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As filed with the Securities and Exchange Commission on August 5, 2024
Registration No. 333- ? SECURITIES AND EXCHANGE COMMISSION
UNITED STATES
Washington, D.C. 20549
FORM S-3 REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
REZOLUTE, INC.
(Exact Name of Registrant as Specified in Its Charter) ? (State or Other Jurisdiction of
Incorporation or Organization)?
27-3440894
(I.R.S. Employer Identification No.)
275 Shoreline Drive, Suite 500
Redwood City, CA 94065
(650) 206-4507
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices) ?
Nevan Elam
Chief Executive Officer 275 Shoreline Drive, Suite 500 Redwood City, CA 94065
Telephone: (650) 206-4507
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service) ? Copies to:
Anthony W. Epps Dorsey & Whitney LLP 1400 Wewatta St #400 Denver, CO 80202 (303) 629-3400
Approximate date of commencement of proposed sale to the public: From time to time after the effective date of this registration statement. If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the
following box. ?
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, please check the following box. ?
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ?
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ?
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ?
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ?
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer ? Smaller reporting company ? Accelerated Filer ? Emerging growth company ? Non-accelerated filer ?
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ?
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, or until this registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to Section 8(a), may determine.
TABLE OF CONTENTS
PROSPECTUS
SUBJECT TO COMPLETION, DATED AUGUST 5, 2024
Up to 4,500,000 Shares of Common Stock and
This prospectus relates to the resale of 4,500,000 shares of Common Stock, par value $0.001 per share (“Common Stock”) of Rezolute, Inc. by certain selling stockholders named herein (the “Selling Stockholders”) consisting of, (i) 1,500,000 shares of Common Stock, (ii) 610,404 shares of Common Stock and (iii) 2,389,596 shares of Common Stock issuable upon the exercise of pre-funded warrants (the “Warrants”) of the Company.
The Warrants were issued pursuant to the securities exchange agreement dated March 8, 2024 between the Company and certain Selling Stockholders. The Warrants have an exercise price of $0.001 per share. We may receive proceeds from the exercise of the Warrants if the Warrants are exercised on a cash basis. 610,404 shares of Common Stock covered by this prospectus were issued a certain Selling Stockholder upon the partial exercise of the Warrants.
Certain shares of the Common Stock was issued pursuant to the securities purchase agreement dated June 25, 2024 and July 5, 2024, respectively, between the Company and certain Selling Stockholders. We will not receive any proceeds from the sale of any shares of Common Stock by the Selling Stockholders pursuant to this prospectus.
Our registration of the securities covered by this prospectus does not mean that the Selling Stockholders will offer or sell any of the shares of Common Stock. The Selling Stockholders may sell the shares of Common Stock offered by this prospectus from time to time on terms to be determined at the time of sale through ordinary brokerage transactions or through any other means described in this prospectus under the caption “Plan of Distribution.” The shares of Common Stock may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices.
Our Common Stock is listed on The Nasdaq Capital Market under the symbol “RZLT”. On July 26, 2024, the last reported sale price for our Common Stock was $4.68 per share. Each prospectus supplement to this prospectus will indicate if the securities offered thereby will be listed on any securities exchange.
Investing in our securities involves risks. You should carefully review the risks and uncertainties described under the heading “Risk Factors” beginning on page 11 of this prospectus, any applicable prospectus supplement or any related free writing prospectus, and in any documents incorporated by reference herein or therein before investing in our securities.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS
THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this prospectus is , 2024
The information in this prospectus is not complete and may be changed. We may not sell these securities
BadCuda
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REZOLUTE ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR PHASE 3 REGISTRATIONAL STUDY OF RZ358 FOR TREATMENT OF HYPOGLYCEMIA DUE TO TUMOR HYPERINSULINISM
August 05, 2024 7:30am EDT Download as PDF
Second rare disease program with RZ358 in Phase 3 development
Follows successful treatment of multiple patients with tumor hyperinsulinism
under the Company’s Expanded Access Program
REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI). The Company is initiating start-up activities for the study which will be primarily conducted in the U.S. and patient enrollment is planned to commence in the first half of 2025. Ersodetug is also being studied in an ongoing global, pivotal, Phase 3 clinical trial in patients with congenital HI. Topline data from that study is expected in mid-2025.
“Hypoglycemia associated with tumor HI requires treatment to prevent serious adverse outcomes and to improve patients’ daily function and quality of life, including enabling them to receive tumor directed therapies,” said Brian Roberts, M.D., Chief Medical Officer at Rezolute. “We are encouraged by the substantial real-world benefit we’ve witnessed in tumor HI patients who have previously received ersodetug in our Expanded Access Program, coupled with the safety and efficacy demonstrated in clinical studies in patients with congenital HI, a similar condition. We believe that the clearance of our IND for this Phase 3 study reflects FDA’s recognition of the potential for ersodetug to address this serious unmet need and we are excited to be moving one step closer to a potential universal treatment for hypoglycemia caused by all forms of HI.”
The Phase 3 registrational study is a double-blind, randomized, placebo-controlled trial of 24 participants who have inadequately controlled hypoglycemia because of tumor HI. Eligible participants will be randomized in 1:1 fashion (12 per treatment arm) to receive ersodetug 9 mg/kg per week or matched placebo, as an add-on to standard of care. Up to 24 additional participants may be enrolled into an open-label arm, in participants whose hypoglycemia is being managed by IV glucose in a hospital setting. Following a 6-week pivotal treatment period, all participants may receive ersodetug in open-label extension. The primary endpoint is the change in Level 2 (moderate) and Level 3 (severe) hypoglycemia events by self-monitored blood glucose. Additional endpoints include overall hypoglycemia events, time in hypoglycemia by continuous glucose monitor, patient reported quality of life, hospitalizations, and change in glucose requirements (for open-label hospitalized participants).
Ersodetug is a fully human monoclonal antibody that binds to an allosteric site on the insulin receptor at target tissues such as liver, fat and muscle. Ersodetug counteracts excess insulin receptor activation caused by insulin and related hormones thereby correcting hypoglycemia. Ersodetug has the potential to be universally effective at treating hypoglycemia caused by any form of HI, including congenital or acquired forms.
About Tumor Hyperinsulinism (HI)
Tumor HI is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia as a result of excessive activation of the insulin receptor. Insulinomas are the most common type of ICT and may cause hypoglycemia by stimulating the over production of insulin. A variety of different NICTs, particularly hepatocellular carcinoma, can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as IGF-2 that bind to and activate the insulin receptor. With high morbidity and mortality rates within tumor HI, there remains a significant unmet need for new therapies directed at hypoglycemia treatment. Ersodetug has shown real-world benefit in patients with insulinoma and preclinical studies have shown that ersodetug can similarly blunt IGF-2 and insulin-mediated insulin-receptor signaling.
About Rezolute, Inc.
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by HI. The Company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital HI and tumor HI.
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