Aankondiging • Jun 11
Cellectis S.A. Presents Final Phase 1 Results of Lasme-Cel and Preliminary Results on Eti-Cel At Eha 2026 Congress Cellectis S.A. presented final Phase 1 data from the BALLI-01 clinical trial evaluating lasme-cel, a CD22 directed allogeneic CAR-T therapy, in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and preliminary data from the NATHALI-01 study evaluating eti-cel, a dual CD20 and CD22 directed CAR-T in relapsed/refractory B-cell non Hodgkin lymphoma (r/r B-NHL), at the European Hematology Association 2026 Annual Congress. 45 patients in third line and beyond (3L+) were treated in the BALLI-01 study. 15 patients were treated at the recommended Phase 2 dose and 7 in the target Phase 2 population. Patients were heavily pretreated with those in the target Phase 2 population receiving a median of 5 prior lines of therapy (Range 2-11). Almost all patients were previously treated with blinatumumab (82%) and were also heavily exposed to CD19 CAR-T (53%), CD22-directed antibody-drug conjugate (ADC) (56%) and many had a prior hematopoietic stem cell transplantation (HSCT) (47%). In the target Phase 2 population, an overall response rate (ORR) of 100% (7/7) was achieved with a complete remission/complete remission with incomplete count recovery (CR/CRi) rate of 57% (4/7). Of these, 75% achieved minimal residual disease negative (MRD-ve) status. All patients subsequently proceeded to HSCT. Lasme-cel demonstrated a manageable safety profile. Cytokine release syndrome (CRS) grade 3 occurred in 4% of patients. Immune effector cell-associated neurotoxicity syndrome (ICANS) grade 3 occurred in 4% of patients. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) grade 3 occurred in 2% of patients. All CRS, ICANS, and IEC-HS resolved. The Pivotal Phase 2 BALLI-01 trial is open for recruitment. The first interim analysis is expected in Fourth Quarter 2026. Oral Presentation: Safety and efficacy of UCART22 in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (B-ALL): results of the Phase 1 BALLI-01 trial. Date/Time: Saturday, June 13 at 5:15 - 6:30pm, local time. Session Title: Advances in the treatment of lymphoblastic leukemia. Session Room: K1. Abstract Number: 4689. Note: presentation slides will be uploaded to Cellectis' website concurrently with the live presentation. The NATHALI-01 preliminary data on the role of alemtuzumab in optimizing responses will be presented as a poster by Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France. Eti-cel is a highly differentiated product being the first allogeneic dual CAR-T targeting both CD20 and CD22, for patients with r/r B-NHL. As of the February 2026 data cutoff, 14 patients with r/r B-NHL had been treated across three dose levels, in a heavily pre-treated population with a median of 3 prior lines of therapy, 93% of whom had received prior CD19-directed CAR-T therapy, and all of whom presented with stage IV disease at baseline. In the optimal dose cohort, ORR and complete response (CR) were 88% and 63%, respectively. The analysis identified a positive correlation between alemtuzumab exposure and clinical outcomes: higher alemtuzumab exposure created a favorable lower inflammatory homeostatic milieu prior to eti-cel infusion and was associated with enhanced eti-cel expansion and higher response rates. Additionally, responders maintained sustained low-level interleukin 2 (IL-2) secretion when compared to non-responders. These findings provide a scientific rationale for the implementation of a weight-based alemtuzumab dosing regimen, currently under investigation to optimize lymphodepletion. Additionally, subcutaneous low-dose IL-2 is being investigated to further enhance eti-cel expansion and treatment response. The NATHALI-01 study is open for recruitment with the full Phase 1 clinical data expected in Fourth Quarter 2026. Poster Presentation: Alemtuzumab exposure and sustained IL-2 drive UCART20x22 expansion and clinical response in adults with relapsed or refractory B-cell non-Hodgkin lymphoma: NATHALI-01 study. Date/Time: Saturday, June 13 at 6:45 - 7:45pm, local time. Session: Poster Session 2. Poster Number: 4758. Note: poster presentation will be uploaded to Cellectis' website at the opening of the poster session. Aankondiging • Jun 10
Cellectis S.A. Receives FDA RMAT Designation for Lasme-Cel, the First Allogeneic Car-T Therapy in A Pivotal Trial for Patients with R/R B-All Cellectis S.A. announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22-targeting allogeneic CAR-T cell therapy product candidate, for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The granting of RMAT designation reflects the FDA's recognition of the potential for lasme-cel to address the unmet medical need faced by patients with r/r B-ALL. The RMAT designation is supported by Phase 1 BALLI-01 data demonstrating promising efficacy and a manageable safety profile. Final Phase 1 data from the BALLI-01 trial of lasme-cel will be presented in an oral session at the 2026 Congress of the European Hematology Association (EHA) this Saturday, June 13 at 5:15 – 6:30pm CET by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at MD Anderson Cancer Center in Houston. The BALLI-01 trial Pivotal Phase 2 is open for enrollment. Information on participant eligibility and participating clinical centers can be found on clinicaltrials: BALLI-01 (NCT04150497). Aankondiging • May 22
Cellectis S.A., Annual General Meeting, Jun 25, 2026 Cellectis S.A., Annual General Meeting, Jun 25, 2026. Location: at the biopark auditorium, 11 rue watt, 4th floor, 75013., paris France New Risk • May 13
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$41m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$41m free cash flow). Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$173m net loss in 3 years). Share price has been volatile over the past 3 months (9.3% average weekly change). Reported Earnings • May 13
First quarter 2026 earnings released: US$0.18 loss per share (vs US$0.18 loss in 1Q 2025) First quarter 2026 results: US$0.18 loss per share (improved from US$0.18 loss in 1Q 2025). Revenue: US$7.55m (down 37% from 1Q 2025). Net loss: US$17.8m (loss narrowed 2.0% from 1Q 2025). Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 53% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 51% per year but the company’s share price has only increased by 27% per year, which means it is significantly lagging earnings growth. Aankondiging • May 05
Cellectis S.A. to Report Q1, 2026 Results on May 11, 2026 Cellectis S.A. announced that they will report Q1, 2026 results After-Market on May 11, 2026 Aankondiging • Apr 29
Cellectis Presents Epigenetic Editing Platform To Turn Genes Off Without Altering DNA Cellectis presented new research on a TALE-based epigenetic editing approach, that does not cut or permanently modify the DNA sequence, making it a potentially safer alternative for genome editing, at the American Society of Gene and Cell Therapy annual meeting, that will be held on May 11-15, in Boston (MA). The data will be presented in a poster: Title: TALE-based epigenetic modulators show sustained knock-down of target genes in T-cells and HEPG2 via a high-throughput multiplex screening platform. Transcription activator-like effector-based epigenetic modulators (TALEM) are engineered fusion proteins consisting of a TALE DNA-binding domain with functional domains that mediate epigenetic modifications. These proteins can be precisely guided to a target location in the genome to switch genes on or off through a process known as epigenetic editing. Unlike traditional gene editing tools, this approach does not induce DNA breaks and DNA sequence modifications, making it a potentially safer alternative for genome editing. In this work, Cellectis developed a high-throughput screening system capable of rapidly assembling and testing hundreds of these TALEM, identifying which combinations are most effective at regulating a given gene. This strategy was used for two distinct genes: one highly expressed in hepatocytes (active in liver cells) and another implicated in T-cell dysfunction and exhaustion, a key challenge in cancer immunotherapy. In both cases, the approach achieved >90% reduction in gene activity, which remained stable throughout the study. Reported Earnings • Mar 20
