Rezolute Inc Stock Price, News & Analysis

Rezolute (NASDAQ: RZLT) reported Q3 FY2025 financial results and provided updates on its late-stage rare disease programs. The company's Phase 3 sunRIZE study for congenital hyperinsulinism (HI) is expected to complete enrollment in May 2025, with topline data anticipated in December 2025. Notably, the FDA granted Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor HI. The company plans to initiate the registrational upLIFT study for tumor HI mid-2025. Financially, Rezolute raised $97 million through an underwritten offering in April 2025, extending cash runway to mid-2027. Q3 results showed cash and investments of $88.4 million, R&D expenses of $15.3 million (up from $12.4M YoY), and a net loss of $18.9 million (compared to $17.1M YoY).

Rezolute (NASDAQ: RZLT) has received Breakthrough Therapy Designation (BTD) from the FDA for ersodetug in treating hypoglycemia caused by tumor hyperinsulinism (HI). The designation was granted based on clinical trial data and successful real-world treatment experiences through the Company's Expanded Access Program. This marks ersodetug's second BTD, following an earlier designation for congenital HI treatment.

The company plans to initiate a registrational study for tumor HI patients in mid-2025, with topline results expected in H2 2026. Rezolute will engage with the FDA to discuss the registrational trial and requirements for a BLA filing, aiming to expand ersodetug's indication beyond congenital HI.

The BTD status acknowledges ersodetug's potential to offer substantial improvement over existing treatments for this serious condition, where current standard care often fails to manage persistent hypoglycemia effectively.

Rezolute (NASDAQ: RZLT), a late-stage rare disease company specializing in treatments for hypoglycemia caused by hyperinsulinism, has announced its participation in four upcoming investor conferences in May and June 2025. The company's management will attend:

• The Citizens JMP Life Sciences Conference (May 7-8)
• H.C. Wainwright BioConnect Investor Conference (May 20)
• Craig-Hallum Institutional Investor Conference (May 28)
• Jefferies Global Healthcare Conference (June 3-5)

Management will be available for one-on-one meetings with investors during these conferences. Interested investors should contact their respective conference representatives to schedule meetings.

Rezolute (NASDAQ: RZLT) has successfully closed its previously announced underwritten offering, raising approximately $96.9 million in net proceeds. The offering included 24,940,769 shares of common stock at $3.25 per share, including 4,153,846 shares from the underwriters' option, and pre-funded warrants for 6,905,385 shares at $3.2490 per warrant.

The offering attracted notable investors including Federated Hermes Kaufmann Funds, Blackstone Multi-Asset Investing, and Great Point Partners. Additionally, existing investors have committed to purchase up to $4.2 million in shares through a separate private placement expected to close around May 7, 2025.

Guggenheim Securities served as the sole book-running manager, with BTIG, H.C. Wainwright & Co., and Jones as lead managers. The company plans to use the proceeds for research and development, general corporate expenses, and working capital needs.

Rezolute (NASDAQ: RZLT) has announced the pricing of an underwritten offering of common stock and pre-funded warrants, expected to raise approximately $90 million in gross proceeds. The offering includes 20,786,923 shares of common stock priced at $3.25 per share and pre-funded warrants for up to 6,905,385 shares at $3.2490 per warrant.

The offering features participation from notable investors including Federated Hermes Kaufmann Funds, Blackstone Multi-Asset Investing, and Great Point Partners. Guggenheim Securities is serving as the sole book-running manager. The closing is expected around April 24, 2025. The company plans to use the proceeds for research and development, general corporate expenses, and working capital needs.

Rezolute (NASDAQ: RZLT) received a positive recommendation from the Independent Data Monitoring Committee (DMC) for its Phase 3 sunRIZE study of ersodetug in Congenital Hyperinsulinism (HI). The DMC advised continuing the trial as planned without increasing the sample size.

The interim analysis was conducted after approximately half of enrolled patients completed primary assessments, focusing on hypoglycemia events as the primary endpoint. The company remains on track to complete enrollment in May 2025, with topline data expected in December 2025.

U.S. clinical sites are now active and enrolling patients as part of the global study. The company remains blinded to the partial study data and statistical outputs from the DMC. The recommendation aligns with previous Phase 2 RIZE study outcomes, real-world observations from their Expanded Access Program, and pharmacokinetic data from the sunRIZE study's open-label arm.

Rezolute (Nasdaq: RZLT) has appointed Erik Harris to its Board of Directors, effective immediately. Harris, currently serving as Chief Commercial Officer and Executive Vice President at Ultragenyx, brings over 20 years of biopharmaceutical expertise to the company.

Harris has significant experience in global product launches, building commercial teams, and developing strategic partnerships. His appointment comes at a important time as Rezolute advances its lead programs through clinical development and prepares for potential commercialization, particularly focusing on ersodetug for hyperinsulinism treatment.

Rezolute (NASDAQ: RZLT) reported Q2 FY2025 financial results and business updates. The company's lead drug ersodetug received Breakthrough Therapy Designation and Orphan Drug Designation for hyperinsulinism (HI) treatment. A Data Monitoring Committee reviewed the open-label arm of the sunRIZE study, confirming safe drug concentrations in infant participants.

Financial highlights: Cash position at $105.3 million as of December 31, 2024, down from $127.1 million in June 2024. Q2 R&D expenses increased to $12.6 million from $12.0 million year-over-year. G&A expenses rose to $4.5 million from $3.2 million. Net loss widened to $15.7 million from $13.9 million.

Key milestones: Phase 3 sunRIZE study enrollment expected to conclude in Q2 2025, with topline results in Q4 2025. A Phase 3 study for tumor HI is planned to begin in H1 2025, with results expected in H2 2026.

Rezolute (NASDAQ: RZLT) announced key updates for its Phase 3 sunRIZE study of ersodetug, treating hypoglycemia due to congenital hyperinsulinism. The Data Monitoring Committee (DMC) reviewed the open-label arm involving 8 infant participants aged 3 months to 1 year, confirming that target drug concentrations were safely achieved at tested doses of 5 or 10 mg/kg.

Key findings show ersodetug was generally safe and well-tolerated in infants, with drug levels comparable to effective exposures in older pediatric participants from the Phase 2b RIZE study. The DMC approved infant enrollment in the double-blind portion of the study.

Study enrollment completion is expected in Q2 2025, with topline results in Q4 2025, subject to an upcoming interim analysis. The interim analysis, scheduled for early Q2 2025, could recommend continuing the study as planned, increasing the sample size by 33%, or stopping for futility. If expanded, enrollment would extend to Q4 2025 with results by mid-2026.