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.

PRIME eligibility granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism PRIME eligibility granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism

Rezolute Receives Priority Medicines (PRIME) Eligibility from European Medicines Agency for Enhanced Regulatory Support of RZ358 in Congenital Hyperinsulinism

REDWOOD CITY, Calif., Oct. 11, 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 results following administration of RZ358 to a patient with refractory hypoglycemia due to tumor-mediated hyperinsulinism (tmHI) on a compassionate-use basis, under its expanded access program (EAP).

Rezolute Announces Further Evidence of RZ358's Efficacy in Tumor-Mediated Hyperinsulinism

Planning to initiate Phase 3 Study for RZ358 (“sunRIZE study”) in the fourth quarter of 2023 Planning to initiate Phase 3 Study for RZ358 (“sunRIZE study”) in the fourth quarter of 2023

Rezolute Reports Full Year Fiscal 2023 Results and Highlights Company Progress

REDWOOD CITY, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced that Nevan Charles Elam, Chief Executive Officer and Founder, will participate in two upcoming investor conferences.

Rezolute to Participate in Upcoming Investor Conferences in September

Study to be initiated in Europe and other ex-US geographies in Q4 2023, with topline results expected 1H 2025 Conference call scheduled today at 4:30 p.m. ET  REDWOOD CITY, Calif.

Rezolute to Initiate a Pivotal Phase 3 Study of RZ358 in Participants 3 Months of Age and Older with Congenital Hyperinsulinism

Oculis Holding AG

Dallas, Texas--(Newsfile Corp. - June 1, 2023) - Stonegate Healthcare Partners (SHP), a healthcare strategy consulting firm, is pleased to announce the release of a thematic report that examines innovative advancements in the treatment of diabetic eye disease, including diabetic retinopathy (DR) and diabetic macular edema (DME). The report, Beyond VEGF: Therapies Revolutionizing Diabetic Eye Disease, highlights the unmet needs and the companies leading innovation in this field.

Stonegate Healthcare Partners Announces Publishing of a Thematic Report - Beyond VEGF: Therapies Revolutionizing Diabetic Eye Disease

The Company is poised to commence Phase 3 for RZ358 in the third quarter of calendar year 2023 The Company is poised to commence Phase 3 for RZ358 in the third quarter of calendar year 2023

Rezolute Reports Third Quarter Fiscal 2023 Results and Highlights Company Progress

RZ402 is an oral therapy being developed as a potential alternative to anti-vascular growth factor (anti-VEGF) injections into the eye RZ402 is an oral therapy being developed as a potential alternative to anti-vascular growth factor (anti-VEGF) injections into the eye

Rezolute KOL Event Highlights Significant Unmet Medical Need in Diabetic Macular Edema

Conference call and webcast to be held on Wednesday, March 22 at 4:30 pm EDT Conference call and webcast to be held on Wednesday, March 22 at 4:30 pm EDT

Rezolute to Highlight RZ402 Phase 2 Clinical Program with Leading Clinical Expert

Initiated Phase 2 proof-of-concept study of RZ402

Rezolute Reports Second Quarter Fiscal 2023 Results and Highlights Company Progress

RZ402 is an oral therapy being developed as a potential alternative to invasive and suboptimal injections into the eye RZ402 is an oral therapy being developed as a potential alternative to invasive and suboptimal injections into the eye

Rezolute Announces Initiation of a Phase 2 Study of RZ402 in Patients with Diabetic Macular Edema

Phase 2 proof-of-concept study of RZ402 expected to be initiated by the end of this year

Rezolute Reports First Quarter Fiscal 2023 Results and Highlights Company Progress

REDWOOD CITY, Calif., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of devastating metabolic diseases, today announced that Nevan Charles Elam, Chief Executive Officer and Founder, will participate in a fireside chat at the Jefferies London Healthcare Conference on Thursday, November 17, 2022, at 11:25 a.m. EST/4:25 p.m. GMT.

Rezolute to Present at the Jefferies London Healthcare Conference

REDWOOD CITY, Calif., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of devastating metabolic diseases, today announced it will present clinical data from its Phase 1b multiple-ascending dose (MAD) study of RZ402 in Diabetic Macular Edema (DME) in a podium presentation at The Retina Society 55th Annual Scientific Meeting being held November 2-5, 2022 in Pasadena, CA.

