Phio Pharmaceuticals reported a third-quarter 2026 net loss of $4.2 million, compared with $2.4 million in the prior-year period, as the clinical-stage biotechnology company increased research and development spending to advance PH-762 toward a planned Phase 2b clinical study. The company ended September with approximately $10.6 million in cash and cash equivalents, compared with $21 million at the end of 2025.
Phio, headquartered in King of Prussia, Pennsylvania, is developing therapeutic products based on its proprietary INTASYL gene-silencing technology.
Its lead candidate, PH-762, is an investigational treatment designed to silence the PD-1 gene and potentially enhance the body’s immune response against cancer cells.
The company is initially focusing on skin cancers, including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.
Phio’s third-quarter financial results reflect increased investment in manufacturing, toxicology research, and clinical development activities associated with PH-762.
Research and development expenses totaled approximately $3.1 million during the quarter, compared with $1.2 million in the third quarter of 2025.
The increase of approximately 159% was driven primarily by nonclinical toxicology studies, drug substance manufacturing, and clinical supply preparations.
Additional development expenses also contributed to the increase.
For the first nine months of 2026, research and development expenses reached approximately $8.9 million, compared with $3.1 million in the prior-year period.
The 180% increase reflected approximately $4.5 million in additional toxicology, manufacturing, and clinical supply expenses related to PH-762.
The company also reported higher employee, consultant, and patent-related costs associated with the development program.
Management expects research and development spending to continue increasing as PH-762 progresses through clinical development.
General and administrative expenses declined approximately 9% during the third quarter.
These expenses totaled $1.2 million, compared with $1.3 million in the prior-year quarter.
The reduction primarily reflected lower spending on outsourced consulting services.
For the first nine months of 2026, general and administrative expenses increased 6% to approximately $3.8 million, compared with $3.5 million in the previous year.
Higher employee expenses, including stock-based compensation, were partially offset by lower spending on external consultants and services.
Phio reported a third-quarter operating loss of approximately $4.3 million, compared with $2.5 million a year earlier.
The company’s net loss increased to approximately $4.16 million from $2.39 million.
The loss per share narrowed to $0.36 from $0.44, reflecting a higher weighted-average share count despite the increase in total net loss.
For the first nine months of 2026, Phio reported a net loss of approximately $12.3 million, compared with $6.3 million during the corresponding period of 2025.
The nine-month loss per share was $1.06, compared with $1.30 a year earlier.
Beyond the financial results, Phio reported several milestones involving the development of PH-762.
The company completed its multicenter Phase 1b dose-escalation clinical study in June 2026.
The study evaluated PH-762 administered directly into tumors before surgery, an approach known as neoadjuvant treatment.
The trial enrolled 22 patients, including 20 with cutaneous squamous cell carcinoma, one with melanoma, and one with Merkel cell carcinoma.
Its primary objectives included evaluating safety and tolerability, assessing tumor response, and identifying an appropriate dose or dose range for further development.
Following completion of the trial, Phio submitted its final clinical study report to the U.S. Food and Drug Administration.
The submission included a meeting request and briefing materials outlining the completed Phase 1b results, nonclinical and clinical pharmacology programs, and the company’s proposed Phase 2b development strategy.
Phio expects FDA feedback by the end of November 2026.
That feedback is expected to help clarify the regulatory and clinical requirements for advancing PH-762 into its next stage of development.
The company is targeting initiation of a Phase 2b neoadjuvant clinical study in cutaneous squamous cell carcinoma during the first quarter of 2027.
Phio also reported progress in preparing manufacturing capabilities for the planned study.
The company completed and released its first commercial-scale batch of PH-762 active pharmaceutical ingredient manufactured under current Good Manufacturing Practice requirements.
The drug substance was shipped to its drug product manufacturing partner for preparation of clinical trial supplies.
The milestone supports the company’s preparations for larger clinical studies and potential future manufacturing requirements.
Phio also advanced its nonclinical toxicology work as part of the PH-762 development program.
The company believes these activities will support continued clinical evaluation, subject to regulatory feedback and other development requirements.
PH-762 is based on Phio’s INTASYL platform, which uses small interfering RNA technology to silence selected genes.
The lead candidate targets PD-1, a protein involved in regulating immune responses.
By silencing PD-1, Phio aims to enhance the ability of immune cells to attack cancer.
The company is evaluating whether this approach could eventually provide a nonsurgical treatment option for certain skin cancers.
However, PH-762 remains investigational, and its safety and effectiveness have not been established through the clinical testing required for regulatory approval.
Phio also strengthened its intellectual property position during the quarter.
The company reported a portfolio of 56 issued patents and 34 pending patent applications worldwide.
These patents and applications cover aspects of its INTASYL platform and therapeutic candidates.
Existing patents provide protection extending to at least 2038, with additional pending applications potentially extending coverage into 2044.
The company’s financial position remains an important consideration as it prepares for the next stage of clinical development.
Cash and cash equivalents declined to $10.6 million at September 30 from approximately $21 million at the beginning of the year.
Total assets were approximately $11.3 million at September 30, while total liabilities reached approximately $2.7 million.
Phio ended the quarter with approximately $8.6 million in shareholders’ equity.
The company continues to focus its financial resources on PH-762 while managing general and administrative costs.
The upcoming FDA interaction and planned Phase 2b initiation represent important milestones for evaluating the next steps in its development strategy.
Phio’s third-quarter results highlight the increasing costs associated with advancing an investigational cancer therapy while demonstrating progress in clinical preparations, manufacturing readiness, and regulatory engagement.
The company’s near-term priorities include obtaining FDA feedback, completing preparations for the next clinical study, and maintaining sufficient financial resources to support continued development.
KEY QUOTE:
“We have successfully executed on critical development objectives to advance the PH-762 program toward Phase 2b study initiation. 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.”
Robert J. Bitterman, President And CEO Of Phio Pharmaceuticals
