PresentationKelly McCarthy All right. Good afternoon, everyone. I'm very happy to be here with the CEO of Rezolute, Nevan Elam. This is Kelly McCarthy from the Morgan Stanley Healthcare team and really excited to have you at our conference. I know you got a great schedule of meetings, and we're excited to talk a little bit more about the Rezolute story. So before we get into it, I'm going to read this quick disclaimer. For important disclosures, please see the Morgan Stanley research disclosure website at w ...

Rezolute (NasdaqCM:RZLT) FY Conference September 09, 2025 12:20 PM ET Speaker0I'm very happy to be here with the CEO of Resolute, Nevan Elam. This is Kelly McCarthy from the Morgan Stanley Healthcare team, and really excited to have you at our conference. I know you got a great schedule of meetings, and we're excited to talk a little bit more about the Resolute story. So before we get into it, I'm gonna read this quick disclaimer. For important disclosures, please see the Morgan Stanley research disclosure ...

Open-label study in as few as 16 tumor hyperinsulinism (HI) patients Study initiated and enrolling patients in the U.S. and Europe Topline data expected in the second half of 2026 REDWOOD CITY, Calif., Sept. 02, 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 the Company has gained alignment with FDA on a significantly streamlined clinical development path ...

Core Insights - Rezolute, Inc. has appointed Sunil Karnawat as Chief Commercial Officer to lead the launch strategy and global market readiness for its therapy, ersodetug, which is currently in Phase 3 studies for treating hyperinsulinism [1][2] Company Overview - Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI) with its antibody therapy, ersodetug, which has shown meaningful benefits in clinical trials [4] Leadership Appointment - Sunil Karnawat brings over 25 years of experience in global commercialization of biopharmaceuticals and medical devices, having successfully launched products in various therapeutic areas, including ultra-rare diseases [2] - Karnawat's previous roles include Vice President at Cytokinetics and Ultragenyx, where he led the launch of four ultra-rare disease products [2] - His educational background includes an MBA from the Wharton School and a Ph.D. in Engineering [2] Inducement Grant - In connection with Karnawat's appointment, the Board of Directors approved an inducement stock option of 275,000 shares at an exercise price of $6.55 per share, with a vesting schedule tied to his continued employment [3]

Core Viewpoint - Rezolute, Inc. is actively participating in the BTIG Virtual Biotechnology Conference, indicating its commitment to engaging with investors and stakeholders in the biotechnology sector [1][2]. Company Overview - Rezolute, Inc. is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI) [3]. - The company's antibody therapy, ersodetug, aims to treat all forms of HI and has demonstrated significant benefits in both clinical trials and real-world applications for congenital HI and tumor HI [3].

Core Insights - Rezolute, Inc. is focused on treating hypoglycemia caused by hyperinsulinism and has announced a late-breaking presentation at ENDO 2025 regarding its Phase 3 study of ersodetug [1][2] Group 1: Study Details - The Phase 3 sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ersodetug in patients aged 3 months to 45 years with congenital hyperinsulinism [3] - The study aims to enroll approximately 56 participants across more than a dozen countries, including the U.S., and has completed enrollment [4] - Key efficacy endpoints include the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia over six months of treatment [4] Group 2: Drug Information - Ersodetug is a fully human IgG2 monoclonal antibody that binds allosterically to the insulin receptor, aiming to decrease receptor over-activation and improve hypoglycemia [5] - The drug has shown substantial benefit in clinical trials and real-world use for treating both congenital and tumor-related hyperinsulinism [7] Group 3: Medical Context - Congenital hyperinsulinism is the most common cause of recurrent hypoglycemia in children, often presenting within the first month of life and can lead to severe complications if not managed properly [6] - More than half of children with congenital hyperinsulinism require long-term medical treatment for hypoglycemia that is not adequately addressed by existing therapies [6]

Core Insights - Enrollment in the sunRIZE study has been completed with 62 participants, surpassing the initial target of 56, including approximately 15% from U.S. sites [1][4] - Topline data from the study is expected to be released in December 2025, with a potential Biologics License Application submission to the FDA anticipated in 2026 if data supports it [2][4] Group 1: Study Details - The sunRIZE study is a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial aimed at evaluating the efficacy and safety of ersodetug for treating congenital hyperinsulinism (HI) in patients aged 3 months to 45 years [3][4] - Participants are randomized into three treatment arms to receive either ersodetug (5 or 10 mg/kg) or a matched placebo, administered bi-weekly during an initial loading phase, followed by every four weeks for six months [3][4] - The primary and key secondary efficacy endpoints include the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia over the treatment period [4] Group 2: Product Information - Ersodetug is a fully human IgG2 monoclonal antibody that binds allosterically to the insulin receptor, aiming to reduce receptor over-activation by insulin and related substances, thereby improving hypoglycemia [5][6] - The therapy is designed to treat all forms of hyperinsulinism and has shown substantial benefits in clinical trials and real-world applications for both congenital and tumor-related HI [6]

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, 2025 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 ...

