RZLT Rezolute Inc

Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to transform the treatment paradigms of devastating metabolic diseases, will host a virtual event to highlight the Company’s RZ402 Phase 2 clinical program and the rationale for an oral plasma kallikrein inhibitor (PKI) in diabetic macular edema (DME) on Wednesday, March 22, 2023, from 4:30 p.m. – 6:00 p.m. EDT.

Rezolute management will be joined by Robert Bhisitkul, M.D., Ph.D., a practicing ophthalmologist and retina specialist at The University of California, San Francisco Medical Center. Dr. Bhisitkul also serves as a Professor of Clinical Ophthalmology and Director of the Retina Fellowship at The University of San Francisco School of Medicine.

The Company plans to host a similar event in mid-2023 to highlight its RZ358 clinical program as it enters Phase 3.

Conference Call Information

Rezolute management will host a conference call and webcast at 4:30 p.m. EDT on Wednesday, March 22, 2023. Analysts and investors are invited to participate in the event by dialing 1-877-270-2148 from the U.S. and Canada or 1-412-902-6510 internationally and asking to be joined into the Rezolute Bio call. The live webcast can be accessed on the investor page of Rezolute’s website at https://ir.rezolutebio.com/ir-calendar. A replay of the webcast will be available approximately two hours after the completion of the event.

About Diabetic Macular Edema (DME)

Diabetic retinopathy (DR) affects approximately one third of adults with diabetes and is the leading cause of vision loss in the working age population. DME is a severe vision-threatening complication of 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-vascular growth factor (anti-VEGF) injections into the eye are the current standard of care for DME, requiring repeated administration over recurring 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.

About RZ402

RZ402 is a selective and potent PKI being developed as a potential once-daily oral therapy 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.

RZ402 has been shown to reduce and prevent retinal vascular leakage in animal models by up to 90%. Results from a Phase 1b multiple ascending dose (MAD) study showed that RZ402 was readily bioavailable with dose-dependent increases in systemic exposures. RZ402 concentrations substantially exceeded target efficacious concentrations based on a combination of in-vitro and in-vivo pharmacology studies in animals, supporting the potential as a once daily therapy for DME. RZ402 was generally safe and well-tolerated, including at higher doses than previously tested in the single ascending dose (SAD) study. There were no serious adverse events, adverse drug reactions, or identified risks.

About the Contact Activation Kallikrein-Kinin SystemThe contact-activation kallikrein-kinin system promotes increased vascular permeability and inflammation via key downstream mediators, including bradykinin, and activation of the intrinsic pathway of coagulation. Pathophysiologic upregulation of this system has been linked to a variety of diseases which are characterized by vascular dysfunction, including diabetic macular edema.

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 both significantly improve outcomes and reduce the treatment burden for patients, the treating physician, and the healthcare system. Patient, clinician, and advocate voices are integrated in the Company’s drug development process, enabling Rezolute to boldly address a range of severe conditions. Rezolute is steadfast in its mission to create profound, positive, and lasting impact on patients’ lives. The Company’s lead clinical asset, RZ358, is in late-stage development for the treatment of congenital hyperinsulinism, a rare pediatric endocrine disorder. Rezolute is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema. For more information, visit www.rezolutebio.com or follow us on Twitter.

Forward-Looking StatementsThis 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. 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 Rezolute’s 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.

Investor:Kimberly Minarovich/Jillian AugustineArgot Partnersrezolute@argotpartners.com212-600-1902

Media:Ingrid MezoCanale Communications, Inc.ingrid.mezo@canalecomm.com301-473-2881