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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):
May 21, 2024
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
May 21, 2024, Rezolute, Inc. issued a press release to announce positive topline results from a Phase 2 clinic study of RZ402
in 94 patients with diabetic macular edema who are naïve to or have received limited anti-vascular growth factor injections.
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.
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: May 24, 2024 |
By: |
/s/Nevan Charles Elam |
|
|
Nevan Charles Elam |
|
|
Chief Executive Officer |
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1509261/000110465924065073/tm2415552d1img001.jpg)
Rezolute Reports Positive Topline Results from
Phase 2 Proof of Concept Study of RZ402 in Patients with Diabetic Macular Edema (DME)
Met
primary study endpoints: good safety profile and reduction in central subfield thickness (CST)
First
oral therapy to demonstrate reduction in macular edema; supports potential for early disease intervention
Virtual
investor event to be held today at 5:30pm ET
REDWOOD
CITY, Calif., May 21, 2024 – Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”),
a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and
rare diseases, today announced positive topline results from the Phase 2 clinical study of RZ402 in patients with DME who are naïve
to or have received limited anti-vascular growth factor (anti-VEGF) injections.
“The results
are monumental for the DME community,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers
Eye Institute, and Professor of Medicine and Professor of Pediatrics at the Stanford University School of Medicine, and a member of Rezolute’s
Scientific Advisory Board. “I am impressed by the significant reduction in CST in this study across all three dosages as retinal
thickness is the key biomarker to determine whether a therapy may offer a potential benefit to patients. These data are very encouraging
and are supportive of the potential for a new first-line, non-invasive treatment for DME.”
94 participants were enrolled in the U.S. multi-center,
randomized, double-masked, placebo-controlled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered
as a monotherapy over a 12-week (three month) treatment period.
“I am encouraged to see the initial results of this proof-of-concept
study and am enthusiastic about the possibility of an oral therapy to treat DME,” said Arshad Khanani, MD, MA, FASRS, Clinical
Professor at the Reno School of Medicine, University of Nevada, and Primary Investigator of the study. “Importantly, an oral therapy
would afford us the opportunity to address both eyes and intervene much earlier, potentially altering the long-term prognosis for individuals
with DME.”
“We are very excited about these results and, importantly, would
like to thank the patients, the leading retina specialists across the country, and their motivated staff who all made this study possible,”
said Raj Agrawal, MD, Vice President and Head of Ophthalmological Clinical Development at Rezolute.
Study design and eligibility criteria
| · | DME
patients with mild to moderate non-proliferative diabetic retinopathy (DR) |
| · | Patients
must have received no more than three anti-VEGF injections previously (none within eight
weeks of randomization) |
| · | CST
of ≥320 microns in males and ≥305 microns in females |
| · | Best
Corrected Visual Acuity (BCVA) of ≤78 letters on Early Treatment Diabetic Retinopathy
Study (ETDRS) assessment |
| · | Eligible
participants were randomized equally, to one of three RZ402 active treatment arms at doses
of 50, 200, and 400 mg, or a placebo control arm, to receive study drug once daily for 12
weeks, before completing a four-week follow-up |
RZ402 met both primary endpoints of change
in macular edema (CST) and a good safety profile
| · | CST
improved significantly at all RZ402 dose levels compared to placebo (up to approximately
50 microns; p=0.02) |
| o | Continued
downward trajectory in CST over course of study and at end of treatment |
| o | No
significant difference between RZ402 dose levels, though response was largest at the 200
mg dose |
| o | Sub-analysis
by DME severity (CST ≥400 microns) indicates an improvement of approximately 75 microns
at the 200 mg dose |
| o | CST
declined in most patients who received the 200 mg dose of RZ402, including clinically significant
improvements from baseline in more than 20% of participants, compared to none in placebo,
with high rates of worsening |
| · | RZ402
was safe and well-tolerated |
| o | Adverse
events (AEs) were generally mild and rates were comparable to placebo |
| o | Three
participants experienced serious AEs which were all judged by the Investigator as unrelated
to study drug |
| o | No
ocular adverse effects that are typically seen with intravitreal injections |
| o | Electrocardiograms
(ECGs), vitals, and safety labs were unremarkable |
| · | Target
concentrations were exceeded at all three dose levels and continue to support once daily
oral dosing |
Secondary and additional endpoints
| · | No
significant improvements in BCVA compared to placebo |
| o | In-line
with expectations for a study of this duration |
| o | Observed
improvements in CST would predict visual improvements in a longer duration study |
| · | Five
RZ402 treated participants at 200 mg (20 percent) experienced a 1-step improvement in Diabetic
Retinopathy Severity Score (DRSS) compared to one participant in placebo |
The Company plans to present these data and further
findings at an upcoming medical conference.
Virtual Investor Event
The Company will host a virtual investor event
to review these topline results today at 5:30pm ET. The event will be webcast live and a replay of the webcast will be archived
in the Events section of the Company’s investor relations website following the event.
Date: Tuesday,
May 21st, 5:30pm ET
Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=6VUQj5bb
Dial-in:
| · | Toll
Free: 1-877-270-2148 |
| · | International:
1-412-902-6510 |
About DME
DME is a severe, systemic, vision-threatening
complication of diabetic retinopathy (DR) characterized by swelling of the retina and thickening of the macula, the part of the eye that
is responsible for high-resolution vision. Anti-VEGF injections into the eye are the current standard of care for DME, requiring continued
administration over long periods of time to preserve vision. Due to their invasive route of administration and occasional serious side
effects, there is a tendency to delay treatment until later in the disease course, and long-term compliance with eye injection regimens
can be difficult for patients. Coupled with inadequate responsiveness in some patients, this leads to overall undertreatment and suboptimal
vision outcomes in DME patients. DME is a result of a systemic microvascular complication of diabetes, manifesting in the retinal blood
vessels behind the eyes, and therefore commonly affects both eyes. With currently available intravitreal anti-VEGF therapies, two separate
eye injections are required, or treatment of one eye or both eyes may be deferred, when both eyes are affected.
About RZ402
RZ402 is an oral, small molecule, selective and potent, plasma kallikrein inhibitor (PKI), for the chronic treatment of DME.
By inhibiting the activation of kallikrein, RZ402 is designed to block bradykinin production and its resulting effects on vascular leakage
and inflammation. Topline results from the Phase 2 study of RZ402 in patients with DME demonstrated a significant reduction in central
subfield thickness (CST) in the Study Eye at all RZ402 dose levels compared to placebo (up to approximately 50 micron improvement) and
was safe and well-tolerated.
About Rezolute, Inc.
Rezolute strives to disrupt current treatment
paradigms by developing transformative therapies for devastating rare and chronic metabolic diseases. Its novel therapies hold the potential
to significantly improve outcomes and to reduce the treatment burden for patients, treating physicians and the healthcare system. Rezolute
is steadfast in its mission to create a profound, positive and lasting impact on the lives of patients. Patient, clinician and advocate
voices are integrated in the Company’s drug development process. Rezolute places an emphasis on understanding the patient’s
lived experiences, enabling the Company to boldly address a range of severe conditions. 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," "prove," "potential," "seek," "strive,"
"try," or future or conditional verbs such as "predict," "could," "may," "likely,"
"should," "will," "would," or similar expressions. These forward-looking statements include, but are not
limited to statements regarding the RZ402 study, the ability of RZ402 to become an effective treatment for diabetic macular edema, the
effectiveness or future effectiveness of RZ402 to become an effective treatment for diabetic macular edema, and statements regarding
clinical trial timelines for RZ402. 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
LHA Investor Relations
Tirth T. Patel
tpatel@lhai.com
212-201-6614
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