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Cellectis SA (CLLS.OQ)

CLLS.OQ on NASDAQ Stock Exchange Global Market

26.20USD
19 Oct 2018
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Latest Key Developments (Source: Significant Developments)

FDA Grants Cellectis IND Approval For UCART22 In B-ALL
Monday, 4 Jun 2018 04:30pm EDT 

June 4 (Reuters) - Cellectis SA ::FDA GRANTS CELLECTIS IND APPROVAL FOR UCART22 IN B-ALL.CELLECTIS SA - U.S. FDA APPROVED CO'S IND TO START PHASE 1 TRIAL FOR UCART22 FOR TREATMENT OF B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA IN ADULT PATIENTS.  Full Article

Calyxt Announces Closing of 60.9 Million Dollar Public Offering
Wednesday, 23 May 2018 02:21am EDT 

May 23 (Reuters) - CELLECTIS SA ::SAID ON TUESDAY CALYXT ANNOUNCES SUCCESSFUL CLOSING OF $60.9 MILLION PUBLIC OFFERING.CALYXT'S FOLLOW-ON PUBLIC OFFERING OF 4,057,500 SHARES OF CALYXT COMMON STOCK (INCLUSIVE OF FULL EXERCISE BY UNDERWRITERS OF OPTION TO BUY 457,500 ADDITIONAL SHARES).CALYXT'S PUBLIC OFFERING PRICE OF $15.00 PER SHARE.GROSS PROCEEDS TO CALYXT FROM PUBLIC OFFERING ARE ABOUT $60.9 MILLION.  Full Article

Cellectis Announces Approval Of Amendment To Protocol For UCART123 Phase 1 Clinical Trial
Wednesday, 23 May 2018 02:12am EDT 

May 23 (Reuters) - CELLECTIS SA ::ANNOUNCED ON TUESDAY APPROVAL OF AMENDMENT TO PROTOCOL FOR PHASE 1 CLINICAL TRIAL OF UCART123 PRODUCT CANDIDATE IN ACUTE MYELOID LEUKEMIA (AML) PATIENTS.DOSE LEVEL 1 TO BE ADMINISTERED INCREASES FROM 6.25X104 TO 2.5X105 UCART123 CELLS PER KILOGRAM.DOSE LIMITING TOXICITIES (DLT) OBSERVATION PERIOD DECREASES FROM 42 TO 28 DAYS POST-UCART123 INFUSION, EXCEPT FOR PATIENTS WITH APLASTIC BONE MARROW AT DAY 28.FOR PATIENTS WITH APLASTIC BONE MARROW AT DAY 28, DLT OBSERVATION PERIOD REMAINS 42 DAYS.TIME INTERVAL BETWEEN FIRST AND SECOND PATIENT FOR UCART123 INFUSION AT EACH NEW DOSE LEVEL SHORTENS FROM 42 DAYS TO 28 DAYS (42 DAYS FOR APLASTIC ANEMIA), THEN TO 14 DAYS FOR SUBSEQUENT PATIENTS.POTENTIAL SECOND UCART123 INFUSION IS IMPLEMENTED.NEW AML CLINICAL CENTER OPENS AT MD ANDERSON CANCER CENTER IN HOUSTON, TEXAS, TO INCREASE PATIENT ENROLLMENT PACE.THE FDA REVIEW PERIOD FOR THIS PROTOCOL AMENDMENT HAS PASSED AND CELLECTIS OBTAINED IRB’S APPROVAL.  Full Article

Pfizer and Allogene enter into agreement for Pfizer's CAR T cell therapy
Tuesday, 3 Apr 2018 08:00am EDT 

April 3 (Reuters) - Pfizer Inc ::SAYS CO AND ALLOGENE THERAPEUTICS ENTER INTO ASSET CONTRIBUTION AGREEMENT FOR PFIZER’S ALLOGENEIC CAR T IMMUNO-­ONCOLOGY PORTFOLIO.SAYS AGREEMENT AIMS TO ACCELERATE THE DEVELOPMENT OF PFIZER'S CAR T CELL THERAPY.SAYS ALLOGENE WILL RECEIVE RIGHTS FROM CO TO 16 PRE-CLINICAL CAR T ASSETS LICENSED FROM CELLECTIS AND SERVIER.SAYS ALLOGENE WILL RECEIVE RIGHTS TO ONE CLINICAL ASSET FROM SERVIER CALLED UCART19.SAYS CO WILL HOLD 25 PERCENT STAKE IN ALLOGENE THERAPEUTICS; CO WILL BE REPRESENTED ON ALLOGENE'S BOARD.  Full Article

Cellectis Q4 Operating Loss Widens To 27.8 Million Dollars
Tuesday, 13 Mar 2018 03:08am EDT 

March 13 (Reuters) - Cellectis SA ::REPORTED ON MONDAY Q4 TOTAL REVENUES OF $6.9 MILLION VS $13.0 MILLION YR AGO.Q4 OPERATING LOSS $27.8 MILLION VS LOSS $20.3 MILLION YR AGO.Q4 NET LOSS $28.7 MILLION VS LOSS $13.5 MILLION YR AGO.CASH POSITION OF $297 MILLION AS OF DECEMBER 31, 2017, COMPARED TO $291 MILLION AS OF DECEMBER 31, 2016."2018 WILL BE A TURNING POINT FOR CELLECTIS, EXTENDING OUR LEAD IN THE ALLOGENEIC CAR T-CELL FIELD" - CEO.  Full Article

Cellectis, Servier And Pfizer Present Preliminary Data From Two UCART19 Phase I Studies
Wednesday, 13 Dec 2017 01:56am EST 

Dec 13 (Reuters) - CELLECTIS ::SERVIER AND PFIZER PRESENT PRELIMINARY DATA FROM UCART19 PHASE I STUDIES IN ADULT AND PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA.STUDIES DEMONSTRATED SAFETY AND TOLERABILITY OF UCART19.STUDIES RESULTED IN 83-PCT COMPLETE REMISSION RATE ACROSS THE PATIENT POPULATION.IN 'CALM' TRIAL (UCART19 IN ADVANCED LYMPHOID MALIGNANCIES) FOR ADULTS, FIVE OUT OF SEVEN PATIENTS ACHIEVED MOLECULAR REMISSION AT DAY 28.'CALM' TRIAL: ONE GRADE 1 CUTANEOUS ACUTE GVHD OCCURED; NO SEVERE NEUROTOXICITY OBSERVED; CYTOKINE RELEASE SYNDROMES WERE MOSTLY MANAGEABLE.ONE PATIENT IN 'CALM' TRIAL DEVELOPED GRADE 4 CYTOKINE RELEASE SYNDROME AND NEUTROPENIC SEPSIS LEADING TO DEATH AT DAY 15.IN 'PALL' TRIAL (PEDIATRIC ACUTE LYMPHOBLASTIC LEUKEMIA) FOR CHILDREN, ALL FIVE PATIENTS ACHIEVED MOLECULAR REMISSION;.'PALL' TRIAL: ONE GRADE 1 CUTANEOUS ACUTE GVHD OCCURED; NO SEVERE NEUROTOXICITY OBSERVED.'PALL TRIAL': CYTOKINE RELEASE SYNDROMES WERE MOSTLY MANAGEABLE.  Full Article

Cellectis Appoints Stéphane Depil Senior VP Research & Development And Chief Medical Officer
Monday, 4 Dec 2017 04:31pm EST 

Dec 4 (Reuters) - CELLECTIS SA ::CELLECTIS APPOINTS IMMUNO-ONCOLOGY LEADER STÉPHANE DEPIL TO POSITION OF SENIOR VICE PRESIDENT RESEARCH & DEVELOPMENT AND CHIEF MEDICAL OFFICER.  Full Article

Cellectis says cash position at Sept. 30 of $304.1 million
Tuesday, 14 Nov 2017 03:39am EST 

Nov 14 (Reuters) - CELLECTIS SA ::ANNOUNCED ON MONDAY: CASH, CASH EQUIVALENTS AND CURRENT FINANCIAL ASSETS AT SEPT 30 STOOD AT $304.1 MLN VS $271.2 MLN AT JUNE 30 .Q3 TOTAL REVENUES AND OTHER INCOME $7.3 MLN VS $12.6 MLN YEAR AGO.Q3 FINANCIAL LOSS $3.4 MLN VS LOSS OF $1.2 MLN YEAR AGO .Q3 NET LOSS ATTRIBUTABLE TO SHAREHOLDERS $26.2 MLN VS LOSS OF $14.1 MLN YEAR AGO.EXPECTS ITS CASH, CASH EQUIVALENTS AND CURRENT FINANCIAL ASSETS WILL BE SUFFICIENT TO FUND ITS CURRENT OPERATIONS INTO 2020.  Full Article

Fda lifts clinical hold on cellectis phase 1 clinical trials with UCART123 in AML and BPDCN
Monday, 6 Nov 2017 07:01pm EST 

Nov 6 (Reuters) - Cellectis SA :FDA lifts clinical hold on cellectis phase 1 clinical trials with UCART123 in AML and BPDCN.Says ‍working with investigators and clinical sites to obtain IRB'S approval on revised protocols and resume patient enrollment​.Cellectis SA says ‍agreed with FDA to decrease of cohort dose level to 6.25x10(4) UCART123 cells/ in Phase 1 UCART123 protocols​.  Full Article

Cellectis says FDA places clinical hold of UCART123 studies following fatality
Monday, 4 Sep 2017 10:14pm EDT 

Sept 5 (Reuters) - CELLECTIS SA ::ANNOUNCED TODAY HAVING RECEIVED NOTICE FROM FDA THAT CLINICAL HOLD WAS PLACED ON BOTH UCART123 ONGOING PHASE 1 STUDIES IN ACUTE MYELOID LEUKEMIA (AML) AND IN BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN).CLINICAL HOLD WAS INITIATED AFTER CELLECTIS REPORTED ONE FATALITY IN BPDCN CLINICAL TRIAL (ABC STUDY).CELLECTIS IS WORKING CLOSELY WITH THE INVESTIGATORS AND THE FDA IN ORDER TO RESUME THE TRIALS WITH AN AMENDED PROTOCOL INCLUDING A LOWERED DOSING OF UCART123.  Full Article

BRIEF-Cellectis Operating Loss Widens To 21.7 Million US Dollars

* SAID ON WEDNESDAY ITS Q2 REVENUES WERE $5.0 MLN VS $6.5 MLN YEAR AGO