On March 16, 2022 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the fiscal year ended December 31, 2021 (Press release, Prelude Therapeutics, MAR 16, 2022, View Source [SID1234610173]).
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"With Prelude’s core competencies in cancer biology and medicinal chemistry, in approximately five years we have successfully created a highly differentiated diverse pipeline that includes five distinct targets and six proprietary small molecule compounds, each with best-in-class potential aimed at addressing clinically validated pathways for cancers with selectable underserved patients," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "Given the clinical progress we made in 2021, we have made important strategic portfolio prioritization and resource allocation decisions focusing on select molecules and indications where we see the greatest need and most efficient path to establishing proof-of-concept. This includes selecting PRT811 as the lead candidate in our PRMT5 program and prioritizing development of the intravenous formulation of our MCL1 candidate, PRT1419, and rapidly selecting a Phase 2 dose for PRT2527, our CKD9 inhibitor, in selected patients with cancers dependent on CKD9."
"Our discovery team continued to exceed expectations by bringing two new candidates into our pipeline, a differentiated SMARCA2/BRM protein degrader and most recently, PRT3645, a differentiated, selective and highly brain penetrant CDK4/6 inhibitor. We remain on track to file Investigational New Drug applications for each of these molecules in 2022."
Dr. Vaddi added, "Dr. Jane Huang’s appointment as President and Chief Medical Officer strengthens our leadership team. Dr. Huang’s extensive experience in oncology drug development, strong associations within the oncology community and success in building high-performing clinical development and operational teams supports our commitment to discover and deliver safe and effective precision oncology medicines to patients with underserved cancers."
Program Highlights and 2022 Objectives
PRMT5: Prelude is prioritizing PRT811 for continued clinical development focusing on splicing mutated myeloid malignancies and solid tumors, including uveal melanoma, and IDH1 mutated high grade gliomas. Prelude intends to complete the data analyses of the ongoing expansion cohorts for PRT543, including adenoid cystic carcinoma (ACC). Prelude expects to report data for the PRMT5 program in 2H/2022.
MCL1: Prelude is prioritizing development of the intravenous (IV) formulation of PRT1419 which demonstrated a desirable pharmacokinetic, pharmacodynamic and safety profile with potential for differentiation from competitor compounds. Prelude plans to initiate a combination trial with venetoclax by mid-year and report data by year-end 2022.
CKD9: Prelude intends to complete enrollment in the Phase 1 dose escalation study and identify a recommended Phase 2 dose by 2H/2022.
CDK4/6: Prelude intends to file an Investigational New Drug (IND) application mid-year and initiate a Phase 1 trial in 2H/2022.
SMARCA2/BRM: Prelude plans to complete IND-enabling studies and submit an IND application by year-end 2022.
Corporate Update
On March 9, 2022, Prelude announced the appointment of Jane Huang, M.D., 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.
Full Year 2021 Financial Results
Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2021 were $291.2 million. Following Prelude’s recently announced program prioritization initiatives, the Company has extended its cash guidance and 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: R&D expenses for the year ended December 31, 2021 increased $38.6 million to $86.8 million compared to $48.2 million for the year ended December 31, 2020. The increase year-over-year was primarily due to increased clinical research costs to support the advancement of Prelude’s clinical programs and related chemistry, manufacturing and other costs for the clinical trials, in addition to an increase in discovery-stage program expenses.
General and Administrative (G&A) Expenses: G&A expenses for the year ended December 31, 2021 increased by $16.4 million to $27.0 million compared to $10.6 million for the year ended December 31, 2020. The increase was primarily due to increased employee headcount and an increase in professional fees as Prelude expanded its operations to support R&D efforts and incurred additional costs associated with operating as a public company.
Net Loss: Net loss for the year ended December 31, 2021 was $111.7 million or $2.43 per share, compared with a net loss of $56.9 million, or $4.56 per share for the year ended December 31, 2020.