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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 March 31, 2026


☐	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: 001-38359

Adicet Bio, Inc.

(Exact name of registrant as specified in its charter)


Delaware		81-3305277
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
131 Dartmouth Street, 3rd Floor Boston, MA		02116
(Address of principal executive offices)		(Zip Code)

(650) 503-9095

(Registrant’s telephone number, including area code)

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 $0.0001 per share	ACET	The Nasdaq Capital 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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth 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 May 11, 2026, the registrant had 9,348,236 shares of common stock, $0.0001 par value per share, outstanding.

Table of Contents


		Page

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS		3

PART I.	FINANCIAL INFORMATION	5
Item 1.	Consolidated Financial Statements (Unaudited)	5
	Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025	5
	Consolidated Statements of Operations and Comprehensive Loss for the Three Months ended March 31, 2026 and 2025	6
	Consolidated Statements of Stockholders’ Equity for the Three Months ended March 31, 2026 and 2025	7
	Consolidated Statements of Cash Flows for the Three Months ended March 31, 2026 and 2025	9
	Notes to Unaudited Consolidated Financial Statements	10
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	31
Item 4.	Controls and Procedures	32
PART II.	OTHER INFORMATION	33
Item 1.	Legal Proceedings	33
Item 1A.	Risk Factors	33
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	85
Item 3.	Defaults Upon Senior Securities	85
Item 4.	Mine Safety Disclosures	85
Item 5.	Other Information	85
Item 6.	Exhibits	85
Signatures		87

Summary of the Material Risks Associated with Our Business

•

We have a limited operating history and face significant challenges and expenses as we build our capabilities.

•

Our business is highly dependent on the success of prula-cel (formerly ADI-001). If we are unable to obtain regulatory approval for prula-cel in one or more indications and effectively commercialize this product candidate for the treatment of patients in indications for which we receive approval (if any), our business would be significantly harmed.

•

Our gamma delta T cell candidates represent a novel approach to the treatment of autoimmune diseases and cancer indications that creates significant challenges for us.

•

Our product candidates are based on novel technologies, which makes it difficult to predict the likely success of such product candidates and the time and cost of product candidate development and obtaining regulatory approval.

•

Our clinical trials may fail to demonstrate the safety and efficacy of any of our product candidates, which would prevent or delay regulatory approval and commercialization.

•

We may not be able to file Investigational New Drug (IND) applications, or comparable regulatory submissions, to commence additional clinical trials on the timelines we expect, and even if we are able to, the U.S. Food and Drug Administration (FDA) or analogous regulatory authorities may not permit us to proceed.

•

We may encounter substantial delays in our clinical trials, or may not be able to conduct our trials on the timelines we expect.

•

The market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small.

•

We may not realize the anticipated benefits of our workforce reduction and strategic pipeline prioritization.

•

Although we have commenced manufacturing operations at our manufacturing facility, we currently depend on the ability of our third-party suppliers and manufacturers with whom we contract to perform adequately, particularly with respect to the timely production and delivery of our product candidates, including prula-cel. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

•

We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

•

We will need substantial additional financing to develop our product candidates and implement our operating plans. If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our product candidates.

•

The pharmaceutical industry in China is highly regulated and such regulations, including the Foreign Investment Law and the “negative list,” are subject to change which may affect development, approval and commercialization of our product candidates.

•

The uncertainties in the People’s Republic of China’s legal system regarding the Foreign Investment Law may subject our contractual arrangements to different interpretations or enforcement challenges, subject us to severe penalties or force us to relinquish our interests in our operations.

•

Business disruptions, including armed conflicts, could substantially delay our clinical trials or seriously harm our future revenue and financial condition and increase our costs and expenses.

•

A variety of risks associated with conducting research and clinical trials abroad and marketing our product candidates internationally could materially adversely affect our business, including the potential impact of global conflicts on our supply or clinical trials.

•

We have in the past failed and may in the future fail to achieve and maintain effective internal control over financial reporting, which could harm our business and negatively impact the value of our common stock.

•

If our collaboration with Regeneron Pharmaceuticals, Inc. (Regeneron) is terminated, or if Regeneron materially breaches its obligations thereunder, our business, prospects, operating results, and financial condition would be materially harmed.

•

Our existing and future collaborations will be important to our business. If we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected.

•

The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.

•

If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our market.

•

We depend on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which would harm our business.

•

The trading price of our common stock is highly volatile, which could result in substantial losses for purchasers of our common stock. Securities class action or other litigation involving our company or members of our management team could also substantially harm our business, financial condition and results of operations.

•

Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. 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 and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, among other things, statements about:

•

the timing of and our ability to execute our clinical trials for prula-cel in autoimmune indications, including the ability to successfully complete our Phase 1 clinical trial in lupus nephritis (LN) and initiate Phase 1 clinical trials in lupus erythematosus (SLE), systemic sclerosis (SSc), anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and rheumatoid arthritis (RA);

•

the timing, costs and effects of our workforce reduction and strategic pipeline prioritization;

•

our expectations regarding the preclinical development of ADI-212, and our ability to develop other product candidates in our research pipeline;

•

our expectations regarding prula-cel, including site activation and enrollment for and the availability, timing and announcement of data from our Phase 1 clinical trials for prula-cel and timing and plans for a potential Phase 2 pivotal trial;

•

our expectations regarding discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) of a potential path to support Biologics License Applications (BLA) and Marketing Authorization Applications (MAA) for our product candidates;

•

the anticipated timing of our submission of Investigational New Drug (IND) applications or equivalent regulatory filings and initiation of future clinical trials, including the timing of the anticipated results;

•

our expectations regarding the impact of unstable market and economic conditions, including impacts of inflation, tariffs and adverse developments affecting the financial services industry, on our business, results of operations or financial conditions;

•

the timing of and our ability to obtain and maintain regulatory approvals for our product candidates;

•

the rate and degree of acceptance and clinical utility of any products for which we receive regulatory approval;

•

our expectations regarding the manufacturing of our product candidates and any products for which we receive regulatory approval by us or by our third-party suppliers;

•

our commercialization, marketing and manufacturing capabilities and strategy;

•

our intellectual property position and strategy;

•

our ability to identify additional product candidates with significant commercial potential;

•

our plans to enter into collaborations for the development and commercialization of product candidates;

•

the potential benefits of any current and future collaboration;

•

our research and development activities outside of the United States, including in China, and related contractual relationships;

•

our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

•

the success of competing therapies that are or may become available;

•

developments relating to our competitors and our industry;

•

our ability to retain the continued service of our key professionals and to identify, hire, and retain additional qualified professionals;

•

our financial performance;

•

our expectations related to the use of cash, cash equivalents and short-term investments in treasury securities;

•

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

•

our ability to maintain effective internal control over financial reporting;

•

the impact of government laws and regulations; 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 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, particularly in the “Risk Factors” section, that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that 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 or incorporated by reference as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This Quarterly Report on Form 10-Q includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We are responsible for all of the disclosure contained in this Quarterly Report on Form 10-Q, and we believe these industry publications and third-party research, surveys and studies are reliable.

PART I—FINANCIAL INFORMATION

Item 1. Consolidated Financial Statements (Unaudited).

ADICET BIO, INC.

Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)


	March 31, 2026			December 31, 2025
Assets
Current assets:
Cash and cash equivalents	$	36,245		$	38,918
Short-term investments in treasury securities		101,347			119,612
Prepaid expenses and other current assets		2,479			2,396
Total current assets		140,071			160,926
Restricted cash		2,869			2,872
Property and equipment, net		15,183			16,532
Operating lease right-of-use asset		10,239			10,927
Finance lease right-of-use asset		942			1,022
Other non-current assets		78			76
Total assets	$	169,382		$	192,355
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	2,929		$	4,739
Accrued and other current liabilities		12,490			13,606
Operating lease liability		2,748			2,837
Finance lease liability		131			349
Total current liabilities		18,298			21,531
Operating lease liability, net of current portion		10,161			10,910
Finance lease liability, net of current portion		858			642
Other non-current liabilities		—			62
Total liabilities		29,317			33,145
Commitments and contingencies (Note 10)
Stockholders’ equity:
Preferred stock, $0.0001 par value, 10,000,000 shares authorized as of March 31, 2026 and December 31, 2025, respectively; none issued and outstanding as of March 31, 2026 and December 31, 2025, respectively		—			—
Common stock, $0.0001 par value, 300,000,000 shares authorized as of March 31, 2026 and December 31, 2025, respectively; 9,597,693 and 9,586,770 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively		1			10
Additional paid-in capital		775,042			773,795
Accumulated deficit		(634,941	)		(614,697	)
Accumulated other comprehensive (loss) income		(37	)		102
Total stockholders’ equity		140,065			159,210
Total liabilities and stockholders’ equity	$	169,382		$	192,355

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

ADICET BIO, INC.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)


	For the Three Months Ended March 31,
	2026			2025
Operating expenses:
Research and development	$	17,487		$	22,814
General and administrative		4,083			7,071
Total operating expenses		21,570			29,885
Loss from operations		(21,570	)		(29,885	)
Interest income		1,342			1,683
Interest expense		(23	)		—
Other expense, net		7			(12	)
Loss before income tax provision		(20,244	)		(28,214	)
Income tax provision		—			—
Net loss	$	(20,244	)	$	(28,214	)
Net loss per share, basic and diluted	$	(1.88	)	$	(4.96	)
Weighted-average common shares used in computing net loss per share, basic and diluted		10,744,621			5,691,965
Other comprehensive income
Unrealized loss on treasury securities, net of tax		(139	)		(25	)
Total other comprehensive income		(139	)		(25	)
Comprehensive loss	$	(20,383	)	$	(28,239	)

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

ADICET BIO, INC.

Consolidated Statements of Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)


	Common Stock						Additional Paid In			Accumulated			Accumulated Other Comprehensive			Total Stockholders'
	Shares			Amount			Capital			Deficit			Income (Loss)			Equity
Balance at December 31, 2025		9,586,770		$	10		$	773,795		$	(614,697	)		102		$	159,210
Immaterial correction from par to additional paid-in capital		—			(9	)		9			—			—			—
Issuance of common stock upon vesting of restricted stock		19,555			—			—			—			—			—
Shares withheld for taxes		(8,632	)		—			(65	)		—			—			(65	)
Stock-based compensation expense		—			—			1,303			—			—			1,303
Net loss		—			—			—			(20,244	)		—			(20,244	)
Other comprehensive income		—			—			—			—			(139	)		(139	)
Balance at March 31, 2026		9,597,693		$	1		$	775,042		$	(634,941	)	$	(37	)	$	140,065

ADICET BIO, INC.

Consolidated Statements of Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)


	Common Stock					Additional Paid In			Accumulated			Accumulated Other Comprehensive			Total Stockholders'
	Shares			Amount		Capital			Deficit			Income			Equity
Balance at December 31, 2024		5,160,545		$	5	$	684,482		$	(497,894	)	$	16		$	186,609
Issuance of common stock upon vesting of restricted stock		15,943			—		—			—			—			—
Shares withheld for taxes		(7,161	)		—		(104	)		—			—			(104	)
Stock-based compensation expense		—			—		3,180			—			—			3,180
Net loss		—			—		—			(28,214	)		—			(28,214	)
Other comprehensive income		—			—		—			—			(25	)		(25	)
Balance at March 31, 2025		5,169,327		$	5	$	687,558		$	(526,108	)	$	(9	)	$	161,446

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

ADICET BIO, INC.

Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)


	Three Months Ended March 31,
	2026			2025
Cash flows from operating activities
Net loss	$	(20,244	)	$	(28,214	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense		1,342			1,680
Noncash lease expense		743			845
Stock-based compensation expense		1,303			3,180
Net amortization of premiums and accretion of discounts on investments		(790	)		(1,208	)
Amortization of deferred transaction costs		—			15
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(85	)		762
Other non-current assets		3			100
Accounts payable		(1,800	)		629
Operating lease liability		(817	)		(989	)
Accrued and other current and non-current liabilities		(1,145	)		(2,197	)
Net cash used in operating activities		(21,490	)		(25,397	)
Cash flows from investing activities
Purchases of short-term treasury securities		(20,084	)		(34,369	)
Maturities of short-term treasury securities		39,000			33,000
Purchases of property and equipment		(37	)		(1,492	)
Net cash provided by (used in) investing activities		18,879			(2,861	)
Cash flows from financing activities
Taxes withheld and paid related to net share settlement of equity awards		(65	)		(104	)
Net cash used in financing activities		(65	)		(104	)
Net change in cash, cash equivalents and restricted cash		(2,676	)		(28,362	)
Cash, cash equivalents and restricted cash at the beginning of period		41,790			59,398
Cash, cash equivalents and restricted cash at the end of period	$	39,114		$	31,036
Reconciliation of cash, cash equivalents and restricted cash to consolidated balance sheets:
Cash and cash equivalents	$	36,245		$	28,133
Restricted cash		2,869			2,903
Cash, cash equivalents and restricted cash in consolidated balance sheets	$	39,114		$	31,036
Supplemental cash flow information
Supplemental disclosures of noncash investing and financing activities
Purchases of property and equipment included in accounts payable and accrued expenses	$	164		$	224
Remeasurement of finance lease resulting in a reduction of ROU asset	$	25		$	—

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

ADICET BIO, INC.

Notes to Interim Consolidated Financial Statements (Unaudited)

1. Organization and Nature of the Business

Adicet Bio, Inc. (formerly resTORbio, Inc. (resTORbio), together with its subsidiaries, the Company) is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Company is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients.

Adicet Bio, Inc. (when referred to prior to the merger, Former Adicet) was incorporated in November 2014 in Delaware. On September 15, 2020, Former Adicet completed a merger (Merger) with resTORbio, pursuant to which Former Adicet merged with a wholly owned subsidiary of resTORbio in an all-stock transaction with Former Adicet surviving as a wholly owned subsidiary of resTORbio and changing its name to “Adicet Therapeutics, Inc.” (Adicet Therapeutics). In connection with the Merger, the Company changed its name from “resTORbio, Inc.” to “Adicet Bio, Inc.” The Company’s principal executive offices are located in Boston, Massachusetts. The Company also has offices in Redwood City, California.

Adicet Bio Israel Ltd. (formerly Applied Immune Technologies Ltd.) (Adicet Israel) is a wholly owned subsidiary of the Company and is located in Haifa, Israel. Adicet Israel was founded in 2006. During 2019, the Company consolidated its operations, including research and development activities, in the United States and as a result, substantially reduced its operations in Israel.

Adicet (Shanghai) Biotechnology Co., Ltd. (Adicet Shanghai) is a wholly owned subsidiary of Adicet Therapeutics and is located in Shanghai, China. Adicet Shanghai was founded in May 2024.

In May 2024, the Company initiated research and development activities in China through a series of contractual agreements entered into and among Shanghai Adicet Biotechnology Co., Ltd. (Shanghai Adicet), a variable interest entity, Adicet Shanghai, and the shareholders of Shanghai Adicet. The Company was the primary beneficiary of Shanghai Adicet which was considered a consolidated entity under accounting principles generally accepted in the United States of America (U.S. GAAP). In July 2025, Adicet Therapeutics entered into an equity transfer agreement with the then-stockholders of Shanghai Adicet to acquire 100% equity interests of Shanghai Adicet from its then-stockholders (the Acquisition). In connection with the Acquisition, tax filings and registration were completed in August 2025. In August 2025, upon completion of the registration, Shanghai Adicet is now a wholly owned subsidiary of Adicet Therapeutics and will continue to conduct research and development activities in China. The transaction did not have a material impact on the financial statements. The Company consolidates the financial results of this entity into its consolidated financial statements in accordance with U.S. GAAP.

Liquidity

The Company has incurred significant net operating losses and negative cash flows from operations and has an accumulated deficit of $634.9 million as of March 31, 2026. The Company has historically financed its operations primarily through a collaboration and licensing arrangement, public and private placements of equity securities and debt, and cash received in the Merger with resTORbio. To date, none of the Company’s product candidates have been approved for sale and therefore the Company has not generated any revenue from product sales. Management expects operating losses and negative cash flows to continue for the foreseeable future, until such time, if ever, that it can generate significant sales of its product candidates currently in development.

On March 12, 2021, the Company entered into a Capital On Demand™ Sales Agreement (the JonesTrading Sales Agreement) with JonesTrading Institutional Services LLC, as sales agent, to provide for the offering, issuance and sale of up to an aggregate amount of $75.0 million of shares of common stock from time to time in “at-the-market” (ATM) offerings. In August 2022, pursuant to the JonesTrading Sales Agreement and subject to the limitations thereof, the Company sold an aggregate of 163,233 shares of common stock of the Company, par value $0.0001 per share (common stock), at $275.68 per share resulting in net proceeds to the Company of $43.4 million after deducting sales agent commissions and expenses. In November 2022, the Company filed a new prospectus supplement to the 2021 Shelf Registration Statement for the offer and sale of up to $100.0 million of shares of common stock from time to time through the sales agent, which includes the $30.0 million of shares of common stock not sold under the original prospectus and up to an additional $70.0 million of shares of common stock (the JonesTrading ATM Program). In January 2024, the Company raised aggregate net proceeds of

approximately $19.3 million through the JonesTrading ATM Program. In March 2024, the Company terminated the JonesTrading ATM Program.

On January 22, 2024, the Company entered into an Underwriting Agreement (the Underwriting Agreement) with Jefferies LLC (Jefferies) and Guggenheim Securities, LLC (Guggenheim), as representatives of the underwriters (the 2024 Underwriters), related to an underwritten public offering (the Offering) of 1,690,917 shares (the Shares) of common stock, and, in lieu of common stock to an investor, pre-funded warrants (the Pre-Funded Warrants) to purchase 527,833 shares of common stock (the Warrant Shares). The Shares were sold at a public offering price of $38.40 per share and the Pre-Funded Warrants were sold at a public offering price of $38.3984 per underlying share, which represents the per share public offering price of each share of common stock minus the $0.0016 per share exercise price for each pre-funded warrant. The purchase price paid by the 2024 Underwriters to the Company was $36.096 per Share and $36.0944 per Pre-Funded Warrant, representing a discount to the 2024 Underwriters of 6.0%. In addition, the Company granted the 2024 Underwriters an option exercisable for 30 days from the date of the Underwriting Agreement to purchase, at the public offering price less underwriting discounts and commissions, up to an additional 332,813 shares of common stock. On January 23, 2024, the 2024 Underwriters exercised this option in full. The Company received net proceeds from the Offering, after deducting the underwriting discount and commissions and other offering expenses, of approximately $91.7 million. The Company may receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants.

In March 2024, the Company entered into an Open Market Sales AgreementSM (the Jefferies Sales Agreement) with Jefferies to sell shares of its common stock from time to time, through an ATM equity offering program under which Jefferies will act as sales agent or principal. As of March 31, 2026, no shares of common stock have been sold under the Jefferies Sales Agreement.

On October 7, 2025, the Company entered into an Underwriting Agreement (the 2025 Underwriting Agreement) with Jefferies and Guggenheim, as representatives of the underwriters (the 2025 Underwriters), related to an underwritten registered direct offering (the 2025 Offering) of 4,375,062 shares (the 2025 Shares) of common stock, and, in lieu of common stock to an investor, pre-funded warrants (the 2025 Pre-Funded Warrants) to purchase 625,000 shares of common stock (the 2025 Warrant Shares). The 2025 Shares were sold at a price of $16.00 per share and the 2025 Pre-Funded Warrants were sold at a price of $15.9984 per underlying share, which represents the per share offering price of each share of common stock minus the $0.0016 per share exercise price for each pre-funded warrant. The purchase price paid by the 2025 Underwriters to the Company was $15.04 per 2025 Share and $15.03856 per 2025 Pre-Funded Warrant, representing a discount to the 2025 Underwriters of 6.0%. The Company received net proceeds from the 2025 Offering, after deducting the underwriting discount and commissions and other offering expenses, of approximately $74.8 million. The Company may receive nominal proceeds, if any, from the exercise of the 2025 Pre-Funded Warrants.

The Company expects that its cash, cash equivalents and short-term investments in treasury securities will be sufficient to fund its forecasted operating expenses and capital expenditure requirements for at least the next twelve months from the issuance of these unaudited interim consolidated financial statements.

All of the Company’s revenue to date has been generated from a collaboration and license agreement (the Regeneron Agreement) with Regeneron Pharmaceuticals, Inc, (Regeneron). The Company does not expect to generate any significant product revenue until it obtains regulatory approval of and commercializes any of the Company’s product candidates or enters into additional collaborative agreements with third parties, and it does not know when, or if, either will occur. The Company expects to continue to incur significant losses for the foreseeable future, and it expects the losses to increase as the Company continues the development of, and seeks regulatory approvals for, its product candidates and begins to commercialize any approved products. The Company is subject to all of the risks typically related to the development of new product candidates, including, but not limited to, raising additional capital, development by its competitors of new technological innovations, risk of failure in preclinical and clinical studies, safety and efficacy of its product candidates in clinical trials, the risk of relying on external parties such as contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), the regulatory approval process, market acceptance of the Company’s products once approved, lack of marketing and sales history, dependence on key personnel and protection of proprietary technology and it may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect its business.

Until such time as the Company can generate significant revenue from product sales, if ever, the Company expects to finance its operations through the sale of equity, debt financings, collaborative or other arrangements with corporate or other sources of financing. Adequate funding may not be available to the Company on acceptable terms or at all. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and the Company’s ability

to pursue its business strategies. Although the Company continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all.

2. Summary of Significant Accounting Policies

Basis of Presentation

The unaudited interim consolidated financial statements and related disclosures have been prepared in conformity with U.S. GAAP.

Significant Accounting Policies

The Company’s significant accounting policies are described in Note 2, "Summary of Significant Accounting Policies," to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to the significant accounting policies during the three months ended March 31, 2026.

Unaudited Interim Financial Information

The accompanying unaudited consolidated financial statements as of March 31, 2026, and for the three months ended March 31, 2026, have been prepared by the Company, pursuant to the rules and regulations of the SEC, for interim financial statements. Certain information and disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2025. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial position as of March 31, 2026 and consolidated results of operations for the three months ended March 31, 2026 and 2025 and consolidated cash flows and stockholders' equity for the three months ended March 31, 2026 and 2025 have been made. The results of operations for the three months ended March 31, 2026 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2026.

Concentration of Credit Risk

Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash, cash equivalents and short-term investments in treasury securities. The Company’s cash and cash equivalents, as well as its short-term investments in treasury securities, are held at two financial institutions in the U.S., one financial institution in China and one financial institution in Israel and such amounts may, at times, exceed insured limits. The Company invests its cash equivalents in treasury securities and money market funds. The Company limits its credit risk associated with cash equivalents and short-term investments in treasury securities by placing them with banks and institutions it believes are highly creditworthy and in highly rated investments. The Company has not experienced any losses on its deposits of cash and cash equivalents or its short-term investments in treasury securities to date.

