Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company's Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (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 that it received U.S. Food and Drug Administration (FDA) clearance for its ...

In addition, the Company has entered into an agreement for a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), of 1,500,000 shares of its common stock, at a sale price of $4.00 per share. Contacts: Rezolute, Inc. NEW YORK, June 27, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious ...

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). The Company's antibody therapy, RZ358, is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI). | --- | |---------------------------------------| | | | Contacts: | | Rezolute, Inc. | | Christen Baglaneas | | cbaglanea ...

NEW YORK, June 13, 2024 (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 its previously announced underwritten public offering of an aggregate of 11,250,000 shares of its common stock at an offering price of $4.00 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 3,750,000 sha ...

Jefferies and Cantor are acting as the joint book-running managers for the offering. BTIG, Craig-Hallum, H.C. Wainwright & Co., Jones and Maxim Group LLC are acting as co-managers for the offering. A shelf registration statement on Form S-3 (File No. 333-275562) relating to the securities to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on November 29, 2023. The public offering will be made only by means of a prospectus supplem ...

NEW YORK, June 13, 2024 (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 that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an ...

NEW YORK, June 13, 2024 (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 that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an ...

Met primary study endpoints: good safety profile and reduction in central subfield thickness (CST) First oral therapy to demonstrate reduction in macular edema; supports potential for early disease intervention Virtual investor event to be held today at 5:30pm ET REDWOOD CITY, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare di ...

Core Insights - Rezolute, Inc. announced positive topline results from the Phase 2 clinical study of RZ402 for diabetic macular edema (DME), demonstrating a good safety profile and significant reduction in central subfield thickness (CST) [1][5][9] - The study indicates the potential for RZ402 to serve as a first-line, non-invasive oral therapy for DME, which could alter long-term patient outcomes [2][3] Study Results - The Phase 2 study enrolled 94 participants in a randomized, double-masked, placebo-controlled design, evaluating RZ402 as a monotherapy over a 12-week period [2][6] - RZ402 showed a significant improvement in CST across all dosage levels compared to placebo, with a maximum reduction of approximately 50 microns (p=0.02) [6][9] - The 200 mg dose of RZ402 yielded the most substantial response, with over 20% of participants experiencing clinically significant improvements [6][11] Safety Profile - RZ402 was reported to be safe and well-tolerated, with adverse events generally mild and comparable to placebo [11] - No ocular adverse effects typically associated with intravitreal injections were observed, and safety assessments including ECGs and vital signs were unremarkable [11] Future Plans - The company plans to present further findings and data at an upcoming medical conference [7] - A virtual investor event is scheduled to discuss these topline results, indicating ongoing engagement with stakeholders [8] About DME and RZ402 - DME is a severe complication of diabetic retinopathy characterized by retinal swelling, and current treatments involve invasive anti-VEGF injections [8][9] - RZ402 is an oral, small molecule plasma kallikrein inhibitor designed to block bradykinin production, potentially reducing vascular leakage and inflammation associated with DME [9]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39683 REZOLUTE, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 27-3440894 (State or other jurisdicti ...