SC 13G/A - Rezolute, Inc. (0001509261) (Subject)

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Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism (HI) Ersodetug continues to advance in clinical development as a potential treatment for hypoglycemia caused by all forms of hyperinsulinism; topline sunRIZE data expected second half of this year REDWOOD CITY, Calif., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrou

REDWOOD CITY, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced that its compensation committee has approved the issuance of One Hundred and Fifty Thousand (150,000) shares of its common stock as an inducement award (the "Inducement Award") permitted under Nasdaq Rule 5635(c)(4) to its new Senior Vice President of Global Product Supply. The Inducement Award was granted on November 30, 2024 and was priced at our closing price on November 29, 2024. The Inducement Award will vest 25% one year aft

REDWOOD CITY, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ersodetug for the treatment of hypoglycemia due to tumor HI. "FDA's granting of Orphan Drug Designation is a recognition of the serious unmet need patients with tumor hyperinsulinism face and validates the potential significant benefit that ersodetug can provide," said Susan Stewart, J.D, Chief Regulatory Officer of Rezolute. "Tumor HI requir

Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), advancing in two late-stage, registrational clinical trials in two indications Phase 3 sunRIZE study on track; U.S. enrollment expected to commence in the first part of 2025 Phase 3 tumor HI study expected to commence in the first half of 2025 REDWOOD CITY, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today reported financial results and provided a business update for the three months ended September 30, 202

REDWOOD CITY, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced that management will participate in the following investor conferences: Event: Guggenheim's Innaugural Healthcare Innovation Conference Date: November 11-13, 2024 Event: Jefferies London Healthcare ConferenceDate: November 19-21, 2024 Management will be participating in one-on-one investor meetings throughout the conferences. Investors interested in scheduling a meeting with the Rezolute management team should contact their Gug

FDA lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed in the U.S. Phase 3 study for ersodetug for the treatment of tumor HI expected to commence in the first half of 2025 REDWOOD CITY, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2024. "We are thrilled to close out the year with FDA alignment to advance ersodetug in two

REDWOOD CITY, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company developing a novel therapy to treat hyperinsulinism (HI), today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical holds on RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital HI. Ersodetug is currently being studied in sunRIZE, a global Phase 3, multi-center, double-blind, randomized, placebo-controlled, safety and efficacy registrational study in participants with congenital HI. The Company will now commence study start-up activities in the U.S. with the goal of includi

REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI), today announced that management will participate in the following investor conferences: Event: H.C. Wainwright 26th Annual Global Investment ConferenceDate: September 9-11, 2024 Event: Cantor Global Healthcare ConferenceDate: September 17-19, 2024 Management will be participating in one-on-one investor meetings throughout the conferences. Investors interested in scheduling a meeting with the Rezolute management team should contact

Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company's Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI). The Company is initiating start-up activities for th

REDWOOD CITY, Calif., July 31, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute, will participate in a fireside chat during the BTIG Virtual Biotechnology Conference on Monday, August 5, 2024, at 12:00 p.m. ET. Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their BTIG representative. About Rezolute, Inc. Rez

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REDWOOD CITY, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced the addition of Daron Evans, MS, MBA, to its leadership team as Chief Financial Officer as well as the grant of share options as a material inducement for his appointment (the "Inducement Grant"). About Mr. Evans "This is a pivotal year for Rezolute as we initiated our Phase 3 clinical study for RZ358 in congenital hyperinsulinism and anticipate reporting topline data from our Phase 2 study for RZ402 in diabetic macular edema in the secon

REDWOOD CITY, Calif., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced that the Company has initiated dosing in a Phase 1b multiple-ascending dose study of RZ402, Rezolute's investigational oral plasma kallikrein inhibitor (PKI) for the treatment of diabetic macular edema (DME). Rezolute also announced the appointment of ophthalmology expert and key opinion leader, Dr. Rajat Agrawal, MD, MS, as Vice President, Clinical Development to lead the RZ402 clinical development program. "The Phase 1b study will evaluate the

REDWOOD CITY, Calif., May 20, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced the addition of Davelyn Hood, MD, to its leadership team as Director, Scientific and Patient Affairs. In her new role, Dr. Hood will be a key member of the team in furthering the development of RZ358, Rezolute's monoclonal antibody currently being evaluated in a Phase 2b clinical trial to treat congenital hyperinsulinism, a rare disease that is the most common cause of persistent low blood sugars in children. "Dr. Hood is an ideal addition to our

REDWOOD CITY, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing novel therapies for diseases related to chronic glucose imbalance, today announced the addition of Quan Dong Nguyen, MD, MSc, FAAO, FARVO to its Scientific Advisory Board. Dr. Nguyen is a renowned expert in retinal vascular and uveitic diseases and is expected to provide valuable strategic and scientific counsel related to RZ402, the Company's investigational oral plasma kallikrein inhibitor (PKI), for the treatment of diabetic macular edema (DME). "Dr. Quan Dong Nguyen has a distinguished track record of innovative research leading to new treatments f

REDWOOD CITY, Calif., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq:RZLT), focused on advancing therapies for rare, metabolic and life-threatening diseases, announced today the appointment of IssuerDirect as the Company’s registrar and transfer agent and shareholder support provider. IssuerDirect will now be responsible for all transfers of Rezolute shares rather than VStock Transfer, LLC. Shareholders need take no action related to this transaction. About Rezolute, Inc.Rezolute is advancing targeted therapies for rare, metabolic, and life-threatening diseases. Its lead clinical asset, RZ358, is in Phase 2b development as a potential treatment for congenital HI, a rare pediatri

