[8-K] Phio Pharmaceuticals Corp. Reports Material Event

Rhea-AI Filing Summary

PHIO Pharmaceuticals Corp. reported new clinical results from its intratumoral PH-762 dose-escalation trial in cutaneous carcinoma. The company highlighted that safety and tolerability were favorable across all dose levels. Pathology data showed a 70% overall response rate for squamous cell carcinomas, and among the 14 responders, 10 achieved 100% clearance of their tumors. These findings suggest PH-762 demonstrated meaningful anti-tumor activity in this early study while maintaining a manageable safety profile.

Insights

Biotech & Clinical Trials Analyst

Early PH-762 data show strong tumor responses with favorable safety.

The company reports that intratumoral PH-762 in a dose-escalation cutaneous carcinoma trial produced favorable safety and tolerability at all dose levels. For squamous cell carcinomas, pathology data indicated a 70% overall response rate, with 10 of 14 responders reaching complete, 100% clearance.

For an early-stage oncology program, a high response rate and multiple complete responses are encouraging signals of biological activity. Because these data come from a dose-escalation study, sample sizes and follow-up duration are typically limited, so durability of response and performance in larger, controlled settings remain important unknowns.

Subsequent disclosures on additional patient enrollment, longer-term outcomes, and potential expansion cohorts for PH-762 will help clarify how robust and reproducible these initial response and safety findings are over time.

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, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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):  January 20, 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 January 20, 2026, the Company issued a press release announcing key tumor response data from all cohorts in their intratumoral PH-762 dose escalation cutaneous carcinoma trial. Data supported favorable safety and tolerability at all dose escalations. Pathology data indicated a 70% overall response rate for squamous cell carcinomas, where 10 of the 14 responders reported a 100% clearance. 

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 January 20, 2026.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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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: January 20, 2026	By:	/s/ Robert J. Bitterman
		Robert J. Bitterman President & Chief Executive Officer

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