Rezolute Inc Stock Price, News & Analysis

Rezolute (Nasdaq: RZLT) has received FDA clearance for its IND application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI). This marks the company's second rare disease program with RZ358 in Phase 3 development. The study will primarily be conducted in the U.S., with patient enrollment planned for the first half of 2025.

The Phase 3 registrational study is a double-blind, randomized, placebo-controlled trial involving 24 participants with inadequately controlled hypoglycemia due to tumor HI. The primary endpoint is the change in Level 2 and Level 3 hypoglycemia events. Ersodetug is a fully human monoclonal antibody that binds to an allosteric site on the insulin receptor, potentially offering a universal treatment for hypoglycemia caused by all forms of HI.

Rezolute (Nasdaq: RZLT), a late-stage biopharmaceutical company focused on developing novel therapies for rare diseases, has announced its participation in the BTIG Virtual Biotechnology Conference. The company's CEO and Founder, Nevan Charles Elam, will engage in a fireside chat on August 5, 2024, at 12:00 p.m. ET.

The Rezolute management team will also be available for one-on-one investor meetings throughout the conference. Interested investors are encouraged to contact their BTIG representative to schedule a meeting. This event provides an opportunity for Rezolute to showcase its progress in developing transformative therapies and engage with potential investors.

Rezolute announced the exercise of underwriters’ option to purchase an additional 1,786,589 shares at $4.00 per share, generating $6.7M in funding. This increases the total gross proceeds from the public offering to approximately $67M. The offering closed on June 24, 2024, with Rezolute selling 13,036,589 shares alongside pre-funded warrants for 3,750,000 shares. Additionally, Rezolute has a concurrent private placement of 1,500,000 shares at $4.00 per share. Jefferies and Cantor served as joint book-running managers, with BTIG, Craig-Hallum, H.C. Wainwright & Co., Jones, and Maxim Group as co-managers.

Rezolute, a late-stage biopharmaceutical company, announced the successful closure of its public offering, generating approximately $60 million in gross proceeds. The offering included 11.25 million shares of common stock at $4.00 per share and 3.75 million pre-funded warrants for $3.999 each. The company netted roughly $56.4 million after deducting underwriting discounts and commissions. The funds will support general corporate activities, post-Phase 3 preparation for the RZ358 program targeting congenital hyperinsulinism (cHI), and a potential late-stage clinical study of RZ358 for tumor hyperinsulinism (tHI) linked to islet and non-islet cell tumors.

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.