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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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:
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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 8, 2022, Adicet Bio, Inc. announced its financial results for the quarter ended September 30, 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, 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 Number |
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Description |
99.1 |
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Press release issued by Adicet Bio, Inc. on November 8, 2022, 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 thereunto duly authorized.
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ADICET BIO, INC. |
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Date: November 8, 2022 |
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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 2022 Financial Results and Provides Business Updates
As of ASH abstract data-cut date, ADI-001 demonstrated a positive safety and efficacy profile; Company to provide more recent data cut from its ongoing Phase 1 study during ASH Annual Meeting
Company to host ADI-001 webcast event on December 11, 2022 at 9:00 a.m. ET
On track to initiate a potentially pivotal program for ADI-001 in the first half of 2023
Strong balance sheet with $282.7 million in cash and cash equivalents as of September 30, 2022; Cash runway into first half of 2025
Company to host R&D webcast event detailing four new pipeline candidates on November 10, 2022 at 9:00 a.m. ET
REDWOOD CITY, Calif. and BOSTON – November 8, 2022 – 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 third quarter ended September 30, 2022.
“We have continued to make very encouraging clinical progress in 2022, reporting promising safety and efficacy data for our lead candidate ADI-001 for the potential treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma,” said Chen Schor, President and Chief Executive Officer at Adicet Bio. “We’re currently enrolling patients in dose level 4 and expect to initiate a potentially pivotal program with the recommended Phase 2 dose for ADI-001 in the first half of 2023. We look forward to providing additional clinical data on ADI-001 at the American Society of Hematology Annual Meeting in December as well as promising preclinical data on our emerging pipeline programs at the upcoming Society for Immunotherapy of Cancer’s Annual Meeting and our upcoming R&D event.”
Third Quarter 2022 and Recent Operational Highlights:
In December 2022, the Company plans to provide data from a more recent data-cut date from the ongoing Phase 1 study of ADI-001 in adults with relapsed or refractory B-cell NHL during the upcoming 2022 ASH Annual Meeting. The Company will host an ADI-001 webcast on Sunday, December 11, 2022, at 8:00 a.m. CT / 9:00 a.m. ET to discuss data from the ongoing study.
Financial Results for Third Quarter 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 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 including, but not limited to, preclinical and clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 and Adicet’s preclinical programs and potential safety, durability, tolerability and therapeutic effects of ADI-001; expected plans and timing for the release of additional clinical data from Adicet’s Phase 1 trial of ADI-001 in NHL patients; future progress of the Phase 1 trial, including ongoing patient enrollment in the dose level 4 cohort; the anticipated timing for the
selection of a recommended Phase 2 dose and expectations around initiation of a potentially pivotal study for ADI-001; the launch of in-house manufacturing capabilities in Adicet’s Redwood City facility; and Adicet’s growth as a company 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, 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; Adicet’s ability to execute on its strategy; Adicet’s ability to meet production and product release expectations; as well as those risks and uncertainties set forth in the company’s most recent annual report on Form 10-K and subsequent filings with the Securities and Exchange Commission. 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 September 30, |
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Nine Months Ended September 30, |
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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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$ |
3,429 |
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$ |
24,990 |
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$ |
4,262 |
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Operating expenses: |
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Research and development |
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16,570 |
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11,926 |
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46,231 |
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34,285 |
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General and administrative |
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6,415 |
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5,213 |
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19,745 |
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15,868 |
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Total operating expenses |
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22,985 |
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17,139 |
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65,976 |
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50,153 |
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Loss from operations |
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(22,985 |
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(13,710 |
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(40,986 |
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(45,891 |
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Interest income |
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1,224 |
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4 |
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1,581 |
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54 |
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Interest expense |
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(18 |
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(50 |
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(54 |
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(151 |
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Other expense, net |
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(217 |
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(246 |
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(456 |
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(312 |
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Loss before income tax provision |
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(21,996 |
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(14,002 |
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(39,915 |
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(46,300 |
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Income tax provision |
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— |
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11 |
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— |
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(114 |
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Net loss |
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$ |
(21,996 |
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$ |
(14,013 |
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$ |
(39,915 |
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$ |
(46,186 |
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Net loss per share, basic and diluted |
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$ |
(0.53 |
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$ |
(0.44 |
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$ |
(0.98 |
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$ |
(1.54 |
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Weighted-average common shares used in computing net loss per share, basic and diluted |
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41,642,815 |
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31,876,016 |
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40,547,792 |
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29,954,616 |
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Other comprehensive loss: |
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Unrealized loss on marketable debt securities, net of tax |
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— |
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— |
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— |
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(24 |
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Total other comprehensive loss |
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— |
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— |
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— |
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(24 |
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Comprehensive loss |
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$ |
(21,996 |
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$ |
(14,013 |
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$ |
(39,915 |
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$ |
(46,210 |
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ADICET BIO, INC.
Consolidated Balance Sheets
(in thousands)
(unaudited)
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September 30, |
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December 31, |
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Cash and cash equivalents |
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$ |
282,679 |
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$ |
277,544 |
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Working capital |
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268,516 |
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266,121 |
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Total assets |
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354,303 |
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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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(208,240) |
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(168,324) |
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Total stockholders’ equity |
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317,658 |
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303,129 |
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