UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 6, 2024, Adicet Bio, Inc. announced its financial results for the quarter ended September 30, 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. |
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Description |
99.1 |
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Press Release of Adicet Bio, Inc. dated November 6, 2024, furnished herewith. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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 hereunto duly authorized.
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ADICET BIO, INC. |
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Date: November 6, 2024 |
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By: |
/s/ Nick Harvey |
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Name: |
Nick Harvey |
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Title: |
Chief Financial Officer |
Adicet Reports Third Quarter 2024 Financial Results and Provides Business Updates
ADI-001 Phase 1 clinical trial expanded to include a total of six autoimmune disease indications; preliminary clinical data in lupus nephritis (LN) anticipated in 1H25
Strong balance sheet with $202.1 million in cash, cash equivalents and short-term investments as of September 30, 2024
REDWOOD CITY, Calif. & BOSTON – November 6, 2024 – 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 third quarter ended September 30, 2024.
“Our commitment to delivering best-in-class gamma delta 1 T cell therapies for patients battling autoimmune diseases and cancer is reflected in the expansion of our clinical pipeline in the third quarter. We are now investigating ADI-001 across six autoimmune indications to provide potentially transformative curative therapies for these debilitating diseases. Additionally, in the fourth quarter we plan to open enrollment for our Phase 1 trial of ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC), our first gamma delta 1 CAR T cell therapy for solid tumors. This progress highlights the broad and important potential applications of our gamma delta platform,” said Chen Schor, President and Chief Executive Officer. “Looking ahead, we anticipate advancing enrollment in these trials and expect to share preliminary clinical data from both lupus nephritis with ADI-001 and metastatic/advanced ccRCC with ADI-270 in the first half of 2025.”
Third Quarter 2024 and Recent Operational Highlights:
Autoimmune diseases
Hematologic malignancies and solid tumor indications
Corporate Updates
Financial Results for Third Quarter 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.
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: the expansion of Adicet’s clinical pipeline and the preclinical and clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 and ADI-270, including the potential safety, durability, tolerability and efficacy of these product candidates as well as their potential promising profiles; the progress, timing and success of the Company’s ongoing and planned Phase 1 clinical trials of ADI-001 in autoimmune diseases, including expectations for site activation, enrollment and data readouts; the Company’s clinical trial of ADI-270 in metastatic/advanced ccRCC, including expectations for site enrollment and data readouts; and expectations regarding the Company’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 FDA 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 entitled “Risk Factors” in Adicet’s most recent quarterly report on Form 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the SEC. 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.
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
ADICET BIO, INC.
Consolidated Statements of Operations and Comprehensive Income
(in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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26,253 |
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26,167 |
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76,050 |
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81,284 |
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General and administrative |
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6,900 |
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6,633 |
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20,822 |
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19,726 |
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Goodwill impairment |
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— |
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19,462 |
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— |
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19,462 |
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Total operating expenses |
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33,153 |
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52,262 |
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96,872 |
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120,472 |
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Loss from operations |
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(33,153 |
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(52,262 |
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(96,872 |
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(120,472 |
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Interest income |
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2,730 |
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2,520 |
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8,647 |
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7,800 |
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Interest expense |
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(1 |
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(1 |
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(3 |
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(25 |
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Other expense, net |
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(54 |
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(142 |
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(167 |
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(472 |
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Loss before income tax provision |
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(30,478 |
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(49,885 |
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(88,395 |
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(113,169 |
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Income tax provision |
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— |
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— |
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— |
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— |
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Net loss |
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$ |
(30,478 |
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$ |
(49,885 |
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$ |
(88,395 |
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$ |
(113,169 |
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Net loss per share, basic and diluted |
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$ |
(0.34 |
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$ |
(1.16 |
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$ |
(1.02 |
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$ |
(2.63 |
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Weighted-average common shares used in computing net loss per share, basic and diluted |
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90,846,293 |
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42,980,641 |
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86,865,285 |
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43,001,901 |
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Other comprehensive income |
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Unrealized gain on treasury securities, net of tax |
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121 |
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— |
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121 |
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— |
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Total other comprehensive income |
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121 |
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— |
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121 |
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— |
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Comprehensive loss |
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$ |
(30,357 |
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$ |
(49,885 |
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$ |
(88,274 |
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$ |
(113,169 |
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ADICET BIO, INC.
Consolidated Balance Sheets Information
(in thousands)
(Unaudited)
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September 30, |
December 31, |
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2024 |
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2023 |
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Cash, cash equivalents, and short term investments in treasury securities |
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$ |
202,065 |
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$ |
159,711 |
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Working capital |
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186,922 |
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142,985 |
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Total assets |
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245,962 |
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207,295 |
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Accumulated deficit |
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(469,167 |
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(380,772 |
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Total stockholders’ equity |
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211,531 |
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170,175 |
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