Cellectis S.A. (CLLS): Business Model Canvas [Dec-2025 Updated]

You're digging into Cellectis S.A. (CLLS) right now, trying to map out the engine as they push lasme-cel toward pivotal Phase 2 trials. Honestly, their model hinges on that proprietary TALEN gene-editing tech powering 'off-the-shelf' CAR T-cells, which is a huge value prop for patients needing rapid help. We see this clearly in their structure: major Research and Development expenses funded by partnerships like the one with AstraZeneca, which contributed to their $82.55 million Trailing Twelve Months revenue as of September 30, 2025, all while keeping a war chest of $225 million in cash. It's a classic biotech pivot from pure licensing to late-stage execution, so check out the full canvas below to see exactly how the key activities and cost structure support this critical phase.

Cellectis S.A. (CLLS) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Cellectis S.A. (CLLS) relies on to drive its pipeline and secure its financial runway. These alliances are critical for both R&D acceleration and potential commercialization.

The partnerships structure is built around leveraging Cellectis S.A.'s gene editing platform across multiple therapeutic areas and indications.

External Collaboration and Licensing Agreements

• - AstraZeneca (AZN) Joint Research and Collaboration Agreement (JRCA) initiated in November 2023.
• - Servier/Allogene Therapeutics relationship based on exclusive license granted by Cellectis S.A. for allogeneic products targeting the CD70 target.
• - The Servier arbitration proceeding has an expected arbitral decision on or before December 15, 2025.

The financial and program scope of these major external relationships is summarized below:

Cellectis S.A. (CLLS) also relies on academic and clinical research institutions to execute its ongoing trials.

• - The BALLI-01 study (NCT04150497) started on October 14, 2019.
• - The study's Primary Completion is estimated for June 30, 2026.
• - In the target Phase 2 population for lasme-cel, the CR/CRi rate was 56%.

Regarding manufacturing, Cellectis S.A. maintains significant internal capability, which supplements the need for Contract Development and Manufacturing Organizations (CDMOs).

• - Cellectis S.A. has proprietary GMP manufacturing units operating in Raleigh, North Carolina and Paris, France.
• - This in-house capacity maximizes the chances for eligible patients to be treated without delay.

Cellectis S.A. (CLLS) - Canvas Business Model: Key Activities

You're looking at the core engine of Cellectis S.A. (CLLS) right now-the activities that consume capital and drive the potential for future value. It's all about advancing that allogeneic CAR T pipeline, especially as they transition into pivotal trials.

The primary activity is the Research and development (R&D) of these 'off-the-shelf' allogeneic CAR T-cell therapies. For the nine-month period ending September 30, 2025, consolidated R&D expenses were $69.1 million, a slight decrease from the $69.7 million spent in the same period of 2024. To be fair, the quarterly spend fluctuates; for the three months ending September 30, 2025, R&D was $24,069 thousand. This spending fuels the entire platform, from discovery to process optimization.

The most critical near-term activity is Advancing lasme-cel (UCART22) into pivotal Phase 2 for r/r B-ALL. You saw the regulatory hurdle cleared in July 2025 when Cellectis S.A. completed the end-of-Phase 1 multidisciplinary meetings with both the FDA and EMA. They are on track to launch the pivotal Phase 2, BALLI-01, in the second half of 2025, with the first patient enrollment expected in Q4 2025. The goal is a Biologics License Application (BLA) submission in 2028.

Here's a quick look at the data supporting that pivotal move:

The company continues Utilizing the TALEN gene-editing platform for new target discovery, largely through its strategic alliance with AstraZeneca. This Joint Research and Collaboration Agreement (AZ JRCA) is active across three programs, including two allogeneic CAR-T therapies and one in vivo gene therapy. AstraZeneca secured exclusive rights to 25 genetic targets and has the option to develop up to 10 candidate products using the technology. Also, Cellectis S.A. is presenting novel non-viral gene editing and base editing research at the 2025 ASGCT meeting, showing platform expansion beyond the lead candidates.

A key differentiator is the In-house manufacturing of clinical-grade cell therapy product (Process 2). This capability is central to their 'off-the-shelf' promise. In the BALLI-01 Phase 1 study, 22 patients received the Cellectis-manufactured Process 2 product, which achieved the 68% ORR mentioned above. You know they operate state-of-the-art facilities in both Paris, France, and Raleigh, North Carolina, to support this end-to-end control.

