Full Press Release Details
Prime Medicine Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Announced preclinical data providing further
proof-of-concept for Prime Editing s ability to achieve restoration of genetic function, as well as new preliminary safety analyses demonstrating no detected off-target activity
Nominated PM359, first development candidate for the treatment
of Chronic Granulomatous Disease (CGD)
Successfully completed upsized initial public offering, raising
$199 million in gross proceeds
Cambridge, Mass., March 9, 2023 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology
company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results and provided a business update for the fourth quarter and full year ended
In 2022, we made important progress in our efforts to build Prime Medicine and demonstrate the promise of Prime Editors as
a potentially best-in-class genetic medicine approach, said Keith Gottesdiener, M.D., President and Chief Executive Officer of Prime Medicine. In addition to
closing our upsized initial public offering in October, we recently disclosed new preclinical proof-of-concept data in multiple indications and announced new preliminary
safety analyses demonstrating minimal or no off-target editing in two preclinical models. We believe this progress, coupled with advancements in our chemistry, manufacturing and controls (CMC) and delivery
capabilities and Prime Editing platform, provides a tremendous foundation as we aim to maximize Prime Editing s broad therapeutic potential.
Dr. Gottesdiener continued, Today, we are delighted to share the achievement of a key milestone, the selection of PM359 as our first development
candidate for the treatment of chronic granulomatous disease (CGD). We designed and optimized PM359 to achieve high efficiency and highly precise editing of hematopoietic stem cells (HSC), and have observed long-term in vivo engraftment of
Prime Edited HSCs in a mouse model of CGD. We look forward to advancing PM359 into investigational new drug (IND)-enabling studies later this year, while continuing to advance our broader portfolio toward additional preclinical proof-of-concept readouts.
Recent Business Updates
Anticipated Upcoming Milestones
Prime Medicine expects
the following activities and next steps to drive the Prime Editing platform forward:
Full Year 2022 Financial Results:
Based on its current operating plans, Prime Medicine expects that its cash, cash equivalents and short-term investments as of December 31, 2022 will be
sufficient to fund its anticipated operating expenses and capital expenditure requirements into 2025.
About Prime Medicine
Prime Medicine is a biotechnology company committed to delivering a new class of differentiated, one-time, curative
genetic therapies to address the widest spectrum of diseases. The company is deploying Prime Editing technology, a versatile, precise, efficient and broad gene editing technology, which is designed to make only the right edit at the right position
within a gene. With the potential to repair approximately 90 percent of known disease-causing genetic mutations across many organs and cell types, medicines based on Prime Editing could offer a one-time
curative genetic therapeutic option to a broad set of patients.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including,
without limitation, implied and express statements about Prime Medicine s beliefs and expectations regarding: the initiation, timing, progress and results of its research and development programs, preclinical studies and future clinical trials
and the release of data related thereto, including the initiation of IND-enabling studies for PM359; its ability to advance its portfolio toward additional preclinical proof-of-concept readouts; its ability to demonstrate, and the timing of, preclinical proof-of-concept in vivo for
multiple programs; its development and optimization of various non-viral and viral delivery systems; its ability to demonstrate superior off-target profiles for Prime
Editing programs; its expansion of Prime Editing using proprietary recombinase and/or retrotransposon technologies as well as the use of its PASSIGE technology; its ability advance any product candidates that Prime Medicine may identify and
successfully complete any clinical studies, including the manufacture of any such product candidates; its ability to quickly leverage programs within its initial target indications and to progress additional programs, including those beyond the
reach of Prime Editing s current areas of focus, to further develop its pipeline and maximize therapeutic potential; the timing of its regulatory filings, including its anticipated initial IND submission as early as 2024 with additional filings
anticipated in 2025; the implementation of its strategic plans for its business, programs and technology; and its estimates of expenses, capital requirements, and needs for additional financing as well as its cash runway into 2025. The words
may, might, will, could, would, should, expect, plan, anticipate, intend, believe, expect,
estimate, seek, predict, future, project, potential, continue, target and similar words or expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based
on management s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without limitation, risks associated with: uncertainties related to the authorization, initiation and conduct of preclinical and other development requirements for potential product candidates,
including uncertainties related to regulatory approvals; risks related to the development and optimization of new technologies, the results of preclinical studies, or clinical studies not being predictive of future results in connection with future
studies; the scope of protection Prime Medicine is able to establish and maintain for intellectual property rights covering its Prime Editing technology; Prime Medicine s ability to identify and enter into future license agreements and
collaborations; and general economic, industry and market conditions, including rising interest rates and inflation. These and other risks and uncertainties are described in greater detail in the section entitled Risk Factors in Prime
Medicine s most recent Quarterly Report on Form 10-Q, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Prime
Medicine s views only as of today and should not be relied upon as representing its views as of any subsequent date. Prime Medicine explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties
(expressed or implied) are made about the accuracy of any such forward-looking statements.
