Full Press Release Details
Prelude Therapeutics Announces Second Quarter 2021 Financial Results and Operations Update
- Data from Dose Escalation Portion of Phase 1 Trials of Lead Oral PRMT5 Inhibitors
PRT543 and PRT811 to be Presented in 4Q21 -
- Enrollment Ongoing in Multiple Expansion Cohorts in Phase 1 Trial of PRT543; Dose Expansion Portion of Phase 1 Trial of PRT811 Expected to Commence in 3Q21 -
- Dose Escalation Portion of Phase 1 Trials of Oral and IV Formulations of
MCL1 Inhibitor PRT1419 Ongoing -
-Strong Cash Position of $343 Million to Support Clinical and
Discovery Pipeline Advancement -
Wilmington, DE - Aug 12, 2021 - Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced its financial results for the second quarter ended June 30, 2021 and provided an update on recent clinical and development pipeline progress.
"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
Second 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
| Three Months Ended June 30, | ||||||||
| (in thousands, except share and per share data) | 2021 | 2020 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 22,409 | $ | 9,776 | ||||
| General and administrative | 5,513 | 1,660 | ||||||
| Total operating expenses | 27,922 | 11,436 | ||||||
| Loss from operations | (27,922 | ) | (11,436 | ) | ||||
| Other income, net | 1,057 | 28 | ||||||
| Net loss | $ | (26,865 | ) | $ | (11,408 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.58 | ) | $ | (5.50 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 46,057,112 | 2,074,108 |
| (in thousands, except share data) | June 30, 2021 | December 31, 2020 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 343,119 | $ | 218,309 | ||||
| Prepaid expenses and other current assets | 1,456 | 2,500 | ||||||
| Total current assets | 344,575 | 220,809 | ||||||
| Property and equipment, net | 3,109 | 2,480 | ||||||
| Right-of-use asset | 1,897 | - | ||||||
| Deferred offering costs | - | 301 | ||||||
| Total assets | $ | 349,581 | $ | 223,590 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,844 | $ | 3,920 | ||||
| Accrued expenses and other current liabilities | 6,430 | 7,455 | ||||||
| Operating lease liability | 1,403 | - | ||||||
| Total current liabilities | 14,677 | 11,375 | ||||||
| Other liabilities | - | 32 | ||||||
| Operating lease liability | 543 | - | ||||||
| Total liabilities | 15,220 | 11,407 | ||||||
| Stockholders' equity: | ||||||||
| Voting common stock, $0.0001 par value: 487,149,741 shares authorized; 35,636,695 and 32,595,301 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 4 | 3 | ||||||
| Non-voting common stock, $0.0001 par value; 12,850,259 shares authorized; 11,402,037 and 11,110,371 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 489,947 | 319,605 | ||||||
| Accumulated deficit | (155,591 | ) | (107,426 | ) | ||||
| Total stockholders' equity | 334,361 | 212,183 | ||||||
| Total liabilities and stockholders' equity | $ | 349,581 | $ | 223,590 |
Investors: Melissa Forst
Media: Deborah Elson