Rezolute Announces Presentation at The Retina Society 55th Annual Scientific Meeting

Rezolute, Inc. (RZLT) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Rezolute, Inc. (RZLT) Upgraded to Buy: Here's Why

Announced a $130 million registered direct offering and concurrent private placement priced at-the-market

Rezolute Reports Fourth Quarter and Full Year Fiscal 2022 Results and Highlights Company Progress

Data from Phase 2b RIZE Study in congenital hyperinsulinism will be presented in oral presentation

Rezolute Announces Presentation at the 60th Annual ESPE Meeting

REDWOOD CITY, Calif., June 01, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced that Brian Roberts, M.D., previously Senior Vice President and Head of Clinical Development, has been promoted to Chief Medical Officer. Dr. Roberts joined Rezolute in 2017 as Vice President of Clinical Development and a member of the founding management team, with responsibilities that included oversight of preclinical, regulatory, and clinical operations functions.

Rezolute Announces Promotion of Brian Roberts, M.D. to Chief Medical Officer

Announced a $130 million registered direct offering and concurrent private placement

Rezolute Reports Third Quarter Fiscal 2022 Financial Results and Highlights Company Progress

Company to Host Analyst and Investor Conference Call on Wednesday, May 4 at 4:30 p.m. ET Company to Host Analyst and Investor Conference Call on Wednesday, May 4 at 4:30 p.m. ET

Rezolute to Host Corporate Update Call on May 4, 2022

REDWOOD CITY, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced the closing of its previously announced underwritten registered direct offering of an aggregate of 18,026,315 shares of its common stock at an offering price of $3.80 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 12,921,055 shares of common stock at an offering price of $3.799 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. Certain of the pre-funded warrants offered to investors are only exercisable upon receipt of stockholder approval of an increase in the authorized shares of Rezolute's common stock which Rezolute will first seek to obtain at an annual meeting of stockholders to be held by June 30, 2022, and the shares of common stock underlying such pre-funded warrants are not being registered under the Securities Act of 1933, as amended (the “Securities Act”). Concurrent with the underwritten registered direct offering, certain existing investors agreed to purchase pre-funded warrants to purchase up to 3,263,157 shares of common stock in a private placement at the same offering price as the offering price of the pre-funded warrants offered in the underwritten registered direct offering. The concurrent private placement is expected to close subject to satisfaction of the closing conditions.

Rezolute, Inc. Announces Closing of Registered Direct Offering

REDWOOD CITY, Calif., May 01, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced the pricing of an underwritten registered direct offering of an aggregate of 18,026,315 shares of its common stock at an offering price of $3.80 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 12,921,055 shares of common stock at an offering price of $3.799 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. Certain of the pre-funded warrants offered to investors are only exercisable upon receipt of stockholder approval of an increase in the authorized shares of Rezolute's common stock which Rezolute will first seek to obtain at an annual meeting of stockholders to be held by June 30, 2022, and the shares of common stock underlying such pre-funded warrants are not being registered under the Securities Act of 1933, as amended (the “Securities Act”). Concurrent with the underwritten registered direct offering, certain existing investors agreed to purchase pre-funded warrants to purchase up to 3,263,157 shares of common stock in a private placement at the same offering price as the offering price of the pre-funded warrants offered in the underwritten registered direct offering. Gross proceeds from the underwritten registered direct offering and the concurrent private placement before deducting underwriting discounts and commissions, placement agent fees and other offering expenses are expected to be approximately $130 million. The pre-funded warrants issued in the private placement and the shares of our common stock issuable upon exercise of such pre-funded warrants are not being registered under the Securities Act, but are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

Rezolute, Inc. Announces Aggregate $130 Million Registered Direct Offering and Concurrent Private Placement Priced At-the-Market

Results Presented Today at the Pediatric Endocrine Society's 2022 Annual Meeting Results Presented Today at the Pediatric Endocrine Society's 2022 Annual Meeting

Rezolute Announces Positive Data from its Phase 2b (RIZE) Study of RZ358 in Patients with Congenital Hyperinsulinism

Rezolute to host conference call presentation and discussion of the data on Sunday, May 1 at 2:30 p.m. ET

RZ358 Phase 2b (RIZE Study) Topline Data to be Unveiled at Pediatric Endocrine Society Annual Meeting on May 1, 2022

Rezolute joins group aimed at helping advance timely access to life-saving therapies for those impacted by rare diseases Rezolute joins group aimed at helping advance timely access to life-saving therapies for those impacted by rare diseases

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