On August 9, 2022 Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2022 and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, AUG 9, 2022, View Source [SID1234617902]).

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"We continue to execute on building a deep portfolio of highly differentiated small molecules by delivering an IND submission every 12-18 months. Today, Prelude is pleased to announce the acceptance of our latest IND for PRT3645, a differentiated and highly brain penetrant CDK4/6 inhibitor. We believe PRT3645 has the potential to extend the reach of CDK4/6 inhibition beyond HR+ breast cancers, for which the first generation CDK4/6 inhibitors were approved," said Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "Our current cash runway is expected to fund our operations into the second half of 2024 enabling us to reach significant pipeline milestones."

Jane Huang, M.D., President and Chief Medical Officer of Prelude, shared "Having multiple programs in clinical development is a clear testament to the strength of Prelude’s drug discovery engine and the research team. It’s now the clinical organization’s responsibility to take these highly potent and selective molecules from our research colleagues and execute efficient clinical trials. By adding a differentiated CDK4/6 inhibitor to our growing clinical portfolio, we strengthen our likelihood of achieving effective treatments for multiple cancers and underserved patient populations."

Recent Highlights and Upcoming Objectives

Brain Penetrant CDK4/6: Phase 1 clinical trial, to begin in Q4, will include select cancer types including sarcomas, P16 mutated mesothelioma, gliomas, HPV negative head and neck cancers and CDK pathway-altered non-small cell lung cancer, in addition to HR+/HER2+ and HR+/HER2- breast cancer with or without brain metastases.

PRMT5 Inhibitor Program: As previously announced, Prelude has prioritized PRT811 for clinical development in select expansion cohorts. Prelude will complete data analyses of the ongoing expansion cohorts and expects to announce next steps for the PRMT5 program in the second half of 2022.

MCL1 Inhibitor Program: Prelude remains on track to begin evaluating combinations with PRT1419 and report early findings by the end of 2022. MCL1 inhibition has potential in hematologic indications such as acute myeloid leukemia, mantle cell lymphoma and chronic lymphocytic leukemia.

CDK9 Inhibitor Program: Prelude remains on track to complete dose escalation and identify a recommended Phase 2 dose for PRT2527 in the upcoming months. CDK9 inhibition has shown strong preclinical activity in both prostate and MYC-amplified solid tumors and hematological malignancies.

SMARCA2/BRM Protein Degrader Program: Prelude remains on track to complete IND-enabling studies and submit an IND application by year-end 2022. SMARCA2 inhibition has the greatest potential in patients with SMARCA4 deficient cancers, including up to 10% of all non-small cell lung cancers.
Second Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of June 30, 2022, were $246.3 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 second quarter of 2022, R&D expense decreased by $1.1 million to $21.3 million for the three months ended June 30, 2022 from $22.4 million for the three months ended June 30, 2021. Included in research and development expenses for the quarter ending June 30, 2022, was $2.5 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $2.2 million for the three months ended June 30, 2021. The decrease in research and development expense was primarily due to the wind down of PRT543 clinical development in the PRMT5 programs as we are concentrating further development efforts on our PRT811 candidate in biomarker-selected patients in specific cancer types. 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 second quarter of 2022, G&A expenses increased to $8.2 million for the three months ended June 30, 2022, from $5.5 million for the three months ended June 30, 2021. Included in the general and administrative expenses for the quarter ended June 30, 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 same period in 2021. The increase in general and administrative expense was primarily due to an increase in non-cash stock-based compensation expense, and an increase in professional fees as we expanded our operations to support our research and development efforts.

Net Loss: For the three months ended June 30, 2022, net loss was $27.4 million, or $0.58 per share of common stock, basic and diluted compared to $26.9 million, or $0.58 per share, respectively, for the prior year period. Included in the net loss for the quarter ended June 30, 2022, was $6.0 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $4.2 million for the prior year period.