Form 8-K
8-K — Phio Pharmaceuticals Corp.
Accession: 0001437749-26-010164
Filed: 2026-03-30
Period: 2026-03-30
CIK: 0001533040
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Other Events
Documents
8-K — phio20260326_8k.htm (Primary)
EX-99 — EXHIBIT 99 (ex_937626.htm)
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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): March 30, 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 March 30, 2026, Phio Pharmaceuticals Corp. (the “Company”) issued a press release announcing it has entered into a cGMP drug product manufacturing services agreement with a U.S. manufacturer for clinical supply.
The full text of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 8.01. Financial Statements and Exhibits.
(d) Exhibits
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).
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: March 30, 2026
By:
/s/ Robert J. Bitterman
Robert J. Bitterman
President & Chief Executive Officer
3
EX-99 — EXHIBIT 99
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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
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