Rezolute Inc. (NASDAQ:RZLT) is one of the top long-term biotechnology stocks to buy. Wedbush analyst Yun Zhong reaffirmed a Buy rating on Rezolute Inc. (NASDAQ:RZLT) stock on October 23, citing strong confidence in the company’s lead candidate, ersodetug. Is Rezolute Inc. (RZLT) One of the Top Long-Term Biotechnology Stocks to Buy White medicinal tablets. Photo by Kaboompics.com Currently in Phase 3 trials for congenital hyperinsulinism (cHI), the drug has shown promise in addressing a significant unmet ...

REDWOOD CITY, Calif., Oct. 09, 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 it has granted as of September 30, 2025 equity inducement awards to two new employees. The equity awards were approved by the Compensation Committee of the Company’s Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4) and were made as a material inducement to th ...

Company Highlights - Cidara Therapeutics Inc. (CDTX) reached a 52-week high of $87.19 as it advances its development plan for CD388, a non-vaccine preventive treatment for seasonal influenza, with enrollment in a Phase 3 study expected to start by September 2025 targeting 6,000 participants [1] - Maze Therapeutics Inc. (MAZE) saw its stock rise to a 52-week high of $27.09 following positive Phase 1 clinical results for MZE782, an oral therapy for Phenylketonuria and chronic kidney disease, with plans to enter Phase 2 studies in 2026 [3][4] - Medpace Holdings Inc. (MEDP) is set to report Q3 2025 financial results on October 22, 2025, and has raised its full-year guidance twice, indicating strong operational momentum, with the stock hitting a 52-week high of $506.55 [5][6] - Monopar Therapeutics Inc. (MNPR) rebounded from potential Nasdaq delisting to a 52-week high of $73.75, planning to seek approval for ALXN1840 for Wilson disease in early 2026, supported by long-term clinical data [7][8] - Prenetics Global Limited (PRE) projects 2025 revenue between $85 million and $100 million, a significant increase from $30.6 million in 2024, with its new wellness brand IM8 Health on track for $100 million in annual recurring revenue [9][10] - Protagonist Therapeutics Inc. (PTGX) is nearing a major milestone with Icotrokinra for psoriasis, having submitted a regulatory application to the FDA and EMA in July 2025, with the stock reaching a 52-week high of $66.70 [11][12] - uniQure N.V. (QURE) announced positive results from its Phase I/II study of AMT-130 for Huntington's disease, planning to submit a Biologics License Application in Q1 2026, with the stock soaring over 200% to a 52-week high of $51.21 [13][14] - Rezolute Inc. (RZLT) surged to a 52-week high of $9.02 ahead of topline results from its pivotal Phase III trial for hypoglycemia treatment, expected in December [15][16] - United Therapeutics Corp. (UTHR) reached a 52-week high of $442.01 as anticipation builds for data from the TETON-2 study of nebulized Tyvaso in idiopathic pulmonary fibrosis, with positive results reported earlier [17][18]

Core Insights - Several clinical-stage biotech companies experienced significant after-hours trading momentum due to anticipated trial data releases and pipeline updates [1] Company Summaries - **MBX Biosciences Inc. (MBX)**: Shares surged 33% in after-hours trading, rising from $10.00 to $13.77, following the announcement of topline results from its Phase 2 trial of Canvuparatide, expected on September 22 [2][3] - **Structure Therapeutics Inc. (GPCR)**: Stock increased 11.37% to $26.26 after closing at $23.58, driven by interest in its lead candidate aleniglipron, with topline results from two Phase 2b trials expected by the end of 2025 [4] - **Cartesian Therapeutics Inc. (RNAC)**: Shares rose 5.51% to $9.96 after a decline during the day, with preliminary data from the Phase 2 trial of Descartes-08 expected in the second half of 2025 [5][6] - **Rapport Therapeutics Inc. (RAPP)**: Stock increased 3.60% to $27.31, following positive topline results from its Phase 2a trial for RAP-219, with Phase 3 trials expected to start in 2026 [9][10] - **Rezolute Inc. (RZLT)**: Shares rose 3.77% to $7.99 after a decline during the day, with topline data from the Phase 3 sunRIZE trial for congenital hyperinsulinism expected in December 2025 [11][12]

PART I [Item 1. Business](index=6&type=section&id=Item%201.%20Business) Rezolute, Inc. is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI) with its lead clinical asset, ersodetug. The company is advancing ersodetug through Phase 3 studies for congenital HI (sunRIZE study, topline results expected **Dec 2025**) and tumor HI (upLIFT study, topline results expected **H2 2026**), both of which have received Breakthrough Therapy Designation from the FDA. The company protects its intellectual property, faces competition, and operates under significant government regulation, with R&D expenses increasing in **FY2025** - Rezolute, Inc. is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI)[18](index=18&type=chunk) - Lead clinical asset, ersodetug, is an intravenously administered human monoclonal antibody that down-modulates insulin's binding, signaling, and action to counteract elevated insulin effects[19](index=19&type=chunk)[20](index=20&type=chunk) - The sunRIZE Phase 3 study for congenital HI completed enrollment in **May 2025**, with topline results anticipated in **December 2025**[21](index=21&type=chunk) - Ersodetug received Orphan Drug Designation (U.S., EU), Rare Pediatric Disease Designation (U.S.), PRIME designation (EMA), ILAP designation (UK), and Breakthrough Therapy Designation (FDA) for congenital HI[27](index=27&type=chunk) - The upLIFT Phase 3 study for tumor HI initiated in **mid-2025**, with topline results anticipated in the **second half of calendar 2026**. The study design was modified to a single-arm open-label trial with as few as **16 participants**[29](index=29&type=chunk)[30](index=30&type=chunk) - Ersodetug received Breakthrough Therapy Designation by the FDA in **May 2025** for tumor HI[28](index=28&type=chunk) [Summary of Clinical Assets](index=6&type=section&id=Summary%20of%20Clinical%20Assets) This section details the company's lead asset, ersodetug, and its development for congenital and tumor hyperinsulinism, with the sunRIZE Phase 3 study for congenital HI completing enrollment in **May 2025** and results expected in **December 2025**, and the upLIFT Phase 3 study for tumor HI starting in **mid-2025** with results expected in **H2 2026**, both indications having received significant regulatory designations - Ersodetug is a potential treatment for hypoglycemia caused by multiple forms of hyperinsulinism, acting by down-modulating insulin's effects[19](index=19&type=chunk)[20](index=20&type=chunk) - sunRIZE Phase 3 study for congenital HI completed enrollment in **May 2025**, exceeding its target of **56 participants** with **62 enrolled**. Topline results are expected in **December 2025**[21](index=21&type=chunk)[149](index=149&type=chunk) - Preliminary data from sunRIZE showed an average participant age of **3.4 years**, with **35% under 2**, **95% on standard treatments**, and an average of **15 hypoglycemia events** per week[23](index=23&type=chunk) - Ersodetug has received Orphan Drug, Rare Pediatric Disease, PRIME (EMA), ILAP (UK), and Breakthrough Therapy (FDA) designations for congenital HI[27](index=27&type=chunk) - upLIFT Phase 3 study for tumor HI initiated in **mid-2025**, with topline results expected in **H2 2026**. The FDA agreed to modify the study design to a single-arm open-label trial with as few as **16 participants**[29](index=29&type=chunk)[30](index=30&type=chunk)[150](index=150&type=chunk) - The addressable market for congenital HI and tumor HI in the U.S. is estimated at over **1,500 patients** each[26](index=26&type=chunk)[37](index=37&type=chunk) [Expanded Access Program ("EAP")](index=10&type=section&id=Expanded%20Access%20Program%20(%22EAP%22)) The EAP provides ersodetug on a compassionate use basis for severe, unmanageable hypoglycemia across various HI indications, showing substantial improvement and good tolerability in **13 tumor HI patients** and **5 congenital HI patients**, many of whom were refractory to standard care - The EAP makes ersodetug available for compassionate use when therapeutic options have failed and an individual's hypoglycemia is unmanageable[38](index=38&type=chunk) - **13 tumor HI patients** and **5 congenital HI patients** have received ersodetug through the EAP, demonstrating substantial improvement in hypoglycemia and good tolerability[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) - Tumor HI patients in the EAP often required continuous intravenous dextrose and were hospitalized; ersodetug led to discontinuation or substantial reduction of IV dextrose and outpatient maintenance[38](index=38&type=chunk)[39](index=39&type=chunk) [Intellectual Property](index=12&type=section&id=Intellectual%20Property) Rezolute protects its intellectual property through patents, trade secrets, and trademarks, holding an exclusive worldwide license from XOMA for ersodetug, with patents expiring between **2030 and 2036**, and expects further data and marketing exclusivity - The company maintains and builds its patent portfolio through new filings, prosecution, and licensing, and protects know-how, trade secrets, and trademarks[42](index=42&type=chunk) - Holds a worldwide, exclusive license from XOMA for ersodetug, covering **38 issued patents** (**4 U.S.