Full Press Release Details
Prelude Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Operational Update
- Dose Escalation Portion of Phase 1 Trial of PRT543 Complete; Additional Expansion Cohorts Set to Initiate Early in the Second Quarter -
-Clinical Data Readouts Expected in 2H21 for Lead PRMT5 Inhibitors PRT543 and PRT811 -
- Phase 1 Dose-Escalation Study of Oral PRT1419 Ongoing -
- Preclinical Data from Multiple Programs to be Presented at the Upcoming 2021 AACR Annual Meeting -
Wilmington, DE - March 16, 2021 - Prelude Therapeutics Inc. ("Prelude", "the Company", "we", "our") (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced its financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent developments.
"2020 marked a highly transformational year for Prelude with the successful completion of an initial public offering and progress across our three clinical-stage programs," said Kris Vaddi, PhD, Chief Executive Officer of Prelude Therapeutics. "We are firmly committed to bringing novel therapies to patients in areas of high unmet need, and we have entered 2021 with both the momentum and resources that we believe will carry us through several key milestones. Notably, we are pleased to announce the completion of dose escalation activities in our ongoing Phase 1 trial of PRT543, our lead PRMT5 inhibitor, in patients with advanced solid tumors and hematologic malignancies, and that we will soon begin initiating additional expansion cohorts. We look forward to sharing clinical data for this program, as well as for our second PRMT5 inhibitor, PRT811, in the second half of this year."
Dr. Vaddi added, "The ongoing Phase 1 trial of our third clinical candidate, PRT1419, an MCL1 inhibitor, also continues to progress, with the addition of dose expansion cohorts expected in the second half of the year. Finally, the continued advancement of our preclinical programs remains a high priority for us in 2021, with the anticipated submission of an IND application for PRT2527, our CDK9 inhibitor, in the second half of this year."
Recent Highlights and Upcoming Milestones
Fourth Quarter and Full Year 2020 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.
| Year ended December 31, | ||||||||
| (in thousands, except share and per share data) | 2020 | 2019 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 48,177 | $ | 24,279 | ||||
| General and administrative | 10,586 | 3,830 | ||||||
| Total operating expenses | 58,763 | 28,109 | ||||||
| Loss from operations | (58,763 | ) | (28,109 | ) | ||||
| Other income, net | 1,834 | 539 | ||||||
| Net loss | $ | (56,929 | ) | $ | (27,570 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (4.56 | ) | $ | (16.52 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 12,478,463 | 1,668,549 |
| December 31, | ||||||||
| (in thousands, except share and per share data) | 2020 | 2019 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 218,309 | $ | 18,879 | ||||
| Prepaid expenses and other current assets | 2,500 | 1,345 | ||||||
| Total current assets | 220,809 | 20,224 | ||||||
| Property and equipment, net | 2,480 | 1,647 | ||||||
| Deferred offering costs | 301 | - | ||||||
| Total assets | $ | 223,590 | $ | 21,871 | ||||
| Liabilities, convertible preferred stock and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Capital lease obligation | $ | - | $ | 258 | ||||
| Accounts payable | 3,920 | 1,974 | ||||||
| Accrued expenses and other current liabilities | 7,455 | 2,603 | ||||||
| Total current liabilities | 11,375 | 4,835 | ||||||
| Other liabilities | 32 | 5 | ||||||
| Total liabilities | 11,407 | 4,840 | ||||||
| Convertible preferred stock, $0.0001 par value: | ||||||||
| Series A convertible preferred stock: No shares and 13,574,008 shares authorized at December 31, 2020 and 2019, respectively; No shares and 11,736,119 shares issued and outstanding at December 31, 2020 and 2019, respectively | - | 36,595 | ||||||
| Series B convertible preferred stock: No shares and 18,500,000 shares authorized at December 31, 2020 and 2019, respectively; No shares and 7,628,846 shares issued and outstanding at December 31, 2020 and 2019, respectively | - | 29,848 | ||||||
| Series C convertible preferred stock: No shares authorized, issued or outstanding at December 31, 2020 and 2019 | - | - | ||||||
| Total convertible preferred stock | - | 66,443 | ||||||
| Stockholders' equity: | ||||||||
| Voting common stock, $0.0001 par value: 487,149,741 and 42,000,000 shares authorized at December 31, 2020 and 2019, respectively; 32,595,301and 3,161,653 shares issued and outstanding at December 31, 2020 and 2019, respectively | 3 | - | ||||||
| Non-voting common stock, $0.0001 par value: 12,850,259 and no shares authorized at December 31, 2020 and 2019, respectively; 11,110,371 and no shares issued and outstanding at December 31, 2020 and 2019, respectively | 1 | - | ||||||
| Additional paid-in capital | 319,605 | 1,085 | ||||||
| Accumulated deficit | (107,426 | ) | (50,497 | ) | ||||
| Total stockholders' equity (deficit) | 212,183 | (49,412 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 223,590 | $ | 21,871 |
Investors: Melissa Forst
Media: Deborah Elson