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Prime Medicine, Inc.

For the period ended Mar 31, 2026. Filed May 7, 2026.

View on SEC.gov

About this filing

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, 2026 · Filed May 7, 2026

PRME$4.65+4.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-07.

0001628280-25-050422

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-07.

0001628280-26-031726

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 113 previous paragraphs and 97 current paragraphs.

47 unchanged; 30 reworded; 19 added; 28 removed; 8 previous and 1 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 (19)

Current report

We are a biotechnology company focused on developing a new class of genetic medicines designed to provide durable, and potentially curative, treatment options for patients with diseases driven by defined genetic alterations, acquired cellular dysfunction, or dysregulated gene expression.

Current report

These were offset by a $1.2 million increase in clinical expenses as we advance our Wilson Disease and AATD programs.

Current report

The $4.1 million increase in general and administrative expenses for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily driven by a $5.7 million increase in professional and consultant fees, a majority of which are arbitration-related legal expenses. This was offset by a $1.6 million decrease in personnel expenses driven primarily by fewer G&A personnel resulting from the workforce reduction announced in May 2025.

Current report

In March 2026, we converted our automatic shelf registration statement on Form S-3ASR (File No. 333-291348), originally filed with the SEC on November 7, 2025, to a non-automatic shelf registration statement on Form S-3, or the Registration Statement, by post-effective amendments, for the issuance and sale of up to $500.0 million of our common stock, preferred stock, debt securities, warrants and/or units or any combination thereof. The Registration Statement was declared effective by the SEC on March 4, 2026.

Current report

In November 2023, we entered into the Sales Agreement with Jefferies under which we may, from time to time, issue and sell shares of our common stock having an aggregate sales proceeds of up to $300.0 million, in a series of one or more at-the-market equity offerings as part of our 2023 ATM Program. Any shares will be sold pursuant to the Registration Statement and the sales agreement prospectus filed therewith, which covers the offer and sale of shares of our common stock under the 2023 ATM Program having an aggregate offering price of up to $200.0 million of the $300.0 million authorized under the Sales Agreement. If we wish to offer and sell additional shares of our common stock under the Sales Agreement in excess of the $200.0 million registered under the Registration Statement, for up to an additional $100.0 million, we must file with the SEC one or more additional prospectus supplements to register under the Securities Act, the offer and sale of any such additional shares of our common stock we wish to offer and sell from time to time under the Sales Agreement. Jefferies is not required to sell any specific share amounts but acts as our sales agent, using commercially reasonable efforts consistent with its normal trading and sales practices. We will pay Jefferies a commission equal to 3.0% of the aggregate gross proceeds we receive from each sale of our shares of common stock. Our common stock will be sold at prevailing market prices at the time of the sale, and as a result, prices may vary. As of March 31, 2026, we have not sold any shares of common stock under the 2023 ATM Program.

Current report

Since our inception, we have incurred substantial losses. As of March 31, 2026, we had an accumulated deficit of $937.5 million and we expect to generate operating losses and negative operating cash flows for the foreseeable future. As stated above, as of March 31, 2026, we maintained cash, cash equivalents, and short-term investments of $135.5 million.

Current report

In accordance with 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, and short-term investments as of March 31, 2026, our current and forecasted level of operations and forecasted cash flows, 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. As a result, we concluded 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.

Current report

The condensed consolidated financial statements as of March 31, 2026 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.
Removed paragraphs (28)

Previous report

We are a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies. We are deploying Prime Editing technology, which we believe is a versatile, precise, and efficient gene editing technology.

Previous report

•$4.0 million increase in license and IP costs, primarily due to the issuance of restricted stock units; and

Previous report

•$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 report

•$4.0 million decrease in personnel expenses resulting from the workforce reduction announced in May 2025; and

Previous report

The $2.9 million decrease in general and administrative expense for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 is primarily driven by a $3.1 million decrease in personnel expenses resulting from the workforce reduction announced in May 2025, including a decrease of $1.9 million in stock-based compensation expense.

Previous report

The $4.7 million increase in research and development expense for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was primarily driven by:

Previous report

•$9.7 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; and

Previous report

•$5.3 million increase in license and IP costs as we advance ourin vivo liver franchise and pipeline.