**) and pending applications, with patents expiring between **2030 and 2036**[44](index=44&type=chunk) - Expects further exclusivity for product candidates through data and marketing exclusivity under pharmaceutical regulatory laws, potentially up to **12 years** from BLA approval[44](index=44&type=chunk) [Competition](index=12&type=section&id=Competition) Rezolute faces competition from pharmaceutical and biotechnology companies, academic institutions, and governmental agencies in talent acquisition and technology development, with several companies, including Amylyx Pharmaceuticals, Hanmi Pharmaceuticals, and Zealand Pharma, developing therapies for HI that could compete with ersodetug - Competition exists from pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and private research organizations in personnel and technology[45](index=45&type=chunk) - Potential competitors for ersodetug in HI include Amylyx Pharmaceuticals, Hanmi Pharmaceuticals, and Zealand Pharma[45](index=45&type=chunk) [Government Regulation](index=12&type=section&id=Government%20Regulation) The company's products require extensive regulatory approval from governmental agencies like the FDA and foreign authorities, involving rigorous preclinical testing and clinical trials, and is also subject to various federal, state, and local laws regarding manufacturing, safety, and hazardous substance handling - All potential products require regulatory approval by governmental agencies (e.g., FDA, EMA) prior to commercialization, involving rigorous preclinical testing and clinical trials[46](index=46&type=chunk) - The company is subject to federal, state, and local laws and regulations concerning safe working conditions, laboratory practices, animal use, and hazardous substance handling[47](index=47&type=chunk)[48](index=48&type=chunk) [Research and Development](index=14&type=section&id=Research%20and%20Development) R&D expenses were **$61.5 million** in **FY2025**, an increase from **$55.7 million** in **FY2024**, primarily driven by increased clinical and manufacturing costs for ersodetug Research and Development Expenses | Fiscal Year Ended June 30 | 2025 (Millions) | 2024 (Millions) | | :------------------------ | :-------------- | :-------------- | | R&D Expenses | **$61.5** | **$55.7** | - The increase in R&D expenses was primarily due to a **$11.8 million** increase in ersodetug clinical and manufacturing costs, partially offset by a **$7.0 million** decrease in RZ402 costs[176](index=176&type=chunk) [Human Capital Management](index=14&type=section&id=Human%20Capital%20Management) As of **June 30, 2025**, Rezolute had **71 full-time employees**, with **52 in R&D**. The company prioritizes diversity and inclusion, and focuses on attracting, developing, and retaining talent through various programs and benefits, including equity compensation - As of **June 30, 2025**, the company had **71 full-time employees**, with **52 in research and development** and **19 in general and administrative functions**, all located in the United States[50](index=50&type=chunk) - The company adopted an equity and inclusion policy on **May 30, 2023**, and leverages formal and informal programs to identify, foster, and retain top talent, offering benefits and equity compensation[51](index=51&type=chunk)[52](index=52&type=chunk) [Corporate Information](index=14&type=section&id=Corporate%20Information) Rezolute, Inc. was incorporated in Delaware in **2010**, reincorporated in Nevada in **2021**, and maintains its executive office in Redwood City, CA. The company files reports with the SEC, which are available on www.sec.gov - Incorporated in Delaware in **2010**, reincorporated in Nevada in **June 2021**[54](index=54&type=chunk) - Maintains an executive office at 275 Shoreline Drive, Suite 500, Redwood City, CA 94065[54](index=54&type=chunk) - Files annual, quarterly, current reports, proxy statements, and other information with the Securities and Exchange Commission (SEC), available at www.sec.gov[54](index=54&type=chunk)[55](index=55&type=chunk) [Item 1A. Risk Factors](index=16&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks that could adversely affect Rezolute's business, financial condition, and results of operations, including potential delays or failures in clinical trials and regulatory approvals, product liability exposure, the need for substantial additional capital, and challenges in intellectual property protection, as well as risks related to its history of losses, potential loss of 'smaller reporting company' status, and global economic conditions - Delays or termination of clinical trials could increase costs, delay revenue generation, and adversely affect commercial prospects[57](index=57&type=chunk)[58](index=58&type=chunk) - Product candidates may produce serious adverse events, leading to trial interruptions, delays, or denial of regulatory approval[61](index=61&type=chunk) - The company has a history of losses (**$74.4 million** in **FY2025**, **$68.5 million** in **FY2024**) and will need substantial additional capital to fund operations and achieve profitability[87](index=87&type=chunk)[174](index=174&type=chunk) - Product liability claims from clinical studies or commercial sales could result in substantial liabilities, reputational damage, and financial losses, potentially exceeding insurance coverage[91](index=91&type=chunk)[92](index=92&type=chunk) - The company's intellectual property portfolio may not adequately protect product candidates, leading to direct competition, and patent litigation can be expensive and time-consuming[113](index=113&type=chunk)[117](index=117&type=chunk) - Federal and state laws impose substantial restrictions on the utilization of net operating loss (NOL) carryforwards due to ownership changes, potentially limiting future profitability[93](index=93&type=chunk)[345](index=345&type=chunk) [Risks Related to Our Product Development and Commercialization](index=16&type=section&id=Risks%20Related%20to%20Our%20Product%20Development%20and%20Commercialization) Significant risks include delays or termination of clinical trials due to regulatory disagreements, enrollment issues, adverse events, or manufacturing problems; failure to meet safety or efficacy requirements will prevent regulatory approval and commercialization, and reliance on third parties for trials and manufacturing introduces additional risks - Clinical testing is expensive, time-consuming, and uncertain; delays can arise from regulatory disagreements, investigator/site activation, IRB/EC approvals, protocol changes, manufacturing issues, patient enrollment/retention, funding, and adverse effects[58](index=58&type=chunk)[59](index=59&type=chunk) - Adverse events in clinical trials could force the company to stop development or prevent regulatory approval[61](index=61&type=chunk) - Failure to obtain regulatory approval for product candidates will prevent marketing and sales, hindering profitability[69](index=69&type=chunk) - Reliance on contract research organizations (CROs) and third-party suppliers for clinical trials and manufacturing means less control over timing, conduct, expense, and potential supply chain delays[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) [Risks Related to Our Business](index=23&type=section&id=Risks%20Related%20to%20Our%20Business) The company has a history of net losses (**$74.4 million** in **FY2025**) and an accumulated deficit of **$403.9 million**, requiring substantial additional capital; other risks include product liability exposure, limitations on net operating loss (NOL) carryforwards, potential future loss of "smaller reporting company" status, and adverse effects from global economic conditions and foreign operations Key Financial Metrics | Fiscal Year Ended June 30 | 2025 (Millions) | 2024 (Millions) | | :------------------------ | :-------------- | :-------------- | | Net Losses | **$(74.4)** | **$(68.5)** | | Accumulated Deficit | **$(403.9)** | **$(329.4)** | | Cash Used in Operating Activities | **$(69.1)** | **$(57.4)** | - As of **June 30, 2025**, cash and cash equivalents were **$94.1 million** and investments in marketable debt securities were **$73.8 million**, expected to provide adequate capital for at least **12 months**[87](index=87&type=chunk)[188](index=188&type=chunk) - Product liability claims could result in substantial liabilities, reputational damage, and financial losses, potentially exceeding insurance coverage[91](index=91&type=chunk)[92](index=92&type=chunk) - U.S. federal NOL carryforwards of **$201.4 million** are subject to significant limitations under IRC Section 382 due to ownership changes, with **$33.4 million** expiring without utilization[93](index=93&type=chunk)[346](index=346&type=chunk) - If market capitalization increases, the company may no longer qualify as a "smaller reporting company," leading to enhanced disclosure requirements and increased compliance costs[97](index=97&type=chunk) - Operations outside the U.S. are subject to different local politics, business factors, and regulatory requirements, including data privacy laws like HIPAA and GDPR[98](index=98&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) [Risks Related to Our Intellectual Property](index=30&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success depends on its intellectual property, but current patent positions may not cover all necessary rights, and future licenses may not be available on reasonable terms; patents can be challenged, invalidated, or circumvented, and trade secrets are difficult to protect; litigation regarding intellectual property is expensive and could delay product commercialization - Current patent positions and license portfolio may not include all patent rights needed for full development and commercialization, and future necessary rights may not be available on commercially reasonable terms[107](index=107&type=chunk)[108](index=108&type=chunk)[110](index=110&type=chunk) - Patents may be