# EDGAR Filing Document

**Accession Number:** 0001509261
**File Stem:** 0001104659-25-085892
**Filing Date:** 2025-9
**Character Count:** 37710
**Document Hash:** c7ceb73cecf0b8385db82efdc37576f0
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-085892.hdr.sgml**: 20250902

**ACCESSION NUMBER**: 0001104659-25-085892

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 42

**CONFORMED PERIOD OF REPORT**: 20250902

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250902

**DATE AS OF CHANGE**: 20250902

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Rezolute, Inc.
- **CENTRAL INDEX KEY:** 0001509261
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 273440894
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39683
- **FILM NUMBER:** 251282786

**BUSINESS ADDRESS:**
- **STREET 1:** 275 SHORELINE DRIVE, SUITE 500
- **CITY:** REDWOOD CITY
- **STATE:** CA
- **ZIP:** 94065
- **BUSINESS PHONE:** 650-206-4507

**MAIL ADDRESS:**
- **STREET 1:** 275 SHORELINE DRIVE, SUITE 500
- **CITY:** REDWOOD CITY
- **STATE:** CA
- **ZIP:** 94065

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** AntriaBio, Inc.
- **DATE OF NAME CHANGE:** 20130114

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** FITS MY STYLE INC
- **DATE OF NAME CHANGE:** 20110104

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, DC 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the**

**Securities Exchange Act of 1934**

**Date of report (Date of earliest event reported): September 2, 2025**

**<u>REZOLUTE, INC.</u>**

**(Exact Name of Registrant as Specified in Charter)**

---

| | | |
|:---|:---|:---|
| <u>**<u>Nevada</u>**</u> | <u>**<u>001-39683</u>**</u> | <u>**<u>27-3440894</u>**</u> |
| **(State or Other Jurisdiction**<br> **of Incorporation)** | **(Commission**<br> **File Number)** | **(I.R.S. Employer**<br> **Identification No.)** |

---

**<u>275 Shoreline Drive, Suite 500, Redwood City, CA 94065</u>**

**(Address of Principal Executive Offices, and Zip Code)**

**<u>650-206-4507</u>**

**Registrant's Telephone Number, Including Area Code**

**<u>Not Applicable</u>**

**(Former Name or Former Address, if Changed Since Last Report)**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (*see* General Instruction A.2. below):

◻ Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

◻ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

◻ Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

◻ Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| **Common Stock, par value $0.001 per share** | **RZLT** | **Nasdaq Capital Market** |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

Emerging growth company ◻

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

---

| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.** |

---

On September 2, 2025, Rezolute, Inc. (the "Company") issued a press release to announce alignment with the FDA on design for Ongoing Phase 3 Trial of Ersodetug in Tumor Hyperinsulinism. In addition, the Company updated its corporate presentation to reflect updates to the upLIFT study.

The information in this Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.

The poster contains forward looking statements. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "prove," "potential," "seek," "strive," "try," or future or conditional verbs such as "predict," "could," "may," "likely," "should," "will," "would," or similar expressions. The Company's ability to predict results or the actual results of the Company's plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers of the poster are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law or regulation, the Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in the Company's filings with the SEC, including the Risk Factors contained in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC's website at <u>www.sec.gov</u>.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) *Exhibits*.

---

| | |
|:---|:---|
| Exhibit No. | Description |
| [99.1](tm2524786d1_ex99-1.htm) | [Press Release, dated September 2, 2025](tm2524786d1_ex99-1.htm) |
| [99.2](tm2524786d1_ex99-2.htm) | [Corporate Presentation](tm2524786d1_ex99-2.htm) |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL) |

---

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **REZOLUTE, INC.** | **REZOLUTE, INC.** |
| DATE: September 2, 2025 | By: | */s/ Nevan Charles Elam* |
|  |  | Nevan Charles Elam |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Rezolute Announces Alignment with FDA on Streamlined Design for Ongoing Phase 3 Trial of Ersodetug in Tumor Hyperinsulinism**

 

*Open-label study in as few as 16 tumor hyperinsulinism (HI) patients*

 

*Study initiated and enrolling patients in the U.S. and Europe*

 

*Topline data expected in the second half of 2026*

**REDWOOD CITY, Calif., September 2, 2025** -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced that the Company has gained alignment with FDA on a significantly streamlined clinical development path for its ongoing Phase 3 study (upLIFT) of ersodetug for the treatment of hypoglycemia caused by tumor HI.