Stern Investor Relations, Inc.
Condensed Consolidated Balance Sheet Data (unaudited)
| December 31, 2022 | December 31, 2021 | |||||||
| Cash, cash equivalents, and short term investments | $ | 293,921 | $ | 269,620 | ||||
| Total assets | 360,314 | 301,856 | ||||||
| Total liabilities | 44,044 | 62,296 | ||||||
| Series A and B preferred stock | 395,800 | |||||||
| Total stockholders equity (deficit) | 316,270 | (156,240 | ) |
Condensed Consolidated Statement of Operations (unaudited)
(in thousands, except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 29,061 | $ | 52,889 | $ | 86,725 | $ | 70,550 | ||||||||
| General and administrative | 9,625 | 7,187 | 29,819 | 13,924 | ||||||||||||
| Total operating expenses | 38,686 | 60,076 | 116,544 | 84,474 | ||||||||||||
| Loss from operations | (38,686 | ) | (60,076 | ) | (116,544 | ) | (84,474 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of preferred stock tranche right liability | (74,319 | ) | ||||||||||||||
| Change in fair value of anti-dilution obligation | (6,681 | ) | ||||||||||||||
| Change in fair value of related party short-term investment | (1,709 | ) | (1,466 | ) | (8,128 | ) | (391 | ) | ||||||||
| Other income (expense), net | 926 | 12 | 1,903 | 12 | ||||||||||||
| Total other expense, net | (783 | ) | (1,454 | ) | (6,225 | ) | (81,379 | ) | ||||||||
| Net loss before income taxes | (39,469 | ) | (61,530 | ) | (122,769 | ) | (165,853 | ) | ||||||||
| Provision for (benefit from) income taxes | (186 | ) | 1,381 | (948 | ) | (486 | ) | |||||||||
| Net loss | (39,283 | ) | (62,911 | ) | (121,821 | ) | (165,367 | ) | ||||||||
| Accretion of preferred stock to redemption value | (1,468 | ) | ||||||||||||||
| Cumulative dividend on preferred stock | (1,314 | ) | (6,362 | ) | (20,193 | ) | (17,284 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (40,597 | ) | $ | (69,273 | ) | $ | (142,014 | ) | $ | (184,119 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.56 | ) | $ | (4.21 | ) | $ | (4.19 | ) | $ | (14.19 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 74,194,068 | 16,468,363 | 33,891,264 | 12,973,495 | ||||||||||||
| Comprehensive Loss: | ||||||||||||||||
| Net loss | $ | (39,283 | ) | $ | (62,911 | ) | $ | (121,821 | ) | $ | (165,367 | ) | ||||
| Change in unrealized losses on investments, net of tax | 70 | (18 | ) | (357 | ) | (27 | ) | |||||||||
| Total other comprehensive loss | 70 | (18 | ) | (357 | ) | (27 | ) | |||||||||
| Comprehensive Loss | $ | (39,213 | ) | $ | (62,929 | ) | $ | (122,178 | ) | $ | (165,394 | ) |