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8-K
NONE0001720580false00017205802022-03-152022-03-15

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 15, 2022

 

 

Adicet Bio, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38359

81-3305277

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

200 Clarendon Street

Floor 6

 

Boston, Massachusetts

 

02116

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 650 503-9095

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

ACET

 

The Nasdaq Global Market

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, 2022, Adicet Bio, Inc. announced its financial results for the quarter and year ended December 31, 2021. 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.

 

Description

99.1

 

Press Release of Adicet Bio, Inc. dated March 15, 2022

104

 

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.

 

 

 

Adicet Bio, Inc.

 

 

 

 

Date:

March 15, 2022

By:

/s/ Nick Harvey

 

 

Name:

Title:

Nick Harvey
Chief Financial Officer

 
EX-99.1

Exhibit 99.1

Adicet Reports Fourth Quarter and Full Year 2021 Financial Results and Highlights Recent Company Progress

 

•
Complete and near complete responses observed starting at lowest dose in interim findings from Phase 1 study of ADI-001 in non-Hodgkin’s lymphoma (NHL); additional interim clinical data expected in the first half of 2022
•
Successfully raised $94.2 million in net proceeds through a public follow-on offering

 

MENLO PARK, Calif. and BOSTON, Mass – March 15, 2022 – Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2021.

 

“2022 marks an exciting new chapter for Adicet. Our clinical and operational accomplishments in the fourth quarter of 2021, including the presentation of positive clinical data for our lead asset ADI-001 in NHL, in which we observed complete responses starting at our lowest dose level, and our subsequent successful capital raise, serve as a strong foundation to continue to execute against key upcoming milestones,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “We’re pleased to share that we’ve completed dosing of subjects in dose level two and are enrolling subjects in dose level three in our Phase 1 trial and remain on track to report additional interim clinical data in the first half of 2022, which we hope will further reinforce the potential of Adicet’s first-in-class allogeneic, off-the-shelf gamma delta CAR T cell platform for patients living with cancer.”

 

Fourth Quarter 2021 and Recent Operational Highlights:

 

•
Announced positive interim clinical data from Phase 1 study ADI-001. In December 2021, Adicet reported positive interim data from its ongoing dose escalation Phase 1 study evaluating the safety and tolerability of ADI-001, Adicet’s investigational therapy targeting CD20 for the potential treatment of NHL. Complete and near complete responses were observed starting at lowest dose level (30 million CAR+ cells), as well as evidence of in vivo expansion and circulating pharmacodynamic biomarkers consistent with ADI-001 activation. Overall, ADI-001 infusions were generally well-tolerated, with no ADI-001 related serious adverse events, including Graft Versus Host Disease (GvHD), neurotoxicity or high-grade Cytokine release syndrome (CRS) reported as of the November 22, 2021 data cutoff. Adicet has completed dosing of subjects in dose level two and is currently enrolling subjects in dose level three. The Company anticipates reporting additional interim clinical data in the first half of 2022.
•
Successfully raised $94.2 million in net proceeds through a public follow-on offering. In December 2021, Adicet successfully completed a capital financing of $100.6 million in aggregate gross proceeds. After deducting underwriting discounts and commissions and offering expenses, the Company received $94.2 million of net proceeds. The Company plans to utilize the net proceeds from the financing to advance its pipeline of gamma delta CAR T cell therapies.
•
Regeneron Pharmaceuticals to license the exclusive, worldwide rights to ADI-002. In January 2022, Regeneron Pharmaceuticals, Inc. exercised its option to license the exclusive, worldwide rights to ADI-002, Adicet’s allogeneic gamma delta CAR T cell therapy directed against Glypican-3. In conjunction with the exercise of the option, Regeneron paid an exercise fee of $20.0 million to Adicet.
•
ADI-001 preclinical data published in Clinical and Translational Immunology. In February 2022, Clinical and Translational Immunology published data highlighting the key properties of ADI-001, the

 

 