Risks and Uncertainties

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies, clinical trials, and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting.

The Company’s product candidates are still in development and, to date, none of the Company’s product candidates have been approved for sale and, therefore, the Company has not generated any revenue from product sales.

There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below.

Recently Adopted Accounting Pronouncements

In September 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances the transparency and usefulness of income tax disclosures. This amendment requires public issuers to disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income, or loss, by the applicable statutory income tax rate. Additionally, this amendment requires issuers to disclose the amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign taxes as well as the amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid (net of refunds received) is equal to or greater than 5 percent of total income taxes paid (net of refunds received). For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company adopted ASU 2023-09 in the fourth quarter of 2025 on a prospective basis.

Accounting Pronouncements Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires the disaggregation of certain expense captions into specified categories in disclosures within the notes to the consolidated financial statements to provide enhanced transparency into the expense captions presented on the face of the statements of income and comprehensive income. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, with early adoption permitted, and may be applied either prospectively or retrospectively to financial statements issued for reporting periods after the effective date of ASU 2024-03 or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its related disclosures.

3. Fair Value Measurements

The Company determines the fair value of financial and non-financial assets and liabilities using the fair value hierarchy which establishes three levels of inputs that may be used to measure fair value, as follows:

Level 1 — Observable inputs, such as quoted prices in active markets for identical assets or liabilities.

Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 — Unobservable inputs which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.

The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):


	March 31, 2026
	Level 1		Level 2		Level 3		Total
Assets:
Treasury securities (1) (3)	$	101,347	$	—	$	—	$	101,347
Money market funds (2) (3)		32,078		—		—		32,078
Total fair value of assets	$	133,425	$	—	$	—	$	133,425


	December 31, 2025
	Level 1		Level 2		Level 3		Total
Assets:
Treasury securities (1) (3)	$	119,612	$	—	$	—	$	119,612
Money market funds (2) (3)		31,641		—		—		31,641
Total fair value of assets	$	151,253	$	—	$	—	$	151,253

(1)

Included in short-term investments in treasury securities in the consolidated balance sheets. These securities have maturity dates of greater than three months, but less than twelve months from the date of purchase.

(2)

Included in cash and cash equivalents in the consolidated balance sheets.

(3)

Treasury securities and money market funds are included within Level 1 of the fair value hierarchy because they are actively traded and valued using quoted market prices.

4. Marketable Securities

The following tables show the Company's available-for-sale securities adjusted cost, net unrealized gains and losses and fair value by significant investment category (in thousands):


	March 31, 2026
	Amortized Cost		Unrealized Gains		Unrealized Losses			Fair Value
Marketable Securities:
Treasury securities	$	101,384	$	—	$	(37	)	$	101,347
Total	$	101,384	$	—	$	(37	)	$	101,347


	December 31, 2025
	Amortized Cost		Unrealized Gains		Unrealized Losses		Fair Value
Marketable Securities:
Treasury securities	$	119,510	$	102	$	—	$	119,612
Total	$	119,510	$	102	$	—	$	119,612

5. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	March 31, 2026		December 31, 2025
Prepaid insurance	$	634	$	829
Prepaid maintenance		538		338
Interest receivable		405		342
Prepaid employee benefits		251		6
Prepaid software subscription and licensing fees		246		382
Prepayments to CROs and CDMOs		57		185
Other prepaid expenses and current assets		348		314
Total prepaid expenses and other current assets	$	2,479	$	2,396

6. Property and Equipment, net

Property and equipment, net consisted of the following (in thousands):


	Useful life (in years)	March 31, 2026			December 31, 2025
Leasehold improvements	Lesser of useful life or lease term	$	28,447		$	28,422
Laboratory equipment	3		13,725			13,725
Furniture and fixtures	3		802			802
Construction in progress	—		166			198
Computer equipment	3		320			319
Software	3		453			453
			43,913			43,919
Less: Accumulated depreciation and amortization			(28,730	)		(27,387	)
Property and equipment, net		$	15,183		$	16,532

Depreciation and amortization expense was $1.3 million and $1.7 million for the three months ended March 31, 2026 and 2025, respectively.

7. Accrued and Other Current Liabilities

Accrued and other current liabilities consisted of the following (in thousands):


	March 31, 2026		December 31, 2025
Accrued CRO costs	$	5,589	$	5,707
Accrued compensation		3,701		5,632
Accrued professional services		1,415		1,200
Accrued CDMO costs		964		479
Accrued other research and development expenses		652		367
Accrued other liabilities		169		221
Total accrued and other liabilities	$	12,490	$	13,606

8. Term Loan

On April 28, 2020, the Company entered into a Loan and Security Agreement (the Loan Agreement) as amended on July 8, 2020, September 14, 2020, September 15, 2020, October 21, 2021 (the 2021 Loan Amendment), December 2, 2022 (the 2022 Loan Amendment) and May 30, 2023 with Banc of California (formerly known as Pacific Western Bank) to finance leasehold improvements for the facilities in Redwood City, CA and other purposes permitted under the Loan Agreement. Under the 2021 Loan Amendment, Banc of California will provide one or more Term Loans (as defined in the 2021 Loan Amendment), as well as Non-Formula Ancillary Services which shall not exceed $5.5 million in the aggregate. Non-Formula Ancillary Services are defined as automated clearinghouse transactions, corporate credit card services, letters of credit, or other treasury management services. Per the terms of the Loan Agreement, the aggregate sum of the outstanding Term Loans and Non-Formula Ancillary Services shall at no time exceed $15.0 million, which each Term Loan to be in an amount of not less than $1.0 million.

On March 13, 2023, the Company and Banc of California executed a letter agreeing that, notwithstanding the covenants included in the 2022 Loan Amendment, until June 30, 2023 (i) the Company and its subsidiaries will not be required to maintain the lesser of $200 million or seventy percent (70%) of its combined balances in demand deposit accounts, money market funds and/or insured cash sweep (ICS) accounts with Banc of California and (ii) the Company must maintain its combined balances at Banc of California or its affiliates, including Pacific Western Asset Management (the Letter).

On May 30, 2023, the Company further amended its Loan Agreement with Banc of California (the 2023 Loan Amendment). Pursuant to the 2023 Loan Amendment, the Company must maintain the lesser of (i) $35.0 million or (ii) all of the Company’s combined balances in demand deposit accounts, money market accounts, and/or insured cash sweep accounts with Banc of California. If the Company’s total cash and investments drop to less than $35.0 million, the 2023 Loan

Amendment permits the Company to maintain cash and/or investments in one or more accounts outside of Banc of California up to a total of $2.5 million.

In April 2024, the Term Loan availability under the Loan Agreement expired. The Non-Formula Ancillary Services, which shall not exceed $5.5 million in the aggregate, remained available. On November 27, 2024, the Company executed a payoff letter (the Payoff Letter) with Banc of California to repay in full all outstanding indebtedness and terminate all commitments and obligations, subject to certain exceptions, under the Loan Agreement. Under the Payoff Letter, the Company agreed to pay Banc of California approximately $10,000 in administrative fees and establish cash collateral accounts and execute pledge and security agreements to secure ancillary services provided by Banc of California. The Company paid the $10,000 administrative fees in December 2024. No termination penalty was paid in connection with the Payoff Letter. As of March 31, 2026, we have $2.9 million of restricted cash held in cash collateral accounts.

9. Third Party Agreements

Regeneron

On July 29, 2016, the Company entered into a license and collaboration agreement with Regeneron, which was amended in April 2019, with such amendment becoming effective in connection with Regeneron’s investment in the Company’s Series B redeemable convertible preferred stock private placement transaction in July 2019 (as amended, the Regeneron Agreement).

Financial Terms. The Company received a non-refundable upfront payment of $25.0 million from Regeneron upon execution of the Regeneron Agreement and an aggregate of $20.0 million of additional payments for research funding from Regeneron as of March 31, 2026. In addition, Regeneron may have to pay the Company additional amounts in the future consisting of up to an aggregate of $80.0 million of option exercise fees, as specified in the Regeneron Agreement. Per the terms of the agreement, Regeneron must pay the Company high single digit royalties as a percentage of net sales for immune cell products (ICPs) to targets for which it has exclusive rights, and low single digit royalties as a percentage of net sales on any non-ICP product comprising a targeting moiety generated by the Company through the use of Regeneron’s proprietary mice. The Company must pay Regeneron mid-single to low double digit, but less than teens, of royalties as a percentage of net sales of ICPs to targets for which the Company has exercised exclusive rights, and low to mid-single digit of royalties as a percentage of net sales of targeting moieties generated from the Company’s license to use Regeneron’s proprietary mice. Royalties are payable until the longer of the expiration or invalidity of the licensed patent rights or twelve (12) years from first commercial sale. No royalties have been earned or paid under the Regeneron Agreement through March 31, 2026.

On January 28, 2022, Regeneron exercised its option to license the exclusive, worldwide rights to ADI-002, an allogeneic gamma delta CAR T cell therapy directed against Glypican-3, pursuant to the Regeneron Agreement. In conjunction with the exercise of the option, Regeneron paid an exercise fee of $20.0 million to the Company on January 28, 2022, and the Company completed the transfer of the associated license rights to Regeneron during the first quarter of 2022. The $20.0 million option exercise fee, plus $5.0 million of revenue recognized relating to the combined performance obligation, resulted in an aggregate of $25.0 million recorded as revenue for the year ended December 31, 2022. The Company's obligations under the combined performance obligation were completed during the year ended December 31, 2022.

Regeneron is responsible, at its sole cost, for all development, manufacturing and commercialization of ADI-002 and must pay the Company high single digit royalties as a percentage of any net sales of ADI-002 for a period commencing on the first commercial sale until the longer of (i) the expiration or invalidity of the licensed patent rights or (ii) a low double digit amount of years from first commercial sale.

Twist Bioscience

In March 2021, the Company entered into an Antibody Discovery Agreement (the Twist Agreement) with Twist Bioscience Corporation (Twist). Under the terms of the Twist Agreement, Twist will utilize its proprietary platform technology to assist the Company with the discovery of novel antibodies related to target antigens selected by the Company. The Company maintains the sole and exclusive rights to any program antibodies discovered under the Twist Agreement and has the right to patent, assign, license or transfer any work product under the agreement. Furthermore, the Company has the right to sublicense its rights to program antibodies to third parties. The Company may terminate the Twist Agreement at any time, with or without cause, upon a specified period advance written notice.

Per the terms of the agreement, the Company will pay Twist an upfront, non-refundable project initiation fee, a technology access fee, as well as a project fee for each project entered into under the agreement. Additionally, the Company will pay fees for development and regulatory milestones in the tens of millions of dollars and low single digit royalties on net sales to Twist for programs initiated under the agreement. In November 2022, the Company entered into an amendment to the Twist Agreement (the Twist Amendment). The Twist Amendment updates the language associated with Twist's audit rights as well as the amounts associated with technology access fees.

On a cumulative basis as of March 31, 2026, the Company has incurred and expensed $1.1 million related to project initiation fees, technology access fees and projects fees as research and development expense related to this agreement.

