Full Press Release Details
Prelude Therapeutics Announces Third Quarter 2021 Financial Results and Operations Update
PRT543 and PRT811 Demonstrate Favorable Safety Profile, Tolerability and Evidence of Preliminary Clinical Activity in Phase 1 Dose Escalation in Unselected Patients
Phase 1 Dose Expansion Ongoing in Biomarker-Selected Solid Tumor and Hematologic Malignancy Expansion Cohorts for PRT543; Dose Expansion Portion of Phase 1 Trial of PRT811 to Commence 4Q21 with Data Readouts Anticipated for Both Programs in 2022
PRT2527 IND Cleared by FDA; Phase 1 Clinical Trial Evaluating IV Monotherapy in Patients with Selected Solid Tumors Anticipated to Begin by Year-End
Strong Cash, Cash Equivalents and Marketable Securities Position of $320 Million to Support Clinical and Discovery Pipeline Advancement
Wilmington, DE - November 12, 2021 - Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced its financial results for the third quarter ended September 30, 2021 and provided an update on recent clinical and development pipeline progress.
"We continue to make significant progress advancing our novel pipeline of therapeutic candidates, most notably with the recent presentation of dose escalation data from the Phase 1 trials of our lead PRMT5 inhibitors, PRT543 and PRT811," said Kris Vaddi, PhD, Chief Executive Officer. "We were pleased by these initial data in unselected patients, which demonstrated key points of differentiation for our molecules, including good tolerability and potency, and a desirable therapeutic window. In addition, evidence of preliminary clinical activity was observed in multiple tumor types displaying preclinically validated genomic features. We look forward to leveraging learnings from these data as we execute on the dose escalation portion of the trials and evaluate PRT543 and PRT811 in biomarker-selected patient populations, with data readouts from these cohorts anticipated in 2022. Beyond our PRMT5 inhibitors, the balance of our pipeline continues to advance. During the quarter we received IND clearance from the FDA for PRT2527, our CDK9 inhibitor, positioning us to commence a Phase 1 study of this molecule before year-end."
Recent Highlights and Upcoming Milestones
Third Quarter 2021 Financial Results
About Prelude Therapeutics
Prelude Therapeutics is a clinical-stage precision oncology company developing innovative, potential best-in-class molecules targeting critical cancer cell pathways involved in cancer pathogenesis. Prelude's initial clinical candidates, PRT543 and PRT811, are potent, selective, oral PRMT5 inhibitors in Phase 1 development for the treatment of advanced solid tumors, primary and secondary CNS cancers and select myeloid malignancies. PRT1419, a potent and selective MCL1 inhibitor, is in Phase 1 development for patients with relapsed/refractory hematologic malignancies and solid tumors. PRT2527, a highly selective CDK9 inhibitor, is anticipated to begin Phase 1 clinical development by year-end as a monotherapy in patients with selected solid tumors. In addition, the Company's pipeline includes PRT-SCA2, a SMARCA2 protein degrader, PRT-K4, a highly selective kinase inhibitor, and additional discovery stage programs.
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 AND COMPREHENSIVE LOSS
| Three Months Ended September 30, | ||||||||
| (in thousands, except share and per share data) | 2021 | 2020 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 22,721 | $ | 15,293 | ||||
| General and administrative | 8,115 | 2,851 | ||||||
| Total operating expenses | 30,836 | 18,144 | ||||||
| Loss from operations | (30,836 | ) | (18,144 | ) | ||||
| Other income, net | 149 | 1,384 | ||||||
| Net loss | $ | (30,687 | ) | $ | (16,760 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.66 | ) | $ | (5.25 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 46,330,794 | 3,194,471 | ||||||
| Comprehensive loss | ||||||||
| Net loss | $ | (30,687 | ) | $ | (16,760 | ) | ||
| Unrealized gain(loss) on marketable securities, net of tax | (176 | ) | - | |||||
| Comprehensive loss | $ | (30,863 | ) | $ | (16,760 | ) |
| (in thousands, except share data) | September 30, 2021 | December 31, 2020 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 61,424 | $ | 218,309 | ||||
| Marketable securities | 259,441 | - | ||||||
| Prepaid expenses and other current assets | 5,032 | 2,500 | ||||||
| Total current assets | 325,897 | 220,809 | ||||||
| Property and equipment, net | 3,213 | 2,480 | ||||||
| Right-of-use asset | 2,107 | - | ||||||
| Deferred offering costs | - | 301 | ||||||
| Total assets | $ | 331,217 | $ | 223,590 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 11,062 | $ | 3,920 | ||||
| Accrued expenses and other current liabilities | 6,765 | 7,455 | ||||||
| Operating lease liability | 1,836 | - | ||||||
| Total current liabilities | 19,663 | 11,375 | ||||||
| Other liabilities | - | 32 | ||||||
| Operating lease liability | 312 | - | ||||||
| Total liabilities | 19,975 | 11,407 | ||||||
| Stockholders' equity: | ||||||||
| Voting common stock, $0.0001 par value: 487,149,741 shares authorized; 35,789,759 and 32,595,301 shares issued and outstanding at September 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 September 30, 2021 and December 31, 2020, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 497,691 | 319,605 | ||||||
| Accumulated other comprehensive income (loss) | (176 | ) | - | |||||
| Accumulated deficit | (186,278 | ) | (107,426 | ) | ||||
| Total stockholders' equity | 311,242 | 212,183 | ||||||
| Total liabilities and stockholders' equity | $ | 331,217 | $ | 223,590 |
Executive Director, Corporate Affairs