challenged, deemed unenforceable, invalidated, or circumvented, and the coverage claimed in a patent application can be significantly reduced[114](index=114&type=chunk) - Reliance on trade secrets is risky as they are difficult to protect and may be independently discovered or disclosed despite confidentiality agreements[115](index=115&type=chunk) - Litigation regarding patents and other proprietary rights is expensive, time-consuming, and could cause delays in bringing product candidates to market[117](index=117&type=chunk)[118](index=118&type=chunk) [Risks Related to Our Common Stock](index=34&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The market price of common stock could decline due to the sale of a substantial number of shares (overhang) or changes in investor relations activities; changes in U.S. tax law, including the recent OBBBA, could also adversely affect the business - Offers or availability for sale of a substantial number of shares of common stock (overhang) could cause the price to decline and make additional financing more difficult[122](index=122&type=chunk)[124](index=124&type=chunk) - Investor relations activities and supply and demand factors may affect the price of common stock[125](index=125&type=chunk) - Changes in U.S. tax law, including the recent enactment of the One Big Beautiful Bill Act (OBBBA), could adversely affect the business[126](index=126&type=chunk)[127](index=127&type=chunk) [Item 1B. Unresolved Staff Comments.](index=36&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) As a smaller reporting company, Rezolute is not required to provide information on unresolved staff comments - The company is a smaller reporting company and is not required to provide information on unresolved staff comments[128](index=128&type=chunk) [Item 1C. Cybersecurity.](index=36&type=section&id=Item%201C.%20Cybersecurity.) Rezolute has established processes for assessing, identifying, and managing cybersecurity risks, including physical, procedural, and technical safeguards, response plans, regular tests, and employee training; external consultants are engaged, and the Audit Committee provides oversight; no material cybersecurity incidents occurred in **FY2025**, and management does not believe there are currently any known risks likely to materially affect the business - Established processes for assessing, identifying, and managing cybersecurity risks, including safeguards, response plans, regular tests, and policy reviews[129](index=129&type=chunk) - Engages external risk management consultants and computer security firms to enhance cybersecurity oversight and provides periodic employee training[130](index=130&type=chunk) - The Audit Committee of the Board of Directors provides direct cybersecurity risk oversight[132](index=132&type=chunk) - No known risks from cybersecurity threats are reasonably likely to materially affect the business, and no cybersecurity incidents occurred in **fiscal year 2025**[133](index=133&type=chunk) [Item 2. Properties.](index=38&type=section&id=Item%202.%20Properties.) Rezolute leases two office facilities: a corporate headquarters in Redwood City, CA (**9,300 sq ft**, lease until **Oct 2027**) and an office in Bend, OR (**5,000 sq ft**, lease until **Feb 2027**); the company believes its current properties are sufficient for its needs - Leases a **9,300 square feet** corporate headquarters facility in Redwood City, CA, with a lease term through **October 2027**[134](index=134&type=chunk) - Leases a **5,000 square feet** office space in Bend, OR, with a lease term through **February 2027**[135](index=135&type=chunk) - Believes current physical properties are sufficient and adequate to meet current and projected requirements[135](index=135&type=chunk) [Item 3. Legal Proceedings.](index=38&type=section&id=Item%203.%20Legal%20Proceedings.) For a discussion of the company's legal proceedings, refer to "Notes to Consolidated Financial Statements - Commitments and Contingencies" in Part II, Item 8 - For a discussion of the Company's legal proceedings, see "Notes to Consolidated Financial Statements - Commitments and Contingencies" in Part II. Item 8[136](index=136&type=chunk) [Item 4. Mine Safety Disclosures.](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to Rezolute, Inc - This item is not applicable[137](index=137&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.](index=38&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) Rezolute's common stock has traded on Nasdaq under the symbol "RZLT" since **November 9, 2020**; as of **September 15, 2025**, there were **246 holders** of record; the company has never paid cash dividends and has no plans to do so in the foreseeable future, intending to reinvest all available funds into business development - Common stock has traded on Nasdaq under the symbol "RZLT" since **November 9, 2020**[140](index=140&type=chunk) - As of **September 15, 2025**, there were **246 holders** of record of the company's common stock[141](index=141&type=chunk) - The company has never paid cash dividends and intends to employ all available funds in the development of its business, with no plans to pay cash dividends in the foreseeable future[143](index=143&type=chunk) - No recent sales of unregistered securities[144](index=144&type=chunk) [Item 6. [Reserved]](index=40&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information - This item is reserved[146](index=146&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=40&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides an overview of Rezolute's financial condition and results of operations for the fiscal years ended **June 30, 2025** and **2024**; the company remains in a clinical stage with no meaningful revenue, focusing on advancing ersodetug through Phase 3 trials for congenital and tumor HI; it incurred net losses and relies on equity financings for liquidity, with management believing current resources are sufficient for at least **12 months**, but additional long-term financing will be needed - The company's priorities for **H2 2025** and **H1 2026** are to complete the sunRIZE study (topline data **Dec 2025**), continue enrollment in the tumor HI study, and submit a Biologics License Application (BLA) for ersodetug in **mid-2026**, assuming supportive data[148](index=148&type=chunk) - The company has not generated any meaningful revenues since inception and expects to incur operating losses for the foreseeable future, requiring additional capital[155](index=155&type=chunk)[156](index=156&type=chunk) Key Financial Metrics | Metric | FY2025 (Millions) | FY2024 (Millions) | | :----- | :---------------- | :---------------- | | Net loss | **$(74.4)** | **$(68.5)** | Cash Flow Summary | Cash Flow Type | FY2025 (Millions) | FY2024 (Millions) | | :------------- | :---------------- | :---------------- | | Operating activities | **$(69.1)** | **$(57.4)** | - The company raised **$107.0 million** in net proceeds from the issuance of equity securities in **FY2025** and **$62.6 million** in **FY2024**[185](index=185&type=chunk) [Executive Summary](index=40&type=section&id=Executive%20Summary) Rezolute's immediate priorities are to execute on two Phase 3 clinical trials for ersodetug: completing the sunRIZE study for congenital HI (topline data expected **Dec 2025**) and continuing enrollment in the upLIFT study for tumor HI (topline data expected **H2 2026**), with a goal to submit a Biologics License Application (BLA) in **mid-2026** - Priorities for **H2 2025** and **H1 2026** include completing the sunRIZE study for congenital HI (topline data **Dec 2025**), continuing enrollment in the tumor HI study, and submitting a BLA for ersodetug in **mid-2026**[148](index=148&type=chunk) [Clinical Development](index=40&type=section&id=Clinical%20Development) The company is focused on advancing ersodetug for all forms of HI; the pivotal Phase 3 sunRIZE study for congenital HI completed enrollment in **May 2025**, exceeding its target, with topline results expected in **December 2025**; the upLIFT study for tumor HI is enrolling in the U.S. and Europe, with its design modified to a single-arm open-label trial, and topline results expected in **H2 2026** - Completed enrollment in the pivotal Phase 3 sunRIZE clinical study of ersodetug for congenital HI in **May 2025**, exceeding the target with **62 participants**. Topline results are anticipated in **December 2025**[149](index=149&type=chunk) - The upLIFT study in tumor HI is currently enrolling in the U.S. and Europe. The FDA agreed to modifications to the study design, including removing the need for a double-blind randomized placebo-controlled trial, limiting it to a single-arm open-label portion with as few as **16 participants**. Topline results are anticipated in the **second half of 2026**[150](index=150&type=chunk)[151](index=151&type=chunk) [Recent Developments](index=42&type=section&id=Recent%20Developments) Recent developments include the appointment of Sunil Karnawat as Chief Commercial Officer in **August 2025**, with a compensation package including salary, bonus, and equity grants; the company also completed a private placement in **May 2025** (**$4.2 million** net proceeds) and an underwritten public offering in **April 2025** (**$96.8 million** net proceeds) - Sunil Karnawat was appointed Chief Commercial Officer on **August 18, 2025**, with an annual base salary of **$475,000**, a signing bonus of **$65,000**, and eligibility for an annual performance bonus target of **40%** of base salary[152](index=152&type=chunk) - Mr. Karnawat received an inducement grant of stock options to purchase **275,000 shares** and **25,000 shares** of RSUs[152](index=152&type=chunk) - Completed