CRISPR

On May 16, 2023, the Company entered into a license and collaboration agreement with CRISPR Therapeutics AG (CRISPR Agreement) to non-exclusively license CRISPR’s gene editing technology (CRISPR Technology) for use in up to a specified number of gamma delta licensed products. CRISPR also has an option to co-develop and co-commercialize a future gamma delta product (the Option Product). Additionally, the parties have agreed on prostate-specific membrane antigen (PSMA) as a collaboration target that the Company will develop an Option Product against. CRISPR has opt-in rights to participate in a 50/50 cost and profit split for the Option Product. If CRISPR elects to opt-in, the Option Product would be designated a collaboration product. If CRISPR elects to not opt-in, the Option Product becomes a licensed product. The Company will lead and be primarily responsible for the development, manufacturing, and commercialization of the Collaboration Product in accordance with plans agreed upon by both parties.

For each licensed product, the Company will retain worldwide rights and may be required to make potential future payments based on the achievement of development and regulatory approval milestones totaling low double digit million dollars for each non-collaboration product, sales milestones totaling low double digit million dollars for each non-collaboration product, and tiered royalties up to low-single digit percentages on net product sales of such product. Unless earlier terminated, the term of the CRISPR Agreement will terminate (i) on a country-by-country basis with respect to each licensed product until the end of the last royalty term in such country for such licensed product and (ii) when a party opts out for collaboration products.

As of March 31, 2026, the Company has not paid any amounts nor are any amounts owed by the Company under the CRISPR Agreement, and no milestones have been achieved.

City of Hope

On July 9, 2024, City of Hope (COH) and the Company entered into a license agreement (COH Agreement) under which COH granted the Company a non-exclusive, worldwide license to patent rights related to its membrane-bound IL12 technology for use in gamma delta T cell products (Licensed Products). The Company may sublicense Licensed Products through multiple tiers. Unless earlier terminated, the term of the COH Agreement continues, on a country-by-country and Licensed Product-by-Licensed Product basis, until the royalty expiration date for each Licensed Product in each country. The Company may terminate the COH Agreement at any time, with or without cause, upon advance written notice.

As consideration for the license, the Company may pay fees for development and regulatory milestones that together total in the single digit millions of dollars and sales milestones in the low-to-mid double digit millions of dollars. Additionally, the Company will pay low single digit percentage royalties on net sales to COH for licensed products covered under the COH Agreement. The Company will pay COH a portion of all consideration received for sublicensing a Licensed Product, ranging from low double digit percentage to a low single digit percentage, such percentage decreasing as development advances for the Licensed Product.

As of March 31, 2026, the Company has incurred no payments under the COH agreement.

10. Commitments and Contingencies

Leases

The Company has operating leases for office and laboratory space in Redwood City, California, and Boston, Massachusetts, as well as one finance lease for lab instruments.

Redwood City

In 2018, Adicet Therapeutics executed a non-cancelable lease agreement, as amended in 2022, pursuant to which the Company leases office and laboratory facility at 1000 Bridge Parkway and a portion of 1200 Bridge Parkway in Redwood City, California (the Redwood City Lease).

On January 9, 2023, Adicet Therapeutics entered into a third lease amendment with Westport Office Park, LLC (the Third Amendment). The Third Amendment further amends the Redwood City Lease and increases the tenant improvement allowance as of January 1, 2023 by an additional $3.0 million. The Company fully utilized the allowance for the continued buildout of office and laboratory space at 1000 Bridge Parkway in 2023. Per the terms of this amendment, this additional allowance will be repaid through equal monthly payments of principal amortization and interest on a monthly basis over the term of the lease at an interest rate of eight percent (8%) per annum. The Company received the allowance on February 21, 2023 and increased the operating lease liability accordingly.

On August 7, 2023, Adicet Therapeutics entered into a fourth lease amendment with Westport Office Park, LLC (the Fourth Amendment). The Fourth Amendment amends the period over which the tenant improvement allowance received in the Third Amendment will be amortized and identifies the monthly amortization payable by the Company.

On November 19, 2025, Adicet Therapeutics entered into a fifth lease amendment with Westport Office Park, LLC (the Fifth Amendment). The Fifth Amendment acknowledges that the portion of the Redwood City Lease related to 1200 Bridge Parkway expired on June 30, 2025.

Boston

In 2018, the Company entered into a lease agreement, as amended in 2019, for office space at 500 Boylston St, Boston, Massachusetts (500 Boylston Lease). Under the terms of the 500 Boylston Lease, the Company was permitted to assign, sublease or transfer this lease, with the consent of the landlord.

On July 19, 2021, the Company entered into a sublease agreement with RFS OPCO LLC (Sublessee), whereby the Company agreed to sublease to Sublessee all of the 9,501 rentable square feet of 500 Boylston St. The expected undiscounted cash flows to be received from the sublease as of March 31, 2026 is as follows (in thousands):


	March 31, 2026
2026	$	250
2027 and thereafter		—
Total	$	250

Further, the Company remains liable for the remaining lease payments under the 500 Boylston Lease, totaling $0.3 million, which is included in the future minimum lease payments table below.

The future minimum lease payments under all non-cancelable lease obligations as of March 31, 2026 were as follows (in thousands):


	Operating Leases			Finance Leases
2026	$	2,945		$	213
2027		3,714			250
2028		3,808			250
2029		3,906			250
2030		662			250
2031 and thereafter		—			—
Total undiscounted lease payments		15,035			1,213
Less: imputed interest		(2,126	)		(224	)
Total lease liability		12,909			989
Less: current portion		(2,748	)		(131	)
Lease liability, net of current maturities	$	10,161		$	858

The following table presents the lease cost and information related to the lease right-of-use assets, net and lease liabilities for the quarter ended March 31, 2026 (in thousands):


	Three Months Ended
	March 31, 2026
Lease Cost
Operating lease cost	$	837
Short-term lease cost		41
Finance lease cost:
Amortization of right-of-use assets		55
Interest on lease liabilities		15
Sublease income		(125	)
Total lease cost	$	823
Other Information
Operating cash flows used for lease liabilities	$	(817	)
Financing cash flows used for finance lease liabilities		—
Weighted-average remaining lease term - operating leases (in years)		3.8
Weighted-average remaining lease term - finance leases (in years)		4.4
Weighted-average discount rate - operating leases		6.90	%
Weighted-average discount rate - finance leases		10.00	%

For the three months ended March 31, 2026, the Company recognized $0.8 million and less than $0.1 million in operating lease and short-term lease costs, respectively. Additionally, for the three months ended March 31, 2026, the Company recognized $0.1 million in sublease income.

For the three months ended March 31, 2026, the Company recognized less than $0.1 million in reduction of right-of-use assets and interest on lease liabilities for the finance lease.

The Company maintains letters of credit in connection with the Company’s office leases in Redwood City, CA and Boston, MA. Refer to Note 17 Restricted Cash for additional information about these letters of credit.

11. Stockholders' Equity

Common Stock

The Company’s Restated Certificate of Incorporation, which became effective as of June 6, 2024, authorized the Company to issue 300,000,000 shares of common stock, par value $0.0001 per share.

Common stockholders are entitled to dividends if and when declared by the board of directors of the Company subject to the prior rights of the preferred stockholders. As of March 31, 2026, no dividends on common stock had been declared by the board of directors.

The Company has the following shares of common stock reserved for future issuance:


	March 31, 2026		December 31, 2025
Stock options and restricted stock units available for future grant		361,516		682,713
Stock options issued and outstanding		1,583,057		763,464
Unvested restricted stock units		74,503		46,842
Common stock warrants issued and outstanding		1,152,833		1,152,833
Total common stock reserved		3,171,909		2,645,852

On January 22, 2024, the Company entered into the Underwriting Agreement with Jefferies and Guggenheim, as representatives of the 2024 Underwriters, related to the Offering of 2,023,729 shares of common stock, which included 332,812 shares sold and issued upon the exercise in full by the 2024 Underwriters of their option to purchase additional shares of common stock, and, in lieu of common stock to certain investors, pre-funded warrants to purchase 527,833 shares of common stock. The pre-funded warrants were sold at a public offering price of $38.3984 per pre-funded warrant, which represents the per share public offering price of each share of common stock minus the $0.0016 per share exercise price for

each pre-funded warrant. The pre-funded warrants do not have an expiration date and are exercisable at any time. The pre-funded warrants are classified as equity within the Company's consolidated balance sheet. The Company received net proceeds from the Offering, after deducting the underwriting discount and commissions and other offering expenses, of approximately $91.7 million. The Company may receive nominal proceeds, if any, from the exercise of the pre-funded warrants.

On October 7, 2025, the Company entered into the 2025 Underwriting Agreement with Jefferies and Guggenheim, as representatives of the 2025 Underwriters, related to the 2025 Offering of 4,375,062 shares of common stock, and, in lieu of common stock to an investor, pre-funded warrants to purchase 625,000 shares of common stock. The 2025 Shares were sold at a price of $16.00 per share and the 2025 Pre-Funded Warrants were sold at a price of $15.9984 per underlying share, which represents the per share offering price of each share of common stock minus the $0.0016 per share exercise price for each pre-funded warrant. The pre-funded warrants do not have an expiration date and are exercisable at any time. The pre-funded warrants are classified as equity within the Company's consolidated balance sheet. The Company received net proceeds from the 2025 Offering, after deducting the underwriting discount and commissions and other offering expenses, of approximately $74.8 million. The Company may receive nominal proceeds, if any, from the exercise of the 2025 Pre-Funded Warrants.

The following provides a roll forward of outstanding pre-funded warrants to purchase common stock as of March 31, 2026:


Issuance Date	Number of Shares of Common Stock Issuable		Weighted Average Exercise Price
Outstanding, December 31, 2025		1,152,833	$	0.0016
Warrants issued		—		—
Warrants exercised		—		—
Warrants forfeited		—		—
Outstanding, March 31, 2026		1,152,833	$	0.0016

12. Stock-based Compensation

Stock-based Compensation Expense

Total stock-based compensation expense recognized was as follows (in thousands):


	Three Months Ended March 31,
	2026		2025
Research and development	$	835	$	1,620
General and administrative		468		1,560
Total stock-based compensation	$	1,303	$	3,180

Stock Options

A summary of stock option activity for the three months ended March 31, 2026 is set forth below:


	Number of Shares Underlying Outstanding Options			Weighted Average Exercise Price		Weighted- Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Outstanding, December 31, 2025		763,464		$	40.23		8.0	$	—
Options granted		867,811		$	6.85
Options exercised		—		$	—
Options forfeited or cancelled		(48,218	)	$	62.15
Outstanding, March 31, 2026		1,583,057		$	21.27		9.0	$	—
Options exercisable, March 31, 2026		399,651		$	50.71		7.2	$	—
Vested and expected to vest, March 31, 2026		1,583,057		$	21.27		9.0	$	—

The assumptions used in the Black-Scholes option-pricing model to calculate stock-based compensation are as follows:


	Three Months Ended March 31,
	2026	2025
Fair value of common stock	$6.81 - $7.99	$12.16 - $14.4
Expected term (years)	6.02 - 6.08	6.0 - 6.1
Volatility	91.38% - 92.00%	88.28% - 88.60%
Risk free rates	3.62% - 4.06%	4.03% - 4.43%
Dividend rate	0.0%	0.0%

Restricted Stock Units (RSUs)

The summary of RSU activity and related information for the three months ended March 31, 2026 is set forth below:


	Number of Units Outstanding			Weighted Average Grant Date Fair Value
Outstanding, December 31, 2025		46,842		$	37.81
RSUs granted		50,138		$	7.04
RSUs vested		(19,555	)	$	59.57
RSUs forfeited		(2,922	)	$	23.54
Outstanding, March 31, 2026		74,503		$	11.96

Option repricing

On August 8, 2023, the board of directors approved a stock option repricing (the Option Repricing) effective on August 14, 2023 (the Effective Date) in accordance with the terms of the Company’s 2015 Stock Incentive Plan (the 2015 Plan) and Second Amended and Restated 2018 Stock Option and Incentive Plan (the 2018 Plan, and together with the 2015 Plan, the Plans). Pursuant to the Option Repricing, the exercise price of each stock option previously granted under the Plans, totaling 401,994 options, was amended to reduce the exercise price of such options to $34.24 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on the Effective Date, as updated to reflect the reverse stock split.

