Phio Pharmaceuticals' Q3 Net Loss Widens to $4.2M on PH-762 Push

Phio Pharmaceuticals posted a third-quarter 2026 net loss of $4.2 million, up from $2.4 million a year earlier, as the company nearly tripled research spending to push its lead cancer candidate PH-762 toward a planned Phase 2b study. The loss per share nonetheless narrowed to $0.36 from $0.44, because a higher weighted-average share count spread the damage across more stock.

The cash picture tightened considerably. The King of Prussia, Pennsylvania-based biotech ended September with roughly $10.6 million in cash and cash equivalents, down from about $21 million at the end of 2025 — in effect, the company burned through half its liquidity in nine months. Total assets stood at approximately $11.3 million, against liabilities of about $2.7 million, leaving shareholders' equity near $8.6 million.

Where did the money go?

Research and development expenses reached approximately $3.1 million in the quarter, versus $1.2 million in the third quarter of 2025 — an increase of about 159%. Management attributed the jump primarily to nonclinical toxicology studies, drug substance manufacturing, and clinical supply preparations, with additional development expenses and higher employee, consultant, and patent-related costs also contributing.

For the first nine months of 2026, R&D spending totaled roughly $8.9 million, compared with $3.1 million in the prior-year period — a 180% rise that included about $4.5 million in additional PH-762-related toxicology, manufacturing, and clinical supply costs. The company expects R&D spending to keep climbing as the program advances. In short, the burn rate is a deliberate bet on the clinic, not administrative drift.

General and administrative costs moved in the opposite direction in the quarter, declining roughly 9% to $1.2 million from $1.3 million, mainly on lower outsourced consulting. Over nine months, G&A still rose 6% to about $3.8 million from $3.5 million, driven by higher employee expenses including stock-based compensation. Operating loss widened to approximately $4.3 million from $2.5 million.

What did the Phase 1b trial deliver?

Phio completed its multicenter Phase 1b dose-escalation study in June 2026. The trial tested PH-762 injected directly into tumors before surgery — a neoadjuvant approach — in 22 patients: 20 with cutaneous squamous cell carcinoma, one with melanoma, and one with Merkel cell carcinoma. Its primary objectives covered safety and tolerability, tumor response, and identifying a dose or dose range for further development.

The company has since submitted its final clinical study report to the U.S. Food and Drug Administration, along with a meeting request and briefing materials covering the Phase 1b results, nonclinical and clinical pharmacology programs, and its proposed Phase 2b strategy. Phio expects FDA feedback by the end of November 2026, which it says should clarify the regulatory and clinical requirements for the next stage. That feedback, it should be noted, has not yet arrived — the timeline is a target, not a commitment.

CEO Robert J. Bitterman said: "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."

Is the company ready to scale?

On manufacturing, Phio completed and released its first commercial-scale batch of PH-762 active pharmaceutical ingredient under current Good Manufacturing Practice requirements and shipped it to its drug product manufacturing partner for clinical trial supplies. The company also advanced nonclinical toxicology work, which it believes will support continued clinical evaluation, subject to regulatory feedback.

PH-762 is built on Phio's proprietary INTASYL platform, which uses small interfering RNA to silence selected genes — in this case PD-1, a protein that regulates immune responses. Silencing PD-1 is intended to strengthen immune cells' ability to attack cancer, and the company is testing whether the approach could eventually offer a nonsurgical option for certain skin cancers. The company itself cautions that PH-762 remains investigational, with safety and effectiveness not yet established through the testing required for approval.

The intellectual property portfolio grew to 56 issued patents and 34 pending applications worldwide, with existing protection extending to at least 2038 and pending applications potentially reaching into 2044.

Phio is targeting initiation of a Phase 2b neoadjuvant study in cutaneous squamous cell carcinoma in the first quarter of 2027. Whether the company can fund that study, and any FDA contingencies attached to it, on a $10.6 million cash base remains the question the quarter's numbers do not answer.