SELECTUS (CLLS) Q2 2025: Cash Runway Secured Through 2027 as Pivotal CAR-T Phase 2 Launches
Selectus enters the second half of 2025 with pivotal trial readiness, regulatory clarity, and a $230 million cash reserve extending operations into late 2027. The company’s focus on late-stage allogeneic CAR-T programs, robust AstraZeneca partnership, and a pending arbitration outcome with Servier set up a catalyst-rich period, with R&D Day in October positioned to detail the phase 2 path for its lead asset. Investors face a decisive inflection as Selectus pivots from phase 1 data to late-stage execution, while regulatory and legal outcomes remain key watchpoints.
Summary
- Late-Stage Pipeline Milestone: Initiation of pivotal phase 2 for UCART22 in ALL marks a shift to registration focus.
- Financial Cushion Extended: Cash position funds operations and trials well into 2027, supporting strategic flexibility.
- Regulatory and Legal Catalysts: Clear FDA/EMA alignment and imminent Servier arbitration outcome shape near-term risk/reward.
Performance Analysis
Selectus reported a cash, cash equivalents, and deposits balance of $230 million at June 30, 2025, down from $264 million at year-end, reflecting ongoing R&D investment and operational expenses tied to advancing its wholly owned CAR-T assets and partnered programs. The primary cash outflows were driven by supplier payments, workforce expenses, and lease obligations, partially offset by revenue receipts and interest income. Management confirmed that the current cash runway is sufficient to fund both pivotal and ongoing studies through the second half of 2027, even under conservative assumptions for milestone receipts.
Operationally, the company completed phase 1 dose escalation for UCART22, its lead allogeneic CAR-T candidate for relapsed/refractory acute lymphoblastic leukemia (ALL), and secured regulatory alignment with both FDA and EMA for phase 2 design and endpoints. The NATAL-E01 study, evaluating dual-targeted CAR-T (UCART20x22) in non-Hodgkin’s lymphoma (NHL), continues to enroll with data expected by year end. The AstraZeneca collaboration remains active across three cell and gene therapy programs, while a major legal milestone looms with the Servier arbitration decision due by December 15, 2025.
- Cash Burn Reflects R&D Acceleration: The $33 million decrease in cash reserves is consistent with increased trial activity and site expansion for pivotal studies.
- Regulatory Milestone Achieved: End-of-phase 1 meetings with FDA and EMA yielded clear guidance on endpoints and study design, de-risking the phase 2 path.
- Partnered Pipeline Progress: AstraZeneca joint programs advance in parallel, providing diversification beyond wholly owned assets.
The company’s Q2 performance was less about revenue inflection and more about operational execution, regulatory de-risking, and maintaining financial flexibility for late-stage trial commitments.
Executive Commentary
"We’re excited to prepare for the initiation of a phase two trial for LASMIS cell, UCAR T22, in relapsed or refractory acute lymphoblastic leukemia in the second half of this year."
Dr. André Choulika, Chief Executive Officer
"Importantly, we are well positioned financially to execute on our pipeline as our cash, cash equivalents and fixed-term deposits as of June 30th, 2025 remain sufficient to fund our operations into H2 2027."
Arthur Strill, Interim Chief Financial Officer & Chief Business Officer
Strategic Positioning
1. Pivotal Transition for Lead CAR-T Program
The move to phase 2 for UCART22 signals Selectus’s evolution from early-stage biotech to a company with registration ambitions. The phase 1 dataset, regulatory feedback, and trial design clarity will be detailed at the October R&D Day, with endpoints, population, and safety database size all aligned with FDA and EMA expectations. This pivotal study targets a high unmet need in relapsed/refractory ALL, positioning Selectus to compete in a space with limited off-the-shelf options.
2. Portfolio Diversification and Partnership Leverage
The ongoing AstraZeneca partnership spans three distinct programs: allogeneic CAR-T for hematologic malignancies, allogeneic CAR-T for solid tumors, and in vivo gene therapy for a genetic disorder. This collaboration provides non-dilutive funding, scientific validation, and a hedge against single-asset risk, while maintaining Selectus’s focus on its wholly owned assets.
