FDA clearance of two new INDs: PRT3789 (First-in-class Selective SMARCA2 degrader) and PRT3645 (next generation CDK4/6 inhibitor)
Company to reprioritize clinical pipeline and discontinue PRMT5 program for internal development
Strong cash, cash equivalents and marketable securities of $224.0 million as of September 30, 2022, expected to fund multiple data catalysts with a runway into the fourth quarter of 2024
WILMINGTON, Del., Nov. 14, 2022 (GLOBE NEWSWIRE) — Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the third quarter ended September 30, 2022 and provided an update on recent clinical and development pipeline progress.
“We made meaningful advancements in the third quarter and to date in the fourth quarter, including FDA clearance for two new INDs, one for PRT3645, a next generation, brain penetrant CDK4/6 inhibitor and one for PRT3789, a novel, first-in-class selective SMARCA2 degrader. We’ve also made good progress in the clinical development of our CDK9 inhibitor, PRT2527 and PRT1419, the MCL1 inhibitor,” stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude.
“We continue to expand our highly innovative clinical pipeline. In order to focus resources on bringing compounds with the highest likelihood of success forward, we have decided to discontinue the internal development of our PRMT5 program. While PRT811 demonstrated a best-in-class safety profile and evidence of clinical activity in biomarker-selected patients with glioma and splicing mutated uveal melanoma, our prioritization reflects the high benchmark we set for clinical and regulatory success,” Dr. Vaddi added. “We are committed to delivering impactful medicines to patients and building significant and sustainable value.”
“Since joining Prelude, I have had the opportunity to critically review and to assess each program and identify clear next steps for clinical development,” said Jane Huang, M.D., President and Chief Medical Officer of Prelude. “With this prioritization, we believe we can generate proof-of-concept clinical data in the next 12 to 24 months to guide our future regulatory pathways to approval. Our CDK9 and MCL1 inhibitors are selective and potent, with potentially superior safety profiles. PRT3645 was specifically designed to be a brain penetrant CDK4/6 inhibitor and our SMARCA2 molecule is a unique, first-in-class degrader, targeting specific patient populations. I believe these programs offer the best chance to improve patient outcomes and I share our investigators’ excitement in our highly differentiated molecules.”
Recent Highlights and Upcoming Objectives
Third Quarter 2022 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of September 30, 2022, were $224.0 million. Prelude anticipates that its existing cash, cash equivalents and marketable securities will be sufficient to fund Prelude’s operations into the fourth quarter of 2024.
Research and Development (R&D) Expenses: For the third quarter of 2022, R&D expenses increased to $22.9 million for the three months ended September 30, 2022, from $22.7 million for the three months ended September 30, 2021. Included in research and development expenses for the quarter ending September 30, 2022, was $3.2 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $3.3 million for the three months ended September 30, 2021. Research and development expenses remain steady as our clinical pipeline advances into clinical trials. We expect our research and development expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.
General and Administrative (G&A) Expenses: For the third quarter of 2022, G&A expenses decreased to $7.5 million for the three months ended September 30, 2022, from $8.1 million for the three months ended September 30, 2021. Included in the general and administrative expenses for the quarter ended September 30, 2022, was $3.2 million of non-cash expense related to stock-based compensation expense, including employee stock options, as compared to $3.8 million for the same period in 2021. The decrease in general and administrative expenses was primarily due to non-cash stock-based compensation expense and prudent management of expenses.
Net Loss: For the three months ended September 30, 2022, net loss was $30.0 million, or $0.63 per share of common stock, basic and diluted compared to $30.7 million, or $0.66 per share, respectively, for the prior year period. Included in the net loss for the quarter ended September 30, 2022, was $6.4 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $7.1 million for the prior year period.
About Prelude
Prelude is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. Prelude’s diverse pipeline is comprised of highly differentiated, potentially best-in-class proprietary small molecule compounds aimed at addressing clinically validated pathways for cancers with selectable underserved patients. Prelude’s pipeline includes four candidates currently in clinical development: PRT1419, a potent, selective inhibitor of MCL1; PRT2527, a potent and highly selective CDK9 inhibitor, PRT3645, a brain penetrant CDK4/6 inhibitor, and PRT3879 a first-in-class SMARCA2/BRM protein degrader.
