prme-20250930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________________ to ___________________

Commission file number 001-41536

Prime Medicine, Inc.

(Exact name of registrant as specified in its charter)


Delaware						84-3097762
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

60 First Street, Cambridge, MA						02141
(Address of principal executive offices)						(Zip code)

(617) 465-0013

(Registrant’s telephone number, including area code)

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.00001 per share	PRME	Nasdaq Global Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of October 31, 2025, the registrant had 180,510,658 shares of common stock, par value $0.00001 per share, outstanding.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains express or implied statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, and objectives of management, are forward-looking statements, which are based on management’s belief and assumptions and on information currently available to our management. These statements involve substantial risks, assumptions and uncertainties. The words “anticipate,” “believe,” “envision,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “predict,” “project,” “strategy,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate,” “vision” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

The forward-looking statements in this Quarterly Report on Form 10-Q include statements about:

•the initiation, timing, progress and results of our research and development programs, product candidates, preclinical studies and future clinical trials;

•our ability to demonstrate, and the timing of, preclinical proof-of-concept in vivo for multiple programs;

•our ability to advance any current and future product candidates that we may identify and successfully complete any clinical studies, including the manufacture of any such product candidates;

•our ability to pursue our areas of focus and any other additional programs we may advance;

•our ability to quickly leverage programs within our initial target indications and to progress additional programs to further develop our pipeline;

•the timing of our investigational new drug (“IND”) application submissions;

•the ability of our Prime Editing technology to address unmet medical needs in patients;

•the implementation of our strategic plans for our business, programs and technology;

•the scope and duration of protection we are able to establish and maintain for intellectual property rights covering our Prime Editing technology;

•developments related to our competitors and our industry;

•our ability to leverage the clinical, regulatory, and manufacturing advancements made by gene therapy and gene editing programs to accelerate our clinical trials and approval of product candidates;

•our ability to maintain existing collaborations or strategic relationships, to identify and enter into future license agreements and collaborations on favorable terms, if at all, and to realize the intended and potential benefits of such agreements and collaborations;

•developments related to our Prime Editing technology;

•regulatory developments in the United States and foreign countries;

•our ability to attract and retain key scientific and management personnel;

•the accuracy of our estimates regarding our expenses, capital requirements and needs for additional financing;

•our expectations regarding the anticipated timeline of our cash runway and future financial performance;

•our evaluation of strategic alternatives and potential partnership opportunities for PM359, including our ability to execute and realize the anticipated benefits of any strategic alternatives we may pursue;

•our ability to maintain an effective system of internal controls;

•the effect of unfavorable macroeconomic conditions or market volatility resulting from national or global economic conditions or geopolitical developments, including rising inflation and capital market disruptions, changes in or disruptions of U.S. governmental agencies, whether from a continued U.S. federal government shutdown or reduced resources, new or increased international tariffs and retaliatory tariffs, trade protection measures, economic sanctions and economic slowdowns or recessions that may result from such developments which could harm our research and development efforts as well as the value of our securities and our ability to access capital markets;

•our expectations regarding the anticipated timeline of our cash runway and future financial performance; and

•other risks and uncertainties, including those listed under the caption “Risk Factors.”

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and these statements may be affected by inaccurate assumptions or by known or unknown risks and uncertainties. You should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q and in subsequent SEC filings, particularly in the “Risk Factors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Unless otherwise disclosed, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments we may make or enter into.

You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed as exhibits to our other filings with the Securities and Exchange Commission (the “SEC”) completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date hereof, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise after the date of such statements, except as required by applicable law.

This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates. Such information is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained statistical and other industry and market data from our own internal estimates and research, as well as from reports, industry publications and research, surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we are not aware of any misstatements regarding any third-party information presented in this Quarterly Report on Form 10-Q, their estimates, in particular as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors, including those discussed under the section titled “Risk Factors” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q, if any, our Annual Report on Form 10-K that was filed with the SEC on February 28, 2025, and in other SEC filings.

PRIME MEDICINE, INC.

FORM 10-Q

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2025

TABLE OF CONTENTS


		Page
PART I - FINANCIAL INFORMATION		5
Item 1.	Financial Statements (unaudited)	5
	Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024	5
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended June 30, 2025 and, 2024	6
	Condensed Consolidated Statements of Stockholders ’ Equity for the Three and Nine Months Ended June 30, 2025 and, 2024	7
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended June 30, 2025 and, 2024	9
	Notes to Condensed Consolidated Financial Statements	11
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	25
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	34
Item 4.	Controls and Procedures	34

PART II - OTHER INFORMATION		36
Item 1.	Legal Proceedings	36
Item 1A.	Risk Factors	36
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	38
Item 3.	Defaults Upon Senior Securities	38
Item 4.	Mine Safety Disclosure	38
Item 5.	Other Information	38
Item 6.	Exhibits	39
	Signatures	40

From time to time we may use our website, our X (formerly known as Twitter) account (@PrimeMedicine) or our LinkedIn profile at https://www.linkedin.com/company/prime-medicine to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.primemedicine.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our social media is not incorporated into, and does not form a part of, this Quarterly Report on Form 10-Q.