Full year 2025 earnings: EPS and revenues exceed analyst expectations Full year 2025 results: US$0.67 loss per share (further deteriorated from US$0.41 loss in FY 2024). Revenue: US$79.6m (up 62% from FY 2024). Net loss: US$67.6m (loss widened 84% from FY 2024). Revenue exceeded analyst estimates by 8.3%. Earnings per share (EPS) also surpassed analyst estimates by 48%. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 51% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 51% per year but the company’s share price has only increased by 15% per year, which means it is significantly lagging earnings growth. Aankondiging • Mar 13
Cellectis S.A. to Report Q4, 2025 Results on Mar 19, 2026 Cellectis S.A. announced that they will report Q4, 2025 results at 5:40 PM, Central European Standard Time on Mar 19, 2026 New Risk • Jan 19
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 39% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$34m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 41% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (39% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$104m net loss in 2 years). Board Change • Nov 15
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was an independent director. The company's board is composed of: 1 new director. 2 experienced directors. 9 highly experienced directors. 5 independent directors (6 non-independent directors). Independent Director Andre Muller was the last independent director to join the board, commencing their role in 2025. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Aankondiging • Nov 14
Cellectis S.A. Announces Board Appointments Cellectis S.A. announced in September 2025, appointed Kimberly A. Box to its Board of Directors, strengthening the Company’s governance and commercialization strategy leadership capabilities. Ms. Box brings extensive leadership experience in technology operations, strategic transformation, and scaling innovation into global markets, including three decades at Hewlett Packard in multiple executive roles. Her appointment reinforces Cibus’ readiness for upcoming product launches and supports the Board’s focus on long-term value creation and commercial execution. In November 2025, Cibus appointed Craig Wichner to its Board of Directors, strengthening the Company's agricultural sector expertise and strategic advisory capabilities. His extensive experience in sustainable agriculture, farmland investment management, and data-driven business models brings valuable perspective as Cibus advances its productivity and sustainability trait programs toward commercialization. Mr. Wichner is the Founder and Managing Partner of Farmland LP, a leading U.S. farmland investment management firm with more than $350 million in assets and over 19,000 acres under management. Mr. Wichner also serves on the Board's Strategy Committee and the special committee evaluating strategic alternatives to maximize shareholder value. New Risk • Nov 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 42% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$34m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 42% per year for the foreseeable future. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$104m net loss in 2 years). Reported Earnings • Nov 09
Third quarter 2025 earnings released: EPS: US$0.01 (vs US$0.23 loss in 3Q 2024) Third quarter 2025 results: EPS: US$0.01 (up from US$0.23 loss in 3Q 2024). Revenue: US$37.2m (up 106% from 3Q 2024). Net income: US$589.0k (up US$23.6m from 3Q 2024). Profit margin: 1.6% (up from net loss in 3Q 2024). Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 30% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 44% per year but the company’s share price has only increased by 6% per year, which means it is significantly lagging earnings growth. Aankondiging • Nov 01
Cellectis S.A. to Report Q3, 2025 Results on Nov 07, 2025 Cellectis S.A. announced that they will report Q3, 2025 results After-Market on Nov 07, 2025 Aankondiging • Oct 31
Cibus, Inc. to Report Q3, 2025 Results on Nov 13, 2025 Cibus, Inc. announced that they will report Q3, 2025 results on Nov 13, 2025 Aankondiging • Sep 26
Factor Bioscience Files Complaint Against Cellectis, Inc. and Astrazeneca Alleging Infringement of Foundational Gene-Editing Patents Factor Bioscience Inc. (Factor) announced a complaint filed against Cellectis Inc., Cellectis SA, AstraZeneca PLC, AstraZeneca Ireland Limited, and AstraZeneca Holdings B.V. In the complaint, Factor alleges that Cellectis transformed its research program after learning about Factor's patented mRNA TALENs technology in 2013 and proceeded to illegally exploit that technology, including in its partnership with AstraZeneca, by infringing Factor's patents. The lawsuit focuses on the infringement of Factor's U.S. Patent Nos. 10,662,410, 10,829,738, and 10,982,229 – infringement that Cellectis has conducted itself and through a series of partnerships, including with AstraZeneca. For the past 14 years, Factor and its licensees have made tremendous strides towards making available breakthrough allogeneic cell therapies, including groundbreaking products for the treatment of cancer. Factor remains committed to increasing the accessibility of innovative therapeutic products through its internal development programs and in collaboration with its licensees and strategic partners. Reported Earnings • Aug 05
Second quarter 2025 earnings released: US$0.28 loss per share (vs US$0.28 loss in 2Q 2024) Second quarter 2025 results: US$0.28 loss per share (improved from US$0.28 loss in 2Q 2024). Revenue: US$9.50m (flat on 2Q 2024). Net loss: US$25.3m (flat on 2Q 2024). Revenue is forecast to grow 27% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 40% per year but the company’s share price has fallen by 10% per year, which means it is significantly lagging earnings. Aankondiging • Jul 29
Cellectis S.A. to Report Q2, 2025 Results on Aug 04, 2025 Cellectis S.A. announced that they will report Q2, 2025 results After-Market on Aug 04, 2025 Aankondiging • Jun 27
Cellectis S.A. Announces Board Changes During the Cellectis S.A.'s Combined General Meeting of Shareholders on June 26, 2025, André Muller was appointed as a Director of the Company’s Board of Directors, effective immediately. In addition, at the close of the Combined General Meeting of Shareholders, the term of Axel-Sven Malkomes expired and the previously announced resignation of Pierre Bastid became effective. In connection with the above-mentioned changes to the Board of Directors, the Board of Directors have appointed André Muller (Chair), Donald Bergstrom, and Rainer Boehm as the members of the Company’s Audit Committee. Each of Messrs. Muller, Bergstrom and Boehm is independent. Pharmaceuticals Ltd. a listed Swiss biotech company. Previously, Mr. Muller served as Chief Financial Officer of Idorsia Pharmaceuticals Ltd. and Actelion Pharmaceuticals Ltd. He held various financial positions at Pierre Fabre SA, an international pharmaceutical and dermo- cosmetics company. Mr. Muller holds a Master's degree in Business Administration from the EMLYON Business School in Lyon. New Risk • Jun 10
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.0% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 8.0% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$86m net loss in 2 years). Share price has been volatile over the past 3 months (8.7% average weekly change). Aankondiging • May 22
Cellectis S.A., Annual General Meeting, Jun 26, 2025 Cellectis S.A., Annual General Meeting, Jun 26, 2025. Location: 11 rue watt 4th floor, 75013, paris France Reported Earnings • May 14
