Rezolute, Inc. - RZLT STOCK NEWS

Rezolute announced the pricing of a public offering worth $60 million, involving 11,250,000 common stock shares priced at $4.00 each and pre-funded warrants for 3,750,000 shares priced at $3.999 each. The offering is expected to close around June 17, 2024, pending customary conditions. Jefferies and Cantor are leading this offering, with BTIG, Craig-Hallum, H.C. Wainwright & Co., Jones and Maxim Group as co-managers. Gross proceeds are estimated at $60 million before any deductions. A shelf registration statement filed with the SEC on November 29, 2023, supports this offering. Rezolute is focused on developing treatments for hyperinsulinism.

Rezolute, a late-stage biopharmaceutical company specializing in therapies for rare diseases, announced a proposed public offering of its common stock and pre-funded warrants. The company aims to grant underwriters a 30-day option to purchase an additional 15% of shares. This offering is subject to market conditions, and Jefferies and Cantor are managing the process. A shelf registration statement was filed with the SEC and declared effective on November 29, 2023. Copies of the prospectus supplement and accompanying prospectus will be available via the SEC's website and through Jefferies and Cantor Fitzgerald & Co.

Rezolute (Nasdaq: RZLT) announced that its CEO, Nevan Charles Elam, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 6, 2024, at 1:00 p.m. ET in New York City. The event will feature a live webcast available on Rezolute's investor relations website, which will be archived for 90 days. Additionally, the management team will engage in one-on-one meetings with investors throughout the conference.

Rezolute announced positive topline results from its Phase 2 study of RZ402 in Diabetic Macular Edema (DME) patients. The study met primary endpoints, showing a significant reduction in central subfield thickness (CST) and a good safety profile. This is the first oral therapy to demonstrate such effects, highlighting potential for early disease intervention. The study involved 94 participants and evaluated three dosages over 12 weeks. Results indicated a significant improvement in CST, especially at the 200 mg dose, with no severe adverse effects related to the drug. A virtual investor event will be held today at 5:30 pm ET to discuss these findings.

Rezolute, a clinical-stage biopharmaceutical company, reported its third quarter financial results for fiscal 2024, ending March 31, 2024. The company announced the initiation of patient enrollment in the global Phase 3 clinical study of RZ358 for congenital hyperinsulinism (cHI), with topline results expected mid-2025. Rezolute also completed an in-vivo toxicology study in Norway rats, showing no liver abnormalities at the highest dose tested. Ongoing interactions with the FDA aim to resolve partial clinical holds for RZ358.

In other developments, Rezolute completed patient dosing in a Phase 2 study of RZ402 for diabetic macular edema, with topline results expected in May 2024. Financially, the company reported cash and equivalents of $81.6 million, a decrease from $118.4 million as of June 30, 2023. Research and development expenses were $12.4 million, and general and administrative expenses rose to $3.8 million. Net loss stood at $17.1 million, compared to $15.7 million a year ago.

Rezolute, Inc. (Nasdaq: RZLT) announces the presentation of sub-analyses from the Phase 2 RIZE study at the 2024 Pediatric Endocrine Society Annual Meeting. The study evaluates RZ358 in treating congenital hyperinsulinism, showing potential as a safe and effective therapy. Key findings include significant improvements in hypoglycemia events and glucose levels, indicating promise for patients with HI.

Rezolute, Inc. (RZLT) announces positive results from a preclinical study validating the potential of lead compound RZ358 to treat hypoglycemia in non-islet cell tumors (NICTs). The company's drug shows promise in addressing hyperinsulinism caused by various tumor types, expanding its potential patient population. Dr. Brian Roberts, Chief Medical Officer, highlights the broad utility of RZ358 in treating hypoglycemia resulting from any form of hyperinsulinism, including expanded tumor indications. Rezolute plans to initiate a single registrational study with the FDA for patients with hypoglycemia due to tumor hyperinsulinism, potentially including both ICTH and NICTH patients, which could more than double the addressable market for RZ358. Additionally, the company is conducting a Phase 3 clinical trial in congenital HI, further showcasing the drug's versatility and potential therapeutic benefits.

Rezolute, Inc. (Nasdaq: RZLT) announces progress in Phase 3 clinical study of RZ358 for congenital hyperinsulinism and potential late-stage development for tumor-associated hyperinsulinism. Financial results for the second quarter of fiscal 2024 show $96.0 million in cash and investments, with $13.9 million net loss.

Rezolute, Inc. (RZLT) appoints Daron Evans, MS, MBA, as Chief Financial Officer and grants share options as an inducement for his appointment, aiming to strengthen its leadership team in the pursuit of developing therapies for metabolic and rare diseases.