At a meeting held with FDA on August 19, 2025, the agency agreed to modifications to the design of the study including removing the need to conduct a double-blind randomized placebo-controlled trial. The truncated study will include as few as 16 participants and will be limited to the single-arm open-label portion of the upLIFT study, which has been the focus of the Company's patient recruitment efforts. FDA also confirmed that Rezolute's pivotal sunRIZE trial in congenital HI, which is on track to report topline results in December 2025, would serve as confirmatory clinical evidence, and is demonstrative of FDA's recognition of the broad applicability of ersodetug in multiple forms of HI.

"We are absolutely delighted with this regulatory outcome," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "The FDA's staff and leadership have been very vocal about the desire to responsibly simplify clinical development for rare diseases, particularly when there is real-world evidence of benefit combined with mechanistic plausibility. We believe that the alignment we have achieved with the agency exemplifies this innovative approach and is substantially based upon the favorable outcomes that we have observed over the last two years treating more than 10 patients with tumor HI under our Expanded Access Program."

Brian Roberts, M.D., Chief Medical Officer at Rezolute went on to say, "This revised and simplified plan for the upLIFT study and approval pathway marks an important development for us as well as the community of healthcare providers, patients, and families living with serious hypoglycemia caused by tumor HI. By focusing on an open-label study in upLIFT, while building upon the robust clinical foundation established in the congenital HI indication, we are expediting development with the goal of making this therapy available as efficiently as possible."

**About upLIFT** 

The Phase 3 registrational study is a single-arm, open-label, pivotal trial in approximately 16 participants with insulinoma or non-islet cell tumors who have uncontrolled hypoglycemia caused by tumor hyperinsulinism (HI). Eligible participants requiring continuous intravenous (IV) glucose will receive ersodetug 9 mg/kg per week for 8 weeks, as an add-on to standard of care. Following this 8-week pivotal treatment period, all participants may receive ersodetug in long-term extension. The primary endpoint is the number of participants achieving at least a 50 percent reduction from baseline in IV glucose requirements (glucose infusion rate; GIR). Additional endpoints include the number of participants and time to discontinuation of GIR, time to discharge from the hospital, extent of hypoglycemia events and hypoglycemia time in the outpatient setting by self-monitored blood glucose and continuous glucose monitor, respectively, and patient reported quality of life.

**About Tumor Hyperinsulinism** 

Tumor hyperinsulinism (HI) is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia as a result of over-activation of the insulin receptor. Insulinomas are the most common type of ICT and cause hypoglycemia by stimulating the over production of insulin. A variety of different NICTs, particularly hepatocellular carcinoma, can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as IGF-2 that bind to and activate the insulin receptor. With high morbidity and mortality rates within tumor HI, there remains a significant unmet need for new therapies directed at hypoglycemia treatment. Ersodetug has shown real-world benefit in patients with insulinoma and NICTs.

**About Ersodetug** 

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.

**About Rezolute, Inc.**

Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company's antibody therapy, ersodetug, is designed to treat all forms of HI and has shown meaningful benefit in clinical trials and real-world use for the treatment of both congenital and tumor HI. For more information, visitwww.rezolutebio.com.

**Forward-Looking Statements**

This release, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. These forward-looking statements include, but are not limited to, statements regarding the potential efficacy of ersodetug in the congenital HI and tumor HI patient populations, the timeline for achieving results in the upLIFT studies and the potential approval and commercialization of ersodetug. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in the Rezolute's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC's website at www.sec.gov. You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement.

