Prelude Therapeutics Announces Q1 2024 Financial Results and Corporate Update

Prelude Therapeutics Incorporated, a clinical-stage precision oncology company, has released its financial results for Q1 2024 and provided updates on its clinical development and corporate activities.

CEO Kris Vaddi highlighted significant progress with the company's lead drug candidates, PRT3789, a first-in-class SMARCA2 degrader, and PRT2527, a potentially best-in-class CDK9 inhibitor. Both drugs are poised to deliver initial Phase 1 data by the end of the year, potentially leading to new therapeutic options for patients with significant medical needs.

Prelude's leadership team has been bolstered by the addition of Sean Brusky as Chief Business Officer and Robert Doody as Senior Vice President of Investor Relations. These appointments bring valuable expertise to support Prelude's anticipated growth.

Clinical Program Highlights

PRT3789 - SMARCA2 Degrader
PRT3789, a highly-selective, first-in-class SMARCA2 degrader, targets cancers with SMARCA4 mutations, which generally have a poor prognosis and limited treatment options. The drug is in Phase 1 clinical trials, with monotherapy dose escalation expected to conclude by mid-2024. This will be followed by the identification of the recommended Phase 2 dose and the continuation of enrollment in cohorts enriched for non-small cell lung cancer (NSCLC) and SMARCA4 loss-of-function mutations. The trial aims to determine safety, tolerability, pharmacokinetics, pharmacodynamics, and appropriate indications for further development.

PRT7732 - Oral SMARCA2 Degrader
PRT7732, another SMARCA2 degrader, is distinguished by its oral bioavailability and structural uniqueness from PRT3789. The molecule is currently undergoing preclinical studies and is expected to enter Phase 1 clinical trials in the latter half of 2024. Its design may allow for use in earlier lines of therapy, offering new treatment possibilities.

PRT2527 - CDK9 Inhibitor
PRT2527 is a potent, selective CDK9 inhibitor designed to minimize off-target toxicity. It is being evaluated as monotherapy in B-cell malignancies and acute myeloid leukemia (AML). Additionally, it has begun combination dosing with zanubrutinib in B-cell malignancies. Phase 1 development is ongoing, with monotherapy dose escalation anticipated to conclude by mid-year. Further studies in AML patients are set to start in the first half of 2024.

Recent Presentations at AACR 2024
At the American Association for Cancer Research (AACR) Annual Meeting, Prelude presented new preclinical data on its SMARCA2 degrader, CDK9 inhibitor, and next-generation oral CDK4/6 inhibitor. These findings underscore the potential of Prelude's drug candidates to meet critical unmet needs in oncology.

Corporate Developments
In April 2024, Sean Brusky joined as Chief Business Officer, bringing experience from Pardes Biosciences and Genentech/Roche. Robert Doody was appointed Senior Vice President of Investor Relations, with prior roles at Aclaris Therapeutics and Provention Bio.

Financial Overview
As of March 31, 2024, Prelude had $201.9 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2026. Research and development expenses increased to $27.4 million from $21.8 million in the prior year, primarily due to the timing of clinical research programs. General and administrative expenses decreased slightly to $6.9 million. Net loss for Q1 2024 was $31.4 million, or $0.42 per share, compared to a net loss of $27.7 million, or $0.58 per share, in Q1 2023.

Summary
Prelude Therapeutics continues to advance its innovative drug candidates, supported by a robust financial position and strengthened leadership team. The company remains focused on developing targeted therapies for cancers with significant unmet needs, with multiple promising candidates in its pipeline poised for further clinical validation in 2024.

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