First quarter 2025 earnings released: US$0.18 loss per share (vs US$0.079 profit in 1Q 2024) First quarter 2025 results: US$0.18 loss per share (down from US$0.079 profit in 1Q 2024). Revenue: US$12.0m (up 85% from 1Q 2024). Net loss: US$18.1m (down 421% from profit in 1Q 2024). Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 25% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 32% per year but the company’s share price has fallen by 26% per year, which means it is significantly lagging earnings. Aankondiging • Apr 29
Cellectis Presents Non-Viral Gene Editing and Base Editing Innovation at the ASGCT Annual Meeting Cellectis unveils research data on TALEN®?-mediated non-viral transgene insertion for advancing cellular and gene therapies, and advancements in genetic editing using TALE base editors (TALEB), at the Society of Gene and Cell Therapy (ASGCT) annual meeting, that will be held on May 13-17, 2025 in New Orleans. The data are presented in two posters: TALEN®?- Mediated non-viral Transgene Insertion for the Advancement of Cellular and Gene Therapies. Cell and gene therapy approaches can use gene-editing tools and introduce transgenes to modify disease-associated genes, thus providing a potential therapeutic solution for a wide array of diseases. In this work, Cellectis combines TALEN®?- mediated gene editing with non-viral delivery of transgene for advancing cellular and gene therapies. and explores gene insertion-efficacy and cellular health using single-stranded DNA (ssDNA) for payload delivery in different cell types. This innovative approach has the potential to address the challenges associated with traditional lentiviral viral methods or AAV-mediated transgene insertion such as manufacturing constraints, potential genomic toxicities or limited payload size. Research data show: Non-viral methods for gene editing: TALEN®? mediated gene editing combined with non-viral templates (linear and circular bDNA) can be used for highly efficient gene insertion in T-cells as well as hematopoietic stem and progenitor cells (HSPCs) promoting viability and insertion specificity. Advantages of Circular bDNA over viral vectors: Transcriptomic analysis and in vivo data demonstrate that bssDNA-mediated cell engineering allows better maintenance of HSPC fitness as well as more stable gene editing, compared to traditional viral donor template-mediated transgene delivery. The implementation of these gene-editing techniques holds significant potential for the development of next-generation therapies, aiming to provide alternative efficient, and safe therapeutic options for patients with cancer, autoimmune diseases, monogenic disorders, and various other conditions. TALE base editors (TaleB) are fusions of a transcription activator-like effector domain (TALE), split-DddA deaminase halves, and a uracil glycosylase inhibitor (UGI). The C-to-T class of TALEB edits double-stranded DNA by converting a cytosine (C) to a thymine (T) and does not involve DNA strandNick. This method also takes advantage of a highly precise and efficient knock-in of bODN in primary T cells to develop an assay to assess how the composition and spacer variations of target sequences affect TALEB activity/efficiency. Research data show: Efficiency of C-to-T editing: TALEB enables efficient conversion of C to T. Variations in target sequences and surrounding bases affecting editing efficiency. An educated choice of the TALEB architecture further allows to control the editing outcome. Assessment of off-target editing risks: Studies have been conducted to evaluate off-target editing, showing no detectable editing in primary cells at previously described sites, highlighting the specificity of TALEB for potential therapeutic applications. Aankondiging • Apr 25
Cellectis S.A. to Report Q1, 2025 Results on May 08, 2025 Cellectis S.A. announced that they will report Q1, 2025 results on May 08, 2025 New Risk • Mar 18
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €85.2m (US$93.2m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$62m net loss in 3 years). Share price has been volatile over the past 3 months (8.1% average weekly change). Market cap is less than US$100m (€85.2m market cap, or US$93.2m). Reported Earnings • Mar 14
Third quarter 2024 earnings released: US$0.23 loss per share (vs US$0.32 loss in 3Q 2023) Third quarter 2024 results: US$0.23 loss per share. Revenue: US$18.1m (up US$16.4m from 3Q 2023). Net loss: US$23.1m (loss widened 32% from 3Q 2023). Revenue is forecast to grow 25% p.a. on average during the next 4 years, compared to a 26% growth forecast for the Biotechs industry in France. Breakeven Date Change • Mar 14
No longer forecast to breakeven The 5 analysts covering Cellectis no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$126.2m in 2027. New consensus forecast suggests the company will make a loss of US$40.5m in 2027. Aankondiging • Mar 08
Cellectis S.A. to Report Q4, 2024 Results on Mar 13, 2025 Cellectis S.A. announced that they will report Q4, 2024 results at 5:40 PM, Central European Standard Time on Mar 13, 2025 New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 40% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$42m net loss in 3 years). Share price has been volatile over the past 3 months (8.0% average weekly change). New Risk • Jan 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of French stocks, typically moving 6.0% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$42m net loss in 3 years). Share price has been volatile over the past 3 months (6.0% average weekly change). Shareholders have been diluted in the past year (40% increase in shares outstanding). Buy Or Sell Opportunity • Jan 06
Now 27% overvalued after recent price rise Over the last 90 days, the stock has risen 2.9% to €1.91. The fair value is estimated to be €1.51, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has declined by 21% over the last 3 years. Earnings per share has grown by 22%. For the next 3 years, revenue is forecast to grow by 24% per annum. Earnings are also forecast to grow by 30% per annum over the same time period. Aankondiging • Nov 06
Cellectis Presents Multiple Strategies to Enhance Car T-Cell Efficacy in Solid Tumors at the SITC Annual Meeting Cellectis announced that pre-clinical data to enhance CAR T cell activity against solid tumors while preventing potential toxicity, will be presented at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC), that will take place on November 6-10, 2024 in Houston, Texas. The data will be presented in a poster: Title: Breaking barriers in solid tumors with SMART allogeneic CAR T-cells. Date /Time: November 9th, 2024 from 9:00am to 8:30pm ET. Presenter: Beatriz Aranda-Orgilles, Associate Director, Immuno Oncology at Cellectis. Poster number: 254. Despite the success of CAR T-cell therapies treating blood cancers, these cutting-edge technologies continue to face obstacles in solid tumors. A main barrier is the hostile tumor microenvironment (TME), which forms an
immunosuppressive barrier and restricts T-cell infiltration into the tumor. Other contributing causes such as
tumor antigen diversity or low expression of CAR-targeted tumor-associated antigens (TAA) in normal tissues can
lead to antigen escape or on-target off-tumor toxicity, respectively. These factors can lead to relapse and
pose a challenge for therapeutic safety. Cellectis presents several strategies using TALEN®-mediated gene editing to generate allogeneic CAR T-cells while repurposing PD-1 function with tightly regulated functionalities, with the objective to increase efficacy and avoid potential toxicities in solid tumors. Using in vitro and in vivo techniques, it show that TME-induced FAP-dependent expression of CAR tethers cytotoxic activity to the tumor area and can minimize potential "on-target off-tumor" toxicities. In a parallel approach, it integrate IL-12 into PD-1 regulatory elements to confine IL-12 to the TME and inactivate TGFBR2 to overcome TGFB1-mediated resistance. This strategy enhances proliferation and infiltration of CAR T-cells, while reducing tumor burden and limiting side effects. Overall, its data show the potential of repurposing immune pathways to create armored allogeneic CAR T-cells with enhanced activity in immunosuppressive microenvironments while minimizing potential safety issues. These approaches have the potential to provide a therapeutic option for patients with solid malignancies. Reported Earnings • Nov 05