a private placement in **May 2025**, selling **1,295,383 shares** of common stock for net proceeds of **$4.2 million**[153](index=153&type=chunk) - Completed an underwritten public offering in **April 2025**, issuing **20,786,923 common shares** and **6,905,385 pre-funded warrants**, generating **$96.8 million** in net proceeds after deducting offering costs[154](index=154&type=chunk) [Factors Impacting our Results of Operations](index=42&type=section&id=Factors%20Impacting%20our%20Results%20of%20Operations) The company has not generated meaningful revenue since inception and expects continued operating losses due to the time required for clinical trials and regulatory approval; it anticipates needing additional capital from external sources to fund operations and product commercialization - The company has not generated any meaningful revenues since its inception and anticipates it will be some time before substantial revenues are generated, if ever, due to the time required for clinical trials and regulatory approval[155](index=155&type=chunk)[156](index=156&type=chunk) - Expects to generate operating losses for the foreseeable future and will need additional capital from external sources, which may be costly or require unfavorable terms[156](index=156&type=chunk) [Key Components of Consolidated Statements of Operations](index=42&type=section&id=Key%20Components%20of%20Consolidated%20Statements%20of%20Operations) This section defines the key components of the consolidated statements of operations: Research and Development (R&D) expenses, General and Administrative (G&A) expenses, Interest and other income, and Loss from change in fair value of derivative liabilities; R&D includes clinical trial costs, personnel, licensing, and consultants; G&A covers administrative personnel, legal, auditing, and investor relations - Research and development (R&D) expenses primarily consist of clinical trial costs, compensation and benefits for R&D personnel, licensing costs, and consultants and outside services[157](index=157&type=chunk) - General and administrative (G&A) expenses primarily include compensation and benefits for administrative, finance, accounting, and executive functions, as well as travel, legal, auditing, and investor relations costs[160](index=160&type=chunk) - Interest and other income primarily consists of interest income earned on marketable debt securities and temporary cash investments[161](index=161&type=chunk) - Loss from change in fair value of derivative liabilities reflects adjustments to fair value for warrant and embedded derivative liabilities[162](index=162&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=44&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) The preparation of financial statements requires significant judgments and estimates, particularly for marketable debt securities (fair value, credit losses), derivative liabilities (fair value), share-based compensation (fair value, vesting), and clinical trial accruals (work completion estimates) - Significant accounting estimates include determining allowances for credit losses on marketable debt securities, fair value of derivative liabilities, fair value of share-based compensation, and estimates related to clinical trial accrued liabilities[163](index=163&type=chunk)[164](index=164&type=chunk)[238](index=238&type=chunk) - Investments in marketable debt securities are accounted for as available-for-sale, recorded at fair value, with unrealized gains and losses reported in shareholders' equity. Credit losses are recognized if declines in fair value are credit-related[165](index=165&type=chunk)[244](index=244&type=chunk) - Research and development costs are expensed as incurred, and clinical trial activities performed by third parties are accrued based on estimates of work completed[168](index=168&type=chunk)[169](index=169&type=chunk)[250](index=250&type=chunk) - Share-based compensation is measured at fair value using the Black-Scholes Merton option-pricing model for stock options and the closing market price for RSUs, recognized over the vesting period[170](index=170&type=chunk)[252](index=252&type=chunk) - Warrant and embedded derivative liabilities are adjusted to fair value at each reporting period, with changes recognized as gains and losses in the consolidated statements of operations[172](index=172&type=chunk)[256](index=256&type=chunk) [Results of Operations](index=47&type=section&id=Results%20of%20Operations) Rezolute reported net losses of **$74.4 million** in **FY2025**, an increase from **$68.5 million** in **FY2024**; R&D expenses increased by **10%** to **$61.5 million**, primarily due to ersodetug clinical and manufacturing costs; G&A expenses increased by **25%** to **$18.4 million**, driven by compensation and professional fees; interest income increased, while derivative liability losses decreased significantly as warrants were reclassified to equity Consolidated Results of Operations | Metric | FY2025 (Thousands) | FY2024 (Thousands) | Change (Amount) | Change (%) | | :------------------------------------------ | :----------------- | :----------------- | :-------------- | :--------- | | Operating expenses: | | | | | | Research and development | **$61,527** | **$55,743** | **$5,784** | **10%** | | General and administrative | **$18,367** | **$14,680** | **$3,687** | **25%** | | Total operating expenses | **$79,894** | **$70,423** | **$9,471** | **13%** | | Operating loss | **$(79,894)** | **$(70,423)** | **$(9,471)** | **13%** | | Non-operating income (expense): | | | | | | Interest and other income | **$5,482** | **$4,870** | **$612** | **13%** | | Loss from change in fair value of warrant derivative liability | **$0** | **$(2,850)** | **$2,850** | **100%** | | Loss from change in fair value of embedded derivative liabilities | **$0** | **$(56)** | **$56** | **100%** | | Total non-operating income (expense), net | **$5,482** | **$1,964** | **$3,518** | **179%** | | Net loss | **$(74,412)** | **$(68,459)** | **$(5,953)** | **9%** | - No revenue was generated for the fiscal years ended **June 30, 2025** and **2024**, as the company is in a clinical stage[175](index=175&type=chunk) - R&D expenses increased by **$5.8 million** (**10%**) in **FY2025**, primarily due to an **$11.8 million** increase in ersodetug clinical and manufacturing costs, partially offset by a **$7.0 million** decrease in RZ402 costs[176](index=176&type=chunk) - Ersodetug program costs increased by **$11.8 million**, driven by **$6.7 million** in manufacturing costs, **$3.2 million** for the tumor HI Phase 3 study, and **$1.9 million** for the sunRIZE clinical trial[177](index=177&type=chunk) - G&A expenses increased by **$3.7 million** (**25%**) in **FY2025**, mainly due to a **$1.8 million** increase in G&A compensation and benefits (due to more employees and higher bonuses) and a **$1.8 million** increase in professional fees for pre-commercial planning[180](index=180&type=chunk) - Interest and other income increased by **$0.6 million** (**13%**) in **FY2025** due to a higher average balance of investments in marketable debt securities[181](index=181&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) As of **June 30, 2025**, Rezolute had **$167.9 million** in total capital resources (**$94.1 million** cash, **$73.8 million** marketable debt securities) and **$159.2 million** in working capital; the company has incurred cumulative net losses of **$403.9 million** and relies on equity financings, having raised **$107.0 million** in **FY2025**; management believes current resources are sufficient for at least **12 months** but will need additional financing for long-term obligations, including significant milestone payments for license agreements Capital Resources and Working Capital | Metric | June 30, 2025 (Thousands) | June 30, 2024 (Thousands) | | :-------------------------------- | :------------------------ | :------------------------ | | Cash and cash equivalents | **$94,107** | **$70,396** | | Investments in marketable debt securities | **$73,751** | **$56,478** | | Total Capital Resources | **$167,858** | **$126,874** | | Working Capital | **$159,233** | **$119,047** | | Cumulative Net Losses | **$(403,856)** | **$(329,444)** | - Primary source of liquidity has historically been from private placements and public offerings of equity securities, with net proceeds of **$107.0 million** in **FY2025** and **$62.6 million** in **FY2024**[185](index=185&type=chunk) - Management believes current capital resources are adequate to meet contractual obligations and fund planned activities for at least **12 months** from the issuance date of the consolidated financial statements[188](index=188&type=chunk)[273](index=273&type=chunk) - Significant long-term contractual obligations include a **$25.0 million** regulatory milestone payment to XOMA upon ersodetug approval and additional clinical and regulatory milestone payments up to **$25.0 million** to ActiveSite[189](index=189&type=chunk)[270](index=270&type=chunk) - Future commercialization of ersodetug and RZ402 could trigger additional milestone payments and royalties up to **$202.5 million** (**$185.0 million** to XOMA and **$17.5 million** to ActiveSite)[190](index=190&type=chunk) Cash Flow Summary | Cash Flow Type | FY2025 (Thousands) | FY2024 (Thousands) | Change (Thousands) | | :----------------------------- | :----------------- | :----------------- | :----------------- | | Operating activities | **$(69,075)** | **$(57,368)** | **$(11,707)** | | Investing activities | **$(14,541)** | **$48,699** | **$(63,240)** | | Financing activities | **$107,327** | **$63,029** | **$44,298** | [Off-Balance Sheet Arrangements](index=53&type=section&id=Off-Balance%20Sheet%20Arrangements) The