On November 5, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company developing therapeutics using its proprietary INTASYL gene-silencing technology to eliminate cancer, reported financial results for the quarter ended September 30, 2026, and provided a business update.

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"We have successfully executed on critical development objectives to advance the PH-762 program toward Phase 2b study initiation," said Robert J. Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "Commercial-scale drug substance manufacturing was completed and shipped to our drug product manufacturer in preparation for making clinical trial supply material. We have submitted detailed information to FDA providing final analysis of our Phase 1b clinical trial and the fundamentals of our intended upcoming Phase 2b study."

PH-762 Development Update

PH-762 was evaluated in a U.S. multicenter Phase 1b dose-escalation clinical trial assessing intratumoral administration in patients with cutaneous squamous cell carcinoma (cSCC), melanoma, and Merkel cell carcinoma. The study (NCT 06014086) was designed to evaluate the safety and tolerability of neoadjuvant treatment with PH-762, assess tumor response, and identify a dose or dose range for further clinical development. The study enrolled 22 patients, consisting of 20 patients with cutaneous squamous cell carcinoma, one patient with melanoma, and one patient with Merkel cell carcinoma.

The clinical trial was completed in June 2026, and the final clinical study report was submitted to FDA with a meeting request and briefing document outlining the nonclinical and clinical pharmacology programs, scientific rationale for continued development, completed Phase 1b results, and details of the planned Phase 2b neoadjuvant study in cSCC. The submission seeks FDA feedback on the proposed development strategy and next steps, with a response expected from the FDA by the end of November 2026.

The Company also announced the successful release of its first commercial-scale cGMP batch of PH-762 drug substance (active pharmaceutical ingredient), representing an important CMC (chemistry, manufacturing and controls) milestone that supports the planned Phase 2b clinical program, which is expected to be initiated in the first quarter of 2027.

Scientific and Corporate Activities

During the quarter, the Company presented PH-762 Phase 1b clinical trial data at scientific and investor conferences and roadshows. These included the Life Sciences Future Conference, King of Prussia, PA, H.C. Wainwright Conference, NYC, NIBA 153rd Conference, Fort Lauderdale, FL, Life Sciences Virtual Investor Conference, and Renmark Financial Virtual Non-Deal Roadshows.

The Company further strengthened its intellectual property position through multiple patent-related achievements during the quarter. Phio’s patent portfolio currently includes 56 issued patents and 34 pending applications worldwide, providing broad protection for its INTASYL self-delivering RNAi therapeutic platform and product candidates through at least 2038, with additional pending applications extending potential protection into 2044.

Financial Results

Cash Position

As of September 30, 2026, we had cash and cash equivalents of $10.6 million as compared with $21.0 million at December 31, 2025. The Company continues to focus its resources on advancing PH-762 while prudently managing general and administrative expenses.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2026 were $3.0 million, an increase of $1.9 million or 159%, compared with the three months ended September 30, 2025. The increase was primarily driven by a $1.5 million increase in nonclinical toxicology study costs, drug substance costs and clinical supplies costs as compared to the clinical study costs that occurred during the prior year period, and a $0.3 million increase in other development related costs.

Research and development expenses for the nine months ended September 30, 2026 were $8.9 million, an increase of $5.8 million or 180% as compared with the nine months ended September 30, 2025. The increase in research and development expenses was primarily driven by a $4.5 million increase in nonclinical toxicology study costs, drug substance costs and clinical supplies costs, all of which were associated with advancing the PH-762 program. In addition, research and development expenses increased by approximately $0.3 million related to employee headcount costs, $0.6 million related to outside services and consultants and $0.2 million related to patent activity.

Management believes that research and development expenses will continue to increase as we advance our PH-762 program.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2026 were $1.2 million, a decrease of $100 thousand or 9%, compared with the three months ended September 30, 2025. This decrease was primarily driven by a reduction in outsourced consulting services.

General and administrative expenses for the nine months ended September 30, 2026 increased 6% or $200 thousand as compared with the nine months ended September 30, 2025. The increase was primarily driven by a $1.2 million increase in employee costs, of which $0.7 million related to increased stock-based compensation expenses. This increase was partially offset by a $1.1 million decrease in outside services and consultant expenses as compared to the prior year period.

Net Loss

Net loss was $4.2 million for the three months ended September 30, 2026 as compared with $2.4 million for the three months ended September 30, 2025. The increase in net loss was attributable to higher research and development expenses associated with advancing the PH-762 program.

(Press release, Phio Pharmaceuticals, NOV 5, 2026, View Source [SID1234674320])