Adicet Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress
Expanded clinical pipeline into autoimmune diseases with
On track to file IND for ADI-270 in renal cell carcinoma in 2Q 2024
Extended projected cash runway into 2H 2026
“We are excited to explore the potential of our gamma delta T cell platform in autoimmune diseases following the FDA’s IND clearance of ADI-001 in lupus nephritis,” said
Fourth Quarter 2023 and Recent Operational Highlights:
Autoimmune diseases
-
IND clearance for ADI-001 in lupus nephritis. In
December 2023 , the FDA cleared the Company’s IND application for ADI-001 in lupus nephritis. Adicet plans to initiate a Phase 1 study to evaluate the safety and efficacy of ADI-001 in lupus nephritis during the second quarter of 2024. Preliminary clinical data from the trial are expected in the fourth quarter of 2024 or first quarter of 2025, pending study site activation progression and patient enrollment. - Expansion of ADI-001 development in autoimmune diseases. Adicet expects to expand into additional autoimmune indications in the near future. The Company anticipates providing preliminary clinical data in the fourth quarter of 2024 or first half of 2025, subject to clearance of INDs in those indications as well as successful site initiation and patient enrollment in the relevant clinical protocols.
Hematologic malignancies and solid tumor indications
-
Continuing to advance ADI-001 in Phase 1 GLEAN study in mantle cell lymphoma (MCL). The Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma (NHL) is ongoing, with enrollment focused on the MCL patient population, which demonstrated the greatest clinical benefit in the
June 2023 clinical update. Adicet expects to provide a clinical update on safety, efficacy and 6-month complete response data in MCL patients in the second half of 2024. - Advancing ADI-270 preclinical development in solid tumors. ADI-270 is designed to home to solid tumors, with a highly specific targeting moiety for CD70 and an armoring technology of dominant negative TGF beta receptor to address immunosuppressive factors in the tumor microenvironment. Adicet remains on track to file an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024 and expects to provide clinical data from a Phase 1 study in the first half of 2025, following regulatory clearance and subject to study initiation progress.
-
Presented persistence and pharmacodynamic data from ADI-001 Phase 1 study at the 65th
American Society of Hematology (ASH) Annual Meeting. InDecember 2023 , Adicet presented new pharmacokinetic and pharmacodynamic data from the Phase 1 study of ADI-001 at the ASH Annual Meeting. The data demonstrated robust dose-dependent expansion and persistence in patients with relapsed or refractory aggressive B-cell NHL. ADI-001’s strong exposure and persistence profile observed in the study to date further validates Adicet’s gamma delta T cell technology.
Corporate updates
-
Hired
Benjamin Hsu , M.D., Ph.D., as Vice President Clinical Development - Autoimmune. InMarch 2024 , Adicet appointed Dr.Benjamin Hsu , M.D., Ph.D., as Vice President Clinical Development.Dr. Hsu brings over 20 years of experience in the biotech and pharmaceutical industry with extensive expertise in immunology and rheumatology clinical development.Dr. Hsu will lead the clinical design and execution of the clinical development plan for Adicet’s gamma delta T cell therapies for autoimmune diseases. -
Extended projected cash runway into 2H 2026. In
January 2024 , Adicet successfully raised$91.8 million in net proceeds through an underwritten public offering and received$19.3 million in net proceeds under its at-the-market (ATM) program.
Financial Results for Fourth Quarter and Full Year 2023:
Three months Ended
-
Research and Development (R&D) Expenses: R&D expenses were
$24.8 million for the three months endedDecember 31, 2023 , compared to$25.0 million during the same period in 2022. The$0.2 million decrease was primarily driven by a$2.7 million decrease in expenses related to contract development manufacturing organizations (CDMOs), contract research organizations (CROs) and consultant costs related to our lead product candidate ADI-001. This decrease was partially offset by an increase of$1.3 million in payroll and personnel expenses, an increase of$0.7 million in lab expenses and an increase of$0.6 million in facility and other expenses. -
General and Administrative (G&A) Expenses: G&A expenses were
$6.8 million for the three months endedDecember 31, 2023 , compared to$6.6 million during the same period in 2022. The$0.2 million increase was primarily driven by an increase of$0.9 million in payroll and personnel expenses. This increase was partially offset by a$0.4 million decrease in professional fees and a$0.4 million decrease in facility and other expenses. -
Net Loss: Net loss for the three months ended
December 31, 2023 was$29.5 million , or a net loss of$0.69 per basic and diluted share, including non-cash stock-based compensation expense of$4.9 million , as compared to a net loss of$29.9 million , or a net loss of$0.72 per basic and diluted share, including non-cash stock-based compensation expense of$4.3 million during the same period in 2022.
