Rezolution Pictures

Rezolute to Participate in BTIG’s 3rd Annual Ophthalmology Day

Retrieved on: 
Friday, November 17, 2023

REDWOOD CITY, Calif., Nov. 17, 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 that the management team will participate in BTIG’s 3rd Annual Ophthalmology Day, taking place virtually on November 27th.

Key Points: 
  • REDWOOD CITY, Calif., Nov. 17, 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 that the management team will participate in BTIG’s 3rd Annual Ophthalmology Day, taking place virtually on November 27th.
  • The Rezolute team is scheduled to participate in a question and answer session on November 27th at 11:30 am PT / 2:30 pm ET, including a discussion of RZ402, its oral plasma kallikrein inhibitor for diabetic macular edema.
  • The Company will also hold investor meetings over the course of the conference day.

Rezolute Reports First Quarter Fiscal 2024 Results

Retrieved on: 
Monday, November 13, 2023

REDWOOD CITY, Calif., Nov. 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 its financial results for the first quarter of fiscal 2024 ended September 30, 2023.

Key Points: 
  • REDWOOD CITY, Calif., Nov. 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 its financial results for the first quarter of fiscal 2024 ended September 30, 2023.
  • “We are on track to commence our Phase 3 study for RZ358 to treat congenital hyperinsulinism prior to year-end and are delighted to have recently obtained PRIME eligibility from the European Medicines Agency for this indication,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute.
  • “We also anticipate completing enrollment this quarter for our ongoing Phase 2 study of RZ402 for the treatment of diabetic macular edema and plan to provide an update on the study prior to year end.”
    Plan to initiate sunRIZE, a pivotal Phase 3 clinical study in patients with cHI, in Europe and other geographies outside the US in the fourth quarter 2023
    Continuing the administration of RZ358 in the US with FDA approval under a compassionate use program to treat patients with tumor associated hyperinsulinism, including for a patient with refractory hypoglycemia due to metastatic insulinoma who has remained on RZ358 for nearly a year
    Multi-center, randomized, double-masked, placebo-controlled, parallel-arm study ongoing to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections
    Cash, cash equivalents and investments in marketable debt securities totaled $106.9 million as of September 30, 2023, compared to $118.4 million as of June 30, 2023
    Research and development expenses were $12.2 million for the first quarter of fiscal 2024, compared to $7.7 million for the same period in fiscal 2023, with the increase primarily attributable to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses which included employee compensation and stock-based compensation
    General and administrative expenses were $3.7 million for the first quarter of fiscal 2024, compared to $2.5 million for the same period in fiscal 2023, with the increase primarily attributable to higher personnel-related expenses, including employee compensation and stock-based compensation
    Net loss was $14.5 million for the first quarter of fiscal 2024, compared to $9.8 million for the same period in fiscal 2023

Ziegler Advises Southtowns Radiology On Its Imaging Center Acquisition By Rezolut

Retrieved on: 
Monday, December 11, 2023

CHICAGO, Dec. 11, 2023 /PRNewswire-PRWeb/ -- Ziegler, a specialty investment bank, is pleased to announce it served as the exclusive financial advisor to Southtowns Radiology on the sale of their outpatient imaging center business to Rezolut, portfolio company of private investment firm Sunny River Management.

Key Points: 
  • Ziegler, a specialty investment bank, is pleased to announce it served as the exclusive financial advisor to Southtowns Radiology on the sale of their outpatient imaging center business to Rezolut, portfolio company of private investment firm Sunny River Management.
  • CHICAGO, Dec. 11, 2023 /PRNewswire-PRWeb/ -- Ziegler, a specialty investment bank, is pleased to announce it served as the exclusive financial advisor to Southtowns Radiology on the sale of their outpatient imaging center business to Rezolut, portfolio company of private investment firm Sunny River Management.
  • Founded in 1959 and led by a team of over 20 physicians, Southtowns Radiology is a leading provider of radiology services in Western New York, providing women's imaging, preventative screenings, MRI, CT, Interventional Radiology, and a host of additional diagnostic imaging services.
  • Through this partnership with Southtowns Radiology, Rezolut is well-positioned to continue its growth and expansion of Radiology services.

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

Retrieved on: 
Tuesday, October 17, 2023

REDWOOD CITY, Calif., Oct. 17, 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 that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to RZ358 for the treatment of congenital hyperinsulinism (HI).

Key Points: 
  • REDWOOD CITY, Calif., Oct. 17, 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 that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to RZ358 for the treatment of congenital hyperinsulinism (HI).
  • PRIME eligibility is granted by EMA to drug candidates that target an unmet medical need and show potential benefit for patients based on clinical trial results.
  • The PRIME initiative was created to provide proactive and enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation with the goal of having new therapies reach patients faster.
  • “We are excited to receive PRIME eligibility for RZ358, especially as we plan to initiate our Phase 3 study for RZ358 this quarter,” remarked Susan Stewart, JD, Chief Regulatory Officer at Rezolute.

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

Retrieved on: 
Wednesday, October 11, 2023

The Company previously reported on the successful use of RZ358 for a patient with refractory hypoglycemia due to metastatic insulinoma, which has since been published in a recent edition of the New England Journal of Medicine (389;8).

