Phio Pharmaceuticals Reports 2023 Year End Financial Results and Provides Business Update
- Phio Pharmaceuticals Corp. made significant progress in 2023 with their lead product candidate PH-762, submitting an IND to the FDA and receiving clearance for trials in skin cancer.
- The company has two patients who have completed treatment with PH-762, with no reported adverse events.
- Phio has four sites under contract to participate in the trial, including prestigious institutions like George Washington University and Banner MD Anderson.
- They entered into a collaboration agreement with AgonOx for a Phase 1 clinical trial using PH-762 and AgonOx's DP TIL technology for advanced melanoma and other solid tumors.
- Phio implemented a cost rationalization program in 2023, resulting in reduced expenses and redirected funds towards the Phase 1B clinical trial of PH-762.
- The company filed new patent applications and received five new patents in the US, Japan, South Korea, and Hong Kong, enhancing their intellectual property portfolio.
- Scientific data on INTASYL compounds was presented at various conferences, showcasing their potential in cancer immunotherapy and as cytotoxic agents.
- Financially, Phio had $8.5 million in cash at the end of 2023, reduced both research and development expenses and general administrative expenses, and reported a net loss of $10.8 million for the year.
- Phio Pharmaceuticals Corp. continues to focus on advancing their innovative RNAi platform technology and developing novel treatments for cancer, particularly in the field of immuno-oncology.
- None.
The financial results of Phio Pharmaceuticals Corp. reveal a strategic pivot from discovery research to product development, as evidenced by their cost rationalization program. The reduction in research and development expenses by 10% year-over-year and the decrease in general and administrative expenses, albeit marginal, indicate a leaner operational model. Their cash position, while lower compared to the previous year, may reflect the investment in their clinical trials, which is a common occurrence in biotech firms at this stage. The net loss per share improvement is notable, from $10.10 to $5.20, suggesting a more favorable financial performance and potentially more efficient use of resources. However, the decreased cash position raises questions about the company's runway and the need for future capital raises, which could dilute existing shareholders or add debt to the balance sheet.
Phio Pharmaceuticals' progress in clinical trials for PH-762 is significant, especially with the FDA clearance for Phase 1B trials in various forms of skin cancer. The focus on early-stage cutaneous squamous cell carcinoma (cSCC) fills a therapeutic gap, as there are no drugs specifically approved for early stages of this cancer. If PH-762 proves to be effective in reducing or eliminating tumors, it could become a game-changer in dermatological oncology. The safety profile, with no adverse events reported in the initial cohort, is promising. However, the true efficacy and market potential of PH-762 will only be clear after more extensive trials. The patent portfolio enhancement also suggests a commitment to securing intellectual property rights, which is important for maintaining a competitive edge in the biotech industry.
The strategic enhancement of Phio's patent portfolio with new applications and international patent grants underscores the company's proactive approach to safeguarding their innovations. Patents are the lifeblood of biotech firms, providing the legal framework to protect their inventions and ensure market exclusivity upon product approval. The patents covering the intratumoral administration of PH-762 for skin cancer treatments and the combination of INTASYL compounds with systemic antibodies could extend Phio's commercial reach and open up collaborative opportunities with larger pharmaceutical companies. However, the patent landscape in biotech is complex and the strength of these patents will be critical in fending off competition and generating potential licensing revenue.
– Four sites across the country participating in clinical trial for lead product candidate PH-762
– Two patients have already completed treatment
– New patent granted for skin related treatments, extending Phio’s expertise in dermatological treatments for skin care and skin cancer
MARLBOROUGH, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- 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, 2023 and provided a business update.
Recent Corporate Updates
PH-762
In 2023, we made substantial progress as a focused drug development organization. In April, we submitted our first IND to the U.S. Food and Drug Administration (FDA), addressing an immuno-oncology disorder and seeking clearance to commence a Phase 1B dose escalation trial in various forms of skin cancer with our lead INTASYL compound PH-762. One month later we received clearance from the FDA to begin our trial in stage IV melanoma, Merkel cell and cutaneous squamous cell carcinoma (cSCC), including the early stages I and II in cSCC. The latter clearance was significant since there are no drugs specifically approved to treat early stages I and II of cSCC. The current standard of care for these diseases is surgical intervention, which may not always be an ideal medical option when tumor size or placement occur on certain areas of the face and scalp. Our INTASYL compound PH-762 may offer an alternative which could shrink tumor size, if not eliminate the lesion, as well as reducing the extent of surgical intervention to allow for tissue sparing and facilitating a faster patient recovery.
As of February, the first two patients in our first cohort have completed treatment with PH-762 with no reported adverse events.
We now have four investigation sites under contract to participate in the trial. The sites consist of George Washington University, Banner MD Anderson, Centricity and Integrity Research.
