Phio Pharmaceuticals releases first PH-762 batch

The batch was manufactured under cGMP regulations, the approved Master Batch Record and applicable ICH Q7 guidelines, with quality confirmed by accompanying certificates.

Rhea-AI Filing Summary

Phio Pharmaceuticals Corp. announced the successful release of its first commercial-scale cGMP batch of PH-762 drug substance, the active pharmaceutical ingredient for its lead clinical program. The company described the completed batch as an operational milestone supporting supply-chain readiness and advancing PH-762 to the next stage of clinical development.

The validated drug substance will proceed through final drug-product completion for Phio’s planned Phase 2b clinical study, which is expected to be initiated in the first quarter of 2027. Phio said the milestone also supports its clinical development and potential commercialization strategy for PH-762.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Expected Phase 2b initiation: First quarter of 2027

1 metrics

Expected Phase 2b initiation First quarter of 2027 Planned PH-762 clinical study

Key Terms

current Good Manufacturing Practice (cGMP), drug substance, Certificate of Analysis, ICH Q7 guidelines

4 terms

current Good Manufacturing Practice (cGMP) regulatory

"manufactured in compliance with current Good Manufacturing Practice (cGMP) regulations"

Current good manufacturing practice (cGMP) are regulatory rules that require drug, medical device, and certain food makers to follow up-to-date standards for production, quality control, cleanliness, documentation, and staff training so products are consistently safe and effective. For investors, cGMP compliance is like a company passing routine safety inspections: it lowers the risk of costly recalls, regulatory fines, and production shutdowns, and supports steady revenue and preserved company value.

drug substance technical

"PH-762 drug substance (active pharmaceutical ingredient)"

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.

Certificate of Analysis technical

"accompanying Certificate of Analysis"

A certificate of analysis is a lab-issued report listing the tested composition, purity, potency and any contaminants of a product batch. Investors use it like a product report card: it shows whether goods meet safety standards and regulatory rules, supports marketing claims, and reduces the risk of recalls or fines—factors that can affect sales, liabilities and a company’s reputation.

ICH Q7 guidelines regulatory

"applicable ICH Q7 guidelines"

FAQ

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

What did PHIO announce about PH-762?

Phio announced the successful release of its first commercial-scale cGMP batch of PH-762 drug substance, the active pharmaceutical ingredient for its lead clinical program.

When is PHIO’s planned PH-762 Phase 2b study expected to begin?

Phio expects to initiate the planned Phase 2b clinical study in the first quarter of 2027. The validated drug substance will proceed through final drug-product completion for the study.

What standards and quality documentation applied to PHIO’s PH-762 batch?

Phio said the batch was manufactured in compliance with current Good Manufacturing Practice regulations, the approved Master Batch Record and applicable ICH Q7 guidelines. Its established specifications and quality requirements were confirmed by an accompanying Certificate of Analysis and Certificate of Compliance.

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

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Available on EDGAR 10/13/2026 - 08:42 AM EDT Accepted by SEC EDGAR 10/13/2026 - 08:41 AM EDT Learn about SEC filing dates

false 0001533040 0001533040 2026-10-13 2026-10-13

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported):  October 13, 2026

PHIO PHARMACEUTICALS CORP.

(Exact name of registrant as specified in its charter)

Delaware	001-36304	45-3215903
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

411 Swedeland Road, Suite 23-1080
King of Prussia, PA	19406
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (610) 947-0251

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class:		Trading Symbol(s):		Name of each exchange on which registered:
Common Stock, par value $0.0001 per share		PHIO		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01. Other Events.

On October 13, 2026, the Company issued a press release announcing the successful completion of its first commercial-scale cGMP Batch of PH-762 drug substance, a key operational milestone that supports the planned initiation of the Company's Phase 2b clinical trial in the first quarter of 2027.

The full text of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press release issued by the Company on October 13, 2026.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	PHIO PHARMACEUTICALS CORP.
Date: October 13, 2026	By:	/s/ Robert J. Bitterman
		Robert J. Bitterman President & Chief Executive Officer

3

Exhibit 99.1

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

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

KING OF PRUSSIA, Pa., 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 is expected to be initiated in the first quarter of 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  

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 10.3 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.5 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 15.5 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.7 KB