Finally, Managing regulatory interactions with the FDA and EMA for lead candidates is a constant, high-stakes activity. Beyond the lasme-cel end-of-Phase 1 meetings in July 2025, the company is also awaiting the arbitral decision from the Servier arbitration, which is expected by December 15, 2025. Also, they are preparing for an eti-cel (UCART20x22) update at ASH 2025, with the full Phase 1 dataset expected in 2026.

Cellectis S.A. (CLLS) - Canvas Business Model: Key Resources

You're mapping out the core assets Cellectis S.A. relies on to execute its clinical-stage strategy, so let's look at the hard numbers and tangible items they possess as of late 2025.

The foundation of Cellectis S.A.'s value is undeniably its technology and the resulting pipeline assets, backed by a specific level of financial liquidity.

Proprietary Technology and Intellectual Property

• Proprietary TALEN gene-editing technology platform, which the company pioneered for allogeneic CAR T-cells.
• The economic fundamentals of Cellectis S.A. are centered on its intellectual property (IP) portfolio covering gene editing and CAR T-cells.
• The company presented novel non-viral gene editing and base editing research at the 2025 ASGCT annual meeting.

Financial Strength

Liquidity is a key resource, providing the runway to advance the pipeline. As of the nine-month period ending September 30, 2025, Cellectis S.A. held $225 million in consolidated cash, cash equivalents, and fixed-term deposits. This level of capital is projected to fund operations into the second half of 2027 (H2 2027).

Manufacturing and Infrastructure

Cellectis S.A. maintains end-to-end manufacturing autonomy, controlling the cell and gene therapy value chain from start to finish.

Clinical-Stage Pipeline Assets

The clinical assets represent near-term value catalysts. The company is advancing its wholly-owned pipeline, with two key assets showing recent data points.

• lasme-cel (UCART22): Showed an overall response rate (ORR) of 68% in a subset of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) patients in the Phase 1 BALLI-01 study. End-of-Phase 1 meetings with the FDA and EMA were completed in July 2025, with a pivotal Phase 2 launch expected in H2 2025.
• eti-cel (UCART20x22): Preliminary data demonstrated an encouraging overall response rate (ORR) of 86% and a complete response (CR) rate of 57% at the current dose level (n=7). The full Phase 1 dataset is expected to be presented in 2026.

The AstraZeneca partnership also represents a key resource, with R&D activities ongoing for three programs: one allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors, and one in vivo gene therapy for a genetic disorder.

Cellectis S.A. (CLLS) - Canvas Business Model: Value Propositions

You're looking at the core benefits Cellectis S.A. (CLLS) is bringing to the cell therapy space with its allogeneic platform. This isn't about autologous (patient-specific) manufacturing; it's about ready-to-use products, which changes the logistics entirely.

• - Off-the-shelf allogeneic CAR T-cells, eliminating the need for patient-specific manufacturing.

Cellectis S.A. pioneers the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells. They control the cell and gene therapy value chain end-to-end with in-house manufacturing capabilities in Paris, France, and Raleigh, North Carolina. The company's cash, cash equivalents and fixed-term deposits stood at $225 million as of September 30, 2025, which they believe funds operations into H2 2027.

• - Potential for rapid disease control in heavily pretreated patients (e.g., r/r B-ALL).

For relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) treated with lasme-cel (UCART22) in the BALLI-01 Phase 1 study, efficacy metrics are clear:

This efficacy held across prior treatments: 60% response rate in subjects previously treated with CAR-T, 50% in transplant patients, and 80% in those treated with blinatumomab. The company anticipates submitting a Biologics License Application (BLA) in 2028.

• - Dual-targeted CAR T-cell approach (eti-cel) for enhanced efficacy in r/r NHL.

Eti-cel (UCART20x22) for relapsed/refractory non-Hodgkin lymphoma (r/r NHL) in the NATHALI-01 trial showed preliminary results:

The preliminary data demonstrated an Overall Response Rate (ORR) of 86% and a Complete Response (CR) rate of 57% based on a cohort of 7 patients.

• - Enabling hematopoietic stem cell transplantation for previously ineligible patients.

In the lasme-cel study, the survival curve suggests a trend to longer overall survival for patients who proceeded to hematopoietic stem cell transplantation (HSCT) following therapy compared to those who did not undergo transplant.

For context on the business scale supporting these developments, consolidated revenues and other income for the nine-month period ending September 30, 2025, reached $67.4 million. The consolidated adjusted net loss attributable to shareholders for that same nine-month period was $37.4 million, or a loss of $0.37 per share.

Cellectis S.A. (CLLS) - Canvas Business Model: Customer Relationships

You're looking at the core relationships Cellectis S.A. maintains to drive its clinical and commercial narrative forward. These aren't just transactional; they are deep, science-driven engagements that underpin their valuation.

The relationship with pharmaceutical partners is definitely high-touch, especially with AstraZeneca. This collaboration, which started in November 2023, is structured around developing up to 10 candidate products across three distinct programs.

The Servier arbitration is a key relationship management item to watch, with the arbitral decision expected on or before December 15, 2025.

Engagement with clinical investigators and Key Opinion Leaders (KOLs) is crucial for validating the science. For instance, the Company's leadership team and KOLs presented the full Phase 1 dataset and pivotal Phase 2 trial design for lasme-cel (UCART22) at the R&D Day on October 16, 2025.

The data itself speaks to the KOL interest. Preliminary results for eti-cel (UCART20x22) showed an Overall Response Rate (ORR) of 86% and a Complete Response (CR) rate of 57% (n=7). The Chief Medical Officer, Adrian Kilcoyne, MD, MPH, MBA, noted that data confirmed optimization of efficacy, supporting the pivotal Phase 2 program expected to start in Q4 2025.

Regarding investor relations, while you noted no Q3 2025 conference call, Cellectis S.A. did report Q3 2025 financial results on November 7, 2025, following a Q2 2025 call on August 5, 2025.

The financial stability supports this relationship management, as cash, cash equivalents, and fixed-term deposits stood at $225 million as of September 30, 2025, providing runway into H2 2027. For direct inquiries, the CFO & Chief Business Officer is Arthur Stril, reachable at investors@cellectis.com, and the Citibank ADR US contact line is +1 212 723 5435.

Managing regulatory bodies like the FDA and EMA involves hitting specific procedural milestones. Cellectis completed the end-of-Phase 1 multidisciplinary regulatory interactions for lasme-cel (UCART22) with both agencies in July 2025.

• The pivotal Phase 2 for lasme-cel is expected to initiate in H2 2025.
• The Chief Medical Officer indicated readiness to start enrollment in the pivotal Phase 2 program in Q4 2025.
• A Phase 1 readout for eti-cel in r/r NHL is still expected in late 2025.

Finance: confirm the cash burn rate implied by the H2 2027 runway projection by Friday.

Cellectis S.A. (CLLS) - Canvas Business Model: Channels

You're looking at how Cellectis S.A. gets its product information and, critically, its investigational therapies, into the hands of patients and partners right now in late 2025. It's all about clinical sites and strategic alliances at this stage; the direct sales force is definitely a future consideration.

Direct clinical trial sites for product delivery to patients

The immediate channel for product delivery is through the network of clinical trial sites running the ongoing studies. These sites are the physical locations where the gene-edited cell therapies are administered to patients under strict protocols. For instance, the delivery mechanism is currently channeled through the ongoing Phase 1 studies:

• - NATHALI-01 study, evaluating eti-cel (UCART20x22) in relapsed/refractory non-Hodgkin lymphoma (r/r NHL).
• - BALLI-01 study, evaluating lasme-cel (UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

Cellectis is preparing to transition the lasme-cel channel by initiating a pivotal Phase 2 trial in the second half of 2025, which will require an expanded network of specialized treatment centers.

Licensing and collaboration agreements for out-licensed programs

A major part of the Cellectis S.A. channel strategy involves out-licensing its technology for development and commercialization by partners. This is where you see significant non-dilutive funding potential and validation of their platform. Here's a look at the key financial and program details as of late 2025:

The AstraZeneca collaboration is actively using Cellectis S.A.'s in-house manufacturing capabilities in Paris (France) and Raleigh (North Carolina), which is a key operational channel supporting these external programs.

