UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 15, 2023, Adicet Bio, Inc. announced its financial results for the quarter and year ended December 31, 2022. 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 15, 2023, 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 15, 2023 |
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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 2022 Financial Results and Highlights Recent Company Progress
REDWOOD CITY, Calif. and BOSTON – March 15, 2023 – Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2022.
“In 2022, Adicet demonstrated strong execution in advancing our gamma delta T cell therapy pipeline and clinical proof of concept for our therapeutic approach that may provide significant benefit for people living with cancer. Following the Phase 1 clinical update in December evaluating ADI-001 for relapsed or refractory non-Hodgkin’s lymphoma, we are continuing to track and enroll patients in the study and expect to report additional efficacy, durability, and safety data in the second quarter of 2023. We plan to discuss the design of our first potential pivotal study with the FDA in the second quarter of this year and initiate the pivotal portion of the study in the second half of the year, potentially in the third quarter,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “In addition, we plan to build on the preclinical data presented at ISCT, SITC and our R&D event, to expand our pipeline of first-in-class allogeneic, off-the-shelf gamma delta CAR T-cell product candidates, and in the second half of 2023, expect to submit an IND for ADI-925, our novel CAd gamma delta T cell product candidate.”
Fourth Quarter 2022 and Recent Operational Highlights:
Financial Results for Fourth Quarter and Full Year 2022:
Three months Ended December 31, 2022
Twelve Months Ended December 31, 2022
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and chimeric antigen adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for 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 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, ADI-925 and Adicet’s preclinical programs; the potential safety, durability, tolerability and therapeutic effects of ADI-001; expected plans, progress and timing for the release of additional clinical data from Adicet’s Phase 1 trial of ADI-001 in relapsed/refractory NHL patients, including ongoing patient
enrollment and the identification of a recommended Phase 2 dose; initiation of a potentially pivotal study in the second half of 2023, potentially in the third quarter; planned discussions with the FDA; the planned timing and submission of regulatory filings, including the potential IND for ADI-925 in the second half of 2023 and other preclinical programs; the utility, benefits and potential of in-house manufacturing capabilities in Adicet’s Redwood City facility; and Adicet’s growth as a company, the contributions of its executive officers and expectations regarding its 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, 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; regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; Adicet’s ability to meet production and product release expectations; the effect of COVID-19 on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical trials, business operations, employee hiring and retention, and ability to raise additional capital. 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 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 and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue—related party |
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$ |
— |
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$ |
5,468 |
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$ |
24,990 |
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$ |
9,730 |
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Operating expenses: |
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Research and development |
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25,015 |
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14,658 |
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71,246 |
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48,943 |
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General and administrative |
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6,550 |
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6,352 |
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26,295 |
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22,220 |
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Total operating expenses |
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31,565 |
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21,010 |
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97,541 |
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71,163 |
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Loss from operations |
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(31,565 |
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(15,542 |
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(72,551 |
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(61,433 |
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Interest income |
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2,179 |
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37 |
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3,760 |
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91 |
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Interest expense |
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(26 |
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(25 |
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(80 |
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(176 |
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Other expense, net |
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(463 |
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(294 |
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(919 |
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(606 |
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Loss before income tax provision |
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(29,875 |
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(15,824 |
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(69,790 |
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(62,124 |
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Income tax provision |
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— |
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(11) |
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— |
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(125 |
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Net loss |
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$ |
(29,875 |
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$ |
(15,813 |
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$ |
(69,790 |
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$ |
(61,999 |
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Net loss per share, basic and diluted |
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$ |
(0.72 |
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$ |
(0.47 |
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$ |
(1.70 |
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$ |
(2.00 |
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Weighted-average common shares used in computing net loss per share, basic and diluted |
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41,651,298 |
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33,912,230 |
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41,080,286 |
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30,952,152 |
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ADICET BIO, INC.
Consolidated Balance Sheets
(in thousands)
(unaudited)
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December 31, |
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2022 |
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2021 |
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Cash and cash equivalents |
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$ |
257,656 |
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$ |
277,544 |
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Working capital |
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241,331 |
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266,121 |
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Total assets |
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330,690 |
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338,938 |
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Contract liabilities – related party, current |
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— |
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4,805 |
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Accumulated deficit |
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(238,114 |
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(168,324) |
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Total stockholders’ equity |
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292,338 |
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303,129 |
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