Phio Pharmaceuticals Reports 2025 Financial Results, Extends Cash Runway into 2027

Lead Candidate PH-762 Completes Phase 1b Trial with Favorable Safety Data, FDA Submission Planned for Q2 2026

Published on Mar. 5, 2026

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Phio Pharmaceuticals, a clinical-stage biopharmaceutical company, has reported its financial results for the year ended December 31, 2025, and provided a business update. The company's lead clinical development program, PH-762, completed a Phase 1b trial with favorable safety and tolerability data, and Phio is targeting an FDA submission in the second quarter of 2026 to seek guidance on next steps for the clinical study design. Phio also strengthened its balance sheet through equity financings and warrant exercises, generating $23.7 million in net proceeds and extending the company's cash runway into the first half of 2027.

Why it matters

Phio's progress with PH-762 and its improved financial position are significant milestones for the company as it continues to develop its proprietary INTASYL® siRNA gene silencing technology to treat various forms of skin cancer. The favorable safety data from the Phase 1b trial and the planned FDA submission are important steps towards potentially bringing a new non-surgical treatment option to patients.

The details

The Phase 1b trial for PH-762 evaluated the safety and tolerability of the intratumoral injection of PH-762 in patients with cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. The trial enrolled a total of 22 patients, with 20 having cutaneous squamous cell carcinoma, one with melanoma, and one with Merkel cell carcinoma. While the final study data is pending formal analysis, Phio is targeting an FDA submission in the second quarter of 2026 to propose and seek guidance on next steps for the clinical study design of PH-762. To support the continued development of PH-762, Phio entered into agreements for drug substance development, cGMP manufacturing, and a non-clinical toxicology study.

  • The Phase 1b trial for PH-762 was fully enrolled in November 2025.
  • Phio is targeting an FDA submission in the second quarter of 2026 to propose and seek guidance on next steps for the clinical study design of PH-762.

The players

Phio Pharmaceuticals Corp.

A clinical-stage biopharmaceutical company advancing its proprietary INTASYL® siRNA gene silencing technology to eliminate cancer.

PH-762

Phio's lead clinical development program, an INTASYL compound that silences the PD-1 gene implicated in various forms of skin cancer.

Robert Bitterman

President and CEO of Phio Pharmaceuticals.

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What they’re saying

“Final cohort results mark the culmination of a productive 2025 fiscal year for Phio. Concluding the Phase 1b study with favorable safety, tolerability and pathology data, advancing the CMC and toxicology initiatives while extending our cash runway into 2027 are noteworthy milestones on our continuing pathway to potential approval.”

— Robert Bitterman, President and CEO (Phio Pharmaceuticals)

What’s next

Phio is targeting an FDA submission in the second quarter of 2026 to propose and seek guidance on next steps for the clinical study design of PH-762.

The takeaway

Phio's progress with its lead candidate PH-762 and its improved financial position are significant steps forward in the company's efforts to develop a new non-surgical treatment option for various forms of skin cancer using its proprietary INTASYL® technology.