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Regulus Therapeutics Inc., a clinical stage biopharmaceutical company, engages in the discovery and development of drugs that targets microRNAs to treat a range of diseases in the United States. Its product candidates include RG-012, an anti-miR targeting miR-21 that is in Phase II clinical trial for the treatment of Alport syndrome, a life-threatening kidney disease; and RGLS8429, an anti-miR targeting miR-17, which is in Phase 1b clinical study for the treatment of autosomal dominant polycystic kidney disease. The company is also developing a pipeline of preclinical drug products for target organ-selective delivery strategies. Regulus Therapeutics Inc. was incorporated in 2007 and is headquartered in San Diego, California.

Regulus Therapeutics Inc.

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BASEL, MAY 27, 2025 - NOVARTIS TODAY ANNOUNCED THAT REDWOOD MERGER SUB INC., A DELAWARE CORPORATION AND AN INDIRECT WHOLLY OWNED SUBSIDIARY OF NOVARTIS (PURCHASER), HAS COMMENCED A TENDER OFFER TO ACQUIRE ALL OF THE OUTSTANDING SHARES OF COMMON STOCK, PAR VALUE $0.001 PER SHARE (THE SHARES), OF REGULUS THERAPEUTICS INC., A DELAWARE CORPORATION (REGULUS), IN EXCHANGE FOR (I) $7.00 IN CASH PER SHARE, SUBJECT TO ANY APPLICABLE WITHHOLDING AND WITHOUT INTEREST THEREON, PLUS (II) ONE CONTINGENT VALUE RIGHT (EACH, A CVR) PER SHARE, REPRESENTING THE RIGHT TO RECEIVE ONE CONTINGENT PAYMENT OF $7.00 IN CASH, SUBJECT TO ANY APPLICABLE WITHHOLDING AND WITHOUT INTEREST THEREON, UPON THE ACHIEVEMENT OF A REGULATORY MILESTONE. SUCH OFFER IS BEING MADE UPON THE TERMS AND SUBJECT TO THE CONDITIONS SET FORTH IN THE OFFER TO PURCHASE, DATED MAY 27, 2025, AND THE RELATED LETTER OF TRANSMITTAL (TOGETHER, THE OFFER) AND PURSUANT TO THE TERMS OF THE PREVIOUSLY ANNOUNCED AGREEMENT AND PLAN OF MERGER, DATED AS OF APRIL 29, 2025 (THE MERGER AGREEMENT), AMONG NOVARTIS, PURCHASER AND REGULUS.

NOVARTIS ANNOUNCES COMMENCEMENT OF TENDER OFFER TO ACQUIRE REGULUS THERAPEUTICS

ENTERED INTO AN AGREEMENT TO BE ACQUIRED BYNOVARTIS FOR$7.00PER SHARE IN CASH, WITH POTENTIAL TO RECEIVE AN ADDITIONAL$7.00PER SHARE IN CASH THROUGH A CONTINGENT VALUE RIGHT ("CVR") UPON THE ACHIEVEMENT OF A REGULATORY MILESTONE, FOR A TOTAL EQUITY VALUE OF UP TO APPROXIMATELY $1.7 BILLION; EXPECTED TO BE COMPLETED IN THE SECOND HALF OF 2025, SUBJECT TO CUSTOMARY CLOSING CONDITIONS POSITIVE TOPLINE DATA FROM THE COMPLETED FOURTH COHORTOF PATIENTS IN THE PHASE 1B MULTIPLE-ASCENDING DOSE (MAD) STUDY OF FARABURSEN (RGLS8429) FOR THE TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) COMPANY ON TRACK FOR INITIATION OF PHASE 3 SINGLE PIVOTAL TRIAL IN THE THIRD QUARTER 2025 SAN DIEGO , MAY 8, 2025 /PRNEWSWIRE/ -- REGULUS THERAPEUTICS INC. (NASDAQ: RGLS), A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE MEDICINES TARGETING MICRORNAS (THE "COMPANY" OR "REGULUS"), TODAY REPORTED FINANCIAL RESULTS FOR THE FIRST QUARTER ENDED MARCH 31, 2025, AND PROVIDED A CORPORATE UPDATE. "WE RECENTLY ANNOUNCED THAT WE HAVE ENTERED INTO AN AGREEMENT TO BE ACQUIRED BY NOVARTIS, WHOSE ESTABLISHED GLOBAL DEVELOPMENT AND COMMERCIAL CAPABILITIES WILL POTENTIALLY BRING FARABURSEN TO PATIENTS WITH ADPKD, WHO CURRENTLY HAVE LIMITED TREATMENT OPTIONS," SAIDJAY HAGAN, CEO OF REGULUS THERAPEUTICS.

REGULUS THERAPEUTICS REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND RECENT UPDATES

NEW YORK CITY & NEW ORLEANS--(BUSINESS WIRE)--FORMER ATTORNEY GENERAL OF LOUISIANA CHARLES C. FOTI, JR., ESQ. AND THE LAW FIRM OF KAHN SWICK & FOTI, LLC (KSF) ARE INVESTIGATING THE PROPOSED SALE OF REGULUS THERAPEUTICS INC. (NASDAQCM: RGLS) TO NOVARTIS AG. UNDER THE TERMS OF THE PROPOSED TRANSACTION, SHAREHOLDERS OF REGULUS WILL RECEIVE $7.00 PER SHARE IN CASH AND A CONTINGENT VALUE RIGHT PROVIDING FOR PAYMENT OF $7.00 PER SHARE, CONTINGENT UPON THE ACHIEVEMENT OF A MILESTONE WITH RESPECT.

REGULUS THERAPEUTICS INVESTOR ALERT BY THE FORMER ATTORNEY GENERAL OF LOUISIANA: KAHN SWICK & FOTI, LLC INVESTIGATES ADEQUACY OF PRICE AND PROCESS IN PROPOSED SALE OF REGULUS THERAPEUTICS INC. - RGLS

NOVARTIS TO ACQUIRE REGULUS FOR $7.00 PER SHARE IN CASH, WITH POTENTIAL TO RECEIVE AN ADDITIONAL $7.00 PER SHARE IN CASH THROUGH A CONTINGENT VALUE RIGHT, FOR A TOTAL EQUITY VALUE OF UP TO APPROXIMATELY $1.7 BILLION TRANSACTION IS EXPECTED TO BE COMPLETED IN THE SECOND HALF OF 2025, SUBJECT TO CUSTOMARY CLOSING CONDITIONS SAN DIEGO , APRIL 30, 2025 /PRNEWSWIRE/ -- REGULUS THERAPEUTICS INC. (NASDAQ: RGLS), A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE MEDICINES TARGETING MICRORNAS (THE "COMPANY" OR "REGULUS"), TODAY ANNOUNCED THAT IT HAS ENTERED INTO AN AGREEMENT AND PLAN OF MERGER WITH NOVARTIS AG ("NOVARTIS") AND AN INDIRECTLY WHOLLY OWNED SUBSIDIARY OF NOVARTIS, PURSUANT TO WHICH NOVARTIS WILL ACQUIRE REGULUS FOR AN INITIAL PAYMENT OF $7.00 PER SHARE IN CASH AT CLOSING, OR $0.8 BILLION. THE UPFRONT CASH PORTION OF THE CONSIDERATION REPRESENTS A PREMIUM OF 274 PERCENT TO REGULUS' 60-DAY VOLUME-WEIGHTED AVERAGE STOCK PRICE AND 108 PERCENT TO REGULUS' CLOSING PRICE ON APRIL 29, 2025.

REGULUS THERAPEUTICS ENTERS INTO AGREEMENT TO BE ACQUIRED BY NOVARTIS AG

SAN DIEGO , APRIL 2, 2025 /PRNEWSWIRE/ -- REGULUS THERAPEUTICS INC. (NASDAQ: RGLS), A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE MEDICINES TARGETING MICRORNAS (THE "COMPANY" OR "REGULUS"), TODAY ANNOUNCED THAT JAY HAGAN, CEO, WILL PARTICIPATE IN A PRESENTATION AT THE 2025 OPPENHEIMER INNOVATION ON THE ISLAND BIOTECH SUMMIT ON WEDNESDAY, APRIL 9 TH AT 11:32 A.M. ET. THE LIVE EVENT AND REPLAY OF THE PRESENTATION WILL BE AVAILABLE UNDER "EVENTS AND PRESENTATIONS" THROUGH THE INVESTOR RELATIONS SECTION OF THE COMPANY'S WEBSITE AT HTTPS://IR.REGULUSRX.COM/EVENTS AND ARCHIVED FOR 90 DAYS FOLLOWING THE PRESENTATION DATE.

