aibioPhio completes first commercial-scale cGMP batch of PH-762 drug substance
Tickers PHIO
The batch is a manufacturing milestone that supports the planned start of a Phase 2b trial in the first quarter of 2027. The company issued a press release announcing it on October 13, 2026.
Key facts
- Company
- Phio Pharmaceuticals Corp. (NASDAQ: PHIO)
- News type
- Company Updates
- Primary source
- Phio Pharmaceuticals Corp. 8-K (2026-10-13)
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) completed its first commercial-scale cGMP batch of PH-762 drug substance, according to an 8-K dated October 13, 2026. The company described the batch as a key operational milestone that supports the planned start of its Phase 2b clinical trial in the first quarter of 2027. The company announced the batch in a press release issued the same day, which it attached to the 8-K as Exhibit 99.1.
The manufacturing milestone
The batch is the company's first commercial-scale batch of PH-762 drug substance produced under current good manufacturing practices (cGMP). The company's 10-K says its INTASYL technology is readily manufactured under those practices. The 8-K was signed by Robert J. Bitterman, President and Chief Executive Officer. The 8-K itself contains no financial statements. Its only exhibits are the press release and the interactive data cover page.
What PH-762 is
Phio is a clinical-stage biopharmaceutical company. Its INTASYL small interfering RNA technology is designed to make immune cells more effective in killing tumor cells. PH-762 is an INTASYL compound designed to reduce the expression of PD-1, a protein that inhibits T cells' ability to kill cancer cells. The company says reducing PD-1 expression can increase the capacity of T cells to kill cancer cells.
The company's preclinical studies showed that direct-to-tumor application of PH-762 produced potent anti-tumoral effects and inhibited tumor growth in a dose-dependent fashion in PD-1 responsive and refractory models. It also reported activity against distant untreated tumors, which it said indicates a systemic anti-tumor response.
The Phase 1b trial
PH-762 is being evaluated in a U.S. multi-center Phase 1b dose-escalating trial, NCT 06014086, through intratumoral injection in patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The trial was fully enrolled in November 2025 with 22 patients: 20 with cutaneous squamous cell carcinoma (cSCC), one with melanoma and one with Merkel cell carcinoma.
The trial is a small, uncontrolled dose-escalation study, and 20 of its 22 patients had one cancer type, cSCC. The company said final study data are pending formal analysis. It targeted an FDA submission in the second quarter of 2026 to propose next steps in clinical study design for PH-762. The company's revised data support an overall response rate of 65% for cSCC, a figure that counts partial responses of greater than 50% clearance and gives no control group for comparison. Among the 20 cSCC patients, 13 were classified as pathologic responders, including 9 patients with complete response (100% clearance), 2 with major or near clear response (greater than 90% clearance) and 2 with partial response (greater than 50% clearance).
A single patient with metastatic Merkel cell carcinoma had a partial response. Seven cSCC patients and one melanoma patient had responses below 50%, but none of the patients experienced disease progression. The company said intratumoral PH-762 has been well tolerated in all enrolled patients, with no dose-limiting toxicities and no clinically relevant treatment-emergent adverse effects in any patient who received it. The trial has evaluated PH-762 in five dose-escalating cohorts, increasing drug concentration 20-fold from the first cohort to the final cohort.
Financial position
The company's financial data shows research and development expense of $4.6 million for 2025, compared with $3.6 million for 2024. The net loss was $8.7 million for 2025 and $7.2 million for 2024. Cash used in operations was $8.0 million in 2025 and $7.1 million in 2024. Year-end cash and cash equivalents were $21.0 million at December 31, 2025.
According to the company's 10-Q, cash and cash equivalents were $13.0 million at June 30, 2026.
What comes next
Cash and cash equivalents fell from $21.0 million at December 31, 2025 to $13.0 million at June 30, 2026, while the company used $8.0 million of cash in operations in 2025, and the filing gives no financing plan for the Phase 2b trial. The company plans to start the Phase 2b trial in the first quarter of 2027. The filing does not say whether the FDA has responded to the submission the company targeted for the second quarter of 2026. It also does not state the status of the final Phase 1b data analysis.