Loading...
•
Sep 30, 2024
Adicet Bio Q3 2024 Earnings Report
Reported financial results and operational highlights for the third quarter ended September 30, 2024.
Key Takeaways
Adicet Bio reported a net loss of $30.5 million for the third quarter of 2024, with cash, cash equivalents, and short-term investments totaling $202.1 million as of September 30, 2024. The company is advancing its clinical pipeline, including ADI-001 for autoimmune diseases and ADI-270 for solid tumors.
Expanded ADI-001 Phase 1 clinical trial to include six autoimmune disease indications.
Preliminary clinical data in lupus nephritis (LN) anticipated in 1H25.
Strong balance sheet with $202.1 million in cash, cash equivalents and short-term investments as of September 30, 2024.
Enrollment for Phase 1 trial of ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) is planned to open in the fourth quarter.
Adicet Bio
Adicet Bio
Forward Guidance
Adicet Bio anticipates advancing enrollment in clinical trials and expects to share preliminary clinical data from both lupus nephritis with ADI-001 and metastatic/advanced ccRCC with ADI-270 in the first half of 2025.
Positive Outlook
- The Company opened enrollment for patients with LN in 4Q24 and expects to initiate enrollment for patients with SLE, SSc, IIM, and SPS in 1Q25, and for patients with AAV in 2H25.
- The Company plans to report preliminary clinical data from the Phase 1 clinical study of ADI-001 in LN in 1H25, and for other autoimmune diseases in 2H25, subject to study site initiation and patient enrollment.
- FDA cleared the Company’s Investigational New Drug (IND) amendment application to evaluate ADI-001 in IIM and SPS as part of the Phase 1 clinical trial in autoimmune diseases.
- Adicet will present an oral abstract highlighting previously presented ADI-001 clinical biomarker data at ACR Convergence 2024 taking place November 14-19 in Washington, D.C.
- The Company expects that current cash, cash equivalents and short-term investments as of September 30, 2024, will be sufficient to fund its operating expenses into the second half of 2026.
Challenges Ahead
- 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.
- Regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable.
- 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.
- Positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies.