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ALSEN — Sensorion SA News Story

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Brief: Sensorion End-June Cash Position At Around EUR 55 Mln

Sept 27 (Reuters) - SENSORION SA  ALSEN.PA :
    * SENSORION REPORTS 2021 FIRST HALF RESULTS
    * SENS-401 TRIAL PROTOCOL FOR SSNHL SUCCESSFULLY AMENDED,
CLINICAL
TRIAL APPLICATION FILING IN CIO IN ADULTS CONFIRMED FOR H2 2021
    * PLANS TO FILE CLINICAL TRIAL APPLICATION (CTA) IN H1 2023
FOR
OTOF-GT
    * LAUNCH OF A THIRD GT PROGRAM TARGETING GJB2-GT FOR ADULT
AND
PEDIATRIC SEGMENTS
    * CASH POSITION OF C.EUR 55M AT JUNE 30, 2021 PROVIDES
UNCHANGED
RUNWAY UNTIL END OF H2 2022
    * OTOF-GT GENE THERAPY PROGRAM: CLEAR ADVICE FROM EUROPEAN
MEDICINES AGENCY TO PROGRESS PROGRAM
    * THIRD COLLABORATION WITH INSTITUT PASTEUR: GJB2 GENE
THERAPY
TARGETING ADULT AND PEDIATRIC SEGMENTS
    * IN Q3 2021, SENSORION RECEIVED CLEAR FEEDBACK FROM EMA'S
ADVISORS ON OVERALL DEVELOPMENT PLAN FOR OTOF-GT
    * NATURAL HISTORY STUDY WILL ENABLE SENSORION TO SELECT MOST
RELEVANT AND CLINICALLY MEANINGFUL ENDPOINTS AND CLINICAL TRIAL
DESIGN AS OTOF-GT PROGRESSES INTO CLINIC
    * EXPECTS TO FILE A CLINICAL TRIAL APPLICATION (CTA) FOR ITS
OTOF-GT PROGRAM IN H1 2023
    * SENS-401 IN CIO: CLINICAL TRIAL APPLICATION FILING
CONFIRMED IN
H2 2021
    * SENS-401 FOR HEARING PRESERVATION IN COMBINATION WITH
COCHLEAR
IMPLANTATION: TO BEGIN FIRST CLINICAL TRIAL WITH COCHLEAR
LIMITED
    * H2 STRATEGY AND PROSPECTS FOR CASH: INTENDS TO USE NEW
FUNDS TO
DEVELOP ITS CURRENT GENE THERAPY PROGRAMS, SUPPORT ITS
PHARMACOLOGY AND CLINICAL STUDIES OF SENS-401 AND FOR GENERAL
CORPORATE PURPOSES
    * EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H2
2021 -
SUBMISSION OF CLINICAL TRIAL APPLICATION FOR SENS-401 CIO STUDY
IN ADULTS
    * EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H2
2021 -
SUBMISSION OF CLINICAL TRIAL APPLICATION FOR PILOT STUDY
SENS-401 WITH COCHLEAR IMPLANT
    * EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: END OF
2021
- TOP LINE DATA READOUT FOR SENS-401 PHASE 2 CLINICAL STUDY IN
SSNHL
    * EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H1
2022 –
START OF THE PILOT STUDY SENS-401 IN COMBINATION WITH COCHLEAR
IMPLANTS
    * EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H1
2022 –
SENSORION AND INSTITUT PASTEUR DISCLOSING NEXT STEPS FOR THE
USHER-GT PROGRAM
    * EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H1
2022 –
GJB2-GT CANDIDATE SELECTION
    * EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H1
2023 -
SUBMISSION OF THE CLINICAL TRIAL APPLICATION FOR THE OTOF-GT
PROGRAM (CTA/IND)

Source text for Eikon:  ID:nBw8K7Vg9a 
Further company coverage:  ALSEN.PA 

 (Gdansk Newsroom)
 ((gdansk.newsroom@thomsonreuters.com; +48 587 696 600;))

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