Selecta Biosciences Q4 2023 Earnings Report
Key Takeaways
Cartesian Therapeutics reported its full year 2023 financial results, highlighting a pro forma cash balance of $118.3 million as of December 31, 2023, expected to fund operations into the second half of 2026. The company is advancing its pipeline with key milestones anticipated, including topline data from the Phase 2b study of Descartes-08 in myasthenia gravis expected mid-2024 and initiation of a Phase 2 study of Descartes-08 in systemic lupus erythematosus in 1H24.
Topline data from the Phase 2b study of Descartes-08 in myasthenia gravis remains on track for mid-2024.
Phase 2 study of Descartes-08 in systemic lupus erythematosus is on track to initiate in 1H24.
Planning is underway for a first-in-human Phase 1 dose escalation study of Descartes-15 following recent IND clearance.
Pro forma cash, cash equivalents, and restricted cash were approximately $118.3M as of December 31, 2023, expected to support planned operations into the second half of 2026.
Selecta Biosciences
Selecta Biosciences
Forward Guidance
Cartesian Therapeutics anticipates several value-creating milestones throughout the year, with a focus on advancing its mRNA cell therapies for autoimmune diseases.
Positive Outlook
- Topline data from the randomized Phase 2b study of Descartes-08 in patients with MG expected mid-2024.
- Initiation of Phase 2 study of Descartes-08 in patients with SLE expected for first half of 2024.
- IND application cleared for Descartes-15, with planning underway for a first-in-human Phase 1 dose escalation study.
- Plans to transition corporate headquarters to Frederick, Maryland, with a state-of-the-art cGMP compliant facility.
- Completed merger with Selecta Biosciences, Inc. and concurrent $60.25 million private financing.
Challenges Ahead
- Uncertainties inherent in the initiation, completion, and cost of clinical trials.
- Potential delays in enrollment of patients.
- Undesirable side effects of the Company’s product candidates.
- Reliance on third parties to conduct clinical trials.
- Potential delays in regulatory approvals.