**Contacts:**

**Rezolute, Inc.**

Christen Baglaneas

<u>cbaglaneas@rezolutebio.com</u>

508-272-6717

## Exhibit 99.2

**Exhibit 99.2**

![](tm2524786d1_ex99-2img001.jpg)

A Late - stage Rare Disease Company Treating Hyperinsulinism Corporate Presentation NASDAQ: RZLT

![](tm2524786d1_ex99-2img002.jpg)

Forward Looking Statements \| 2 This presentation, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward - looking statements regarding our prospective performance and strategies within the meaning of Section 27 A of the Securities Act and Section 21 E of the Securities Exchange Act of 1934 , as amended . We intend such forward - looking statements to be covered by the safe harbor provisions for forward - looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions . Forward - looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "prove," "potential," "seek," "strive," "try," or future or conditional verbs such as "predict," "could," "may," "likely," "should," "will," "would," or similar expressions . These Forward - Looking statements include, but are not limited to, statements regarding the sunRIZE clinical study, the RIZE study, the complete removal of the partial clinical holds on RZ 358 for the treatment of hypoglycemia, the Investigational New Drug (IND) application for RZ 358 (ersodetug), the ability of RZ 358 to become an effective treatment, the effectiveness or future effectiveness of RZ 358 as a treatment, statements regarding clinical trial timelines for the treatment . Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain . Accordingly, actual results may differ materially from anticipated results . Readers are cautioned not to place undue reliance on these forward - looking statements, which speak only as of the date of this release . Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward - looking statements to reflect events or circumstances that occur after the date on which such statements were made . Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in the Rezolute's Annual Report on Form 10 - K and Quarterly Reports on Form 10 - Q, which are available at the SEC's website at www . sec . gov . You are urged to consider these factors carefully in evaluating the forward - looking statements in this release and are cautioned not to place undue reliance on such forward - looking statements, which are qualified in their entirety by this cautionary statement . This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction .

![](tm2524786d1_ex99-2img003.jpg)

Seasoned management team with demonstrated success from early development through commercialization Total $1B+ global market opportunity with additional upside with market expansion Compelling real - world evidence of patient benefit under the Company's Expanded Access Program Two rare disease Phase 3 programs evaluating ersodetug to treat hypoglycemia in congenital HI and tumor HI RZ358 (ersodetug) is an antibody designed to treat hypoglycemia caused by all forms of hyperinsulinism (HI) A Rare Disease Company Treating Hyperinsulinism \| 3 $180 million in cash with runway to mid - 2027

![](tm2524786d1_ex99-2img004.jpg)

Milestone Expected Next Milestone Phase 3 Phase 2 Phase 1 IND - Enabling Target Program December 2025 Topline data Congenital Hyperinsulinism RZ358 (e rsodetug) 2H 2026 Topline data Tumor Hyperinsulinism RZ358 (e rsodetug) Two Phase 3 Indications Targeting Hyperinsulinism \| 4

![](tm2524786d1_ex99-2img005.jpg)

RZ358 Treatment for Hyperinsulinism (HI) E rsodetug

![](tm2524786d1_ex99-2img006.jpg)

Rare disease caused by tumors that produce insulin or insulin - like substances such as IGF - 2 Rare pediatric genetic disease characterized by excessive insulin production Hypoglycemia as a Result of HI c ongenital HI t umor HI Ersodetug has shown substantial benefit in studies and real - world use for treatment of HI \| 6 Hypoglycemia o Severe, persistent, life - threatening complication of over activation of the insulin receptor o Consequence of multiple forms of HI o Lack of effective treatment options

![](tm2524786d1_ex99-2img007.jpg)

\| 7 o Fully human monoclonal antibody with a novel mechanism acting downstream from production source (e.g. pancreas) o Allosterically binds to the insulin receptor to counteract excess signaling by insulin or related hormones (e.g. IGF) o Modulating effect helps maintain glucose values in a healthy range o Administered by IV infusion every 2 to 4 weeks INSULIN or IGF - 2 GLUCOSE Ersodetug Reduces Insulin Binding & Signaling Ersodetug Increases Available Blood Glucose Reduced Glucose Uptake Antibody Designed to Treat All Forms of HI

![](tm2524786d1_ex99-2img008.jpg)

Congenital HI Congenital HI

![](tm2524786d1_ex99-2img009.jpg)

o 1 in 28,000 live births in the US 1 , translating to approximately 130 new patients per year o Often presents within first month of life o Most common cause of persistent hypoglycemia in infants and children o Requires constant monitoring as serious hypoglycemic lows are often missed o Risk of coma, death, and other serious complications o 50% of children have neurological deficiencies caused by hypoglycemic lows o No therapy has been developed and approved for chronic treatment 2 Disease Background \| 9 Source: 1) The birth prevalence of congenital hyperinsulinism: a narrative review of the epidemiology of a rare disease: https://www.rezolutebio.com/wp - content/uploads/2024/06/The - birth - prevalence - of - congenital - hyperinsulinism_a - narrative - review - of - the - epidemiology - of - a - rare - disease.pdf . 2) Based on the RIZE clinical trial outcomes and the evidence of benefit in this serious condition with substantial unmet m edi cal need, ersodetug was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA), a priority medicines (PRIME) desig nat ion by the European Medicines Agency (EMA), an Innovation Passport designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group, and Orphan Drug Designation in the US and EU for the trea tme nt of hypoglycemia due to congenital HI.

