Adicet Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress
- None.
- Net loss increased in Q4 2023 compared to the same period in 2022, with higher R&D and G&A expenses. Goodwill impairment of $19.5 million in 2023 impacted the financials. Cash and cash equivalents decreased from $257.7 million in 2022 to $159.7 million in 2023.
- R&D expenses surged to $106.0 million in 2023 from $71.2 million in 2022, driven by payroll, CDMOs, CROs, and consultant costs related to ADI-001. G&A expenses slightly increased to $26.5 million in 2023. Net loss rose to $142.7 million in 2023 from $69.8 million in 2022.
Insights
The FDA clearance of Adicet Bio's IND for ADI-001 targeting lupus nephritis marks a significant step forward for the company's clinical pipeline, potentially expanding its therapeutic reach beyond oncology into autoimmune diseases. This strategic move may diversify Adicet's portfolio and reduce reliance on its cancer therapies, potentially mitigating risk and opening new revenue streams. The initiation of the Phase 1 clinical trial in 2Q 2024 positions the company as a front-runner in applying gamma delta T cell platform technology to autoimmune conditions, a space that has seen less innovation compared to cancer immunotherapy.
Furthermore, the extended cash runway into 2H 2026, following a successful capital raise, provides the company with a cushion to pursue its clinical programs without the immediate need for additional financing, which is reassuring for investors concerned about dilution or funding risks. The financial stability may also give Adicet the flexibility to navigate through the typical uncertainties of clinical trials and regulatory approvals.
Adicet Bio's financial results for the fourth quarter and full year of 2023 indicate a controlled burn rate, with R&D expenses decreasing slightly despite the company's expansion into new clinical areas. The net loss has remained relatively stable, which could be interpreted as a positive sign of financial discipline in the high-cost biotech industry. However, the reported goodwill impairment of $19.5 million reflects a significant write-down of intangible assets, which may raise concerns about the company's previous acquisitions and their integration into the current business strategy.
The company's cash position, while lower at the end of 2023 compared to the previous year, is bolstered by the recent capital infusion. This financial maneuvering suggests a proactive approach to capital management, which is critical in an industry where cash flow is inherently unpredictable due to the nature of clinical development timelines and regulatory milestones.
The advancement of ADI-001 into a Phase 1 trial for lupus nephritis is a noteworthy development, given the unmet need in effective treatments for autoimmune diseases. The potential of ADI-001, based on its robust B-cell depletion and tissue tropism, underscores the innovation within Adicet's approach to cell therapy. However, the true test will come with the preliminary clinical data expected in late 2024 to early 2025, which will be critical in validating the therapeutic efficacy and safety profile of the treatment.
Additionally, the progress of ADI-001 in non-Hodgkin’s lymphoma and the preclinical development of ADI-270 for renal cell carcinoma shows a promising breadth of applications for the company's gamma delta T cell technology. The upcoming clinical updates in the second half of 2024 will be pivotal in assessing the viability of these therapies and their competitive edge in the oncology market.
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 Chen Schor, President and Chief Executive Officer at Adicet Bio. “We believe ADI-001 is ideally suited for the treatment of autoimmune diseases given its robust B-cell depletion consistent with other autologous CAR T therapies tested in autoimmune diseases, its tissue tropism potential in autoimmune diseases, and the safety and efficacy data observed in our Phase 1 study. In addition, ADI-001’s off-the-shelf availability and safety profile has the potential to make cell therapy for autoimmune diseases available to patients in community setting. We look forward to initiating the Phase 1 study in lupus nephritis in the second quarter of 2024 and are on track to expand the program to additional autoimmune indications.”
Mr. Schor continued: “In addition, we are continuing to enroll MCL patients in our ongoing Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma. With the completion of the successful capital raise and other net proceeds from stock sales under the at-the-market program in January, extending our cash runway into the second half of 2026, we are well-positioned to continue clinical execution across our pipeline through multiple upcoming milestones.”
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. In December 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. In March 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 $19.3 million
Financial Results for Fourth Quarter and Full Year 2023:
Three months Ended December 31, 2023
-
Research and Development (R&D) Expenses: R&D expenses were
$24.8 million $25.0 million $0.2 million $2.7 million $1.3 million $0.7 million $0.6 million -
General and Administrative (G&A) Expenses: G&A expenses were
$6.8 million $6.6 million $0.2 million $0.9 million $0.4 million $0.4 million -
Net Loss: Net loss for the three months ended December 31, 2023 was
$29.5 million $0.69 $4.9 million $29.9 million $0.72 $4.3 million
Twelve Months Ended December 31, 2023
-
Research and Development (R&D) Expenses: R&D expenses were
$106.0 million $71.2 million $34.8 million $11.5 million $10.7 million $8.5 million $4.1 million -
General and Administrative (G&A) Expenses: G&A expenses were
$26.5 million $26.3 million $0.2 million $3.3 million $1.2 million $1.0 million $0.9 million $0.3 million $2.6 million -
Goodwill Impairment: Goodwill was impaired by
$19.5 million -
Net Loss: Net loss for the year ended December 31, 2023 was
$142.7 million $3.31 $20.3 million $69.8 million $1.70 $17.1 million -
Cash Position: Cash and cash equivalents were
$159.7 million $257.7 million $91.8 million $19.3 million
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate 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 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
ADICET BIO, INC. 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 |
|
Goodwill impairment |
|
|
— |
|
|
|
— |
|
|
|
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 |
|
ADICET BIO, INC. Consolidated Balance Sheets (in thousands) |
||||||||
|
|
December 31, |
December 31, |
|||||
|
|
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/
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
Source: Adicet Bio, Inc.
FAQ
When is Adicet Bio initiating a Phase 1 clinical trial in lupus nephritis for ADI-001?
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