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 May 9, 2023, Adicet Bio, Inc. announced its financial results for the quarter ended March 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 May 9, 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: May 9, 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 First Quarter 2023 Financial Results and Provides Business Updates
On track to report additional efficacy, durability and safety data and provide a regulatory update and plan for ADI-001 pivotal program in 2Q 2023
Strong balance sheet with $231.6 million in cash, cash equivalents and investments as of March 31, 2023
Redwood City, Calif. and BOSTON – May 9, 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 first quarter ended March 31, 2023.
“We are excited about the continued clinical progress of our lead asset ADI-001,” said Chen Schor, President and Chief Executive Officer of Adicet. “In the second quarter, we plan to discuss with the FDA the path forward for a potential pivotal study for ADI-001 in post-CAR T large B-cell lymphoma patients and expect to initiate this study in the fourth quarter of 2023. We plan to report updated efficacy, durability and safety data from ADI-001’s ongoing Phase 1 trial, as well as provide an update on our meeting with the FDA in the second quarter of 2023. Additionally, Adicet is making steady advances in developing our early-stage pipeline candidates, including presenting promising data demonstrating preclinical proof-of-concept for our armored allogeneic gamma delta T cell therapy ADI-270 at ASGCT later this month. Further, we are on track to submit an IND for our novel CAd gamma delta T cell product candidate ADI-925 in the second half of this year.”
First Quarter 2023 and Recent Operational Highlights:
Financial Results for First Quarter 2023:
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, ADI-270 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 ongoing Phase 1 trial of ADI-001 in relapsed/refractory NHL patients; initiation of a potentially pivotal study for ADI-001 in the fourth quarter of 2023; planned discussions with the FDA around our current and future preclinical and clinical programs; 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; 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 Income (Loss)
(in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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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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$ |
24,990 |
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Operating expenses: |
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Research and development |
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26,756 |
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13,483 |
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General and administrative |
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6,566 |
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6,801 |
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Total operating expenses |
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33,322 |
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20,284 |
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Income (loss) from operations |
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(33,322 |
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4,706 |
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Interest income |
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2,666 |
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32 |
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Interest expense |
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(19 |
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(18 |
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Other expense, net |
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(206 |
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(102 |
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Income (loss) before income tax provision |
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(30,881 |
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4,618 |
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Income tax provision |
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— |
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— |
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Net income (loss) |
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$ |
(30,881 |
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$ |
4,618 |
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Net income (loss) per share attributable to common stockholders, basic |
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$ |
(0.72 |
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$ |
0.12 |
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Net income (loss) per share attributable to common stockholders, diluted |
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$ |
(0.72 |
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$ |
0.10 |
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Weighted-average common shares used in computing net income (loss) per share attributable to common stockholders, basic |
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42,955,688 |
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39,823,246 |
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Weighted-average common shares used in computing net income (loss) per share attributable to common stockholders, diluted |
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42,955,688 |
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45,958,941 |
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ADICET BIO, INC.
Consolidated Balance Sheet Information
(in thousands)
(unaudited)
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March 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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$ |
231,640 |
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$ |
257,656 |
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Working capital |
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216,713 |
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241,331 |
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Total assets |
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304,974 |
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330,690 |
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Accumulated deficit |
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(268,995 |
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(238,114 |
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Total stockholders’ equity |
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266,215 |
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292,338 |
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