![](tm2524786d1_ex99-2img010.jpg)

o Diazoxide (DZ) is first line treatment and the only approved medication for hypoglycemia caused by HI • 60% of patients do not respond to DZ • May experience frequent and serious adverse reactions including volume overload, heart failure, and pulmonary hypertension • Patients report 1 intolerable side effects including increased body hair (92%), loss of appetite (43%), swelling (27%), facial changes (27%), and gastrointestinal upset (26%) o Other available treatment options are suboptimal • Glucagon tends to be temporizing and short - term • Somatostatin analogs have marginal efficacy and potentially serious pediatric side effects • Pancreatectomy is an invasive option in DZ non - responsive patients, but frequently requires adjuvant medications until insulin - dependent diabetes eventually ensues • Intensive feeding regimens (e.g. tube feeding) often underlie all of these approaches • Each of these therapies can contribute to a cycle of poor appetite and feeding aversions Inadequate Standard of Care Source: 1) HI Global Registry 2024 Annual Report: 223patients surveyed, 183 have taken DZ. \| 10

![](tm2524786d1_ex99-2img011.jpg)

Therapies in Development 11 Clinical Barriers HI Indication Dosing Stage Mechanism Asset N/A Congenital, Tumor, PBH 2 IV 1 , once monthly Phase 3 Insulin receptor allosteric modulator Ersodetug • Utility in chronic use unproven; likely need to combine with other therapies Congenital Continuous Infusion Pump Phase 3 Glucagon analogue Dasiglucagon (Zealand) • No plans to pursue cHI • MOA suited to PBH PBH IV, 1 - 2 times daily Phase 3 GLP - 1 receptor antagonist Avexitide (Amylyx) • Earlier in development • Similar drawbacks as dasiglucagon Congenital SC injection, once weekly Phase 2 Glucagon analogue HM - 15136 (Hanmi) Source: 1) formulation allows for subcutaneous dosing. 2) Phase 2 data supports potential use. SC: subcutaneous. SOC: standar d o f care. PBH: post - bariatric hypoglycemia. MOA: mechanism of action. Ersodetug is a fully human monoclonal antibody designed to treat all forms of HI and has shown substantial benefit in clinical trials a nd real - world use

![](tm2524786d1_ex99-2img012.jpg)

o Global, multi - center, double - blind, randomized, controlled, safety and efficacy registrational study o Patient population (n=56) • Ages 3 months + who do not have adequate glycemic control with standard of care medical management o Primary endpoint: change in average hypoglycemia events per week • Secondary endpoints include change in average daily percent time in hypoglycemia, change in severe hypoglycemia events and time, time in a target glucose range, and symptomatic hypoglycemia events o Pivotal treatment arms • ~48 participants ages 1 year and above randomized in double blind, placebo - controlled fashion • Three bi - weekly loading doses, then 4 monthly doses over a total 6 - month treatment period • 5 mg/kg (+ SOC) (n = 16) • 10 mg/kg (+ SOC) (n = 16) • Placebo (SOC only) (n = 16) • Open label treatment arm: ~8 participants ages 3 months to 1 year • Eligible participants may continue in a long - term extension study following pivotal treatment o Topline results expected December 2025 \| 12 Phase 3: The sunRIZE Study SOC: standard of care.

