WILMINGTON, DE — Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the second quarter ending June 30, 2024. The company also provided significant updates on its clinical development pipeline and corporate initiatives.
In notable clinical developments, Prelude announced that interim Phase 1 data for its innovative intravenous SMARCA2 degrader, PRT3789, has been selected for an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024. This highlights the potential of PRT3789 in treating patients with SMARCA4-mutated cancers, an area of high unmet medical need. PRT3789 is currently in Phase 1 clinical development, focusing on safety, tolerability, and determining a recommended Phase 2 dose.
Moreover, Prelude received investigational new drug (IND) authorization from the U.S. Food and Drug Administration (FDA) for PRT7732, its first-in-class oral SMARCA2 degrader. This milestone permits Prelude to advance PRT7732 into Phase 1 clinical trials in the second half of 2024.
The company has also entered into a clinical collaboration with Merck. Together, they will evaluate PRT3789 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with SMARCA4-mutated cancers. This collaboration is underpinned by promising pre-clinical data, suggesting that the combination of SMARCA2 degradation and anti-PD-1 therapy may enhance anti-tumor immunity.
Prelude’s pipeline includes PRT2527, a potentially best-in-class CDK9 inhibitor. PRT2527 is designed to avoid off-target toxicities seen with less selective CDK9 inhibitors. The company plans to present interim Phase 1 data for PRT2527 in the fourth quarter of 2024, with ongoing trials in lymphoid and myeloid hematological malignancies.
Financially, Prelude reported a stable position with $179.8 million in cash, cash equivalents, and marketable securities as of June 30, 2024. This cash reserve is projected to fund operations into 2026.
Research and development (R&D) expenses for Q2 2024 rose to $29.5 million from $25.0 million in the same period the previous year. This increase is attributed to higher costs in chemistry, manufacturing, and controls (CMC) to support pre-clinical and clinical research efforts. General and administrative (G&A) expenses also increased slightly to $7.7 million, up from $7.4 million, due to higher professional fees as the company expands its operations.
The net loss for the quarter was $34.7 million, or $0.46 per share, compared to $30.4 million, or $0.54 per share, in the prior year. Included in the net loss were $6.1 million of non-cash expenses related to share-based payments, a slight decrease from $6.7 million in the previous year.
Dr. Kris Vaddi, CEO of Prelude, expressed confidence in the company’s progress towards its R&D goals. “We are focused on advancing our two lead clinical programs, including the first-in-class, highly selective SMARCA2 degrader, PRT3789, and a potent and selective CDK9 inhibitor, PRT2527, both on track to report initial clinical results this year,” stated Dr. Vaddi.
Dr. Jane Huang, President and Chief Medical Officer, added, “We are very pleased with the progress of both of our SMARCA2 degraders, PRT3789 and PRT7732. We look forward to sharing initial clinical data at the upcoming ESMO Congress in September.”
Prelude Therapeutics continues to make significant strides in the field of precision oncology, with a robust pipeline and strategic collaborations aimed at addressing high unmet medical needs in cancer treatment.
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