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Phio Pharmaceuticals Reports Q1 2024 Results and Provides Business Update

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Phio Pharmaceuticals reported its Q1 2024 financial results and provided updates on its lead product candidate PH-762. The company is conducting a Phase 1b clinical trial across four sites in the US, with promising preliminary results. Phio also presented new data on the immunotherapeutic activity of its INTASYL compound and received a patent for two compounds treating age-related skin disorders. Despite a decrease in cash position, the company managed to reduce research and development expenses, resulting in a lower net loss compared to the previous year.

Positive
  • Positive business aspects include the progress in the Phase 1b clinical trial for PH-762 across multiple sites, showcasing promising results and patient enrollment.

  • New data presented at key conferences demonstrated the potential of the INTASYL compound to improve the function of immune cells and inhibit tumor growth, indicating strong therapeutic potential.

  • Receiving a patent for two compounds targeting age-related skin disorders highlights Phio's commitment to innovation and expanding its product portfolio.

Negative
  • A decrease in cash position from $8.5 million to $6.5 million raises concerns about the company's ability to fund future research and development endeavors.

  • Although research and development expenses were reduced, the net loss of $2.2 million for Q1 2024 still indicates significant financial challenges for the company.

Insights

Phio Pharmaceuticals' Q1 2024 report indicates a significant reduction in both research and development and general and administrative expenses, which resulted in a lower net loss compared to the same period in the previous year. This may suggest efficiency improvements in the company's operations, a important element for sustainability especially for biotech firms in the clinical stage. However, investors should note that the company's cash position has decreased from $8.5 million to $6.5 million which raises questions about the runway and the potential need for future financing that could lead to dilution.

The progress of the INTASYL siRNA platform is noteworthy, as it represents the core of Phio's clinical developments. The fact that Phio's lead product candidate PH-762 is in a Phase 1b clinical trial and has enrolled three patients, with two already completing treatment, is a positive step towards potential FDA approval. Investors should consider the trial's success rate, safety profile and efficacy data as these will be pivotal in determining PH-762's market potential. The industry is also taking notice with a patent grant for two INTASYL compounds, signaling a protective moat around their technology for age-related skin disorders, which can be attractive for long-term valuation.

The granting of patents by the USPTO for RXI-185 and RXI-231 is a forward-looking indicator of Phio’s commitment to expanding its proprietary product portfolio. Patents not only protect intellectual property but also enhance a company's valuation due to potential monetary benefits from licensing deals or strategic partnerships. This strategic move should be seen as laying the groundwork for future revenue streams, albeit in the long term, as it is contingent on the successful development and marketing approval of the compounds.

–Four sites across the country participating in Phase 1b clinical trial for lead product candidate PH-762

Three patients have been enrolled

MARLBOROUGH, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today reported its Q1 2024 financial results and provided a business update.

Recent Corporate Updates

  • Phio’s INTASYL compound PH-762 is currently being investigated in an open-label Phase 1b clinical study (NCT 06014086) to evaluate the safety and tolerability of intratumoral PH-762 in cutaneous squamous cell (cSCC), melanoma, or Merkel cell carcinoma. Two patients have already completed treatment. Four sites across the US are now engaged in the Phase 1b study.   The sites are:
    • George Washington University in Washington DC
    • Banner MD Anderson in Arizona
    • Centricity Research in Ohio
    • Integrity Research in Florida.
  • Presented new data on the immunotherapeutic activity of INTASYL at:
    • 10th Annual Immunotherapy of Cancer Conference (ITOC10): this preclinical data demonstrates the potential of the INTASYL compound PH-905 targeting Cbl-b to improve the function of natural killer (NK) cells.
    • 27th Annual American Society of Gene and Cell Therapy (ASGCT): this preclinical data demonstrates that intratumoral injection of PH-762 significantly inhibits tumor growth in murine cells and may generate memory-specific T cells.
  • The INTASYL siRNA platform is the focus of a National Spotlight on PBS Viewpoint, a national program hosted by Dennis Quaid, and on Fox Business Network; both are airing through May.
  • Patent granted by USPTO for two of its INTASYL Compounds, RXI-185 and RXI-231 that treat age-related skin disorders including photo-aging and dermal hyperpigmentation targeting down-regulation of the Matrix metalloproteinase-1(MMP-1) and Tyrosinase (TYR) proteins.

