Ersodetug

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. All shares of common stock and pre-funded warrants to be sold in the offering will be offered by Rezolute. The closing of the offering is expected to occur on or about April 24, 2025, subject to the satisfaction of customary closing conditions. The deal includes participation from new and existing investors, including Federated Hermes Kaufmann Funds, Blackstone Multi-Asset Investing, Great Point Partners, LLC, Marshall Wace, Woodline Partners LP, Nantahala Capital, Squadron Capital Management and select mutual funds. Guggenheim Securities is acting as the sole book-running manager for the offering. BTIG, H.C. Wainwright & Co., and Jones are acting as lead managers for the offering. Craig-Hallum and Maxim Group LLC are acting as co-managers for the offering. WG Partners LLP is acting as financial advisor. Rezolute intends to use the net proceeds from the offering for research and development, general corporate expense and working capital needs. A shelf registration statement on Form S-3 (File No. 333-275562) relating to the securities to be offered in the offering was filed with the Securities and Exchange Commission (the “SEC”) and was declared effective on November 29, 2023. The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and final prospectus supplement and the accompanying prospectus relating to and describing the terms of the underwritten offering will be filed with the SEC and, when available, may be obtained on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, New York 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Rezolute, Inc. 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, ersodetug, 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 HI and tumor HI. Forward-Looking Statements Any statements in this press release about the Company’s future expectations, plans and prospects, including statements regarding the proposed offering, including statements regarding Rezolute’s expectations on the timing and completion of the offering and the anticipated use of proceeds therefrom, constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company’s strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to market and other financial conditions, the potential completion of the proposed offering or the size or terms thereof, satisfaction of customary closing conditions related to the proposed offering and other factors discussed in the “Risk Factors” section contained in the preliminary prospectus supplement and final prospectus supplement that will be filed with the SEC and the reports that the Company has filed with the SEC. Any forward-looking statements represent the Company’s views only as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. Contacts: Rezolute, Inc.Christen Baglaneascbaglaneas@rezolutebio.com508-272-6717 MediaSarah LimaSarah@GalvinPR.com(774) 766-0200

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. (Nasdaq: RZLT) (the “Company or “Rezolute”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced the DMC’s recommendation to continue the Phase 3 sunRIZE study as planned in patients with congenital HI, without an increase in the study sample size. “We are thrilled with the DMC’s favorable recommendation, which appears to validate our initial assumptions for the design and powering of the Phase 3 sunRIZE study,” said Brian Roberts, M.D., Chief Medical Officer at Rezolute. “While we remain blinded to the partial study data and are not privy to any of the statistical outputs from the DMC, we are nevertheless encouraged by this recommendation considering past outcomes from the Phase 2 RIZE study with the same objectively measured glycemic primary endpoint, real-world observations from our Expanded Access Program, and previously announced pharmacokinetic data from the open-label arm of the sunRIZE study. With U.S. clinical sites now also enrolling patients as part of our global study, and the Company tracking to complete enrollment next month, we look forward to announcing topline results, anticipated in December of this year, and remain confident in the potential of ersodetug to be a best-in-class treatment option for people living with hyperinsulinism.” The interim analysis of the Phase 3 sunRIZE study was performed by an unblinded DMC and was based on a pre-specified analysis of the primary study endpoint (hypoglycemia events), after approximately half of enrolled patients completed the primary assessments. The analysis was intended to evaluate for study futility or otherwise to inform a potential sample size increase, for purposes of optimizing the study power and statistical confidence in the final analysis outcomes. The Company has remained blinded throughout the interim analysis and has not seen the information made available to the DMC to inform its decision making, nor received any other information from the DMC after their meeting, other than its recommendation to continue the study as planned. About sunRIZEThe Phase 3 sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital HI who are experiencing poorly controlled hypoglycemia. Participants between the ages of 3 months to 45 years old are eligible to participate. The study is enrolling up to 56 participants in more than a dozen countries around the world. About ErsodetugErsodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of HI, thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI. About Congenital HyperinsulinismCongenital HI is the most common cause of recurrent and persistent hypoglycemia in children. Patients with congenital HI typically present with signs or symptoms of hypoglycemia within the first month of life. These episodes can result in significant brain injury and death if not recognized and managed appropriately. Additionally, recurrent, or cumulative, hypoglycemia can lead to progressive and irreversible damage over time, including serious and devastating brain injury, seizures, neuro-developmental problems, feeding difficulties, and significant impact on patient and family quality of life. In cases of congenital HI that are unresponsive to medical management, surgical removal of the pancreas may be required. More than half of children with congenital HI require long-term medical treatment for hypoglycemia that is not addressed by available therapies. About Rezolute, Inc.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, ersodetug, 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 HI and tumor HI. For more information, visit www.rezolutebio.com. Forward-Looking StatementsThis release, like many written and oral communications presented by Rezolute and its authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. These forward-looking statements include, but are not limited to, statements regarding the ability of ersodetug to become an effective treatment for congenital HI, statements regarding the potential regulatory approval and commercialization of ersodetug, the efficacy of the Phase 3 sunRIZE study, statements related to the Phase 3 sunRIZE study sample size, and statements regarding the timing of the completion of enrollment and release of topline data. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available on the SEC’s website at www.sec.gov. You are urged to consider these factors carefully by evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. Contacts: InvestorsChristen Baglaneascbaglaneas@rezolutebio.com 508-272-6717 MediaSarah LimaSarah@GalvinPR.com(774) 766-0200