The repriced options otherwise retained their existing terms and conditions as set forth in the Plans and applicable award agreements. The stock option modification resulted in $4.6 million of incremental compensation cost, which was calculated using the Black-Scholes option-pricing model. Of the incremental compensation cost, less than $0.1 million and $0.1 million was recognized in the three months ended March 31, 2026 and 2025, respectively. The remaining incremental compensation cost of $0.1 million, net of the reversal of expense related to employee terminations prior to August 14, 2024, will be recognized on the straight-line basis over the remaining vesting period of the repriced options. The incremental cost is included in general and administrative expense and research and development expense on the consolidated statements of operations.

Effective August 21, 2024, the board of directors approved a rescission of the Option Repricing for certain non-employee directors of the Company. All of the affected stock options have been reverted to their original exercise price as established at the time of the grant. The Company will continue to recognize the incremental fair value from the Option Repricing for the impacted options. The compensation expense associated with the Option Repricing for these options was not material.

13. Net Loss per Share

The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data):


	Three Months Ended March 31,
	2026			2025
Net loss - basic and diluted	$	(20,244	)	$	(28,214	)
Weighted-average shares used in computing net loss per share, basic and diluted		10,744,621			5,691,965
Net loss per share, basic and diluted	$	(1.88	)	$	(4.96	)

The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the period presented because including them would have been antidilutive:


	As of March 31,
	2026		2025
Options to purchase common stock		1,583,057		1,148,156
Unvested restricted stock units		74,503		57,141
Total		1,657,560		1,205,296

14. Income Taxes

The Company recognized no income tax expense during the three and three months ended March 31, 2026 and 2025. The Company maintains a full valuation allowance against its deferred tax assets due to the Company’s history of losses as of March 31, 2026.

On July 4, 2025, the One Big Beautiful Bill Act (OBBBA), which includes a broad range of tax reform provisions, was signed into law in the United States and we continue to assess its impact. The OBBBA is not currently expected to materially impact the Company’s effective tax rate or cash flows in the current fiscal year.

15. Related Party

As of the latest public filing made by Regeneron, Regeneron owned 60,511 shares of the Company’s common stock. Regeneron became a related party in July 2019 as a result of Series B redeemable convertible preferred stock financing which was subsequently converted into common stock. For the three months ended March 31, 2026, the Company recorded no revenue from the Regeneron Agreement. See Note 9 for a discussion of the Regeneron Agreement.

16. Segment Reporting

The Company’s operations are organized and reported as a single reportable segment, which includes all activities related to the discovery, development, and commercialization of allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Company’s Chief Executive Officer, who is the chief operating decision maker (CODM), reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. This presentation is consistent with how the Company’s CODM assesses the performance of the Company and makes operating decisions on a consolidated basis. The CODM assesses performance and decides how to allocate resources based on consolidated net loss that also is reported on the consolidated statements of operations and comprehensive loss as net loss. The CODM uses consolidated net loss to monitor budget versus actual results, assess cash runway, and benchmark against the Company’s competitors. The measure of segment assets is reported on the consolidated balance sheets as total assets. The Company’s assets are primarily held in the United States.

The following table sets forth the Company’s segment information (in thousands):


	Three Months Ended March 31,
	2026			2025
External program expenses for product candidates
Prula-cel	$	2,046		$	3,368
ADI-270		369			1,366
ADI-212		948			68
Total external program expenses for product candidates		3,363			4,802
Non-program specific expenses(1)		3,015			2,675
Personnel-related expenses (including non-cash stock-based compensation)(2)		9,526			14,793
Depreciation		1,342			1,680
Professional services and consulting fees		1,693			2,264
Facilities and infrastructure expenses		1,781			2,226
Other segment expense(3)		850			1,445
Interest income		(1,342	)		(1,683	)
Other expense, net(4)		16			12
Income tax provision		—			—
Segment net loss	$	20,244		$	28,214

(1)

Relates to platform research and development expenses which are not attributed to specific programs.

(2)

Relates to personnel-related expenses including non-cash stock-based compensation for the three months ended March 31, 2026 and 2025 of $1.3 million and $3.2 million, respectively.

(3)

Relates to other expenses primarily for software subscriptions and licenses, office expenses, travel and entertainment, director compensation and recruiting fees.

(4)

Consists of interest expense and other expenses.

17. Restricted Cash

As of March 31, 2026, the Company maintained letters of credit of $2.9 million, which are collateralized with bank accounts at financial institutions in accordance with the agreements. The letters of credit are included within restricted cash on the Company's consolidated balance sheets. Total restricted cash as of March 31, 2026 and December 31, 2025 consisted of the following (in thousands):


	March 31, 2026		December 31, 2025
Redwood City, CA lease(1)	$	2,306	$	2,306
Boston, MA lease		263		266
Corporate credit card services		300		300
Total	$	2,869	$	2,872

(1)

Includes the Company's lease at 1000 Bridge Parkway and 1200 Bridge Parkway.

18. Subsequent Events

In April 2026, the Company entered into an exchange agreement with RA Capital Management, L.P. and RA Capital Healthcare Fund, L.P. (together, RA Capital), pursuant to which RA Capital exchanged 250,000 shares of the Company's common stock, par value $0.0001 per share, for a pre-funded warrant to acquire 250,000 shares of the Company's common stock. The 250,000 shares of common stock subject to the exchange agreements were retired on the date of the exchange.

The pre-funded warrant has an exercise price of $0.0001 per underlying share. The exercise price and the number of shares of common stock issuable upon exercise of the pre-funded warrant is subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock. The pre-funded warrant is exercisable from the date of issuance by means of a cashless exercise. Under the pre-funded warrant, the Company may not effect the exercise of the pre-funded warrant, and a holder will not be entitled to exercise any portion of the pre-funded warrant that, upon giving effect to such exercise, would cause: (i) the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates) to exceed 9.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise, or (ii) the combined voting power of the Company’s securities beneficially owned by the holder (together with its affiliates) to exceed 9.99% of the combined voting power of all of the Company’s securities then outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrant, unless such percentage is increased upon at least 61 days’ prior notice, but not in excess of 19.99%.

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

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and related footnotes included in our Annual Report on Form 10-K for the year ended December 31, 2025. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, such as our plans, objectives, expectations, intentions and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section entitled “Risk Factors” included elsewhere in this Quarterly Report on Form 10-Q, as supplemented by our subsequent filings with the SEC.

Overview

We are a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. We are advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients.

Our approach to activate, engineer and manufacture allogeneic gamma delta T cell product candidates derived from the peripheral blood cells of unrelated donors allows us to generate new product candidates in a rapid and cost-efficient manner. Our allogeneic "off-the-shelf" manufacturing process is designed to allow product from unrelated donors to be stored and sold on demand to treat patients without inducing a graft versus host immune response. This is in contrast to products based on alpha beta T cells, which either must be manufactured for each patient from his or her own T cells, or require significant gene editing to manufacture if the T cells are derived from donors that are unrelated to the patient.

Our lead product candidate, prula-cel, a first-in-class allogeneic gamma delta T cell therapy expressing a CAR targeting CD20, is being developed for the potential treatment of autoimmune diseases. We are also pursuing ADI-212, a next-generation gene-edited and armored clinical candidate designed to target prostate-specific membrane antigen (PSMA). ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and to deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. We aim to submit a new regulatory submission, such as an Investigational New Drug (IND) application or equivalent every 12-18 months.

Prula-cel

We are advancing patient enrollment in our Phase 1 program of prula-cel across multiple autoimmune diseases. In December 2023, the U.S. Food and Drug Administration (FDA) cleared our IND application for prula-cel in lupus nephritis (LN) and has subsequently authorized the evaluation of prula-cel in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM) and stiff person syndrome (SPS) within the Company’s Phase 1 clinical trial. In November 2025, we reached alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials. Prula-cel has received Fast Track Designation by the FDA for the potential treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement and for SSc.

We believe the favorable safety profile, cellular kinetics and B cell depletion in peripheral blood and secondary lymphoid tissue demonstrated with prula-cel clinical experience to date is favorable for development in autoimmune diseases. We believe the potential market opportunity for prula-cel in B cell mediated autoimmune diseases is substantial based on the prevalence in the U.S., EU5, China and Japan of greater than 1.7 million patients with autoimmune diseases where CAR-T cell therapy has demonstrated clinical proof-of-concept, including SLE (which includes LN), SSc, IIM and SPS.

In October 2025, we announced positive preliminary results from seven SLE and LN patients dosed in our ongoing Phase 1 trial of prula-cel in autoimmune diseases as of the August 31, 2025 data cut-off date. We plan to meet with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, we expect to initiate start up activities for a potential pivotal program in LN or LN and SLE patients in the second half of 2026. We plan to provide a clinical update for this trial in LN and SLE patients in mid-2026, including data from at least 20 patients with a

minimum of six months of follow up, with an additional update in the second half of 2026. We expect to provide a clinical update in patients with SSc in the second half of 2026.

We are also advancing a Phase 1 trial of prula-cel in patients with treatment-refractory rheumatoid arthritis (RA). The study is evaluating prula-cel using two conditioning regimens: cyclophosphamide alone and cyclophosphamide with fludarabine, to explore the potential to reduce the need for conditioning. We plan to provide a clinical update on this trial in the second half of 2026.

ADI-212

We are advancing ADI-212, a next-generation gene-edited and armored clinical candidate designed to target prostate-specific membrane antigen. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 (mbIL-12) armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. We expect to submit a regulatory filing for ADI-212 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the third quarter of 2026. Subject to regulatory clearance to proceed with a clinical trial, we plan to initiate patient enrollment in the fourth quarter of 2026. We believe the potential market opportunity for ADI-212 in mCRPC is significant based on the prevalence in the U.S., EU5, China and Japan of approximately 75,000 patients with second or third line advanced disease.

Additional Early-Stage Programs (CAR and Other Technologies)

Our pipeline also includes additional early-stage gamma delta T cell therapy programs for autoimmune diseases, hematological malignancies and solid tumors. Additionally, we have ongoing preclinical programs and activities focused on a differentiated in vivo CAR-T platform targeting heme malignancies.

Financial Operations Overview

Revenue

We have no products approved for commercial sale and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for our product candidates, which we expect will not be for at least several years, if ever.

Expenses

Research and Development

Research and development expenses, which consist primarily of costs incurred in connection with the development of our product candidates, are expensed as incurred. Research and development expenses consist primarily of:

•

employee related costs, including salaries, benefits and stock-based compensation expenses for research and development employees;

•

costs incurred under agreements with consultants, contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs);

•

lab materials, supplies and maintenance of equipment used for research and development activities; and

•

allocated facility-related costs, such as rent, utilities, insurance, repairs and maintenance, depreciation and amortization, information technology costs and general support services.

