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Rezolute, Inc., a clinical stage biopharmaceutical company, develops transformative therapies for metabolic diseases associated with chronic glucose imbalance in the United States. The company's lead product candidate is RZ358, a human monoclonal antibody that is in Phase 2b clinical trial for the treatment of congenital hyperinsulinism, an ultra-rare pediatric genetic disorder. It is also developing RZ402, a selective and potent plasma kallikrein inhibitor, which is in Phase 1 clinical trial for the chronic treatment of diabetic macular edema. The company was formerly known as AntriaBio, Inc. and changed its name to Rezolute, Inc. in December 2017. Rezolute, Inc. was founded in 2010 and is headquartered in Redwood City, California.

Rezolute, Inc.

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REDWOOD CITY, CALIF., JULY 22, 2025 (GLOBE NEWSWIRE) -- REZOLUTE, INC. (NASDAQ: RZLT) (REZOLUTE OR THE COMPANY), A LATE-STAGE RARE DISEASE COMPANY FOCUSED ON TREATING HYPOGLYCEMIA CAUSED BY HYPERINSULINISM, TODAY ANNOUNCED THAT MANAGEMENT WILL PARTICIPATE IN THE BTIG VIRTUAL BIOTECHNOLOGY CONFERENCE, TAKING PLACE JULY 29-30, 2025.

REZOLUTE TO PARTICIPATE IN THE BTIG VIRTUAL BIOTECHNOLOGY CONFERENCE

REDWOOD CITY, CALIF., JULY 09, 2025 (GLOBE NEWSWIRE) -- REZOLUTE, INC. (NASDAQ: RZLT) (REZOLUTE OR THE COMPANY), A LATE-STAGE RARE DISEASE COMPANY FOCUSED ON TREATING HYPOGLYCEMIA CAUSED BY HYPERINSULINISM (HI), TODAY ANNOUNCED THAT THE ABSTRACT TITLED PRELIMINARY PATIENT DEMOGRAPHICS AND BASELINE CHARACTERISTICS FROM A PHASE 3 STUDY (SUNRIZE) OF ERSODETUG FOR HYPOGLYCEMIA DUE TO CONGENITAL HYPERINSULINISM: TRIAL IN PROGRESS HAS BEEN SELECTED FOR A LATE-BREAKING PRESENTATION AT ENDO 2025 TAKING PLACE JULY 12-15, 2025 IN SAN FRANCISCO, CA, USA.

REZOLUTE ANNOUNCES PRESENTATION OF PARTICIPANT BASELINE DATA FROM ITS FULLY ENROLLED PHASE 3 STUDY OF ERSODETUG IN CONGENITAL HYPERINSULINISM AT THE UPCOMING ANNUAL MEETING OF THE ENDOCRINE SOCIETY (ENDO 2025)

TARGET ENROLLMENT EXCEEDED WITH 62 PARTICIPANTS ENROLLED, INCLUDING APPROXIMATELY 15 PERCENT FROM U.S. SITES TOPLINE DATA IS ANTICIPATED IN DECEMBER OF 2025 REDWOOD CITY, CALIF., MAY 28, 2025 (GLOBE NEWSWIRE) -- REZOLUTE, INC. (NASDAQ: RZLT) (REZOLUTE OR THE COMPANY), A LATE-STAGE RARE DISEASE COMPANY FOCUSED ON TREATING HYPOGLYCEMIA CAUSED BY HYPERINSULINISM (HI), TODAY ANNOUNCED THAT ENROLLMENT IS COMPLETE IN THE SUNRIZE STUDY, A GLOBAL, PHASE 3 MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL ARM STUDY DESIGNED TO EVALUATE THE EFFICACY AND SAFETY OF ERSODETUG FOR THE TREATMENT OF HYPOGLYCEMIA IN PATIENTS WITH CONGENITAL HI.

REZOLUTE ANNOUNCES COMPLETION OF ENROLLMENT IN THE PHASE 3 SUNRIZE STUDY OF ERSODETUG IN PATIENTS WITH CONGENITAL HYPERINSULINISM

SUNRIZE ENROLLMENT ON TRACK INCLUDING U.S. SITES AND EXPECTED TO BE COMPLETED IN MAY 2025; TOPLINE DATA ANTICIPATED IN DECEMBER 2025

REZOLUTE REPORTS THIRD QUARTER FISCAL 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

REGISTRATIONAL STUDY IN PATIENTS WITH TUMOR HYPERINSULINISM (HI) EXPECTED TO COMMENCE MID-YEAR DESIGNATION UNDERSCORES NEED FOR THERAPIES TO TREAT SEVERE HYPOGLYCEMIA IN THE ONCOLOGY SETTING REDWOOD CITY, CALIF., MAY 05, 2025 (GLOBE NEWSWIRE) -- REZOLUTE, INC. (NASDAQ: RZLT) (REZOLUTE OR THE COMPANY), A LATE-STAGE RARE DISEASE COMPANY FOCUSED ON TREATING HYPOGLYCEMIA CAUSED BY HI, TODAY ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS GRANTED BREAKTHROUGH THERAPY DESIGNATION (BTD) TO ITS INVESTIGATIONAL THERAPY, ERSODETUG, FOR THE TREATMENT OF HYPOGLYCEMIA CAUSED BY TUMOR HI.

