Prelude Therapeutics Q2 2024 Financial Results and Corporate Update

Prelude Therapeutics Incorporated, a clinical-stage precision oncology company, has reported its financial results for the second quarter ending June 30, 2024, and provided significant updates on its clinical development pipeline and various corporate developments.

CEO Kris Vaddi highlighted the company's progress toward its R&D objectives for 2024 and beyond, focusing on advancing two lead clinical programs. These include the highly selective SMARCA2 degrader, PRT3789, and the potent CDK9 inhibitor, PRT2527. Both programs are expected to yield initial clinical data this year.

Dr. Vaddi emphasized the potential of targeting the SMARCA pathway, which could lead to a versatile 'pipeline in a program.' The company is advancing the first highly selective oral SMARCA2 degrader, PRT7732, into clinical trials. Additionally, Prelude will soon initiate a study of PRT3789 in combination with Merck’s KEYTRUDA in collaboration with Merck. Further, with AbCellera, Prelude is working on developing precision ADCs with SMARCA payloads to target a broader range of cancers without SMARCA4 mutations.

Jane Huang, President and Chief Medical Officer, expressed satisfaction with the progress of PRT3789 and PRT7732. She anticipates sharing initial clinical data from the Phase 1 study of PRT3789, which has been selected for an oral presentation at the upcoming ESMO Congress in September. For PRT2527, interim Phase 1 clinical data is expected in the fourth quarter of this year.

Clinical Program Updates and Upcoming Milestones

PRT3789
PRT3789 is a first-in-class, highly selective intravenous SMARCA2 degrader targeting patients with SMARCA4 mutations, which often result in poor prognosis. PRT3789 is in Phase 1 clinical development, focusing on biomarker-selected patients with SMARCA4 mutations. Enrollment for the study is on track, with monotherapy dose escalation expected to conclude in 2024. The trial aims to establish the safety and tolerability of PRT3789, both as monotherapy and in combination with docetaxel.

An educational video series on SMARCA biology and the development of highly selective SMARCA2 degraders is available on the company's website.

PRT7732
PRT7732 is a potent, highly selective, and orally bioavailable SMARCA2 degrader. Following FDA IND authorization, it is anticipated to enter Phase 1 clinical development in the latter half of 2024.

PRT2527
PRT2527 is a selective CDK9 inhibitor designed to avoid off-target toxicities. Currently, the company is advancing PRT2527 as a monotherapy for lymphoid and myeloid hematological malignancies and in combination with zanubrutinib for B-cell malignancies. Monotherapy dose escalation in B-cell malignancies is expected to complete this year, with interim Phase 1 data set for the fourth quarter of 2024.

Financial Performance
For the second quarter of 2024, Prelude reported $179.8 million in cash, cash equivalents, and marketable securities. The company expects this cash runway to support operations into 2026.

R&D Expenses
Research and development expenses increased to $29.5 million from $25.0 million in the previous year, primarily due to higher costs in chemistry, manufacturing, and controls to support ongoing research programs.

G&A Expenses
General and administrative expenses rose to $7.7 million from $7.4 million in the prior year, largely because of increased professional fees to support expanding operations.

Net Loss
The company reported a net loss of $34.7 million for the quarter, higher than the $30.4 million net loss for the same period last year. This included $6.1 million in non-cash expenses related to share-based payments.

Conclusion
Prelude Therapeutics continues to make significant strides in its precision oncology programs, supported by robust financial health and strategic collaborations. With several promising drugs in the pipeline and ongoing clinical trials, the company is well-positioned to address high unmet medical needs in cancer treatment.

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