Release Date: May 16, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Inhibikase Therapeutics Inc (IKT, Financial) is making rapid progress in the enrollment of its Phase two trial for Parkinson's disease, with expectations to enroll the final patient in June and report top-line data in the second half of the year.
- The company had positive interactions with FDA divisions, advancing regulatory discussions for its IKCO and Pro programs, potentially positioning these assets for opportunities in pulmonary arterial hypertension and blood and stomach cancers.
- Inhibikase Therapeutics Inc (IKT) has developed a novel antibody against a key marker of alpha-synuclein pathology in Parkinson's disease, which could enhance the tracking of disease pathology and treatment efficacy.
- The company held a productive pre-NDA meeting with the FDA, which provided a clear roadmap for NDA submission for its IKTO and Pro programs, potentially expanding the treatment's indications.
- Inhibikase Therapeutics Inc (IKT) has sufficient cash to fund operations through November 2024, providing stability for ongoing projects and research.
Negative Points
- Inhibikase Therapeutics Inc (IKT) reported a net loss of $4.6 million for the quarter, indicating ongoing financial challenges despite slight improvements from the previous year.
- There were 25 mild and three moderate adverse events observed in the ongoing trial, which might raise concerns about the treatment's safety profile.
- Four participants withdrew from the trial without completing the 12-week period, potentially impacting the study's outcomes and data integrity.
- The company is still working to find the necessary capital to initiate a two one-year extension trial, indicating potential financial constraints on future research phases.
- Inhibikase Therapeutics Inc (IKT) is in the early stages of seeking partners for its drug development, which is crucial for funding and successful trial continuation but has not yet secured any agreements.
Q & A Highlights
Q: What are the key biomarkers being developed by Inhibikase Therapeutics for their Revo trial, and what would constitute a positive result from this trial?
A: Milton Werner, President, CEO, & Director of Inhibikase Therapeutics, explained that the company is at the forefront of biomarker development, focusing on biomarkers that can accurately measure the pathological aggregate of alpha-synuclein, specifically phosphorylated at tyrosine 39. A positive trial result would show an impact on these biomarkers, indicating a drug treatment effect on the underlying pathology of the disease. Additionally, improvements in quality of life measures or Parkinson's disease severity would also be considered positive outcomes.
Q: What are the next steps for Inhibikase Therapeutics following the Revo trial, assuming positive results?
A: Milton Werner mentioned that positive results would lead to a Phase 3 trial. The company hopes to have the capital to run a 12-month extension study to continue measuring patients, although funding for this is not yet secured.
Q: Can you describe the potential trial design for IKT-001 Pro for treating pulmonary arterial hypertension (PAH)?
A: Milton Werner described a standard Phase 2 trial design involving a smaller cohort with a primary endpoint of pulmonary vascular resistance. The trial is planned to enroll 140 patients and will measure safety profiles over 24 weeks. If favorable, the protocol may be amended to incorporate a full Phase 3 program, with the primary Phase 3 endpoint being the six-minute walking distance.
Q: What makes IKT-001 Pro a novel chemical entity, and what are the implications for its development and approval process?
A: Werner highlighted that IKT-001 Pro is viewed as a novel chemical entity because it delivers imatinib as a pro-drug, potentially with an improved safety and tolerability profile. This status could lead to patent and new molecular entity exclusivity, possibly accelerated approval due to its novel mechanism of action for PAH.
Q: What are Inhibikase Therapeutics' plans regarding partnering for IKT-001 Pro?
A: Milton Werner indicated that the company is actively seeking partners and is in discussions with potential collaborators. The regulatory milestones achieved make a stronger case for potential licensing or collaboration to help fund the significant trial work required for this drug.
Q: What financial results did Inhibikase Therapeutics report for the first quarter of 2024?
A: Garth Lees-Rolfe, CFO, reported a net loss of $4.6 million or $0.73 per share for Q1 2024, with research and development expenses amounting to $2.8 million. The company had $9.7 million in cash and equivalents, expected to fund operations through November 2024.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
