On August 14, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics using its proprietary INTASYL siRNA gene silencing technology to eliminate cancer, reported its financial results for the quarter ended June 30, 2025 and provided a business update (Press release, Phio Pharmaceuticals, AUG 14, 2025, View Source [SID1234655312]).
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Recent Corporate Updates
PH-762 Clinical Progress
Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. To date, a total of 15 patients with cutaneous carcinomas have been treated across four cohorts in the Phase 1b trial. These cohorts included 13 patients with cSCC, one patient with metastatic melanoma and one patient with metastatic Merkel cell carcinoma. There have been no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients who received intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. No patients exhibited clinical progression of disease during the treatment phase of this trial.
The cumulative pathologic responses in the 13 patients with cSCC include five with complete response (100% clearance), one patient with a near complete response (>90% clearance), one with a partial response (>50% clearance) and six patients with a pathologic non-response (< 50% clearance).
The Merkel cell carcinoma patient with stage 4 metastatic disease had a pathological partial response (>50% clearance). The melanoma patient was a non-responder (<50% clearance).
Phio is now enrolling what is expected to be the 5th and final cohort in the Phase 1b trial.
In addition, the Company entered into a comprehensive drug substance development services agreement with a U.S. manufacturing company. The company will provide analytical and process development and cGMP manufacture of Phio’s lead development compound PH-762.
Scientific News
In May 2025, Phio delivered a podium presentation for its INTASYL self-delivering siRNA technology at the Society of Investigative Dermatology (SID). The Company presented its Phase 1b clinical trial results to date. The Company also delivered podium presentations on its INTASYL compounds PH-762 and PH-894 in April 2025 at the 11th Annual Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ITOC 11) conference in Munich, Germany. In June 2025, Phio presented interim data on its Phase 1b clinical trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference.
Subsequent Events
On July 25, 2025, the Company entered into warrant inducement agreements with certain holders of the Company’s existing warrants to purchase an aggregate of 928,596 shares of common stock in connection with the exercise of common stock warrants issued between December 2024 and January 2025 with exercise prices between $2.00 and $2.485 per share. In connection with this financing, the Company raised approximately $2.2 million after expenses.
Financial Results
Cash Position
At June 30, 2025, the Company had cash and cash equivalents of approximately $10.8 million as compared with approximately $5.4 million at December 31, 2024.
Research and Development Expenses
Research and development expenses for the three months ended June 30, 2025 were $1.1 million compared to $0.9 million for the same period in 2024. The increase in research and development expenses was primarily driven by higher CRO pass-through costs associated with increased patient enrollment, as well as higher consulting and salary-related costs.
Research and development expenses for the six months ended June 30, 2025 were $1.9 million compared to $2.0 million for the same period in 2024. The fluctuation was immaterial and within expected operating ranges.
General and Administrative Expenses
General and administrative expenses for the three months ended June 30, 2025 were $1.2 million compared to $1.0 million for the same period in 2024. The increase in general and administrative expenses was primarily driven by an increase in salary-related costs.
General and administrative expenses for the six months ended June 30, 2025 were $2.2 million compared to $1.8 million for the same period in 2024. The increase in general and administrative expenses was primarily driven by an increase in salary-related costs.
Net Loss
Net loss was $2.2 million for the three months ended June 30, 2025 compared with $1.8 million for the same period in 2024. The increase in net loss was due to the changes in research and development and general and administrative expenses as described above.