On February 13, 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, reported its financial results for the second quarter of fiscal 2024 ended December 31, 2023, and provided an update on recent business developments and outlook (Press release, Rezolute, FEB 13, 2024, View Source [SID1234640043]).

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"2024 is an exciting year of execution and milestones across our pipeline, with RZ358 continuing to demonstrate benefit to patients with hypoglycemia resulting from varying causes of hyperinsulinism, and in different indications," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We recently initiated sunRIZE, a global, pivotal, Phase 3 clinical study in patients with congenital hyperinsulinism, and we also continue to see favorable outcomes from our Expanded Access Program with RZ358, in patients with tumor-associated hyperinsulinism caused by insulinomas, for which we are evaluating a potential development program. Additionally, we completed enrollment in the Phase 2 study of RZ402 in patients with diabetic macular edema and look forward to reporting topline data from that program in the second quarter of 2024."

Clinical and Regulatory Highlights

RZ358 is a monoclonal antibody for the treatment of hyperinsulinism.

cHI
Rezolute initiated sunRIZE, a global, pivotal, Phase 3 clinical study in participants with cHI, in Europe and other geographies outside of the U.S.
Topline results expected mid-2025.
Innovation and Licensing Application Passport (ILAP) designation awarded to RZ358 for the treatment of cHI by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
Designation was granted based on the recognition of substantial unmet medical need in this condition and the potential benefit to patients as evidenced by the Phase 2b RIZE study results in cHI, which safely demonstrated significant improvements in hypoglycemia.
Supplements analogous PRIME designation status already granted by the European Medicines Agency (EMA) in E.U.
taHI
RZ358 has been shown to counteract excessive insulin action downstream, at the insulin-receptor on target organs. The unique mechanism of action of RZ358 makes the therapy a potential universal treatment for hypoglycemia resulting from any cause of hyperinsulinism, including neuroendocrine tumors (insulinomas).
Given the unmet need in taHI and the potential therapeutic benefit of RZ358 as demonstrated in the individual case reports from the EAP, the Company met with FDA in January 2024 (January Meeting) and received a favorable opinion from the Agency on the feasibility of RZ358 being studied in a late-stage clinical trial as a new development program and second rare disease indication for RZ358.
In the January Meeting, FDA indicated that current dose caps on cHI studies would not be applicable to taHI studies. Therefore, considering the indication is primarily adult, current partial clinical holds pertaining to cHI studies would be largely irrelevant in taHI.
The Company remains engaged with FDA in the attempt to resolve ongoing partial clinical holds on clinical studies in the cHI indication.
RZ402 is a selective and potent oral plasma kallikrein inhibitor for the treatment of diabetic macular edema (DME).

Completed enrollment in Phase 2 U.S., multi-center, randomized, double-masked, placebo-controlled, parallel-arm study evaluating the safety, efficacy, and pharmacokinetics of RZ402 administered as an oral monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections.
Topline results expected in the second quarter of 2024.
Corporate Highlights

Expanded leadership team with appointment of Daron Evans, M.S., M.B.A, as Chief Financial Officer.
Mr. Evans has substantial experience leading public and private life science companies, with expertise in corporate finance, capital markets, and strategic transactions. He will help shepherd Rezolute through its next chapter in late-stage development.
Second Quarter Fiscal 2024 Financial Results

Cash, cash equivalents and investments in marketable debt securities totaled $96.0 million as of December 31, 2023, compared to $118.4 million as of June 30, 2023

Research and development expenses were $12.0 million for the second quarter of fiscal 2024, compared to $10.9 million for the same period in fiscal 2023, with the increase primarily attributable to increased expenditures in clinical trial activities and manufacturing costs

General and administrative expenses were $3.2 million for the second quarter of fiscal 2024, compared to $3.4 million for the same period in fiscal 2023, with the decrease primarily attributable to lower personnel-related expenses

Net loss was $13.9 million for the second quarter of fiscal 2024, compared to $13.6 million for the same period in fiscal 2023