Full Press Release Details
Phio Pharmaceuticals Reports 2024 Year End Financial
Results and Provides Business Update
clinical trial for INSTASYL siRNA lead product candidate PH-762
Cohort now fully enrolled in on-going clinical study
Massachusetts-(Newsfile Corp.-March 31, 2025) - Phio
Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL
siRNA gene silencing technology designed to make the body's
immune cells more effective in killing cancer cells. Phio today reported
its financial results for the year ended December 31, 2024, and provided a business update.
Recent Corporate Updates
PH-762 Clinical Progress
PH-762 is currently being evaluated in
a U.S. multi-center Phase 1b dose-escalating clinical trial through the intratumoral injection of PH-762 for the treatment of patients
with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The trial (NCT 06014086) is designed to evaluate the safety
and tolerability of neoadjuvant use of intratumorally injected PH-762 in up to 30 patients to assess tumor response and determine the
dose or dose range for continued study of PH-762 in future trials. In May and December 2024, respectively, a Safety Monitoring Committee
(SMC) reviewed data from the first and second dose cohorts treated with PH-762, and in both instances recommended escalation to the next
dose concentration. A total of 7 patients with cutaneous carcinomas have been enrolled in dose cohorts 1 and 2. The second cohort enrolled
a total of 4 patients, all of whom were diagnosed with cutaneous squamous cell carcinoma. At Day 36 (tumor excision), a complete response
(100% tumor clearance) was reported for 2 patients, a partial response (90% tumor clearance) was reported for 1 patient and 1 patient
had stable disease, having not progressed. Patients in the first cohort maintained stable disease.
To date, intratumoral injection of PH-762
has been well tolerated in all enrolled patients. There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse
effects in the patients receiving intratumoral PH-762. The third dose cohort is fully enrolled and patients in this cohort are currently
in the treatment or follow-up phase of the study. Phio expects to complete enrollment of all patients in the study in the third quarter
In December 2024 and January 2025, Phio raised
an aggregate of approximately $9.2 million in registered direct offerings and concurrent private placements, before deduction of commissions
and other expenses. Additional gross proceeds of approximately $2.9 million were raised from the exercise of warrants previously issued
on July 12, 2024. With these proceeds, the Company now believes it has sufficient capital to complete the treatment phase of the Phase
Cost Rationalization
In 2023, Phio commenced a cost rationalization
program resulting from its strategy to transition from discovery research to a product development focus. In combination with headcount
reductions, Phio did not renew its building lease in Marlborough, MA., the lease for which expired on March 31, 2024. The Company has
established a smaller research footprint in the Massachusetts Biomedical Initiatives in Worcester, MA, where the Company leases laboratory
space. Expense reductions have been redirected to funding the Phase 1b clinical trial for PH-762.
In May 2024, Phio terminated its Clinical
Co-Development Agreement with AgonOx, Inc. (AgonOx). The Clinical Co-Development Agreement was entered into to conduct a Phase 1 clinical
trial of PH-762 in combination with Agonox's "double positive" tumor infiltrating lymphocytes (DP TIL) in patients with
advanced melanoma and other advanced solid tumors. The primary trial objectives were to evaluate the safety and to study the potential
for enhanced therapeutic benefit from the administration of PH-762 treated DP TIL. AgonOx had enrolled three patients. The first two patients
were treated with DP TIL only, and a third patient was treated with a combination of DP TIL and PH-762. Clinical results for the single
patient who received a combination of DP TIL and PH-762. Clinical results for the single patient who received a combination of DP TIL
and PH-762 showed tumor size reductions of 65%, 100% and 81%, respectively, in three melanoma lesions. In assessing patient enrollment
delays and the cost to continue the trial, management chose to redirect funding and focus on its self-directed phase 1b clinical trial
Patent Portfolio Enhancement
Phio's portfolio includes 77 issued patents,
69 of which cover its INTASYL technology. There are 19 patent families broadly covering both the composition and methods of use of the
Company's self-delivering INTASYL technology and uses of INTASYL compounds targeting immune checkpoints for cancer therapy, cellular
differentiation and metabolism targets for Adoptive Cell Therapy immunotherapies.
