Faio Pharmaceuticals reports year-end 2023 financial results and provides business update

– Four locations nationwide participate in clinical trials for lead product candidate PH-762

– Two patients have already completed treatment.

– New patents for skin-related treatments have been granted, expanding Fio's expertise in skin care and dermatological treatments for skin cancer.

MARLBORO, Mass., April 2, 2024 (Globe Newswire) — Phio Pharmaceuticals Corporation (Nasdaq: PHIO), a clinical-stage biotechnology company, announced that its proprietary INTASYL™ RNAi platform technology It is designed to be more effective at killing tumor cells. Today, we reported our financial results for the year ended December 31, 2023, providing an update on our business.

Latest company information

PH-762

In 2023, we made significant progress as an organization focused on drug development. In April, the company filed its first IND with the U.S. Food and Drug Administration (FDA) to address immuno-oncology and develop a second drug trial targeting various forms of skin cancer using the company's lead INTASYL compound, PH-762. Permission was sought to begin a Phase 1B dose escalation study. . One month later, we received permission from the FDA to begin a clinical trial targeting stage IV melanoma, Merkel cell carcinoma, and cutaneous squamous cell carcinoma (cSCC), including early stages I and II of cSCC. . The latter clearance was important as there are no drugs specifically approved for the treatment of early stages I and II of cSCC. The current standard treatment for these diseases is surgical intervention, but this is not always the ideal medical option when the size or location of the tumor occurs in certain areas of the face or scalp. Our INTASYL compound PH-762 has the potential to reduce tumor size without removing the lesion, reducing the extent of surgical intervention and sparing tissue, providing an alternative to promote faster recovery for patients. There is a gender.

As of February, the first two patients in the first cohort have completed treatment with PH-762, with no adverse events reported.

There are currently four research sites contracted to participate in the trial. This site is organized by George Washington University, Banner MD Anderson, and Centricity and Integrity Research.

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AgonOx Research and Development

In February 2021, Takeda entered into a clinical co-development collaboration agreement (“Clinical Co-development Agreement”) with AgonOx, a private company developing a pipeline of novel immunotherapy drugs targeting key regulators of cancer immune responses. ”) was concluded. Under a clinical co-development agreement, the Company and AgonOx are working to develop T cell-based therapies using PH-762 and AgonOx's “double positive” tumor-infiltrating lymphocyte (“DP TIL”) technology. AgonOx is conducting a Phase 1 clinical trial of DP TIL with PH-762 treatment in patients with advanced melanoma and other advanced solid tumors. In August and September, AgonOx injected its first two patients with DP TIL. In November, a third patient was injected with a combination of her TIL and our PH-762 product candidate. Infusions to additional patients have been delayed due to facility renovations at Providence Cancer Research Center, which is scheduled to reopen in May 2024.

Cost rationalization

In 2023, we implemented a cost rationalization program to drive our transition from discovery research to product development. As a result, we have decided not to renew our building lease in Marlborough, Massachusetts, which will expire on March 31, 2024. A smaller research site is located at the Massachusetts Biomedical Initiative in Worcester, Massachusetts, where the company occupies 321 square feet. A view of the laboratory space. Additionally, we streamlined our discovery research workforce, resulting in a 36% headcount reduction. The cost savings were directed to funding the Phase 1B clinical trial of PH-762.

Strengthen patent portfolio

Two new patent applications have been filed covering intratumoral administration of PH-762 and the synergistic combination of INTASYL compounds and systemic antibodies for the treatment of various skin cancers. In addition, five new patents covering multiple of his INTASYL compounds were granted in the United States (two), Japan (one), South Korea (one), and Hong Kong (one).

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The company is also a member of the American Association for Cancer Research (AACR), the Society for Immunotherapy of Cancer (SITC), the American Society for Gene and Cell Therapy (ASGCT), and the AACR-NCI-EORTC Triple Conference on Molecular Targets and Cancer Therapy. New data on INTASYL PH-894 presented showing that local treatment with PH-894 reduces BRD4 expression and upregulates MART-1 expression to enhance immune responses against cancer cells while reducing toxicity associated with systemic therapy. We have shown that this is a strategy to increase This further supports the development of PH-894 for injectable solid tumor indications such as melanoma.