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)

PRIME MEDICINE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)


(in thousands, except share and per share amounts)	September 30, 2025		December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	71,396	$	182,476
Short-term investments	137,030		2,998
Short-term investment — related party	4,861		4,968

Prepaid expenses	2,493		6,777
Other current assets	15,626		14,667
Total current assets	231,406		211,886

Property and equipment, net	22,046		24,404
Operating lease right-of-use assets	117,869		47,156
Restricted cash	13,691		14,062

Total assets	$	385,012	$	297,508
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	9,354	$	11,351
Accrued expenses and other current liabilities	11,000		15,904

Deferred revenue — related party	6,951		7,092
Operating lease liability	7,714		3,614
Total current liabilities	35,019		37,961
Deferred revenue, net of current — related party	59,751		63,218
Operating lease liability, net of current	110,421		37,180

Research and development funding liability	18,000		6,000
Total liabilities	223,191		144,359
Commitments and contingencies
Stockholders’ equity
Common stock, par value of $0.00001 per share; 775,000,000 shares authorized; 180,309,471 and 131,160,842 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively	2		2
Additional paid-in capital	1,004,061		840,358
Accumulated other comprehensive loss	33		1
Accumulated deficit	(842,275)		(687,212)
Total stockholders’ equity	161,821		153,149
Total liabilities and stockholders’ equity	$	385,012	$	297,508

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

PRIME MEDICINE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands, except share and per share amounts)	2025		2024		2025		2024
Revenue:
Collaboration revenue — related party	$	1,179	$	—	$	3,748	$	—
Collaboration revenue	46		209		46		800
Total revenue	1,225		209		3,794		800
Operating expenses:
Research and development	43,990		40,340		125,927		121,185
General and administrative	11,208		14,101		37,609		37,860
Total operating expenses	55,198		54,441		163,536		159,045
Loss from operations	(53,973)		(54,232)		(159,742)		(158,245)
Other income:
Interest income	1,141		697		3,066		1,984
Accretion (amortization) of investments	752		885		1,621		3,201
Change in fair value of short-term investment — related party	1,454		215		(107)		(544)
Other income, net	44		(83)		99		(2)
Total other income, net	3,391		1,714		4,679		4,639





Net loss attributable to common stockholders	$	(50,582)	$	(52,518)	$	(155,063)	$	(153,606)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.32)	$	(0.44)	$	(1.11)	$	(1.34)
Weighted-average common shares outstanding, basic and diluted	160,503,183		119,764,270		139,244,743		114,492,416

Comprehensive loss:
Net loss	$	(50,582)	$	(52,518)	$	(155,063)	$	(153,606)
Change in unrealized loss on investments, net of tax	43		92		32		36
Comprehensive loss	$	(50,539)	$	(52,426)	$	(155,031)	$	(153,570)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

PRIME MEDICINE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)


	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Losses		Accumulated Deficit		Total Stockholders’ Equity
(in thousands, except share amounts)	Shares	Amount
Balance as of December 31, 2024	131,160,842	$	2	$	840,358	$	1	$	(687,212)	$	153,149




Stock-based compensation expense	—	—		5,681		—		—		5,681
Change in unrealized loss on investments, net of tax	—	—		—		(16)		—		(16)
Net loss	—	—		—		—		(51,890)		(51,890)
Balance as of March 31, 2025	131,160,842	$	2	$	846,039	$	(15)	$	(739,102)	$	106,924
Exercise of pre-funded warrants	3,199,984	—		—		—		—		—
Issuance of common stock under the employee stock purchase plan	133,612	—		197		—		—		197
Stock-based compensation expense	—	—		6,325		—		—		6,325
Change in unrealized loss on investments, net of tax	—	—		—		5		—		5
Net loss	—	—		—		—		(52,591)		(52,591)
Balance as of June 30, 2025	134,494,438	$	2	$	852,561	$	(10)	$	(791,693)	$	60,860
Issuance of common stock from public offering, net of issuance costs of $5.8 million	43,700,000	—		138,380		—		—		138,380

Issuance of restricted stock units	2,000,000	—		—		—		—		—
Issuance of common stock upon exercise of stock options	115,033	—		373		—		—		373
Stock-based compensation expense	—	—		12,747		—		—		12,747
Change in unrealized loss on investments, net of tax	—	—		—		43		—		43
Net loss	—	—		—		—		(50,582)		(50,582)
Balance as of September 30, 2025	180,309,471	$	2	$	1,004,061	$	33	$	(842,275)	$	161,821

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

PRIME MEDICINE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)


	Common Stock	Additional Paid-in Capital		Accumulated Other Comprehensive Losses		Accumulated Deficit			Total Stockholders’ Equity
(in thousands, except share amounts)			Shares					Amount
Balance as of December 31, 2023		97,377,121		$	2	$	624,414		$	(15)	$	(491,330)	$	133,071
Issuance of common stock from public offering, net of issuance costs of $8.9 million		22,560,001		—		132,055			—		—		132,055
Issuance of pre-funded warrants, net of issuance costs of $1.2 million		—		—		18,800			—		—		18,800
Issuance of common stock under the employee stock purchase plan		74,488		—		436			—		—		436
Issuance of common stock upon exercise of stock options		9,664		—		36			—		—		36
Stock-based compensation expense		—		—		5,209			—		—		5,209
Change in unrealized loss on investments, net of tax		—		—		—			(80)		—		(80)
Net loss		—		—		—			—		(45,761)		(45,761)
Balance as of March 31, 2024		120,021,274		2		780,950			(95)		(537,091)		243,766
Issuance of common stock upon exercise of stock options		9,539		—		35			—		—		35
Stock-based compensation expense		—		—		8,091			—		—		8,091
Change in unrealized loss on investments, net of tax		—		—		—			24		—		24
Net loss		—		—		—			—		(55,327)		(55,327)
Balance as of June 30, 2024		120,030,813		$	2	$	789,076		$	(71)	$	(592,418)	$	196,589
Issue of common stock under the Securities Purchase Agreement to BMS — related party		11,006,163		—		38,081			—		—		38,081
Issuance of common stock under the employee stock purchase plan		115,021		—		401			—		—		401

SEC Form 10-Q filed by Prime Medicine Inc.