On November 12, 2021 Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the third quarter ended September 30, 2021 and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, NOV 12, 2021, View Source [SID1234595536]).

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"We continue to make significant progress advancing our novel pipeline of therapeutic candidates, most notably with the recent presentation of dose escalation data from the Phase 1 trials of our lead PRMT5 inhibitors, PRT543 and PRT811," said Kris Vaddi, PhD, Chief Executive Officer. "We were pleased by these initial data in unselected patients, which demonstrated key points of differentiation for our molecules, including good tolerability and potency, and a desirable therapeutic window. In addition, evidence of preliminary clinical activity was observed in multiple tumor types displaying preclinically validated genomic features. We look forward to leveraging learnings from these data as we execute on the dose escalation portion of the trials and evaluate PRT543 and PRT811 in biomarker-selected patient populations, with data readouts from these cohorts anticipated in 2022. Beyond our PRMT5 inhibitors, the balance of our pipeline continues to advance. During the quarter we received IND clearance from the FDA for PRT2527, our CDK9 inhibitor, positioning us to commence a Phase 1 study of this molecule before year-end."

Recent Highlights and Upcoming Milestones

PRT543

Phase 1 Dose Escalation Study Data Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting; Data from Expansion Cohorts to be Presented in 2022: In October 2021, the Company presented data from the dose escalation portion of its Phase 1 trial of PRT543, which is designed to be a potent and selective inhibitor of PRMT5, in unselected patient populations. PRT543 demonstrated target engagement and inhibition of PRMT5 functional activity, as well as preliminary clinical activity. PRT543 was generally well tolerated. Patient enrollment is ongoing in specific biomarker-selected solid tumor and hematologic malignancy expansion cohorts. The Company expects to present data from the expansion cohorts in 2022.

Phase 1 Dose Escalation Data for PRT543 in Patients with Myeloid Malignancies to be Presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: Data from the dose escalation portion of the ongoing Phase 1 clinical trial of PRT543 in patients with myelodysplastic syndrome (MDS) and myelofibrosis (MF), including safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity, will be featured during a poster session at the 63rd ASH (Free ASH Whitepaper) Annual Meeting and Exposition being held December 11-14, 2021.

PRT811

Phase 1 Dose Escalation Study Data Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting; Dose Expansion Portion of Phase 1 Trial to Commence 4Q21: In October 2021, the Company presented data from the dose escalation portion of its Phase 1 trial of PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, in patients with unselected advanced solid tumors. PRT811 demonstrated dose dependent inhibition of PRMT5 activity and demonstrated signs of preliminary clinical activity. PRT811 was generally well-tolerated. Prelude will shortly commence the dose expansion portion of the Phase 1 trial in selected patients with central nervous system cancers (CNS) and non-CNS cancers. The Company expects to present data from the expansion cohorts in 2022.

PRT1419

Phase 1 Dose Escalation Portion of Oral and Intravenous (IV) PRT1419 Trial Ongoing: The dose escalation portion of the Company’s first-in-human Phase 1 study investigating both an oral and IV formulation of MCL-1 inhibitor, PRT1419, the Company’s third clinical candidate, in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, and solid tumors, remains ongoing. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the first half of 2022.

PRT2527

Dose Escalation Phase 1 Trial of PRT2527 on Track to Begin by Year-End: During the third quarter the Company received clearance for an Investigational New Drug (IND) application for PRT2527, which is designed to be a potent and selective CDK9 inhibitor. The Company anticipates beginning a Phase 1 trial of PRT2527 by year-end evaluating IV infusion monotherapy in patients with selected solid tumors.

Preclinical Data Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting: In October 2021, the Company presented new preclinical data demonstrating that intermittent intravenous administration of PRT2527 demonstrated strong efficacy in hematological malignancies and solid tumor models with MYC dysregulation.

Discovery Programs

The Company continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, by year-end. The Company also continues to make progress in the PRT-K4 discovery program and expects to initiate IND-enabling studies by year-end.

Corporate Update

On November 5, 2021, Brian Piper, our Chief Financial Officer, notified the Company that he will be resigning from the Company, effective November 19, 2021, to pursue other opportunities.

The Company reported the appointment of Laurent Chardonnet as its new Chief Financial Officer starting November 29, 2021. Mr. Chardonnet joins from Axcella Health where, since 2019, he served as Senior Vice President, CFO. Prior to Axcella, he spent 15 years at Incyte Corporation where he held roles of increasing responsibility including Vice President Finance, Treasurer and Principal Accounting Officer, Head of Finance and Administration for the company’s European division, and Vice President of Alliances and Global Strategy. Mr. Chardonnet received his Master of Business Administration from Vanderbilt University and his initial business degree from the Institut Supérieur de Gestion in Paris

The Company and Dr. David Mauro, the Company’s Chief Medical Officer, mutually agreed that Dr. Mauro would depart from the Company to pursue other opportunities. Dr. Mauro’s last day with the Company was on November 9, 2021. The Company has an ongoing search for a successor. Dr. Victor Sandor, former Chief Medical Officer of Array Biopharma and current board member and chair of the Science and Technology Committee, will provide strategic and operational oversight of clinical development during this time.

Third Quarter 2021 Financial Results

Cash, Cash Equivalents, and Marketable Securities: Cash, cash equivalents, and marketable securities as of September 30, 2021 were $320.9 million.

Research and Development (R&D) Expenses: For the third quarter of 2021, R&D expense increased by $7.4 million to $22.7 million for the three months ended September 30, 2021 from $15.3 million for the three months ended September 30, 2020. The increase was mainly due to increased clinical research costs to support the advancement of our clinical programs as well as an increase in discovery-stage program expenses. Our chemistry, manufacturing and other costs for the clinical trials also increased.

General and Administrative (G&A) Expenses: For the third quarter of 2021, G&A expense increased by $5.2 million to $8.1 million for the three months ended September 30, 2021 from $2.9 million for the three months ended September 30, 2020. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount and an increase in our professional fees as we expanded our operations to support our research and development efforts and incurred additional costs to operate as a public company.

Net Loss: For the third quarter of 2021, net loss was $30.7 million, or $0.66 per share, compared with a net loss of $16.8 million, or $5.25 per share, for the same period in 2020.

Financial Guidance: The Company believes that its current cash, cash equivalents and marketable securities will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023.