Rezolute Inc - RZLT STOCK NEWS

Rezolute, Inc. (Nasdaq: RZLT) reported its Q4 and full fiscal year 2024 financial results and provided a business update. Key highlights include:

1. FDA lifted partial clinical holds on ersodetug for congenital HI treatment; Phase 3 sunRIZE study to proceed in the U.S.

2. Phase 3 study for ersodetug in tumor HI expected to start in H1 2025.

3. Positive topline results from Phase 2 proof-of-concept study of RZ402 in DME patients.

4. Cash, cash equivalents, and investments were $127.1 million as of June 30, 2024.

5. Full fiscal year 2024 R&D expenses increased to $55.7 million from $43.8 million in 2023.

6. Full fiscal year 2024 net loss was $68.5 million compared to $51.8 million in 2023.

Rezolute, Inc. (Nasdaq: RZLT) announced that the FDA has lifted partial clinical holds on RZ358 (ersodetug), their potential treatment for hypoglycemia caused by congenital hyperinsulinism (HI). This allows the company to include U.S. participants in their ongoing global Phase 3 sunRIZE study. Rezolute plans to begin U.S. enrollment in early 2025, aiming to announce topline data in the second half of 2025. The FDA concluded that liver toxicity observed in rats is likely strain-specific and not relevant to humans. This development follows FDA clearance for a separate Phase 3 study in tumor-associated HI, positioning Rezolute to advance two Phase 3 rare disease programs globally.

Rezolute, Inc. (Nasdaq: RZLT), a late-stage rare disease company focusing on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI), has announced its participation in two upcoming investor conferences. The company will attend the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, and the Cantor Global Healthcare Conference from September 17-19, 2024.

During these events, Rezolute's management team will be available for one-on-one meetings with investors. Interested parties are encouraged to contact their H.C. Wainwright and Cantor representatives to schedule meetings. This participation provides an opportunity for investors to gain insights into Rezolute's progress in addressing rare diseases, particularly its work on hypoglycemia caused by hyperinsulinism.

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.