Third quarter 2024 earnings released: US$0.23 loss per share (vs US$0.32 loss in 3Q 2023) Third quarter 2024 results: US$0.23 loss per share. Revenue: US$18.1m (up US$16.4m from 3Q 2023). Net loss: US$23.1m (loss widened 32% from 3Q 2023). Revenue is forecast to grow 32% p.a. on average during the next 3 years, compared to a 31% growth forecast for the Biotechs industry in France. Aankondiging • Oct 31
Cellectis S.A. to Report Q3, 2024 Results on Nov 04, 2024 Cellectis S.A. announced that they will report Q3, 2024 results After-Market on Nov 04, 2024 New Risk • Aug 11
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 80% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (80% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$35m net loss in 3 years). Share price has been volatile over the past 3 months (7.2% average weekly change). Reported Earnings • Aug 07
Second quarter 2024 earnings released: US$0.28 loss per share (vs US$0.089 loss in 2Q 2023) Second quarter 2024 results: US$0.28 loss per share (further deteriorated from US$0.089 loss in 2Q 2023). Revenue: US$9.50m (up 375% from 2Q 2023). Net loss: US$25.3m (loss widened 405% from 2Q 2023). Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 32% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 46% per year, which means it is significantly lagging earnings. Aankondiging • Aug 07
Cibus, Inc. Achieves Positive Initial Field Trial Results for Stacked Gene Editing Herbicide Tolerant Traits in Rice Cibus Inc. announced that it has positive initial field trial results of a novel weed management solution for rice farmers. Initial results have shown that using two herbicides provided an excellent weed management system in rice. If ultimately successful, stacking gene edited herbicide tolerant (HT) traits in a rice variety would enable the use of two herbicides with difference modes of action to control weeds. Rice containing stacked gene edited herbicide tolerant traits would allow farmers ultimately to use a comprehensive weed management solution. This stacked trait product would give farmers an excellent solution to manage weeds that impact yield and quality and would be applicable to many rice markets globally, providing a broader weed control solution to further reduce the risk of resistant weeds that often occur over time when using one mode of action herbicide. Cibus believes stacked traits are a key element of modernizing crop breeding. Gene editing provides the ability to develop complex traits more efficiently and to address major farming yield constraints such as weeds, disease and inefficient fertilizer use. Cibus is seeking to address each of these problems in its trait development pipeline. Importantly, Cibus is a leader in the development of gene edited traits in plants like herbicide tolerance in Rice. The Company's plant trait intellectual property is developed using its Rapid Trait Development System (RTDS®?) including Gene Repair Oligonucleotides (GRON) and molecular scissors including Transcription activator-like effector nucleases (TALENs). Aankondiging • Jun 14
Cellectis Announces the Publication of A Scientific Article in Nature Communications Cellectis S.A. announced the publication of a scientific article in Nature Communications, unveiling a non-viral gene therapy approach for sickle cell disease. Sickle cell disease (SCD) is one of the most common inherited diseases worldwide. SCD is caused by a single point mutation in the HBB gene, which encodes the subunit of hemoglobin (Hb). normally, red blood cells adopt a disc-like shape that allows them to move easily through the blood vessels and deliver oxygen throughout the body. In sickle cell disease, red blood cells become crescent or sickle"-shaped, a dysfunctional state that impacts blood flow, oxygen delivery and triggers multiple debilitating symptoms including intense pain crisis. Cellectis leverages TALEN technology and a non-viral gene repair template delivery to develop a clinically relevant gene editing process in hematopoietic stem and progenitor cells (HSPCs). This process enables efficient HBB gene correction with high precision, specificity and minimal genomic adverse events. Applying this HBB gene correction process to SCD patient-HSPCs results in over 50% expression of normal adult hemoglobin in mature red blood cells and in the correction of sickle phenotype, without inducing -thalassemic phenotype. Edited HSPCs engraft efficiently in an immunodeficient murine model and maintain clinically relevant levels of HBB gene correction events. This comprehensive preclinical data package sets the stage for the therapeutic application of autologous gene corrected HSPCs to address SCD. New Risk • Jun 12
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$78m Forecast net loss in 3 years: US$55m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (80% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$55m net loss in 3 years). Reported Earnings • May 29
First quarter 2024 earnings released: EPS: US$0.079 (vs US$0.49 loss in 1Q 2023) First quarter 2024 results: EPS: US$0.079 (up from US$0.49 loss in 1Q 2023). Revenue: US$6.50m (up 83% from 1Q 2023). Net income: US$5.64m (up US$31.0m from 1Q 2023). Profit margin: 87% (up from net loss in 1Q 2023). Revenue is forecast to grow 45% p.a. on average during the next 3 years, compared to a 36% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 43% per year, which means it is significantly lagging earnings. Aankondiging • May 29
Cellectis S.A. to Report Q1, 2024 Results on May 28, 2024 Cellectis S.A. announced that they will report Q1, 2024 results After-Market on May 28, 2024 Aankondiging • May 26
Cellectis S.A., Annual General Meeting, Jun 28, 2024 Cellectis S.A., Annual General Meeting, Jun 28, 2024. Location: 11 rue watt, paris France New Risk • May 23
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 80% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (80% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$10m net loss in 3 years). Share price has been volatile over the past 3 months (7.3% average weekly change). Aankondiging • May 03
Cellectis Announces Chief Financial Officer Changes Cellectis announced the resignation of Mr. Bing Wang from his position of the company with immediate effect, and the concomitant appointment of Mr. Arthur Stril as interim Chief Financial Officer, replacing Mr. Bing Wang. Mr. Stril joined the company in 2018 as Vice President, Corporate Development, and was appointed Chief Business Officer in 2020. He has been managing the company’s business development and portfolio management teams and most recently led the execution of the company’s strategic collaboration and investment agreements with AstraZeneca. As interim Chief Financial Officer, Mr. Stril will oversee the finance and investor relations functions, and continue to oversee the business development functions. He will remain based in the company’s New York office. Mr. Stril began his career at the European Commission’s Directorate-General for Competition, controlling global pharmaceutical mergers. He later became head of the Hospital Financing Unit at the French Ministry of Health. Since 2023, Mr. Stril serves on the board of directors of Primera Therapeutics as a director designated by the company. Mr. Stril graduated with a Master of Mathematics from Cambridge University and a Master of Physics from the École Normale Supérieure and holds immunotherapy and immuno-oncology diplomas from the University of Paris. Mr. Stril is also a member of the French Corps des Mines and is on the Board of Advisors of non-profit Life Science Cares. Reported Earnings • Apr 30
