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Rezolute, Inc. (NASDAQ: RZLT) is a clinical-stage biopharmaceutical company focused on developing innovative drug therapies aimed at improving the lives of patients suffering from metabolic and orphan diseases. The company's core mission is to address significant unmet medical needs through a diversified pipeline of cutting-edge treatments.
One of Rezolute's most promising candidates is RZ358, currently in Phase 2 clinical trials. RZ358 is a monoclonal antibody designed for the treatment of congenital hyperinsulinism (CHI), an ultra-orphan condition. This drug has shown significant promise in improving hypoglycemia across multiple endpoints, with plans to report topline data by mid-second quarter 2024.
Another key asset is AB101, a once-weekly injectable basal insulin presently in Phase 1 trials. AB101 has the potential to revolutionize diabetes management by reducing the therapeutic burden on patients and enhancing compliance. Additionally, Rezolute is developing RZ402, a plasma kallikrein inhibitor targeting diabetic macular edema (DME), with plans to file an IND in the latter half of 2018.
Rezolute applies proprietary formulation and manufacturing capabilities to well-characterized molecules, creating differentiated, patent-protected therapies. This approach not only improves existing standards of care but also offers significant commercial potential. The company has received multiple designations for its products, including Orphan Drug Designation for RZ358 in the U.S. and Europe, and PRIME designation by the European Medicines Agency.
Recent developments include plans to complete enrollment for ongoing studies by the end of 2024 and to report topline results by mid-year 2025. These milestones underline Rezolute's commitment to advancing its clinical programs and bringing transformative therapies to market.
For more detailed information and latest updates, visit the company's official website at www.rezolutebio.com.
Rezolute, Inc. (Nasdaq: RZLT) presented a natural history study revealing significant hypoglycemia in patients with congenital hyperinsulinism during the European Society for Paediatric Endocrinology 2021. The study involved 22 patients, showing mean hypoglycemia durations of over 2.5 hours daily. Notably, hypoglycemia levels exceeded recommended guidelines, raising concerns about long-term consequences such as developmental delays. Rezolute is advancing its Phase 2b RIZE study of RZ358, a monoclonal antibody aimed at addressing this condition, with topline results expected in Q1 2022.
Rezolute, Inc. (RZLT) reported its financial results for Q4 and full fiscal year 2021, highlighting progress in clinical programs such as RZ358 and RZ402. As of June 30, 2021, cash reserves stood at $41 million. R&D expenses rose to $4.4 million for Q4, up from $2.4 million in the previous year, totaling $15 million for the year. G&A expenses also increased to $2.2 million in Q4, leading to a net loss of $6.5 million for the quarter and $20.9 million for the full year. The company anticipates topline data for RZ358 and RZ402 in Q1 2022.
Rezolute, Inc. (Nasdaq: RZLT) has commenced dosing in the second cohort of its Phase 2b trial for RZ358, targeting hypoglycemia due to congenital hyperinsulinism. Following a favorable safety review of Cohort 1, the company plans to escalate dosing to 6 mg/kg and expects to conclude enrollment by the end of 2021, aiming for top-line results in Q1 2022. Rezolute also appointed Dr. Adrian Vella to its Scientific Advisory Board, enhancing expertise for RZ358's development. The study will assess RZ358's safety and tolerability in patients inadequately controlled by existing therapies.
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical firm, announced that CEO Nevan Charles Elam will present at two virtual investment conferences. The H.C. Wainwright 23rd Annual Global Investment Conference will take place on September 13, 2021, and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit is scheduled for September 21, 2021. Both presentations will be accessible on the Rezolute website’s 'IR Calendar' page for 90 days post-event. Rezolute is developing therapies for metabolic diseases, notably RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema.
Rezolute, Inc. (Nasdaq: RZLT) has initiated dosing in a Phase 1b study of RZ402, an investigational oral plasma kallikrein inhibitor for diabetic macular edema (DME). This study aims to evaluate RZ402's safety in healthy volunteers and will guide dosing for a future Phase 2 study. The company also appointed Dr. Rajat Agrawal as Vice President of Clinical Development. DME, a complication of diabetic retinopathy, poses treatment challenges. RZ402 aims to provide a more convenient oral option compared to current invasive treatments. Results from this study are expected in Q1 2022.
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company, announced that CEO Nevan Charles Elam will present at two virtual investment conferences. The BTIG Virtual Biotechnology Conference is scheduled for August 10, 2021, at 12:00 p.m. ET, while the Canaccord Genuity 41st Annual Growth Conference will take place on August 12, 2021, at 3:30 p.m. ET. A live webcast for the latter will be available on the company’s Investors page, with a replay accessible for 90 days after the event.
Rezolute is focused on developing therapies for metabolic diseases, including its lead asset, RZ358, for congenital hyperinsulinism.
Rezolute, Inc. (Nasdaq: RZLT) has been added to the Russell Microcap® Index, effective June 28, 2021. This inclusion allows Rezolute to reach a broader investor base, as the Russell indexes are widely used for benchmarking in investment management. The Russell Microcap® Index listing lasts one year and enhances visibility for Rezolute’s therapeutic developments, particularly RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema. With $10.6 trillion in assets benchmarked against Russell indexes, this move is expected to positively affect the company's market presence.
Rezolute, Inc. (Nasdaq: RZLT) has announced that CEO Nevan Charles Elam will present at two virtual investor conferences. The first event is the Jefferies Virtual Healthcare Conference on June 4, 2021, at 12:30 p.m. ET, followed by the JMP Securities Life Sciences Conference on June 17, 2021, at 1:30 p.m. ET. Interested parties can access live webcasts on the company's IR Calendar page, with replays available for 30 days afterward.
Rezolute is focused on developing treatments for metabolic diseases, specifically its lead asset RZ358 aimed at congenital hyperinsulinism.
Rezolute, Inc. (Nasdaq: RZLT) has appointed Davelyn Hood, MD, as Director of Scientific and Patient Affairs, enhancing its leadership team for the RZ358 clinical program targeting congenital hyperinsulinism. Dr. Hood brings over a decade of experience in the field and a personal connection to the disease as a parent of a child affected by it. RZ358, currently in a Phase 2b trial, aims to regulate insulin levels in patients with this rare condition. The therapy has received Orphan Drug and Pediatric Rare Disease designations in both the US and EU.
Rezolute, Inc. (RZLT), a clinical-stage biopharmaceutical company, has appointed Dr. Quan Dong Nguyen to its Scientific Advisory Board. Dr. Nguyen, a prominent expert in retinal diseases, will provide strategic counsel for RZ402, an oral plasma kallikrein inhibitor aimed at treating diabetic macular edema (DME). His extensive background includes leading pivotal clinical trials and contributing to the approval of existing therapies such as EYLEA and Lucentis. This addition is expected to enhance Rezolute's clinical development strategy and address unmet needs in DME treatment.
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