Financial Results  

Cash Position

At March 31, 2024, we had cash of $6.5 million as compared with $8.5 million at December 31, 2023.

Research and Development Expenses

Research and development expenses were $1.1 million for the three months ended March 31, 2024 as compared with $2.1 million for the three months ended March 31, 2023, a decrease of 46%. The decrease was primarily driven by the Company’s cost rationalization measures in transitioning from a discovery research company to a product development company resulting in decreased costs for the wind-down of preclinical studies, salary-related costs and lab supplies. Additional decreases in research and development expenses were due to clinical consulting fees incurred in connection with the Company’s IND filing and manufacturing fees for PH-762 in the prior year period.

General and Administrative Expenses

General and administrative expenses were $1.1 million for the three months ended March 31, 2024 as compared with $1.5 million for the three months ended March 31, 2023, a decrease of 28%. The decrease was primarily due to decreases in consulting expenses and legal expenses as compared to the prior year period.

Net Loss

Net loss was $2.2 million for the three months ended March 31, 2024 as compared with $3.6 million for the three months ended March 31, 2023. The decrease in net loss was primarily due to the changes in research and development expenses, as described above.

About Phio Pharmaceuticals Corp.

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing 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.

Contact: 
Phio Pharmaceuticals Corp. 
ir@phiopharma.com  

PR Contact 
Michael Adams 
Bridge View Media 
adams@bridgeviewmedia.com  


PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
(Unaudited)
         
  Three Months
Ended March 31,
 
  2024  2023 
Operating expenses:        
Research and development $1,148  $2,134 
General and administrative  1,061   1,468 
Total operating expenses  2,209   3,602 
Operating loss  (2,209)  (3,602)
Total other income, net  55    
Net loss $(2,154) $(3,602)
         
Net loss per common share: Basic and diluted $(0.47) $(3.15)
Weighted average number of common shares outstanding: Basic and diluted  4,580,072   1,142,213 


PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)
       
  March 31,
2024
  December 31,
2023
 
ASSETS        
Cash and cash equivalents $6,475  $8,490 
Prepaid expenses and other current assets  373   832 
Right of use asset     33 
Property and equipment, net  2   6 
Other assets  3   3 
Total assets $6,853  $9,364 
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Accounts payable $320  $657 
Accrued expenses  929   942 
Lease liability     35 
Total liabilities  1,249   1,634 
Total stockholders’ equity  5,604   7,730 
Total liabilities and stockholders’ equity $6,853  $9,364 


FAQ

What is Phio Pharmaceuticals' lead product candidate currently under investigation?

Phio's lead product candidate PH-762 is being evaluated in an open-label Phase 1b clinical trial for cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.

Where are the Phase 1b clinical trial sites located for PH-762?

The Phase 1b clinical trial for PH-762 is being conducted across four sites in the US, including George Washington University, Banner MD Anderson, Centricity Research, and Integrity Research.

What recent data was presented by Phio Pharmaceuticals at key conferences?

Phio presented new data on the immunotherapeutic activity of its INTASYL compound at the 10th Annual Immunotherapy of Cancer Conference and the 27th Annual American Society of Gene and Cell Therapy, showcasing its potential to improve immune cell function and inhibit tumor growth.

What patent was recently granted to Phio Pharmaceuticals?

Phio Pharmaceuticals received a patent from USPTO for two INTASYL compounds, RXI-185 and RXI-231, targeting age-related skin disorders by down-regulating MMP-1 and TYR proteins.

How did the company's financial results for Q1 2024 compare to the previous year?

Phio Pharmaceuticals reported a lower net loss of $2.2 million for Q1 2024 compared to $3.6 million for Q1 2023, attributed to reduced research and development expenses despite a decrease in cash position.

Phio Pharmaceuticals Corp.

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