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 $108 million in cash with runway through Q1 2028 and described ersodetug’s late-stage programs for congenital and tumor hyperinsulinism. The completed Phase 3 sunRIZE pivotal study did not meet its primary endpoint, weekly hypoglycemia events measured by SMBG; the company attributed this to a confounding placebo/study effect caused by functional unblinding.
sunRIZE’s secondary CGM time-in-hypoglycemia endpoint was not statistically significant at the specified Week 24/end-of-treatment analysis: the reported 10 mg/kg result was a 32% reduction (p=0.30). In the ongoing Phase 3 upLIFT tumor-HI study, 7 of the initial 8 participants met the primary endpoint and achieved complete discontinuation of intravenous glucose. The eighth participant elected hospice care at home and died one week later due to cancer progression; Rezolute counts that participant as a non-responder. Topline results are expected mid-December 2026.
Jennison Associates LLC reported beneficial ownership of 5,332,068 Rezolute, Inc. common shares, equal to 5.5% of the class, as of September 30, 2026. It reported sole voting power over 5,332,068 shares and shared dispositive power over 5,332,068 shares, with zero shared voting power and zero sole dispositive power. The statement was signed by Beata Markowicz, Senior Vice President, Compliance.
Rezolute, Inc. (RZLT) CFO Daron Evans reported gifting 16,000 common shares on October 21, 2026; his directly held balance afterward was 395,400 shares. On the same date, Minor Child #2 and Minor Child #3 each were reported as acquiring 4,000 shares as gifts, with 11,000 shares held indirectly for each afterward. Evans also reported no longer having a reportable beneficial interest in 23,000 shares owned by Minor Child #1. PoC Capital LLC, managed by Evans, held 40,000 shares; Evans disclaimed beneficial ownership except to the extent of his pecuniary interest.
Rezolute, Inc. (RZLT) scheduled its 2027 annual meeting for December 2, 2026, asking stockholders to elect seven directors and vote on four other proposals: auditor ratification, advisory executive compensation, a charter amendment to increase authorized common stock from 165,000,000 to 225,000,000 shares, and an adjournment if needed to solicit additional proxies when support for the share increase is insufficient. The share increase is subject to stockholder approval. Common stock outstanding and entitled to vote was 96,728,913 shares as of October 5, 2026.
Stockholders are also being asked to ratify Grant Thornton LLP as auditor for the fiscal year ending June 30, 2027. Audit fees were $603,220 for fiscal 2026 and $613,000 for fiscal 2025. The advisory vote on named executive compensation is non-binding. The 2026 summary compensation table lists total compensation of $5,711,410 for Chief Executive Officer Nevan Charles Elam, $2,564,957 for Chief Medical Officer Brian Roberts, $2,285,466 for Chief Financial and Business Officer Daron Evans, and $2,623,909 for Chief Commercial Officer Sunil Karnawat.
Rezolute, Inc. completed enrollment in its Phase 3 upLIFT study of ersodetug for tumor hyperinsulinism, with topline results expected mid-December 2026. The open-label, single-arm study enrolled 16 participants; 7 of the 8 participants enrolled in its first half met the responder criterion, and each achieved complete discontinuation of intravenous glucose with ersodetug. The eighth participant chose hospice care shortly after enrollment, died one week later due to cancer progression, and is counted by the company as a non-responder for the primary endpoint.
Rezolute reported no drug-related safety findings thus far and plans to continue its expanded access program for compassionate use. Ersodetug remains investigational, and statements about its safety and efficacy have not been approved by any health authority.
Rezolute, Inc. (RZLT) is soliciting votes for its 2027 annual meeting on December 2, 2026, including on a proposal to amend its articles to raise authorized common stock from 165,000,000 to 225,000,000 shares. The virtual meeting is open to holders of record on October 5, 2026; 96,728,913 common shares were outstanding and entitled to vote on that date.