AgonOx Study Development
In February 2021, we entered into a clinical co-development collaboration agreement (the “Clinical Co-Development Agreement”) with AgonOx, a private company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer. Under the Clinical Co-Development Agreement, we and AgonOx are working to develop a T cell-based therapy using PH-762, and AgonOx’s “double positive” tumor infiltrating lymphocytes (“DP TIL”) technology. AgonOx is conducting a Phase 1 clinical trial of PH-762 treated DP TIL in patients with advanced melanoma and other advanced solid tumors. In August and September, AgonOx infused the first two patients with their DP TIL. In November, a third patient was infused with a combination of TIL and our PH-762 product candidate. Further patient infusions have been delayed due to a facility renovation at the Providence Cancer Research Center, which is expected to reopen in May 2024.
Cost Rationalization
In 2023 we implemented a cost rationalization program driven by our transition from discovery research to product development. This resulted in a decision not to renew our building lease in Marlborough, MA., which lease expires on March 31, 2024. A smaller research footprint has been established in the Massachusetts Biomedical Initiatives in Worcester, MA, where we occupy 321 sq. ft of laboratory space. Additionally, we rationalized discovery research personnel resulting in a headcount reduction of
Patent Portfolio Enhancement
Two new patent applications were filed covering the intratumoral administration of PH-762 for the treatment of various skin cancers, and the synergistic combination of an INTASYL compound and a systemic antibody. In addition, five new patents covering multiple INTASYL compounds were granted in the US (2), Japan (1), South Korea (1) and Hong Kong (1).
Scientific News
We presented new data on the immunotherapeutic activity of INTASYL compounds alone and as Adoptive Cell Therapy at 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 triple meeting of AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. New data was presented on INTASYL PH-894 showing that local treatment with PH-894 presents a strategy to decrease BRD4 expression and upregulate MART-1 expression to increase immune response to cancer cells while reducing toxicities associated with systemic therapies. This further supports development of PH-894 for injectable solid tumor indications such as melanoma.
In addition, data was presented that demonstrates the effectiveness of PH-894 as an antitumor cytotoxic agent (directly killing tumor cells). The addition of PH-894 to cells in vitro elicited concentration-associated apoptosis of all human cancer cell lines tested, including head and neck squamous cell carcinoma (HNSCC), breast cancer, lung cancer, glioblastoma, melanoma, colon cancer, ovarian cancer, and cervical cancer.
As previously disclosed, we have elected to defer further work on our PH-894 product candidate in order to prioritize and advance our PH-762 clinical trials.
Financial Results
Cash Position
At December 31, 2023 we had cash of
Research and Development Expenses
Research and development expenses were
General and Administrative Expenses
General and administrative expenses were
Net Loss
Net loss was
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, which include statements regarding the anticipated benefits of our INTASYL™ RNAi platform and the results from our ongoing clinical trials, 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 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 risks 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.
Phio Pharmaceuticals Corp. PR Contact:
adams@bridgeviewmedia.com
| PHIO PHARMACEUTICALS CORP. CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands, except share and per share data) (Unaudited) | |||||||
| Year Ended December 31, | |||||||
| 2023 | 2022 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 6,332 | $ | 7,012 | |||
| General and administrative | 4,366 | 4,450 | |||||
| Loss on impairment of property and equipment | 126 | – | |||||
| Total operating expenses | 10,824 | 11,462 | |||||
| Operating loss | (10,824 | ) | (11,462 | ) | |||
| Total other expense, net | (2 | ) | (18 | ) | |||
| Net loss | $ | (10,826 | ) | $ | (11,480 | ) | |
| Net loss per common share: | |||||||
| Basic and diluted | $ | (5.20 | ) | $ | (10.10 | ) | |
| Weighted average number of common shares outstanding | |||||||
| Basic and diluted | 2,083,569 | 1,136,566 | |||||
| PHIO PHARMACEUTICALS CORP. CONSOLIDATED BALANCE SHEETS (Amounts in thousands, except share data) (Unaudited) | |||||||
| December 31, 2023 | December 31, 2022 | ||||||
| ASSETS | |||||||
| Cash | $ | 8,490 | $ | 11,781 | |||
| Restricted cash | – | 50 | |||||
| Prepaid expenses and other current assets | 832 | 615 | |||||
| Right of use asset | 33 | 161 | |||||
| Property and equipment, net | 6 | 183 | |||||
| Other assets | 3 | 24 | |||||
| Total assets | $ | 9,364 | $ | 12,814 | |||
| LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | |||||||
| Accounts payable | $ | 657 | $ | 779 | |||
| Accrued expenses | 942 | 1,025 | |||||
| Lease liability | 35 | 170 | |||||
| Total preferred stock | – | 2 | |||||
| Total stockholders’ equity | 7,730 | 10,838 | |||||
| Total liabilities, preferred stock and stockholders’ equity | $ | 9,364 | $ | 12,814 | |||
