Cellectis Announces Q2 2024 Financial Results

Cellectis, a clinical-stage biotechnology company focused on developing groundbreaking cell and gene therapies through its pioneering gene-editing platform, has announced substantial progress and financial results for the first half of 2024. The company has seen significant milestones, especially in regulatory designations and financial performance, reflecting its commitment to advancing healthcare innovations.

A major highlight from the past months includes the receipt of Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the FDA for UCART22, aimed at treating acute lymphoblastic leukemia (ALL). This recognition also extends to the European Commission, which granted ODD for the same therapeutic candidate. These designations are crucial as they can expedite the development, approval, and commercialization processes, providing potential regulatory, financial, and commercial incentives. UCART22 is particularly significant for patients with relapsed or refractory ALL who have limited treatment options.

On August 1, 2024, the FDA further extended its support by granting ODD to Cellectis’ investigational medicinal product CLLS52 (alemtuzumab), which is used as part of the lymphodepletion regimen in conjunction with UCART22, as evaluated in the BALLI-01 clinical trial. This regimen has shown importance in sustaining lymphodepletion and enhancing UCART22 cell expansion, leading to improved clinical activity.

Cellectis is actively enrolling patients in several key clinical trials, including BALLI-01 for relapsed or refractory B-cell acute lymphoblastic leukemia, NatHaLi-01 for relapsed or refractory B-cell non-Hodgkin lymphoma, and AMELI-01 for relapsed or refractory acute myeloid leukemia. The company anticipates further updates on these trials by the end of 2024.

In terms of research and development, Cellectis announced a major breakthrough in a non-viral gene therapy approach for sickle cell disease (SCD). Published in Nature Communications on June 12, 2024, the company demonstrated the efficacy of a clinically relevant gene editing process using TALEN® technology. This process enables precise correction of the HBB gene in hematopoietic stem and progenitor cells (HSPCs), resulting in significant expression of normal adult hemoglobin and correction of the sickle phenotype without adverse effects.

On the partnership front, Cellectis has initiated an arbitration proceeding to terminate its License Agreement with Servier and seek compensation for losses due to inadequate development and unpaid milestones. Additionally, Allogene announced an Amendment and Settlement Agreement in May 2024, which expanded the licensed territory for anti-CD19 CAR T cell product candidates to include the European Union, the United Kingdom, China, and Japan.

Corporate updates include a significant investment from AstraZeneca. On May 6, 2024, AstraZeneca completed a $140 million investment in Cellectis, acquiring 10,000,000 "class A" and 18,000,000 "class B" convertible preferred shares. This investment has resulted in AstraZeneca holding approximately 44% of Cellectis' share capital and 30% of its voting rights. Following this investment, Marc Dunoyer and Dr. Tyrell Rivers were nominated to Cellectis' board of directors, representing AstraZeneca.

Financially, the company reported a consolidated cash position of $273 million as of June 30, 2024, compared to $156 million as of December 31, 2023. This increase is primarily attributed to investments, revenue inflows, and cash management strategies. Cellectis projects that its current cash reserves will fund operations into 2026.

For the first half of 2024, revenues and other income totaled $16.0 million, a significant increase from $5.6 million in the same period of 2023. This rise is mainly due to revenues recognized from the Joint Research and Collaboration Agreement with AstraZeneca and milestones achieved under the License Agreement with Servier. Research and development expenses also saw an increase, primarily driven by heightened manufacturing activities to support the R&D pipeline.

Cellectis reported a net loss attributable to shareholders of $19.6 million for the six months ended June 30, 2024, a substantial improvement from a $41.8 million loss in the same period of 2023. The improved financial performance is driven by increased revenues, reduced non-cash stock-based compensation expenses, and a positive net financial gain.

In conclusion, Cellectis continues to make significant strides across its clinical programs, research initiatives, and corporate partnerships, positioning itself strongly in the biotech landscape. With robust financial health and ongoing advancements in gene editing technologies, the company remains committed to developing innovative therapies for patients with unmet medical needs.