Investor R&D Days and scientific conferences for data dissemination

Disseminating clinical data is a critical channel to inform investors, regulators, and the medical community about product progress. You saw this in action recently:

• - ASH 2025: Cellectis presented a development update for eti-cel on December 7, 2025, in Orlando, FL. Preliminary data showed an Overall Response Rate (ORR) of 86% and a Complete Response (CR) rate of 57% (n=7).
• - Investor R&D Day: Held on October 16, 2025, in New York City, this event was used to present the Phase 1 dataset and late-stage development strategy for lasme-cel (UCART22) in r/r B-ALL.
• - Data Readouts: The full Phase 1 dataset for eti-cel is expected to be shared in 2026.

These events are the primary way Cellectis S.A. communicates clinical validation to the market, which is important given their consolidated revenues and other income reached $67.4 million for the nine-month period ended September 30, 2025.

Direct sales force and distribution network upon commercialization (future)

As of late 2025, Cellectis S.A. is a clinical-stage company, so a fully established direct sales force and commercial distribution network for its own products are not yet active channels. The company's current cash position of $225 million as of September 30, 2025, is projected to fund operations into H2 2027, which covers the expected timeline for pivotal Phase 2 initiation and further clinical data, but commercial build-out would require future planning.

Cellectis S.A. (CLLS) - Canvas Business Model: Customer Segments

You're looking at the core groups Cellectis S.A. (CLLS) serves right now, late in 2025. It's a mix of deep-pocketed partners and critically ill patients, which is typical for a clinical-stage gene-editing firm. The numbers tell you where the near-term revenue is coming from and where the long-term value is being built.

The first segment is definitely the big pharma and biotech players who need access to your TALEN® gene-editing platform. This is where the immediate financial validation comes from. Look at the AstraZeneca deal; it's a massive anchor for this segment. AstraZeneca invested $140 million in preferred shares, buying in at $5.00 per share. This strategic relationship grants them exclusive rights to 25 genetic targets and the option to develop up to 10 candidate products. Cellectis started by receiving an upfront payment of $25 million under that research agreement. The success of this partnership directly impacts your top line; for the six months ending June 30, 2025, revenue recognized under the AstraZeneca Joint Research Collaboration Agreement was $20.0 million. Your trailing twelve-month revenue as of September 30, 2025, was $75.3M, with Q3 2025 revenue hitting $37.16M.

The second and third segments are the oncology patients who need life-saving, off-the-shelf cell therapies. These are the patients driving the clinical milestones. For relapsed/refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL), your lead candidate, lasme-cel (UCART22), has shown compelling Phase 1 data. In the BALLI-01 study, 40 transplant ineligible third line or beyond (3L+) patients were dosed. The Overall Response Rate (ORR) reached 100% in the target Phase 2 population (n=9). If you look at the recommended Phase 2 dose (RP2D), the ORR was 83% among 12 patients. The median Overall Survival (OS) for those achieving a complete response was 14.8 months.

For relapsed/refractory Non-Hodgkin Lymphoma (r/r NHL), your eti-cel (UCART20x22) program is also targeting a high-need group. Preliminary data from the NATHALI-01 study showed an ORR of 86% and a 57% Complete Response (CR) rate based on a small cohort of n=7 patients. You're planning to share the full Phase 1 dataset for eti-cel in 2026.

Here's a quick look at the patient populations and associated clinical data as of late 2025:

Finally, the fourth segment involves patients with genetic disorders, which is being addressed through the AstraZeneca alliance. This is an early-stage focus area for the partnership. The agreement explicitly includes development on one in vivo gene therapy program targeting a genetic disorder. While specific patient numbers aren't public for this program yet, the structure is set up for Cellectis to receive milestone payments ranging from $70 million up to $220 million, per each of the 10 candidate products, plus royalties, if those candidates advance.

You can see the customer base is bifurcated: large, well-capitalized partners providing near-term revenue and clinical validation, and patient populations representing the future commercial opportunity, which is why your cash runway extending into H2 2027 is so important right now. Finance: draft 13-week cash view by Friday.

Cellectis S.A. (CLLS) - Canvas Business Model: Cost Structure

You're looking at the core expenses that fuel Cellectis S.A.'s engine, which is heavily weighted toward innovation and clinical execution. These costs are the price of admission for staying at the forefront of allogeneic CAR T-cell therapy.

