newsfilter
← Earnings
Earnings Releases·

Rezolute — First Quarter Fiscal 2027 Earnings Summary

  • Financial Performance:

    • Cash, cash equivalents, and investments in marketable securities totaled $90.0 million as of September 30, 2026, a decrease from $107.8 million as of June 30, 2026.
    • Research and development (R&D) expenses were $12.8 million for the quarter, down from $13.1 million in the same period of the prior year, driven by decreased manufacturing and patient affairs costs, partially offset by increased stock-based compensation.
    • General and administrative (G&A) expenses were $6.6 million for the quarter, down from $6.7 million in the prior year period, primarily due to lower professional fees, partially offset by increased stock-based compensation.
    • Net loss was $18.5 million for the first quarter of fiscal 2027, compared to a net loss of $18.2 million in the same period a year ago.
    • Basic and diluted net loss per common share was $0.18 for the quarter, consistent with the prior year period.
    • Total operating expenses were $19.4 million for the quarter, compared to $19.8 million in the prior year period.
  • Guidance and Future Outlook:

    • The Company plans to submit a Biologics License Application (BLA) for ersodetug for one or potentially both indications (tumor HI and congenital HI) in 2027.
    • Topline results for the Phase 3 upLIFT study in tumor HI are expected by mid-December 2026.
    • Management highlighted a potential $5 billion combined market opportunity for ersodetug during a Guggenheim Healthcare Spotlight Series presentation on October 29, 2026.
  • Business Segments and Product Lines:

    • Tumor HI: The Phase 3 upLIFT study is ongoing with enrollment complete. Seven of the eight participants enrolled in the first half met the primary endpoint responder criterion and achieved complete discontinuation of intravenous glucose; the eighth participant discontinued for hospice care and was classified as a non-responder. Ersodetug has been well-tolerated with no drug-related safety findings reported.
    • Congenital HI: The FDA reviewed additional data and recommended the Company file for review under a BLA for congenital HI following a pre-BLA meeting. The Phase 3 sunRIZE study did not meet its primary endpoint regarding statistically significant reductions in hypoglycemia events by finger-stick SMBG compared to placebo, though consistent and clinically relevant improvements were observed across multiple CGM-based endpoints. The open-label extension phase of the sunRIZE study is ongoing with high participation and indicators of improved glycemic control.
  • Other Key Points:

    • Ersodetug is a fully human monoclonal antibody acting allosterically on the insulin receptor to treat refractory hypoglycemia caused by any form of hyperinsulinism (HI).
    • The Company participated in a virtual Q&A on October 29, 2026, focusing on the commercial outlook and launch strategy for ersodetug.
    • Total assets were $96.0 million as of September 30, 2026, compared to $112.8 million as of June 30, 2026.
    • Accumulated deficit increased to $(499.9) million as of September 30, 2026, from $(481.4) million as of June 30, 2026.
    • Working capital decreased to $84.4 million as of September 30, 2026, from $99.1 million as of June 30, 2026.
Company
REZOLUTE INC
Sector
Healthcare
Industry
Biotechnology