Core Viewpoint - Rezolute, Inc. is experiencing a positive trajectory in its stock price, driven by the FDA's Breakthrough Therapy designation for its lead candidate, Ersodetug, which is expected to expedite its approval process [1][2] Group 1: Drug Development and Market Potential - Ersodetug is designed to treat hard-to-treat hyperinsulinism, with initial focus on tumor-induced cases, but has potential for broader applications [2] - The company anticipates that sales could peak at over $1 billion for its initial target markets, positioning Ersodetug as a potential blockbuster product [3] - Revenue generation is expected to begin in 2026, with a projected growth trajectory over the next eight to ten years as treatment indications expand [3][4] Group 2: Financial Outlook and Analyst Sentiment - Analysts unanimously rate RZLT stock as a Buy, with a price target suggesting a 55% upside from the current price [5] - H.C. Wainwright's analyst has set a price target of $14, indicating a potential 20% upside compared to the consensus [6] - Institutional ownership exceeds 80%, with increasing bullish activity, suggesting continued upward momentum for the stock [7] Group 3: Stock Performance and Risks - The stock price has increased over 200% in 2025, with technical indicators showing bullish trends, although resistance near $8 may limit short-term gains [13] - The company is currently pre-revenue but has sufficient capital to sustain operations for approximately six more quarters, despite ongoing net losses [11][12] - There is a risk of dilution due to potential partnerships and cash injections, with share count increasing by 36% year-to-date [12]

Core Insights - The article discusses Rezolute, Inc. (NASDAQ: RZLT) and its potential as a candidate in the pharmaceutical sector, particularly focusing on the drug RZ402 [2]. Company Overview - Rezolute, Inc. is highlighted for its innovative approaches in the biotech industry, with a specific emphasis on RZ402, which may present unexpected opportunities for investors [2]. Investment Analysis - The author provides a comprehensive analysis of Rezolute, including a model portfolio of over 10 small and mid-cap stocks, aimed at assisting healthcare investors in making informed decisions [2].

Core Insights - The presentation features a discussion between Kelly McCarthy from Morgan Stanley and Nevan Elam, CEO of Rezolute, highlighting the company's narrative and strategic direction [1]. Company Overview - Rezolute is positioned within the healthcare sector, and the conference serves as a platform to elaborate on its business model and future prospects [1].

Summary of Resolute's Conference Call Company Overview - **Company**: Resolute - **Focus**: Treatment of hyperinsulinism, a rare disease affecting insulin regulation in patients, particularly in congenital and tumor settings [2][4] Core Points and Arguments - **Disease Background**: Hyperinsulinism leads to dangerous hypoglycemia due to excessive insulin production, either from congenital genetic defects or tumors [2][3] - **Therapeutic Approach**: Resolute is developing an antibody designed to modulate insulin binding rather than blocking it, allowing for a universal treatment across different forms of hyperinsulinism [3][4] - **Clinical Development**: Currently in Phase 3 trials for both congenital and tumor-related hyperinsulinism, with promising results in correcting glucose levels in patients [4][6] - **Market Size**: Approximately 3,500 individuals in the US have congenital hyperinsulinism, while the tumor market is estimated to be twice as large, indicating significant commercial potential [5][24] - **FDA Alignment**: Recent alignment with the FDA on the uplift study for tumor hyperinsulinism is seen as a significant development, allowing for a streamlined Phase 3 study [6][7] - **Data Timeline**: Expected data from the congenital hyperinsulinism program in December 2025, with a goal of demonstrating a 35% difference in treatment efficacy compared to placebo [11][13] Important Insights - **Patient Impact**: The therapy has shown substantial improvements in quality of life for patients previously facing end-of-life situations, highlighting the therapy's potential impact [7][16] - **Regulatory Path**: Breakthrough therapy designation received for both congenital and tumor hyperinsulinism, with plans to file a Biologics License Application (BLA) by mid-2026 [18][19] - **Commercial Strategy**: The company plans to independently commercialize the drug in the US, with potential partnerships evaluated for international markets [29][26] - **Pricing Strategy**: Anticipated robust pricing for the drug, especially in pediatric rare disease markets, with expectations of minimal pushback from payers [27][26] Additional Considerations - **Competitive Landscape**: Resolute does not view other therapies as direct competitors, emphasizing its unique position as the only therapy applicable across all forms of hyperinsulinism [41][42] - **Community Engagement**: There is growing excitement among key opinion leaders (KOLs) and patient advocacy groups due to the long absence of effective therapies for hyperinsulinism [22][23] - **Team Dynamics**: The company has a dedicated team with low attrition, fostering a mission-driven culture focused on making a difference in patients' lives [32][30] Conclusion - Resolute is positioned at a critical juncture with its innovative therapy for hyperinsulinism, showing promise in clinical trials and receiving regulatory support, which could lead to significant advancements in treatment options for affected patients [43][44]

Core Insights - Rezolute, Inc. has aligned with the FDA on a streamlined clinical development path for its Phase 3 study (upLIFT) of ersodetug, aimed at treating hypoglycemia caused by tumor hyperinsulinism (HI) [1][2] - The FDA has approved modifications to the study design, allowing for a single-arm open-label trial with as few as 16 participants, eliminating the need for a double-blind randomized placebo-controlled trial [2][3] - The pivotal sunRIZE trial in congenital HI is expected to report topline results in December 2025 and will serve as confirmatory evidence for the efficacy of ersodetug [2] Company Overview - Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, with its antibody therapy, ersodetug, showing meaningful benefits in clinical trials and real-world applications [8] - The company has treated over 10 patients with tumor HI under its Expanded Access Program, contributing to the favorable outcomes that influenced the FDA's decision [3] Study Details - The upLIFT study is a single-arm, open-label pivotal trial involving approximately 16 participants with insulinoma or non-islet cell tumors experiencing uncontrolled hypoglycemia due to tumor HI [4] - Participants will receive ersodetug at a dosage of 9 mg/kg per week for 8 weeks, with the primary endpoint being a 50% reduction in intravenous glucose requirements [4] Disease Context - Tumor hyperinsulinism is a rare disease caused by islet cell tumors (ICTs) and non-islet cell tumors (NICTs), leading to hypoglycemia through over-activation of the insulin receptor [5] - Insulinomas are the most common ICTs, while various NICTs, particularly hepatocellular carcinoma, can also cause hypoglycemia by secreting insulin-like substances [5] Mechanism of Action - Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor, reducing receptor over-activation by insulin and related substances, thereby improving hypoglycemia [7]

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 ...