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false 0001533040 0001533040 2026-01-20 2026-01-20
 


 
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
 
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: January 20, 2026
By:
/s/ Robert J. Bitterman
   
Robert J. Bitterman
President & Chief Executive Officer
 
 
3
EX-99.1 2 ex_907103.htm EXHIBIT 99.1 ex_907103.htm

 

 

Exhibit 99.1

logo01.jpg

Phio Pharmaceuticals Announces Key Tumor Response Data from all Cohorts in Intratumoral PH-762 Dose Escalation Cutaneous Carcinoma Trial

 

Pathology data indicate 70% overall response rate for squamous cell carcinomas –10 out of 14 responders reported 100% clearance 

 

Favorable safety and tolerability at all dose escalations

 

KING OF PRUSSIA, PA, January 20, 2026 (NEWSFILE) —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 a summary of the pathology results and safety outcomes across all cohorts in its Phase 1b dose escalation clinical trial with the INTASYL compound PH-762 for the treatment of skin cancer.

 

A total of 22 patients with cutaneous carcinomas completed treatment across five cohorts in the Phase 1b trial and underwent excision of the treated lesional site. Among the 20 patients with cSCC, 14 patients were determined to be pathologic responders, including 10 patients with complete response (100% clearance), 2 patients with major/near clear response (greater than 90% clearance), and 2 patients with partial response (greater than 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response with greater than 50% clearance. Six cSCC patients and one melanoma patient had responses of less than 50%, however, none of the patients experienced a progression of the disease.

 

There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in any patients who received intratumoral PH-762 in this trial. PH-762 has been well tolerated in all enrolled patients in each of the five dose escalating cohorts, increasing drug concentration 20-fold from the first to the final cohort. Safety data through an extended follow-up period is expected to be reported in the second quarter of 2026.

 

“The pathology data is remarkable with an overall response rate of 70%, complemented by a favorable safety data.  With this data in hand, we are now actively beginning the follow-on clinical trial design in the next step in the regulatory development pathway.” said Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals.

 

The Phase 1b clinical trial is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cSCC, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. Per the trial’s protocol, patients received four injections of PH-762 at weekly intervals and pathologic response was assessed 2 weeks following the final injection of PH-762.

 

About Phio Pharmaceuticals Corp.

 

Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company advancing its INTASYL® gene silencing technology focused on immuno-oncology therapeutics. Phio’s INTASYL compounds are designed to enhance the body’s immune cells to more effectively kill cancer cells. Phio’s lead clinical program is an INTASYL compound, PH-762, a potent silencer of PD-1 gene implicated in various forms of skin cancer. The ongoing Phase 1b trial (NCT# 06014086) is evaluating 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, expectations regarding timing of enrollment, the expectations that we have sufficient capital to complete the treatment phase of our ongoing Phase 1b clinical trial, and 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, results from our preclinical and clinical activities, our ability to execute on business strategies, the timing or likelihood of regulatory filings and approvals, 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