Company’s investigational therapy targeting CD20 for the potential treatment of B-cell NHL. These preclinical findings underscore ADI-001’s potent, rapid targeting activity, which combines innate, adaptive and CAR-mediated mechanisms. Preclinical data also demonstrated efficient kinetics of cell killing compared to traditional CAR T cells, highly durable and proliferative cell activity, and decreased expression of cell exhaustion markers, all of which may support high anti-tumor potency and therapeutic potential.
•
Appointed Michael G. Kauffman, M.D., Ph.D., to the Company’s Board of Directors. In November 2021, Adicet announced the appointment of Dr. Michael Kauffman to its Board of Directors. Dr. Kauffman is currently a board member for Karyopharm Therapeutics, Verastem Oncology and Kezar Life Sciences, and brings over 20 years of experience in the life sciences industry, including expertise in preclinical research, clinical development and regulatory strategy to Adicet’s board.
•
Presented Preclinical Data for ADI-002 at the 36th Society for Immunotherapy of Cancer (SITC) Annual Meeting. In November 2021, Adicet presented preclinical findings for ADI-002 at the SITC Annual Meeting. The data demonstrated potent gamma delta CAR T cell activation, cytotoxicity, tumor-specific homing, proliferation, and enhanced activity without evidence of graft versus host alloreactivity. ADI-002 is designed specifically to target solid tumors.

 

Financial Results for Fourth Quarter and Full Year 2021:

Three months Ended December 31, 2021

•
Research and Development (R&D) Expenses: R&D expenses were $14.7 million for the three months ended December 31, 2021, compared to $9.7 million during the same period in 2020. The $5.0 million increase is primarily driven by an increase of $1.8 million of payroll and personnel expenses, a net increase of $1.8 million for expenses related to contract manufacturing organizations (CMO), contract research organizations (CRO) and consultant costs related to our lead product candidate ADI-001, and other externally sponsored research expenses, and an increase of $1.3 million in facility and other expenses. Payroll and personnel expenses for the three months ended December 31, 2021, includes $1.6 million of non-cash stock-based compensation expense compared to $0.6 million during the same period in 2020.
•
General and Administrative (G&A) Expenses: G&A expenses were $6.4 million for the three months ended December 31, 2021, compared to $5.1 million during the same period in 2020. The $1.3 million increase is primarily driven by an increase of $1.8 million of payroll and personnel expenses, partially offset by a decrease of $0.5 million of professional fees for legal, consulting, accounting, tax and other services. Payroll and personnel expenses for the three months ended December 31, 2021, includes $2.7 million of non-cash stock-based compensation expense compared to $1.1 million during the same period in 2020.
•
Net Loss: Net loss attributable to common shareholders for the three months ended December 31, 2021 was $15.8 million, or a net loss of $0.47 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million, as compared to a net loss of $9.0 million during the same period in 2020, or a net loss of $0.46 per basic and diluted share, including non-cash stock-based compensation expense of $1.6 million.

 

 

 