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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 for PRT1419 and PRT3645, the timing of reporting expected findings related to PRT1419, PRT2527, PRT2645 and PRT3789, the potential benefits of Prelude’s product candidates and platform, and the sufficiency of cash and cash equivalents to fund operating expenses and capital expenditures into the fourth quarter of 2024. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although Prelude believes that the expectations reflected in such forward-looking statements are reasonable, Prelude 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 Prelude’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Prelude’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 Prelude’s business, clinical trial sites, supply chain and manufacturing facilities, Prelude’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Prelude’s ability to fund development activities and achieve development goals, Prelude’s ability to protect intellectual property, and other risks and uncertainties described under the heading “Risk Factors” in documents Prelude 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 Prelude undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
PRELUDE THERAPEUTICS INCORPORATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
Three Months Ended September 30, | ||||||||
(in thousands, except share and per share data) | 2022 | 2021 | ||||||
Operating expenses: | ||||||||
Research and development | $ | 22,889 | $ | 22,721 | ||||
General and administrative | 7,517 | 8,115 | ||||||
Total operating expenses | 30,406 | 30,836 | ||||||
Loss from operations | (30,406 | ) | (30,836 | ) | ||||
Other income, net | 448 | 149 | ||||||
Net loss | $ | (29,958 | ) | $ | (30,687 | ) | ||
Per share information: | ||||||||
Net loss per share of common stock, basic and diluted | $ | (0.63 | ) | $ | (0.66 | ) | ||
Weighted average common shares outstanding, basic and diluted | 47,449,811 | 46,330,794 | ||||||
Comprehensive loss | ||||||||
Net loss | $ | (29,958 | ) | $ | (30,687 | ) | ||
Unrealized gain (loss) on marketable securities, net of tax | (69 | ) | (176 | ) | ||||
Comprehensive loss | $ | (30,027 | ) | $ | (30,863 | ) |
PRELUDE THERAPEUTICS INCORPORATED
BALANCE SHEETS
(UNAUDITED)
(in thousands, except share data) | September 30, 2022 |
December 31, 2021 |
||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 52,022 | $ | 31,828 | ||||
Marketable securities | 172,021 | 259,405 | ||||||
Prepaid expenses and other current assets | 2,850 | 3,882 | ||||||
Total current assets | 226,893 | 295,115 | ||||||
Restricted cash | 4,044 | 4,044 | ||||||
Property and equipment, net | 5,110 | 3,929 | ||||||
Right-of-use asset | 1,354 | 1,707 | ||||||
Other assets | 4,926 | 303 | ||||||
Total assets | $ | 242,327 | $ | 305,098 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 10,250 | $ | 7,840 | ||||
Accrued expenses and other current liabilities | 9,922 | 9,621 | ||||||
Operating lease liability | 1,388 | 1,740 | ||||||
Total current liabilities | 21,560 | 19,201 | ||||||
Other liabilities | 3,360 | — | ||||||
Total liabilities | 24,920 | 19,201 | ||||||
Commitments | ||||||||
Stockholders’ equity: | ||||||||
Voting common stock, $0.0001 par value: 487,149,741 shares authorized; 36,444,776 and 36,200,299 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 4 | 4 | ||||||
Non-voting common stock, $0.0001 par value; 12,850,259 shares authorized; 11,402,037 and 11,402,037 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 1 | 1 | ||||||
Additional paid-in capital | 525,682 | 505,723 | ||||||
Accumulated other comprehensive income (loss) | (2,363 | ) | (711 | ) | ||||
Accumulated deficit | (305,917 | ) | (219,120 | ) | ||||
Total stockholders’ equity | 217,407 | 285,897 | ||||||
Total liabilities and stockholders’ equity | $ | 242,327 | $ | 305,098 |
Investor Contact:
Lindsey Trickett
Vice President, Investor Relations
240.543.7970
ltrickett@preludetx.com
Media Contact:
Helen Shik
Shik Communications
617.510.4373
Helen@ShikCommunications.com
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