![](tm2524786d1_ex99-2img013.jpg)

o Inclusion criteria • Age: ≥3m - 45y • Patients on SOC medications\* and/or nutritional supplementation: • ≥2 months of stable treatment • OR had previously discontinued SOC medication due to adverse effects and/or failure to respond • Persistent hypoglycemia o Baseline characteristics (n=63) • 3.4y is average age: 35% were <2 years old (range: 3m – 15y) • 15 (average) hypoglycemia events/week (range: 3 - 44 events/week) • 19% daily percent time in hypoglycemia (range: 5% - 73%) • 95% taking ≥1 SOC treatments • 40% on diazoxide • 67% on SSAs • 19% on2+ medications • 40% on enteral, scheduled and/or continuous • 13% had previous pancreatectomy sunRIZE: Patient Demographics \*SOC medications included diazoxide, paseoreotide , lanreotide , octreotide. CGM, continuous glucose monitor; cHI, congenital hyperinsulinism; HI, hyperinsulinism; K ATP , ATP - sensitive potassium; mo , month; Ph2B, phase 2B; SOC, standard of care; y, years. Demirbilek H, et al. Med . 2025;6(6):100611. \| 13

![](tm2524786d1_ex99-2img014.jpg)

o 23 participants • Average age ~6.5 (16 participants were between 2 - 6 years of age) • Diverse group across gender and genetics o ~20 % average daily time in hypoglycemia and 13 hypoglycemia events per week at baseline • Participants were on standard of care o Predictable and dose - dependent pharmacokinetics o Generally safe and well - tolerated • No adverse drug reactions • No study terminations • No clinically - significant hyperglycemia or hyperglycemia AEs o Study exceeded expectations for glucose correction: • Improvement in hypoglycemia time and events of up to ~ 90 % at top doses • Nearly universal response rate at the top dose \| 14 SOC: standard of care. AEs: adverse events. Phase 2b RIZE Study Results

![](tm2524786d1_ex99-2img015.jpg)

Baseline End of Treatment 0 5 10 15 Time by CGM [N=15 ∧ ] % T i m e (M e d i a n) -61% p < 0.0005 Baseline End of Treatment 0 5 10 15 Event Rate by BGM (N=15 ∧) E v e n t s P e r W e e k (M e d i a n) p < 0.0005 - 74% Hypoglycemia (<70 mg/dL) Severe Hypoglycemia (<50 mg/dL) Baseline End of Treatment 0 1 2 3 4 Event Rate by BGM (N=15 ∧) E v e n t s P e r W e e k (M e d i a n) p < 0.001 - 89% BGM: blood glucose monitoring. CGM: continuous glucose monitoring. Median data presented. One 9 mg/kg participant excluded from analyses for stopping background therapy while on study; two others wore CGM incorrectly which impacted efficacy by CGM but were included in analyses. \| 15 Substantial Improvement in All Hypoglycemia Metrics Pooled 6 and 9 mg/kg dose levels representative of Phase 3 population and dosing Improvement in time in hypoglycemia and overall events of ~75% and up to ~90% at top doses

![](tm2524786d1_ex99-2img016.jpg)

\| 16 2 - Year - Old on SSA 6 - Year - Old; Failed meds, pancreatectomy Average Daily Time in Hypoglycemia ~40% Average Daily Time in Hypoglycemia ~45% Baseline CGM period (≥10 days) Treatment Evaluable CGM (2 - weeks) RZ358 9 mg/kg RZ358 6 mg/kg On Treatment On Treatment SSA: Somatostatin Analog. CGM: continuous glucose monitoring. Compelling Patient Responses Nearly universal patient response rate (>50% hypoglycemia correction) observed at mid and top doses

![](tm2524786d1_ex99-2img017.jpg)

\| 17 Side Effects w/ DZ DZ Tolerated Surgery for Focal Disease Current SoC: Pancreatectomy Responsive to Diazoxide Unresponsive to Diazoxide ~130 cHI Patients Diagnosed in US per Year 1 ~20 pts/yr Addressable population of ~1,500 (up to 15 years of therapy) Source: 1) The birth prevalence of congenital hyperinsulinism: a narrative review of the epidemiology of a rare disease: https://www.rezolutebio.com/wp - content/uploads/2024/06/The - birth - prevalence - of - congenital - hyperinsulinism_a - narrative - review - of - the - epidemiology - of - a - rare - disease.pdf . HI: hyperinsulinism. DZ: D iazoxide . DZR : Diazoxide Responsive. DZNR: Diazoxide Non - Responsive (kATP channel defect). ~50 pts/yr ~60 pts/yr Post Pancreatectomy Adjuvant Medical Management Addressable U.S. Market Driven by Both Diazoxide - Responsive and Diazoxide - Unresponsive Patients