[Business and Pipeline Update](index=1&type=section&id=Business%20and%20Pipeline%20Update) Rezolute is advancing its HI clinical programs, including the sunRIZE study and a new registrational study for tumor HI, supported by a recent $97 million financing [Pipeline Progress and Anticipated Milestones](index=1&type=section&id=Recent%20Pipeline%20Progress%20and%20Anticipated%20Milestones) The company's clinical pipeline is progressing with key milestones for its hyperinsulinism drug, ersodetug, including Phase 3 study completion and Breakthrough Therapy Designation - The Phase 3 sunRIZE study for congenital HI is expected to complete enrollment in May 2025, with topline results anticipated in December 2025[1](index=1&type=chunk)[5](index=5&type=chunk) - In May 2025, the FDA granted Breakthrough Therapy Designation (BTD) to ersodetug for treating hypoglycemia due to tumor HI, based on clinical data and real-world evidence from the Expanded Access Program[1](index=1&type=chunk)[5](index=5&type=chunk) - A registrational study for tumor HI, named "upLIFT", is planned to start in mid-2025, with topline data expected in the second half of 2026[10](index=10&type=chunk) - An independent Data Monitoring Committee recommended the continuation of the sunRIZE study as planned without increasing the sample size following an interim analysis in April 2025[5](index=5&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) Recent corporate developments include a successful financing round and a key board appointment to enhance commercialization expertise - In April 2025, the company closed an underwritten offering that raised approximately **$97 million**, extending its cash runway to the middle of 2027[10](index=10&type=chunk) - Appointed Erik Harris, Chief Commercial Officer at Ultragenyx, to its Board of Directors in March 2025 to provide commercialization expertise[10](index=10&type=chunk) [Fiscal Third Quarter 2025 Financial Results](index=2&type=section&id=Fiscal%20Third%20Quarter%20Financial%20Results) Rezolute reported an increased net loss of $18.9 million for Q3 FY2025 due to higher operating expenses, with cash reserves at $88.4 million [Financial Performance (Statement of Operations)](index=2&type=section&id=Financial%20Performance%20(Statement%20of%20Operations)) The company's operating expenses and net loss increased in Q3 FY2025 compared to the prior year, driven by higher R&D and G&A costs Operating Metrics (Three Months Ended March 31) | Operating Metric | Three Months Ended Mar 31, 2025 ($ Millions) | Three Months Ended Mar 31, 2024 ($ Millions) | Change (YoY) (%) | | :--- | :--- | :--- | :--- | | Research and development | 15.3 | 12.4 | +23.4 | | General and administrative | 4.7 | 3.8 | +23.7 | | Total operating expenses | 20.0 | 16.2 | +23.5 | | Net loss | 18.9 | 17.1 | +10.5 | | Net loss per common share | 0.27 | 0.34 | N/A | [Financial Position (Balance Sheet)](index=2&type=section&id=Financial%20Position%20(Balance%20Sheet)) The company's cash, cash equivalents, and investments decreased to $88.4 million as of March 31, 2025, impacting total assets and stockholders' equity Balance Sheet Highlights | Balance Sheet Item | As of March 31, 2025 ($ Millions) | As of June 30, 2024 ($ Millions) | | :--- | :--- | :--- | | Cash, cash equivalents and investments | 88.4 | 127.1 | | Total assets | 94.7 | 132.7 | | Total stockholders' equity | 82.6 | 121.0 | [Company and Product Overview](index=3&type=section&id=Company%20and%20Product%20Overview) Rezolute is a late-stage rare disease company focused on developing treatments for hypoglycemia caused by hyperinsulinism (HI) with its primary drug candidate, ersodetug [About Ersodetug](index=3&type=section&id=About%20Ersodetug) Ersodetug is a fully human monoclonal antibody designed to treat hypoglycemia by reducing insulin receptor over-activation, making it potentially effective for all forms of hyperinsulinism - Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor[11](index=11&type=chunk) - It is designed to decrease receptor over-activation by insulin and related substances (like IGF-2) to improve hypoglycemia[11](index=11&type=chunk) - Due to its mechanism of acting downstream from the pancreas, it has the potential to be universally effective for treating hypoglycemia from any congenital or acquired form of hyperinsulinism (HI)[11](index=11&type=chunk) [About Rezolute, Inc.](index=3&type=section&id=About%20Rezolute%2C%20Inc.) Rezolute, Inc. is a late-stage rare disease company specializing in developing treatments for hypoglycemia caused by hyperinsulinism - Rezolute is a late-stage rare disease company with a focus on treating hypoglycemia caused by hyperinsulinism (HI)[12](index=12&type=chunk)

Core Insights - Rezolute, Inc. is focused on treating hypoglycemia caused by hyperinsulinism and has received Breakthrough Therapy Designation from the FDA for its drug ersodetug [1][2][6] Pipeline Progress and Milestones - The Phase 3 sunRIZE study for congenital hyperinsulinism (HI) is on track to complete enrollment in May 2025, with topline results expected in December 2025 [6] - An independent Data Monitoring Committee recommended the continuation of the sunRIZE study after an interim analysis in April 2025 [6] - The registrational upLIFT study for tumor HI is anticipated to begin mid-2025, with topline data expected in the second half of 2026 [6] Financial Performance - As of March 31, 2025, cash, cash equivalents, and investments in marketable securities totaled $88.4 million, down from $127.1 million as of June 30, 2024 [8] - Research and development expenses increased to $15.3 million for the third quarter of fiscal 2025, compared to $12.4 million for the same period a year ago [9] - General and administrative expenses rose to $4.7 million for the third quarter of fiscal 2025, up from $3.8 million in the same period last year [10] - The net loss for the third quarter of fiscal 2025 was $18.9 million, compared to a net loss of $17.1 million for the same period a year ago [10] Corporate Updates - Erik Harris, a rare disease commercial leader, was appointed to the Board of Directors in March 2025 [6] - The company closed an underwritten offering in April 2025, raising approximately $97 million, extending its cash runway to mid-2027 [6][7]