On November 13, 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 September 30, 2025 and provided a business update.

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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. Per the trial’s protocol, patients receive four injections of PH-762 at weekly intervals and pathologic response is assessed on day 36 after the initial injection of PH-762. To date, pathologic results for the fifth and final cohort were as follows: 100% tumor clearance in one of three patients, > 90% clearance in the second patient, and > 50% clearance in the third patient at Day 36.

To date, a total of 18 patients with cutaneous carcinomas have completed treatment across five dose escalating cohorts in the Phase 1b trial. The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance). Six patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients in the study, however, exhibited clinical progression of disease.

To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. Phio may continue to screen and treat additional patients as part of the fifth cohort.

In July 2025, the Company entered into a comprehensive drug substance development services agreement with a U.S. manufacturing company pursuant to which the manufacturer will provide analytical and process development and cGMP manufacture of Phio’s lead development compound, PH-762.

Scientific and Investor Presentations

In September 2025, Phio delivered podium presentations for its INTASYL self-delivering siRNA technology at the Wainwright Global Investment Conference and the Life Sciences PA Life Sciences Future Conference. The Company presented its Phase 1b clinical trial results to date. The Company also delivered virtual presentations on its INTASYL compounds PH-762 and PH-894 in October 2025 at the Renmark Video Non Deal Roadshow. A poster highlighting an update on the ongoing clinical study for PH-762 was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in National Harbor, MD. In addition, a podium presentation entitled "Synthesized INTASYL siRNA Technology Downregulating Gene Expression" will be held at the Advanced Therapies USA conference 2025 in Philadelphia, PA.

Warrant Inducements

On July 25, 2025, the Company entered into warrant inducement agreements with certain holders of certain of the Company’s existing common stock warrants to exercise such warrants for an aggregate of 928,596 shares of the Company’s common stock. In consideration for the exercise of such warrants and the payment of an additional $0.125 per new warrant, the Company agreed to issue to such holders new unregistered common stock warrants to purchase an aggregate of up to 1,857,192 shares of common stock with an exercise price of $2.485 per share. In connection with this financing, the Company raised approximately $2.1 million after expenses.

On November 3, 2025, the Company entered into warrant inducement agreements with certain holders of certain of the Company’s existing common stock warrants to exercise such warrants for an aggregate of 5,663,182 shares of the Company’s common stock. In consideration for the exercise of such warrants and the payment of an additional $0.125 per new warrant, the Company agreed to issue to such holders new unregistered common stock warrants to purchase an aggregate of up to 11,326,364 shares of common stock with an exercise price of $2.05 per share. In connection with this financing, the Company expects to raise approximately $12.1 million, of which $11.5 million has been received by the Company, with the remainder expected by November 18, 2025.

Third Quarter 2025 Financial Results

Cash Position

At September 30, 2025, the Company had cash and cash equivalents of approximately $10.7 million as compared with approximately $5.4 million at December 31, 2024.

As of the date of this release, the Company had estimated cash and cash equivalents of approximately $21.3 million, which is projected to sustain operations into the first half of 2027.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2025 were $1.2 million compared to $0.6 million for the same period in 2024. The increase in research and development expenses was primarily driven by higher clinical trial costs and chemistry, manufacturing and controls (CMC) costs in connection with advancing our PH-762 program, as well as an increase in R&D employee personnel-related costs.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2025 were $1.3 million compared to $0.9 million for the same period in 2024. The increase in general and administrative expenses was primarily driven by an increase in outsourced professional fees related to accounting and legal services as well as employee stock compensation expense.

Net Loss

Net loss was $2.4 million for the three months ended September 30, 2025 compared with $1.5 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.

(Press release, Phio Pharmaceuticals, NOV 13, 2025, View Source [SID1234659914])