Prime Medicine Inc
For the period ended Mar 31, 2025. Filed May 8, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 8, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001628280-24-047130
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0001628280-25-023486
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 107 previous paragraphs and 95 current paragraphs.
56 unchanged; 22 reworded; 13 added; 22 removed; 7 previous and 4 current paragraphs rearranged.
Tables are not compared: 7 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
In March 2025, we announced a preclinical program for the treatment of alpha-1 antitrypsin deficiency, our second program within our liver franchise, which, with our Wilson’s Disease program, we expect to advance into the clinic next year.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Other Income (Expense)
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Other Income (Expense)
Current report
Going Concern
Current report
Since our inception, we have incurred substantial losses. As of March 31, 2025, we had an accumulated deficit of $739.1 million and we expect to generate operating losses and negative operating cash flows for the foreseeable future. As stated above, as of March 31, 2025, we maintained cash, cash equivalents, short-term investments, and related party short-term investments of $144.3 million.
Current report
In accordance with Accounting Standards Codification, or ASC, 205-40, Going Concern, or ASC 205-40, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date on which this Quarterly Report on Form 10-Q is filed. Based on the our cash, cash equivalents, short-term investments, and related party short-term investments as of March 31, 2025, our current and forecasted level of operations and forecasted cash flows we determined that substantial doubt exists about our ability to continue as a going concern for 12 months from the date these condensed consolidated financial statements are issued. Our ability to continue as a going concern is dependent upon our ability to obtain the necessary financing to meet our obligations and repay our liabilities arising from normal business operations when they come due. Management plans to provide for capital requirements through financing or other transactions, and selling shares under our “at the market offering” program. There can be no assurance that we will be able to raise additional capital to fund operations with terms acceptable to us, or at all. Because certain elements of our plans to mitigate the conditions that raised substantial doubt about our ability to continue as a going concern are outside of our control, including the ability to raise capital through an equity or other financing, those elements cannot be considered probable according to ASC 205-40, and therefore cannot be considered in the evaluation of mitigating factors.
Current report
The condensed consolidated financial statements as of March 31, 2025 have been prepared under the assumption that we will continue as a going concern for the next 12 months and that contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. Our ability to continue as a going concern is dependent upon our uncertain ability to obtain additional capital, reduce expenditures and/or execute on its business plan. These condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Current report
•$51.9 million net loss;
Current report
•$45.8 million net loss;
Removed paragraphs (22)
Previous report
In September 2024, we announced that we are strategically focusing our pipeline on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. This diversified portfolio of high value, investigational therapeutic programs is organized around our core areas of focus: hematology, immunology and oncology, liver, and lung. We are advancing additional programs as potential partnership opportunities.
Previous report
BMS Collaboration Agreement
Previous report
In September 2024, we entered into the Research Collaboration and License Agreement (the “BMS Collaboration Agreement”) with Juno Therapeutics, Inc., a wholly-owned subsidiary of Bristol-Myers Squibb Company (“BMS”), pursuant to which we granted to BMS an exclusive worldwide license to certain Prime Editing technology for developing, manufacturing and commercializingex vivo T-cell therapeutic products directed to select targets.
Previous report
Under the terms of the BMS Collaboration Agreement, we will design optimized Prime Editor reagents for a select number of targets, including reagents that use our Prime Assisted Site-Specific Integrase Gene Editing (“PASSIGE”) technology. BMS will be responsible for development, manufacturing and commercialization of theex vivo T-Cell therapeutic products, with support from us in gene editing strategy and reagent development.
Previous report
We will receive a $55.0 million upfront payment and have received a $55 million equity investment from BMS. We are also eligible to receive more than $3.5 billion in milestones, including up to $185 million in preclinical milestones, up to $1.2 billion in development milestones, and more than $2.1 billion in commercialization milestones, along with royalties on net sales. See Note 9, Significant Agreements, to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.
Previous report
The $0.6 million decrease in research and development expense for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 was primarily driven by an $8.5 million decrease in lab supplies purchases of materials for our ongoing Phase 1 clinical trial in Q3 2023.