company did not have any off-balance sheet arrangements with unconsolidated organizations or financial partnerships during the fiscal years ended **June 30, 2025** and **2024** - The company did not have any relationships with unconsolidated organizations or financial partnerships for off-balance sheet arrangements during the fiscal years ended **June 30, 2025** and **2024**[205](index=205&type=chunk) [Recently Issued Accounting Pronouncements](index=53&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section refers to Note 1 of the consolidated financial statements for the impact of recently issued accounting pronouncements - Information regarding the impact of certain recently issued accounting pronouncements on the consolidated financial statements is provided in Note 1[206](index=206&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk.](index=53&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Rezolute is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide the information under this item[207](index=207&type=chunk) [Item 8. Financial Statements and Supplementary Data.](index=54&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data.) This item presents the audited consolidated financial statements for Rezolute, Inc. and its subsidiaries for the fiscal years ended **June 30, 2025** and **2024**, including the Report of Independent Registered Public Accounting Firm, balance sheets, statements of operations and comprehensive loss, statements of shareholders' equity, statements of cash flows, and comprehensive notes to the financial statements; the financial statements are prepared in conformity with GAAP and received an unqualified opinion from Grant Thornton LLP - Includes the Report of Independent Registered Public Accounting Firm, consolidated balance sheets, statements of operations and comprehensive loss, statements of shareholders' equity, and statements of cash flows for the fiscal years ended **June 30, 2025** and **2024**[210](index=210&type=chunk) - The consolidated financial statements present fairly, in all material respects, the financial position and results of operations in conformity with accounting principles generally accepted in the United States of America[213](index=213&type=chunk) - No critical audit matters were identified by the independent registered public accounting firm[217](index=217&type=chunk) [Report of Independent Registered Public Accounting Firm](index=55&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Grant Thornton LLP, the independent registered public accounting firm, issued an unqualified opinion on Rezolute's consolidated financial statements for the fiscal years ended **June 30, 2025** and **2024**, stating they present fairly the financial position and results of operations in conformity with GAAP; no critical audit matters were identified - Grant Thornton LLP provided an unqualified opinion on the consolidated financial statements for the fiscal years ended **June 30, 2025** and **2024**[213](index=213&type=chunk) - The audit was conducted in accordance with PCAOB standards, and no critical audit matters were identified[215](index=215&type=chunk)[217](index=217&type=chunk) [Consolidated Balance Sheets](index=57&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets show total assets increased to **$175.5 million** in **FY2025** from **$132.7 million** in **FY2024**, driven by increases in cash and marketable debt securities; total liabilities increased to **$13.4 million** from **$11.7 million**, while total shareholders' equity increased to **$162.1 million** from **$121.0 million** Consolidated Balance Sheet Summary | Asset/Liability/Equity | June 30, 2025 (Thousands) | June 30, 2024 (Thousands) | | :-------------------------------- | :------------------------ | :------------------------ | | **Assets:** | | | | Cash and cash equivalents | **$94,107** | **$70,396** | | Investments in marketable debt securities | **$73,751** | **$56,478** | | Total current assets | **$171,145** | **$128,653** | | Total assets | **$175,490** | **$132,737** | | **Liabilities:** | | | | Total current liabilities | **$11,912** | **$9,606** | | Total liabilities | **$13,363** | **$11,734** | | **Shareholders' Equity:** | | | | Additional paid-in capital | **$565,903** | **$450,473** | | Accumulated deficit | **$(403,856)** | **$(329,444)** | | Total shareholders' equity | **$162,127** | **$121,003** | - Total assets increased by **$42.7 million**, primarily due to increases in cash and cash equivalents (**$23.7 million**) and marketable debt securities (**$17.3 million**)[221](index=221&type=chunk) - Accumulated deficit increased by **$74.4 million** to **$403.9 million**, reflecting ongoing net losses[221](index=221&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=58&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of **$74.4 million** in **FY2025**, an increase from **$68.5 million** in **FY2024**; operating expenses rose by **13%** to **$79.9 million**, driven by R&D and G&A increases; interest and other income increased, while losses from derivative liabilities were zero in **FY2025** compared to **$2.9 million** in **FY2024**; basic and diluted net loss per common share was **$(0.98)** in **FY2025**, an improvement from **$(1.33)** in **FY2024** due to a higher weighted average share count Consolidated Statements of Operations Summary | Metric | FY2025 (Thousands) | FY2024 (Thousands) | | :------------------------------------------ | :----------------- | :----------------- | | Research and development | **$61,527** | **$55,743** | | General and administrative | **$18,367** | **$14,680** | | Total operating expenses | **$79,894** | **$70,423** | | Operating loss | **$(79,894)** | **$(70,423)** | | Interest and other income, net | **$5,482** | **$4,870** | | Loss from change in fair value of embedded derivative liability | **$0** | **$(56)** | | Loss from change in fair value of warrant derivative liability | **$0** | **$(2,850)** | | Net loss | **$(74,412)** | **$(68,459)** | | Comprehensive loss | **$(74,340)** | **$(68,187)** | | Net loss per common share: Basic and diluted | **$(0.98)** | **$(1.33)** | | Weighted average number of common shares outstanding: Basic and diluted | **75,999,290** | **51,466,150** | - Net loss increased by **$5.9 million** (**9%**) in **FY2025** compared to **FY2024**[174](index=174&type=chunk)[223](index=223&type=chunk) - Basic and diluted net loss per common share improved from **$(1.33)** in **FY2024** to **$(0.98)** in **FY2025**, despite a higher net loss, due to a significant increase in weighted average shares outstanding[223](index=223&type=chunk) [Consolidated Statements of Shareholders' Equity](index=59&type=section&id=Consolidated%20Statements%20of%20Shareholders'%20Equity) Total shareholders' equity increased to **$162.1 million** in **FY2025** from **$121.0 million** in **FY2024**; this increase was primarily driven by **$107.5 million** in proceeds from equity issuances (underwritten offerings and private placements) and **$7.1 million** in share-based compensation, partially offset by a net loss of **$74.4 million** Shareholders' Equity Changes | Metric | June 30, 2024 (Thousands) | Equity Changes in FY2025 (Thousands) | June 30, 2025 (Thousands) | | :-------------------------------- | :------------------------ | :--------------------------- | :------------------------ | | Common Stock | **$53** | **$33** | **$87** | | Additional Paid-in Capital | **$450,473** | **$115,430** | **$565,903** | | Accumulated Other Comprehensive Loss | **$(79)** | **$72** | **$(7)** | | Accumulated Deficit | **$(329,444)** | **$(74,412)** | **$(403,856)** | | Total Shareholders' Equity | **$121,003** | **$41,124** | **$162,127** | - Proceeds from equity securities in the **2025** Underwritten Offering (net of underwriting discounts) contributed **$76.194 million** to additional paid-in capital[227](index=227&type=chunk) - Proceeds from **2025** Pre-Funded Warrants contributed **$21.089 million** to additional paid-in capital[227](index=227&type=chunk) - Gross proceeds from the **2024** and **2025** Private Placements contributed **$6.0 million** and **$4.210 million**, respectively[227](index=227&type=chunk) - Share-based compensation added **$7.121 million** to additional paid-in capital in **FY2025**[227](index=227&type=chunk) - Net loss of **$74.412 million** reduced accumulated deficit[227](index=227&type=chunk) [Consolidated Statements of Cash Flows](index=60&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$69.1 million** in **FY2025** from **$57.4 million** in **FY2024**, primarily due to higher net losses; net cash used in investing activities was **$14.5 million** in **FY2025**, a shift from **$48.7 million** provided in **FY2024**, reflecting increased purchases of marketable debt securities; net cash provided by financing activities significantly increased to **$107.3 million** in **FY2025** from **$63.0 million** in **FY2024**, driven by proceeds from equity offerings Cash Flow Summary | Cash Flow Type | FY2025 (Thousands) | FY2024 (Thousands) | | :------------------------------------------ | :----------------- | :----------------- | | Net Cash Used in Operating Activities | **$(69,075)** | **$(57,368)** | | Net Cash Provided by (Used in) Investing Activities | **$(14,541)** | **$48,699** | | Net Cash Provided by Financing Activities | **$107,327** | **$63,029** | | Net increase in cash and cash equivalents | **$23,711** | **$54,360** | | Cash and cash equivalents at end of fiscal year | **$94,107** | **$70,396** | - The increase in cash used in operating activities was mainly due to a higher net loss (**$74.4 million** in **FY2025** vs. **$68.5 