Rezolute

Rezolute, Inc. operates as a biopharmaceutical company, which engages in the development of drug therapies for patients with metabolic and orphan diseases. Its products include RZ358-Phase 2, an antibody for the ultra-orphan indication of congenital hyperinsulinism, AB101-Phase 1, a once-weekly injectable basal insulin, and RZ402, which targets diabetic macular edema. The company was founded by Nevan Charles Elam, Ho Young Huh, and Sankaram Mantripragada on July 26, 2010 and is headquartered in Redwood City, CA.

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Rezolute, Inc. operates as a biopharmaceutical company, which engages in the development of drug therapies for patients with metabolic and orphan diseases. Its clinical assets include Ersodetug, a potential treatment for hypoglycemia caused by multiple forms of hyperinsulinism, and RZ402, an oral plasma kallikrein inhibitor and potential therapy for the chronic treatment of diabetic macular edema. The company was founded by Nevan Charles Elam, Ho Young Huh, and Sankaram Mantripragada on July 26, 2010 and is headquartered in Redwood City, CA.

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REDWOOD CITY, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced that its compensation committee has approved the issuance of One Hundred and Fifty Thousand (150,000) shares of its common stock as an inducement award (the “Inducement Award”) permitted under Nasdaq Rule 5635(c)(4) to its new Senior Vice President of Global Product Supply. The Inducement Award was granted on November 30, 2024 and was priced at our closing price on November 29, 2024. The Inducement Award will vest 25% one year after the executive's start date and will vest monthly for 36 months after.

Rezolute Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4)

The FDA bestows an Orphan Drug status to Rezolute's ersodetug for treating hypoglycemia due to tumor hyperinsulinism. Shares rise.

RZLT Stock Rises on FDA's Orphan Designation for Rare Disease Drug

Rezolute, Inc. expects to report top-line results from the phase 3 sunRIZE study using ersodetug + placebo to treat patients with Congenital Hyperinsulinism in the 2nd half of 2025. The global Congenital Hyperinsulinism treatment market is estimated to be worth $327.8 million by 2032; the Company believes that cHI and tHI could both generate sales >$1 billion. A phase 3 registrational study, using ersodetug for patients with Tumor Hyperinsulinism expected to start in the 1st half of 2025 and release top-line data from it 2nd half of 2026.

Rezolute: Ersodetug Downstream Tech Could Ignite The Hyperinsulinism Market

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

Rezolute Reports Fourth Quarter and Full Year Fiscal 2024 Financial Results and Provides Business Update

The FDA removes the partial clinical holds on Rezolute's phase III study evaluating RZ358 for treating congenital hyperinsulinism.

RZLT Stock Up as FDA Lifts Clinical Holds on Rare Disease Study

Monday, the FDA removed partial clinical holds on Rezolute, Inc.'s RZLT RZ358 (ersodetug), a potential treatment for hypoglycemia (low blood sugar) caused by congenital hyperinsulinism (HI).

FDA Gives Green Signal To Rezolute's Genetic Disorder Treatment

Rezolute Inc said on Monday the U.S. Food and Drug Administration has removed the partial clinical hold on its late-stage study testing its experimental treatment for low blood sugar.

US FDA lifts partial clinical hold on Rezolute's blood sugar treatment

Commencing study startup activities in the U.S.; participant enrollment anticipated in early 2025 Commencing study startup activities in the U.S.; participant enrollment anticipated in early 2025

FDA Lifts Partial Clinical Holds on RZ358 for the Treatment of Congenital Hyperinsulinism and Authorizes U.S. Inclusion in Ongoing Phase 3 Study

Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company's Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI).

Rezolute Announces FDA Clearance of IND Application for Phase 3 Registrational Study of RZ358 for Treatment of Hypoglycemia Due to Tumor Hyperinsulinism

Additional $6.7M in funding resulting in approximately $67M in gross proceeds Additional $6.7M in funding resulting in approximately $67M in gross proceeds

Rezolute Announces Exercise of Underwriters' Option to Purchase Additional Shares and Concurrent Private Placement

NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced the closing of its underwritten public offering of 11,250,000 shares of its common stock at a price to the public of $4.00 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 3,750,000 shares of its common stock at a price to the public of $3.999 per pre-funded warrant, in each case, before underwriting discounts and commissions. All of the shares and warrants in the public offering were sold by the Company.

