Phio Pharmaceuticals Announces Successful Completion of First Commercial-Scale cGMP Batch of PH-762 Drug Substance

The batch met established specifications and quality requirements, confirmed by Certificates of Analysis and Compliance.

Rhea-AI Summary

Phio Pharmaceuticals (PHIO) has released its first commercial-scale batch of PH-762 drug substance, completing a manufacturing milestone for its cancer treatment program.

The active pharmaceutical ingredient met established specifications and quality requirements and was manufactured under current Good Manufacturing Practice (cGMP) regulations. It will now undergo final drug product completion steps for use in the planned Phase 2b study. Phio plans to initiate that trial in the first quarter of 2027 and said the manufacturing milestone supports supply chain readiness and its potential commercialization strategy.

Positive

• Minor pointFirst commercial-scale PH-762 drug substance batch successfully released, completing a manufacturing milestone.
• Minor pointBatch quality requirements met, with manufacturing compliant with cGMP regulations and applicable ICH Q7 guidelines.
• Minor point. Forward-looking: it has not happened yet and may not happen.Phase 2b trial initiation planned for the first quarter of 2027.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.Final drug product completion steps remain before the validated drug substance is ready for clinical study use.

Key Figures

Planned Phase 2b initiation: First quarter 2027

Planned Phase 2b initiation

First quarter 2027

Planned PH-762 clinical study

Historical Context

1 past event · Latest: Sep 14

1 event

1. Sep 14

   FDA submission

   24h Move

   +0.0%

   Phio submitted an FDA briefing package for PH-762 and said clinical supplies were being prepared for the planned Phase 2b study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cGMP, siRNA, ich q7, drug substance

4 terms

cGMP regulatory

"first commercial-scale cGMP batch of PH-762 drug substance"

cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

siRNA medical

"proprietary INTASYL® siRNA gene-silencing platform"

Small interfering RNA (siRNA) is a short strand of genetic material that binds to and destroys the messenger RNA that carries instructions for making a specific protein, effectively switching that gene off. Investors care because siRNA is a platform for precise medicines: successful trials or approvals can create high-value drugs, while delivery challenges, manufacturing complexity, patent positions and regulatory risk can sharply affect a biotech company's prospects.

ich q7 regulatory

"applicable ICH Q7 guidelines"

ICH Q7 is an international regulatory guidance titled “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” that sets recommended quality and manufacturing practices for the production of active pharmaceutical ingredients (APIs). It describes expectations for a pharmaceutical quality system, personnel, facilities and equipment, materials and controls, production and in-process controls, laboratory controls, documentation, change control, deviation handling, and internal audits to help ensure APIs are consistently produced to quality standards. It is a guidance document (not a law) issued by the International Council for Harmonisation and is applied by regulators and manufacturers to API manufacture; it is focused on APIs and does not replace GMP requirements specific to finished drug products or local statutory rules.

drug substance technical

"first commercial-scale cGMP batch of PH-762 drug substance"

The drug substance is the primary active ingredient in a medicine—the chemical or biological material that produces the intended therapeutic effect. Think of it like the main ingredient in a recipe: its availability, purity, cost to make, and the ability to produce it at scale affect regulatory approvals, manufacturing reliability and profit margins, so investors watch it as a key factor in a drug’s commercial prospects and risk profile.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Critical Manufacturing Milestone Supports Supply Chain Readiness and Planned Phase 2b Clinical Trial Initiation in First Quarter 2027

King of Prussia, Pennsylvania--(Newsfile Corp. - October 13, 2026) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary INTASYL® siRNA gene-silencing platform, today announced the successful release of its first commercial-scale cGMP batch of PH-762 drug substance (active pharmaceutical ingredient), representing a critical operational and strategic milestone as the Company advances PH-762 to the next stage of clinical development.

The batch was manufactured in accordance with established specifications and quality requirements, as confirmed by the accompanying Certificate of Analysis and Certificate of Compliance. Manufacturing was conducted in compliance with current Good Manufacturing Practice (cGMP) regulations, the approved Master Batch Record, and applicable ICH Q7 guidelines.

Validated drug substance will now proceed through the final steps of drug product completion for use in Phio's planned Phase 2b clinical study, which drug product is expected to be initiated in the first quarter 2027. Successful completion of this commercial-scale manufacturing milestone underscores the Company's supply chain readiness and supports the next steps in its clinical development and potential commercialization strategy for PH-762.

"This achievement culminates a complex coordination and cross functional execution process started some 16 months ago among numerous highly skilled scientists and engineers," said Robert Bitterman, President and CEO of Phio Pharmaceuticals. "This is a meaningful advancement in the PH-762 program, mitigating key development and manufacturing risks, and positions the Company to execute on important upcoming clinical and regulatory milestones."

About Phio Pharmaceuticals Corp.

Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company advancing its proprietary INTASYL^® siRNA gene silencing technology to eliminate cancer. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Phio's lead clinical development 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, the potential for PH-762 to present a viable non-surgical alternative for skin cancer, our plans and expectations regarding FDA submissions and related interactions, our belief that our planned Phase 2b clinical study is expected to be initiated in the first quarter of 2027, our belief that the release of our first commercial-scale cGMP batch of PH-762 drug substance (active pharmaceutical ingredient) validates our supply chain readiness, supports our clinical development and potential commercialization strategy for PH-762 and reduces key development and manufacturing risks, and other statements regarding our 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, our ability to successfully manufacture commercial-scale drug product, the impact of future FDA interactions on the development of our product candidates; our ability to work with the FDA; the development of our product candidates, results from our nonclinical, 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 PH-762 into additional 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 risks identified in our most recent 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 U.S. Securities and Exchange Commission. 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.  

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/318121

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What manufacturing milestone did Phio Pharmaceuticals complete for PH-762?

Phio successfully released its first commercial-scale cGMP batch of PH-762 drug substance, the active pharmaceutical ingredient. The batch met established specifications and quality requirements and will proceed through final drug product completion steps for the planned Phase 2b study.

When does Phio Pharmaceuticals plan to start the PH-762 Phase 2b trial?

Phio plans to initiate the PH-762 Phase 2b clinical trial in the first quarter of 2027. The released drug substance still needs to proceed through final drug product completion steps for use in that study.