On August 10, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported its financial results for the quarter ended June 30, 2023 and provided a business update (Press release, Phio Pharmaceuticals, AUG 10, 2023, View Source [SID1234634208]).
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"Following FDA clearance of our IND for PH-762, we are moving forward with plans for a clinical trial for stages one, two and four of cutaneous squamous cell (cSCC), stage four melanoma and Merkel cell," said Robert Bitterman, President and CEO.
The initial multi-center, dose-escalating, Phase 1b clinical trial is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762.
Recent Corporate Updates
· Announced initiation of a collaborative clinical trial with PH-762, AgonOx’s Tumor Infiltrating Lymphocyte Program (AGX148) and Providence Cancer Institute. AgonOx is expected to enroll the first patient this summer.
· Retained Jennifer Phillips, Pharm.D., as Vice-President for Regulatory Affairs and Corporate Affairs.
Financial Results
Cash Position
At June 30, 2023, the Company had cash of $11.3 million as compared with $11.8 million at December 31, 2022.
Research and Development Expenses
Research and development expenses were $1.4 million for the quarter ended June 30, 2023 compared with $1.3 million for the quarter ended June 30, 2022, an increase of 6%. The increase was primarily due to increased clinical-related costs to support the two PH-762 Phase 1 clinical trials in the U.S., partially offset by decreased costs related to the completion of the Company’s IND-enabling preclinical studies for PH-894 as compared to the prior year period.
General and Administrative Expenses
General and administrative expenses were $1.2 million for the quarter ended June 30, 2023 compared with $1.2 million for the quarter ended June 30, 2022. General and administrative expenses were primarily consistent with the prior year period.
Net Loss
Net loss was $2.5 million, or $1.47 per share, for the quarter ended June 30, 2023, compared with $2.5 million, or $2.22 per share, for the quarter ended June 30, 2022. Overall, net loss was primarily consistent with the prior year period with changes in research and development expense as described above.
About INTASYL
INTASYL compounds are chemically modified siRNAs that provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity, targeting a broad range of cell types and tissues. INTASYL drugs are designed to precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy (ACT) applications.
In comparison to biologics and cell and gene therapies, INTASYL has a favorable preclinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial dosing convenience to the prescriber and patient.