Previous report
This was offset by:
Previous report
•$3.9 million increase in license fees for amounts due to the Broad resulting from the BMS Collaboration Agreement;
Previous report
•$1.7 million increase in personnel expense, primarily due to an increase in non-cash stock-based compensation expense of $0.8 million; and
Previous report
The $3.6 million increase in general and administrative expense for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 is primarily driven by a $2.5 million increase in personnel expense, a majority of which was an increase in non-cash stock-based compensation expense of $1.9 million.
Previous report
Operating Expenses
Previous report
•$9.1 million increase in personnel expense, including an increase in non-cash stock-based compensation expense of $4.4 million, driven by our increased headcount of our research and development function;
Previous report
•$3.5 million increase in license fees for amounts due to the Broad resulting from the BMS Collaboration Agreement; and
Previous report
•$2.9 million increase in clinical expenses related to PM359, our candidate to treat chronic granulomatous disease.
Previous report
This was offset by a $9.4 million decrease in lab supplies due to purchases of materials for our ongoing Phase 1 clinical trial in Q3 2023.
Previous report
•$8.2 million increase in personnel expense, a majority of which was an increase in non-cash stock-based compensation expense of $6.3 million; and
Previous report
•$1.1 million increase in facility related and other primarily related to the ongoing build out of our facility at 60 First Street.
Previous report
This was offset by a $1.7 million decrease in professional and consultant fees for legal services.
Previous report
•$153.6 million net loss;
Previous report
•$132.5 million net loss;
Previous report
These were offset by:
Previous report
•$38.1 million of proceeds from issuance of common stock to BMS in September 2024;
Reworded paragraphs (22)
Previous wording
Other income (expense), net primarily consists of interest and other income earned on our short-term investments and the change in the fair value of our short-term investment in Beam Therapeutics Inc. (“Beam”), a related party, in connection with the Beam Collaboration Agreement, which is discussed in greater detail in Note 11, License and Collaboration Agreements, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023.
Current wording
Other income (expense), net primarily consists of interest and other income earned on our short-term investments and the change in the fair value of our short-term investment in Beam Therapeutics Inc. (“Beam”), a related party, in connection with the Beam Collaboration Agreement, which is discussed in greater detail in Note 9, License and Collaboration Agreements, to the audited consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024.
Previous wording
•$1.6 million increase in facility-related expense primarily due to the expansion and build out of our laboratory space.
Current wording
The $2.8 million increase in research and development expense for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily driven by a $3.6 million increase in facility-related expense primarily due to the expansion and build out of our laboratory space at 60 First Street and 500 Arsenal Street.
Previous wording
The $7.6 million increase in general and administrative expense for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 is primarily driven by:
Current wording
The $2.1 million increase in general and administrative expense for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 is primarily driven by a $1.3 million increase in personnel expenses.
Previous wording
Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we commence the clinical development of our programs and continue our platform development and early-stage research activities. We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have funded our operations primarily with proceeds from sales of preferred stock and from our public offerings and through payments from our collaboration partners. As of September 30, 2024, we had cash, cash equivalents, and investments of $175.5 million, excluding our restricted cash, or $189.6 million, including restricted cash.
Current wording
Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we commence the clinical development of our programs and continue our platform development and early-stage research activities. We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have funded our operations primarily with proceeds from sales of preferred stock and from our public offerings and through payments from our collaboration partners. As of March 31, 2025, we had cash, cash equivalents, and investments of $144.3 million, excluding our restricted cash, or $158.3 million, including restricted cash.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2024 was driven primarily by the following uses of cash:
Current wording
Net cash used in operating activities for the three months ended March 31, 2025 was driven primarily by the following uses of cash:
Previous wording
•$71.9 million change in deferred revenue from consideration received from BMS in September 2024; and
Current wording
•$1.4 million change in deferred revenue — related party.
Previous wording
•$32.3 million of non-cash amounts included in net loss, which primarily consisted of stock-based compensation expense, non-cash lease expense, depreciation and amortization expense, and change in fair value of short-term investment — related party;
Current wording
•$10.7 million of non-cash amounts included in net loss, which primarily consisted of stock-based compensation expense, non-cash lease expense, depreciation expense, and change in fair value of short-term investment — related party; and
Previous wording
•$6.9 million change in accounts payable.