We allocate our external costs by product candidate. We do not allocate our internal costs by product candidate as a significant amount of internal research and development expenses are not tracked by product candidate, and we believe the allocation of such costs would be arbitrary and would not provide a meaningful assessment as we have used our employee and infrastructure resources across multiple product candidate research and development programs.

We are focusing substantially all of our resources on the development of our product candidates. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to predict when, if ever, material net cash inflows will

commence from sales of our product candidates. The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including:

•

the scope, rate of progress and expense of clinical trials and other research and development activities;

•

clinical trial results;

•

uncertainties in clinical trial enrollment rate or design;

•

significant and changing government regulation;

•

the timing and receipt of any regulatory approvals;

•

the FDA’s or other regulatory authority’s influence on clinical trial design;

•

establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;

•

expenses incurred in connection with our license and collaboration agreements, including license payments, program expenses and milestone obligations payable by us;

•

commercializing product candidates, if and when approved, whether alone or in collaboration with others;

•

obtaining and maintaining patent and trade secret protection and regulatory exclusivity for product candidates;

•

continued applicable safety profiles of the products following approval; and

•

retention of key research and development personnel.

A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans.

Adequate funding may not be available to us on acceptable terms or at all. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. If we are unable to raise additional funds when needed, we may be required to delay, reduce or terminate some or all of our development programs and clinical trials or we may also be required to sell or license to other rights to our product candidates in certain territories or indications that we would prefer to develop and commercialize ourselves. If we are required to enter into collaborations and other arrangements to supplement our funds, we may have to give up certain rights that limit our ability to develop and commercialize our product candidates or may have other terms that are not favorable to us or our stockholders, which could materially affect our business and financial condition.

General and Administrative

General and administrative expenses consist principally of payroll and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and tax services, allocated overhead expenses, including rent, equipment, depreciation, information technology costs and utilities, and other general operating expenses not otherwise classified as research and development expenses.

We anticipate that our general and administrative expenses will increase for the foreseeable future due to expenses related to operating as a public company, including expenses related to personnel costs, expanded infrastructure and higher consulting, legal and accounting services costs associated with complying with the applicable Nasdaq and SEC requirements, investor relations costs and director and officer insurance premiums.

Interest Income

Interest income consists primarily of interest earned on our cash, cash equivalents, restricted cash and short-term investments in treasury securities.

Interest Expense

Interest expense consists primarily of interest on finance lease liabilities.

Other Expense, Net

Other expense, net primarily consists of state franchise and capital taxes not related to income.

Results of Operations

Comparison of the Three Months Ended March 31, 2026 and 2025

The following table summarizes our results of operations for the periods indicated (in thousands, except percentages):


	Three Months Ended March 31,
	2026			2025			Change			% Change
Operating expenses
Research and development	$	17,487		$	22,814		$	(5,327	)		(23	%)
General and administrative		4,083			7,071			(2,988	)		(42	%)
Total operating expenses		21,570			29,885			(8,315	)		(28	%)
Loss from operations		(21,570	)		(29,885	)		(8,315	)		(28	%)
Interest income		1,342			1,683			(341	)		(20	%)
Interest expense		(23	)		—			23			0	%
Other expense, net		7			(12	)		(19	)		(158	%)
Loss before income tax benefit		(20,244	)		(28,214	)		(7,970	)		(28	%)
Income tax provision		—			—			—			0	%
Net loss	$	(20,244	)	$	(28,214	)	$	(7,970	)		(28	%)

Research and development


	Three Months Ended March 31,
	2026		2025
Payroll and personnel expenses(1)	$	7,152	$	10,791
Costs incurred under agreements with consultants, CDMOs, and CROs		3,391		3,901
Lab materials, supplies and maintenance of equipment used for research and development activities		1,593		2,956
Other research and development expenses(2)		5,351		5,166
Total research and development expenses	$	17,487	$	22,814

(1) Employee related costs, including salaries, benefits, bonuses, and stock-based compensation expenses for research and development employees.

(2) Professional fees and allocated facility-related costs, such as rent, utilities, insurance, repairs and maintenance, depreciation and amortization, information technology costs and general support services.

Research and development expenses decreased by $5.3 million, or 23%, during the three months ended March 31, 2026 as compared to the same period in 2025. The decrease in research and development expenses was primarily due to a $3.6 million decrease in payroll and personnel expenses due to lower headcount, a $1.4 million decrease in expenses related to lab supplies and materials, a $0.5 million decrease related to lower CRO expenses and a $0.2 million decrease in allocated facility-related expenses. The decrease was partially offset by a $0.4 million increase in professional fees.

General and administrative

General and administrative expenses decreased by $3.0 million, or 42%, during the three months ended March 31, 2026 as compared to the same period in 2025. The decrease in general and administrative expenses was due to a decrease in payroll and personnel related expenses of $1.4 million primarily related to a decrease in stock-based compensation and lower headcount, a $1.0 million decrease in allocated facility-related expenses and a $0.6 million decrease in professional fees.

Interest income

Interest income decreased by $0.3 million, or 20% during the three months ended March 31, 2026 as compared to the same period in 2025, which was primarily due to lower interest rates and lower cash balances for the period.

Other expense, net

Other expense, net decreased by less than $0.1 million, or 158%, during the three months ended March 31, 2026 as compared to the same period in 2025. This was due to a decrease in state franchise taxes and realized losses related to foreign exchange rates.

Liquidity and Capital Resources

Sources of Liquidity

We have historically funded our operations primarily through a collaboration and licensing arrangement, public and private placements of equity securities and debt, and cash received in our merger with resTORbio, Inc.

In January 2024, we raised aggregate net proceeds of approximately $19.3 million through the JonesTrading ATM Program. In March 2024, we terminated the JonesTrading ATM Program and entered into the Jefferies ATM Program. As of March 31, 2026, no shares of common stock have been sold through the Jefferies ATM Program.

On January 22, 2024, we entered into an underwriting agreement (the Underwriting Agreement) with Jefferies LLC (Jefferies) and Guggenheim Securities, LLC (Guggenheim), as representatives of the underwriters, related to an underwritten public offering (the Offering) of shares of our common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of our common stock. We received net proceeds from the Offering, after deducting the underwriting discount and commissions and other estimated offering expenses, of approximately $91.7 million. We may receive nominal proceeds, if any, from the exercise of the pre-funded warrants.

On October 7, 2025, we entered into an underwriting agreement with Jefferies and Guggenheim, as representatives of the underwriters, related to an underwritten registered direct offering (the 2025 Offering) of shares of our common stock, and, in lieu of our common stock to an investor, pre-funded warrants to purchase shares of our common stock. We received net proceeds from the 2025 Offering, after deducting the underwriting discount and commissions and other estimated offering expenses, of approximately $74.8 million. We may receive nominal proceeds, if any, from the exercise of the 2025 Pre-Funded Warrants.

As of March 31, 2026, we had cash, cash equivalents and short-term investments of $137.6 million and restricted cash of $2.9 million held in cash collateral accounts. We expect that our cash, cash equivalents and short-term investments will be sufficient to fund our forecasted operating expenses, capital expenditure requirements and debt service payments for at least the next twelve months from the issuance of our unaudited consolidated financial statements included in this Quarterly Report on Form 10-Q.

Future Funding Requirements

We have incurred losses since inception and have incurred losses of $20.2 million and $28.2 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $634.9 million.

As of March 31, 2026, we had cash, cash equivalents, and short-term investments in treasury securities of $137.6 million. We believe that our cash, cash equivalents and short-term investments in treasury securities will be sufficient for us to fund our operations for at least twelve months from the issuance date of our unaudited consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. We have based these estimates on assumptions that may prove to be wrong, and we could deplete our available capital resources sooner than we expect. Because of the risks and uncertainties associated with research, development, and commercialization of product candidates, we are unable to estimate the exact amount of our working capital requirements.

All of our revenue to date has been generated from a collaboration and license agreement (the Regeneron Agreement) with Regeneron Pharmaceuticals, Inc, (Regeneron). We do not expect to generate any significant product revenue until we obtain regulatory approval of and commercialize any of our product candidates or enter into additional collaborative agreements with third parties, and we do not know when, or if, either will occur. We expect to continue to incur significant losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates and begin to commercialize any approved products. We are subject to all of the risks typically related

to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. We may seek to raise capital through private or public equity or debt financings, collaborative or other arrangements with corporate sources, or through other sources of financing. We anticipate that we will need to raise substantial additional capital, the requirements for which will depend on many factors, including:

•

the scope, timing, rate of progress and costs of our drug discovery efforts, preclinical development activities, laboratory testing and clinical trials for our product candidates;

•

the timing, number and scope of clinical programs we decide to pursue;

•

the cost, timing and outcome of preparing for and undergoing regulatory review of our product candidates;

•

the scope and costs of development and commercial manufacturing activities;

•

the cost and timing associated with commercializing our product candidates, if they receive marketing approval;

•

the extent to which we acquire or in-license other product candidates and technologies;

•

the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

•

our ability to establish and maintain collaborations on favorable terms, if at all;

•

our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our product candidates and, ultimately, the sale of our products, following FDA approval;

•

our implementation of operational, financial and management systems;

•

the impact of potential health emergencies on United States and global economic conditions that may impact our ability to access capital on terms anticipated, or at all; and

•

the post-merger costs associated with being a public company.

Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials or we may also be required to sell or license to other rights to our product candidates in certain territories or indications that we would prefer to develop and commercialize ourselves. If we are required to enter into collaborations and other arrangements to supplement our funds, we may have to give up certain rights that limit our ability to develop and commercialize our product candidates or may have other terms that are not favorable to us or our stockholders, which could materially affect our business and financial condition.

See the section of this Quarterly Report on Form 10-Q titled “Risk Factors” for additional risks associated with our substantial capital requirements.

Summary Statement of Cash Flows

The following table sets forth the primary sources and uses of our cash and cash equivalents for each of the periods presented below (in thousands):


	Three Months Ended March 31,
	2026			2025
Net cash provided by (used in):
Operating activities	$	(21,490	)	$	(25,397	)
Investing activities		18,879			(2,861	)
Financing activities		(65	)		(104	)
Net decrease in cash, cash equivalents and restricted cash	$	(2,676	)	$	(28,362	)

Cash Flows from Operating Activities

Net cash used in operating activities was $21.5 million for the three months ended March 31, 2026. Cash used in operating activities consisted of net loss partially offset by non-cash adjustments of $2.6 million, and a net decrease in operating assets and liabilities of $3.8 million. Non-cash items primarily included depreciation and amortization of $1.3 million, stock-based compensation expense of $1.3 million, non-cash lease expense of $0.7 million and a net amortization of premiums and accretion discounts on investments of $0.8 million. The net change in assets and liabilities was primarily due to a decrease in accounts payable of $1.8 million, a net decrease in accrued and other current and non-current liabilities of $1.1 million, a decrease in operating lease liability of $0.8 million and a decrease in prepaid expenses of $0.1 million offset by an increase in other current assets of less than $0.1 million.

