Phio Pharmaceuticals Reports 2022 Year End Financial Results and Provides Business Update.

MARLBOROUGH, Mass: Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today reported its financial results for the year ended December 31, 2022 and provided a business update.

"This year will be a transformative period for Phio, as we continue to make significant progress advancing our proprietary platform, INTASYL, into the clinic," said Robert Bitterman, Phio's President and Chief Executive Officer. "We are completely focused on executing our clinical strategy for PH-762. Over the past several months we have achieved several key milestones, including completing enrollment of the first cohort in our Phase 1b study for PH-762 in Europe, receiving Data Monitoring Committee (DMC) approval to open enrollment of the second cohort and receiving regulatory clearance to initiate the first U.S. clinical trial for PH-762 in adoptive cell therapy. Simultaneously, we are preparing to finalize documentation to submit an IND for PH-762 for the study of cutaneous squamous cell carcinoma and other cutaneous malignancies. We look forward to continuing to provide updates on these programs over the coming months as we strive to build shareholder value."

Recent Corporate Updates

In February 2023, the Company announced an independent DMC completed its prespecified review of interim safety data in the Company's ongoing Phase 1b clinical trial (EU) of PH-762, an INTASYL compound targeting PD-1, for the treatment of advanced melanoma, which is being conducted at the Gustave Roussy Institute (Villejuif, France). The safety data review disclosed no dose-limiting toxicity, and no drug-related severe adverse events or serious adverse events, and the DMC recommended proceeding to the enrollment of the subsequent dose cohort, as intended per the study protocol.

In the first quarter of 2023, following the recommendation by the DMC, the Company opened enrollment of subjects in the second cohort of the ongoing Phase 1b dose escalation clinical trial (EU) of PH-762 for the treatment of advanced melanoma.

In January 2023, the Company announced its partner AgonOx, Inc. received confirmation from the FDA to proceed with the planned Phase 1 clinical trial in adoptive cell therapy (ACT) designed to assess safety and to study the potential for an enhanced therapeutic benefit from the administration of Phio's PH-762 treated...