Full year 2023 earnings released: US$1.92 loss per share (vs US$1.99 loss in FY 2022) Full year 2023 results: US$1.92 loss per share. Net loss: US$109.5m (loss widened 21% from FY 2022). Revenue is forecast to grow 42% p.a. on average during the next 3 years, compared to a 35% growth forecast for the Biotechs industry in France. Breakeven Date Change • Apr 30
No longer forecast to breakeven The 7 analysts covering Cellectis no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$8.41m in 2026. New consensus forecast suggests the company will make a loss of US$10.0m in 2026. Aankondiging • Apr 23
Cellectis Presents Novel TALEN® Editing Processes Enabling Highly Efficient Gene Correction and Gene Insertion in HSPCs Cellectis will present first data exploring novel TALEN® editing processes in hematopoietic stem and progenitor cells (HSPCs) at the American Society of Gene and Cell Therapy (ASGCT) being held on May 7 to 11, 2024. Poster presentation: Intron Editing of HSPC Enables Lineage-Specific Expression of Therapeutics: Gene therapy using edited hematopoietic and progenitor stem cells (HSPCs) has the potential to provide a lifelong supply of genetically encoded therapeutics. The most therapies are impacted with the difficulty to cross the blood-brain barrier (BBB). The BBB is a continuous endothelial membrane that, along with pericytes and other components of the neurovascular unit, limits the entry of toxins, pathogens, protein and small molecules to the brain. Cellectis has developed a TALEN® mediated promoter-less intron editing technology that enables the expression of a therapeutic transgene exclusively by monocyte derived from edited HSPCs. The edited cells containing genetically encoded therapeutic proteins have the capacity to cross the blood-brain barrier and secrete the corresponding therapeutic within the brain. This novel editing approach is an important addition to the HSPC gene editing toolbox that might unlock new strategies for the treatment of metabolic and neurological diseases. Research data showed that: Intron editing can be performed within B-cell, T-cell, Monocyte-specific endogenous genes (CD20, CD4 and CD11b, respectively); Intron editing allows expression of transgenes in a lineage-specific manner without markedly impacting the expression of the endogenous gene targeted; Editing of CD11b intron using a therapeutic transgene encoding IDUA (the enzyme missing in Type-1 Mucopolysaccharidosis patients) enables to restrict the expression of IDUA to the myeloid lineage; Edited HSPCs efficiently engraft in the bone-marrow of immunodeficient mice and differentiate into edited myeloid cells that can cross the BBB and populate the brain; The intron editing strategy described in this work is versatile and could be potentially used to vectorize multiple genetically encoded-therapeutic proteins to the brain and thus address multiple metabolic and neurological disorders. Poster presentation: Circularization of Non-Viral Single-Strand DNA Template for Gene Correction and Gene Insertion Improves Editing Outcomes in HSPCs: The most of the gene insertion approaches used to edit HSPCs ex vivo are hampered by the low efficiency of DNA template delivery into their nucleus. Cellectis has developed and optimized a novel gene editing process, leveraging the TALEN® technology and circular single strand DNA template delivery, enabling highly efficient gene insertion in HSPCs. Research data showed that: Non-viral single strand DNA delivery associated to TALEN® technology allows gene insertion in long-term repopulating hematopoietic stem cells; Circularization of the single strand DNA further increases the rates of gene insertion without impacting cellular viability and fitness of HSPCs, facilitating the development of next generation of ex vivo cell therapies. Aankondiging • Dec 23
Cellectis S.A. Announces Board Appointments Cellectis S.A.'s shareholders also approved the appointments of Mr. Marc Dunoyer and Dr. Tyrell Rivers as directors of the Cellectis board of directors, which appointment remains subject to the completion of the Additional Investment. Mr. Marc Dunoyer is Chief Strategy Officer of AstraZeneca and Chief Executive Officer of Alexion, AstraZeneca Rare Disease. He had previously served as an Executive Director and AstraZeneca’s Chief Financial Officer from November 2013. Mr. Marc Dunoyer’s career in pharmaceuticals, which has included periods with Roussel Uclaf, Hoechst Marion Roussel and GSK, has given him extensive industry experience. He is a qualified accountant and joined AstraZeneca in 2013, serving as Executive Vice-President, Global Product and Portfolio Strategy from June to October 2013. Prior to that, he served as Global Head of Rare Diseases at GSK and (concurrently) Chairman, GSK Japan. Mr. Dunoyer is a member of the Boards of Orchard Therapeutics Plc and JCR Pharmaceuticals. He holds an MBA from HEC Paris and a Bachelor of Law degree from Paris University. Dr. Tyrell Rivers is Executive Director of Corporate Ventures at AstraZeneca, where he is responsible for creating and executing innovative, value-enhancing business strategies. Prior to assuming this role in 2014, he worked at MedImmune Ventures, specializing in life science investing. Earlier in his career, Dr. Rivers held various positions at Merck & Co., where he led technical support for commercial vaccines and directed global business initiatives for accessing key technologies for research and development. He currently serves as a Board member of ADC Therapeutics, Cerapedics, and Quell Therapeutics. Dr. Rivers holds his B.S. in Chemical Engineering from the Massachusetts Institute of Technology, a Ph.D. in Chemical Engineering from the University of Texas at Austin, and an M.B.A. from the New York University Stern School of Business. New Risk • Nov 10
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 57% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (54% average weekly change). Shareholders have been substantially diluted in the past year (57% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). New Risk • Nov 09
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$72m Forecast net loss in 3 years: US$20m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$76m free cash flow). Share price has been highly volatile over the past 3 months (54% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). New Risk • Nov 08
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$76m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$76m free cash flow). Share price has been highly volatile over the past 3 months (54% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Reported Earnings • Nov 08
Third quarter 2023 earnings released: US$0.31 loss per share (vs US$0.63 loss in 3Q 2022) Third quarter 2023 results: US$0.31 loss per share (improved from US$0.63 loss in 3Q 2022). Revenue: US$1.64m (down 14% from 3Q 2022). Net loss: US$17.5m (loss narrowed 39% from 3Q 2022). Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 8% per year but the company’s share price has fallen by 46% per year, which means it is significantly lagging earnings. Aankondiging • Nov 02
Cellectis S.A. to Report Q3, 2023 Results on Nov 06, 2023 Cellectis S.A. announced that they will report Q3, 2023 results After-Market on Nov 06, 2023 New Risk • Nov 01
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 54% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (54% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (€50.0m market cap, or US$52.7m). Board Change • Oct 29
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was an independent director. The company's board is composed of: 1 new director. 7 experienced directors. 4 highly experienced directors. 2 independent directors (7 non-independent directors). Independent Non-Executive Chairman JP Garnier was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Aankondiging • Oct 13