During 2024, Phio presented new data on its INTASYL
self-delivering siRNA technology applications at several conferences including American Academy of Cancer Research (AACR), Society for
Immunotherapy of Cancer (SITC), American Society of Gene and Cell Therapy (ASGCT) and at the Annual Oligonucleotide Therapeutics Society
(OTS). Most recently, the Company was invited to present its phase 1b clinical trial results to date at the American Academy of Dermatology
(AAD) in the Late-Breaking Research Session. The Company's INTASYL PH-804 compound was highlighted in the peer reviewed journal,
Cancer Immunology, Immunotherapy in an article entitled, "INTASYL Self Delivering RNAi Decreases TIGIT Expression, Enhancing
NK Cell Cytotoxicity: A Potential Application to Increase the Efficacy of NK Adoptive Cell Therapy Against Cancer", authored
by M. Maxwell et al.
At December 31, 2024, the Company had cash of approximately
$5.4 million as compared with approximately $8.5 million at December 31, 2023.
During the year ended December 31, 2024,
the Company completed multiple financings and received total net proceeds of approximately $4.0 million after deducting placement agent
fees and offering expenses.
Subsequent to year-end, the Company completed additional
financings and received total net proceeds of approximately $6.8 million after deducting placement agent fees and offering expenses.
Research and Development Expenses
Research and development expenses for the year
ended December 31, 2024 decreased approximately $2.7 million, or 42%, as compared with the year ended December 31, 2023. The decrease
in research and development expenses was primarily driven by the Company's cost rationalization measures in transitioning from a
research company to a product development company. These actions resulted in a decrease of approximately $1.0 million of expense due to
the wind-down of preclinical studies, a reduction of approximately $0.8 million in salary-related costs including stock-based compensation
expense, and approximately $0.2 million in lab supplies associated with the reduction in headcount. Additionally, the Company experienced
a reduction in clinical consulting fees and clinical trial-related fees of approximately $0.4 million incurred in connection with its
IND filing for PH-762 and its former PH-762 trials in ACT and European clinical trial, as well as a decrease of approximately $0.2 million
in manufacturing fees for PH-762 compared with 2023.
General and Administrative Expenses
General and administrative expenses were approximately
$3.7 million for the year ended December 31, 2024 as compared with approximately $4.4 million for the year ended December 31, 2023, a
decrease of 14%. The decrease was primarily due to decreases in professional fees for a total of approximately $0.4 million primarily
related to legal and patent expenses and in the Company's D&O insurance premium of approximately $0.9 million as compared to
Net loss was approximately $7.2 million, or ($9.08)
per share, for the year ended December 31, 2024 as compared with a net loss of approximately $10.8 million, or $46.76 per share, for the
year ended December 31, 2023. The decrease in net loss was primarily due to the changes in research and development expenses, as described
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biotechnology
company advancing its proprietary INTASYL siRNA gene silencing technology to eliminate cancer. INTASYL can target and silence virtually
any gene with high degree of specificity across a wide range of cell types and tissues. INTASYL is designed to enhance the ability of
immune cells to more effectively kill tumor cells. INTASYL has also demonstrated enhancement to adoptive cell therapy. Notably,
INTASYL is a self-delivering RNAi technology focused on immuno-oncology therapeutics without the need for formulation enhancements or
manipulations to reach its target.
Phio's lead clinical program, PH-762, is an INTASYL compound
that silences PD-1. PH-762 is a potential non-surgical treatment for skin cancers. The on-going Phase 1b trial (NCT# 06014086) received
FDA clearance for an Investigational New Drug Application to evaluate PH-762 in the treatment of cutaneous SCC, melanoma and Merkel cell
carcinoma in second quarter of 2023.
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