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Cellectis Bolsters Financial Position with AstraZeneca Collaboration, Advances CAR-T Pipeline

• Cellectis' cash reserves surged to $264 million, fueled by a strategic investment and collaboration revenue from AstraZeneca, extending the company's financial runway to 2027. • Three new R&D programs have been initiated with AstraZeneca, encompassing allogeneic CAR T therapies for hematological malignancies and solid tumors, plus an in vivo gene therapy. • The UCART123 program for relapsed/refractory acute myeloid leukemia is being deprioritized to concentrate resources on the more promising BALLI-01 and NATHALI-01 studies. • Phase I data for the BALLI-01 (UCART22) and NATHALI-01 (UCART20x22) studies are expected in 2025, with strong patient demand reported for the UCART20x22 program.

Cellectis, a biotechnology firm specializing in gene-editing therapies, announced its Third Quarter 2024 earnings, highlighting a strengthened financial position and advancements in its CAR-T pipeline, primarily driven by its collaboration with AstraZeneca.
The collaboration with AstraZeneca has spurred the initiation of three new research and development programs, including two allogeneic CAR T therapies and an in vivo gene therapy. Cellectis is shifting focus from the UCART123 program to prioritize assets with greater potential and aims to extend its cash runway to 2027.

Financial Highlights

Cellectis reported a substantial increase in cash reserves, rising to $264 million from $156 million at the end of 2023. This boost is largely attributed to a strategic investment from AstraZeneca, with $140 million received directly and $47 million in collaboration funding.
Arthur Stril, Chief Financial Officer of Cellectis, stated, "We have been able to extend our cash runway through a combination of milestones received from the progress of our partnerships as well as prudent cash management for our wholly owned R&D pipeline and controlled SG&A expenses."

Pipeline Updates

The company is prioritizing patient enrollment for clinical trials, particularly the BALLI-01 study evaluating UCART22 in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). Cellectis anticipates presenting Phase I data in 2025.
Adrian Kilcoyne, Chief Medical Officer, noted, "Recruitment in BALLI-01... has progressed well. We have now completed patient identification for all remaining open slots... to reach a total of 40 subjects treated... we expect the Phase I dataset to be available in 2025."
Cellectis is also enrolling patients in the NATHALI-01 study, which is assessing UCART20x22, a dual CAR-T asset, in relapsed/refractory non-Hodgkin lymphoma (NHL). This study addresses a critical unmet need for patients who have relapsed following multiple lines of therapy, including autologous CD19 CAR T-cell therapy.

Strategic Reprioritization

Cellectis is deprioritizing the UCART123 program for relapsed/refractory acute myeloid leukemia (AML) to concentrate on more promising assets. Despite encouraging early data, the company is focusing resources on programs with a higher likelihood of success, namely UCART22 and UCART20x22.

Future Outlook

Cellectis plans to present Phase I data in 2025 and remains committed to sharing significant updates and maintaining open communication with stakeholders. The company's strategic focus on its most promising assets and effective financial management positions it for continued progress and a stable financial outlook into 2027.
Andre Choulika, Chief Executive Officer of Cellectis, expressed confidence in the company's direction, stating, "We strongly believe that our product candidates, our technologies and our in-house manufacturing capabilities will lead us and our partners to a paradigm shift for patients with hard-to-treat cancers and genetic disorders."
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Reference News

[1]
Earnings call: Cellectis reports robust cash reserves, new R&D initiatives - Investing.com
investing.com · Nov 6, 2024

Cellectis reported a $108 million increase in cash reserves to $264 million, driven by a $140 million investment from As...

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