Rezolute (RZLT) 8-K Filings

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) 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. 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. reported encouraging interim results from its Phase 3 upLIFT study of ersodetug in tumor-related hyperinsulinism, a rare cause of severe low blood sugar. The trial has enrolled 8 of a planned 16 participants, meaning enrollment is halfway complete. Of these 8 participants, 6 have already met the primary endpoint, achieving at least a 50 percent reduction from baseline in intravenous glucose requirements during the 8-week treatment phase and fully discontinuing IV glucose while on ersodetug. One participant with advanced metastatic colon cancer elected hospice care and is counted as a non-responder, while the eighth participant remains in the pivotal phase. All participants who finished the pivotal period chose to enter the long-term extension, with treatment up to 6 months, and ersodetug has been well-tolerated with no drug-related safety issues reported. Topline results from the fully enrolled study are anticipated 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. 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 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. reported a larger net loss for its fiscal second quarter ended December 31, 2025, as it increased spending on its late-stage rare disease programs. Net loss was $22.8 million, compared with $15.7 million a year earlier, while basic and diluted net loss per share remained $(0.22) on a higher share count.

Research and development expenses rose to $14.3 million from $12.6 million, mainly from higher clinical trial and employee-related costs, including severance tied to a December 2025 reduction in force. General and administrative expenses more than doubled to $9.9 million from $4.5 million, driven by higher professional fees and additional severance.

Cash, cash equivalents and investments in marketable securities totaled $132.9 million as of December 31, 2025, down from $167.9 million as of June 30, 2025, reflecting continued funding of operations. Rezolute highlighted ersodetug, its fully human monoclonal antibody designed to treat hypoglycemia from all forms of hyperinsulinism, as its lead program in both congenital and tumor-related HI.

Rezolute, Inc. furnished an update focused on its sunRIZE clinical trial and early access program for tumor hyperinsulinism (HI). The company issued a press release providing further insights into the sunRIZE trial, a cumulative table summarizing data from the initial nine tumor HI participants in its expanded access program, and an updated corporate presentation deck.

These materials, furnished as Exhibits 99.1, 99.2 and 99.3, include patient characteristics, ersodetug dosing information and observed outcomes for the early participants, as well as broader corporate information. The company states that this information is being furnished rather than filed under the Exchange Act, which limits how it is treated for certain liability and incorporation-by-reference purposes.

Rezolute, Inc. reported results from its 2026 annual stockholder meeting. Stockholders elected all seven director nominees to the board, with each receiving a majority of votes cast. As of the record date of September 22, 2025, 90,811,368 shares of common stock were outstanding and 66,700,068 shares were represented at the meeting, establishing a quorum.

Stockholders ratified Grant Thornton LLP as independent registered public accounting firm for the fiscal year ending June 30, 2026. A non-binding say-on-pay proposal approving compensation for named executive officers also received stockholder approval. In addition, stockholders approved an amendment to the 2021 Stock Incentive Plan to increase the shares available for issuance from 14,450,000 to 21,950,000. An adjournment proposal related to the equity plan amendment was also approved but was not needed once the amendment passed.

Rezolute, Inc. filed an 8-K noting it hosted an investor event and related presentation to provide an update on the Ersodetug development program.

The presentation is furnished as Exhibit 99.1 and is not deemed “filed” under the Exchange Act. The company included customary forward‑looking statements cautions and referred readers to its risk factors in prior SEC filings. Rezolute’s common stock trades on the Nasdaq Capital Market under the symbol RZLT.

Rezolute, Inc. (RZLT) furnished an 8‑K announcing it issued a press release with financial results for the first quarter ended September 30, 2025. The press release is provided as Exhibit 99.1.

The information, including Exhibit 99.1, is being furnished and is not deemed “filed” under the Exchange Act. Rezolute’s common stock trades on the Nasdaq Capital Market under the symbol RZLT.

Rezolute, Inc. reported two corporate actions. The company amended employment agreements for its CEO Nevan C. Elam, CMO Brian Roberts, CFO Daron Evans, and CCO Sunil Karnawat to provide a full gross-up payment for any excise tax and related taxes arising from “excess parachute payments” in a change of control under Section 280G. The company will determine the gross-up amount in its sole discretion, and the amendments will be filed with the next Form 10-Q.

Rezolute also delivered written notice to terminate its Open Market Sale Agreement with Jefferies LLC, effective October 24, 2025. The agreement supported an at-the-market program established under a November 2023 S-3 shelf. The company states it did not undertake any sales under the at-the-market program.

Rezolute, Inc. reported that it has released its financial results for the fourth quarter and fiscal year ended June 30, 2025. The company shared these results through a press release dated September 17, 2025, which is referenced as an exhibit to the current report. The disclosure indicates that detailed financial figures and commentary are contained in the accompanying press release rather than in this summary document.

Rezolute, Inc. reported that it has reached alignment with the U.S. Food and Drug Administration on the design of its ongoing Phase 3 trial of Ersodetug in tumor hyperinsulinism. This means the company and the regulator are now on the same page about how the late-stage study should be run, which is an important step for advancing the program.

The company also updated its corporate presentation to incorporate new information from the upLIFT study. These materials were shared through a press release and an investor presentation that are attached as exhibits to this current report.

Rezolute, Inc. filed an Form 8-K reporting a material corporate event under Item 5.02: the election or appointment of a Chief Commercial Officer. The filing references a press release dated August 20, 2025 and is signed by Chief Executive Officer Nevan Charles Elam. The submission also includes standard cover and interactive data references for the Inline XBRL document and cites communications rules for solicitations and pre-commencement communications under the Securities Act and Exchange Act.

The filing provides notice of an executive appointment but does not disclose the appointee's name, compensation, start date, or other background details within the provided text. No financial tables, transactions, or earnings data are included in the excerpt supplied.