Current wording
•$1.9 million change in accounts payable.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2023 was driven primarily by the following uses of cash:
Current wording
Net cash used in operating activities for the three months ended March 31, 2024 was driven primarily by the following uses of cash:
Previous wording
•$7.7 million change in accounts payable; and
Current wording
•$5.9 million change in accounts payable;
Previous wording
•$2.0 million change in accrued expenses and other current liabilities.
Current wording
•$4.5 million change in accrued expenses and other current liabilities;
Previous wording
•$6.0 million change in lease liabilities.
Current wording
•$3.5 million change in lease liabilities; and
Previous wording
•$9.5 million change in prepaid and other current assets;
Current wording
•$2.8 million change in prepaid and other current assets.
Previous wording
•$22.7 million of non-cash amounts included in net loss, which primarily consisted of change in fair value of short-term investment — related party, non-cash lease expense, and stock-based compensation expense; and
Current wording
These were offset by $8.2 million of non-cash amounts included in net loss, which primarily consisted of stock-based compensation expense, non-cash lease expense, and depreciation expense.
Previous wording
Net cash used in investing activities for the nine months ended September 30, 2023 was driven primarily by the following:
Current wording
Net cash used in investing activities for the three months ended March 31, 2025 was driven primarily by the following:
Previous wording
•$15.5 million of purchases of marketable securities, net of maturities; and
Current wording
•$45.3 million of purchases of marketable securities, net of maturities; and
Previous wording
•$6.9 million of purchases of property and equipment.
Current wording
•$2.4 million of purchases of property and equipment.
Previous wording
Net cash provided by investing activities for the nine months ended September 30, 2024 was driven primarily by the following $25.0 million of maturities of marketable securities, net of purchases, offset by $5.5 million of purchases of property and equipment.
Current wording
•$2.3 million of purchases of property and equipment.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was driven primarily by the following:
Current wording
Net cash provided by financing activities for the three months ended March 31, 2024 was driven primarily by the following:
Previous wording
We believe our existing cash, cash equivalents, and investments, along with the upfront payment of $55.0 million received from BMS in October 2024, will be sufficient to fund our operating expenses and capital expenditure requirements into the first half of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We expect that we will require additional funding to:
Current wording
We believe our existing cash, cash equivalents, and investments, will be sufficient to fund our operating expenses and capital expenditure requirements into the first half of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We expect that we will require additional funding to:
Previous wording
During the nine months ended September 30, 2024, except for the minimum lease commitments disclosed in Note 7, Leases, to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q, there were no significant changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2023.
Current wording
During the three months ended March 31, 2025, except for the minimum lease commitments disclosed in Note 6, Leases, to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q, there were no significant changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2024.
Previous wording
During the nine months ended September 30, 2024, there were no material changes to our critical accounting policies and significant judgements described under Management’s Discussion and Analysis of Critical Accounting Policies and Significant Judgments and Estimates which are included in our Annual Report on Form 10-K for the year ended December 31, 2023.
Current wording
During the three months ended March 31, 2025, there were no material changes to our critical accounting policies and significant judgements described under Management’s Discussion and Analysis of Critical Accounting Policies and Significant Judgments and Estimates which are included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
•$6.7 million change in accrued expenses and other current liabilities; and
Current report — wording carried from elsewhere
Net cash used in investing activities for the three months ended March 31, 2024 was driven primarily by the following:
Current report — wording carried from elsewhere
•$34.7 million of purchases of marketable securities, net of maturities; and
Current report — wording carried from elsewhere
Net cash provided by financing activities for the three months ended March 31, 2025 was driven by $6.0 million of proceeds received under our agreement with Cystic Fibrosis Foundation.
Rearranged previous paragraphs (7)
Previous report — wording carried elsewhere
Comparison of the Nine Months Ended September 30, 2024 and 2023
Previous report — wording carried elsewhere
The $14.7 million increase in research and development expense for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily driven by:
Previous report — wording carried elsewhere
•$8.9 million increase in facility-related expense primarily due to the expansion and build out of our laboratory space;
Previous report — wording carried elsewhere
Change in Fair Value of Related Party Short-Term Investment
Previous report — wording carried elsewhere
The change in fair value of related party short-term investment for each of the periods presented is a result of Beam’s stock price movement.
Previous report — wording carried elsewhere
•$9.0 million change in prepaid and other current assets; and
Previous report — wording carried elsewhere
•$8.9 million change in lease liabilities.