ACET Adicet Bio Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 06, 2025

 

 

Adicet Bio, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-38359	81-3305277
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
131 Dartmouth Street, Floor 3
Boston, Massachusetts				02116
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 503-9095

 

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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 Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On March 6, 2025, Adicet Bio, Inc. announced its financial results for the quarter and year ended December 31, 2024. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release of Adicet Bio, Inc. dated March 6, 2025, furnished herewith.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

		ADICET BIO, INC.
Date: March 6, 2025		By:	/s/ Nick Harvey
		Name:	Nick Harvey
		Title:	Chief Financial Officer

 

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Adicet Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Company Progress

 

Phase 1 clinical trial of ADI-001 in autoimmune diseases ongoing; on track to report preliminary clinical data from lupus nephritis (LN) patient cohort in 1H25

 

Additional LN clinical data and preliminary clinical data from other autoimmune patient cohorts anticipated in 2H25

 

Initiation of ADI-001 Phase 1 clinical trial patient enrollment in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) expected in 2Q25; anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) patient enrollment expected to be initiated in 2H25

 

Advancing patient enrollment in ADI-270 Phase 1 clinical trial in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC); plan to report preliminary data in 1H25

 

$176.3 million in cash, cash equivalents and short-term investments as of December 31, 2024

 

 

REDWOOD CITY, Calif. & BOSTON – March 6, 2025 – Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2024.

 

“In 2025 we plan to continue advancing our gamma delta 1 CAR T cell therapy programs, achieving key milestones and reporting preliminary data in autoimmune and oncology indications,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “The recent FDA Fast Track Designation for ADI-001 in refractory SLE with extrarenal involvement and in SSc highlights the significant unmet need for innovative, off-the-shelf therapies to treat autoimmune diseases. We are continuing to enroll LN patients in our ongoing Phase 1 trial in autoimmune diseases and look forward to sharing preliminary clinical data in the first half of 2025 and additional data in the second half of 2025. We expect to initiate enrollment for SLE, SSc, IIM and SPS patients in the second quarter and for AAV in the second half of the year, and to report clinical data from these additional cohorts in the second half as well.”

Mr. Schor continued: “In addition, we are continuing to enroll patients in our Phase 1 trial of ADI-270 in relapsed or refractory metastatic/advanced ccRCC patients and remain on track to announce preliminary clinical data in the first half of 2025. With a strong clinical foundation and growing momentum, Adicet is well-positioned to transform treatment paradigms for patients battling autoimmune diseases and solid tumors.”

 

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Fourth Quarter 2024 and Recent Operational Highlights:

 

Autoimmune diseases

 

 

 

 

Solid tumor indications

 

 

 

Corporate updates

 

 

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Financial Results for Fourth Quarter and Full Year 2024:

 

Three months ended December 31, 2024

 

Twelve Months Ended December 31, 2024

About Adicet Bio, Inc.

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

 

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Forward-Looking Statements

This press release contains “forward-looking statements” of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. 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, but are not limited to, express or implied statements regarding: clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 in autoimmune diseases and ADI-270 in ccRCC and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; ADI-001’s potential to be an off-the-shelf treatment option for autoimmune indications; ADI-270’s potential to be the first gamma delta CAR T cell therapy to address solid tumors; timing and success of the Phase 1 clinical trial of ADI-001 in LN, SLE, SSc, AAV, IIM and SPS, including timing and expectations for enrollment and future data releases; timing and success of the Phase 1 clinical trial of ADI-270 in ccRCC, including expectations for future data releases; and expectations regarding Adicet’s uses of capital, expenses and financial results, including the expected cash runway.

 

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Adicet’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.

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ADICET BIO, INC.

Consolidated Statements of Operations and Comprehensive Income

(in thousands, except share and per share amounts)

		Three Months Ended December 31,				Years Ended December 31,
		2024		2023		2024		2023
Operating expenses:
Research and development		$ 23,273		$ 24,759		$ 99,323		$ 106,043
General and administrative		7,470		6,807		28,292		26,533
Goodwill impairment		—		—		—		19,462
Total operating expenses		30,743		31,566		127,615		152,038
Loss from operations		(30,743)		(31,566)		(127,615)		(152,038)
Interest income		2,067		2,178		10,714		9,978
Interest expense		(1)		—		(4)		(25)
Other expense, net		(50)		(101)		(217)		(573)
Loss before income tax provision		(28,727)		(29,489)		(117,122)		(142,658)
Income tax provision		—		—		—		—
Net loss		$ (28,727)		$ (29,489)		$ (117,122)		$ (142,658)
Net loss per share, basic and diluted		$ (0.32)		$ (0.69)		$ (1.33)		$ (3.31)
Weighted-average common shares used in computing net loss per share, basic and diluted		90,846,293		43,035,315		87,866,435		43,042,405
Other comprehensive income
Unrealized (loss) gain on treasury securities, net of tax		(105)		—		16		—
Total other comprehensive income		(105)		—		16		—
Comprehensive loss		$ (28,832)		$ (29,489)		$ (117,106)		$ (142,658)

 

 

ADICET BIO, INC.

Consolidated Balance Sheets Information

(in thousands)

 

		December 31,			December 31,
		2024				2023
Cash, cash equivalents and short-term investments in treasury securities		$	176,303			$	159,711
Working capital			160,744				142,985
Total assets			220,219				207,295
Accumulated deficit			(497,894	)			(380,772	)
Total stockholders’ equity			186,609				170,175

 

 

 

 

 

 

 

 

 

 

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Adicet Bio, Inc.

Investor and Media Contacts

 

Investors:

Anne Bowdidge

abowdidge@adicetbio.com

 

Janhavi Mohite

Precision AQ

212-362-1200

janhavi.mohite@precisionaq.com

 

Media:

Kerry Beth Daly

kbdaly@adicetbio.com

 

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v3.25.0.1

Document And Entity Information	Mar. 06, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 06, 2025
Entity Registrant Name	Adicet Bio, Inc.
Entity Central Index Key	0001720580
Entity Emerging Growth Company	false
Entity File Number	001-38359
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	81-3305277
Entity Address, Address Line One	131 Dartmouth Street, Floor 3
Entity Address, City or Town	Boston
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02116
City Area Code	(650)
Local Phone Number	503-9095
Entity Information, Former Legal or Registered Name	Not applicable
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	ACET
Security Exchange Name	NONE

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