0001104659-23-100787.txt : 20230914 0001104659-23-100787.hdr.sgml : 20230914 20230914161021 ACCESSION NUMBER: 0001104659-23-100787 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230914 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230914 DATE AS OF CHANGE: 20230914 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Rezolute, Inc. CENTRAL INDEX KEY: 0001509261 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 273440894 STATE OF INCORPORATION: NV FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39683 FILM NUMBER: 231255218 BUSINESS ADDRESS: STREET 1: 275 SHORELINE DRIVE, SUITE 500 CITY: REDWOOD CITY STATE: CA ZIP: 94065 BUSINESS PHONE: 650-206-4507 MAIL ADDRESS: STREET 1: 275 SHORELINE DRIVE, SUITE 500 CITY: REDWOOD CITY STATE: CA ZIP: 94065 FORMER COMPANY: FORMER CONFORMED NAME: AntriaBio, Inc. DATE OF NAME CHANGE: 20130114 FORMER COMPANY: FORMER CONFORMED NAME: FITS MY STYLE INC DATE OF NAME CHANGE: 20110104 8-K 1 tm2325841d1_8k.htm FORM 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): September 14, 2023

 

 

 

REZOLUTE, INC.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Nevada   001-39683   27-3440894

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

275 Shoreline Drive, Suite 500, Redwood City, CA 94065

(Address of Principal Executive Offices, and Zip Code)

 

650-206-4507

Registrant’s Telephone Number, Including Area Code

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report) 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

  ¨ Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ¨ Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  ¨ Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 per share RZLT Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

Emerging growth company ¨

 

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 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On September 14, 2023, Rezolute, Inc. issued a press release announcing its financial results for the fourth quarter and fiscal year ended June 30, 2023. A copy of this press release is attached hereto as Exhibit 99.1.

 

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.

 

Item 9.01Financial Statements and Exhibits.

 

(d)Exhibits.

 

Exhibit No.   Description
99.1   Press Release, dated September 14, 2023
104   Cover Page Interactive Data File (formatted as inline XBRL)

 

   

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  REZOLUTE, INC.
     
     
DATE:  September 14, 2023 By: /s/Nevan Charles Elam
   

Nevan Charles Elam

Chief Executive Officer 

 

   

 

EX-99.1 2 tm2325841d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

Rezolute Reports Full Year Fiscal 2023 Results and Highlights Company Progress

 

Planning to initiate Phase 3 Study for RZ358 (“sunRIZE study”) in the fourth quarter of 2023

 

REDWOOD CITY, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt treatment paradigms for devastating metabolic diseases, today announced its financial results for the fourth quarter and full fiscal year ended June 30, 2023.

 

“We are delighted that we are poised to initiate sunRIZE -- our Phase 3 study of RZ358, which we hope will bring us one step closer to making this therapy available to patients and their families suffering from congenital hyperinsulinism. We are also anticipating results from our Phase 2 study of RZ402 in the first quarter of 2024, where we hope to demonstrate the safety and proof-of-concept of our oral therapy for diabetic macular edema,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “As we look ahead to these upcoming milestones, we remain committed to our mission of delivering transformative therapies to patients with devastating metabolic diseases.”

 

Corporate and Clinical Highlights

 

·RZ358, monoclonal antibody for the treatment of congenital hyperinsulinism (HI)

·Following the successful Phase 2b RIZE study of RZ358 in congenital HI, which demonstrated that RZ358 safely and substantially improved hypoglycemia, the Company plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outside the US in Q4 2023. Topline results from the sunRIZE study are expected in the first half of 2025.

·RZ402, oral plasma kallikrein inhibitor to treat diabetic macular edema (DME)

·In December 2022, Rezolute announced the initiation of a Phase 2 study of RZ402 in patients with DME. This is a multi-center, randomized, double-masked, placebocontrolled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections. Study enrollment is ongoing, and the Company anticipates topline results from this study in the first quarter of 2024.

 

Fourth Quarter and Full Year Fiscal 2023 Financial Results

 

·Cash and cash equivalents totaled $16.0 million and investments in marketable debt securities totaled $102.3 million as of June 30, 2023.

 

 

 

 

 

·Research and development (R&D) expenses were $10.9 million for the fourth quarter of fiscal 2023, compared to $8.6 million for the same period in fiscal 2022. Full fiscal year 2023 R&D expenses were $43.8 million, compared to $32.5 million in fiscal year 2022. The increase from fiscal year 2022 to fiscal year 2023 was primarily due to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses, which included employee compensation and stock-based compensation.