Previous report

The $0.3 million decrease in general and administrative expense for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 is primarily driven by $1.7 million decrease in personnel expenses driven primarily by a decrease of $2.3 million in stock-based compensation expense, offset by one-time severance payments and other employee termination-related expenses in connection with the May 2025 reduction in force.

Previous report

This is further offset by a $2.1 million increase in professional and consultant fees due an increase in corporate legal expenses.

Previous report

Increase in interest income is a result of an increase in interest bearing marketable securities purchased from funds raised in our August 2025 offering.

Previous report

Accretion (amortization) of investments for each of the periods presented is a result of increase (decrease) in the value of the our marketable securities purchased at a discount (premium) to their face value.

Previous report

In November 2023, we entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) under which we may, from time to time, issue and sell shares of our common stock having aggregate sales proceeds of up to $300.0 million, in a series of one or more at-the-market equity offerings (the “ATM Program”). Effective July 30, 2025, we terminated the sales agreement prospectus (the “ATM Prospectus”) filed with the shelf registration statement on Form S-3 (File No. 333-275321) and related to the shares of our common stock issuable pursuant to the Sales Agreement (the “Prior Registration Statement”). As a result, we will not make any sales of our common stock pursuant to the Sales Agreement, unless and until a new prospectus, prospectus supplement or a new registration statement is filed. Other than the termination of the ATM Prospectus, the Sales Agreement remains in full force and effect. As of the date of this Quarterly Report on Form 10-Q, we have not sold any shares of common stock under the ATM program.

Previous report

Concurrently with the filing of this Quarterly Report on Form 10-Q, we plan to file a new registration statement on Form S-3ASR, including a sales agreement prospectus with respect to the ATM Program, to replace the Prior Registration Statement, which will expire on November 13, 2026, in accordance with applicable SEC regulations. Pursuant to Rule 415(a)(6) under the Securities Act, the offering of securities under the Prior Registration Statement will be deemed terminated as of the effectiveness of the new registration statement.

Previous report

In August 2025, we issued and sold 43,700,000 shares of our common stock, including 5,700,000 shares pursuant to the exercise of the underwriters’ option to purchase additional shares, at a price to the public of $3.30 per share. As a result of the offering, we received approximately $138.4 million in net proceeds, after deducting underwriting discounts, commissions and offering costs of approximately $5.8 million.

Previous report

•$3.6 million change in deferred revenue — related party; and

Previous report

•$1.9 million change in prepaid and other current assets; and

Previous report

•$55.0 million change in collaboration receivable — related party;

Previous report

•$13.5 million change in accrued settlement payment — related party;

Previous report

•$138.4 million of net proceeds from issuances of common stock in our August 2025 public offering; and

Previous report

•$132.1 million of net proceeds from issuances of common stock in our February 2024 public offering;

Previous report

•$38.1 million of proceeds from issuance of common stock to BMS in September 2024;

Previous report

•$18.8 million of proceeds from issuance of pre-funded warrants contemporaneous with our February 2024 public offering; and
Reworded paragraphs (30)

Previous wording

We are focused on advancing ourin vivo liver franchise, where we are advancing programs to cure two of the largest genetic liver diseases, Wilson’s Disease and Alpha-1 Antitrypsin Deficiency, or AATD. Both programs are currently in late stages of pre-clinical development and are on track for IND and/or CTA filings in the first half of 2026 for Wilson’s Disease and the middle of 2026 for AATD. We intend to leverage the modularity of our platform to expeditiously and efficiently develop these programs supported by our universal liver lipid nanoparticle along with potential regulatory, clinical and other synergies from our modular technology.

Current wording

We are advancing ourin vivo programs to cure two of the largest genetic liver diseases, Wilson Disease and AATD. Both programs are currently in late stages of pre-clinical development and are on track for IND and/or Clinical Trial Application filings in the first half of 2026 for Wilson Disease and the middle of 2026 for AATD. We intend to leverage the modularity of our platform to expeditiously and efficiently develop these programs supported by our universal liver lipid nanoparticle along with potential regulatory, clinical and other synergies from our modular technology.