The most significant drain on resources is the High Research and Development (R&D) expenses for clinical trials and discovery. For the nine-month period ended September 30, 2025, consolidated R&D expenses totaled $69.1 million. This reflects the ongoing work on the wholly-owned pipeline, including the pivotal Phase 2 trial preparations for lasme-cel (UCART22) and the ongoing Phase 1 study for eti-cel (UCART20x22).

Directly related to advancing the pipeline are the Manufacturing and quality control costs for in-house cell therapy production. Cellectis S.A. specifically foresees focusing cash spending on supporting development, which includes the manufacturing and clinical trial expenses for lasme-cel and eti-cel, alongside operating its state-of-the-art manufacturing capabilities in Paris and Raleigh. While a specific total cost isn't broken out for this category alone, it is a critical component of the overall R&D spend.

The human capital required to drive this science comes with substantial overhead. Personnel costs, including wages and social expenses, paid out during the first half of 2025 (H1 2025) amounted to $23.6 million. This reflects the specialized, high-value workforce needed for gene editing and cell therapy development.

Protecting the core technology is non-negotiable, leading to ongoing Legal and intellectual property maintenance costs for the TALEN platform. These costs are embedded within operating expenses, supporting the foundational gene-editing technology that underpins all product candidates. The company's commitment to innovation is also shown by presenting novel non-viral gene editing and base editing research at the 2025 ASGCT annual meeting.

Finally, the overhead of running a public, clinical-stage company contributes to the cost base. General and administrative expenses for the second quarter of 2024 (Q2 2024) were reported as $5.078 million. For comparison, consolidated SG&A expenses for the nine-month period ended September 30, 2025, were $15.0 million.

Here's a quick look at some key operating expense components for recent periods:

You can see the R&D spend is substantial, which is typical when pushing assets through late-stage clinical development. The personnel cost is a direct reflection of the talent required to manage the ongoing trials and manufacturing scale-up.

The company's focus remains on advancing its core programs, which dictates where these significant costs are allocated. It's defintely a cost structure built for clinical milestones.

Cellectis S.A. (CLLS) - Canvas Business Model: Revenue Streams

You're looking at the top-line drivers for Cellectis S.A. as of late 2025. The company's revenue generation is heavily weighted toward non-sales revenue, primarily from its strategic partnerships.

The Trailing Twelve Months (TTM) revenue for Cellectis S.A. stood at $82.55 million as of September 30, 2025. This represents significant growth, with the TTM revenue up 129.04% year-over-year. For the third quarter of 2025 alone, Cellectis reported revenues of $37.16 million, beating expectations significantly.

The core of the current revenue stream comes from strategic collaborations, which include upfront payments, milestone achievements, and research funding. The Joint Research Collaboration Agreement (JRCA) with AstraZeneca is a major contributor. For the first half of 2025, revenue recognized under this agreement increased by $20.0 million based on the progress of the three research programs. This type of revenue covers the reimbursement for research and development expenses under the partnership terms.

Looking back at the initial deal structure, Cellectis received a $25 million upfront payment from AstraZeneca, plus $22 million in development milestones related to initial programs by the close of 2024. The Servier License Agreement also provided a one-off development milestone revenue of $5.4 million recorded as of June 30, 2024. The Servier arbitration decision is a near-term event to watch, expected on or before December 15, 2025.

Here is a breakdown of recent revenue performance and key collaboration figures:

The potential for future royalties and sales from licensed and wholly-owned commercial products is significant, though these are not yet contributing to current reported revenue. The lead candidate, lasme-cel (UCART22), has estimates suggesting a robust peak sales potential of up to approximately $1.3 billion contingent on label expansion into second-line and first-line MRD-positive consolidation.

The revenue streams are clearly segmented by the nature of the income:

• - Upfront payments, milestones, and research funding from strategic collaborations (e.g., AstraZeneca).
• - Trailing twelve months (TTM) revenue of $82.55 million as of September 30, 2025.
• - Reimbursement for research and development expenses under partnership agreements, evidenced by the $20.0 million revenue boost from the AstraZeneca JRCA in H1 2025.
• - Potential future royalties and sales from licensed and wholly-owned commercial products, with peak sales estimates for lasme-cel reaching $1.3 billion.

The nine-month revenue for the period ending September 30, 2025, was $67.386 million in total revenues and other income, a near doubling from the $34.052 million reported for the same period in 2024. Finance: draft 13-week cash view by Friday.