Cellectis and Imagine Institute Publish A Proof-Of-Concept Study of A Gene Surgery Candidate to Treat Activated Phosphoinositide 3-Kinase ? Syndrome Type 1 (APDS1) Cellectis announced the publication of a new research paper in Molecular Therapy -- Methods & Clinical Development, demonstrating the efficacy of its TALEN-mediated gene correction of mutated PIK3CD gene in APDS1 T-cells. The research work described in this article was jointly conducted by Imagine Institute and Cellectis teams. About APDS1: Activated phosphoinositide 3-kinase syndrome (also known as APDS type 1 or APDS1) is a rare but devastating disease caused by gain-of-function mutations in the PIK3CD gene and resulting in a combined immunodeficiency. Approved treatments for APDS1 consist in prophylactic measures including long term antibiotics and Ig (immunoglobulin) replacement therapy. Allogeneic hematopoietic stem/progenitor cell (HSPC) transplantation has been proposed as a definitive treatment for APDS1. However, the lack of compatible donor as well as graft failure, graft instability, and poor graft function are still major challenges that must be overcome to reach a positive therapeutic outcome. Thus, so far there are neither optimal nor long-term therapeutic solutions for APDS1 patients and new alternative treatments are highly regarded. The study published here aims at exploring an alternative therapeutic strategy by correcting the mutated PIK3CD gene associated to APDS1 by gene editing. This article describes a TALEN®-mediated gene insertion strategy that allows targeted correction of the dominant gain-of-function mutation of the PIK3CD gene by insertion of a functional sequence in a precise manner. Results show efficient gene insertion in APDS1 patients’ T-cells, normalization of PI3K signaling and rescue of T-cell cytotoxic functions. Preclinical results demonstrated that: The PIK3CD gene can be efficiently corrected by TALEN®-mediated gene insertion of the functional PIK3CD DNA sequence vectorized by AAV, in healthy donor and APDS1 patient T-cells. TALEN®-mediated PIK3CD gene correction rescues PI3K signaling in APDS1 patient T-cells. TALEN®-mediated PIK3CD gene correction normalizes the transcriptomic status of APDS1 patient CD8+ T-cells and rescues their cytolytic activity. In summary, demonstrate that the PIK3CD dominant gain of function mutation associated to APDS1 can be successfully corrected in APDS1 patient T-cells using TALEN® gene editing and AAV-based DNA repair matrix. This correction rescues the cytolytic function of APDS1 T-cells, normalizes their intracellular phospho-AKT levels found at basal and at activated states as well as the transcriptomic signature of certain genes involve in T-cells’ cytolytic function, activation, and fitness. Reported Earnings • Aug 06
Second quarter 2023 earnings released: US$0.09 loss per share (vs US$0.42 loss in 2Q 2022) Second quarter 2023 results: US$0.09 loss per share (improved from US$0.42 loss in 2Q 2022). Revenue: US$2.00m (down 28% from 2Q 2022). Net loss: US$5.00m (loss narrowed 74% from 2Q 2022). Revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 26% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings. Aankondiging • Jul 29
Cellectis S.A. to Report Q2, 2023 Results on Aug 03, 2023 Cellectis S.A. announced that they will report Q2, 2023 results at 5:40 PM, Central European Standard Time on Aug 03, 2023 Aankondiging • Jun 01
Cellectis Publishes an Article in Cancer Immunology Research Demonstrating Preclinical Evidence of UCART20x22 Product Candidate to Target a Broad Spectrum of Patients with B-Cell Malignancies Cellectis published an article in Cancer Immunology Research demonstrating pre-clinical proof-of-concept data of UCART20x22 product candidate, Cellectis’ first allogeneic dual CAR T-cell targeting the CD20 and CD22 antigens, to overcome current mechanisms of resistance to CAR T-cell therapies in B-cell Non-Hodgkin lymphoma (B-NHL), while providing a potential alternative to CD19 directed therapy. B-cell Non-Hodgkin lymphoma (B-NHL) remains one of the most common cancers worldwide, with reports an estimate of 544,000 new cases and 260,000 deaths worldwide in 2020. Despite the efficacy of current CAR T-cell therapies, studies on patients treated with autologous CAR T-cells are revealing several causes for relapses that includes: antigen loss, low antigen expression or insufficient CAR T-cell potency and persistence, among others. While several suitable targets to treat B-cells malignancies have been identified, CD19 has been the focus of attention leading to a crowded space with limited therapeutic alternatives for CD19 low or negative relapses. The limited amount of eligible treatment options after relapse from autologous CAR T-cell therapy or for patients not eligible for autologous therapies, underscores the urgent need to develop novel therapies with the potential to improve patient outcome. To address these challenges, Cellectis developed UCART20x22, its first allogeneic dual CAR T-cell product candidate targeting two validated antigens commonly expressed in B-cell malignancies, CD20 and CD22, and whose expression is preserved after CD19 CAR T-cell treatment. Cellectis provides pre-clinical proof of concept demonstrating potent and sustained activity of different designs of allogeneic CD20xCD22 CAR in vitro and in vivo against various antigen combinations and models recapitulating antigen escape, a current challenge in the field that can lead to treatment failure. Moreover, UCART20x22 is developed to be available off-the-shelf and to offer a solution for patients whose T-cells are not functional or for which autologous manufacturing fails. Preclinical data showed that: The use of a bicistronic vector favors the generation of dual CAR T-cells co- expressing both CD20 and CD22 CARs CAR T-cells efficiently and persistently eradicate double positive tumor cells over time. More importantly, compared to the single CAR, the dual CAR displayed similarly strong cytolytic activity over time against tumor cells expressing a single antigen, validating the benefit of using a dual CAR approach. Both CD20xCD22 CAR versions tested in this study potently targeted tumor cells in vivo in a dose dependent manner, with both doses of 3 and 10 million CAR T-cells achieving complete tumor clearance. Xenograft models mimicking antigen escape with an aggressive lymphoma model demonstrate that the dual CD20xCD22 CAR is capable to eliminate all tumors despite of losing one antigen, thus providing a potential solution for this challenge in the field. Bone marrow and spleen analysis of the surviving animals treated with the dual CAR at the end of the study, revealed that dual CAR T-cells efficiently eradicated the tumor and are capable to persist in the bone marrow for longer than one hundred days Primary NHL samples with variable levels of CD20 and CD22 can successfully be eradicated with the dual CD20xCD22 CAR suggesting that UCART20x22 has the potential to reach a large patient population. Full tumor elimination is achieved in a dose dependent manner in a Patient-Derived Xenograft (PDX) model recapitulating mantle cell lymphoma at day 20 with a dose of 3 million CAR T-cells or higher. UCART20x22 features TALEN®-mediated disruptions of the TRAC gene (to minimize the risk of graft-versus-host disease) and of the CD52 gene (to permit use of a CD52-directed monoclonal antibody in patients’ lymphodepletion regimen) to enhance CAR T engraftment, expansion and persistence. UCART20x22 is Cellectis’ first product candidate fully designed, developed and manufactured in-house at Cellectis. UCART20x22 is evaluated in the NATHALI-01 Phase 1/2a clinical study in patients with r/r B-NHL (NCT05607420). Aankondiging • May 23
