WILMINGTON, Del., March 15, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported its financial results for the fiscal year ended December 31, 2022, and provided a corporate update.
“We made considerable progress in 2022, including the filing and acceptance of two new INDs for our next generation CDK4/6 inhibitor and our first-in-class, highly selective SMARCA2 degrader. Our current clinical pipeline consists of four differentiated and internally discovered molecules that effectively target and block key oncogenic pathways in both hematological malignancies and solid tumors. Prelude’s highly productive internal discovery engine continues to deliver novel molecules across multiple therapeutic classes, including significant advances in our research efforts focused on identifying an orally available SMARCA2 degrader,” stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude.
Jane Huang, M.D., President and Chief Medical Officer of Prelude stated, “Prelude's six preclinical and two clinical abstracts accepted for presentation at the upcoming AACR Annual Meeting reflect the productivity and success of our research and development efforts. Initial data from PRT2527 and PRT1419 demonstrate encouraging safety, favorable pharmacokinetic and pharmacodynamic profiles in solid tumors, and support continued advancement in hematological cancers. Looking ahead, our top priority for 2023 is to efficiently advance these compounds forward into proof-of-concept clinical studies and determine appropriate next steps for each program.”
“Our recently announced collaboration with BeiGene reflects our commitment to maximize the therapeutic value of combining our highly selective and potent CDK9 inhibitor, PRT2527, with BTK inhibitors in hematologic malignancies,” added Dr. Huang.
Program Updates and Upcoming Milestones
PRT2527- CDK9 Inhibitor Program
PRT2527 is a potent and selective small molecule that has the potential to avoid off target toxicity and achieve higher clinical activity than other CDK9 programs currently in development. The Company is currently advancing PRT2527 as monotherapy in both solid and hematological indications. The Company also intends to pursue the clinically validated approach of combining PRT2527 with approved BTK inhibitors, beginning with its recently announced clinical collaboration with BeiGene.
Key 2023 objectives for this program include:
PRT1419- MCL1 Inhibitor Program
Based on the Phase 1 dose escalation study in solid tumors, and safety measured by troponin levels and changes in ejection fraction, the Company is now advancing PRT1419 in hematologic malignancies as monotherapy. The Company also plans to study PRT1419 in combination with venetoclax and in combination with azacytidine.
Key 2023 objectives for this program include:
PRT3645-Next Generation CDK4/6 Inhibitor Program
PRT3645 is a highly selective and differentiated CDK4/6 inhibitor. PRT3645 is a CDK4 biased compound with tissue and brain penetration qualities, and has potential in multiple indications including gliomas, head and neck cancers and non-small cell lung cancer, in addition to HR+/HER2- and HR+/HER2+ breast cancers.
Key 2023 objective includes:
SMARCA2 Targeted Protein Degrader Program
PRT3789 is an IV administered, potent and highly selective SMARCA2 degrader. It is designed to achieve the requisite high selectivity for SMARCA2 over the isoform, SMARCA4, through a targeted protein degrader approach. PRT3789 is a first-in-class SMARCA2 candidate and is currently in Phase 1 clinical development in biomarker selected SMARCA4 mutant patients.
Prelude’s discovery team has also identified orally bioavailable SMARCA2 degraders.
Key objectives include:
Upcoming presentations
The following clinical abstracts will be presented at AACR 2023:
The following preclinical abstracts will be presented at AACR 2023:
Corporate Update
On February 20, 2023, Bryant D. Lim, Esq., joined Prelude Therapeutics as Chief Legal Officer and Corporate Secretary. He has more than 20 years of experience in pharma and biotech, with expertise in business development, regulatory matters, fundraising and SEC reporting. Kris Vaddi, Ph.D. commented, “We are excited to welcome Bryant to Prelude and expand our leadership team to include his relevant expertise. Bryant is an excellent addition, helping us to move forward in our growth as a Company.”
Full Year 2022 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 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 next generation CDK4/6 inhibitor, and PRT3789 an IV administered, potent and highly selective SMARCA2 degrader. For more information, visit our website and follow us on LinkedIn and Twitter.
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 PRT2527 and PRT1419, the timing of reporting expected findings related to PRT1419, PRT2527, PRT3645 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 through 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
| Year ended December 31, | ||||||||
| (in thousands, except share and per share data) | 2022 | 2021 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 92,889 | $ | 86,778 | ||||
| General and administrative | 30,651 | 26,957 | ||||||
| Total operating expenses | 123,540 | 113,735 | ||||||
| Loss from operations | (123,540 | ) | (113,735 | ) | ||||
| Other income, net | 8,102 | 2,041 | ||||||
| Net loss | $ | (115,438 | ) | $ | (111,694 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (2.44 | ) | $ | (2.43 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 47,371,589 | 46,049,763 | ||||||
| Comprehensive loss | ||||||||
| Net loss | $ | (115,438 | ) | $ | (111,694 | ) | ||
| Unrealized gain (loss) on marketable securities, net of tax | (981 | ) | (711 | ) | ||||
| Comprehensive loss | $ | (116,419 | ) | $ | (112,405 | ) | ||
PRELUDE THERAPEUTICS INCORPORATED
BALANCE SHEETS
| December 31, | ||||||||
| (in thousands, except share and per share data) | 2022 | 2021 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 30,605 | $ | 31,828 | ||||
| Marketable securities | 171,123 | 259,405 | ||||||
| Prepaid expenses and other current assets | 2,652 | 3,882 | ||||||
| Total current assets | 204,380 | 295,115 | ||||||
| Restricted cash | 4,044 | 4,044 | ||||||
| Property and equipment, net | 4,908 | 3,929 | ||||||
| Right-of-use asset | 1,792 | 1,707 | ||||||
| Other assets | 5,376 | 303 | ||||||
| Total assets | $ | 220,500 | $ | 305,098 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,777 | $ | 7,840 | ||||
| Accrued expenses and other current liabilities | 13,093 | 9,621 | ||||||
| Operating lease liability | 1,832 | 1,740 | ||||||
| Total current liabilities | 21,702 | 19,201 | ||||||
| Other liabilities | 3,361 | - | ||||||
| Total liabilities | 25,063 | 19,201 | ||||||
| Commitments | ||||||||
| Stockholders’ equity: | ||||||||
| Voting common stock, $0.0001 par value: 487,149,741 shares authorized; 36,496,994 and 36,200,299 shares issued and outstanding at December 31, 2022 and 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 December 31, 2022 and 2021, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 531,682 | 505,723 | ||||||
| Accumulated other comprehensive income (loss) | (1,692 | ) | (711 | ) | ||||
| Accumulated deficit | (334,558 | ) | (219,120 | ) | ||||
| Total stockholders’ equity | 195,437 | 285,897 | ||||||
| Total liabilities and stockholders’ equity | $ | 220,500 | $ | 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
| Last Trade: | US$0.76 |
| Daily Change: | -0.03 -4.02 |
| Daily Volume: | 56,419 |
| Market Cap: | US$32.230M |
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