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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):
March 24, 2026
REZOLUTE, INC.
(Exact Name of Registrant as Specified in Charter)
| Nevada |
|
001-39683 |
|
27-3440894 |
|
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
275 Shoreline Drive, Suite 500, Redwood
City, CA 94065
(Address of Principal Executive Offices,
and Zip Code)
650-206-4507
Registrant’s Telephone Number, Including
Area Code
Not Applicable
(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
March 24, 2026, Rezolute, Inc. (the “Company”) issued a press release to announce results from its recent meeting with the
FDA.
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.
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 www.sec.gov.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release, dated March 24, 2026 |
| 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: March 24, 2026 |
By: |
/s/ Nevan
Charles Elam |
| |
|
Nevan Charles Elam |
| |
|
Chief Executive Officer |
| |
|
|
Exhibit 99.1
Rezolute Provides
Update on its Congenital Hyperinsulinism Program Following FDA Meeting
FDA encourages
the Company to submit comprehensive data from sunRIZE and the ongoing open-label extension to inform next steps for the program
REDWOOD CITY, Calif., March
24, 2026 – Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease
company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today announced outcomes from an in-person
Type B meeting with the U.S. Food and Drug Administration (FDA) held on March 17, 2026, related to sunRIZE, a Phase 3, multicenter,
double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI.
In December 2025, the Company reported
that sunRIZE demonstrated reductions from baseline in hypoglycemia events, but the study did not meet its primary endpoint
because the reductions were not statistically significant compared to placebo, which the Company believes was a result of a pronounced
study effect.
Although consistent and clinically
significant improvements in time in hypoglycemia by continuous glucose monitoring (CGM) were observed compared
to placebo over the course of the entire pivotal treatment period, nominal statistical significance was
not achieved in this key secondary endpoint at the pre-specified Week 24 end-of-treatment period.
During the meeting with FDA, the
Company presented summary results from sunRIZE including: (i) information to support the Company’s belief
that the primary endpoint was confounded as a result of behavioral factors; (ii) evidence of pharmacologic activity, as target
therapeutic drug concentrations were achieved in both treatment groups with highly sensitive biomarker responses of decreased insulin
cell signaling; (iii) consistent improvements compared to placebo in time in hypoglycemia and a variety of other CGM-based glycemic
endpoints; and (iv) preliminary favorable observations from the ongoing open-label extension portion of the study
(OLE), which indicate continued improvement in glycemic parameters in the ersodetug treatment arms
and placebo roll-over, concurrent with a notable reduction of other background standard-of-care therapies.
FDA acknowledged the challenges posed by the potential
impact of varied behavioral factors on clinical trials in this heterogeneous patient population, including the associated limitations
of self-monitored blood glucose (SMBG) based metrics in measuring hypoglycemia in congenital HI.
The Company believes that the unblinded nature of self-monitored
glucose necessary for patient standard of care, together with perceptions of treatment assignment, may have led to divergent
behaviors between treatment groups during the study, which may have impacted the measurement of hypoglycemia by SMBG.
While acknowledging these challenges, the agency reiterated the expectation
for adequate and well-controlled studies and outcomes as the standard for evaluating substantial evidence of efficacy criteria as the
basis for approving new therapies.
The agency and the Company then discussed summary outcomes from various
CGM-based glycemic endpoints and preliminary observations from the OLE. These and other outcomes from the pivotal portion of the
sunRIZE trial will be shared by oral presentation at an upcoming scientific conference.
As a next step for the program, FDA encouraged the Company to submit study
reports and analysis datasets for the agency’s independent evaluation. Following that review, the Company believes
that a determination may be made whether there is sufficient evidence to support the submission of a marketing application for sunRIZE
or if additional information is required. The Company expects to have an update on the program in the second half of 2026.
“We are extremely encouraged by
the outcome of our meeting with FDA including the fact that, while acknowledging their feedback was preliminary, the agency did not dismiss
sunRIZE outright on the basis of not meeting its primary endpoint,” said
Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “FDA was
engaged with the content we presented, asked astute questions necessary to fully understand the results,
and expressed a desire to conduct a thorough review that would assist in decision making regarding advancement
of the program.”
Mr. Elam continued, “We are grateful
for FDA’s hands-on approach and look forward to continuing to work with them to hopefully find a timely path forward to make
ersodetug available to patients and families in need.”
“As an attendee of the meeting,
I was extremely impressed observing FDA and Rezolute working together with a common understanding of the profound
burden congenital hyperinsulinism
places on patients and caregivers, and for their commitment to advance meaningful improvements in care,” said Julie
Raskin, Chief Executive Officer of
Congenital Hyperinsulinism International, an international advocacy organization. “Our
community has long awaited new treatment options, and this
open dialogue reflects important progress toward potentially safely bringing more effective and better-tolerated therapies.”
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 been studied in clinical trials and used in real-world cases for the treatment
of both congenital 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, the potential efficacy of ersodetug in treating hypoglycemia, the timing
and ability of the Company to provide study reports and analysis datasets for the FDA’s independent evaluation, the
persuasiveness of the study reports and analysis datasets and the possibility of FDA agreeing to advance the congenital HI program
based on those study reports and analysis datasets notwithstanding the lack of statistical significance in the sunRIZE study, the
timing of any FDA response to the study reports and analysis datasets, the timing of any update on the sunRIZE program and the
timing and content of any future presentations and market updates related the sunRIZE program. 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 Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are
available at the U.S. Securities and Exchange Commission’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.
Rezolute Contacts:
Christen Baglaneas
cbaglaneas@rezolutebio.com
508-272-6717
Carrie McKim
cmckim@rezolutebio.com
336-608-9706