Twelve Months Ended December 31, 2021

•
Research and Development (R&D) Expenses: R&D expenses were $48.9 million for the year ended December 31, 2021, as compared to $34.3 million for year ended December 31, 2020. The increase of $14.6 million in R&D expenses year-over-year was primarily due to an increase of $5.8 million related to payroll and personnel expenses due to increases in headcount of employees involved in research and development activities and an increase in stock-based compensation of $3.1 million. In addition, there was an increase of $3.7 million in fees incurred for CMO, CRO and consultant costs due to ramping up manufacturing and clinical development activities related to our first product candidate ADI-001 and other externally sponsored research, and an increase of $4.9 million in facilities and other expenses.
•
General and Administrative (G&A) Expenses: G&A expenses were $22.2 million for the year ended December 31, 2021, compared to $22.8 million for the year ended December 31, 2020. The decrease was primarily due to a decrease of $6.3 million in professional fees related to legal and audit fees incurred due to our reverse merger in 2020, partially offset by an increase of $3.1 million of payroll and personnel expenses, which included higher stock-based compensation of $4.2 million and salaries and benefits of $1.0 million and lower temporary contractor fees of $2.2 million. There was also an increase of $2.8 million in facilities and other expenses and $0.5 million in other administrative costs.
•
Net Loss: Net loss attributable to common shareholders for the year ended December 31, 2021 was $62.0 million, or a net loss of $2.00 per basic and diluted share, including non-cash stock-based compensation expense of $12.5 million, as compared to a net loss in 2020 of $36.7 million, or a net loss of $5.01 per basic and diluted share, including non-cash stock-based compensation expense of $5.3 million.
•
Cash Position: Cash and cash equivalents and marketable debt securities were $277.5 million as of December 31, 2021, compared to $94.6 million as of December 31, 2020. In December 2021, the Company successfully completed a public offering resulting in $94.2 million of net proceeds. The Company expects that current cash and cash equivalents and marketable debt securities as of December 31, 2021, will be sufficient to fund its operating expenses at least into the second half of 2024.

 

About Adicet Bio, Inc.

 

Adicet Bio, Inc. is a 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 CAR and T cell receptor-like targeting moieties to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. For more information, please visit our website at http://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, express or implied statements regarding preclinical and clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001, potential safety, tolerability and therapeutic effects of ADI-001 and the timing of the interim clinical data from our Phase 1 trial of ADI-001 in NHL patients; the potential therapeutic effects of ADI-002; the contributions resulting from members of the board of directors; and Adicet’s growth as a company and its expectations regarding its uses of capital, expenses, future accumulated deficit and other fourth quarter and year end 2021 financial results. 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 clinical trials, 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 timing, if at all; that positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; current or future clinical studies may fail to demonstrate adequate safety and efficacy of our product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; as well as those risks and uncertainties set forth in Adicet’s most recent annual report on Form 10-K and subsequent filings with the Securities and Exchange Commission (SEC). 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 its 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

 

 

 

 

Adicet Bio, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended December 31,

 

Year ended December 31,

 

2021

 

2020

 

2021

 

2020

 

Revenue—related party

 $ 5,468

 

$ 5,410

 

$ 9,730

 

$ 17,903

Operating expenses:

 

 

 

 

 

 

 

Research and development

  14,658

 

  9,683

 

  48,943

 

  34,334

General and administrative

  6,352

 

  5,076

 

  22,220

 

  22,760

Total operating expenses

  21,010

 

  14,759

 

  71,163

 

  57,094

Loss from operations

  (15,542)

 

  (9,349)

 

  (61,433)

 

  (39,191)

Interest income

  37

 

  81

 

  91

 

  785

Interest expense

  (25)

 

  (50)

 

   (176)

 

  (134)

Other income (expense), net

(294)

 

  221

 

  (606)

 

  (953)

Loss before income tax benefit

  (15,824)

 

  (9,097)

 

  (62,124)

 

  (39,493)

Income tax expense (benefit)

  (11)

 

  (139)

 

  (125)

 

  (2,815)

Net loss

$ (15,813)

 

$ (8,958)

 

 $ (61,999)

 

$ (36,678)

Net loss per share attributable to common stockholders, basic and diluted

$ (0.47)

 

$ (0.46)

 

$ (2.00)

 

$ (5.01)

Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted

  33,912,230

 

  19,618,469

 

  30,952,152

 

  7,319,977

 

 

 

 

 

Adicet Bio, Inc.

Balance Sheet Data

(unaudited)

(in thousands)

 

 

December 31,

 

 

2021

 

2020

 

Cash, cash equivalents and marketable debt securities

 

 $ 277,544

 

$ 94,614

Working capital

 

  266,121

 

77,857

Total assets

 

  338,938

 

  153,835

Contract liabilities—related party

 

  4,805

 

  13,980

Accumulated deficit

 

  (168,324)

 

  (106,325)

Total stockholders' equity (deficit)

 

  303,129

 

  109,827