Shares of Phio Pharmaceuticals Corp. (NASDAQ: PHIO) experienced a significant rise on Tuesday, propelled by the announcement of positive results from its Phase 1b clinical trial assessing PH-762, the company’s principal investigational therapy. The biotechnology firm, with a market capitalization around $9 million, saw its trading volume swell dramatically to approximately 5.82 million shares, markedly surpassing its average daily volume near 412,000 shares, as reported by Benzinga Pro.
The Phase 1b study primarily focused on evaluating PH-762’s safety profile and efficacy in patients diagnosed with cutaneous carcinomas, a category of skin cancers. The trial enrolled 22 patients who each received four intratumoral injections of PH-762. Treatment response was assessed following surgical excision of the targeted lesion sites at a minimum of four weeks post the final injection.
PH-762 was administered across five escalating dose cohorts, with drug concentrations increased by a factor of 20 from the initial to the final group. The Safety Monitoring Committee reviewed the cumulative trial data, finding no instances of serious adverse events or any dose-limiting toxicities throughout the different dosage groups.
Most notably, patients receiving the highest dose level exhibited an 85% pathological response rate, with four out of six responders achieving complete tumor clearance. These findings underscore the therapeutic potential of PH-762 as a non-surgical intervention for certain skin cancer patients, pending further evaluation.
While the formal analysis of the complete study data remains underway, the company indicated plans to submit documentation to the US Food and Drug Administration in the second quarter of 2026. This submission will seek guidance on the subsequent clinical development strategy for PH-762.
Efforts to prepare for advanced trial phases are progressing according to schedule. Process and methods development, including testing for impurities, continue in preparation for manufacturing current Good Manufacturing Practice-compliant material, targeted for the second half of 2026. Additionally, Phio aims to provide material for non-human primate studies by March 2026, which are necessary precursors for initiating pivotal human trials.
The stock’s technical profile presents a nuanced picture. Currently, PHIO shares trade 12.5% below their 20-day simple moving average (SMA) and 17.3% beneath the 50-day SMA. Over the past year, the stock has depreciated by almost 49.44%, positioning it closer to its 52-week lows, highlighting persistent downward momentum.
The relative strength index (RSI) is measured at 34.74, indicating a neutral stance without strong momentum either way. Conversely, the moving average convergence divergence (MACD) remains below its signal line, signaling bearish pressure in the stock’s price action. This combination suggests ongoing mixed signals for investors evaluating PHIO’s short- and medium-term prospects.
Key technical support for PHIO is identified at 81 cents, while resistance is noted at the $1.00 level. At the time of reporting, shares were valued at $1.36, reflecting a gain of 51.11% on the day.
Key Points:
- Phio’s Phase 1b trial for PH-762 showed no serious adverse effects or dose-limiting toxicities across five dose-escalation cohorts.
- The highest dose cohort achieved an 85% pathological response rate, with complete tumor clearance in four out of six responders.
- The trial enrolled 22 patients with cutaneous carcinomas who received four intratumoral injections and were followed for at least four weeks post-treatment.
- Future milestones include an FDA submission targeting Q2 2026 and manufacturing of cGMP material planned for the second half of 2026, with non-human primate studies scheduled by March 2026.
Risks and Uncertainties:
- The complete Phase 1b data await formal analysis and peer-reviewed publication, limiting comprehensive assessment of efficacy and safety.
- Current clinical progress is preliminary; safety and efficacy results from larger, pivotal trials are needed to confirm therapeutic value.
- Upcoming regulatory submissions and manufacturing operations involve timing risks that could impact clinical development pace.
- Technical stock indicators reveal bearish trends, reflecting ongoing market skepticism despite positive clinical data.