Cellectis S.A. American Depositary Shares - CLLS STOCK NEWS

Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS) announced the merger of Calyxt (NASDAQ: CLXT) and Cibus Global. The all-stock transaction will merge these agriculture-based gene editing companies, combining their resources for trait development and plant breeding. Cellectis holds a 49.1% equity interest in Calyxt, expected to decrease to approximately 2.5% post-merger. The merger requires approvals from Calyxt’s stockholders and Cibus’ members, along with necessary regulatory approvals, with closing anticipated in Q2 2023. The merger aims to leverage the strengths of both companies in gene editing technologies.

The merger between Calyxt and Cibus aims to create a leading entity in precision gene editing and sustainable agriculture. Under the all-stock deal, Calyxt shareholders will retain approximately 5% of the new company, which will operate under the name Cibus Inc. Key applications include enhancing productivity traits in seeds and developing renewable low-carbon ingredients. The merger supports a strong collaboration pipeline with major seed companies, with three productivity traits expected to launch in early 2023. Both companies anticipate significant regulatory developments that could enhance market opportunities.

Cellectis has announced its intention to conduct an at-the-market offering (ATM) of up to $60 million in American Depositary Shares (ADS) as of January 4, 2023. This program is set to run until July 6, 2025, unless terminated earlier. The funds raised will primarily support the clinical development of its gene therapies, including UCART 123 and others. The potential dilution for existing shareholders is estimated at approximately 23.04%. Jefferies LLC will act as the sales agent, with shares issued without preferential rights for existing shareholders.

Cellectis (Nasdaq: CLLS) has entered into a collaboration with Primera Therapeutics, facilitated by Mayflower Bioventures. The partnership aims to develop gene editing therapies targeting mitochondrial diseases, which currently lack effective treatments. Primera will leverage its innovations from the Mayo Clinic to address mutations in mitochondrial DNA. Cellectis will acquire a 19% stake in Primera and may earn up to $750 million in milestone payments as well as royalties. This collaboration emphasizes Cellectis’ commitment to addressing unmet medical needs through gene editing.

Cellectis has secured a €40 million credit facility from the European Investment Bank to advance its UCART product pipeline. The facility is structured in three tranches: €20 million for Tranche A, €15 million for Tranche B, and €5 million for Tranche C, each with specific conditions for disbursement. This financing aims to support the development of allogeneic CAR T-cell therapies targeting severe unmet medical needs. The facility is designed to be minimally dilutive for shareholders, carrying a decreasing fixed interest rate, capitalized annually.

Cellectis announced a significant milestone as the first patient was dosed in the U.S. with its UCART22 product candidate, completing the 28-day Dose Limiting Toxicity (DLT) observation period without complications. This achievement underscores Cellectis' in-house manufacturing capabilities, which enhance efficiency in clinical trials for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The company aims to provide timely treatment, controlling the entire process from research and development to clinical manufacturing.

Cellectis announced its total number of shares as of November 30, 2022, standing at 45,579,410, with total voting rights totaling 51,646,286.

Cellectis, listed on both Nasdaq Global Market (ticker: CLLS) and Euronext Growth (ticker: ALCLS), focuses on gene-editing therapies targeting cancers and blood disorders. Its proprietary technologies include TALEN® and PulseAgile.

The company aims to address unmet medical needs through innovative cell and gene therapies, notably for acute myeloid leukemia and multiple myeloma.

Cellectis S.A. (CLLS) announced updated clinical data from its BALLI-01 and AMELI-01 studies at the ASH 2022 meeting. In the BALLI-01 trial, UCART22 showed anti-tumor activity in 60% of patients at dose level 3 (DL3) after FCA lymphodepletion, with one patient maintaining a durable MRD-negative complete response for over 12 months. Meanwhile, AMELI-01 demonstrated a 25% meaningful response rate at dose level 2 (DL2), including a patient achieving sustained MRD-negative status. The company is now enrolling patients in both studies with in-house manufactured product candidates.

Cellectis, a clinical-stage biotechnology company focused on gene editing, will host a live webcast on December 13, 2022, at 7:30 AM ET. The event will review clinical data from the AMELI-01 study evaluating UCART123 and include a company update. Presentations by the management team will precede a Q&A session. Interested participants can register for the webcast on Cellectis’ website. The company, listed on NASDAQ (CLLS) and Euronext Growth (ALCLS), emphasizes its commitment to developing life-saving therapies using its innovative gene-editing platform.