S. sites for VIRAGE, the Phase 2b trial of VCN-01 in patients with newly-diagnosed metastatic pancreatic
ductal adenocarcinoma (PDAC). Dosing in Spain initiated in January 2023 and the first patients have now received their second doses of
intravenous VCN-01, which were well tolerated with safety profile consistent with prior clinical trials. VIRAGE remains on track to complete
enrollment in the first quarter of 2024. Reaching this critical milestone adds to the strong momentum for the trial and we are further
encouraged by the FDA's decision to grant orphan drug designation to VCN-01 for patients with pancreatic cancer, for which there
is an urgent need for new treatment options."
Mr. Shallcross continued, "We are encouraged by the growing
clinical data that underscores VCN-01's multi-modal mechanism of action, alone or in combination with chemotherapy and
immunotherapy products. At the upcoming annual ESMO Congress in Madrid, investigators will present survival data from the ongoing
study of VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck,
which will provide the first clinical insights into the feasibility of combining VCN-01 with an immune checkpoint inhibitor. These
results build on the impressive safety, biochemical and mechanistic data presented last year, demonstrating that VCN-01 improved
tumor immunogenicity in previously immunotherapy refractory patients. In parallel, we look forward to upcoming discussions with
regulatory agencies planned in the second half of 2023 to discuss the development pathway for VCN-01 as an adjunct to chemotherapy
in pediatric patients with advanced retinoblastoma. Further, as we continue to explore the potentially broad synergistic clinical
benefit of VCN-01, we remain committed to pursuing new oncolytic virus candidates to leverage our novel Albumin Shield technology,
which has tremendous potential for our pipeline."
Recent Program Highlights and Anticipated
SYN-004 (ribaxamase):
Second Quarter Ended June 30, 2023 Financial Results
General and administrative expenses increased
to $2.7 million for the three months ended June 30, 2023, from $1.5 million for the three months ended June 30, 2022. This increase of
80% is primarily comprised of increased expense related to the fair value of the contingent consideration adjustment of $0.9 million,
along with higher audit fees, consulting fees, travel, and VCN administrative expenses not included in the prior year, offset by a decrease
in legal costs related to the VCN acquisition. The charge related to stock-based compensation expense was $106,000 for the three months
ended June 30,2023, compared to $86,000 for the three months ended June 30, 2022.
Research and development expenses decreased to
$3.1 million for the three months ended June 30, 2023, from approximately $3.5 million for the three months ended June 30, 2022. This
decrease of 10% is primarily the result of lower expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic
HCT recipients Phase 1a clinical trial of SYN-020, and decreased manufacturing expenses related to our Phase 1a clinical trial of SYN-020,
offset by increased clinical trial expenses related to VCN-01. We anticipate research and development expense to increase as we continue
enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, and our ongoing Phase 1 clinical trial in retinoblastoma, expand GMP
manufacturing activities for VCN-01, and continue supporting our VCN-11 and other preclinical and discovery initiatives. The charge related
to stock-based compensation expense was $40,000 for the three months ended June 30, 2023, compared to $27,000 related to stock-based compensation
expense for the three months ended June 30, 2022.
Other income was $377,000 for the three months
ended June 30, 2023 compared to other expense of $17,000 for the three months ended June 30, 2022. Other income for the three months ended
June 30, 2023 is primarily comprised of interest income of $381,000 and exchange loss of $4,000. Other income for the three months ended
June 30, 2022 is primarily comprised of interest income of $26,000 offset by an exchange loss of $9,000.
Cash and cash equivalents totaled $34.2 million
as of June 30, 2023, compared to $41.8 million as of December 31, 2022.
Theriva Biologics will host a conference call on Tuesday, August 8,
2023, at 8:30 a.m. ET to discuss its financial results for the quarter ended June 30, 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: 13739888. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access
the live and archived webcast of this call via the "News & Media" section of the company's website, https://www.therivabio.com,
under "Events" or by clicking here, up to 90 days after the call.
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 VIRAGE remaining on track to complete enrollment
in the first quarter of 2024, upcoming discussions with regulatory agencies planned in the second half of 2023 to discuss the
development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma, the broad
synergistic clinical benefit of VCN-01, the expected enrollment of 92 patients in the VIRAGE trial, the opportunity for VCN-01 in
combination with immunotherapy products to treat solid tumors, VCN-01 being transformative for patients by providing a potential
systemic line of treatment, the SYN-004 trial being on track to complete the second cohort (Q1 2024). and cash being expected
to provide runway into the fourth quarter of 2024,. These forward-looking statements are based on management's expectations
and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are
difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set
forth or implied by any forward-looking statements. 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 completion of enrollment in Virage in the first quarter of 2024 and completing the SYN-004 second cohort in