# EDGAR Filing Document

**Accession Number:** 0001533040
**File Stem:** 0001437749-26-003575
**Filing Date:** 2026-2
**Character Count:** 11223
**Document Hash:** 284fd8c9f59624588aab0ddb01b3dff6
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-26-003575.hdr.sgml**: 20260210

**ACCESSION NUMBER**: 0001437749-26-003575

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20260210

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260210

**DATE AS OF CHANGE**: 20260210

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Phio Pharmaceuticals Corp.
- **CENTRAL INDEX KEY:** 0001533040
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 453215903
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36304
- **FILM NUMBER:** 26613467

**BUSINESS ADDRESS:**
- **STREET 1:** 411 SWEDELAND ROAD
- **STREET 2:** SUITE 23-1080
- **CITY:** KING OF PRUSSIA
- **STATE:** PA
- **ZIP:** 19406
- **BUSINESS PHONE:** (508) 767-3861

**MAIL ADDRESS:**
- **STREET 1:** 411 SWEDELAND ROAD
- **STREET 2:** SUITE 23-1080
- **CITY:** KING OF PRUSSIA
- **STATE:** PA
- **ZIP:** 19406

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** RXi Pharmaceuticals Corp
- **DATE OF NAME CHANGE:** 20111019

?xml version='1.0' encoding='ASCII'? phio20260206_8k.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): February 10, 2026**

**PHIO PHARMACEUTICALS CORP.**

**(Exact name of registrant as specified in its charter)**

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

---

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

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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:

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| | | |
|:---|:---|:---|
| 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** |

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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. ☐

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**Item 8.01. Other Events.**

On February 10, 2026, the Company issued a press release announcing the Safety Medical Committee's formal conclusion with respect to the Company's Phase 1b clinical trial of PH-762 and updates with respect to the clinical trial's response rates.

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

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press release issued by the Company on February 10, 2026.](ex_918102.htm) |
| 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.

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| | | |
|:---|:---|:---|
|  | **PHIO PHARMACEUTICALS CORP.** | **PHIO PHARMACEUTICALS CORP.** |
| Date: February 10, 2026 | By: | /s/ Robert J. Bitterman |
|  |  | Robert J. Bitterman<br> President & Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![logo01.jpg](logo01.jpg)

**Phio Announces Safety Monitoring Committee**'**s (SMC) Positive Wrap-up on Lead Clinical Candidate PH-762 in Skin Cancer Trial** 

**Maximum Dose Concentration in Final Cohort Yields 85% Pathological Response (6 of 7 Patients); Complete Response (100% Tumor Clearance) in 4 of 6 Responders**

**No Serious Adverse Events or Dose-Limiting Toxicities Identified Across All 5 Dose Escalation Cohorts**

KING OF PRUSSIA, PA, February 10, 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 that the Safety Monitoring Committee (SMC) has concluded its planned safety review for all patients treated with the INTASYL compound PH-762 in Phio's Phase 1b clinical trial. No dose-limiting toxicities or serious adverse events have been reported for any of the 22 enrolled patients who completed 4 intratumoral injections of PH-762 and have been followed through at least 4 weeks after the final injection. PH-762 has been evaluated in patients within five dose-escalating cohorts, increasing drug concentration 20-fold from the first to the fifth and final cohort.

"These results support continued evaluation of this highest dose concentration of PH-762 in the next clinical trial" said Robert Bitterman, President and CEO of Phio Pharmaceuticals. "Reported pathological response coupled with a favorable safety-tolerability profile is clinically meaningful."

While final study data is pending formal analysis, an FDA submission intended to propose and seek guidance for next steps in clinical study design for PH-762 is targeted for the second quarter of 2026. A total of 22 patients with cutaneous carcinomas completed treatment in the Phase 1b trial and underwent excision of the treated lesional site. Revised reported data supports an overall response rate of 65% for squamous cell carcinomas (cSCC). Among the 20 patients with cSCC, 13 patients were classified as pathologic responders, including 9 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. Seven cSCC patients and one melanoma patient had responses of less than 50%, however, none of the patients experienced a progression of the disease.

Concurrently, Chemistry, Manufacturing and Controls (CMC) development for drug substance material (API), is expected to have material available in March 2026 for the non-human primate study, a prerequisite for human pivotal trial commencement. Experimental work and documentation for process and methods development, as well as impurities testing are currently meeting expected timelines to commence manufacturing of cGMP material in the second half of 2026.

**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