million** in **FY2024**)[197](index=197&type=chunk) - Investing activities shifted from providing cash to using cash, primarily due to increased purchases of marketable debt securities (**$128.1 million** in **FY2025** vs. **$66.4 million** in **FY2024**)[202](index=202&type=chunk) - Financing activities were significantly boosted by proceeds from the **2025** Underwritten Offering (**$97.3 million**) and private placements (**$10.2 million**)[203](index=203&type=chunk) [Notes to Consolidated Financial Statements](index=62&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed disclosures on the company's accounting policies, liquidity, investments, leases, license agreements, derivative liabilities, shareholders' equity, share-based compensation, income taxes, commitments, related party transactions, supplemental financial information, net loss per share, financial instruments, and segment disclosures; it also includes information on recently adopted and future accounting pronouncements and subsequent events - The company is a clinical stage biopharmaceutical company operating as a single reportable segment[233](index=233&type=chunk)[237](index=237&type=chunk)[392](index=392&type=chunk) - Management believes current capital resources are adequate for at least **12 months**, but additional financing will be needed for long-term obligations[273](index=273&type=chunk)[191](index=191&type=chunk) - Investments in marketable debt securities totaled **$73.8 million** as of **June 30, 2025**, all maturing within **12 months**[274](index=274&type=chunk) - Lease obligations include a corporate headquarters in Redwood City, CA, and an office in Bend, OR, with total lease payments of **$1.744 million** through **FY2028**[281](index=281&type=chunk)[286](index=286&type=chunk) - License agreements with XOMA and ActiveSite involve significant milestone payments, including **$25.0 million** to XOMA upon ersodetug regulatory approval and up to **$25.0 million** to ActiveSite for clinical/regulatory milestones[288](index=288&type=chunk)[291](index=291&type=chunk) - As of **June 30, 2025**, the company had U.S. federal NOL carryforwards of **$201.4 million**, subject to IRC Section 382 limitations[346](index=346&type=chunk) [NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=62&type=section&id=NOTE%201%20%E2%80%94%20NATURE%20OF%20OPERATIONS%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Rezolute, Inc. is a clinical-stage rare disease company focused on hyperinsulinism; its financial statements are consolidated and prepared under GAAP, requiring significant estimates for areas like marketable debt securities, derivative liabilities, share-based compensation, and clinical trial accruals; the company operates as a single reportable segment; recently adopted ASU 2023-07 on segment reporting had no material impact, and ASU 2023-09 on income tax disclosures will be adopted in **FY2026** - Rezolute, Inc. is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism, with ersodetug as its primary clinical asset[233](index=233&type=chunk) - Consolidated financial statements are prepared in accordance with GAAP, requiring management judgments, estimates, and assumptions for various financial items[235](index=235&type=chunk)[238](index=238&type=chunk) - The company operates as a single reportable operating segment, with its Chief Executive Officer serving as the chief operating decision maker[237](index=237&type=chunk)[392](index=392&type=chunk) - Investments in marketable debt securities are classified as available-for-sale and recorded at fair value, with credit risk assessment for declines in fair value[244](index=244&type=chunk) - Research and development costs are expensed as incurred, and clinical trial activities performed by third parties are accrued based on estimates of work completed[250](index=250&type=chunk)[251](index=251&type=chunk) - Share-based compensation is measured at fair value using the Black-Scholes-Merton model for stock options and the closing market price for RSUs[252](index=252&type=chunk) [NOTE 2 — LIQUIDITY](index=68&type=section&id=NOTE%202%20%E2%80%94%20LIQUIDITY) Rezolute is a clinical-stage company with no revenue, incurring a **$74.4 million** net loss in **FY2025** and an accumulated deficit of **$403.9 million**; as of **June 30, 2025**, it had **$167.9 million** in cash and marketable debt securities, primarily from equity financings (**$107.0 million** in **FY2025**); management believes these resources are sufficient for at least **12 months**, but significant future milestone payments under license agreements will require additional long-term financing - Incurred a net loss of **$74.4 million** and used **$69.1 million** in operating activities in **FY2025**, with an accumulated deficit of **$403.9 million**[268](index=268&type=chunk) - Total capital resources (cash, cash equivalents, and marketable debt securities) were **$167.9 million** as of **June 30, 2025**[268](index=268&type=chunk) - Primary source of liquidity has historically been from private placements and public offerings of equity securities, with **$107.0 million** net proceeds in **FY2025**[269](index=269&type=chunk) - Management believes the company's cash and cash equivalents and investments in marketable debt securities will be adequate to meet contractual obligations and carry out planned activities for at least **12 months**[273](index=273&type=chunk) - A **$25.0 million** milestone payment to XOMA is due upon regulatory approval of ersodetug, not expected to be recognized as a liability within the next **12 months**[270](index=270&type=chunk) [NOTE 3 — INVESTMENTS IN MARKETABLE DEBT SECURITIES](index=70&type=section&id=NOTE%203%20%E2%80%94%20INVESTMENTS%20IN%20MARKETABLE%20DEBT%20SECURITIES) As of **June 30, 2025**, total investments in marketable debt securities were **$73.8 million**, all classified as short-term and maturing within **12 months**; the company invests in liquid, high-quality debt securities with maturities generally **two years or less**; no sales prior to maturity or credit loss allowances were recognized in **FY2025** or **FY2024** Marketable Debt Securities Summary | Investment Type | June 30, 2025 (Thousands) | June 30, 2024 (Thousands) | | :------------------------------ | :------------------------ | :------------------------ | | Short-term investments | **$73,751** | **$56,478** | | Long-term investments | **$0** | **$263** | | Total investments | **$73,751** | **$56,741** | - All marketable debt securities (**$73.8 million**) as of **June 30, 2025**, are scheduled to mature during the **12-month period** ending **June 30, 2026**[274](index=274&type=chunk) - No marketable debt securities were sold prior to maturity, and no allowance for credit losses or other-than-temporary impairment was recognized for the fiscal years ended **June 30, 2025** and **2024**[275](index=275&type=chunk)[276](index=276&type=chunk) Marketable Debt Securities Details | Investment Type | Amortized Cost (Thousands) | Gross Unrealized Gains (Thousands) | Gross Unrealized Losses (Thousands) | Fair Value (Thousands) | | :------------------------------ | :------------------------- | :------------------------- | :-------------------------- | :--------------------- | | Corporate commercial paper | **$16,595** | **$1** | **$(8)** | **$16,588** | | Obligations of U.S. government agencies | **$5,447** | **$0** | **$(2)** | **$5,445** | | U.S. Treasury obligations | **$1,485** | **$0** | **$(1)** | **$1,484** | | Corporate notes and bonds | **$50,231** | **$18** | **$(15)** | **$50,234** | | Total | **$73,758** | **$19** | **$(26)** | **$73,751** | [NOTE 4 — LEASES](index=71&type=section&id=NOTE%204%20%E2%80%94%20LEASES) Rezolute has operating leases for its Redwood City, CA headquarters (**9,300 sq ft**, **$48,000/month** average base rent, expires **Nov 2027**) and Bend, OR office (**5,000 sq ft**, **$9,000/month** average base rent, expires **Feb 2027**); total operating lease liabilities were **$1.6 million** as of **June 30, 2025**, with a weighted-average remaining lease term of **2.3 years**; lease expense was **$0.7 million** in **FY2025** - The lease for the Bend, Oregon office was extended to **February 2027**, with an average base rent of approximately **$9,000 per month**[280](index=280&type=chunk) - The corporate headquarters in Redwood City, California, has a lease through **November 2027**, with an average base rent of approximately **$48,000 per month**[281](index=281&type=chunk) Lease Liabilities and Right-of-Use Assets | Metric | June 30, 2025 (Thousands) | June 30, 2024 (Thousands) | | :-------------------------------- | :------------------------ | :------------------------ | | Right-of-use assets | **$1,348** | **$1,880** | | Current operating lease liabilities | **$632** | **$568** | | Long-term operating lease liabilities | **$983** | **$1,660** | | Total operating lease liabilities | **$1,615** | **$2,228** | Lease Expense | Expense Type | FY2025 (Thousands) | FY2024 (Thousands) | | :------------------------ | :----------------- | :----------------- | | Research and development | **$489** | **$484** | | General and administrative | **$178** | **$196** | | Total | **$667** | **$680** | - As of **June 30, 2025**, the weighted-average remaining lease term was **2.3 years**, and the weighted-average discount rate used was **7.1%**[285](index=285&type=chunk) Future Lease Payments | Fiscal Year Ending June 30 | Amount (Thousands) | | :------------------------- | :----------------- | | 2026 | **$770** | | 2027 | **$750** | | 2028 | **$224** | | Total lease payments | **$1,744** | | Less imputed interest | **$(129)** | | Present value of operating lease liabilities | **$1,615** | [NOTE 