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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):
October 5, 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
October 5, 2026, Rezolute, Inc. (the “Company”) issued a press release to announce an update on the Company’s ongoing
discussions with the FDA regarding the Company’s sunRIZE trial and potential next steps .
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
release 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 October 5, 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: October 5, 2026 |
By: |
/s/ Nevan Charles Elam |
| |
|
Nevan Charles Elam
Chief Executive Officer |
Exhibit 99.1
Rezolute
Announces FDA Recommendation to Hold a Pre-BLA
Meeting as a Precursor to Submitting a Biologics License
Application (BLA) for Congenital
Hyperinsulinism
The
Agency reiterated its commitment to addressing the unmet need for treatment
of congenital and tumor-related hyperinsulinism and to serving
these patient communities
On
track to report topline results for the Phase 3 upLIFT study in tumor HI this quarter
REDWOOD CITY, Calif., October 5,
2026 – Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease
company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (“HI”), today announced that following
a preliminary review of detailed data from the Phase 3 sunRIZE study of ersodetug for the treatment of hypoglycemia due to congenital
HI, the U.S. Food and Drug Administration (“FDA” or “Agency”) recommended a pre-BLA meeting with the Company
as a precursor to submitting a biologics license application (BLA).
As previously reported, sunRIZE,
a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital
HI, demonstrated glycemic improvements, but did not meet the primary endpoint because the reductions in hypoglycemia events by finger-stick
self-monitored blood glucose were not statistically significant compared to placebo. Although the key secondary endpoint of time in hypoglycemia
by continuous glucose monitoring (CGM) was not met in the Week 24 End-of-Treatment evaluable window, consistent and clinically relevant
improvements in hypoglycemia were observed for this and multiple other CGM-based hypoglycemia endpoints in both treatment arms.
At a March 2026 Type B meeting
with FDA, the Agency acknowledged the challenges posed by behavioral factors in clinical trials in this patient population, including
limitations associated with SMBG based measures of hypoglycemia. At the meeting, the Agency requested that the Company provide the continuous
CGM data for its independent review. In June 2026, the Company submitted source and analysis datasets, and summary results from a substantial
number of pre-specified, post-hoc, and sensitivity analyses.
The Agency has reviewed the
data and, despite the trial’s failure to meet the prespecified primary and key secondary endpoints, as a next step, encouraged
the Company to request a Type B pre-BLA meeting as a precursor to submitting a BLA for congenital HI. The Agency explicitly did not
opine on the approvability of ersodetug for congenital HI and noted that any such determination would only be made as a part of an
in-depth evaluation of the supporting data during a formal BLA review, as is customary during the BLA process.
In light of expected topline
results this quarter from the Company’s upLIFT study in tumor HI and the potential for an additional pre-BLA meeting for that indication
should the study results support a submission, the Company will evaluate its overall BLA submission strategy for potentially both programs
following the announcement of upLIFT study results.
“We appreciate FDA’s
thorough review of the extensive body of data generated in sunRIZE and are encouraged by the Agency’s recognition that this data
will require in-depth evaluation during a formal BLA review,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute.
“We share FDA’s commitment to addressing the significant unmet needs of individuals living with rare diseases like congenital
HI, where traditional drug development can present unique challenges. We believe this unusual process of preliminary review of detailed
data demonstrates what can be achieved when regulators, companies, clinicians, and advocacy organizations work collaboratively to evaluate
the totality of evidence for promising rare disease therapies.”
“For many people living with congenital
hyperinsulinism, the threat of severe and unpredictable hypoglycemia remains a daily reality, and existing treatments are not enough,”
said Julie Raskin, Chief Executive Officer of Congenital Hyperinsulinism International (CHI). “We are encouraged by the progress
toward potential new therapies and grateful to the patients, families, researchers, clinicians, regulators, and biotechnology companies
working together to bring better options to our community.”
The open-label extension (OLE)
phase of the study is ongoing, with a continued high retention rate, equating to an ersodetug treatment duration in sunRIZE ranging from
approximately nine months to well over two years. This, along with continued glycemic control and a notable reduction in the use of background
standard of care therapies, potentially indicate continued glycemic and clinical benefit with ersodetug in longer-term use.
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 pancreatic insulin or paraneoplastic IGF-2 secretion and from entero-incretin pathways, it has the potential to be universally
effective at treating refractory hypoglycemia due to any form of hyperinsulinism (HI), including congenital HI, tumor HI
(insulinoma, non-islet cell tumors) or bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of
HI is investigational. Statements about safety and efficacy have not been approved by any health authority.
About Rezolute, Inc.
Rezolute is a late-stage ultra-rare
disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI). The Company’s antibody
therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due
to a variety of causes of 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 overall BLA process, the potential efficacy of ersodetug in treating hypoglycemia as well as our ability to
complete enrollment of the upLIFT study this year and announce topline results. Our ability to predict results or our plans or
strategies is inherently uncertain. Notably, despite the FDA encouraging us to request a pre-BLA meeting for congenital HI, there
can be no assurance that FDA will agree with the Company that the totality of evidence from the sunRIZE program demonstrates a
clinically meaningful benefit or is sufficient to support the approval for ersodetug in congenital HI. Accordingly, FDA may
determine that additional clinical data, including data from a new randomized controlled trial similar to sunRIZE, are required to
support approval. Should the Agency make such a determination, it would adversely impact the timing and feasibility of approval for
the congenital HI indication as well as the the commercial potential for ersodetug. 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.
Contacts:
Christen Baglaneas
Rezolute,
Inc.
1411 Broadway, 16th Floor
New York, NY 10018
cbaglaneas@rezolutebio.com
508-272-6717
Carrie McKim
Rezolute, Inc.
1411 Broadway, 16th Floor
New York, NY 10018
cmkim@rezolutebio.com
336-608-9706
