RZLT Rezolute, Inc. - 8-K

EX-99.1
2
tm2616579d1_ex99-1.htm
EXHIBIT 99.1

Exhibit 99.1

Rezolute Announces
Positive Interim Data for its Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism

Study now 50%
enrolled

6 of 8 participants
have already met the responder criterion for the study’s primary endpoint

Topline results
for the fully enrolled open-label study are expected in the second half of 2026

REDWOOD CITY, Calif., June 2, 2026 -
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused
on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today provided an interim update
on its ongoing open-label Phase 3 study (upLIFT) of ersodetug in tumor HI.

With 8 participants
enrolled in upLIFT to date, comprising both insulinoma and non-islet cell tumor hypoglycemia, the Company is midway through enrollment
of the planned study sample size of 16 participants.

Of the 8 participants
enrolled, 6 have already met the responder criterion for the study’s primary endpoint, which is the number of participants achieving
at least a 50 percent reduction from baseline in intravenous glucose requirements (glucose infusion rate; GIR) within the 8-week pivotal
treatment phase. Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration
of ersodetug.

One of the 8 enrolled
participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal
treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status (ECOG
4). The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to
cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition,
so the participant is being counted as a non-responder for purposes of assessing the primary endpoint.

The 8th participant
was recently enrolled and is still dosing in the pivotal phase of the study. All participants that have completed the 8-week pivotal
treatment period have elected to continue into the open-label extension, with a cumulative treatment duration of up to 6 months. Ersodetug
has been well-tolerated in the pivotal and extension phases of the study, with no drug-related adverse events or other safety findings
reported to date.

“We are very
excited by the interim observations from the upLIFT study as they largely mirror what we previously observed and reported from an initial
case series of patients from our expanded access program for compassionate use,” said Dr. Brian Roberts, Chief Medical Officer of
Rezolute. “These results reveal the clinically impactful hypoglycemia-correcting activity of ersodetug in an unbiased GIR assessment
in patients with HI caused by varying tumor types. This further highlights the aberrant outcome from the recently completed randomized,
placebo-controlled, Phase 3 sunRIZE study in pediatric congenital HI, where we believe that self-monitored glycemic measures were confounded
by divergent caretaker behaviors stemming from functional unblinding to treatment status by real-time glucose monitoring. Importantly,
these findings continue to support the potential for ersodetug to be a universal treatment option for patients with serious and refractory
hypoglycemia caused by congenital and a variety of acquired forms of hyperinsulinism, including tumor HI and following bariatric and
non-bariatric gastrointestinal surgeries. We look forward to announcing topline results of the fully enrolled upLIFT study in tumor HI
in the second half of 2026, as well as continuing our engagement with FDA to determine the path forward for the congenital HI indication.”

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 proportion 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 variants of 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 glucose absorption, gastrointestinal incretin hormones, and pancreatic insulin secretion, it has the potential
to be universally effective at treating refractory hypoglycemia due to a congenital or any acquired form of HI, including tumor HI
(insulinoma, NICTH) or hypoglycemia as a complication of a variety of bariatric or non-bariatric gastrointestinal
surgeries.

About Rezolute,
Inc.

Rezolute is a late-stage ultra-rare disease company
focused on treating refractory hypoglycemia caused by a congenital or any acquired 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 potential efficacy of ersodetug in treating
hypoglycemia associated with either a congenital or any acquired form of HI or the timing of the release of topline results for
upLIFT. 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

[email protected]

508-272-6717

Carrie McKim

[email protected]

336-608-9706