8-K
Phio Pharmaceuticals Corp. (PHIO)
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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 eventreported): May 7,2025
PHIO
PHARMACEUTICALS CORP.
(Exact name of registrant as specified in itscharter)
| Delaware | 001-36304 | 45-3215903 |
|---|---|---|
| (State or other jurisdiction of incorporation)<br> | (Commission File Number) | (I.R.S. Employer Identification No.) |
| 11 Apex Drive, Suite 300A, PMB 2006 | |
|---|---|
| Marlborough, Massachusetts | 01752 |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:
(508)
767-3861
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<br> of each class: | Trading<br> Symbol(s): | Name<br> 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 May 7, 2025, Phio Pharmaceuticals Corp. (“Phio”) issued a press release announcing results in the third cohort in Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) designed to evaluate the safety and tolerability of neoadjuvant use of INTASYL PH-762. 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.
| Number | Description |
|---|---|
| 99.1 | Press Release, dated May 7, 2025 |
| 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: May 7, 2025 | By: | /s/<br> Robert Bitterman |
| Name:<br><br>Title: | Robert Bitterman<br><br> <br>President & Chief Executive Officer |
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Exhibit 99.1
Phio Pharmaceuticals Announces Positive Pathology Results in Third Cohort
in INTASYL^®^ PH-762 Skin Cancer Clinical Trial
– Complete Pathologic Response reported in 2 patients in the Third Cohort with cutaneous squamouscell carcinoma, complementing results in prior cohort
– Phio to present trialresults to date at a podium presentation at Society for Investigative Dermatology (SID) Annual Meeting on May 10th
Marlborough, Massachusetts—(Newsfile Corp.-May 7, 2025) — 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 a complete pathologic response (100% tumor clearance) has been reported for 2 of 3 patients with cutaneous squamous cell carcinoma (cSCC) treated in the third dose cohort. The third patient was reported as having a pathologic non-response (<50% tumor clearance).
“These positive outcomes continue to indicate that PH-762 may present a viable non-surgical alternative in this large and continually expanding skin cancer market,” said Robert Bitterman, President and CEO of Phio Pharmaceuticals.
Phio's ongoing Phase 1b dose escalation clinical trial (NCT 06014086) 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.
To date, a total of 10 patients with cutaneous carcinomas have been treated in Cohorts 1, 2 and 3. These cohorts included 9 patients with cSCC and 1 patient with metastatic melanoma. At day 36 (planned tumor excision), of the 9 patients with cSCC, 4 patients had a pathologic complete response (100% tumor clearance). One patient had a near complete response (>90% clearance) and 1 patient had a partial response (>50% clearance). The other 3 cSCC and one metastatic melanoma patient had a pathologic non-response (< 50% clearance). Patients with pathologic complete response (100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection. No patients, however, exhibited clinical progression of disease.
To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. The fourth cohort is currently enrolling patients; Phio expects to complete enrollment in the trial in the third quarter of 2025.
“The continued positive pathologic responses in this clinical trial of intratumoral PH-762 for cutaneous carcinoma increases our understanding of the potential therapeutic benefit for this immunotherapy. The safety profile supports ongoing dose escalation,” said Mary Spellman, MD, Phio’s acting Chief Medical Officer.
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, that silences the PD-1 gene implicated in various forms of skin cancer. The on-going Phase 1b clinical 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.
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Forward Looking Statements
This press release contains forward-looking statementswithin the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words suchas "intends," "believes," "anticipates," "indicates," "plans," "expects,""suggests," "may," "would," "should," "potential," "designed to," "will,""ongoing," "estimate," "forecast," "target," "predict," "could" and similarreferences, although not all forward-looking statements contain these words. Examples of forward-looking statements contained in thispress release include, among others, the possibility that our INTASYL® siRNA gene silencing technology will make the body’simmune 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, and statements regarding our commercial and clinical strategy, development plans and timelinesand other future events.
These statements are based onlyon our current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstancesthat are difficult to predict and many of which are outside of our control. Our actual results may differ materially from thoseindicated in the forward-looking statements as a result of a number of important factors, including, but not limited to, the impactto our business and operations by inflationary pressures, rising interest rates, recession fears, the development of our productcandidates, results from our preclinical and clinical activities, our ability to execute on business strategies, our ability todevelop our product candidates with collaboration partners, and the success of any such collaborations, the timeline and durationfor advancing our product candidates into clinical development, the timing or likelihood of regulatory filings and approvals, thesuccess of our efforts to commercialize our product candidates if approved, our ability to manufacture and supply our productcandidates for clinical activities, and for commercial use if approved, the scope of protection we are able to establish andmaintain for intellectual property rights covering our technology platform, our ability to obtain future financing, market and otherconditions 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 riskfactors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by ourforward-looking statements. Phio does not undertake to update forward- looking statements to reflect a change in its views, eventsor circumstances that occur after the date of this release, except as required by law.
Contact:
Phio Pharmaceuticals Corp.
Jennifer Phillips: jphillips@phiopharma.com
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