# EDGAR Filing Document

**Accession Number:** 0001533040
**File Stem:** 0001683168-23-001679
**Filing Date:** 2023-3
**Character Count:** 17756
**Document Hash:** 711813ce01407ac2993f8628d56a3d07
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001683168-23-001679.hdr.sgml**: 20230322

**ACCESSION NUMBER**: 0001683168-23-001679

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230322

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230322

**DATE AS OF CHANGE**: 20230322

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Phio Pharmaceuticals Corp.
- **CENTRAL INDEX KEY:** 0001533040
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **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:** 23753631

**BUSINESS ADDRESS:**
- **STREET 1:** 257 SIMARANO DRIVE
- **STREET 2:** SUITE 101
- **CITY:** MARLBOROUGH
- **STATE:** MA
- **ZIP:** 01752
- **BUSINESS PHONE:** (508) 767-3861

**MAIL ADDRESS:**
- **STREET 1:** 257 SIMARANO DRIVE
- **STREET 2:** SUITE 101
- **CITY:** MARLBOROUGH
- **STATE:** MA
- **ZIP:** 01752

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

?xml version="1.0" encoding="utf-8"?

**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 22, 2023**

**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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| | |
|:---|:---|
| **257 Simarano Drive, Suite 101** |  |
| **Marlborough, Massachusetts** | **01752** |
| (Address of principal executive offices) | (Zip Code) |

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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:

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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. ☐

**Item 2.02. Results of Operations and Financial Condition.**

On March 22, 2023, Phio Pharmaceuticals Corp. reported its financial results for the period ended December 31, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the "Report").

The information in this Item 2.02 and attached as Exhibit 99.1 to this Report will not be treated as "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or into another filing under the Exchange Act, unless that filing expressly incorporates this information by reference.

**Item 9.01. Financial Statements and Exhibits.**

(d) Exhibits.

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| | |
|:---|:---|
| **Number** | **Description** |
| 99.1 | [Press Release, dated March 22, 2023](phio_ex9901.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: March 22, 2023 | By: | /s/ Robert Bitterman |
|  |  | Name: Robert Bitterman<br> Title: President & Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**Phio Pharmaceuticals Reports 2022 Year End Financial Results and Provides Business Update**

*– Following safety data review by the DMC, enrollment is now open for the second cohort of its Phase 1b study of PH-762 for the treatment of advanced melanoma –*

*– Received confirmation from the FDA that the planned Phase 1 clinical trial in patients with advanced solid tumors, in collaboration with Phio's development partner AgonOx, may proceed –*

*– Newly integrated management and clinical teams continue to make significant advancements across the Company's development programs –*

MARLBOROUGH, Mass., March 22, 2023 /PRNewswire—Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today reported its financial results for the year ended December 31, 2022 and provided a business update.

"This year will be a transformative period for Phio, as we continue to make significant progress advancing our proprietary platform, INTASYL, into the clinic," said Robert Bitterman, Phio's President and Chief Executive Officer. "We are completely focused on executing our clinical strategy for PH-762. Over the past several months we have achieved several key milestones, including completing enrollment of the first cohort in our Phase 1b study for PH-762 in Europe, receiving Data Monitoring Committee (DMC) approval to open enrollment of the second cohort and receiving regulatory clearance to initiate the first U.S. clinical trial for PH-762 in adoptive cell therapy. Simultaneously, we are preparing to finalize documentation to submit an IND for PH-762 for the study of cutaneous squamous cell carcinoma and other cutaneous malignancies. We look forward to continuing to provide updates on these programs over the coming months as we strive to build shareholder value."

<u>Recent Corporate Updates</u>

&nbsp;&nbsp;&nbsp;&nbsp;· In February 2023, the Company announced an independent DMC completed its
prespecified review of interim safety data in the Company's ongoing Phase 1b clinical trial (EU) of PH-762, an INTASYL compound targeting
PD-1, for the treatment of advanced melanoma, which is being conducted at the Gustave Roussy Institute (Villejuif, France). The safety
data review disclosed no dose-limiting toxicity, and no drug-related severe adverse events or serious adverse events, and the DMC recommended
proceeding to the enrollment of the subsequent dose cohort, as intended per the study protocol.

&nbsp;&nbsp;&nbsp;&nbsp;· In the first quarter of 2023, following the recommendation by the DMC, the
Company opened enrollment of subjects in the second cohort of the ongoing Phase 1b dose escalation clinical trial (EU) of PH-762 for the
treatment of advanced melanoma.

&nbsp;&nbsp;&nbsp;&nbsp;· In January 2023, the Company announced its partner AgonOx, Inc. received
confirmation from the FDA to proceed with the planned Phase 1 clinical trial in adoptive cell therapy (ACT) designed to assess safety
and to study the potential for an enhanced therapeutic benefit from the administration of Phio's PH-762 treated "double positive"
(DP) CD8 tumor infiltrating lymphocyte (TIL) in patients with melanoma and other advanced solid tumors.

&nbsp;&nbsp;&nbsp;&nbsp;· The Company has completed the IND-enabling studies for PH-894 and is in the
process of finalizing the study reports required for an IND submission with PH-894.

&nbsp;&nbsp;&nbsp;&nbsp;· In February 2023, the Company received a letter from The Nasdaq Stock Market
LLC advising the Company that it had regained compliance with Nasdaq's minimum bid price listing requirements following the implementation
of a one-for-twelve reverse split of the Company's common stock. Nasdaq advised that the matter was closed as Phio satisfied all
criteria for continued listing.

