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MarketScreener Homepage  >  Equities  >  Euronext Growth Paris  >  Cellectis    ALCLS   FR0010425595

CELLECTIS

(ALCLS)
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Cellectis : FDA Lifts Clinical Hold on MELANI-01 Study Evaluating Cellectis' Product Candidate UCARTCS1 in Multiple Myeloma

11/18/2020 | 04:25am EST

New York (N.Y.) -- Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1 MELANI-01 trial evaluating the UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM).

Cellectis worked closely with the FDA over the past months, to address the agency's requests, which include adjustments to the MELANI-01 clinical protocol designed to enhance patient safety. Cellectis continues to work with the clinical site staff and investigators to efficiently obtain the required local approvals to reopen the trial and resume patient enrollment.

"We remain confident in the potential clinical benefit of UCARTCS1 product candidate for patients with relapsed/refractory multiple myeloma, a widely unmet medical need that Cellectis will continue to address. The safety of patients enrolled in our clinical trials remains our priority, and we are committed to resuming the clinical development of this promising program," said Carrie Brownstein, MD, Chief Medical Officer, Cellectis.

Patient enrollment is ongoing in Cellectis' two other proprietary Phase 1 dose escalation trials: AMELI-01 evaluating UCART123 in relapsed and refractory acute myeloid leukemia and BALLI-01 evaluating UCART22 in relapsed and refractory B-cell acute lymphoblastic leukemia.

About MELANI-01

MELANI-01 is a Phase 1 open-label First-In-Human dose escalation clinical study evaluating UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM). UCARTCS1 is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for the treatment of CS1/SLAMF7-expressing hematologic malignancies. CS1 (SLAMF7) is highly expressed on MM tumor cells. Learn more about the ongoing clinical trials at www.clinicaltrials.gov

About Multiple Myeloma (MM)

Multiple myeloma is a cancer that affects a type of white blood cells called plasma cells that are specialized mature B-cells, which secrete antibodies to combat infections. Multiple myeloma is characterized by the uncontrolled proliferation of neoplastic plasma cells in the bone marrow, where they overcrowd healthy blood cells. Although MM is a chronic disease and an exact cause has not yet been identified, researchers have made significant progress over the years in managing the disease through better understanding MM's pathophysiology. The progress in finding a cure needs to be continued as The American Cancer Society estimates that 32,270 new cases of MM will be diagnosed, and 12,830 deaths are expected to occur in 2020 in the U.S. alone.

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(C) 2020 M2 COMMUNICATIONS, source M2 PressWIRE

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Financials
Sales 2020 53,4 M 64,6 M 64,6 M
Net income 2020 -74,3 M -89,9 M -89,9 M
Net cash 2020 161 M 195 M 195 M
P/E ratio 2020 -9,53x
Yield 2020 -
Capitalization 1 123 M 1 356 M 1 358 M
EV / Sales 2020 18,0x
EV / Sales 2021 15,5x
Nbr of Employees 259
Free-Float 83,2%
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Mean consensus BUY
Number of Analysts 2
Average target price 27,35 €
Last Close Price 26,25 €
Spread / Highest target 11,2%
Spread / Average Target 4,19%
Spread / Lowest Target -2,86%
EPS Revisions
Managers and Directors
NameTitle
André Choulika Chief Executive Officer
Jean-Pierre Garnier Non-Executive Chairman
Eric Dutang Chief Financial Officer
Philippe Duchateau Chief Scientific Officer
Francisco J. Esteva Vice President-Clinical Development
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