3. Legal and Regulatory Catalysts
The Servier arbitration outcome could materially alter Selectus’s asset base and cash profile, with potential for CD19 product rights and compensation. Regulatory clarity for UCART22 and UCART20x22, with no major concerns from FDA/EMA on endpoints or statistical plans, reduces execution risk and accelerates the path to BLA (Biologics License Application, regulatory submission for marketing approval).
4. Capital Allocation and Risk Management
Management has adopted a prudent approach to cash forecasting, probabilizing milestone inflows and fully loading pivotal trial costs into runway projections. This conservatism ensures operational flexibility even if non-dilutive funding is delayed or legal outcomes are unfavorable.
Key Considerations
The quarter marked a strategic inflection for Selectus, as it transitions from phase 1 data generation to late-stage clinical execution and regulatory engagement. The following considerations frame the company’s evolving risk-reward profile:
- Regulatory Alignment Secured: Both FDA and EMA provided clear, supportive feedback on pivotal trial design, endpoints, and safety database size for UCART22.
- Cash Runway Provides Buffer: $230 million in reserves funds all planned trials and operations into 2027, reducing near-term financing risk.
- Legal Outcome Could Reshape Pipeline: Arbitration with Servier may return CD19 product rights and/or cash, with a decision due by year-end.
- Portfolio Breadth Via Partnership: AstraZeneca collaboration diversifies R&D exposure and validates Selectus’s platform beyond its lead assets.
- Upcoming Catalysts Are Dense: October R&D Day, ASH submissions, year-end data for UCART20x22, and the Servier decision all converge within six months.
Risks
Major risks center on clinical execution, potential regulatory setbacks, and the binary outcome of the Servier arbitration. Any unexpected safety events or efficacy shortfalls in pivotal trials could delay or derail registration prospects. Legal uncertainty around the Servier dispute could impact Selectus’s asset base and future cash position, while broader biotech sector volatility and competitive developments in CAR-T therapies present ongoing external risks.
Forward Outlook
For Q3 and Q4 2025, Selectus guided to:
- Initiation of pivotal phase 2 trial for UCART22 in ALL in the second half of 2025
- Presentation of phase 1 data and late-stage strategy at R&D Day on October 16
- Data updates for UCART20x22 in NHL by year-end
- Arbitration decision with Servier due by December 15
For full-year 2025, management maintained guidance of operational runway into H2 2027, with all pivotal trial costs included. Key factors highlighted were regulatory clarity, cash sufficiency, and a focus on clinical execution.
- Regulatory de-risking for pivotal trial launch
- Dense upcoming catalyst calendar
Takeaways
Selectus faces a pivotal second half as it transitions to late-stage development, with regulatory, legal, and clinical catalysts converging. The company’s financial discipline and partnership breadth provide downside support, but binary outcomes in both the clinic and the courts will drive valuation.
- Late-Stage Execution in Focus: The shift to pivotal trial for UCART22 places Selectus in the registration race for allogeneic CAR-T in ALL, with clear regulatory support and a high unmet need.
- Legal Resolution Could Unlock Value: The Servier arbitration outcome may return valuable CD19 rights and compensation, potentially reshaping the pipeline and balance sheet.
- Dense Catalyst Calendar Ahead: Investors should monitor R&D Day disclosures, year-end data updates, and the arbitration decision as key inflection points for the stock.
Conclusion
Selectus enters a catalyst-rich period with late-stage clinical, regulatory, and legal events set to define its trajectory. The company’s cash runway, regulatory clarity, and partnership depth support execution, but investors must weigh binary clinical and legal risks as the company pivots to pivotal trial mode.
Industry Read-Through
Selectus’s regulatory progress and cash discipline highlight the maturing landscape for allogeneic CAR-T developers, where late-stage clarity and capital sufficiency are prerequisites for investor confidence. The focus on off-the-shelf cell therapies for high unmet needs is echoed across the sector, with regulatory alignment and risk-benefit assessment of lymphodepletion regimens under scrutiny following recent competitor setbacks. Legal disputes over legacy assets, as seen with Servier, add another layer of complexity to pipeline value realization. Investors in cell therapy should watch for further regulatory harmonization and evolving clinical endpoints as the field advances toward commercialization.