Cellectis reports promising data for lasme-cel in r/r B-ALL

NEW YORK - Cellectis (Euronext Growth:ALCLS - NASDAQ: CLLS), a $347.58 million market cap biotechnology company, announced encouraging clinical data from its Phase 1 BALLI-01 study evaluating lasme-cel (UCART22) in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). According to InvestingPro data, the company has shown impressive revenue growth of 223% over the last twelve months.

The data showed an overall response rate of 68% with lasme-cel Process 2 manufacturing (n=22), rising to 83% at the recommended Phase 2 dose (n=12) and reaching 100% in the target Phase 2 population (n=9).

In the target Phase 2 population, 56% of patients achieved complete remission or complete remission with incomplete hematologic recovery, with approximately 80% reaching minimal residual disease-negative status. All patients in this group became transplant eligible, with 78% proceeding to transplant.

The therapy demonstrated efficacy even in heavily pretreated patients. Among 11 patients previously treated with all three targeted therapies (inotuzumab, blinatumomab, and CD19 CAR-T), 8 responded and 7 achieved minimal residual disease-negative status.

Safety data indicated lasme-cel was generally well-tolerated, with one case of grade 2 immune effector cell-associated neurotoxicity syndrome that resolved.

The company has initiated a pivotal Phase 2 trial in r/r B-ALL, with the first patient expected to be enrolled in Q4 2025. Cellectis anticipates submitting a Biologics License Application in 2028. The company’s financial health score on InvestingPro is rated as "GOOD," despite operating with moderate debt levels and not currently being profitable. Subscribers can access 8 additional ProTips and comprehensive financial analysis in the Pro Research Report.

According to the press release, Cellectis estimates lasme-cel could reach approximately 1,900 addressable third-line or later B-ALL patients annually by 2035 across the U.S., Germany, France, Spain, Italy, and UK, with potential peak gross sales of up to $700 million.

The company also shared preliminary data on eti-cel (UCART20x22) for relapsed or refractory non-Hodgkin lymphoma, showing an 86% overall response rate and 57% complete response rate at the current dose level (n=7). The stock has demonstrated strong momentum, trading near its 52-week high of $4.83, with a remarkable 168.55% return over the past six months. For detailed valuation analysis and future growth projections, visit InvestingPro.

In other recent news, Cellectis disclosed its second-quarter 2025 earnings, highlighting a mixed financial outcome. The company reported an earnings per share (EPS) of -0.2075 USD, which fell short of the anticipated -0.1828 USD, marking a negative surprise of 13.51%. Despite this earnings miss, Cellectis surpassed revenue expectations, bringing in 15.73 million USD compared to the forecasted 10.05 million USD. This revenue performance exceeded projections by a significant margin. However, the earnings miss led to a negative market reaction. These recent developments reflect the company’s financial trajectory as it navigates its quarterly performance.

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