Cellectis S.A., Annual General Meeting, Jun 27, 2023 Cellectis S.A., Annual General Meeting, Jun 27, 2023, at 14:30 Central Europe Standard Time. Location: Biopark auditorium, 11 rue Watt 4th floor, 75013 Paris France Agenda: To consider and approve the annual financial statements for the financial year ended December 31, 2022; to consider auditors’ report on the consolidated financial statements for the financial year ended December 31, 2022; to consider management report of the Group and presentation by the auditor of the annual financial statements for the financial year ended December 31, 2022; to consider and approve the consolidated financial statements for the financial year ended December 31, 2022; to consider appropriation of results for the financial year ended December 31, 2022; and to consider other business matters. Aankondiging • May 18
Cellectis S.A. Presents Clinical Data on AMELI-01 and Preclinical Data on Multiplex Engineering for Superior Generation of CAR T- Cells at ASGCT 2023 Cellectis S.A. presented clinical data on its Phase 1 AMELI-01 clinical trial (evaluating UCART123) that were unveiled in an oral presentation at the 64 American Society of Hematology (ASH) annual meeting, as well as preclinical data on multiplex engineering for superior generation of CAR T-cells, at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting. AMELI-01 is a Phase 1 open-label dose-escalation trial evaluating the safety, tolerability, expansion and preliminary activity of UCART123 given at escalating dose levels after lymphodepletion (LD) with either fludarabine and cyclophosphamide (FC) or FC with alemtuzumab (FCA) in patients with relapsed or refractory acute myeloid leukemia (r/r AML). The oral presentation reviewed preliminary data from patients who received UCART123 at one of the following dose levels: dose level 1 (DL1) 2.5x10 cells/kg; dose level 2 (DL2) 6.25x10 cells/kg; intermediate dose level 2 (DL2i) 1.5x10 cells/kg; or dose level 3 (DL3) 3.30x10 cells/kg after lymphodepletion with FC ([n=8, DL1 DL3) or FCA ([n=9, DL2 & DL2i). The FCA LD regimen resulted in robust lymphodepletion for greater than 28 days in all patients. Seven out of nine patients demonstrated UCART123 expansion, with maximum concentration (C) ranging from 13,177 to 330,530 cells/g DNA, an almost nine-fold increase compared with FC LD, and a significant increase in area under the curve (AUC) (0-28 days) (p=0.04; FC 10.2 versus FCA 34.9). Cytokine release syndrome (CRS) occurred in eight patients in the FC arm and nine patients in the FCA arm. In the FC arm, one patient experienced Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) and two patients experienced Grade 4 protocol-defined dose limiting toxicities (DLTs) secondary to CRS. In the FCA arm, two patients experienced Grade 5 DLTs secondary to CRS. Evidence of UCART123 anti-tumor activity was observed in four patients out of fifteen at DL2 or above with best overall responses in the FCA arm. Two out of eight patients (25%) at DL2 in the FCA arm achieved meaningful response: A patient who failed five prior lines of therapy experienced a durable minimal residual disease (MRD) negative complete response (CR) with full count recovery at Day 56 that continues beyond one year. A patient with stable disease achieved greater than 90% bone marrow blast reduction (60% to 5%) at Day 28. The preliminary data show that adding alemtuzumab to the FC LD regimen was associated with sustained lymphodepletion and significantly higher UCART123 cell expansion, which correlated with improved anti-tumor activity. Overall, these preliminary data support the continued administration of UCART123 after FCA lymphodepletion in patients with r/r AML. Based on observed UCART123 expansion patterns and cytokine profiles, pursuant to an amended protocol, a second dose of UCART123 is given after 10-14 days to allow for additional UCART123 expansion and clinical activity without the use of additional lymphodepletion. The UCART123 cell expansion from thesecond dose of UCART123, in the setting of reduced disease burden, is expected to be safe and allow for clearance of residual disease. Aankondiging • May 13
Cellectis Publishes Article in Frontiers in Immunology Unveiling Pre-Clinical Data on A Novel Treatment Paradigm for Successful Car T Immunotherapy Against Stroma-Rich Solid Tumors Cellectis published an article in Frontiers Bioenginnering, demonstrating the efficacy of its TALEN® engineered FAP UCART-cells in cancer-associated fibroblast (CAF) depletion, reduction of desmoplasia and tumor infiltration. Adoptive cell therapy based on chimeric antigen receptor-engineered T (CAR-T) cells has proven to be lifesaving for many cancer patients. However, its therapeutic efficacy has so far been restricted to only a few malignancies, with solid tumors proving to be especially recalcitrant to efficient therapy. Poor intra-tumor infiltration by T cells and T cell dysfunction due to a desmoplastic, immunosuppressive microenvironment are key barriers for CAR T-cell success against solid tumors. Cancer-associated fibroblasts (CAFs) are critical components of the tumor stroma, evolving specifically within the tumor microenvironment (TME). The CAF secretome is a significant contributor to the extracellular matrix and a plethora of cytokines and growth factors that induce immune suppression. Together they form a physical and chemical barrier which induces a T cell-excluding ‘cold’ TME. CAF depletion in stroma rich solid tumors can thus provide an opportunity to convert immune evasive tumors susceptible to tumor-antigen CAR T-cell cytotoxicity. Cellectis used its TALEN®-based gene editing platform to engineer non-alloreactive, immune-evasive UCAR T-cells targeting the unique CAF marker Fibroblast Activation Protein, alpha (FAP) to test whether FAP UCAR T-cell pre-treatment can make ‘cold’ tumors susceptible to subsequent tumor-antigen targeting CAR T-cells. Cellectis also generated non-alloreactive CAR T-cells against the tumor associated antigen (TAA) Mesothelin which is overexpressed in most solid tumors including mesothelioma and large sub-sets of ovarian, breast, pancreatic and lung adenocarcinomas. The combination treatment strategy was tested in a pre-clinical mouse model of triple-negative breast cancer (TNBC), an aggressive, stroma-rich breast cancer sub-type with poor prognosis and very limited treatment options at present. Aankondiging • May 12
Cellectis Announces Poster Presentation on BALLI-01 at the European Hematology Association (EHA) 2023 Cellectis announced the release of an abstract, which was accepted for presentation at the European Hematology Association (EHA) Hybrid Congress, taking place on June 8-15, 2023 in Frankfurt, Germany. The company will present, in a poster session, updated clinical and translational data on its BALLI-01 clinical trial (evaluating UCART22) in patients with relapsed/refractory B-cell acute lymphoblastic Leukemia (r/r B-ALL). BALLI-01 investigation UCART22 product candidate in r/r B-ALL: The abstract includes preliminary clinical data from the Phase 1/2a, open label dose-escalation BALLI-01, in patients with r/r B-ALL having received UCART22 following lymphodepletion (LD) with either fludarabine, cyclophosphamide (FC) or FC with alemtuzumab (FCA). The data show that UCART22 was well tolerated and clinical responses were achieved. UCART22 continues to have a good safety profile, with no serious treatment emergent adverse events (TEAEs) or DLTs reported. Overall, these data support the safety and preliminary efficacy of UCART22 in a heavily pretreated r/r B-ALL population. UCART22 is a genetically modified allogeneic T-cell product manufactured from healthy donor cells. Donor-derived T-cells are transduced using a lentiviral vector to express the anti-CD22 chimeric antigen receptor (CAR) and are further modified using Cellectis’ TALEN® technology to disrupt the T-cell receptor alpha constant (TRAC) and CD52 genes to minimize risk of graft-vs-host disease (GvHD) and allow use of an anti-CD52 antibody for lymphodepletion (LD). Breakeven Date Change • Mar 09
No longer forecast to breakeven The 10 analysts covering Cellectis no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$23.2m in 2025. New consensus forecast suggests the company will make a loss of US$133.3m in 2025. Reported Earnings • Mar 09
