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Phio Pharmaceuticals Announces Positive Recommendation from Safety Monitoring Committee (SMC) of Phase 1b Clinical Study of Phio's Lead Compound PH-762 -Intratumoral PH-762 has encouraging safety profile in the initial c

Key Takeaway: Phio Pharmaceuticals has received a positive recommendation from the Safety Monitoring Committee for its Phase 1b clinical study of the compound PH-762. The committee approved the escalation to the next dose concentration after reviewing data indicating no dose-limiting toxicities or significant adverse events in the initial patient cohort. This study focuses on evaluating the safety and tolerability of PH-762 for treating various stages of cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. The company expresses optimism about the future development of this therapy.
Price reaction · baseline $6.885 (2024-05-24 close) · hit after-hours · 1 other PHIO headline(s) in the window, move may be shared
day 0 close · peak
+1.4%

Market Sentiment Analysis

POSITIVE FACTORS

  • Positive recommendation from the Safety Monitoring Committee for PH-762
  • No dose-limiting toxicities reported in the initial cohort
  • Intratumoral PH-762 well tolerated by patients
  • Escalation to the next dose concentration approved

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~9 mo
Medium dilution risk
Lead asset
DP CD8 TIL
Phase 1 · HNSCC

Full Press Release Details

Pharmaceuticals Announces Positive Recommendation from Safety Monitoring Committee (SMC) of Phase 1b Clinical Study of Phio's Lead
PH-762 has encouraging safety profile in the initial cohort
Escalation to proceed to next dose concentration
MARLBOROUGH, Mass., May 28, 2024 (NEWSFILE)
- 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 announced that a Safety Monitoring
Committee (SMC) reviewed safety data from the first dose cohort treated in the Phase 1b clinical trial with Phio's lead compound
PH-762. Based on these findings, the SMC recommended the escalation to the next dose concentration.
Phio's ongoing Phase 1b clinical study
(NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous
squamous cell carcinoma, Stage 4 melanoma and Stage 4 Merkel cell carcinoma.
There have been no dose-limiting toxicities,
or clinically relevant treatment-emergent adverse events in the initial cohort receiving intratumoral PH-762. The intratumoral injections
have been well tolerated. The SMC has recommended dose escalation and enrollment of the next planned cohort in the clinical study.
"Safety and efficacy data from our clinical
trial will establish the roadmap for continued development of PH-762," said Mary Spellman MD, Phio's acting Chief Medical
Officer. "We are pleased with continued interest in the potential therapy and look forward to continued enrollment in the clinical
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 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 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.

Frequently Asked Questions

What is the focus of Phio Pharmaceuticals?

Phio Pharmaceuticals focuses on developing immune cell therapies using their INTASYL siRNA technology.

What was the outcome of the Phase 1b clinical study?

The Safety Monitoring Committee recommended dose escalation due to the positive safety profile.

Which cancers is PH-762 targeting in the study?

PH-762 targets cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.

How was PH-762 tolerated in initial trials?

Intratumoral PH-762 was well tolerated, with no dose-limiting toxicities reported.

Who commented on the trial's progress?

Mary Spellman, MD, Phio's acting Chief Medical Officer, discussed the trial's safety and efficacy.

Last updated: May 28, 2024