5 — LICENSE AGREEMENTS](index=72&type=section&id=NOTE%205%20%E2%80%94%20LICENSE%20AGREEMENTS) Rezolute has license agreements with XOMA and ActiveSite; under the XOMA License Agreement for ersodetug, milestone payments totaling **$12.0 million** have been made, with a **$25.0 million** payment due upon first regulatory approval; additional sales-based milestones up to **$185.0 million** and royalties are also due; under the ActiveSite License Agreement for the PKI Portfolio (including RZ402), **$4.0 million** in milestone payments have been made, with **$5.0 million** due upon first dosing in a Phase 3 trial, and up to **$17.5 million** for commercial success/alternative indications, plus **2.0%** royalties on sales - The XOMA License Agreement grants an exclusive global license to develop and commercialize ersodetug. Milestone payments made to date include **$2.0 million** (Phase 2 last patient), **$5.0 million** (Phase 3 first patient), and **$5.0 million** (Phase 3 last patient dosed)[288](index=288&type=chunk) - A **$25.0 million** milestone payment to XOMA will be due upon the first regulatory approval of ersodetug by any regulatory authority[288](index=288&type=chunk) - Upon future commercialization of ersodetug, royalties based on net sales and additional milestone payments up to **$185.0 million** related to annual net sales targets will be required[288](index=288&type=chunk) - The ActiveSite License Agreement for the PKI Portfolio (RZ402) requires various milestone payments up to **$46.5 million**. **$1.0 million** was paid (IND clearance) and **$3.0 million** was paid (Phase 2 first patient)[291](index=291&type=chunk) - The next milestone payment to ActiveSite is **$5.0 million** upon the first dosing of a patient in a Phase 3 clinical trial[291](index=291&type=chunk) - The company is also required to pay royalties equal to **2.0%** of any sales of products that use the PKI Portfolio and additional milestone payments up to **$17.5 million** for commercial success or alternative indication approvals[291](index=291&type=chunk) [NOTE 6 — EMBEDDED DERIVATIVE LIABILITY](index=73&type=section&id=NOTE%206%20%E2%80%94%20EMBEDDED%20DERIVATIVE%20LIABILITY) The company accounts for an exit fee agreement from a terminated **$30.0 million** loan as an embedded derivative liability; this fee of **4.00%** (**$0.6 million**) is triggered by certain "Exit Events" before **April 13, 2031**; the estimated fair value of this liability was **$0.5 million** as of **June 30, 2025** and **2024** - An exit fee agreement from a terminated **$30.0 million** Loan and Security Agreement is accounted for as an embedded derivative liability[293](index=293&type=chunk) - The exit fee is **4.00%** of the funded principal balance (**$0.6 million**) and is triggered by certain "Exit Events" occurring prior to **April 13, 2031**[293](index=293&type=chunk) - The estimated fair value of the embedded derivative liability was **$0.5 million** as of **June 30, 2025** and **2024**[293](index=293&type=chunk) [NOTE 7 — SHAREHOLDERS' EQUITY](index=73&type=section&id=NOTE%207%20%E2%80%94%20SHAREHOLDERS'%20EQUITY) Shareholders approved an increase in authorized common shares to **165.0 million** in **December 2024**; the company issued fully vested pre-funded warrants (PFWs) for **28.2 million shares** between **Oct 2021** and **Apr 2025**, all classified as equity; recent equity financings include the **2025** Private Placement (**$4.2 million** net proceeds) and the **2025** Underwritten Offering (**$96.8 million** net proceeds); an Exchange Agreement in **March 2024** involved purchasing **3.0 million common shares** and issuing Exchange PFWs, which were reclassified from derivative liability to equity in **May 2024** - On **December 5, 2024**, shareholders approved an increase in the authorized number of common shares from **100.0 million** to **165.0 million shares**[294](index=294&type=chunk) - Between **October 2021** and **April 2025**, the company issued fully vested pre-funded warrants (PFWs) exercisable to purchase an aggregate of **28.2 million shares** of common stock, all classified in shareholders' equity[295](index=295&type=chunk) Pre-Funded Warrants Activity | PFW Type | Outstanding, June 30, 2024 (Shares) | Issuance in FY2025 (Shares) | Cashless Exercise in FY2025 (Shares) | Outstanding, June 30, 2025 (Shares) | | :---------------- | :---------------------------------- | :-------------------------- | :----------------------------------- | :---------------------------------- | | 2021 PFWs | **123,000** | — | — | **123,000** | | 2022 PFWs | **8,147,371** | — | **(2,526,318)** | **5,621,053** | | Exchange PFWs | **3,000,000** | — | **(3,000,000)** | — | | 2024 PFWs | **3,750,000** | — | — | **3,750,000** | | 2025 PFWs | — | **6,905,385** | — | **6,905,385** | | Total | **15,020,3

[Executive Summary](index=1&type=section&id=executive-summary) This section summarizes Rezolute, Inc.'s focus on hyperinsulinism, recent pipeline progress, CEO's strategic outlook, and key financial results for FY2025 [Introduction and Company Focus](index=1&type=section&id=introduction-company-focus) Rezolute, Inc. is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, reporting financial results for the fourth quarter and full fiscal year ended June 30, 2025 - Rezolute, Inc. (Nasdaq: RZLT) is a late-stage rare disease company[1](index=1&type=chunk) - The company focuses on treating hypoglycemia caused by hyperinsulinism[1](index=1&type=chunk) - Financial results are reported for the fourth quarter and full fiscal year ended June 30, 2025[1](index=1&type=chunk) [CEO's Strategic Outlook](index=1&type=section&id=ceo-strategic-outlook) CEO Nevan Charles Elam highlighted substantial progress across both congenital and tumor hyperinsulinism indications for ersodetug, noting FDA alignment on a streamlined Phase 3 trial for tumor HI and anticipating topline results from the sunRIZE trial in December 2025 - Substantial progress has been made across two indications for ersodetug: **congenital and tumor hyperinsulinism**[2](index=2&type=chunk) - FDA alignment on a streamlined Phase 3 trial in tumor hyperinsulinism is seen as recognition of ersodetug's broad applicability and transformative potential[2](index=2&type=chunk) - Topline results from the sunRIZE trial are expected in **December 2025**[2](index=2&type=chunk) [Recent Pipeline Progress and Anticipated Milestones](index=1&type=section&id=recent-pipeline-progress-anticipated-milestones) This section details the latest advancements in ersodetug's clinical development for congenital and tumor hyperinsulinism, including enrollment completion and expected topline results [Congenital Hyperinsulinism (HI) Program](index=1&type=section&id=congenital-hyperinsulinism-hi-program) Rezolute completed enrollment for the sunRIZE Phase 3 study of ersodetug for congenital HI, exceeding targets with 62 participants, and expects topline results in December 2025 - Completed enrollment in sunRIZE, a Phase 3 study for congenital HI, exceeding enrollment with **62 participants** (approximately **15% from U.S. sites**)[5](index=5&type=chunk) - Topline results from the sunRIZE trial are expected in **December 2025**[5](index=5&type=chunk) - **Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE):** | Characteristic | Value | | :------------- | :---- | | Average Age | 3.4 years (35% <2 years old) | | Hypoglycemia Events | 15 (average) per week | | Daily Percent Time in Hypoglycemia | 19% | | Taking ≥1 SOC treatments | 95% | [Tumor HI Program](index=1&type=section&id=tumor-hi-program) The Company achieved FDA alignment on a significantly streamlined clinical development path for its upLIFT Phase 3 study of ersodetug for tumor HI, reducing the study to as few as 16 participants in a single-arm open-label portion, with topline results expected in the second half of 2026 - Achieved FDA alignment on a significantly streamlined clinical development path for the ongoing Phase 3 study (upLIFT) of ersodetug for tumor HI[5](index=5&type=chunk) - The truncated upLIFT study will include as few as **16 participants** and be limited to the single-arm open-label portion, removing the need for a double-blind randomized placebo-controlled trial[5](index=5&type=chunk) - Enrollment for upLIFT is underway, and topline results are expected in the **second half of 2026**[5](index=5&type=chunk) [Corporate Updates](index=2&type=section&id=corporate-updates) This section highlights recent organizational changes, including key personnel appointments, to strengthen the company's commercialization efforts [Key Personnel Appointment](index=2&type=section&id=key-personnel-appointment) In August 2025, Dr. Sunil Karnawat was appointed as Chief Commercial Officer, bringing over 25 years of experience in global biopharmaceutical commercialization to spearhead the launch strategy for ersodetug - Dr. Sunil Karnawat was appointed as Chief Commercial Officer in **August 2025**[13](index=13&type=chunk) - Dr. Karnawat has over **25 years of experience** in global commercialization of biopharmaceuticals and medical devices[13](index=13&type=chunk) - He will spearhead launch strategy and global market readiness for ersodetug, having previously led commercial functions for launching four ultra-rare disease products at Ultragenyx[13](index=13&type=chunk) [Financial Results](index=2&type=section&id=financial-results) This section presents Rezolute's financial performance for Q4 and the full fiscal year 2025, detailing cash position, operating expenses, net loss, and key balance sheet data [Cash, Cash Equivalents and Investments](index=2&type=section&id=cash-cash-equivalents-investments) Rezolute's cash, cash equivalents, and investments