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Dec 31, 2023
Prime Medicine Q4 2023 Earnings Report
Prime Medicine reported full year 2023 financial results and provided business updates, maturing into a clinical-stage company.
Key Takeaways
Prime Medicine reported its full year 2023 financial results, highlighting its progress in advancing its Prime Editing platform and therapeutic programs. The company is on track to file an IND application or CTA for PM359 in the first half of 2024, with initial data expected in 2025. Additionally, Prime Medicine completed an upsized $161 million public offering.
On track to file IND application or CTA for PM359 in 1H 2024, with initial data expected in 2025.
Progressing broader portfolio across core areas of focus; expect to initiate IND-enabling activities in first liver and ocular disease programs in 2024.
Advancing hotspot and PASSIGE™ Prime Editors for CF following entry into therapeutic development agreement with Cystic Fibrosis Foundation.
Completed upsized $161 million public offering.
Prime Medicine
Prime Medicine
Forward Guidance
Prime Medicine anticipates undergoing a significant transformation in 2024, maturing into a clinical-stage company and bringing the first-ever Prime Editing-based therapeutic candidate to patients. The company expects several activities and next steps to drive its progress, including advancing programs into lead optimization, initiating IND-enabling activities, and establishing delivery platforms.
Positive Outlook
- Open investigational new drug (IND) application and/or clinical trial application (CTA) for Phase 1/2 study in CGD in the first half of 2024, with initial clinical data anticipated 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 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 CTA in the second half of 2025 or first half of 2026.
- Nominate development candidate for Retinitis Pigmentosa/Rhodopsin (RHO) and initiate IND-enabling activities in 2024.
Challenges Ahead
- Uncertainties related to an IND or CTA filing and entering clinical trials.
- Risks related to the development and optimization of new technologies.
- The results of preclinical studies, or clinical studies not being predictive of future results in connection with future studies.
- The scope of protection Prime Medicine is able to establish and maintain for intellectual property rights covering its Prime Editing technology.
- General economic, industry and market conditions, including rising interest rates, inflation, and adverse developments affecting the financial services industry.