Previous wording

We also continue to advance ourin vivo Cystic Fibrosis program with support from the Cystic Fibrosis Foundation, and our efforts to develop Prime Edited CAR-T products for hematology, immunology and oncology in partnership with Bristol-Myers Squibb Company. In addition, we will continue to pursue additional business development opportunities to accelerate innovation, ensure the broadest application of Prime Editing, and further bolster our financial resources.

Current wording

We also continue to advance our in vivo Cystic Fibrosis program with support from Cystic Fibrosis Foundation and our efforts to develop Prime Edited CAR-T products for hematology, immunology, and oncology in partnership with BMS. In addition, we will continue to pursue additional business development opportunities to accelerate innovation, ensure the broadest application of Prime Editing, and further bolster our financial resources.

Previous wording

In August 2025, we announced additional data from the first patient dosed and initial data from the second patient dosed in our Phase 1/2 trial in chronic granulomatous disease, or CGD. In the first patient dosed, a single dose of PM359, our candidate for the treatment of CGD, led to 58% dihydrorhodamine positivity by Day 15, 66% by Day 30 and 71% by Day 60, exceeding levels of dihydrohomadine positivity believed to be potentially curative. In the second patient dosed in the trial, a single dose of PM359 led to a 70% dihydrorhodamine positivity by day 15 and 80% by day 30. In both patients, we also observed successful manufacturing from a single mobilization, no serious adverse events related to PM359 and rapid neutrophil and platelet engraftment when compared to other commercially available autologous genetic therapy benchmarks. Based on the data from the two patients, we continue to believe PM359 has the potential to transform the care of p47phox CGD. We are planning to have regulatory interactions based on the current data set.

Current wording

In August 2025, we announced additional data from the first patient dosed and initial data from the second patient dosed in our Phase 1/2 trial in CGD. We continue to engage in regulatory dialogue with the FDA toward a potential Biologics License Application filing for PM359.

Previous wording

•personnel-related expenses, including salaries, bonuses, benefits and stock-based compensation for employees engaged in manufacturing, research and development functions;

Current wording

•personnel-related expenses, including salaries, bonuses, benefits and stock-based compensation for employees engaged in manufacturing, and research and development functions;

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 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.

Current wording

Other income (expense), net primarily consists of interest and amortization related to our short-term investments.

Previous wording

The $3.7 million increase in research and development expense for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 was primarily driven by:

Current wording

The $6.5 million decrease in research and development expenses for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was primarily driven by:

Previous wording

•$1.3 million decrease in research and development costs due to the deprioritization of our CGD programs as we strategically focus our internal efforts on advancing ourin vivo liver franchise.

Current wording

•$3.8 million decrease in research costs due to the deprioritization of our CGD programs as we strategically focus our internal efforts on advancing ourin vivo liver franchise; and

Previous wording

•$6.0 million decrease in personnel expenses, driven primarily by fewer R&D personnel resulting from the workforce reduction announced in May 2025; and

Current wording

•$3.7 million decrease in personnel expenses, driven primarily by fewer R&D personnel resulting from the workforce reduction announced in May 2025.

Previous wording

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.

Current wording

The change in fair value of related party short-term investment for the three months ended March 31, 2025 was the result of Beam’s stock price movement.

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 advance the preclinical development of our current research programs, commence the clinical development of any product candidates we may identify, 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, 2025, we had cash, cash equivalents, and investments of $213.3 million, excluding our restricted cash, or $227.0 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 advance the preclinical development of our current research programs, commence the clinical development of any product candidates we may identify, 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, 2026, we had cash, cash equivalents, and investments of $135.5 million, excluding our restricted cash, or $149.2 million, including restricted cash.

Previous wording

Net cash used in operating activities for the nine months ended September 30, 2025 was driven primarily by the following uses of cash:

Current wording

Net cash used in operating activities for the three months ended March 31, 2026 was driven primarily by the following uses of cash:

Previous wording

•$2.8 million change in accrued expenses and other current liabilities.

