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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. (RZLT), a clinical-stage biopharmaceutical company, reported its financial results for Q3 FY2021, ending March 31, 2021. The company continues to progress its pipeline, including RZ358 and RZ402. Topline results from a Phase 1 study of RZ402 indicate potential for daily oral dosing in diabetic macular edema treatment. Cash reserves stand at $32 million. R&D expenses rose slightly to $3.8 million, while G&A expenses increased to $1.7 million. The net loss for the quarter was $3.7 million ($0.44 per share), an improvement from a $5 million loss ($0.86 per share) in Q3 2020.
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company, will present at the Oppenheimer Rare and Orphan Disease Summit on May 21, 2021. The presentation will be accessible on-demand at 8:00 AM ET and available for 90 days on the company’s Investors section. Rezolute is focused on developing novel therapies for chronic glucose imbalance, with its lead product, RZ358, undergoing Phase 2b trials for congenital hyperinsulinism. Additionally, RZ402 is being developed for diabetic macular edema. For more details, visit their website.
Rezolute, Inc. (Nasdaq: RZLT) announced positive topline results from its Phase 1a clinical study of RZ402, an oral plasma kallikrein inhibitor for diabetic macular edema (DME). The study showed that RZ402's single dose led to plasma concentrations significantly exceeding target levels, supporting the advancement to a Phase 1b study. The drug was generally safe and well-tolerated, with no serious adverse events reported. The results suggest RZ402 could provide an effective treatment option for DME patients, offering improved delivery and compliance.
Rezolute has secured a $30 million debt financing agreement with SLR Capital Partners to enhance its funding capabilities for advancing targeted therapies for rare and metabolic diseases. The initial $15 million was funded upon closing, with an interest-only period lasting 24 months. The remaining funds may be accessed upon meeting specific milestones. CEO Nevan Elam highlighted that this facility provides non-dilutive operational flexibility as they progress their pipeline, including lead candidate RZ358, currently in Phase 2b development.
Rezolute, Inc. (RZLT) announced positive results from its Phase 2a study of RZ358 for post-gastric bypass hypoglycemia at ENDO 2021. The study demonstrated a significant over 50% improvement in hypoglycemia, achieving near-normal glucose levels. RZ358 was safe, well-tolerated, and did not induce hyperglycemia. The pharmacokinetic model supports the potential effectiveness of RZ358 in future trials, including those for congenital hyperinsulinism. Rezolute is advancing RZ358, which has received Orphan Drug Designation in multiple regions.
Rezolute, Inc. (Nasdaq: RZLT) has appointed Dr. Vlad Hogenhuis and Dr. Nerissa C. Kreher to its Board of Directors as the company advances its lead candidate, RZ358, through late-stage clinical trials for congenital hyperinsulinism.
Dr. Hogenhuis brings extensive experience in rare diseases and has held significant roles in global pharmaceutical companies. Dr. Kreher has a robust background in clinical development within the biotech sector. Their expertise is expected to enhance Rezolute's growth as it continues to develop therapies for rare metabolic disorders.
Rezolute, Inc. (Nasdaq: RZLT) announced CEO Nevan Charles Elam will present at two upcoming virtual investor conferences. The first is the Cowen 41st Annual Health Care Conference on March 3, 2021, at 4:00 p.m. ET. The second is the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 2:30 p.m. ET. Webcasts will be accessible on the conference portals. Rezolute is advancing therapies for rare diseases, focusing on RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema. For details, visit their website.
Rezolute, Inc. (RZLT) reported a net loss of $7.1 million, or $0.88 per share, for Q2 FY2021, an increase from a loss of $6.7 million, or $1.14 per share, in Q2 FY2020. Cash and cash equivalents were $37.0 million as of December 31, 2020, bolstered by $37.5 million from an October 2020 financing round. The ongoing Phase 2b study of RZ358 for congenital hyperinsulinism is enrolling patients, with results expected in H2 2021. Additionally, Rezolute initiated a Phase 1 study of RZ402 in January 2021, targeting diabetic macular edema, with completion anticipated in H1 2021.
Rezolute (RZLT) has initiated dosing in a Phase 1 clinical trial for RZ402, an oral plasma kallikrein inhibitor targeting diabetic macular edema (DME). This trial (RZ402-101) aims to assess safety, tolerability, and pharmacokinetics in healthy adults, with completion expected in early 2021. This milestone expands Rezolute's pipeline, reinforcing its commitment to novel therapies for serious metabolic diseases. RZ402's oral administration could optimize treatment outcomes for DME, where current therapies face compliance challenges.
Rezolute, Inc. (Nasdaq:RZLT) announced the appointment of IssuerDirect as its new registrar, transfer agent, and shareholder support provider, replacing VStock Transfer, LLC. This transition requires no action from shareholders. Rezolute is focused on developing therapies for rare and metabolic diseases, with its lead asset, RZ358, in Phase 2b for treating congenital hyperinsulinism. Another pipeline drug, RZ402, is an oral plasma kallikrein inhibitor, set to enter clinical development for diabetic macular edema.
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