Key Points: 
  • The Company previously reported on the successful use of RZ358 for a patient with refractory hypoglycemia due to metastatic insulinoma, which has since been published in a recent edition of the New England Journal of Medicine (389;8).
  • Notably, the individual with metastatic insulinoma has remained on RZ358 for nearly a year.
  • “We believe that this provides further validation of our long-held view of hyperinsulinism as a group of related conditions, and RZ358 as a potential universal treatment for any of the various causes of hyperinsulinism, whether congenital, induced by gastric bypass, or mediated by tumors.
  • We are in the process of evaluating next steps to develop RZ358 in these additional indications.”

Rezolute Reports Full Year Fiscal 2023 Results and Highlights Company Progress

Retrieved on: 
Thursday, September 14, 2023

Full fiscal year 2023 R&D expenses were $43.8 million, compared to $32.5 million in fiscal year 2022.

Key Points: 
  • Full fiscal year 2023 R&D expenses were $43.8 million, compared to $32.5 million in fiscal year 2022.
  • Full fiscal year 2023 G&A expenses were $12.2 million, compared to $9.4 million in fiscal year 2022.
  • Net loss was $12.7 million for the fourth quarter of fiscal 2023, compared to $9.4 million for the same period in fiscal 2022.
  • Full year fiscal 2023 net loss was $51.8 million compared to net loss of $41.1 million for the fiscal year 2022.

Rezolute to Participate in Upcoming Investor Conferences in September

Retrieved on: 
Wednesday, September 6, 2023

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.

Key Points: 
  • 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.
  • H.C. Wainwright 25th Annual Global Investment Conference taking place September 11-13, 2023 in New York, New York – Company presentation on Tuesday, September 12, 2023 at 2:00 p.m.
  • ET
    Cantor Fitzgerald Global Healthcare Conference taking place September 26-28, 2023 in New York, New York – Panel presentation on Tuesday, September 26, 2023 at 2:10 p.m.
  • ET
    Live webcasts will be available under "Events" in the Investor section of the Company's website at https://ir.rezolutebio.com/news-events/ir-calendar .

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

Retrieved on: 
Tuesday, June 27, 2023

REDWOOD CITY, Calif., June 27, 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 provided an update on its clinical development plans for RZ358, the Company’s product candidate for congenital hyperinsulinism (congenital HI). Rezolute plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outside the US in Q4 2023, with topline results anticipated in the first half of 2025. The sunRIZE study is a randomized, double-blind, placebo-controlled, parallel arm evaluation of RZ358 in participants with congenital HI who are not adequately responding to standard of care medical therapies. The Phase 3 study follows the Company’s successful Phase 2b RIZE study which demonstrated that RZ358 was generally safe and well-tolerated, as well as effective in improving hypoglycemia in participants who were failing available medical therapies.

Key Points: 
  • Rezolute plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outside the US in Q4 2023, with topline results anticipated in the first half of 2025.
  • The sunRIZE study is a randomized, double-blind, placebo-controlled, parallel arm evaluation of RZ358 in participants with congenital HI who are not adequately responding to standard of care medical therapies.
  • The Phase 3 study follows the Company’s successful Phase 2b RIZE study which demonstrated that RZ358 was generally safe and well-tolerated, as well as effective in improving hypoglycemia in participants who were failing available medical therapies.
  • The live audio webcast of the call will be available under "Events" in the Investor section of the Company's website at https://ir.rezolutebio.com/news-events/ir-calendar .

Rezolute Reports Third Quarter Fiscal 2023 Results and Highlights Company Progress

Retrieved on: 
Thursday, May 11, 2023

REDWOOD CITY, Calif., May 11, 2023 (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 its financial results for the third quarter of fiscal 2023 ended March 31, 2023.

Key Points: 
  • REDWOOD CITY, Calif., May 11, 2023 (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 its financial results for the third quarter of fiscal 2023 ended March 31, 2023.
  • Research and development (R&D) expenses were $14.2 million for the third quarter of fiscal 2023, compared to $8.7 million for the same period in fiscal 2022.
  • General and administrative (G&A) expenses were $2.9 million for the third quarter of fiscal 2023, compared to $2.1 million for the same period in fiscal 2022.
  • Net loss was $15.7 million for the third quarter of fiscal 2023, compared to $11.2 million for the same period in fiscal 2022.

XOMA Reports First Quarter 2023 Financial Results and Provides Update on the Acceleration of its Differentiated Royalty Monetization Strategy

Retrieved on: 
Tuesday, May 9, 2023

EMERYVILLE, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its first quarter 2023 financial results and highlighted recent operational achievements as the Company accelerates XOMA’s differentiated biotech royalty and milestone acquisition strategy.

Key Points: 
  • EMERYVILLE, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its first quarter 2023 financial results and highlighted recent operational achievements as the Company accelerates XOMA’s differentiated biotech royalty and milestone acquisition strategy.
  • “In the first quarter, the team acted rapidly and decisively to add a second cashflow-generating, long-duration asset to XOMA’s milestone and royalty portfolio.
  • In February, we received a payment related to the commercial sales of Vabysmo® (faricimab) during the second half of 2022.
  • General and administrative (“G&A”) expenses were $6.2 million for the first quarter of 2023, compared to $5.1 million for the first quarter of 2022.