Twelve Months Ended
-
Research and Development (R&D) Expenses: R&D expenses were
$106.0 million for the year endedDecember 31, 2023 , compared to$71.2 million for the year endedDecember 31, 2022 . The$34.8 million increase was primarily driven by an$11.5 million increase in payroll and personnel expenses resulting from an increase in overall headcount, a net$10.7 million increase in expenses related to CDMOs, CROs and consultant costs related to our lead product candidate ADI-001, a$8.5 million increase in facility and other expenses and a$4.1 million increase in lab expenses. -
General and Administrative (G&A) Expenses: G&A expenses were
$26.5 million for the year endedDecember 31, 2023 , compared to$26.3 million for the year endedDecember 31, 2022 . The$0.2 million increase was primarily driven by a$3.3 million increase in payroll and personnel expenses, which includes an increase in stock-based compensation of$1.2 million , salaries and benefits of$1.0 million and contractor fees of$0.9 million and an increase in recruiting fees of$0.3 million . These increases were primarily due to increased headcount for the period. The overall increase was partially offset by a$2.6 million decrease in facilities and other related expenses. -
Goodwill Impairment:
Goodwill was impaired by$19.5 million during the year endedDecember 31, 2023 following the results of an interim impairment test conducted during the period. This represented the entire remaining balance of goodwill. -
Net Loss: Net loss for the year ended
December 31, 2023 was$142.7 million , or a net loss of$3.31 per basic and diluted share, including non-cash stock-based compensation expense of$20.3 million , as compared to a net loss of$69.8 million , or a net loss of$1.70 per basic and diluted share, including non-cash stock-based compensation expense of$17.1 million during the same period in 2022. -
Cash Position: Cash and cash equivalents were
$159.7 million as ofDecember 31, 2023 , compared to$257.7 million as ofDecember 31, 2022 . Subsequent toDecember 31, 2023 , the Company received$91.8 million of net proceeds from an underwritten public offering and$19.3 million of net proceeds under its ATM program. The Company expects that its cash and cash equivalents as ofDecember 31, 2023 , together with the proceeds raised subsequent to year end, will be sufficient to fund its operating expenses into the second half of 2026.
About
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 the 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 and ADI-270, including the potential submission or timing of clearance of INDs in autoimmune diseases, and the potential safety, durability, tolerability and efficacy of these product candidates; the progress, timing and success of the Company’s ongoing and planned Phase 1 clinical trials of ADI-001 in autoimmune diseases and cancer, including expectations for site activation, enrollment and data readouts; the Company’s plan to expand into other autoimmune indications in the future; the Company’s expectations regarding regulatory filings and clearances, including the submission of an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024; and expectations regarding the Company’s 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 global economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical studies, 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 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; and regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. 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
Consolidated Statements of Operations (in thousands, except share and per share amounts) |
||||||||||||||||
|
Three Months Ended
|
|
Year Ended
|
|||||||||||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
Revenue—related party |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
24,990 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
|
24,759 |
|
|
|
25,015 |
|
|
|
106,043 |
|
|
|
71,246 |
|
General and administrative |
|
|
6,807 |
|
|
|
6,550 |
|
|
|
26,533 |
|
|
|
26,295 |
|
|
|
|
— |
|
|
|
— |
|
|
|
19,462 |
|
|
|
— |
|
Total operating expenses |
|
|
31,566 |
|
|
|
31,565 |
|
|
|
152,038 |
|
|
|
97,541 |
|
Loss from operations |
|
|
(31,566 |
) |
|
|
(31,565 |
) |
|
|
(152,038 |
) |
|
|
(72,551 |
) |
Interest income |
|
|
2178 |
|
|
|
2,179 |
|
|
|
9,978 |
|
|
|
3,760 |
|
Interest expense |
|
|
— |
|
|
|
(26 |
) |
|
|
(25 |
) |
|
|
(80 |
) |
Other expense, net |
|
|
(101 |
) |
|
|
(463 |
) |
|
|
(573 |
) |
|
|
(919 |
) |
Loss before income tax provision |
|
|
(29,489 |
) |
|
|
(29,875 |
) |
|
|
(142,658 |
) |
|
|
(69,790 |
) |
Income tax provision |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(29,489 |
) |
|
$ |
(29,875 |
) |
|
$ |
(142,658 |
) |
|
$ |
(69,790 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.69 |
) |
|
$ |
(0.72 |
) |
|
$ |
(3.31 |
) |
|
$ |
(1.70 |
) |
Weighted-average common shares used in computing net loss per share, basic and diluted |
|
|
43,035,315 |
|
|
|
41,651,298 |
|
|
|
43,042,405 |
|
|
|
41,080,286 |
|
Consolidated Balance Sheets (in thousands) |
||||||||
|
|
|
|
|||||
|
|
2023 |
|
2022 |
||||
Cash and cash equivalents |
|
$ |
159,711 |
|
|
$ |
257,656 |
|
Working capital |
|
|
142,985 |
|
|
|
241,331 |
|
Total assets |
|
|
207,295 |
|
|
|
330,690 |
|
Accumulated deficit |
|
|
(380,772 |
) |
|
|
(238,114 |
) |
Total stockholders’ equity |
|
|
170,175 |
|
|
|
292,338 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240319090811/en/
Investor and Media Contacts
abowdidge@adicetbio.com
Stern Investor Relations, Inc.
212-362-1200
janhavi.mohite@sternir.com
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