![](tm2524786d1_ex99-2img018.jpg)

Tumor HI

![](tm2524786d1_ex99-2img019.jpg)

o Hypoglycemia caused by two distinct tumor types: • Islet Cell Tumors (ICT) • Excessive secretion of insulin • Malignant insulinomas are the most common ICTs that cause hypoglycemia • Non - Islet Cell Tumors (NICT) • Produce and secrete insulin - like substances such as IGF - 2 that over - activate the insulin receptor • Hepatocellular carcinomas (HCC) are the most common NICTs that cause hypoglycemia in addition to several other tumor types including fibrosarcomas and mesotheliomas o Significant unmet need across both tumor types • Resulting hypoglycemia is often severe and may have serious adverse outcomes • Limited treatment options with poor efficacy and safety profiles • High morbidity and mortality rates • Can require hospitalization (often prolonged and in ICU) and interferes with patient quality of life • May prevent adjuvant tumor treatment Disease Background \| 19

![](tm2524786d1_ex99-2img020.jpg)

o Tumor - directed therapies do not directly treat hypoglycemia • Adequate hypoglycemia management is required prior to initiation of tumor - targeted therapies o Therapies to treat malignant insulinoma are often ineffective or poorly tolerated • Diazoxide (DZ) is the only approved treatment • Suboptimal response rates and serious side effects • Somatostatin analogs (SSAs) • Used off - label with limited success • May worsen hypoglycemia in tumor HI setting • mTOR - inhibitors • Used off - label and have p otentially severe side effects o Limited and often ineffective treatment options for hepatocellular carcinoma (HCC) • Medical therapies directed at suppressing insulin secretion such as DZ and SSAs do not work in non - islet cell tumors (NICTs) where HI is caused by non - insulin substances such as IGF - 2 Treatment Options and Unmet Need \| 20 ICT: islet - cell tumor. NICT: non - islet cell tumor. SOC: standard of care.

![](tm2524786d1_ex99-2img021.jpg)

o Multiple ICT patients with severe refractory hypoglycemia • H ospitalized and in life - threatening or hospice - bound condition • Required continuous high volume/concentration intravenous dextrose or nutritional infusion • T umor - directed therapies (e.g., embolization, radiotherapy, chemotherapy) deferred because of hypoglycemia • Physician - requested use of ersodetug o Administration of ersodetug resulted in: • Substantial hypoglycemia improvement with no significant side effects 1 • Discontinuation of intravenous dextrose • Discharge from in - patient to out - patient care • R esumption of tumor - directed therapies Real - world Patient Benefit in Expanded Access Program of Ersodetug \| 21 1) Based on real - world patient benefit demonstrated in Expanded Access Program the US Food and Drug Administration (FDA) granted Orphan Drug Designation to ersodetug for the treatment of hypoglycemia due to tumor HI. Sources: n engl j med 389;8 Aug 24, 2023 - https://www.nejm.org/doi/full/10.1056/NEJMc2307576?query=TOC&cid=NEJM+eToc%2C+August+24%2C+2023+DM2279684_NEJM_Non_Subscriber &bi d=1754093795

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o Global, multi - center, single - arm, open - label registrational study o Patient population (n=~16) • Adult ICT and NICT patients with HI who have not achieved adequate hypoglycemia control with SOC therapies o Primary endpoint: number of participants achieving ≥50% reduction from baseline IV glucose requirements (glucose infusion rate; GIR) • Additional endpoints include number of participants and time to discontinuation of GIR, time to discharge from the hospital, extent of hypoglycemia events and hypoglycemia time in the outpatient setting by self - monitored blood glucose and continuous glucose monitor, respectively, and patient reported quality of life. o Treatment arms and dosing regimen • Treatment arms and dosing regimen • Once weekly administration over 8 - week pivotal treatment period • 9 mg/kg per week as add - on to SOC • All participants may receive ersodetug in long - term extension o Topline results expected second half of 2026 \| 22 Phase 3: The upLIFT Study ICT: islet - cell tumor. NICT: non - islet cell tumor. SOC: standard of care.