Rezolute Announces Closing of Public Offering with Approximately $60M in Gross Proceeds

NEW YORK, June 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced the pricing of its previously announced underwritten public offering of an aggregate of 11,250,000 shares of its common stock at an offering price of $4.00 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 3,750,000 shares of common stock at an offering price of $3.999 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. Gross proceeds from the underwritten public offering before deducting underwriting discounts and commissions and other offering expenses are expected to be approximately $60 million.

Rezolute Announces Pricing of Public Offering of $60 Million of Common Stock and Pre-Funded Warrants

NEW YORK, June 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying pre-funded warrants sold in connection with the public offering. The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering. All of the shares in the public offering are being offered by the Company.

Rezolute Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

REDWOOD CITY, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute, will participate in a fireside chat during the Jefferies Global Healthcare Conference on Thursday, June 6, 2024, at 1:00 p.m. ET in New York City.

Rezolute to Participate in the Jefferies Global Healthcare Conference

Met primary study endpoints: good safety profile and reduction in central subfield thickness (CST) First oral therapy to demonstrate reduction in macular edema; supports potential for early disease intervention Virtual investor event to be held today at 5:30pm ET REDWOOD CITY, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced positive topline results from the Phase 2 clinical study of RZ402 in patients with DME who are naïve to or have received limited anti-vascular growth factor (anti-VEGF) injections.

Rezolute Reports Positive Topline Results from Phase 2 Proof of Concept Study of RZ402 in Patients with Diabetic Macular Edema (DME)

Patient enrollment underway in sunRIZE global Phase 3 clinical study of RZ358 in patients with congenital hyperinsulinism (cHI); topline results expected in mid-2025

Rezolute Reports Third Quarter Fiscal 2024 Financial Results and Provides Business Update

REDWOOD CITY, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that a poster titled “An Analysis of Overnight Hypoglycemia in Patients with Congenital Hyperinsulinism: Results from the RZ358-606 (RIZE) Study” will be presented at the Pediatric Endocrine Society (PES) Annual Meeting, to be held May 2-5, 2024 at the Sheraton Grand Chicago Riverwalk.

Phase 2 RIZE Study Sub-Analyses to be Presented at the 2024 Pediatric Endocrine Society Annual Meeting

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Potential to more than double the addressable patient population living with hypoglycemia resulting from insulin receptor over-activation (tumor hyperinsulinism) Potential to more than double the addressable patient population living with hypoglycemia resulting from insulin receptor over-activation (tumor hyperinsulinism)

Rezolute Reports Validation of the Potential Use of RZ358 for Treatment of Non-Islet Cell Tumor Hypoglycemia (NICTH)

Phase 3 clinical study of RZ358 underway in patients with congenital hyperinsulinism (cHI); topline results expected in mid-2025

Rezolute Reports Second Quarter Fiscal 2024 Results and Provides Business Update

REDWOOD CITY, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced the addition of Daron Evans, MS, MBA, to its leadership team as Chief Financial Officer as well as the grant of share options as a material inducement for his appointment (the “Inducement Grant”).

Rezolute Expands Leadership Team with Appointment of Daron Evans, MS, MBA, as Chief Financial Officer

REDWOOD CITY, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of hypoglycemia due to congenital hyperinsulinism (HI). The Innovation Passport designation was granted based on the substantial unmet medical need in this condition and the potential for RZ358 to benefit patients as evidenced by the Phase 2 RIZE study in congenital HI, which safely demonstrated significant improvements in hypoglycemia events.

Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism

Company anticipates completing enrollment by the end of 2024 and reporting topline results in mid-year 2025 Company anticipates completing enrollment by the end of 2024 and reporting topline results in mid-year 2025

Rezolute Initiates Phase 3 Clinical Study for RZ358 in Congenital Hyperinsulinism

REDWOOD CITY, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced the completion of enrollment in its RZ402 Phase 2 study in diabetic macular edema (“DME”).

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