Other matters include electing seven directors, ratifying Grant Thornton LLP for the fiscal year ending June 30, 2027, an advisory vote on named executive officer compensation, and adjournment if additional proxies are needed for the share-increase proposal. The board recommends voting for each proposal. Nevan Charles Elam serves as CEO and Acting Chairman. For fiscal 2026, reported total compensation was $5,711,410 for Elam, $2,564,957 for Chief Medical Officer Brian Roberts, $2,285,466 for Chief Financial and Business Officer Daron Evans, and $2,623,909 for Chief Commercial Officer Sunil Karnawat. The pay-versus-performance table reports net income of ($77,586,000) for fiscal 2026; Grant Thornton's audit fees were $603,220.
Rezolute, Inc. (RZLT) announced that the FDA recommended a pre-BLA meeting as a precursor to a biologics license application for ersodetug in congenital hyperinsulinism (HI). The FDA did not opine on approvability; it said that determination would follow an in-depth evaluation during a formal BLA review.
The Phase 3 sunRIZE study did not meet its primary endpoint: reductions in hypoglycemia events measured by finger-stick self-monitoring were not statistically significant versus placebo. Its key secondary endpoint—time in hypoglycemia by continuous glucose monitoring in the Week 24 end-of-treatment window—was also not met, although Rezolute reported consistent, clinically relevant improvements across this and other CGM-based endpoints. Rezolute expects topline results from its Phase 3 upLIFT tumor HI study this quarter and will evaluate its overall BLA strategy after those results. The sunRIZE open-label extension is ongoing, with treatment duration ranging from approximately nine months to well over two years.
Rezolute, Inc. (RZLT) reported fiscal 2026 results and clinical updates for ersodetug, its investigational treatment for hypoglycemia associated with hyperinsulinism.
In congenital HI, Phase 3 sunRIZE did not meet its primary endpoint or key secondary endpoint at the Week 24 evaluable window. In September 2026, the FDA was still reviewing Rezolute’s submission to evaluate a potential regulatory path. In tumor HI, 7 of the initial 8 upLIFT participants met the responder criterion, defined as at least a 50 percent reduction from baseline in intravenous glucose requirements. The eighth withdrew before completing the pivotal treatment phase and is counted as a non-responder.
Rezolute recorded a net loss of approximately $77.6 million for fiscal 2026, compared with $74.4 million in fiscal 2025, and net cash used in operating activities was $64.6 million. At June 30, 2026, cash and equivalents plus marketable debt securities totaled $107.8 million. Management believes those resources are adequate to fund contractual obligations, ongoing trials and planned activities for at least 12 months from the financial statements’ issuance; additional equity or debt financing will be needed for all long-term liquidity requirements.
Rezolute, Inc. reported fiscal 2026 results for the year ended June 30, 2026. Cash, cash equivalents and investments in marketable securities were $107.8 million as of June 30, 2026, compared with $167.9 million as of June 30, 2025. Full-year research and development expense was $53.798 million versus $61.527 million; general and administrative expense was $29.168 million versus $18.367 million. Net loss was $77.586 million, compared with $74.412 million, and basic and diluted net loss per common share was ($0.75), versus ($0.98).
Fourth-quarter fiscal 2026 research and development expense was $14.889 million versus $20.863 million, general and administrative expense was $6.673 million versus $4.987 million, and net loss was $20.491 million versus $24.390 million. Ersodetug remains investigational for hyperinsulinism. Rezolute identified its ability to complete upLIFT enrollment this year and announce topline results as forward-looking milestones; it said FDA could determine that a new randomized control trial similar to sunRIZE is the only path forward for congenital HI.
Rezolute, Inc. (RZLT) reported that Chief Commercial Officer Sunil Ratilal Karnawat had 2,267 Common Shares disposed of on September 2, 2026 at $4.50 per share to cover tax withholding obligations arising from the vesting and settlement of Restricted Stock Units. This issuer-mandated "sell to cover" transaction is described as non-discretionary for the reporting person. Following the transaction, he held 69,275 Common Shares directly, plus 8,000 shares in an Individual Retirement Account and 1,898 shares in a Health Savings Account.