Phio (NASDAQ: PHIO) inks PH-762 manufacturing deal after strong 65% response
Rhea-AI Filing Summary
Phio Pharmaceuticals reported that it has signed a cGMP drug product manufacturing services agreement with a U.S.-based manufacturer to produce its lead siRNA compound, PH-762, for clinical and potential commercial supply. PH-762 is being developed as an intratumoral treatment for cutaneous skin cancers.
In a Phase 1b trial of PH-762, 22 patients completed treatment across five dose-escalation cohorts with no dose-limiting toxicities or serious adverse events. The company reported an approximate 65% pathological response rate in cutaneous squamous cell carcinoma across all dosing cohorts, including 85% pathological response, or 6 of 7 patients, in the highest-dose cohort.
Phio indicated that engagement with the FDA on next-stage clinical development of PH-762 is targeted for the second quarter of 2026 and that its cash and cash equivalents are projected to sustain operations into the first half of 2027.
Positive
- None.
Negative
- None.
Insights
PH-762 shows encouraging early data as Phio secures U.S. manufacturing and outlines runway into 2027.
Phio Pharmaceuticals is progressing its lead siRNA candidate PH-762 by locking in a U.S.-based cGMP drug product manufacturer for clinical and potential commercial supply. This supports smoother transition from early trials toward later-stage studies and eventual commercialization if the program succeeds.
The Phase 1b data described are notable for safety and early activity: 22 patients treated across five escalating dose cohorts had no dose-limiting toxicities or serious adverse events. The reported approximate 65% pathological response rate in cutaneous squamous cell carcinoma, including 85% response (6 of 7 patients) at the highest dose, suggests biological activity, though results remain early-stage and from a small sample.
The company targets FDA engagement on next development steps in Q2 2026, an important regulatory milestone for determining trial design and path forward. Management also indicates cash and cash equivalents are projected to fund operations into the first half of 2027, giving a defined financial runway to advance PH-762 and related INTASYL programs before needing additional capital, subject to execution and future conditions.
8-K Event Classification
|
|
|
|
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
|
|
|
|
|
|
|
(Address of principal executive offices)
|
(Zip Code)
|
|
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
|
Title of each class:
|
Trading Symbol(s):
|
Name of each exchange on which registered:
|
||
|
|
|
The
|
|
Exhibit No.
|
Description
|
|
|
99.1
|
Press release issued by the Company on March 30, 2026 | |
|
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL document).
|
|
PHIO PHARMACEUTICALS CORP.
|
||
|
Date: March 30, 2026
|
By:
|
/s/ Robert J. Bitterman
|
|
Robert J. Bitterman
President & Chief Executive Officer
|
||
Exhibit 99.1
Phio Pharmaceuticals Announces Agreement with U.S. cGMP Manufacturing Source for Drug Product, PH-762
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 trial. The company will manufacture Phio’s lead compound PH-762 for both clinical 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 65%, including an 85% pathological response (6 of 7 patients) in the highest-dose cohort.
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
FAQ
What did Phio Pharmaceuticals (PHIO) announce regarding PH-762 manufacturing?
What Phase 1b results for PH-762 did Phio Pharmaceuticals report?
How is PH-762 being used to treat cutaneous carcinomas at Phio Pharmaceuticals (PHIO)?
When does Phio Pharmaceuticals expect to engage the FDA about PH-762’s next-stage development?
How long does Phio Pharmaceuticals expect its cash to last based on this disclosure?
What is Phio Pharmaceuticals’ INTASYL technology mentioned in the PHIO 8-K filing?
Filing Exhibits & Attachments
5 documents