Additionally, data were presented demonstrating the efficacy of PH-894 as an antitumor cytotoxic agent (directly killing tumor cells). When added to cells in vitro, PH-894 inhibited head and neck squamous cell carcinoma (HNSCC), breast cancer, lung cancer, glioblastoma, melanoma, colon cancer, ovarian cancer, and cervical cancer.

As previously disclosed, the Company has elected to postpone further work on its PH-894 product candidate in order to prioritize and advance the PH-762 clinical trial.

Summary of financial results

cash position

Cash held at December 31, 2023 was $8.5 million, compared to $11.8 million at December 31, 2022.

Research and development expenses

Research and development expenses decreased 10% to $6.3 million for the year ended December 31, 2023 compared to $7.0 million for the year ended December 31, 2022. This decrease was primarily due to lower costs associated with completing the preclinical studies that enabled his IND for PH-894, as well as lower costs of research supplies as a result of reduced laboratory personnel and a shift in focus to clinical development. This was due to a decrease, partially offset by an increase. Clinical-related costs for his two PH-762 Phase 1 clinical trials in the US increased compared to the same period last year.

General and administrative expenses

General and administrative expenses were $4.4 million for the year ended December 31, 2023, compared to $4.5 million for the year ended December 31, 2022, a decrease of 2%. This decrease was primarily due to personnel costs related to changes in organizational units, one-time executive compensation for the president and chief executive officer, and lower D&O insurance premiums, but lower legal services professional fees than previously. This was partially offset by an increase in period of years.

net loss

Net loss for the year ended December 31, 2023 was $10.8 million, or $5.20 per share, compared to net loss of $11.5 million, or $10.10 per share, for the year ended December 31, 2022. . The decrease in net loss was primarily due to changes. Research and development expenses are as above.

About Faio Pharmaceuticals Corporation

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biotechnology company whose proprietary INTASYL™ RNAi technology is designed to help immune cells more effectively kill tumor cells. INTASYL is the only self-delivery RNAi technology focused on immuno-oncology treatments. INTASYL drugs do not require specialized formulations or drug delivery systems and precisely target specific proteins that reduce the body's ability to fight cancer.

For more information, please visit our 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,” “suggests,” and “plans.” , “expect”, “suggest”, “may”, “would”, “should”, “could”, “intended”, “will”, ” All forward-looking statements include the words “in progress,” “estimate,” “anticipate,” “target,” “anticipate,” “potential,” and similar references. It does not contain words. These statements, including statements regarding the anticipated benefits of the Company's INTASYL™ RNAi Platform and the results of ongoing clinical trials, are based solely on the Company's current beliefs, expectations and assumptions and are subject to specific subject to uncertainty, risk and changing circumstances. It's hard to predict and much of it is outside of our control. The Company's actual results may differ from those indicated in the forward-looking statements as a result of a number of important factors, including, but not limited to, the impact on the Company's business and operations of inflationary pressures, rising interest rates and recession concerns. It can vary greatly. the development of our product candidates, the results of our preclinical and clinical activities, our ability to execute our business strategy, our ability to develop product candidates with our collaborative partners and the success of such collaborations, the schedule and duration of the evolution of our products and the clinical development of our candidates; the timing or likelihood of regulatory filings and approvals, the success of our efforts to commercialize our product candidates, if approved, the clinical activities and availability of our product candidates for commercial use, if approved; our ability to manufacture and supply, the scope of our intellectual property rights covering our technology platform, future financing, market and other conditions, and our annual report on Form 10-K and subsequent filings on Form 10-K; the extent of the protection we are able to establish and maintain for our intellectual property rights covering the risks identified in our quarterly reports; Q is set forth under the caption “Risk Factors” and in other filings we periodically file with the SEC. Readers are cautioned to review these risk factors and not to act in reliance on any forward-looking statements, as actual results may differ from those anticipated in our forward-looking statements. Recommended. Phio undertakes no obligation to update forward-looking statements to reflect changes in beliefs, events or circumstances after the date of this release, except as required by law.

Phio Pharmaceuticals Corp. spokesperson:
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