Rezolute, Inc. filings document regulatory disclosures for a Nasdaq-listed Nevada biopharmaceutical company developing ersodetug for hyperinsulinism. Recent Current Reports on Form 8-K include Regulation FD disclosures on the sunRIZE congenital hyperinsulinism program, FDA meeting updates, investor presentations, expanded access data in tumor hyperinsulinism, and exhibits containing related press releases and corporate materials.
The filing record also includes Form 8-K disclosures for quarterly financial results, annual stockholder voting matters, board elections and amendments to executive employment agreements. These documents record the company’s clinical-development communications, governance actions, capital-market disclosures and material corporate agreements.
Rezolute, Inc. reported a Schedule 13G showing Balyasny-related entities and Dmitry Balyasny beneficially own 5,048,421 shares of Common Stock. The filing states this position represents approximately 5.28% of class A common stock based on 95,697,685 shares outstanding as of February 9, 2026.
The shares are held directly by Atlas Diversified Master Fund, Ltd., for which Balyasny Asset Management acts as investment manager; the filing lists sole voting and dispositive power of 5,048,421 shares for each reporting person.
Rezolute, Inc. reported a net loss of $16.2M for the quarter and $57.1M for the nine months ended March 31, 2026, as it continues late-stage development of ersodetug for hyperinsulinism. Cash and cash equivalents were $11.2M and marketable debt securities were $109.0M, giving total assets of $125.5M.
Research and development spending reached $38.9M over nine months, focused on the congenital HI sunRIZE study and the tumor HI upLIFT Phase 3 trial. General and administrative expenses were $22.5M, reflecting higher share-based compensation and public company costs.
The company confirmed that sunRIZE did not meet its primary or key secondary endpoints but highlighted pharmacologic activity and glycemic improvements, ongoing open-label extension benefits, and a March 2026 FDA meeting under Breakthrough Therapy designation. Management executed a 29-employee workforce reduction with $1.5M in severance to conserve cash while advancing the upLIFT registrational study, with topline tumor HI data expected in the second half of 2026.
Rezolute, Inc. reported third quarter fiscal 2026 results and updated progress on its hyperinsulinism program. In congenital hyperinsulinism, ersodetug showed clinically relevant, nominally statistically significant continuous glucose monitoring improvements, including more than 50% reductions in daily hypoglycemia time and higher time in normal glucose ranges versus placebo.
For the three months ended March 31, 2026, cash, cash equivalents and marketable securities totaled $120.3 million, down from $167.9 million as of June 30, 2025. Research and development expenses were $11.4 million versus $15.3 million a year earlier, while general and administrative expenses rose to $6.0 million from $4.7 million. Net loss narrowed to $16.2 million from $18.9 million, or $0.16 per share versus $0.27 per share.
Rezolute, Inc. joint Schedule 13G/A amendment reports that Opaleye-related reporting persons beneficially own 6,300,000 shares of common stock, representing 6.58% of the class. The filing states the Adviser and Mr. Silverman have shared voting and dispositive power over those shares.
The filing also lists Opaleye, L.P. holding 6,165,000 shares (6.44%), citing 02/09/2026 outstanding share data of 95,697,685 common shares from a prior Form 10-Q. Signatures are dated 05/11/2026.
Rezolute, Inc. filed an 8-K after presenting expanded Phase 3 sunRIZE results for its antibody ersodetug in congenital hyperinsulinism. Additional continuous glucose monitoring (CGM) analyses showed clinically relevant, nominally statistically significant reductions of about 50–80% in hypoglycemia events and 25–50% increases in time spent in the normal glucose range versus placebo across multiple timepoints.
The company reiterates that sunRIZE did not meet its primary endpoint based on self-monitored blood glucose, with reductions in weekly hypoglycemia events versus placebo not reaching statistical significance. All 59 randomized-phase completers entered an open-label extension; 57 remain on ersodetug with 6–24 months of exposure, where continued glycemic benefit and reduced background standard-of-care therapies have been observed. Following a March 17, 2026 Type B FDA meeting, regulators acknowledged challenges with the primary endpoint and requested complete study data to guide next steps for the congenital hyperinsulinism program.
Rezolute, Inc. CFO Daron Evans bought 10,000 common shares in an open-market purchase at $2.85 per share. Following this March 30, 2026 transaction, he directly owns 414,462 common shares. The filing also reports additional indirect holdings held by his spouse, minor children, and PoC Capital, LLC, a California LLC he manages, for which he disclaims beneficial ownership except to the extent of his pecuniary interest.
The Vanguard Group amended its Schedule 13G reporting for Rezolute Inc., stating it beneficially owns 0 shares of common stock, representing 0% of the class as disclosed in the filing. The amendment explains an internal realignment and separate reporting by subsidiaries effective January 12, 2026.
Rezolute announced outcomes from a recent Type B meeting with the FDA about sunRIZE, its Phase 3 trial of ersodetug for congenital hyperinsulinism. The study previously reduced hypoglycemia events but failed its primary endpoint because the benefit versus placebo was not statistically significant. FDA acknowledged challenges with behavior-driven and self-monitored glucose measures in this rare disease and reviewed continuous glucose monitoring data and open-label extension trends suggesting improved glycemic control and reduced background therapies. FDA encouraged Rezolute to submit full study reports and analysis datasets so the agency can independently determine whether evidence could support a marketing application or if more data are needed. Rezolute expects to provide a program update in the second half of 2026.
Rezolute, Inc.’s Chief Medical Officer Brian Kenneth Roberts reported a mandatory share disposition tied to equity compensation. On the RSU vesting date, he disposed of 11,439 common shares to cover tax withholding obligations at a weighted average price of $2.99 per share, with individual sale prices ranging from $2.98 to $3.07. After this tax-withholding transaction, he directly holds 296,913 common shares and indirectly holds 15,500 common shares in an IRA.
Rezolute, Inc. CFO Daron Evans reported a mandated tax-withholding share disposition related to restricted stock units. On this Form 4, he disposed of 11,438 common shares at a weighted average price of $2.99 per share to cover tax obligations from RSU vesting, as required by the company’s sell-to-cover election and not as a discretionary trade. Following the transaction, he directly holds 404,462 common shares. He also reports additional indirect holdings in Rezolute shares held by his spouse, minor children, and PoC Capital LLC, a California limited liability company he manages, with beneficial ownership in the LLC disclaimed except to the extent of his pecuniary interest.