Net cash used in operating activities was $25.4 million for the three months ended March 31, 2025. Cash used in operating activities consisted of net loss partially offset by non-cash adjustments of $4.5 million and a net decrease in operating assets and liabilities of $1.7 million. Non-cash items primarily included depreciation and amortization of $1.7 million, stock-based compensation expense of $3.2 million, non-cash lease expense of $0.8 million and a net amortization of premiums and accretion discounts on investments of $1.2 million. The net change in assets and liabilities was primarily due to a net decrease in accrued and other current and non-current liabilities of $2.2 million and a decrease in operating lease liability of $1.0 million. The decrease in operating assets and liabilities was partially offset by a $0.8 million increase in prepaid expenses and other current assets and a $0.6 million increase in accounts payable.

Cash Flows from Investing Activities

Net cash provided by investing activities was $18.9 million for the three months ended March 31, 2026, which consisted of $39.0 million related to maturities of short-term treasury securities, net of $20.1 million of purchases of short-term treasury securities and less than $0.1 million of purchases of lab equipment and leasehold improvements for our Good Manufacturing Practice (GMP) cell processing suite at 1000 Bridge Parkway.

Net cash used in investing activities was $2.9 million for the three months ended March 31, 2025, which consisted of $34.4 million of purchases of short-term treasury securities and $1.5 million of purchases of lab equipment and leasehold improvements for our Good Manufacturing Practice (GMP) cell processing suite at 1000 Bridge Parkway. We received $33.0 million related to the maturities of short-term treasury securities.

Cash Flows from Financing Activities

Net cash used by financing activities was $0.1 million for the three months ended March 31, 2026 and March 31, 2025 and consisted of $0.1 million cash paid for taxes withheld on the net share settlement of equity awards for both years.

Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, the reported amounts of revenues and expenses during the reported periods and related disclosures. These estimates and assumptions, including those related to accruals for CDMO, CRO and research and development expenses, and equity-based compensation are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur

in the future. These critical estimates and assumptions are based on our historical experience, our observance of trends in the industry, and various other factors that are believed to be reasonable under the circumstances and form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from our estimates under different assumptions or conditions. A summary of our significant accounting policies is contained in Note 2 of our unaudited consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. There have been no material changes in our critical accounting policies from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 12, 2026.

Smaller Reporting Company

We are a “smaller reporting company” as defined in the Exchange Act. As a smaller reporting company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable, in general, to public companies that are not smaller reporting companies. These provisions include (i) not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes Oxley Act of 2002, as amended; (ii) scaled executive compensation disclosures; and (iii) the option to provide only two years of audited financial statements, instead of three years.

We will continue to be a smaller reporting company for as long as we continue to have (i) less than $250 million in market value of our shares held by non-affiliates as of the last business day of our second fiscal quarter or (ii) less than $100 million of annual revenues in our most recent fiscal year completed before the last business day of our second fiscal quarter and a market value of our shares held by non-affiliates of less than $700 million as of the last business day of our second fiscal quarter.

We may choose to take advantage of some but not all of these exemptions. Accordingly, the information contained herein may be different from the information you receive from other public companies in which you hold stock. We have elected to avail ourselves of the exemption for the delayed adoption of certain accounting standards and, therefore, are not subject to the same new or revised accounting standards as other public companies that are not smaller reporting companies.

Recently Issued and Adopted Accounting Pronouncements

See the section titled “Summary of Significant Accounting Policies” in Note 2 to our unaudited consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Interest Rate Risk

As of March 31, 2026, we had cash, cash equivalents and short-term investments in treasury securities of $137.6 million, which consisted of cash and funds invested in treasury securities and money market funds. Interest income is sensitive to general level of interest rates; however, due to the nature of these investments, an immediate 10% change in interest rates would not have a material impact on our cash, cash equivalents and short-term investments in treasury securities, financial position, or results of operations.

Foreign Currency Exchange Risk

Our headquarters are located in the United States, where a majority of our general and administrative expenses and research and development costs are incurred in U.S. Dollars. As we grow our business, our results of operations and cash flows may be subject to fluctuations due to foreign currency exchange rates. To date, we do not believe foreign currency exchange rate fluctuations have had a significant impact on our results of operations for any periods presented herein.

Inflation Risk

Our assets are primarily monetary, consisting of cash, cash equivalents and short-term investments in treasury securities. Because of their liquidity, these assets are not directly affected by inflation. Since we intend to retain and continue to use our equipment, furniture, fixtures and office equipment, computer hardware and software and leasehold improvements, we believe that the incremental inflation related to replacement costs of such items will not materially affect our operations. Inflation generally affects us by increasing our cost of labor, clinical trial and manufacturing costs. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the three months ended March 31, 2026.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act)) are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act, such as this report, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to our management, including the Chief Executive Officer (CEO) and Chief Financial Officer (CFO), as appropriate to allow timely decisions regarding required disclosure. As of March 31, 2026, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) and concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

There are inherent limitations to the effectiveness of any system of disclosure controls and procedures. These limitations include the possibility of human error, the circumvention or overriding of the controls and procedures and reasonable resource constraints. In addition, because we have designed our system of controls based on certain assumptions, which we believe are reasonable, about the likelihood of future events, our system of controls may not achieve its desired purpose under all possible future conditions. Accordingly, our disclosure controls and procedures provide reasonable assurance, but not absolute assurance, of achieving their objectives.

Changes in Internal Control over Financial Reporting

No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the quarter ended March 31, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

We are not currently subject to any material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Although the results of litigation and claims cannot be predicted with certainty, as of the date of this report, we do not believe we are party to any claim or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

Item 1A. Risk Factors.

Investing in our common stock involves a high degree of risk. Careful consideration should be given to the following risk factors, in addition to the other information set forth in this Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, our Annual Report on Form 10-K for the year ended December 31, 2025, and in other documents that we file with the U.S. Securities and Exchange Commission (SEC), in evaluating us and our business. If any of the following risks and uncertainties actually occurs, our business, prospects, financial condition and results of operations could be materially and adversely affected. The risks described below are not intended to be exhaustive and are not the only risks facing us. New risk factors can emerge from time to time, and it is not possible to predict the impact that any factor or combination of factors may have on our business, prospects, financial condition and results of operations.

The risk factors denoted with a "*", if any, are newly added or have been materially updated from our Annual Report on Form 10-K for the year ended December 31, 2025.

Risks Related to Our Business and Industry

Risks Related to Operating History

We have a limited operating history and face significant challenges and expenses as we build our capabilities.

Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We began operations in November 2014. We have a limited operating history upon which someone can evaluate our business and prospects and is subject to the risks inherent in any early stage company, including, among other things, risks that we may not be able to hire sufficient qualified personnel and establish operating controls and procedures. We currently do not have complete in-house resources to enable our gamma delta T cell platform. As we build our own capabilities, we expect to encounter risks and uncertainties frequently experienced by growing companies in new and rapidly evolving fields, including the risks and uncertainties described herein. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing biopharmaceutical products.

We have incurred net losses since our inception and anticipate that we will incur substantial net losses in the future.

We are an early clinical stage biopharmaceutical company. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. We have no products approved for commercial sale and have not generated any revenue from product sales to date, and we will continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred net losses since our inception. To date, we have financed our operations primarily with proceeds from our license and collaboration agreements and the issuance and sale of our capital stock, including most recently: (i) net proceeds of approximately $19.3 million, after deducting sales agent commissions, but before deducting any expenses related to such sales, from sales of our common stock under our “at-the-market” program in January 2024; (ii) net proceeds of approximately $91.7 million, after deducting the underwriting discount and commissions and other estimated offering expenses, from the sale of our common stock and pre-funded warrants in an underwritten public offering in January 2024; and (iii) net proceeds of approximately $74.8 million, after deducting the underwriting discount and commissions and other estimated offering expenses, from the sale of our common stock and pre-funded warrants in an underwritten registered direct offering in October 2025. For the three months ended March 31, 2026, we recorded net loss of $20.2 million. As of March 31, 2026, we had an accumulated deficit of $634.9 million.

We expect to incur significant expenditures for the foreseeable future, and we expect these expenditures to increase as we continue our research and development of, and seek regulatory approvals for, product candidates based on our gamma delta T cell platform, including prula-cel and ADI-212. Even if we succeed in commercializing one or more of our product candidates,

we will continue to incur substantial research and development and other expenditures to develop and market additional product candidates. In addition, certain of our existing license and collaboration agreements require cash payments upon the achievement of milestone events, royalties and profit-sharing, or other cash payments. These payment obligations, in addition to any payment obligations we may have under future arrangements with third parties, may have a substantial impact on our business, financial condition and profitability.

In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital. Further, even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product candidates or even continue our operations, any of which could have a material adverse effect on our business, financial condition, results of operations, and prospects and cause investors to lose all or part of their investments.

Risks Related to Our Product Candidates

Our business is highly dependent on the success of prula-cel. If we are unable to obtain regulatory approval for prula-cel in one or more indications and effectively commercialize this product candidate for the treatment of patients in indications for which we receive approval (if any), our business would be significantly harmed.

Our business and future success depends on our ability to obtain regulatory approval of, and then successfully commercialize prula-cel, our most advanced product candidate. In November 2024, we dosed our first LN patient in our Phase 1 clinical study of prula-cel in autoimmune diseases and subsequently expanded enrollment to include patients with SLE, SSc, IIM, SPS and AAV. We are also advancing a Phase 1 study of prula-cel in patients with treatment-refractory rheumatoid arthritis (RA).

Our preclinical results or clinical results to date may not predict results for our planned or ongoing trials or any future studies of prula-cel, ADI-212, or any other product candidates. Because of the lack of evaluation of allogeneic products and gamma delta T cell therapy products in the clinic to date, any such product’s failure, or the failure of other allogeneic T cell therapies or gamma delta T cell therapies, may significantly influence physicians’ and regulators’ opinions in regards to the viability of our entire pipeline of allogeneic T cell therapies, which could have a material adverse effect on our reputation. If our gamma delta T cell therapy is viewed as less safe or effective than autologous therapies or other allogeneic T cell therapies, our ability to develop other allogeneic gamma delta T cell therapies may be significantly harmed.

All of our product candidates, including prula-cel and ADI-212, will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. In addition, because prula-cel is our most advanced product candidate, and because our other product candidates are based on similar technology, if prula-cel encounters safety or efficacy problems, manufacturing problems, developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed, which could have a material adverse effect on our business, reputation and prospects.

Our gamma delta T cell candidates represent a novel approach to the treatment of autoimmune diseases and cancer indications that create significant challenges for us.

We are developing a pipeline of gamma delta T cell product candidates and a novel antibody platform that are intended for use in patients with certain autoimmune diseases and cancers. Advancing these novel product candidates creates significant challenges for us, including:

•

negative or inconclusive results from our clinical trials, preclinical studies or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional clinical trials or preclinical studies or abandon a program;

•

delays in enrolling or inability to enroll subjects in our clinical trials;

•

manufacturing our product candidates to our specifications and in a timely manner to support our current and future clinical trials, and, if approved, commercialization;

•

sourcing current and future clinical and, if approved, commercial supplies for the raw materials used to manufacture our product candidates;

•

understanding and addressing variability in the quality of a donor’s T cells, which could ultimately affect our ability to produce product in a reliable and consistent manner;

•

inability to achieve efficacy in autoimmune disease and cancer patients following treatment with our product candidates;

•

achieving a side effect profile from our product candidates in autoimmune diseases and cancer indications that makes them clinically and commercially attractive for further development;

•

educating medical personnel regarding the potential side effect profile of our product candidates, if approved;

•

using medicines to manage adverse side effects of our product candidates which may not adequately control the side effects and/or may have a detrimental impact on the efficacy of the treatment;

•

conditioning patients with chemotherapy or other lymphodepletion agents in advance of administering our product candidates, which may increase the risk of adverse side effects;

•

obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with development of allogeneic T cell therapies for autoimmune diseases and cancer; and

•

establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy.

