Adicet Reports Third Quarter 2020 Financial Results and Provides Business Update
“We are extremely proud of the milestones we’ve achieved this quarter, including the completion of the merger between
- IND application cleared by FDA for lead asset, ADI-001, a first-in-class allogeneic CAR gamma-delta T cell therapy. In
October 2020, Adicet reported that the U.S. Food and Drug Administration(FDA) accepted the Company’s Investigational New Drug (IND) application for lead asset, ADI-001, an allogeneic gamma delta (γδ) T cell therapy expressing a chimeric antigen receptor (CAR) targeting CD20 for treatment of non-Hodgkin’s lymphoma (NHL). The Company expects to initiate the Phase 1 clinical trial in the first quarter of 2021 to evaluate safety and efficacy of ADI-001 in NHL patients. Site initiation activities are underway and interim clinical data from this study are expected in 2021.
- Built out the management team with the appointment of
Nick Harveyas Chief Financial Officer and Don Healey, Ph.D., as Chief Technology Officer. In September 2020, Adicet announced the appointment of Nick Harveyas Chief Financial Officer. Mr. Harveyis responsible for leading the company’s financial strategy and management of activities related to accounting, capital markets and business operations. In October 2020, Dr. Healeyjoined the management team as Chief Technology Officer, responsible for the development of Adicet’s genetically-modified T cell therapies for clinical development and commercialization, including manufacturing, viral vector operations and analytics.
- Successfully completed merger with resTORbio. In
September 2020, Adicet Biocompleted its merger with resTORbio, Inc. and commenced trading on the Nasdaq Global Market under the ticker symbol “ACET” on September 16, 2020.
$10 millionproduct development milestone payment from Regeneron. In August 2020, Adicet announced that it received a $10 millionmilestone payment from Regeneron related to ADI-002 meeting key preclinical development goals, in accordance with the terms of its strategic collaboration with Regeneron. ADI-002 is Adicet's allogeneic off-the-shelf γδ T cell product candidate targeting GPC3 for solid tumors associated with high GPC3 expression such as hepatocellular carcinoma, the most prevalent form of liver cancer.
Financial Results for Third Quarter of 2020:
- Research and Development (R&D) Expenses: R&D expenses increased by
$2.6 millionto $8.9 millionfor the quarter ended September 30, 2020, compared to $6.3 millionduring the same period in 2019. This increase is primarily driven by an increase of $1.9 millionin payroll and personnel expenses due to increases in headcount of employees involved in research and development activities, an increase of $0.9 millionin fees incurred for CROs and CMOs costs due to initiating and ramping up manufacturing and preclinical development activities related to our first product candidate, offset by decrease in costs for other consultants by $0.3 million. Payroll and personnel expenses for the quarter ended September 30, 2020includes $1.0 million of non-cash stock-based compensation expense compared to $0.1 millionduring the same period in 2019 due to an one-time charge of $0.9 millionresulting from the modification of stock awards in connection with the merger.
- General and Administrative (G&A) Expenses: G&A expenses increased by
$5.9 millionto $7.7 millionfor the quarter ended September 30, 2020, compared to $1.8 millionduring the same period in 2019. This increase is primarily driven by an increase of $3.2 millionof payroll and personnel expenses, an increase of $2.4 millionof professional fees for legal, consulting, accounting, tax and other services, and an increase of $0.3 millionin facility and other expenses. Payroll and personnel expenses for the quarter ended September 30, 2020includes $2.0 million of non-cash stock-based compensation expense compared to $0.3 millionduring the same period in 2019 due to an one-time charge of $1.7 millionresulting from the modification of stock awards in connection with the merger. The increase in professional fees was primarily due to transaction costs incurred in connection with the merger with resTORbio of $2.0 millionduring the quarter ended September 30, 2020.
- Net Loss: Net loss attributable to common shareholders for the quarter ended
September 30, 2020was $14.8 million, or a net loss of $2.84per basic and diluted share, including non-cash stock-based compensation expense of $3.0 million, as compared to $14.8 millionduring the same period in 2019, or a net loss of $6.87per basic and diluted share, including non-cash stock-based compensation expense of $0.4 million.
- Cash Position: Cash and cash equivalents and marketable debt securities were
$108.1 millionas of September 30, 2020, compared to $73.0 millionas of December 31, 2019.
Adicet is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like antibodies 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.
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 ADI-002 and potential therapeutic effects of ADI-001 and ADI-002, the timing and outcome of discussions with FDA and other regulatory agencies, expectations regarding the design, implementation, timing, and success of its future clinical studies of ADI-001, including whether they are pivotal or would support registration, expectations regarding its other CAR γδ T cell therapy development activities, the impact of individual executive officers on Adicet’s success, and its expectations regarding its uses of capital, expenses, future accumulated deficit and other third quarter 2020 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 its clinical trials, business operations, and ability to raise additional capital; Adicet’s ability to execute on its strategy; that positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; 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; regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time‑consuming, and inherently unpredictable; regulatory developments in
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
|Three Months Ended
|Nine Months Ended
|Research and development||8,942||$||6,331||$||24,651||$||17,168|
|General and administrative||7,741||1,847||17,684||6,069|
|Total operating expenses||16,683||8,178||42,335||23,237|
|Loss from operations||(13,655||)||(15,225||)||(29,842||)||(24,211||)|
|Other income (expense), net||(1,224||)||171||(1,174||)||2,091|
|Loss before income taxes||(14,776||)||(14,778||)||(30,396||)||(21,559||)|
|Income tax expense (benefit)||3||—||(2,676||)||1|
|Net loss per share —basic and diluted||$||(2.84||)||$||(6.87||)||$||(8.69||)||$||(10.10||)|
|Weighted-average number of common shares used in net loss per share —basic and diluted||5,208,887||2,149,986||3,190,557||2,133,645|
Balance Sheet Data
|September 30,||December 31,|
|Cash, cash equivalents and marketable debt securities||$||108,120||$||72,988|
|Contract liabilities—related party||19,390||21,883|
|Total stockholders' equity (deficit)||116,930||(60,366||)|
Investor and Media Contacts
Stern Investor Relations, Inc.
Source: Adicet Bio, Inc.