Wedbush initiated coverage of Rezolute with a rating of Outperform and set a new price target of $12.00

Guggenheim initiated coverage of Rezolute with a rating of Buy and set a new price target of $11.00

BTIG Research initiated coverage of Rezolute with a rating of Buy and set a new price target of $13.00

Craig Hallum initiated coverage of Rezolute with a rating of Buy and set a new price target of $14.00

Maxim Group initiated coverage of Rezolute with a rating of Buy and set a new price target of $8.00

Canaccord Genuity resumed coverage of Rezolute with a rating of Buy and set a new price target of $17.00

Cantor Fitzgerald initiated coverage of Rezolute with a rating of Overweight and set a new price target of $9.00

Canaccord Genuity reiterated coverage of Rezolute with a rating of Buy and set a new price target of $17.00 from $30.00 previously

JMP Securities reiterated coverage of Rezolute with a rating of Market Outperform and set a new price target of $18.00 from $30.00 previously

ROTH Capital initiated coverage of Rezolute with a rating of Buy and set a new price target of $21.00

Phase 3 clinical study of RZ358 underway in patients with congenital hyperinsulinism (cHI); topline results expected in mid-2025 Benefit shown in individual patient cases with RZ358 for tumor-associated hyperinsulinism (taHI) under Expanded Access Program (EAP); drives alignment with FDA on unmet need and potential to move into late-stage clinical development to further evaluate RZ358 in this population REDWOOD CITY, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- 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 its financial re

REDWOOD CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial results for the first quarter of fiscal 2024 ended September 30, 2023. "We are on track to commence our Phase 3 study for RZ358 to treat congenital hyperinsulinism prior to year-end and are delighted to have recently obtained PRIME eligibility from the European Medicines Agency for this indication," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We also anticipate completing enrollment this quarter for our o

REDWOOD CITY, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt treatment paradigms for devastating metabolic diseases, today announced its financial results for the fourth quarter and full fiscal year ended June 30, 2023. "We are delighted that we are poised to initiate sunRIZE – our Phase 3 study of RZ358, which we hope will bring us one step closer to making this therapy available to patients and their families suffering from congenital hyperinsulinism. We are also anticipating results from our Phase 2 study of RZ402 in the first quarter of 20

Study to be initiated in Europe and other ex-US geographies in Q4 2023, with topline results expected 1H 2025 Conference call scheduled today at 4:30 p.m. ET  REDWOOD CITY, Calif., June 27, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today provided an update on its clinical development plans for RZ358, the Company's product candidate for congenital hyperinsulinism (congenital HI). Rezolute plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outs

REDWOOD CITY, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of devastating metabolic diseases, today announced its financial results for the third quarter of fiscal 2023 ended March 31, 2023. "We are continuing to make progress across our pipeline, including preparation for a Phase 3 study for RZ358 as well as enrollment of patients in our Phase 2 study for RZ402," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "The quarter was punctuated by a Rezolute-hosted virtual key opinion leader event th

REDWOOD CITY, Calif., March 08, 2023 (GLOBE NEWSWIRE) -- 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. D

Initiated Phase 2 proof-of-concept study of RZ402 Anticipate initiation of global Phase 3 clinical study for RZ358 in mid 2023 REDWOOD CITY, Calif., Feb. 10, 2023 (GLOBE NEWSWIRE) -- 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, today announced its financial results for the second quarter of fiscal 2023 ended December 31, 2022. "The past quarter was marked by steady execution across our pipeline as we continue to advance toward our goal of bringing transformative therapies to patients across the spectrum of metabolic disea

Phase 2 proof-of-concept study of RZ402 expected to be initiated by the end of this year REDWOOD CITY, Calif., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of devastating metabolic diseases, today announced its financial results for the first quarter of fiscal 2023 ended September 30, 2022. "I am extremely pleased with our progress this year, having reported positive data from both our clinical programs, Phase 1b study of RZ402 for Diabetic Macular Edema and Phase 2b study of RZ358 for Congenital Hyperinsulinism (HI), as well a

REDWOOD CITY, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced that management will be hosting a corporate update call. The call will highlight recent pipeline advancements and continued activities for the development of RZ358 for Congenital Hyperinsulinism and RZ402 for Diabetic Macular Edema. Conference Call and Webcast Information Rezolute management will host a conference call at 4:30 p.m. ET on Wednesday, May 4, 2022. Analysts and investors are invited to partici

Highly significant ~75% reduction in hypoglycemia events at anticipated therapeutic doses≥50% improvement in hypoglycemia in 100% of patients in high-dose cohort, with no adverse drug reactions or clinically significant hyperglycemiaStudy exceeded expectations for correction of hypoglycemia across multiple metrics, including hypoglycemia events and time in hypoglycemiaPredictable and dose-dependent exposures with a clear dose-responseGood safety and tolerability across all doses with no study discontinuations or adverse drug reactions Results are Phase 3 enabling and demonstrate the potential for RZ358 to be used as a monotherapy as well as a potential universal therapy for all forms of hype