REZOLUTE RECEIVES BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR ERSODETUG IN THE TREATMENT OF HYPOGLYCEMIA DUE TO TUMOR HYPERINSULINISM

REDWOOD CITY, CALIF., MAY 01, 2025 (GLOBE NEWSWIRE) -- REZOLUTE, INC. (NASDAQ: RZLT) (REZOLUTE OR THE COMPANY), A LATE-STAGE RARE DISEASE COMPANY FOCUSED ON SIGNIFICANTLY IMPROVING OUTCOMES FOR INDIVIDUALS WITH HYPOGLYCEMIA CAUSED BY HYPERINSULINISM, TODAY ANNOUNCED THAT MANAGEMENT WILL PARTICIPATE IN THE FOLLOWING INVESTOR CONFERENCES:

REZOLUTE TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCES

NEW YORK, APRIL 25, 2025 (GLOBE NEWSWIRE) -- REZOLUTE, INC. (NASDAQ: RZLT) (REZOLUTE OR THE COMPANY), A LATE-STAGE BIOPHARMACEUTICAL COMPANY COMMITTED TO DEVELOPING NOVEL, TRANSFORMATIVE THERAPIES FOR SERIOUS RARE DISEASES, TODAY ANNOUNCED THE CLOSING OF ITS PREVIOUSLY ANNOUNCED UNDERWRITTEN OFFERING (THE OFFERING) OF AN AGGREGATE OF 24,940,769 SHARES OF ITS COMMON STOCK AT AN OFFERING PRICE OF $3.25 PER SHARE, WHICH INCLUDES 4,153,846 SHARES OF COMMON STOCK PURSUANT TO THE EXERCISE IN FULL OF THE UNDERWRITERS' OPTION TO PURCHASE ADDITIONAL SHARES OF COMMON STOCK AND, TO CERTAIN INVESTORS IN LIEU OF COMMON STOCK, PRE-FUNDED WARRANTS TO PURCHASE UP TO 6,905,385 SHARES OF COMMON STOCK AT AN OFFERING PRICE OF $3.2490 PER PRE-FUNDED WARRANT, WHICH REPRESENTS THE PER SHARE OFFERING PRICE FOR THE COMMON STOCK LESS THE $0.001 PER SHARE EXERCISE PRICE FOR EACH PRE-FUNDED WARRANT.

REZOLUTE, INC. ANNOUNCES CLOSING OF UNDERWRITTEN OFFERING

NEW YORK, APRIL 23, 2025 (GLOBE NEWSWIRE) -- REZOLUTE, INC. (NASDAQ: RZLT) (REZOLUTE OR THE COMPANY), A LATE-STAGE BIOPHARMACEUTICAL COMPANY COMMITTED TO DEVELOPING NOVEL, TRANSFORMATIVE THERAPIES FOR SERIOUS RARE DISEASES, TODAY ANNOUNCED THE PRICING OF AN UNDERWRITTEN OFFERING, PRICED AT-THE-MARKET UNDER NASDAQ RULES, OF AN AGGREGATE OF 20,786,923 SHARES OF ITS COMMON STOCK AT AN OFFERING PRICE OF $3.25 PER SHARE, AND, TO CERTAIN INVESTORS IN LIEU OF COMMON STOCK, PRE-FUNDED WARRANTS TO PURCHASE UP TO 6,905,385 SHARES OF COMMON STOCK AT AN OFFERING PRICE OF $3.2490 PER PRE-FUNDED WARRANT, WHICH REPRESENTS THE PER SHARE OFFERING PRICE FOR THE COMMON STOCK LESS THE $0.001 PER SHARE EXERCISE PRICE FOR EACH PRE-FUNDED WARRANT. GROSS PROCEEDS FROM THE UNDERWRITTEN OFFERING BEFORE DEDUCTING UNDERWRITING DISCOUNTS AND COMMISSIONS AND OTHER OFFERING EXPENSES ARE EXPECTED TO BE APPROXIMATELY $90 MILLION. REZOLUTE HAS ALSO GRANTED THE UNDERWRITERS A 30-DAY OPTION TO PURCHASE UP TO AN ADDITIONAL 4,153,846 SHARES OF COMMON STOCK AT THE OFFERING PRICE, LESS UNDERWRITING DISCOUNTS AND COMMISSIONS.

REZOLUTE ANNOUNCES PRICING OF OFFERING OF $90 MILLION OF COMMON STOCK AND PRE-FUNDED WARRANTS

INDEPENDENT DATA MONITORING COMMITTEE (THE DMC) RECOMMENDS CONTINUATION OF SUNRIZE TRIAL AS PLANNED WITH NO NEED TO INCREASE SAMPLE SIZE ENROLLMENT ON TRACK AND EXPECTED TO BE COMPLETED IN MAY 2025; TOPLINE DATA ANTICIPATED IN DECEMBER 2025 U.S. SITES ACTIVATED AND ENROLLING PATIENTS REDWOOD CITY, CALIF., APRIL 23, 2025 (GLOBE NEWSWIRE) --  REZOLUTE, INC.

REZOLUTE ANNOUNCES POSITIVE RECOMMENDATION AFTER INDEPENDENT INTERIM ANALYSIS OF PHASE 3 SUNRIZE STUDY OF ERSODETUG IN CONGENITAL HYPERINSULINISM (HI)

REDWOOD CITY, CALIF., MARCH 26, 2025 (GLOBE NEWSWIRE) -- REZOLUTE, INC . (NASDAQ: RZLT), A LATE-STAGE BIOPHARMACEUTICAL COMPANY DEDICATED TO DEVELOPING TRANSFORMATIVE THERAPIES FOR RARE DISEASES WITH SERIOUS UNMET NEEDS, ANNOUNCED THE APPOINTMENT OF ERIK HARRIS TO ITS BOARD OF DIRECTORS, EFFECTIVE IMMEDIATELY. MR. HARRIS, WHO CURRENTLY SERVES AS CHIEF COMMERCIAL OFFICER AND EXECUTIVE VICE PRESIDENT AT ULTRAGENYX, BRINGS MORE THAN 20 YEARS OF BIOPHARMACEUTICAL EXPERTISE TO REZOLUTE.

Rezolute, Inc.

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Rezolute, Inc.

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