&nbsp;&nbsp;&nbsp;&nbsp;· The Board of Directors recently appointed Robert Bitterman as the Company's
President and Chief Executive Officer. Mr. Bitterman had previously served as Interim Chief Executive Officer of the Company since September
2022. Mr. Bitterman continues to serve as Chair of the Board, and as the Company's principal executive officer and principal financial
officer.

<u>Upcoming Pipeline Milestones</u>

&nbsp;&nbsp;&nbsp;&nbsp;· Plan to commence a U.S. Phase 1b clinical trial with PH-762 focused on the
treatment of cutaneous squamous cell carcinoma ("cSCC") and other selected cutaneous malignancies in the second half of 2023.

&nbsp;&nbsp;&nbsp;&nbsp;· In partnership with AgonOx, Inc., plan to commence enrollment of subjects
in a clinical trial evaluating the use of PH-762 and DP TIL in ACT during the second quarter of 2023.

&nbsp;&nbsp;&nbsp;&nbsp;· Additional data publications on the Company's pipeline programs.

<u>Financial Results</u>

**Cash Position**

At December 31, 2022, the Company had cash of $11.8 million as compared with $24.1 million at December 31, 2021. The Company expects its current cash will be sufficient to fund currently planned operations through the fourth quarter of 2023.

**Research and Development Expenses**

Research and development expenses decreased 21% to approximately $7.0 million for the year ended December 31, 2022 compared with approximately $8.9 million for the year ended December 31, 2021. The decrease in research and development expenses was primarily driven by manufacturing related costs for the Company's PH-762 and PH-894 compounds and the preclinical studies with PH-762 – both of which were completed in the prior year period – that were offset by increases in clinical-related costs for the Company's ongoing clinical trials with PH-762 in France and in ACT with our partner, AgonOx.

**General and Administrative Expenses**

General and administrative expenses decreased 4% to approximately $4.5 million for the year ended December 31, 2022 compared with approximately $4.6 million for the year ended December 31, 2021. The decrease in general and administrative expenses was primarily due to decreases in total payroll-related expenses as a result of the departure of the Company's former Chief Executive Officer and a reduction in the use of consultants and outside professional services, which were offset by executive search fees in 2022.

**Net Loss**

Net loss decreased 14% to approximately $11.5 million, or $10.10 per share, for the year ended December 31, 2022, compared with $13.3 million, or $12.43 per share, for the year ended December 31, 2021. The decrease in net loss was primarily attributable to the decrease in research and development expenses as described above.

**About INTASYL**

INTASYL compounds are chemically modified siRNAs that provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity, targeting a broad range of cell types and tissues. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy (ACT) applications.

In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial dosing convenience to the prescriber and patient. INTASYL is the only self-delivering RNA interference (RNAi) technology focused on immuno-oncology therapeutics.

**About Phio Pharmaceuticals Corp.**

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology company whose proprietary INTASYL™ RNAi technology is designed to make immune cells more effective in killing tumor cells. INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems.

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. 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 the ongoing coronavirus pandemic, military conflict between Ukraine and Russia, 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.

ir@phiopharma.com

**Investor Contact**<br> Ashley R. Robinson <br> LifeSci Advisors<br> arr@lifesciadvisors.com

**PHIO PHARMACEUTICALS CORP.**

**CONSOLIDATED STATEMENTS OF OPERATIONS** 

**(Amounts in thousands, except share and per share data)** 

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| | | |
|:---|:---|:---|
|  | **Year Ended<br> December 31,** | **Year Ended<br> December 31,** |
|  | **2022** | **2021** |
| Operating expenses: |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | $7012 | $8886 |
| &nbsp;&nbsp;&nbsp;General and administrative | 4450 | 4625 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 11462 | 13511 |
| Operating loss | (11462) | (13511) |
| Total other (expense) income, net | (18) | 224 |
| Net loss | $(11480) | $(13287) |
| Net loss per common share: |  |  |
| &nbsp;&nbsp;&nbsp;Basic | $(10.10) | $(12.43) |
| &nbsp;&nbsp;&nbsp;Diluted | $(10.10) | $(12.43) |
| Weighted average number of common shares outstanding |  |  |
| &nbsp;&nbsp;&nbsp;Basic | 1136566 | 1069234 |
| &nbsp;&nbsp;&nbsp;Diluted | 1136566 | 1069234 |

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**PHIO PHARMACEUTICALS CORP.**

**CONSOLIDATED BALANCE SHEETS** 

**(Amounts in thousands, except share data)** 

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| | | |
|:---|:---|:---|
|  | **December 31,<br> 2022** | **December 31,<br> 2021** |
| **ASSETS** |  |  |
| Cash | $11781 | $24057 |
| Restricted cash | 50 | 50 |
| Prepaid expenses and other current assets | 615 | 620 |
| Right of use asset | 161 | 283 |
| Property and equipment, net | 183 | 133 |
| Other assets | 24 | 27 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $12814 | $25170 |
| **LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS' EQUITY** |  |  |
| Accounts payable | $779 | $283 |
| Accrued expenses | 1025 | 2660 |
| Lease liability | 170 | 295 |
| Total preferred stock | 2 |  |
| Total stockholders' equity | 10838 | 21932 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities, preferred stock and stockholders' equity | $12814 | $25170 |

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