in marketable securities increased to $167.9 million as of June 30, 2025, up from $127.1 million a year prior - **Cash, Cash Equivalents and Investments in Marketable Securities:** | Metric | June 30, 2025 (in millions) | June 30, 2024 (in millions) | YoY Change (in millions) | | :------------------------------------ | :-------------------------- | :-------------------------- | :----------- | | Cash, cash equivalents and investments | $167.9 | $127.1 | +$40.8 | [Operating Expenses](index=2&type=section&id=operating-expenses) Total operating expenses increased year-over-year for both Q4 and the full fiscal year 2025, driven primarily by higher R&D expenditures related to clinical trials, manufacturing, and employee costs, as well as increased G&A expenses from professional fees and headcount - **Total Operating Expenses:** | Period | FY2025 (in thousands) | FY2024 (in thousands) | YoY Change (in thousands) | | :----- | :-------------------- | :-------------------- | :--------- | | Q4 | $25,850 | $23,102 | +$2,748 | | Full Year | $79,894 | $70,423 | +$9,471 | [Research and Development (R&D) Expenses](index=2&type=section&id=research-development-expenses) R&D expenses increased in both Q4 and the full fiscal year 2025, primarily due to higher clinical trial, manufacturing, and employee-related costs - **Research and Development (R&D) Expenses:** | Period | FY2025 (in thousands) | FY2024 (in thousands) | YoY Change (in thousands) | | :----- | :-------------------- | :-------------------- | :--------- | | Q4 | $20,863 | $19,089 | +$1,774 | | Full Year | $61,527 | $55,743 | +$5,784 | - The increase in R&D expenses was primarily due to increased expenditures in clinical trial activities, manufacturing costs for ersodetug, and higher employee-related expenses (including compensation and stock-based compensation)[8](index=8&type=chunk) [General and Administrative (G&A) Expenses](index=2&type=section&id=general-administrative-expenses) G&A expenses rose in both Q4 and the full fiscal year 2025, mainly driven by increased professional fees and employee-related costs due to higher headcount - **General and Administrative (G&A) Expenses:** | Period | FY2025 (in thousands) | FY2024 (in thousands) | YoY Change (in thousands) | | :----- | :-------------------- | :-------------------- | :--------- | | Q4 | $4,987 | $4,013 | +$974 | | Full Year | $18,367 | $14,680 | +$3,687 | - The increase in G&A expenses was primarily attributable to professional fees and employee-related expenses due to increased headcount[9](index=9&type=chunk) [Net Loss and EPS](index=2&type=section&id=net-loss-eps) Rezolute reported an increased net loss for both Q4 and the full fiscal year 2025, with basic and diluted net loss per common share also increasing year-over-year - **Net Loss and Basic/Diluted Net Loss Per Common Share:** | Metric | Period | FY2025 (in thousands) | FY2024 (in thousands) | YoY Change (in thousands) | | :----- | :----- | :-------------------- | :-------------------- | :--------- | | Net Loss | Q4 | $(24,390) | $(22,976) | $(1,414) | | Net Loss | Full Year | $(74,412) | $(68,459) | $(5,953) | | Basic and diluted net loss per common share | Q4 | $(0.26) | $(0.44) | +$0.18 | | Basic and diluted net loss per common share | Full Year | $(0.98) | $(1.33) | +$0.35 | [Condensed Consolidated Financial Statements Data](index=4&type=section&id=condensed-consolidated-financial-statements-data) The condensed consolidated financial statements provide detailed data for the statements of operations and balance sheets, showing increases in total assets, working capital, and total stockholders' equity, alongside the reported losses and increased accumulated deficit - **Condensed Consolidated Statements of Operations Data (Selected):** | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Year Ended June 30, 2025 (in thousands) | Year Ended June 30, 2024 (in thousands) | | :-------------------------- | :-------------------------------------- | :-------------------------------------- | :------------------------------------ | :------------------------------------ | | Research and development | $20,863 | $19,089 | $61,527 | $55,743 | | General and administrative | $4,987 | $4,013 | $18,367 | $14,680 | | Total operating expenses | $25,850 | $23,102 | $79,894 | $70,423 | | Loss from operations | $(25,850) | $(23,102) | $(79,894) | $(70,423) | | Non-operating income (expenses), net | $1,460 | $126 | $5,482 | $1,964 | | Net loss | $(24,390) | $(22,976) | $(74,412) | $(68,459) | | Basic and diluted net loss per common share | $(0.26) | $(0.44) | $(0.98) | $(1.33) | | Shares used to compute basic and diluted net loss per common share | 94,340 | 52,235 | 75,999 | 51,466 | - **Condensed Consolidated Balance Sheets Data:** | Metric | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | | :-------------------------------- | :--------------------------- | :--------------------------- | | Cash and cash equivalents | $94,107 | $70,396 | | Investments in marketable debt securities | $73,751 | $56,741 | | Working capital | $159,233 | $119,047 | | Total assets | $175,490 | $132,737 | | Accumulated deficit | $(403,856) | $(329,444) | | Total stockholders' equity | $162,127 | $121,003 | [Product Information](index=2&type=section&id=product-information) This section provides an overview of ersodetug, a fully human monoclonal antibody designed to treat hypoglycemia caused by hyperinsulinism [About Ersodetug](index=2&type=section&id=about-ersodetug) Ersodetug is a fully human monoclonal antibody designed to treat hypoglycemia caused by hyperinsulinism by allosterically binding to the insulin receptor, thereby decreasing over-activation and offering potential universal effectiveness across all forms of HI - Ersodetug is a fully human monoclonal antibody[11](index=11&type=chunk) - It binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in hyperinsulinism (HI), thereby improving hypoglycemia[11](index=11&type=chunk) - Ersodetug has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI, as it acts downstream from the pancreas[11](index=11&type=chunk) [Company Information](index=2&type=section&id=company-information) This section offers a brief profile of Rezolute, Inc., emphasizing its mission as a late-stage rare disease company developing ersodetug for hyperinsulinism [About Rezolute, Inc.](index=2&type=section&id=about-rezolute-inc) Rezolute, Inc. is a late-stage rare disease company focused on hyperinsulinism-induced hypoglycemia, developing ersodetug, an antibody therapy that has demonstrated meaningful clinical benefit for both congenital and tumor HI - Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI)[12](index=12&type=chunk) - The Company's antibody therapy, ersodetug, is designed to treat all forms of HI[12](index=12&type=chunk) - Ersodetug has shown meaningful benefit in clinical trials and real-world use for the treatment of both congenital and tumor HI[12](index=12&type=chunk) [Legal and Investor Information](index=3&type=section&id=legal-investor-information) This section includes important disclosures regarding forward-looking statements and provides contact details for investor relations inquiries [Forward-Looking Statements](index=3&type=section&id=forward-looking-statements) This section contains standard forward-looking statements regarding prospective performance, strategies, and anticipated milestones, including trial results and ersodetug's effectiveness, and advises caution due to inherent uncertainties and risks detailed in SEC filings - The release contains forward-looking statements regarding prospective performance and strategies, covered by safe harbor provisions[14](index=14&type=chunk) - These statements include the timing of topline results from sunRIZE and upLIFT trials, ersodetug's applicability and effectiveness for hyperinsulinism, and clinical trial timelines[14](index=14&type=chunk) - Readers are cautioned that actual results may differ materially from anticipated results due to inherent uncertainties and factors discussed in SEC filings (e.g., Risk Factors in 10-K and 10-Q)[14](index=14&type=chunk) [Contacts](index=3&type=section&id=contacts) This section provides contact information for investor relations inquiries - Contact information for Rezolute, Inc. is provided for inquiries[15](index=15&type=chunk)

REDWOOD CITY, Calif., Sept. 17, 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 reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2025. “We have made substantial progress this year across our two indications for ersodetug in both congenital and tumor hyperinsulinism,” said Nevan Charles Elam, Chief Executi ...

Core Insights - Rezolute, Inc. is a biopharmaceutical company focused on developing treatments for rare metabolic diseases, with its lead candidate, Ersodetug, having received the FDA's Breakthrough Therapy designation, indicating significant potential for accelerated approval [2][6] - Despite a negative price-to-earnings (P/E) ratio of -7.41, Rezolute's stock is rising in 2025, driven by investor interest in Ersodetug's potential, reflected in a high price-to-sales ratio of 11,579.47 [3][6] - The company's financial metrics show challenges, including a high enterprise value to sales ratio of 11,358.42 and a negative enterprise value to operating cash flow ratio of -10.04, but a low debt-to-equity ratio of 0.0215 indicates minimal reliance on debt [4][5] Financial Stability - Rezolute's current ratio of 8.43 indicates a strong ability to cover short-term liabilities with short-term assets, suggesting financial stability despite the lack of profitability [5]

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]

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...