On August 12, 2021 Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the second quarter ended June 30, 2021 and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, AUG 12, 2021, View Source [SID1234586422]).
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"Prelude’s second quarter was marked by solid operational execution, continued innovation, and organizational growth. We made meaningful progress advancing our pipeline of novel, internally discovered precision oncology therapeutics aimed at addressing several cancers with high unmet need," said Kris Vaddi, PhD, Chief Executive Officer. "Our ongoing clinical programs, including the Phase 1 trials of PRT543 and PRT811, for which we expect to present clinical data in the fourth quarter, and PRT1419 are advancing as planned. In addition, we continue to maintain focus on the advancement of our preclinical and discovery programs, with an IND application submission for PRT2527, our CDK9 inhibitor, and initiation of IND-enabling studies for our discovery programs expected by year end."
Recent Highlights and Upcoming Milestones
PRT543
Dose Expansion Portion of Phase 1 Trial Ongoing; Data from Dose Escalation Portion to be Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting: The Company will present data from the dose escalation portion of the Phase 1 trial in unselected patient populations, including safety, PK and PD data and markers of target engagement, at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting in October. PRT543 is designed to be a potent and selective inhibitor of PRMT5. Patient enrollment is continuing in specific biomarker-selected solid tumor and hematologic malignancy expansion cohorts representing cancers of high unmet need, including adenoid cystic carcinoma (ACC), spliceosome mutated and HRD+ solid tumors and spliceosome-mutated myeloid malignancies. The Company expects to present data from the expansion cohorts at medical meetings throughout 2022.
PRT811
Dose Expansion Portion of Phase 1 Trial Expected to Commence in 3Q21; Data from Dose Escalation Portion to be Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting: The Company will present data from the dose escalation portion of the Phase 1 trial in unselected patient populations, including safety, PK and PD data and markers of target engagement, at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting in October. PRT811 is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor. Prelude anticipates beginning the dose expansion portion of the Phase 1 trial in the third quarter in selected patients with central nervous system cancers, including high grade gliomas and CNS metastatic cancers. The Company expects to present data from the expansion cohorts at medical meetings throughout 2022.
PRT1419
Oral Formulation: Dose Escalation Portion of Phase 1 Trial Ongoing. The dose escalation portion of the Company’s first-in-human Phase 1 study of oral PRT1419, the Company’s third clinical candidate, in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, remains ongoing. PRT1419 is designed to be an orally available, potent, and selective MCL1 inhibitor. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the second half of 2021.
IV Formulation: Dose Escalation Portion of Phase 1 Trial is Now Underway. The Phase 1 trial of an intravenous (IV) formulation of PRT1419, which leverages the optimized physicochemical properties of PRT1419, is now underway in patients with solid tumors.
Discovery Programs
Earlier-Stage Candidates Expected to Advance in 2021. The Company remains on track to submit an Investigational New Drug (IND) application in 2021 for PRT2527, which is designed to be a potent and selective CDK9 inhibitor. In addition, the Company continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, by the end of the year.
Corporate Updates
Martin Babler Appointed to Board of Directors. In July 2021, the Company announced the appointment of Martin Babler to its Board of Directors. Mr. Babler brings to Prelude over 25 years of pharmaceutical and biotech experience, most recently serving as President and Chief Executive Officer of Principia Biopharma until its acquisition by Sanofi S.A. in October 2020. Mr. Babler will serve as a member of the audit committee of the Board.
Michele Porreca Appointed as Chief People Officer. Prelude reported the recent appointment of Michele Porreca as Chief People Officer. In this newly created role, she will lead all aspects of the Company’s human resources management, including, talent management and strategy, organizational effectiveness, total rewards, culture, inclusion, and employee communications. Ms. Porreca brings to Prelude over 20 years of human resources experience, most recently serving as Chief Human Resources Officer at Nabriva Therapeutics.
Second Quarter 2021 Financial Results
Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2021 were $343.1 million.
Research and Development (R&D) Expenses: For the second quarter of 2021, R&D expense increased by $12.6 million to $22.4 million for the three months ended June 30, 2021 from $9.8 million for the three months ended June 30, 2020. The increase was mainly due to increased clinical research costs for the PRT543, PRT811 and PRT1419 (Oral and IV) programs, and increased chemistry, manufacturing and other costs for those trials.
General and Administrative (G&A) Expenses: For the second quarter of 2021, G&A expense increased by $3.9 million to $5.5 million for the three months ended June 30, 2021 from $1.6 million for the three months ended June 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 the Company’s professional fees as a result of expanded operations to support research and development efforts as well as incurred additional costs to operate as a public company.
Net Loss: For the second quarter of 2021, net loss was $26.9 million, or $0.58 per share, compared with a net loss of $11.4 million, or $5.50 per share, for the same period in 2020.
Financial Guidance: The Company believes that its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into mid-2023.