REGULUS THERAPEUTICS TO PRESENT AT THE 2025 OPPENHEIMER INNOVATION ON THE ISLAND BIOTECH SUMMIT

POSITIVETOPLINE DATA FROM THE FOURTH COHORT OF PATIENTS CONSISTENT DEMONSTRATION OFPOLYCYSTIN (PC) BIOMARKER IMPACT CONFIRMING 300 MG FIXED DOSE SELECTION TO ACHIEVE OPTIMAL KIDNEY EXPOSURE PATIENTS RECEIVING 300 MGFARABURSEN DEMONSTRATED A MEAN HALTING OF HEIGHT-ADJUSTED TOTAL KIDNEY VOLUME (HTTKV) GROWTH OVER 4 MONTHS EXPLORATORY ANALYSIS OF PATIENTS FROM HIGH-DOSE COHORTS DEMONSTRATES STATISTICAL SIGNIFICANCE INHTTKV CHANGE COMPARED TO A LARGE COHORT OF HISTORICAL PLACEBO-TREATED PATIENTS, WHICH MEANINGFULLY DERISKS THE 12-MONTH HTTKV ENDPOINT IN THE PLANNED PHASE 3 TRIAL COMPANY ON TRACK FOR INITIATION OF PHASE 3 SINGLE PIVOTAL TRIAL IN THIRD QUARTER 2025 SAN DIEGO , MARCH 27, 2025 /PRNEWSWIRE/ -- REGULUS THERAPEUTICS INC. (NASDAQ: RGLS), A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE MEDICINES TARGETING MICRORNAS (THE "COMPANY" OR "REGULUS"), TODAY ANNOUNCED POSITIVE TOPLINE RESULTS FROM ALL PATIENTS IN THE FOURTH COHORT IN ITS PHASE 1B MAD STUDY OF FARABURSEN FOR THE TREATMENT OF ADPKD. THE PHASE1BMAD STUDY IS A DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL WHICH EVALUATED THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS (PK/PD) OF FARABURSEN IN ADULT PATIENTS WITH ADPKD.

REGULUS THERAPEUTICS ANNOUNCES SUCCESSFUL COMPLETION OF ITS PHASE 1B MULTIPLE-ASCENDING DOSE (MAD) CLINICAL TRIAL OF FARABURSEN (RGLS8429) FOR THE TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)

POSITIVE TOPLINE RESULTS FROM AN INTERIM ANALYSIS OF THE FOURTH COHORTOF PATIENTS IN THE PHASE 1B MULTIPLE-ASCENDING DOSE (MAD) CLINICAL TRIAL OF FARABURSEN (RGLS8429) FOR THE TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) AGREEMENT ON KEY COMPONENTS OF A PHASE 3 SINGLE PIVOTAL TRIAL FOR POTENTIAL ACCELERATED APPROVAL WITH THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) SAN DIEGO , MARCH 13, 2025 /PRNEWSWIRE/ --REGULUS THERAPEUTICS INC . (NASDAQ: RGLS), A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE MEDICINES TARGETING MICRORNAS (THE "COMPANY" OR "REGULUS"), TODAY REPORTED FINANCIAL RESULTS FOR THE FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2024, AND PROVIDED A CORPORATE UPDATE.

REGULUS THERAPEUTICS REPORTS FOURTH QUARTER AND YEAR-END 2024 FINANCIAL RESULTS AND RECENT UPDATES

SAN DIEGO , MARCH 4, 2025 /PRNEWSWIRE/ -- REGULUS THERAPEUTICS INC. (NASDAQ: RGLS), A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE MEDICINES TARGETING MICRORNAS (THE "COMPANY" OR "REGULUS"), TODAY ANNOUNCED THAT MEMBERS OF THE MANAGEMENT TEAM WILL PARTICIPATE IN A FIRESIDE CHAT AT THE LEERINK PARTNERS 2025 GLOBAL HEALTHCARE CONFERENCE ON TUESDAY, MARCH 11 TH AT 3:40 P.M. ET. THE LIVE EVENT AND REPLAY OF THE PRESENTATION WILL BE AVAILABLE UNDER "EVENTS AND PRESENTATIONS" THROUGH THE INVESTOR RELATIONS SECTION OF THE COMPANY'S WEBSITE AT HTTPS://IR.REGULUSRX.COM/EVENTS AND ARCHIVED FOR 90 DAYS FOLLOWING THE PRESENTATION DATE.