Current wording

•$4.5 million change in accrued expenses and other current liabilities; and

Previous wording

•$36.3 million of non-cash amounts included in net loss, which primarily consisted of stock-based compensation expense, restricted stock issuance expense, non-cash lease expense, depreciation expense, and change in fair value of short-term investment — related party;

Current wording

•$8.9 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

•$9.5 million change in prepaid and other current assets;

Current wording

•$1.2 million change in prepaid expenses and other current assets.

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

•$2.0 million change in accrued expenses and other current liabilities.

Current wording

•$6.7 million change in accrued expenses and other current liabilities; and

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 from consideration received from BMS in September 2024.

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 and amortization expense, and change in fair value of short-term investment — related party; and

Previous wording

Net cash provided by investing activities for the nine months ended September 30, 2024 was driven primarily by $25.0 million of maturities of marketable securities, net of purchases, offset by $5.5 million of purchases of property and equipment.

Current wording

Net cash provided by investing activities for the three months ended March 31, 2026 was driven primarily by $43.6 million of maturities of marketable securities, net of purchases.

Previous wording

Net cash used in investing activities for the nine months ended September 30, 2025 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

•$132.9 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

Net cash provided by financing activities for the nine months ended September 30, 2025 was driven primarily by the following:

Current wording

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.

Previous wording

To date, we have not generated any revenue from product sales. We do not expect to generate revenue from product sales unless and until we successfully complete preclinical and clinical development of, receive regulatory approval for, and commercialize a product candidate and we do not know when, or if at all, that will occur. We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the preclinical activities and studies and initiate clinical trials. In addition, if we obtain regulatory approval for any product candidates, we expect to incur significant expenses related to product sales, marketing, and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Further, we have incurred, and expect to continue to incur, costs associated with operating as a public company. The timing and amount of our operating expenditures will depend largely on the factors set out above. For more information, refer to the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and the “Risk Factors” section of subsequent Quarterly Reports on Form 10-Q.

Current wording

To date, we have not generated any revenue from product sales. We do not expect to generate revenue from product sales unless and until we successfully complete preclinical and clinical development of, receive regulatory approval for, and commercialize a product candidate and we do not know when, or if at all, that will occur. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and studies and initiate clinical trials. In addition, if we obtain regulatory approval for any product candidates, we expect to incur significant expenses related to product sales, marketing, and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Further, we have incurred, and expect to continue to incur, costs associated with operating as a public company. The timing and amount of our operating expenditures will depend largely on the factors set out above. For more information, refer to the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, and the “Risk Factors” section of subsequent Quarterly Reports on Form 10-Q.

Previous wording

During the nine months ended September 30, 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.

Current wording

During the three months ended March 31, 2026, 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, 2025.

Previous wording

During the nine months ended September 30, 2025, there were no material changes to our critical accounting policies and significant judgments 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.

Current wording

During the three months ended March 31, 2026, there were no material changes to our critical accounting policies and significant judgments 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, 2025.

Previous wording

The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to

Current wording

The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. As a result of this election, our condensed consolidated financial statements may not be comparable to other public companies that comply with new or revised accounting pronouncements as of public company effective dates. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Change in Fair Value of Short-Term Investment — Related Party
Rearranged previous paragraphs (8)

Previous report — wording carried elsewhere

Change in Fair Value of Related Party Short-Term Investment

Previous report — wording carried elsewhere

Comparison of the Nine Months Ended September 30, 2025 and 2024

Previous report — wording carried elsewhere

•$5.2 million decrease in research costs due to the deprioritization of our CGD programs as we strategically focus our internal efforts on advancing ourin vivo liver franchise.

Previous report — wording carried elsewhere

•$6.0 million change in lease liabilities.

Previous report — wording carried elsewhere

•$12.0 million of proceeds received under our agreement with Cystic Fibrosis Foundation.

Previous report — wording carried elsewhere

Net cash provided by financing activities for the nine months ended September 30, 2024 was driven primarily by the following:

Previous report — wording carried elsewhere

•$6.0 million of proceeds received under our agreement with Cystic Fibrosis Foundation.

Previous report — wording carried elsewhere

“opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. As a result of this election, our condensed consolidated financial statements may not be comparable to other public companies that comply with new or revised accounting pronouncements as of public company effective dates. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.