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 eventreported): February 12, 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, Redwood City,CA 94065
(Address of Principal Executive Offices, andZip Code)
650-206-4507
Registrant’s Telephone Number, IncludingArea Code
Not Applicable
(Former Nameor 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 February 12, 2025, Rezolute, Inc. issued a press release announcing its financial results for the second quarter ended December 31, 2024. 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 February 12, 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: February 12, 2025 | By: | /s/ Nevan Charles Elam |
| Nevan Charles Elam | ||
| Chief Executive Officer |
Exhibit 99.1
Rezolute Reports Second Quarter Fiscal 2025Financial Results and Provides Business Update
Ersodetug, a novel, fullyhuman monoclonal antibody for the treatment of hyperinsulinism (HI), receives Breakthrough Therapy Designation and Orphan Drug Designation
Open-label arm (infantparticipants < 1 year old) of the sunRIZE study has been reviewed by a Data Monitoring Committee (DMC); target drug concentrationswere safely reached at tested doses and infants are approved for enrollment into the double-blind portion of the study
REDWOOD CITY, Calif., February 12, 2025 -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today reported financial results and provided a business update for the three months ended December 31, 2024.
“We have made significant regulatory progress with ersodetug and our focus in 2025 remains squarely on advancing both Phase 3 trials for patients with congenital HI and tumor HI,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “We are encouraged by our momentum and remain dedicated to providing meaningful and innovative treatments for patients with limited options.”
Recent Pipeline Progress and Anticipated Milestones
Congenital HI
| · | The<br> U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to ersodetug<br> for the treatment of hypoglycemia due to congenital HI. |
|---|---|
| · | sunRIZE,<br> a Phase 3, multicenter, double-blind, randomized, controlled safety and efficacy registrational<br> study, is ongoing. |
| --- | --- |
| ○ | Enrollment<br> of U.S. participants is anticipated to occur in the second quarter of 2025. |
| --- | --- |
| ○ | Overall study enrollment expected to conclude in the second quarter of 2025, with topline results expected<br> in the fourth quarter of 2025, subject to outcomes from an interim analysis. |
| · | An independent Data<br> Monitoring Committee (DMC) reviewed safety and pharmacokinetics of ersodetug in eight infant<br> participants in the open-label arm of the sunRIZE study. |
| --- | --- |
| ○ | Ersodetug administered between 5-10 mg/kg during a bi-weekly loading phase and a monthly maintenance<br> phase was generally safe and well-tolerated. |
| --- | --- |
| ○ | Observed ersodetug drug levels at peak and trough were comparable<br> to exposures in older pediatric participants in the Phase 2b RIZE study and validate the<br> chosen dose regimen of 5 and 10 mg/kg administered bi-weekly and monthly. |
| ○ | Subsequent infant participants may be enrolled into the double-blind,<br> placebo-controlled study. |
| --- | --- |
| ○ | The DMC did not analyze efficacy and the Company remains blinded to the results. |
| · | An<br> interim analysis of the primary study endpoint (change in hypoglycemia events) is planned<br> for this quarter, with results and study update to be announced early in the second quarter. |
| --- | --- |
| ○ | Three possible outcomes from the analysis include: (i) futility and the study should be stopped, (ii) continue the study as is<br> or (iii) continue the study as is but increase the sample size by 33% (18 additional patients) to enhance statistical confidence<br> in the final outcome. |
| --- | --- |
Tumor HI
| · | During<br> the quarter, FDA granted Orphan Drug Designation to ersodetug for the treatment of hypoglycemia<br> due to tumor HI. |
|---|---|
| · | A<br> Phase 3 registrational study for ersodetug in patients with tumor HI is anticipated to begin<br> in the first half of 2025. |
| --- | --- |
| · | Topline<br> results are expected in the second half of 2026. |
| --- | --- |
Fiscal Second Quarter Financial Results
Cash, cash equivalents and investments in marketable securities were $105.3 million as of December 31, 2024, compared to $127.1 million as of June 30, 2024.
Research and development expenses were $12.6 million for the second quarter of fiscal 2025, compared with $12.0 million for the same period a year ago, with the increase primarily attributable to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses, which include employee compensation.
General and administrative expenses were $4.5 million for the second quarter of fiscal 2025, compared with $3.2 million for the same period a year ago, with the increase primarily attributable to professional fees and employee-related expenses as a result of increased headcount.
Net loss was $15.7 million for the second quarter of fiscal 2025 compared with a net loss of $13.9 million for the same period a year ago.
About Ersodetug
Ersodetug is a fully human monoclonal antibody that binds to a unique allosteric site on insulin receptors to counteract the effects of insulin receptor over-activation by insulin and related substances (such as IGF-2), thereby improving hypoglycemia in the setting of hyperinsulinism (HI). Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any form of HI.
About sunRIZE
The Phase 3 sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital HI who are experiencing poorly controlled hypoglycemia. Participants between the ages of 3 months to 45 years old are eligible to participate. The study is enrolling up to 56 participants in more than a dozen countries around the world.
About Rezolute, Inc.
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital HI and tumor HI. For more information, visit www.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 second quarter financial results of Rezolute, the efficacy of ersodetug in infant patient populations, the DMC approval and timeline of enrollment of infants into a double-blind and placebo-controlled study of ersodetug, the FDA’s grant of the Breakthrough Therapy Designation for ersodetug, the Phase 3 sunRIZE study of ersodetug, 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.
Contact:
Rezolute, Inc.
Christen Baglaneas
cbaglaneas@rezolutebio.com
508-272-6717
Rezolute,Inc.
CondensedConsolidated Financial Statements Data
(inthousands, except per share data)
| Three Months Ended | Six Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| December<br> 31, | December<br> 31, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Condensed Consolidated Statements of Operations Data: | ||||||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 12,627 | $ | 12,039 | $ | 25,381 | $ | 24,253 | ||||
| General and administrative | 4,453 | 3,155 | 8,640 | 6,855 | ||||||||
| Total operating<br> expenses | 17,080 | 15,194 | 34,021 | 31,108 | ||||||||
| Loss from operations | (17,080 | ) | (15,194 | ) | (34,021 | ) | (31,108 | ) | ||||
| Non-operating income,<br> net | 1,350 | 1,285 | 2,913 | 2,675 | ||||||||
| Net loss | $ | (15,730 | ) | $ | (13,909 | ) | $ | (31,108 | ) | $ | (28,433 | ) |
| Basic and diluted net loss per common<br> share | $ | (0.22 | ) | $ | (0.27 | ) | $ | (0.45 | ) | $ | (0.55 | ) |
| Shares used to compute basic and diluted<br> net loss per common share | 69,940 | 51,408 | 69,839 | 51,409 | ||||||||
| December 31, | June 30, | |||||||||||
| --- | --- | --- | --- | --- | --- | --- | ||||||
| 2024 | 2024 | |||||||||||
| Condensed Consolidated Balance Sheets Data: | ||||||||||||
| Cash and cash equivalents | $ | 8,932 | $ | 70,396 | ||||||||
| Investments in marketable debt securities | 96,383 | 56,741 | ||||||||||
| Working capital | 88,086 | 119,047 | ||||||||||
| Total assets | 112,007 | 132,737 | ||||||||||
| Accumulated deficit | (360,552 | ) | (329,444 | ) | ||||||||
| Total stockholders’ equity | 99,589 | 121,003 |