Cellectis SA (NASDAQ:CLLS) on Monday announced a strategic transformation to become an in vivo gene editing entity focused on long-lasting treatments for chronic diseases.
Following the announcement, the stock fell over 27%.
The board of directors approved the pivot on September 11, realigning resources toward its primary in vivo assets and extending its operational cash runway into the second half of 2028.
Cash, cash equivalents, and fixed-term deposits of $169 million as of June 30, 2026 were expected to provide runway into the fourth quarter of 2027.
In Vivo Pipeline Focus
The company centers its new direction on lead candidates, .HEAL-101, and .HEAL-201.
.HEAL-101 uses a TALE-base editor targeting the APOC3 gene for severe hypertriglyceridemia, a condition affecting an estimated 1 to 2 million patients across the U.S. and Europe.
Preclinical humanized murine models showed .HEAL-101 decreased plasmatic APOC3 levels by up to 70% and reduced circulating triglycerides by up to 76%.
Cellectis plans to launch a Phase 1 trial in China and release preliminary clinical data in the second half of 2027.
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Advancing Epigenetic Modulators
Meanwhile, .HEAL-201 utilizes a TALE-epigenetic modulator targeting the PCSK9 promoter for severe hypercholesterolemia, addressing another 1 to 2 million high-risk patients in the U.S. and Europe.
Preclinical testing demonstrated a greater than 90% reduction in plasmatic PCSK9 levels in murine models.
Cellectis expects to launch a Phase 1 trial in China and share preliminary clinical data in the first half of 2028.
Strategic Realignment And Asset Exit
To optimize financial resources, Cellectis will exit development of allogeneic CAR T-cell candidates lasme-cel and eti-cel due to shifting market dynamics, while seeking strategic partners for these assets.
The company cited that continued and recently accelerated advances in frontline treatment regimens have lowered relapse rates, reducing the number of patients progressing to later lines of therapy.
Concurrently, the rapid emergence of bispecific antibodies and in vivo CAR-T approaches has intensified competition in second and third-line treatment settings.
The operational realignment supports existing cell therapy partnerships with AstraZeneca Plc (NYSE:AZN), Allogene Therapeutics, Inc. (NASDAQ:ALLO), and Servier.
CLLS Price Action: Cellectis shares were trading lower by 27.42% at $2.250 at the time of publication on Monday, according to Benzinga Pro data.
Photo by Gorodenkoff via Shutterstock
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