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 March 19, 2024, Adicet Bio, Inc. announced its financial results for the quarter and year ended December 31, 2023. 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 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 March 19, 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: March 19, 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 Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress
Expanded clinical pipeline into autoimmune diseases with U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug Application (IND) for ADI-001; initiation of Phase 1 clinical trial in lupus nephritis expected in 2Q 2024
On track to file IND for ADI-270 in renal cell carcinoma in 2Q 2024
Extended projected cash runway into 2H 2026
REDWOOD CITY, Calif. & BOSTON – March 19, 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 fourth quarter and year ended December 31, 2023.
“We are excited to explore the potential of our gamma delta T cell platform in autoimmune diseases following the FDA’s IND clearance of ADI-001 in lupus nephritis,” said Chen Schor, President and Chief Executive Officer at Adicet Bio. “We believe ADI-001 is ideally suited for the treatment of autoimmune diseases given its robust B-cell depletion consistent with other autologous CAR T therapies tested in autoimmune diseases, its tissue tropism potential in autoimmune diseases, and the safety and efficacy data observed in our Phase 1 study. In addition, ADI-001’s off-the-shelf availability and safety profile has the potential to make cell therapy for autoimmune diseases available to patients in community setting. We look forward to initiating the Phase 1 study in lupus nephritis in the second quarter of 2024 and are on track to expand the program to additional autoimmune indications.”
Mr. Schor continued: “In addition, we are continuing to enroll MCL patients in our ongoing Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma. With the completion of the successful capital raise and other net proceeds from stock sales under the at-the-market program in January, extending our cash runway into the second half of 2026, we are well-positioned to continue clinical execution across our pipeline through multiple upcoming milestones.”
Fourth Quarter 2023 and Recent Operational Highlights:
Autoimmune diseases
Hematologic malignancies and solid tumor indications
Corporate updates
Financial Results for Fourth Quarter and Full Year 2023:
Three months Ended December 31, 2023
Twelve Months Ended December 31, 2023
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: preclinical and clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 and ADI-270, including the potential submission or timing of clearance of INDs in autoimmune diseases, and the potential safety, durability, tolerability and efficacy of these product candidates; the progress, timing and success of the Company’s ongoing and planned Phase 1 clinical trials of ADI-001 in autoimmune diseases and cancer, including expectations for site activation, enrollment and data readouts; the Company’s plan to expand into other autoimmune indications in the future; the Company’s expectations regarding regulatory filings and clearances, including the submission of an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024; 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 annual report on Form 10-K and our periodic reports on Form 10-Q and Form 8-K filed 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
Anne Bowdidge
abowdidge@adicetbio.com
Janhavi Mohite
Stern Investor Relations, Inc.
212-362-1200
janhavi.mohite@sternir.com
ADICET BIO, INC.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue—related party |
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$ |
— |
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$ |
— |
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$ |
— |
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$ |
24,990 |
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Operating expenses: |
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Research and development |
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24,759 |
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25,015 |
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106,043 |
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71,246 |
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General and administrative |
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6,807 |
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6,550 |
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26,533 |
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26,295 |
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Goodwill impairment |
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— |
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— |
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19,462 |
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— |
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Total operating expenses |
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31,566 |
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31,565 |
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152,038 |
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97,541 |
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Loss from operations |
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(31,566) |
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(31,565 |
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(152,038 |
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(72,551 |
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Interest income |
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2178 |
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2,179 |
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9,978 |
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3,760 |
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Interest expense |
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— |
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(26 |
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(25 |
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(80 |
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Other expense, net |
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(101) |
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(463 |
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(573 |
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(919 |
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Loss before income tax provision |
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(29,489) |
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(29,875 |
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(142,658 |
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(69,790 |
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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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$ |
(29,489) |
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$ |
(29,875 |
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$ |
(142,658 |
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$ |
(69,790 |
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Net loss per share, basic and diluted |
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$ |
(0.69) |
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$ |
(0.72 |
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$ |
(3.31 |
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$ |
(1.70 |
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Weighted-average common shares used in computing net loss per share, basic and diluted |
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43,035,315 |
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41,651,298 |
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43,042,405 |
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41,080,286 |
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ADICET BIO, INC.
Consolidated Balance Sheets
(in thousands)
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December 31, |
December 31, |
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2023 |
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2022 |
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Cash and cash equivalents |
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$ |
159,711 |
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$ |
257,656 |
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Working capital |
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142,985 |
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241,331 |
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Total assets |
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207,295 |
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330,690 |
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Accumulated deficit |
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(380,772 |
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(238,114 |
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Total stockholders’ equity |
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170,175 |
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292,338 |
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