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Phase 3 Study Overview o Multi - center, double - blind, randomized, controlled, safety and efficacy registrational study o Patient population (n= up to 48) • Adult ICT and NICT patients with HI who have not achieved adequate hypoglycemia control with SOC therapies • 24 participants in double - blind, placebo - controlled arm (to evaluate primary endpoint/hypoglycemia events) • Up to 24 participants in open label arm: initial 6 NICT patients and any hospitalized participants on IV glucose o Primary endpoint: change in average hypoglycemia events per week by self - monitored blood glucose • Secondary/additional endpoints: change in average daily percent time in hypoglycemia, change in Level 1 hypoglycemia events and time, hospitalization, patient reported quality of life • Open - label arm to evaluate change in IV glucose requirements in hospitalized participants o Treatment arms and dosing regimen • Once weekly administration over 8 - week pivotal treatment period • 9 mg/kg RZ358 (+ SOC) (n = 12) • Matched placebo (SOC only) (n = 12) • 9 mg/kg RZ358 Open Label Arm (n ≤ 24) • Eligible participants may continue in a long - term extension study following pivotal treatment o IND filed and cleared: start - up activities in progress to enable patient enrollment in 1H 2025 ICT: islet - cell tumor. NICT: non - islet cell tumor. SOC: standard of care. \| 23

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Immediately Addressable U.S. ICT Market \| 24 ~25 % 5 - Year Prevalence ~1,500 2 patients >500 Immediately Addressable Patients with Severe/Refractory Hypoglycemia Malignant Insulinoma Hypoglycemia (Hypo) Diagnosis and Treatment Pathway 1 ICT: islet cell tumor. Source: 1) Based on analysis of seven years of data from the Komodo Claims Assessment; 2) Approximate, average 5 - year prevalence of patients with malignant insulinoma or other malignant pancreatic cancer w/ diagnose d hypoglycemia, who may or may not have already had de - bulking surgery. No Medical Management ~2 0% Further surgery or other de - bulking Two or More HI Treatments Require Medical Management ~55 % Refractory Hypo, HI Treatment Post - Surgery No Further HI Treatments ~40% ~60 % ~225 pts ~375 pts Single HI Treatment Possible Upside ~45 % ~55 %

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Immediately Addressable U.S. NICT Market \| 25 ~40 % 5 - Year Prevalence ~4,000 2 patients >1,000 Immediately Addressable Patients with Severe/Refractory Hypoglycemia No Medical Management ~4 0% Further surgery or other de - bulking Two or More HI Treatments Require Medical Management ~20 % Refractory Hypo, HI Treatment Post - Surgery No Further HI Treatments ~50% ~50 % ~800 pts ~200 pts Single HI Treatment Possible Upside ~25 % ~75 % NICT: non - islet cell tumor. Source: 1) Based on analysis of five years of data from the Komodo Claims Assessment. 2) Komodo incidence applied to to SEER: The Surveillance, Epidemiology, and End Results database. Does not include multiple o the r cancer types with known NICT etiology. Hepatocellular Carcinoma + Hypoglycemia (Hypo) Diagnosis and Treatment Pathway 1

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o Potential to Address Two Rare Disease Markets • ~1,500 addressable cHI patients in US; equivalent patient population in Europe • >500 islet cell tumor patients and >1,000 n on - islet c ell tumor patients addressable in the US o Highly Concentrated Physician Base for cHI • 60% of patients are diagnosed within 1 month of presentation • 80% of addressable patients are seen by centers of excellence (many participating in sunRIZE study) o Tumor HI Patients Identified and treated by both Endocrinologists and Oncologists o Regulatory Designations: Breakthrough Therapy (FDA), Orphan, Pediatric Rare Disease (FDA), PRIME (EMA), ILAP (UK) \| 26 HI: hyperinsulinism. Commercial Opportunity $1B+ global market opportunity across two indications with rare disease drug pricing

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Total $1B+ global market opportunity with additional upside with market expansion Compelling real - world evidence of patient benefit under the Company's Expanded Access Program RZ358 (ersodetug) is an antibody designed to treat hypoglycemia caused by all forms of HI Mission - driven to improve outcomes for individuals with severe hypoglycemia caused by hyperinsulinism (HI) A Rare Disease Company Treating Hyperinsulinism \| 27 $180 million in cash with runway to mid - 2027

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