8-K
Rezolute, Inc. (RZLT)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) ofthe
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):September 17, 2025
REZOLUTE, INC.
(Exact Name of Registrant as Specified in Charter)
| Nevada | 001-39683 | 27-3440894 |
|---|---|---|
| (State or Other Jurisdiction<br><br> <br>of Incorporation) | (Commission<br><br> <br>File Number) | (I.R.S. Employer<br><br> <br>Identification No.) |
275 Shoreline Drive, Suite 500, RedwoodCity, CA 94065
(Address of Principal Executive Offices,and Zip Code)
650-206-4507
Registrant’s Telephone Number, IncludingArea Code
Not Applicable
(FormerName 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) |
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| ¨ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ¨ | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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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 2.02 | Results of Operations and Financial Condition. |
|---|
On September 17, 2025, Rezolute, Inc. issued a press release announcing its financial results for the fourth quarter and fiscal year ended June 30, 2025. A copy of this press release is attached hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K, including Exhibit 99.1, 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.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated September 17, 2025 |
| 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. | ||
|---|---|---|
| DATE: September 17, 2025 | By: | /s/ Nevan Charles Elam |
| Nevan Charles Elam | ||
| Chief Executive Officer |
Exhibit 99.1
Rezolute ReportsFourth Quarter and Full Year Fiscal 2025 Financial Results and Provides Business Update
REDWOODCITY, Calif., September 17, 2025 – 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 Executive Officer and Founder of Rezolute. “We believe that FDA alignment on a streamlined Phase 3 trial in tumor hyperinsulinism is further recognition of ersodetug’s broad applicability across multiple forms of hyperinsulinism and highlights both the urgent need and the transformative potential of our therapy for patients and families living with this condition. We remain on track to report topline results from the sunRIZE trial in December and look forward to progressing towards potential commercialization.”
Recent PipelineProgress and Anticipated Milestones
Congenital Hyperinsulinism(HI)
| · | Completed<br> enrollment in sunRIZE, a Phase 3, multicenter, double-blind, randomized, controlled safety<br> and efficacy registrational study of ersodetug for the treatment of congenital HI. |
|---|---|
| ○ | Exceeded<br> enrollment with 62 participants enrolled, including approximately 15 percent from U.S. sites. |
| --- | --- |
| ○ | Topline<br> results expected in December 2025. |
| --- | --- |
| · | Presented<br> “Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study<br> (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress”<br> at the Annual Meeting of the Endocrine Society (ENDO 2025). The enrolled population is comparable<br> to the Phase 2 RIZE study and include: |
| --- | --- |
| ○ | 3.4y<br> average age: 35% <2 years old |
| --- | --- |
| ○ | 15<br> (average) hypoglycemia events/week |
| --- | --- |
| ○ | 19%<br> daily percent time in hypoglycemia |
| --- | --- |
| ○ | 95%<br> taking ≥1 SOC treatments |
| --- | --- |
Tumor HI
| · | In<br> August 2025, the Company achieved alignment with FDA on a significantly streamlined<br> clinical development path for its ongoing Phase 3 study (upLIFT) of ersodetug for the treatment<br> tumor HI. |
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| o | The<br> truncated study will include as few as 16 participants and will be limited to the single-arm<br> open-label portion of the upLIFT study, removing the need to conduct a double-blind randomized<br> placebo-controlled trial. |
| --- | --- |
| o | Enrollment<br> is underway and topline results are expected in the second half of 2026. |
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Corporate Updates
| · | In<br> August 2025 the Company appointed Dr. Sunil Karnawat as Chief Commercial Officer. |
|---|---|
| o | Dr. Karnawat<br> has over 25 years of experience in global commercialization of biopharmaceuticals and medical<br> devices and will spearhead launch strategy and global market readiness for ersodetug. |
| --- | --- |
| o | Before<br> joining Rezolute, Dr. Karnawat served as a Vice President at Cytokinetics and Ultragenyx.<br> At Ultragenyx, he was responsible for leading key commercial functions in launching four<br> ultra-rare disease products, including Crysvita. |
| --- | --- |
Fourth Quarterand Full Year Fiscal 2025 Financial Results
Cash, cash equivalents and investments in marketable securities were $167.9 million as of June 30, 2025, compared with $127.1 million as of June 30, 2024.
Research and development (R&D) expenses were $20.9 million for the fourth quarter of fiscal 2025, compared with $19.1 million for the same period a year ago. Full fiscal year 2025 R&D expenses were $61.5 million, compared to $55.7 million in fiscal year 2024. The increase from fiscal year 2024 to fiscal year 2025 was primarily due to (i) increased expenditures in clinical trial activities, (ii) manufacturing costs for ersodetug, and (iii) higher employee-related expenses, which included employee compensation and stock-based compensation.
General and administrative (G&A) expenses were $5.0 million for the fourth quarter of fiscal 2025, compared with $4.0 million for the same period a year ago. Full fiscal year 2025 G&A expenses were $18.4 million, compared to $14.7 million in fiscal year 2024. The increase was primarily attributable to professional fees and employee-related expenses due to increased headcount.
Net loss was $24.4 million for the fourth quarter of fiscal 2025 compared with a net loss of $23.0 million for the same period a year ago. Full year fiscal 2025 net loss was $74.4 million compared to net loss of $68.5 million for the fiscal year 2024.
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, visit www.rezolutebio.com.
Forward-LookingStatements
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 the timing of the release of topline results from the sunRIZE trial, the applicability of ersodetug across multiple forms of hyperinsulinism, the timing of the release of topline results from the upLIFT study, the ability of ersodetug to become an effective treatment for congenital hyperinsulinism, the effectiveness or future effectiveness of ersodetug for the treatment of congenital hyperinsulinism, and statements regarding clinical trial timelines for 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
cbaglaneas@rezolutebio.com
508-272-6717
Rezolute, Inc.
CondensedConsolidated Financial Statements Data
(inthousands, except per share data)
| Three Months Ended | Year Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| June 30, | June 30, | |||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||
| Condensed Consolidated Statements of Operations Data: | ||||||||||||
| Operating expenses: | ||||||||||||
| 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 | ||||||||
| June 30, | June 30, | |||||||||||
| --- | --- | --- | --- | --- | --- | --- | ||||||
| 2025 | 2024 | |||||||||||
| Condensed Consolidated Balance Sheets Data: | ||||||||||||
| 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 |