On May 10, 2022 Prelude Therapeutics Incorporated ("Prelude") (Nasdaq: PRLD), a clinical-stage precision oncology company, reported financial results for the first quarter ended March 31, 2022, and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, MAY 10, 2022, View Source [SID1234614058]).

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"Prelude continues to make great progress in discovering and advancing a diverse pipeline of differentiated small molecules, and with our current cash runway, we have the opportunity to deliver on numerous meaningful milestones. I’m delighted to have Jane onboard and am confident in her leadership to guide focused clinical development of our pipeline and organizational growth," said Kris Vaddi, Ph.D., Chief Executive Officer.

"I’m excited to be a part of Prelude’s continued progress," said Jane Huang, M.D., President and Chief Medical Officer. "Looking ahead, we remain on track with ongoing development of our PRMT5 program, that will drive strategic decisions in the second half of the year. In parallel, we are focused on rapidly progressing our MCL1 candidate, PRT1419, into expansion and combination cohorts, and identifying a Phase 2 dose for PRT2527, our CDK9 inhibitor. We are also on track for Investigational New Drug (IND) submissions for both our SMARCA2 degrader and PRT3645, our brain penetrant CDK4/6 inhibitor, in the second half of the year. It’s clear that Prelude’s discovery engine, depth and breadth of the pipeline, coupled with an experienced management team, will position us to deliver potential medicines for patients with underserved cancers."

Recent Highlights and Upcoming Objectives

2022 AACR (Free AACR Whitepaper) Annual Meeting: During the quarter, Prelude participated in the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Four posters and one oral presentation providing data on Prelude’s clinical and preclinical pipeline molecules, with highly potent, selective and differentiated properties, were presented as part of the scientific conference.

PRMT5 Inhibitor Program: As previously announced, Prelude has prioritized PRT811 for clinical development in select expansion cohorts. Prelude intends to complete the data analyses of the ongoing expansion cohorts and expects to announce next steps for the PRMT5 program in 2H2022.

MCL1 Inhibitor Program: As previously announced, Prelude has prioritized development of the intravenous formulation of PRT1419, which demonstrated a desirable pharmacokinetic, pharmacodynamic and safety profile, with potential for differentiation from competitor compounds. Prelude remains on track to begin evaluating combinations with PRT1419 by mid-year.

CDK9 Inhibitor Program: Prelude remains on track to complete enrollment in the Phase 1 dose escalation study of PRT2527 and identify a recommended Phase 2 dose by 2H2022.

CDK4/6 Inhibitor Program: Prelude continues to expect to file an IND application mid-year, with the initiation of a Phase 1 trial of PRT3645 to follow in 2H2022.

SMARCA2/BRM Protein Degrader Program: Prelude remains on track to complete IND-enabling studies and submit an IND application by year-end 2022.
Corporate Update

In March 2022, Prelude announced the appointment of Jane Huang, M.D., effective April 4, 2022, to the newly created position of President and Chief Medical Officer. Dr. Huang joins Prelude from BeiGene Ltd., where she served as Chief Medical Officer, Hematology. Currently, Dr. Huang serves as an Adjunct Clinical Assistant Professor in Thoracic Oncology at Stanford University.
First Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of March 31, 2022, were $266.2 million. Prelude anticipates that its existing cash, cash equivalents and marketable securities will fund Prelude’s operations into the second half of 2024.

Research and Development (R&D) Expenses: For the first quarter of 2022, R&D expense increased to $22.8 million from $16.5 million for the prior year period. Included in research and development expenses for the quarter ended March 31, 2022, was $3.2 million of non-cash expense related to stock-based compensation expense, including employee stock options, as compared to $1.8 million for the prior year period. The increase in research and development expense was primarily due to an increase in discovery-stage program expenses and from the growth and advancement of our clinical pipeline. We expect our research and development expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

General and Administrative (G&A) Expenses: For the first quarter of 2022, G&A expense increased to $7.5 million from $5.5 million for the prior year period. Included in the G&A expenses for the quarter ended March 31, 2022, was $3.6 million of non-cash expense related to stock-based compensation expense, including employee stock options, as compared to $2.0 million for the prior year period. The increase in G&A expense was primarily due to an increase in our non-cash stock compensation expense along with professional fees as we expanded our operations to support our research and development efforts.

Net Loss: For the three months ended March 31, 2022, net loss was $29.5 million, or $0.63 per share of common stock, basic and diluted compared to $21.3 million, or $0.47 per share, respectively, for the prior year period. Included in the net loss for the quarter ended March 31, 2022, was $6.8 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $3.9 million for the prior year period.