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BCS

Current Report · Items 7.01, 9.01 · 8-K

Rezolute, Inc.

RZLTNASDAQEQUITYCurrent

Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On October 5, 2026, Rezolute, Inc. (the “Company”) issued a press release to announce an update on the Company’s ongoing discussions with the FDA regarding the Company’s sunRIZE trial and potential next steps.…

Filed Oct 5, 2026Accepted Oct 5, 2026, 8:00 AM EDTCIK 1509261Accession 0001104659-26-113503
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Company context

Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of HI. For more information, visit www.rezolutebio.com.

Current securities

Recent company filings

  1. PRE 14A filingOct 7, 2026
  2. 10-K filingSep 24, 2026
  3. Results of Operations and Financial ConditionSep 24, 2026
  4. SCHEDULE 13G - filed by Dellora Investments LP regarding Rezolute, Inc.Aug 12, 2026
  5. 4 filingJul 7, 2026

Registered securities in this filing

REZOLUTE, INC. · 8-K · Filed 2026-10-05

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common Stock, par value $0.001 per share

Symbol
RZLT
Exchange
NASDAQ
Classification
COMMON
Status
Current
Filing context

Context: AsOf2026-10-05

Dimensions: Not supplied

Accession 000110465926113503 · 1 registered-security cover member

Read the exact SEC filing ↗

Disclosure sections

Items 7.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On October 5, 2026, Rezolute, Inc. (the “Company”) issued a press release to announce an update on the Company’s ongoing discussions with the FDA regarding the Company’s sunRIZE trial and potential next steps. The information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K. The release contains forward looking statements. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “prove,” “potential,” “seek,” “strive,” “try,” or future or conditional verbs such as “predict,” “could,” “may,” “likely,” “should,” “will,” “would,” or similar expressions. The Company’s ability to predict results or the actual results of the Company’s plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers of the poster are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law or regulation, the Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in the Company’s filings with the SEC, including the Risk Factors contained in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’s website at www.sec.gov.
Filed exhibits (1)
EX-99.1 (by filename) tm2626976d1_ex99-1.htm

Exhibit 99.1 Rezolute Announces FDA Recommendation to Hold a Pre-BLA Meeting as a Precursor to Submitting a Biologics License Application (BLA) for Congenital Hyperinsulinism The Agency reiterated its commitment to addressing the unmet need for treatment of congenital and tumor-related hyperinsulinism and to serving these patient communities On track to report topline results for the Phase 3 upLIFT study in tumor HI this quarter REDWOOD CITY, Calif., October 5, 2026 - Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (“HI”), today announced that following a preliminary review of detailed data from the Phase 3 sunRIZE study of ersodetug for the treatment of hypoglycemia due to congenital HI, the U.S. Food and Drug Administration (“FDA” or “Agency”) recommended a pre-BLA meeting with the Company as a precursor to submitting a biologics license application (BLA). As previously reported, sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI, demonstra…

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