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- Enrollment Now Underway in Multiple Solid Tumor and Hematologic Malignancy Expansion Cohorts in Phase 1 Trial of Oral PRMT5 Inhibitor PRT543 -
- Initial Clinical Data Readouts for Lead Oral PRMT5 Inhibitors PRT543 and PRT811 Expected in 2H21 -
- Dose Escalation Ongoing in Phase 1 Trial of Oral MCL1 Inhibitor PRT1419, with Dose Expansion Cohorts on Track to be Added in 2H21 -
WILMINGTON, Del., May 11, 2021 (GLOBE NEWSWIRE) -- Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced its financial results for the first quarter ended March 31, 2021 and provided an update on recent clinical and development pipeline progress.
“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
PRT811
PRT1419
Discovery Programs
First Quarter 2021 Financial Results
About Prelude Therapeutics
Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company’s lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude’s first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company’s pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities, timing of availability and announcements of clinical results, the timing of the expansion portion for its Phase 1 clinical trial for PRT543, PRT811 and PRT1419, the timing of IND-related activities for PRT2527 and PRT-SCA2 and the potential benefits of the Company’s product candidates and platform. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company’s business, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
STATEMENTS OF OPERATIONS(UNAUDITED)
| Three Months Ended March 31, | ||||||||
| (in thousands, except share and per share data) | 2021 | 2020 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 16,470 | $ | 8,536 | ||||
| General and administrative | 5,497 | 1,201 | ||||||
| Total operating expenses | 21,967 | 9,737 | ||||||
| Loss from operations | (21,967 | ) | (9,737 | ) | ||||
| Other income, net | 667 | 226 | ||||||
| Net loss | $ | (21,300 | ) | $ | (9,511 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.47 | ) | $ | (5.12 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 45,121,955 | 1,857,023 | ||||||
BALANCE SHEETS(UNAUDITED)
| (in thousands, except share data) | March 31,2021 | December 31,2020 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 362,990 | $ | 218,309 | ||||
| Prepaid expenses and other current assets | 2,028 | 2,500 | ||||||
| Total current assets | 365,018 | 220,809 | ||||||
| Property and equipment, net | 2,627 | 2,480 | ||||||
| Right-of-use asset | 2,186 | — | ||||||
| Deferred offering costs | — | 301 | ||||||
| Total assets | $ | 369,831 | $ | 223,590 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,842 | $ | 3,920 | ||||
| Accrued expenses and other current liabilities | 6,179 | 7,455 | ||||||
| Operating lease liability | 1,403 | — | ||||||
| Total current liabilities | 12,424 | 11,375 | ||||||
| Other liabilities | — | 32 | ||||||
| Operating lease liability | 840 | — | ||||||
| Total liabilities | 13,264 | 11,407 | ||||||
| Stockholders’ equity: | ||||||||
| Voting common stock, $ par value: shares authorized; and shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 4 | 3 | ||||||
| Non-voting common stock, $ par value; shares authorized; and shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 485,288 | 319,605 | ||||||
| Accumulated deficit | (128,726 | ) | (107,426 | ) | ||||
| Total stockholders’ equity | 356,567 | 212,183 | ||||||
| Total liabilities and stockholders’ equity | $ | 369,831 | $ | 223,590 | ||||
Contact
Investors: Melissa ForstMedia: Deborah ElsonArgot Partners212.600.1902prelude@argotpartners.com