REGULUS THERAPEUTICS TO PRESENT AT THE LEERINK PARTNERS 2025 GLOBAL HEALTHCARE CONFERENCE

SAN DIEGO , FEB. 4, 2025 /PRNEWSWIRE/ -- REGULUS THERAPEUTICS INC. (NASDAQ: RGLS), A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE MEDICINES TARGETING MICRORNAS (THE "COMPANY" OR "REGULUS"), TODAY ANNOUNCED THAT MEMBERS OF THE MANAGEMENT TEAM WILL PARTICIPATE IN A FIRESIDE CHAT AT THE OPPENHEIMER 35TH ANNUAL HEALTHCARE LIFE SCIENCES CONFERENCE ON TUESDAY, FEBRUARY 11 TH AT 2:40 P.M. ET. THE LIVE EVENT AND REPLAY OF THE PRESENTATION WILL BE AVAILABLE UNDER "EVENTS AND PRESENTATIONS" THROUGH THE INVESTOR RELATIONS SECTION OF THE COMPANY'S WEBSITE AT HTTPS://IR.REGULUSRX.COM/EVENTS AND ARCHIVED FOR 90 DAYS FOLLOWING THE PRESENTATION DATE.

REGULUS THERAPEUTICS TO PRESENT AT THE OPPENHEIMER 35TH ANNUAL HEALTHCARE LIFE SCIENCES CONFERENCE

TOPLINE DATA FROM AN INTERIM ANALYSIS OF THE FOURTH COHORT OF ITS PHASE 1B MULTIPLE-ASCENDING DOSE (MAD) CLINICAL TRIAL SHOWED CONTINUED MECHANISTIC DOSE RESPONSE EXPLORATORY RESULTS OF IMAGING-BASED BIOMARKERS CONTINUED TO SHOW REDUCTION IN HEIGHT-ADJUSTED TOTAL KIDNEY VOLUME (HTTKV) GROWTH RATE SUCCESSFUL END-OF-PHASE 1 MEETING WITH THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) WITH AGREEMENT ON KEY COMPONENTS OF A PHASE 3 SINGLE PIVOTAL TRIAL FOR POTENTIAL ACCELERATED APPROVAL COMPANY TO HOLD CONFERENCE CALL AT 8:30 A.M. ET TODAY SAN DIEGO , JAN.29, 2025 /PRNEWSWIRE/ -- REGULUS THERAPEUTICS INC. (NASDAQ: RGLS), A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE MEDICINES TARGETING MICRORNAS (THE "COMPANY" OR "REGULUS"), TODAY ANNOUNCED POSITIVE CLINICAL AND REGULATORY UPDATES FROM ITS ADPKD PROGRAM.

REGULUS THERAPEUTICS ANNOUNCES POSITIVE CLINICAL AND REGULATORY UPDATES FROM ITS AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) PROGRAM FOR FARABURSEN (RGLS8429)

SAN DIEGO , NOV. 26, 2024 /PRNEWSWIRE/ -- REGULUS THERAPEUTICS INC. (NASDAQ: RGLS), A BIOPHARMACEUTICAL COMPANY FOCUSED ON THE DISCOVERY AND DEVELOPMENT OF INNOVATIVE MEDICINES TARGETING MICRORNAS (THE "COMPANY" OR "REGULUS"), TODAY ANNOUNCED THAT THE COMPANY WILL PARTICIPATE IN THE FOLLOWING INVESTOR CONFERENCES: EVERCORE 7TH ANNUAL HEALTHCONX CONFERENCE: FIRESIDE CHAT ON TUESDAY, DECEMBER 3, 2024, AT 3:50 P.M. ET PIPERSANDLER 36TH ANNUAL HEALTHCARE CONFERENCE: PRESENTATION ON WEDNESDAY, DECEMBER 4, 2024, AT 11:10 A.M.

Regulus Therapeutics Inc.

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Regulus Therapeutics Inc.

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