Item 7.01 Regulation FD Disclosure. On October 14, 2026, Rezolute, Inc. (the “Company”) issued a press release to announce an update on patient enrollment in the Company’s upLIFT study.…
Filed Oct 14, 2026Accepted Oct 14, 2026, 5:11 PM EDTCIK 1509261Accession 0001104659-26-115874
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.
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 14, 2026, Rezolute, Inc. (the “Company”) issued a press release to announce an update on patient enrollment
in the Company’s upLIFT study.
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) tm2627620d1_ex99-1.htm
Exhibit 99.1
Rezolute Announces Completion of Enrollment
in Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism
Topline results expected mid-December 2026
REDWOOD CITY, Calif., October 14, 2026 - Rezolute, Inc.
(Nasdaq: RZLT) (Rezolute or Company), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by
any form of hyperinsulinism (HI), today announced that the open-label Phase 3 study of ersodetug in tumor HI (upLIFT) is now fully enrolled
and topline data are expected mid-December 2026. The Company plans to continue its expanded access program for purposes of providing
ersodetug on a compassionate use basis to individuals living with serious and refractory hypoglycemia due to tumor HI.
The upLIFT study is a single-arm, open-label, registrational study
in 16 participants with insulinoma or non-islet cell tumors who have uncontrolled hypoglycemia caused by tumor HI. The study’s primary
endpoint is the percent of participants who require intravenous glucose for refractory hypoglycemia that achieve at least a 50 percent
reduction from baseline in glucose infusion rate (GIR) within the 8-week pivotal treatment phase. For statistical sig…