Theriva$(TM)$ 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(TM) 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, 2023, and provided a corporate update.
"With continued advancement of our clinical programs, we have the opportunity to achieve several important milestones this year," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "VIRAGE, our Phase 2b trial of VCN-01 in newly-diagnosed metastatic PDAC remains on track to complete enrollment in the first half of 2024. We completed the first safety review with the IDMC, and with a positive recommendation, VIRAGE will continue to enroll patients as planned with no modifications to the protocol. Our clinical data has demonstrated that repeated systemic dosing of VCN-01 is feasible from a safety perspective, and will now focus on determining whether the repeated-dose regimen of VCN-01 may lead to improved clinical outcomes for patients with PDAC and other solid cancers. In addition to advancing the VIRAGE PDAC trial, we continue to work closely with key opinion leaders, and regulatory agencies to refine our protocol and clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. In parallel, our investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma continues to progress and will further inform our clinical development pathway in this area of high unmet need."
Recent Program Highlights and Anticipated Milestones:
VCN-01:
-- Pancreatic Ductal Adenocarcinoma (PDAC): Dosing is underway and
enrollment continues to progress for VIRAGE, the randomized, controlled,
multicenter, open-label Phase 2b trial of VCN-01 in combination with
standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first
line therapy in newly diagnosed bmetastatic PDAC patients. The trial is
expected to enroll 92 evaluable patients and remains on track to complete
enrollment in H1 2024.
-- The Independent Data Monitoring Committee (IDMC) recommended the
continuation of enrollment as planned into the VIRAGE study.
According to the IDMC's expert assessment of clinical data from
patients enrolled at six sites open in the U.S. and nine sites in
Spain, the ongoing Phase 2b trial will continue without any
changes to the protocol. No safety concerns were raised based on
the evaluation of data presented at the IDMC meeting. Intravenous
VCN-01 has been well tolerated and demonstrated a safety profile
consistent with prior clinical trials. Importantly, no additional
toxicities were observed in patients receiving a second dose of
VCN-01.
-- Retinoblastoma: The investigator sponsored Phase 1 trial evaluating the
safety and activity of intravitreal VCN-01 in pediatric patients with
refractory retinoblastoma has completed patient treatment. The trial is
designed to evaluate escalating doses of VCN-01 administered by two
intravitreal injections separated by 14 days. The investigator sponsored
Phase 1 trial, which will complete patient follow-up in H1 2024, will
help inform the planned Phase 2 trial design.
-- This builds on positive preclinical results presented by
collaborators at Fundació Sant Joan de Déu demonstrating
that administration of VCN-01 in combination with topotecan
chemotherapy may improve VCN-01 activity against retinoblastoma.
SYN-004 (ribaxamase):
-- Dosing is underway for the ongoing Phase 1b/2a randomized, double-blinded,
placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic
hematopoietic cell transplant $(HCT.AU)$ recipients for the prevention of
acute graft-versus-host-disease (aGVHD). SYN-004 appeared to be well
tolerated in HCT patients treated with IV meropenem and SYN-004 was not
detected in blood samples from the majority of the evaluable patients.
The trial is on track to complete enrollment into the second cohort in Q2
2024.
Business Updates
-- On November 2, 2023, Theriva signed an exclusive option to license
intellectual property from Sant Joan de Déu-Barcelona Children's
Hospital $(SJD.UK)$ to explore the therapeutic potential of VCN-01 in
combination with topoisomerase I inhibitors. This strengthens a long-term
research collaboration with SJD and builds on ongoing trial evaluating
VCN-01 in pediatric cancers.
-- Theriva is actively pursuing licensing discussions for our SYN-020
intestinal alkaline phosphatase asset.
Full-Year Ended December 31, 2023 Financial Results
General and administrative expenses decreased to $7.1 million for the year ended December 31, 2023, from $9.9 million for the year ended December 31, 2022. This decrease of 28% is primarily comprised of the decrease in the fair value of the contingent consideration of $2.8 million, along with lower salary, investor relations, legal costs, consulting fees related to the VCN acquisition, and director and officer insurance offset by higher audit fees, and other consulting fees. The charge relating to stock based compensation expense was $0.4 million for the year ended December 31, 2023, compared to $0.4 million for the year ended December 31, 2022.
Research and development expenses increased to $14.3 million for the year ended December 31, 2023, from $11.7 million for the year ended December 31, 2022. This increase of 22% is primarily the result of higher clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, offset by lower expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, the completed Phase 1a clinical trial of SYN-020, decreased manufacturing expenses related to our Phase 1a clinical trial of SYN-020 and lower other indirect costs. 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. Research and development expenses also include a charge relating to non-cash stock-based compensation expense of $165,000 for the year ended December 31, 2023, compared to $112,000 for the year ended December 31, 2022. In addition, we expect research and development expenses to increase as we incur higher clinical program costs for our VCN product candidates.
Other income was $1,442,000 for the year ended December 31, 2023, compared to other income of $471,000 for the year ended December 31, 2022. Other income for the year ended December 31, 2023 is primarily comprised of interest income of $1,439,000 and an exchange gain of $3,000. Other income for the year ended December 31, 2022 is primarily comprised of interest income of $512,000 offset by an exchange loss of $41,000.
Cash and cash equivalents totaled $23.2 million as of December 31, 2023, compared to $41.8 million as of December 31, 2022.
The audited financial statements for the year ended December 31, 2023 included in the Company's Annual Report on Form 10-K contain an unqualified 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.
Conference Call
Theriva Biologics will 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 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(TM) Biologics, Inc.
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