Full year 2022 earnings released: US$1.99 loss per share (vs US$2.55 loss in FY 2021) Full year 2022 results: US$1.99 loss per share (improved from US$2.55 loss in FY 2021). Revenue: US$25.7m (down 61% from FY 2021). Net loss: US$90.8m (loss narrowed 21% from FY 2021). Revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 27% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has fallen by 39% per year, which means it is performing significantly worse than earnings. Buying Opportunity • Feb 21
Now 20% undervalued after recent price drop Over the last 90 days, the stock is down 4.1%. The fair value is estimated to be €2.81, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 4.9% over the last 3 years. Earnings per share has declined by 13%. For the next 3 years, revenue is forecast to grow by 48% per annum. Earnings is also forecast to grow by 25% per annum over the same time period. Aankondiging • Feb 08
Cellectis S.A. has completed a Follow-on Equity Offering in the amount of $22 million. Cellectis S.A. has completed a Follow-on Equity Offering in the amount of $22 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 8,800,000
Price\Range: $2.5
Discount Per Security: $0.15 Buying Opportunity • Feb 03
Now 35% undervalued The stock has been flat over the last 90 days. The fair value is estimated to be €3.65, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 4.9% over the last 3 years. Earnings per share has declined by 13%. For the next 3 years, revenue is forecast to grow by 48% per annum. Earnings is also forecast to grow by 25% per annum over the same time period. Aankondiging • Jan 22
Cellectis S.A. announced that it has received $20 million in funding from Cytovia Therapeutics, Inc. Cellectis S.A. announced a private placement and signed an agreement with Cytovia Therapeutics, Inc. for the gross proceeds of $20,000,000 (€18,458,698) on January 20, 2023. The company issued convertible notes in the transaction. Buying Opportunity • Jan 12
Now 22% undervalued Over the last 90 days, the stock is up 33%. The fair value is estimated to be €4.40, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 4.9% over the last 3 years. Earnings per share has declined by 13%. For the next 3 years, revenue is forecast to grow by 43% per annum. Earnings is also forecast to grow by 25% per annum over the same time period. Board Change • Jan 10
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 6 experienced directors. 5 highly experienced directors. Independent Non-Executive Chairman JP Garnier was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Jan 05
Cellectis S.A. Announces the Resignation of Alain Godard as a Member of the Board On December 31, 2022, Alain Godard informed the board of directors (the “Board”) of Cellectis S.A. (the “Company”) of his resignation as a member of the Board, effective immediately. Reported Earnings • Nov 05
Third quarter 2022 earnings released: US$0.63 loss per share (vs US$0.82 loss in 3Q 2021) Third quarter 2022 results: US$0.63 loss per share (improved from US$0.82 loss in 3Q 2021). Revenue: US$1.92m (down 82% from 3Q 2021). Net loss: US$28.5m (loss narrowed 24% from 3Q 2021). Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 24% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 41% per year, which means it is performing significantly worse than earnings. Major Estimate Revision • Aug 11
Consensus revenue estimates fall by 29% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$61.6m to US$43.5m. Forecast losses increased from -US$3.55 to -US$3.66 per share. Biotechs industry in France expected to see average net income growth of 9.8% next year. Consensus price target of €10.60 unchanged from last update. Share price rose 21% to €3.62 over the past week. Reported Earnings • Aug 07
Second quarter 2022 earnings released: US$0.42 loss per share (vs US$0.88 loss in 2Q 2021) Second quarter 2022 results: US$0.42 loss per share (up from US$0.88 loss in 2Q 2021). Revenue: US$2.76m (down 81% from 2Q 2021). Net loss: US$18.9m (loss narrowed 53% from 2Q 2021). Over the next year, revenue is forecast to grow 134%, compared to a 92% growth forecast for the industry in France. Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 35% per year, which means it is performing significantly worse than earnings. Reported Earnings • May 16
First quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2022 results: US$0.70 loss per share (down from US$0.28 loss in 1Q 2021). Revenue: US$3.83m (down 86% from 1Q 2021). Net loss: US$31.9m (loss widened 169% from 1Q 2021). Revenue missed analyst estimates by 78%. Earnings per share (EPS) exceeded analyst estimates by 27%. Over the next year, revenue is forecast to grow 82%, compared to a 162% growth forecast for the industry in France. Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has fallen by 44% per year, which means it is performing significantly worse than earnings. Reported Earnings • Mar 06
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: US$2.55 loss per share (down from US$1.91 loss in FY 2020). Revenue: US$65.5m (down 21% from FY 2020). Net loss: US$114.2m (loss widened 41% from FY 2020). Revenue exceeded analyst estimates by 10%. Earnings per share (EPS) missed analyst estimates by 100%. Over the next year, revenue is forecast to grow 19%, compared to a 289% growth forecast for the pharmaceuticals industry in France. Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has fallen by 39% per year, which means it is performing significantly worse than earnings. Executive Departure • Dec 03
Senior Vice President of Technical Operations - Europe Leopold Bertea has left the company On the 29th of November, Leopold Bertea's tenure as Senior Vice President of Technical Operations - Europe ended after 1.6 years in the role. We don't have any record of a personal shareholding under Leopold's name. Leopold is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 5.83 years. Reported Earnings • Nov 10
Third quarter 2021 earnings released: US$0.82 loss per share (vs US$0.71 loss in 3Q 2020) The company reported a soft third quarter result with increased losses and weaker control over costs, although revenues improved. Third quarter 2021 results: Revenue: US$10.8m (up 17% from 3Q 2020). Net loss: US$37.4m (loss widened 24% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 11% per year but the company’s share price has fallen by 24% per year, which means it is performing significantly worse than earnings. Price Target Changed • Oct 08
Price target decreased to €20.50 Down from €23.00, the current price target is an average from 9 analysts. New target price is 151% above last closing price of €8.18. Stock is down 51% over the past year. Major Estimate Revision • Aug 14
Consensus EPS estimates increase to -US$2.44 The consensus outlook for earnings per share (EPS) in 2021 has improved. 2021 revenue forecast increased from US$82.0m to US$85.8m. EPS estimate increased from -US$2.74 to -US$2.44. Biotechs industry in France expected to see average net income decline 0.6% next year. Consensus price target of €22.25 unchanged from last update. Share price fell 8.9% to €10.92 over the past week. Reported Earnings • Aug 08
Second quarter 2021 earnings released: US$0.88 loss per share (vs US$0.76 loss in 2Q 2020) The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: US$14.6m (up 217% from 2Q 2020). Net loss: US$39.9m (loss widened 24% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 5% per year but the company’s share price has fallen by 22% per year, which means it is performing significantly worse than earnings. Major Estimate Revision • Aug 06
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$78.8m to US$96.8m. EPS estimate unchanged from -US$2.79 at last update. Biotechs industry in France expected to see average net income decline 13% next year. Consensus price target of €22.25 unchanged from last update. Share price rose 4.8% to €11.99 over the past week.