On May 11, 2021 Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the first quarter ended March 31, 2021 and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, MAY 11, 2021, View Source [SID1234579689]).

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"With several novel, internally discovered therapeutics now advancing in clinical trials, our pipeline products are off to a strong start in 2021 and we expect this momentum to carry us through multiple key inflection points," said Kris Vaddi, PhD, Chief Executive Officer. "We initiated numerous expansion cohorts for PRT543, our novel PRMT5 inhibitor, in the ongoing Phase 1 trial in patients with advanced solid tumors and hematologic malignancies. We expect to present initial clinical data for both PRT543 and PRT811, our brain penetrant PRMT5 inhibitor, in the second half of the year."

Dr. Vaddi added, "We continue to enroll the dose escalation portion of our Phase 1 trial of oral PRT1419, our MCL1 inhibitor, and plan to initiate dose expansion and combination cohorts in the second half of the year. Beyond our clinical pipeline, we remain focused on the advancement of our preclinical programs, and expect to submit an IND application for PRT2527, our CDK9 inhibitor, by year end. We are steadfast in our mission to develop novel therapeutic options for several cancers with high unmet need, and we look forward to providing updates on our continued progress as these programs mature."

Recent Highlights and Upcoming Milestones

PRT543

Enrollment Ongoing in Phase 1 Dose Expansion Cohorts. Patient enrollment is underway in additional solid tumor and hematologic malignancy expansion cohorts of the Company’s Phase 1 trial of PRT543, which is designed to be a potent and selective inhibitor of PRMT5. As previously announced, preliminary data from the dose escalation portion of the trial demonstrated early signs of clinical activity and tolerability. The Company anticipates presenting initial clinical data from the Phase 1 trial at medical meetings in the second half of 2021.

Preclinical Data Featured at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. Three preclinical presentations on PRT543 were featured at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021. A copy of each poster is available in the Publications section of the Prelude Therapeutics website.
PRT811

Phase 1 Dose Expansion Cohorts Remain on Track to Begin in Mid-2021. The dose escalation portion of the Company’s Phase 1 trial of its second clinical product candidate, PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, remains ongoing in patients with advanced solid tumors, including gliomas. As previously reported, the trial has demonstrated early signs of clinical activity and tolerability. Prelude remains on track to establish a recommended expansion dose and commence the dose expansion portion of the trial in mid-2021 in patients with central nervous system cancers, including glioblastoma multiforme (GBM), with initial clinical data expected by the end of 2021.
PRT1419

Oral Formulation: Planned Dose Expansion and Combination Cohorts Expected to be Added to Ongoing Phase 1 Trial in the Second Half of 2021. The dose escalation portion of the Company’s first-in-human Phase 1 study of oral PRT1419 in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, is ongoing. PRT1419, which is the Company’s third clinical candidate, 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.

IND Application Cleared. In March 2021, the Company announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for an intravenous (IV) formulation of PRT1419. A Phase 1 trial of the IV formulation, which leverages the optimized physicochemical properties of PRT1419, is expected to commence in the coming months in patients with solid tumors.

Data on Preclinical Characterization Featured at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. Data on the preclinical characterization of PRT1419 was featured at the AACR (Free AACR Whitepaper) Annual Meeting in April 2021. A copy of the poster is available in the Publications section of the Prelude Therapeutics website.
Discovery Programs

Advancement of Earlier-Stage Candidates Expected in 2021. The Company remains on track to submit an IND application in 2021 for PRT2527, which is designed to be a potent and selective CDK9 inhibitor. Prelude also continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, in 2021.

Preclinical Data on SMARCA2 Protein Degradation Featured at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. A poster presentation on the Company’s SMARCA2 protein degradation program was featured at the AACR (Free AACR Whitepaper) Annual Meeting in April 2021. A copy of the poster is available in the Publications section of the Prelude Therapeutics website.
First Quarter 2021 Financial Results

Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2021 were $363.0 million.

Research and Development (R&D) Expenses: For the first quarter of 2021, R&D expense increased by $7.9 million to $16.5 million. The increase was mainly due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for oral PRT1419, as well as preparation for the anticipated initiation of the Phase 1 trial for IV PRT1419 in the first half of 2021. We also incurred an increase in chemistry, manufacturing, and other costs for those trials.

General and Administrative (G&A) Expenses: For the first quarter of 2021, G&A expense increased by $4.3 million to $5.5 million. The increase was primarily due to an increase in personnel related expense due to increases in employee headcount and an increase in the Company’s professional fees as it expanded operations to support R&D efforts and incurred additional costs to operate as a public company.

Net Loss: For the first quarter of 2021, net loss was $21.3 million, or $0.47 per share, compared with a net loss of $9.5 million, or $5.12 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 2023.