Cullinan Oncology Q2 2024 Earnings Report
Key Takeaways
Cullinan Therapeutics reported a net loss of $42.0 million for the second quarter of 2024, with cash, cash equivalents, investments, and interest receivable totaling $664.9 million as of June 30, 2024. The company is advancing its pipeline, including CLN-978 for autoimmune diseases and CLN-619 for oncology, and expects its cash resources to provide runway into 2028.
IND application for CLN-978 in systemic lupus erythematosus (SLE) remains on track to be filed in third quarter of 2024.
Company to pursue rheumatoid arthritis (RA) as second autoimmune indication for CLN-978 development.
CLN-619 combination therapy data presented at ASCO demonstrated objective responses in oncogenic driver mutation NSCLC.
Company completed an oversubscribed private placement of common stock grossing $280 million in April.
Cullinan Oncology
Cullinan Oncology
Forward Guidance
Cullinan expects to complete enrollment in the pivotal Phase 2b portion of REZILIENT1 by year-end 2024 and its cash resources to provide runway into 2028 based on its current operating plan.
Positive Outlook
- Remain on track to file an investigational new drug (IND) application in the third quarter of this year for CLN-978 in SLE.
- Advance CLN-978 toward a first global clinical study in SLE.
- Exploring the broad potential of CLN-978 across autoimmune diseases.
- Expects to complete enrollment in the pivotal Phase 2b portion of REZILIENT1 by year-end 2024.
- Cash resources to provide runway into 2028 based on its current operating plan.
Challenges Ahead
- Dose-limiting injection site reactions were observed during dose escalation with subcutaneous administration of CLN-049.
- Discontinue development of CLN-418 based on initial clinical observations.
- Net loss for the second quarter of 2024 was $42.0 million.
- Uncertainty regarding the timing and results of regulatory submissions
- The risk that any INDs we may file are not cleared by the United States Food and Drug Administration or are not cleared on our expected timelines, or at all