Loading...
•
Jun 30, 2024
Prime Medicine Q2 2024 Earnings Report
Reported financial results for the second quarter and provided a business update.
Key Takeaways
Prime Medicine reported a net loss of $55.3 million for the second quarter of 2024. They achieved a key milestone with FDA clearance to advance PM359 into clinical trials and are initiating Phase 1/2 clinical trial. The company is also advancing multiple programs and expects to share new preclinical data.
Secured FDA clearance to advance PM359 into the clinic for the treatment of chronic granulomatous disease (CGD).
Initiating Phase 1/2 clinical trial for PM359 and anticipate sharing initial clinical data in 2025.
Advanced multiple programs across core areas of focus and will share new preclinical data showcasing proprietary delivery capabilities.
Promoted Mohammed Asmal, M.D, Ph.D. to Chief Medical Officer.
Prime Medicine
Prime Medicine
Forward Guidance
Prime Medicine anticipates several milestones including announcing initial clinical data from the Phase 1/2 clinical trial of PM359 in CGD in 2025, advancing technologies and programs into lead optimization, initiating IND-enabling activities, and nominating development candidates.
Positive Outlook
- Announce initial clinical data from the Phase 1/2 clinical trial of PM359 in CGD in 2025.
- Advance Shielded Hematopoietic Stem Cell (HSC) and Immunotherapy Pairs (SCIP) technology, establish proof-of-concept in HSC and immunotherapy and identify first clinical program(s) with this approach in 2024.
- Advance differentiated CAR-T program, using Prime Assisted Site-Specific Integrase Gene Editing (PASSIGE) technology, into lead optimization.
- Continue to advance preclinical studies for three liver programs and initiate IND-enabling activities for at least one in 2024, leading to an IND and/or clinical trial application (CTA) in the second half of 2025 or first half of 2026.
- Nominate development candidate for Retinitis Pigmentosa/Rhodopsin (RHO-RP) program and initiate IND-enabling activities in 2024.
Challenges Ahead
- Uncertainties related to Prime Medicine’s product candidates entering clinical trials.
- Risks related to the development and optimization of new technologies.
- The effect of unfavorable macroeconomic conditions or market volatility.
- Prime Medicine’s accumulated deficit and the expectation for continued operating losses and negative operating cash flows for the foreseeable future.
- Uncertainties related to opening INDs and obtaining regulatory approvals