The success of our business, including our ability to obtain financing and generate any revenue in the future, will primarily depend on the positive efficacy and safety profile and durability of our product candidates in our clinical trials, regulatory approval, successful development and commercialization of our novel product candidates, and our ability to build out our manufacturing capabilities, any of which may never occur. We have not yet succeeded and may not succeed in demonstrating efficacy and safety or durability for any of our product candidates in clinical trials or in obtaining marketing approval thereafter. Given our early stage of development, it may be several years, if at all, before we have demonstrated the safety and efficacy of a product candidate sufficient to warrant approval for commercialization. If we are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize our product candidates, we may not be able to generate sufficient revenue to continue our business, which could have a material adverse effect on our results of operations and prospects.

We have concentrated our development efforts on our allogeneic gamma delta T cell therapy and our near-term success depends on the successful development of this therapeutic approach. We are in the early stages of developing our platform and product candidates and there can be no assurance that any development problems we have experienced or may experience in the future will not cause significant delays or result in unforeseen issues or unanticipated costs, or that any such development problems or issues can be overcome. We may also experience delays in developing a sustainable, reproducible and scalable manufacturing process or transferring that process to commercial partners, which may prevent us from completing our future clinical studies or commercializing our products on a timely or profitable basis, if at all. In addition, our expectations with regard to the advantages of an allogeneic gamma delta T cell therapy platform relative to other therapies may not materialize or materialize to the degree we anticipate. Further, our scalability and costs of manufacturing may vary significantly as we develop our product candidates and understand these critical factors.

In addition, the clinical study requirements of the FDA, the European Medicines Agency (EMA) and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate are determined according to the type, complexity, novelty and intended use and market of the potential products. The regulatory approval process for novel product candidates such as ours can be more complex and consequently more expensive and take longer than for other, better known or extensively studied pharmaceutical or other product candidates. Allogeneic gamma delta T cell therapies are novel therapies, with no T cell therapies licensed to date in the United States or the European Union to treat autoimmune diseases. Approvals by the EMA and FDA for existing autologous CAR T cell therapies, such as Kymriah® and Yescarta®, as well as other pathways to approval, may not be indicative of what these regulators may require for approval of our therapies. Also, while we expect reduced variability in our product candidates compared to autologous products, we do not have significant clinical data supporting any benefit of lower variability. More generally, approvals by any regulatory agency may not be indicative of what any other regulatory agencies may require for approval or what such regulatory agencies may require for approval in connection with new product candidates.

Our product candidates may also not perform successfully in clinical trials or may be associated with adverse events that distinguish them from the autologous CAR T-cell therapies that have previously been approved or alpha beta T cell therapies

that may be approved in the future. Unexpected clinical outcomes could materially and adversely affect our business, results of operations and prospects.

Our product candidates may cause undesirable side effects or have other properties that could halt our clinical development, prevent our regulatory approval, limit our commercial potential or result in significant negative consequences.

Undesirable or unacceptable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA or other comparable foreign regulatory authorities. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Approved autologous CAR T-cell therapies and those under development have shown frequent rates of cytokine release syndrome and neurotoxicity, and adverse events have resulted in the death of patients. In January 2024, the FDA determined that new boxed warning language related to T-cell malignancies should be included in the labeling for all BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. While we believe our gamma delta T cell approach may lessen such results, similar or other adverse events for our allogeneic gamma delta T cell product candidates may occur and could result in increased government regulation, unfavorable public perception and publicity, potential impacts on enrollment in our clinical trials, potential regulatory delays in the testing or approval of our product candidates, stricter labeling requirements for those product candidates that are approved, and a decrease in demand for any such product candidates. In addition, while we anticipate our focus on gamma delta T cells may lessen the likelihood of graft versus host disease relative to therapies relying on unrelated alpha beta T cells, similar or other adverse events for our allogeneic gamma delta T cell product candidates may occur.

If unacceptable toxicities arise in the development of our product candidates (or third-party product candidates utilizing similar technologies), we could suspend or terminate our trials or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications. A data safety monitoring board may also suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials. Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Novel therapeutic candidates, such as those we are developing, may result in novel side effect profiles that may not be appropriately recognized or managed by the treating medical staff. We anticipate having to train medical personnel using our product candidates to understand the side effect profile of our product candidates for our clinical trials and upon any commercialization of any of our product candidates. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in serious adverse events including patient deaths. Based on available preclinical data and clinical experience with other cell therapy agents, the safety profile of our pipeline product candidates is expected to include cytokine release syndrome, neurotoxicity, and possibly additional adverse events. Any of these occurrences may have a material adverse effect our business, financial condition and prospects.

In addition to side effects and adverse events caused by any product candidates we may develop, the conditioning, administration process or related procedures that may be used with our product candidates may also cause adverse side effects. A T cell therapy patient is generally administered cytotoxic drugs to remove stem cells from the bone marrow to create sufficient space in the bone marrow for the modified stem cells to engraft and produce new cells. This procedure causes side effects and, among other potential risks, can transiently compromise the patient’s immune system, known as neutropenia, and reduce blood clotting, known as thrombocytopenia. If we are unable to demonstrate that such adverse events were caused by the conditioning regimens used, administration process or related procedure, or were otherwise unrelated to the therapy candidate being studied, the FDA, the EMA or other regulatory authorities could order us to cease further development of, or deny approval of, any product candidates we may develop for any or all target indications. Even if we are able to demonstrate that adverse events are not related to our product candidate, such occurrences could affect patient recruitment, the ability of enrolled patients to complete the clinical trial or the commercial viability of any product candidates that obtain regulatory approval.

If we are required by the FDA to obtain approval of a companion diagnostic in connection with approval of any of our product candidates and we do not obtain, or face delays in obtaining, FDA approval of such companion diagnostic, we will not be able to commercialize such product candidate and our ability to generate revenue will be materially impaired.

If the FDA believes that the safe and effective use of any of our product candidates depends on an in vitro diagnostic, then it may require approval or clearance of that diagnostic as a companion diagnostic at the same time that the FDA approves our product candidates, if at all. According to FDA guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product or indication, the FDA generally will not approve the therapeutic product or new therapeutic product indication if the companion diagnostic is not also approved or cleared for that indication. Depending on the data from our clinical trials, we may decide to collaborate with diagnostic companies during our clinical trial enrollment process to help identify patients with characteristics that we believe will be most likely to respond to our product candidates. If a satisfactory companion diagnostic is not commercially available in this situation, we may be required to develop or obtain such test, which would be subject to regulatory approval requirements. The process of obtaining or creating such diagnostic is time consuming and costly.

Companion diagnostics are developed in conjunction with clinical programs for the associated product and are subject to regulation as medical devices by the FDA and comparable foreign regulatory authorities. In January 2024, FDA announced its intention to initiate the reclassification process for most in vitro diagnostics, including companion diagnostics. Further, FDA indicated that in addition to the reclassification process, FDA will continue taking a risk-based approach in the initial classification of individual in vitro diagnostics to determine whether a new test may be classified into class II through the de novo classification process. In so doing, FDA indicated that it may regulate most future companion diagnostics as class II devices. The approval or clearance of a companion diagnostic as part of the therapeutic product’s further labeling limits the use of the therapeutic product to only those patients who express the specific characteristic that the companion diagnostic was developed to detect.

If the FDA or a comparable foreign regulatory authority requires approval or clearance of a companion diagnostic for any of our product candidates, whether before or after the product candidate obtains regulatory approval, we and/or third-party collaborators may encounter difficulties in developing and obtaining approval or clearance for these companion diagnostics. Any delay or failure by us or third party collaborators to develop or obtain regulatory approval or clearance of a companion diagnostic could delay or prevent approval or continued marketing of the relevant product. We or our collaborators may also experience delays in developing a sustainable, reproducible and scalable manufacturing process for the companion diagnostic or in transferring that process to commercial partners or negotiating insurance reimbursement plans, any of which may prevent us from completing our clinical trials or, if approved, commercializing our product candidates on a timely or profitable basis, if at all.

Risks Related to Clinical Trials

Our clinical trials may fail to demonstrate the safety and efficacy of any of our product candidates, which would prevent or delay regulatory approval and commercialization.

Before obtaining regulatory approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe and effective for use in each target indication. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials.

There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy, insufficient durability of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that commence clinical trials are never approved.

In addition, for the ongoing Phase 1 study of prula-cel and any future clinical trials that may be completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit marketing applications for our product candidates. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates. Any of the foregoing could have a material adverse effect on our business, prospects and financial condition.

We may not be able to file IND applications, or comparable regulatory submissions outside the United States, to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA or analogous regulatory authorities may not permit us to proceed.

We have received clearance for INDs to evaluate prula-cel in clinical trials in a number of indications. Our pipeline also includes ADI-212, an optimized next-generation gene-edited and armored clinical candidate targeting prostate specific membrane antigen (PSMA). We expect to submit a regulatory filing for ADI-212, such as an IND application or comparable regulatory submission outside the United States, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the third quarter of 2026 with Phase 1 enrollment anticipated to start in the fourth quarter of 2026 pending regulatory clearance. We aim to submit a new regulatory submission, such as an IND application or equivalent every 12-18 months. We may not be able to make these filings on the timelines we expect, which may cause delays in commencing additional clinical trials. Even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND application or clinical trial application, we cannot guarantee that such regulatory authorities will not change their requirements in the future. Moreover, we cannot be sure that submission of an IND application for any of our other product candidates will result in the FDA allowing trials to begin, or that, once begun, issues will not arise that result in a decision by us, by independent institutional review boards (IRBs) or independent ethics committees, or by the FDA, the EMA or other regulatory authorities to suspend or terminate clinical trials. For example, we may experience manufacturing delays or other delays with IND-enabling

studies or the FDA, the EMA or other regulatory authorities may require additional preclinical studies that we did not anticipate. The inability to initiate clinical trials for any of our product candidates on the timeline we currently anticipate or at all could have a material adverse effect on our business, results of operations and prospects.

We may encounter substantial delays in our clinical trials, or may not be able to conduct our trials on the timelines we expect.

Clinical testing is expensive, time consuming and subject to uncertainty. We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. Even if these trials begin as planned, issues may arise that could result in the suspension, or termination, or clinical hold of such clinical trials. A failure of one or more clinical studies can occur at any stage of testing, and our ongoing or future clinical studies may not be successful. Factors that may prevent successful or timely completion of clinical development include:

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inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation of clinical studies;

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delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for advanced clinical trials;

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delays in developing suitable assays for screening patients for eligibility for trials with respect to certain product candidates;

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delays in reaching a consensus with regulatory agencies on study design;

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obtaining regulatory authorization to begin a trial, which may include the evaluation of a companion diagnostic, if applicable;

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delays in reaching an agreement on acceptable terms with prospective contract research organizations (CROs) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical study sites;

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delays in obtaining required IRB approval at each clinical study site;

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imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND application or amendment, or equivalent application or amendment; as a result of a safety finding that presents unreasonable risk to clinical trial participants; a negative finding from an inspection of our clinical study operations or study sites; developments on trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly; or if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;

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delays in recruiting eligible patients to participate in our clinical studies;

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difficulty collaborating with patient groups and investigators;

Adicet Bio, Inc. 10-Q