Welcome to our dedicated page for Cellectis news (Ticker: CLLS), a resource for investors and traders seeking the latest updates and insights on Cellectis stock.
About Cellectis
Cellectis (NASDAQ: CLLS) is a clinical-stage biopharmaceutical company at the forefront of gene-editing technologies, dedicated to developing innovative cancer immunotherapies and other therapeutic solutions. Leveraging over 18 years of expertise in genome engineering, Cellectis has established itself as a pioneer in the field, utilizing its proprietary TALEN® (Transcription Activator-Like Effector Nucleases) technology and PulseAgile electroporation system to create precise, next-generation therapies. These tools enable the company to harness the immune system's power to target and eliminate cancer cells effectively.
Core Focus: Allogeneic CAR-T and Gene-Edited HSPCs
Cellectis specializes in developing allogeneic Chimeric Antigen Receptor T-cells (UCART) for immuno-oncology applications. Unlike traditional autologous CAR-T therapies, which require harvesting and engineering a patient’s own cells, Cellectis’s allogeneic approach uses gene-edited donor cells. This innovation offers scalability, reduced manufacturing costs, and faster availability, making it a game-changer in cancer treatment. Additionally, the company is advancing gene-edited hematopoietic stem and progenitor cells (HSPCs) for therapeutic indications beyond oncology, showcasing its versatility in genome editing.
Proprietary Technologies
Cellectis’s competitive edge lies in its proprietary technologies:
- TALEN® Technology: A precise and versatile gene-editing tool that enables targeted modifications to DNA, ensuring high specificity and minimal off-target effects.
- PulseAgile Electroporation System: A cutting-edge delivery platform that enhances the efficiency of introducing genetic material into cells.
These technologies form the backbone of Cellectis’s product pipeline, enabling the development of innovative therapies that address unmet medical needs.
Market Position and Industry Context
Cellectis operates within the rapidly growing fields of immuno-oncology and precision medicine. The global demand for effective cancer therapies continues to rise, driven by advancements in biotechnology and an increasing understanding of the immune system's role in combating diseases. As a clinical-stage company, Cellectis focuses on research and development, with a pipeline of promising product candidates undergoing rigorous clinical trials. However, this stage also presents challenges, including regulatory approvals, high R&D costs, and competition from other biotech firms specializing in gene editing and CAR-T therapies.
Competitive Landscape
Key competitors in the gene-editing and CAR-T therapy space include CRISPR Therapeutics, Editas Medicine, and Intellia Therapeutics. Cellectis differentiates itself through its allogeneic approach, which offers significant advantages in scalability and cost-effectiveness. By addressing the limitations of autologous therapies, such as manufacturing complexity and patient-specific variability, Cellectis positions itself as a leader in next-generation cancer immunotherapies.
Challenges and Opportunities
While Cellectis’s innovative approach holds immense promise, the company faces several challenges. These include navigating a complex regulatory environment, managing high development costs, and competing in a crowded market. However, the potential rewards are substantial, with successful therapies offering transformative benefits for patients and significant market opportunities. The company’s focus on leveraging proprietary technologies and addressing unmet medical needs positions it well for long-term success.
Conclusion
Cellectis is a trailblazer in the biopharmaceutical industry, combining cutting-edge gene-editing technologies with a commitment to innovation in cancer immunotherapy and beyond. By leveraging its proprietary TALEN® technology and allogeneic approach, the company aims to revolutionize the treatment landscape, offering scalable, cost-effective solutions to some of the most pressing medical challenges. As a clinical-stage entity, Cellectis represents a high-risk, high-reward opportunity within the dynamic biotechnology sector.
Cellectis (NASDAQ: CLLS) announced that the FDA has granted Orphan Drug Designation (ODD) to CLLS52 (alemtuzumab), used in the lymphodepletion regimen for UCART22 in the BALLI-01 clinical trial for relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). The addition of alemtuzumab to the fludarabine and cyclophosphamide regimen has shown sustained lymphodepletion and higher UCART22 cell expansion, leading to greater clinical activity.
Cellectis invented the combination of CD52 knockout UCART cells with a lymphodepleting regimen containing an anti-CD52 antibody. The CD52 knockout aims to make UCART products resistant to alemtuzumab. ODD status may help expedite and reduce costs for development, approval, and commercialization of CLLS52 for ALL treatment.
Cellectis (NASDAQ: CLLS) announced that the FDA has granted Orphan Drug (ODD) and Rare Pediatric Disease Designation (RPDD) Status to its UCART22 product candidate for treating Acute Lymphoblastic Leukemia (ALL). ALL represents 10% of leukemia cases in the US, progressing rapidly and often fatal if untreated. The designations highlight UCART22's potential to address urgent needs in ALL treatment, especially for patients ineligible for stem cell transplantation or relapsing after other therapies.
