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Phio Pharmaceuticals Corp. reports developments as a clinical-stage siRNA biopharmaceutical company advancing its proprietary INTASYL® gene-silencing technology for immuno-oncology. Company updates center on PH-762, an INTASYL compound designed to silence the PD-1 gene and evaluated as an intratumoral therapy for cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma.
Recurring news themes include PH-762 clinical results, safety and pathology data, nonclinical toxicology work, cGMP clinical-supply manufacturing, regulatory-development steps, financial results, equity financing activity and investor presentations. Coverage also reflects the company's use of self-delivering RNAi technology intended to enhance immune-cell activity against tumor cells without specialized formulation or delivery systems.
Phio Pharmaceuticals (NASDAQ: PHIO) reported 2025 year-end results and a business update. Key milestones include completion of the Phase 1b dose‑escalation for lead candidate PH‑762 with favorable safety and pathology signals, strengthening the balance sheet via financings and warrant exercises that generated $23.7 million in net proceeds, and cash of approximately $21.0 million at December 31, 2025.
The company advanced CMC and toxicology work, secured cGMP drug substance services, initiated a non‑clinical toxicology agreement, and targets an FDA meeting in Q2 2026 to seek guidance on next clinical steps.
Phio Pharmaceuticals (NASDAQ: PHIO) will present at Renmark's Virtual Non-Deal Roadshow on March 9, 2026 at 10 AM EDT to review its INTASYL siRNA platform and recent clinical progress for lead candidate PH-762.
In a Phase 1b trial, 22 patients completed treatment with no dose-limiting toxicities or serious adverse events; reported pathological response in cSCC was ~65% overall and 85% (6 of 7) in the highest-dose cohort. FDA engagement is targeted for Q2 2026. Cash is projected to sustain operations into H1 2027.
Phio Pharmaceuticals (NASDAQ: PHIO) announced leadership changes to support upcoming regulatory engagements and clinical milestones for PH-762 while continuing development of PH-894. Lisa Carson was promoted to Chief Financial Officer, Jennifer Phillips, Pharm.D., to Senior Vice President, Regulatory and Corporate Affairs, and Kimberly Man joined as Vice President of Program Development.
These appointments emphasize enhanced finance, regulatory strategy, and program coordination as the company prepares for the next stage of PH-762 clinical development.
Phio Pharmaceuticals (NASDAQ: PHIO) reported that the Safety Monitoring Committee completed its safety review of PH-762 in a Phase 1b skin cancer trial. No dose-limiting toxicities or serious adverse events were observed among 22 treated patients across five dose-escalation cohorts.
The highest dose cohort (n=7) showed an 85% pathological response (6 of 7), with 4 of 6 responders achieving complete tumor clearance. Overall cSCC response was 65% (13 of 20), including 9 complete responses. An FDA meeting submission is targeted for Q2 2026 and CMC API material is expected in March 2026 ahead of cGMP manufacturing in H2 2026.
Phio Pharmaceuticals (NASDAQ: PHIO) will present at the 3rd Annual DealFlow Discovery Conference on January 28, 2026 at the Borgata Hotel in Atlantic City, NJ. Robert Bitterman, CEO and Chairman, will deliver the company presentation on January 28 at 9:00 AM ET in Borgata Hotel Room #1, and management will be available for one-on-one investor meetings during the event.
The company noted completion of treatment in the Phase 1b trial for PH-762 and emphasized ongoing development of therapeutics using its proprietary INTASYL gene silencing technology targeting cancer.
Phio Pharmaceuticals (NASDAQ: PHIO) reported pathology and safety results from its Phase 1b intratumoral PH-762 dose‑escalation trial in cutaneous carcinomas on January 20, 2026. Across five cohorts, 22 patients completed treatment and excision; among 20 cSCC patients, 14 were pathologic responders (70% overall response): 10 complete responses (100% clearance), 2 near‑complete (>90%), and 2 partial (>50%). One metastatic Merkel cell patient had a partial (>50%) response. No dose‑limiting toxicities or clinically relevant treatment‑emergent adverse events were observed through the reported follow‑up. Drug concentration was escalated 20‑fold from first to final cohort. Extended safety follow‑up is expected in Q2 2026 and follow‑on trial design is underway.
Phio Pharmaceuticals (NASDAQ: PHIO) will present at the Sidoti Micro-Cap Virtual Investor Conference on January 22, 2026 at 1:45 PM ET. CEO and Chairman Robert Bitterman will provide an update on the company's proprietary INTASYL siRNA technology and progress in the ongoing clinical trial of lead compound PH-762 for treatment of skin cancers. The presentation is available via live webcast and the CEO will hold one-on-one investor meetings during the conference on Jan 21–22, 2026. Registration is free and open to non-clients.
Phio Pharmaceuticals (NASDAQ: PHIO) announced FDA acceptance of a nonclinical protocol for its INTASYL candidate PH-762 and said a required toxicology study will commence in Q1 2026. The company also said initiatives to produce commercially viable drug product under cGMP are ongoing and targeted for later in 2026, with part of recent financing directed to these efforts.
Interim Phase 1b results reported from 18 treated patients: among 16 cutaneous squamous cell carcinoma (cSCC) patients, there were 6 complete responses, 2 near-complete responses, and 2 partial responses; six cSCC and one metastatic melanoma showed pathologic non-response. No dose-limiting toxicities or clinically relevant treatment-emergent adverse effects were observed to date.
Phio Pharmaceuticals (NASDAQ: PHIO) announced completion of enrollment in its Phase 1b trial of INTASYL siRNA lead PH-762 for cutaneous squamous cell carcinoma (cSCC), melanoma and Merkel cell carcinoma.
Key facts: 18 patients treated across five dose-escalating cohorts; in 16 cSCC patients there were 6 complete responses, 2 near-complete and 2 partial responses; one Merkel cell carcinoma patient had a partial response; no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects reported.
Additional patients are being treated in the fifth cohort at the highest dose and pathology results are expected in Q1 2026.
Phio Pharmaceuticals (NASDAQ: PHIO) will present a podium talk on its INTASYL siRNA Drug Technology at Advanced Therapies USA 2025 in Philadelphia on November 18, 2025. The presentation, titled "INTASYL® Synthesized siRNA Drug Technology Down-regulating Gene Expression," will be delivered by Melissa Maxwell, M.S. in the Innovation Showcase (Track 2, Seminar Theatre) at 1:15 PM EDT. The company described INTASYL and PH-762 as a promising approach to enhance cancer treatment and a potential non-surgical option for cutaneous carcinomas.
Event dates are November 18–19, 2025 at the Pennsylvania Convention Center.