Financial Performance - Cash, cash equivalents, and investments in marketable securities were $127.1 million as of June 30, 2024, compared to $118.4 million as of June 30, 2023, representing a 6.1% increase[6] - Net loss for Q4 fiscal 2024 was $23.0 million, compared to a net loss of $12.7 million for the same period last year, an increase of 81.1%; full year fiscal 2024 net loss was $68.5 million, compared to a net loss of $51.8 million in fiscal year 2023, a 32.3% increase[7] - Total operating expenses for Q4 fiscal 2024 were $23.1 million, compared to $14.2 million for the same period last year, a 62.3% increase; full fiscal year 2024 total operating expenses were $70.4 million, compared to $56.0 million in fiscal year 2023, a 25.7% increase[12] Research and Development - Research and development (R&D) expenses for Q4 fiscal 2024 were $19.1 million, up from $10.9 million in the same period last year, marking a 75.7% increase; full fiscal year 2024 R&D expenses totaled $55.7 million, compared to $43.8 million in fiscal year 2023, a 27.5% increase[6] - Positive topline results from the Phase 2 proof-of-concept study of RZ402 for diabetic macular edema (DME) were announced, showing significant reduction in central subfield thickness (CST) of up to approximately 50 microns compared to placebo[5] - The company has engaged in discussions with potential partners for further development of RZ402[5] Regulatory Updates - The FDA lifted partial clinical holds on ersodetug for congenital hyperinsulinism (HI), allowing U.S. participant enrollment in the Phase 3 sunRIZE study to begin in early 2025[2] - The FDA cleared the IND application for the Phase 3 study of ersodetug for tumor HI, with patient enrollment anticipated to begin in the first half of 2025 and topline results expected in mid-2026[4] - Topline results from the sunRIZE study are expected in the second half of 2025[3] Administrative Expenses - General and administrative (G&A) expenses for Q4 fiscal 2024 were $4.0 million, compared to $3.3 million for the same period a year ago, a 21.2% increase; full fiscal year 2024 G&A expenses were $14.7 million, up from $12.2 million in fiscal year 2023, a 20.5% increase[7]

FDA lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed in the U.S. Phase 3 study for ersodetug for the treatment of tumor HI expected to commence in the first half of 2025 REDWOOD CITY, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today reported financial resul ...

Rezolute, Inc. (RZLT) announced that the FDA has removed the partial clinical holds on the phase III study evaluating its lead pipeline candidate RZ358 (ersodetug) for the treatment of hypoglycemia caused by congenital hyperinsulinism (HI), an ultra-rare pediatric genetic disorder. Shares of the company were up 22.1% on Sept. 9 following the announcement of the news. The double-blind, placebo-controlled phase III sunRIZE study is designed to evaluate the safety and efficacy of RZ358 in patients with congeni ...

REDWOOD CITY, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company developing a novel therapy to treat hyperinsulinism (HI), today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical holds on RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital HI. Ersodetug is currently being studied in sunRIZE, a global Phase 3, multi-center, double-blind, randomized, place ...

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 ...

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 ...