UCART22, an allogeneic CAR T-cell therapy, is being evaluated in the BALLI-01 Phase 1/2 study. Recent data showed a 67% preliminary response rate at Dose Level 2 for UCART22-P2, manufactured by Cellectis. The company expects to provide updates on BALLI-01 by year-end 2024. These FDA designations may expedite development and reduce costs for UCART22.
On July 5, 2024, Cellectis provided an update on its share capital and voting rights as required by Article 223-16 of the French financial markets authority.
The company, listed on the Euronext Growth market under ISIN code FR0010425595, reported a total of 100,093,635 shares in its capital as of June 30, 2024.
The total number of voting rights for the same period was 88,029,364.
For any queries, media can contact Pascalyne Wilson, Director of Communications, or Patricia Sosa Navarro, Chief of Staff to the CEO. Investor relations are managed by Arthur Stril, Interim CFO, and Ashley R. Robinson from LifeSci Advisors.
Cellectis, a clinical-stage biotechnology company listed on Euronext Growth (ALCLS) and Nasdaq (CLLS), held its shareholders' general meeting on June 28, 2024, in Paris. Approximately 40% of shares were exercised during the meeting, resulting in the adoption of resolutions 1 through 28 and the rejection of resolution 29, aligning with management's recommendations. Detailed voting results and resolutions are accessible on Cellectis' official website.
Cellectis, a clinical-stage biotechnology company, has published a scientific article in Scientific Reports, revealing three key factors for efficient TALE base editing. This gene-editing technology, which does not create DNA breaks like CRISPR/Cas9, holds promise for treating genetic diseases by converting cytosine (C) to thymine (T). The study identifies spacer length, TALEB architecture, and surrounding base composition as critical elements for enhancing editing efficiency. This research deepens the understanding of TALE base editors, potentially expanding their therapeutic applications. The full article is available on the Scientific Reports website.
Cellectis announced a breakthrough in gene therapy for Sickle Cell Disease (SCD) using a non-viral approach published in Nature Communications. The therapy employs TALEN® technology for precise HBB gene correction in hematopoietic stem and progenitor cells (HSPCs). This method achieves over 50% expression of normal hemoglobin in treated cells, effectively correcting the sickle cell phenotype without adverse effects. The preclinical data shows promising therapeutic potential and efficient engraftment in animal models, indicating readiness for clinical application. This innovative approach offers hope for addressing SCD and other genetic diseases.
Cellectis has released its monthly update on share capital and voting rights as of May 31, 2024. The company, listed on Euronext Growth with ISIN code FR0010425595, reports a total of 100,093,635 shares in its capital. The number of voting rights stands at 88,029,374. For more details, media and investor relations contacts are provided.
Cellectis announced that the European Commission granted Orphan Drug Designation (ODD) to UCART22, its allogeneic CAR T product for treating Acute Lymphoblastic Leukemia (ALL).
UCART22 targets CD22 and is being evaluated in the Phase 1/2 BALLI-01 study, focusing on patients with relapsed/refractory ALL.
ALL accounts for 12% of all leukemia cases and progresses rapidly. The 10-year prevalence in the EU is estimated at 1.9 per 100,000 persons.
The ODD was based on preliminary clinical data showing UCART22's significant benefit in heavily pretreated patients. In December 2023, Cellectis reported encouraging data with a 67% response rate at Dose Level 2 for UCART22-P2.
ODD provides regulatory, financial, and commercial incentives.
Cellectis (Euronext Growth: ALCLS, NASDAQ: CLLS), a clinical-stage biotechnology company, will hold its annual general meeting on June 28, 2024, at 2:30 p.m. CET.
The meeting will take place at the Biopark auditorium, 11 rue Watt, 4th floor, 75013 Paris, France.
Details regarding the agenda and participation are available on the Cellectis website.
Cellectis reported its Q1 2024 financial results revealing key business updates and financial highlights. Key points include:
Completion of a $140M equity investment by AstraZeneca, pushing the company's cash position to $143M as of March 31, 2024, and extending its cash runway projection into 2026.
Revenues for Q1 2024 were $6.5M, a significant increase from $3.6M in Q1 2023.
R&D expenses rose to $22.3M from $21.1M, while SG&A expenses were relatively stable at $5.1M.
The company recorded a consolidated net income of $5.6M, compared to a net loss of $30.1M in Q1 2023.
Key clinical programs BALLI-01, NATHALI-01, and AMELI-01 continue to progress with updates expected by year-end 2024.
The appointment of Arthur Stril as Interim CFO was announced, and AstraZeneca now owns approximately 44% of Cellectis' share capital.
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