Phio Pharmaceuticals Announces Agreement with U.S. cGMP Manufacturing Source for Drug Product, PH-762
Rhea-AI Summary
Phio Pharmaceuticals (NASDAQ: PHIO) entered a cGMP U.S. drug product manufacturing services agreement to supply its lead siRNA candidate PH-762 for clinical and potential commercial use. The move supports next-stage trials for intratumoral treatment of cutaneous carcinomas and secures domestic capacity for clinical supply.
Phio reported Phase 1b data: 22 patients treated with no dose-limiting toxicities, ~65% pathological response in cSCC across cohorts, and 85% response in the highest-dose cohort. FDA engagement is targeted for Q2 2026; cash runway is projected into H1 2027.
Positive
- cGMP manufacturing agreement with a U.S. supplier for PH-762 clinical and commercial supply
- Phase 1b safety signal: no dose-limiting toxicities or serious adverse events in 22 patients
- High pathological responses: ~65% overall in cSCC; 85% in highest-dose cohort
- FDA engagement planned for Q2 2026 to discuss next-stage development
Negative
- Cash runway only projected into H1 2027, limiting near-term financial flexibility
- Early-stage data: Phase 1b is small (22 patients), so efficacy requires confirmation in larger trials
News Market Reaction – PHIO
On the day this news was published, PHIO declined 4.76%, reflecting a moderate negative market reaction. Argus tracked a peak move of +2.2% during that session. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $732K from the company's valuation, bringing the market cap to $14.64M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PHIO’s move was stock-specific: only one peer in momentum (BCTX up 3.20%), while other close peers (PHGE, ADAP, APLM, BCDA) showed negative returns.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 23 | Clinical data update | Positive | +2.5% | Phase 1b PH-762 data and upcoming AAD late-breaking presentation. |
| Mar 16 | Investor fireside chat | Positive | +7.3% | Fireside chat highlighting INTASYL platform and PH-762 Phase 1b results. |
| Mar 10 | Investor conference | Positive | +1.6% | Life Sciences Investor Forum presentation on PH-762 progress and plans. |
| Mar 05 | Year-end earnings | Neutral | -0.8% | 2025 results, strengthened cash position and PH-762 program update. |
| Mar 05 | Non-deal roadshow | Positive | +1.7% | Roadshow highlighting INTASYL platform and Phase 1b PH-762 data. |
Shares have typically reacted positively to PH-762 clinical and visibility updates, with multiple aligned upside moves on recent news.
Over March 2026, Phio repeatedly highlighted progress for lead candidate PH-762, including Phase 1b data with strong pathological responses and no dose-limiting toxicities, plus plans for FDA engagement in Q2 2026 and cash runway into H1 2027. These updates often corresponded with modest price gains. The new cGMP drug product agreement builds on prior CMC and manufacturing steps, reinforcing operational readiness for future PH-762 trials and potential commercialization.
Regulatory & Risk Context
An effective resale registration covers up to 11,763,800 warrant shares held by existing stockholders. Phio would receive up to $24.5 million only if all related warrants are exercised for cash; the company is not selling new shares under this prospectus, but warrant exercises could still add to the public float over time.
Market Pulse Summary
This announcement marks a key CMC milestone as Phio secures a U.S.-based cGMP partner to manufacture PH-762 for clinical and potential commercial supply. It builds on Phase 1b data showing robust pathological responses with a clean safety profile and complements guidance for FDA engagement in Q2 2026 and a cash runway into H1 2027. Investors may track execution on manufacturing timelines, regulatory interactions, and any warrant-related share overhang under the existing resale registration.
Key Terms
cGMP regulatory
siRNA medical
intratumoral medical
AI-generated analysis. Not financial advice.
A Critical Next Step in Advancing Phio's PH-762 Program to Treat Cutaneous Carcinomas
King of Prussia, Pennsylvania--(Newsfile Corp. - March 30, 2026) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio announced today that it has entered into a cGMP drug product manufacturing services agreement with a U.S. manufacturer for clinical supply for future clinical trials. The company will manufacture Phio's lead compound PH-762 for both clinical trial and commercial supply.
"It is a pleasure to partner with an organization known for its quality and expertise in drug product manufacturing services," said Mr. Robert Bitterman, Phio's President and CEO. "Further, we value the strategic advantages of working with a U.S. based organization."
Recent Company Highlights
Phio's lead clinical candidate, PH-762, is being evaluated as an intratumoral therapy for cutaneous carcinomas. In its Phase 1b trial, Phio has reported that 22 patients completed treatment across five dose-escalation cohorts, with no dose-limiting toxicities or serious adverse events. The Company has also reported a pathological response rate in cSCC across all dosing cohorts of approximately
Phio has indicated that FDA engagement regarding next-stage clinical development is targeted for the second quarter of 2026 and has reported cash and cash equivalents projected to sustain operations into the first half of 2027.
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company advancing its INTASYL® gene silencing technology in immuno-oncology. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Notably, INTASYL is a self-delivering RNAi technology focused on immuno-oncology therapeutics without the need for formulation enhancements or manipulations to reach its target.
Phio's lead clinical program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The Phase 1b trial (NCT# 06014086) evaluated PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers.
For additional information, visit the Company's website, www.phiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "intends," "believes," "anticipates," "indicates," "plans," "expects," "suggests," "may," "would," "should," "potential," "designed to," "will," "ongoing," "estimate," "forecast," "target," "predict," "could" and similar references, although not all forward-looking statements contain these words. Examples of forward-looking statements contained in this press release include, among others, the possibility that our INTASYL® siRNA gene silencing technology will make the body's immune cells more effective in killing cancer cells, expectations that the U.S. manufacturer we have engaged with to manufacture our lead compound, PH-762, will produce the intended results, our projection that our current cash and cash equivalents will sustain operations into the first half of 2027, timing with respect to FDA engagement, and statements regarding our commercial and clinical strategy, development plans and timelines and other future events.
These statements are based only on our current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including, but not limited to, the impact to our business and operations by inflationary pressures, rising interest rates, recession fears, the development of our product candidates, results from our preclinical and clinical activities, our ability to execute on business strategies, our ability to develop our product candidates with collaboration partners, and the success of any such collaborations, the timeline and duration for advancing our product candidates into clinical development, the timing or likelihood of regulatory filings and approvals, the success of our efforts to commercialize our product candidates if approved, our ability to manufacture and supply our product candidates for clinical activities, and for commercial use if approved, the scope of protection we are able to establish and maintain for intellectual property rights covering our technology platform, our ability to obtain future financing, market and other conditions and those identified in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors" and in other filings the Company periodically makes with the SEC. Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. Phio does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release, except as required by law.
Contact:
Phio Pharmaceuticals Corp.
Jennifer Phillips: jphillips@phiopharma.com
Corporate Affairs
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/290314
FAQ
What did Phio (PHIO) announce about PH-762 manufacturing on March 30, 2026?
How effective was PH-762 in Phio's Phase 1b trial reported March 30, 2026?
What safety results did Phio report for PH-762 in the March 30, 2026 release?
When does Phio expect to engage the FDA about PH-762 next-stage development?
How long is Phio's cash runway after the March 30, 2026 announcement?