 

·General and administrative (G&A) expenses were $3.3 million for the fourth quarter of fiscal 2023, compared to $2.7 million for the same period in fiscal 2022. Full fiscal year 2023 G&A expenses were $12.2 million, compared to $9.4 million in fiscal year 2022. The increase from fiscal year 2022 to fiscal year 2023 was primarily due to higher personnel-related expenses, including employee compensation and stock-based compensation.

 

·Net loss was $12.7 million for the fourth quarter of fiscal 2023, compared to $9.4 million for the same period in fiscal 2022. Full year fiscal 2023 net loss was $51.8 million compared to net loss of $41.1 million for the fiscal year 2022.

 

About Rezolute, Inc.

 

Rezolute strives to disrupt current treatment paradigms by developing transformative therapies for devastating rare and chronic metabolic diseases. Its novel therapies hold the potential to both significantly improve outcomes and reduce the treatment burden for patients, the treating physician, and the healthcare system. Patient, clinician, and advocate voices are integrated in the Company’s drug development process, enabling Rezolute to boldly address a range of severe conditions. Rezolute is steadfast in its mission to create profound, positive, and lasting impact on patients’ lives. The Company’s lead clinical asset, RZ358, is in late-stage development for the treatment of congenital hyperinsulinism, a rare pediatric endocrine disorder. Rezolute is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema. For more information, visit www.rezolutebio.com or follow us on Twitter or LinkedIn.

 

Forward-Looking Statements

 

The information provided herein contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. The “forward-looking statements” include, but are not limited to, statements regarding receiving results from the Phase 2 study of RZ402 in the first quarter of 2024, the ability of RZ358 to treat congenital hyperinsulinism, the timing of the release topline results from sunRIZE, and our ability to meet trial enrollment goals.

 

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Rezolute’s current beliefs, expectations and assumptions regarding the future of its businesses, results of and timing of clinical trials, financial condition and results of operations, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Rezolute’s control. Rezolute’s actual results including the timing and results of clinical trials may differ materially from those indicated in the forward-looking statements. Therefore, you should not place undue reliance on any of these forward-looking statements. Important factors that could cause Rezolute’s actual results including the timing and results of clinical trials to differ materially from those indicated in the forward-looking statements are discussed or identified in Rezolute’s filings made with the U.S. Securities and Exchange Commission. Any forward-looking statements made by Rezolute in this information are based only on information currently available to Rezolute and speak only as of the date on which the statement is made. Rezolute undertakes no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise except as required by applicable law.

 

 

 

 

 

Investor:

Kimberly Minarovich

Argot Partners

rezolute@argotpartners.com

212-600-1902

 

Media:

media-relations@rezolutebio.com

 

 

 

 

 

Rezolute, Inc.

Condensed Consolidated Financial Statements Data

(in thousands, except per share data)

 

   Three Months Ended   Year Ended 
   June 30,   June 30, 
   2023   2022   2023   2022 
Condensed Consolidated Statements of Operations Data:                    
                     
Operating expenses:                    
Research and development  $10,933   $8,574   $43,813   $32,486 
General and administrative   3,305    2,725    12,177    9,357 
Total operating expenses   14,238    11,299    55,990    41,843 
Loss from operations   (14,238)   (11,299)   (55,990)   (41,843)
Non-operating income (expense), net   1,510    1,876    4,203    783 
Net loss  $(12,728)  $(9,423)  $(51,787)  $(41,060)
                     
Net loss per common share                    
Basic  $(0.25)  $(0.30)  $(1.01)  $(2.26)
Diluted  $(0.25)  $(0.37)  $(1.01)  $(2.32)
                     
Weighted average number of common shares outstanding:                    
Basic   51,410    31,429    51,188    18,197 
Diluted   51,410    36,302    51,188    19,487 

 

   June 30,   June 30, 
   2023   2022 
Condensed Consolidated Balance Sheets Data:          
Cash and cash equivalents  $16,036   $150,410 
Investments in marketable debt securities   102,330    - 
Working capital   99,710    149,642 
Total assets   123,721    152,420 
Accumulated deficit   (260,984)   (209,198)
Total stockholders’ equity   123,721    149,471 

 

 

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Cover
Sep. 14, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Sep. 14, 2023
Entity File Number 001-39683
Entity Registrant Name REZOLUTE, INC.
Entity Central Index Key 0001509261
Entity Tax Identification Number 27-3440894
Entity Incorporation, State or Country Code NV
Entity Address, Address Line One 275 Shoreline Drive
Entity Address, Address Line Two Suite 500
Entity Address, City or Town Redwood City
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94065
City Area Code 650
Local Phone Number 206-4507
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol RZLT
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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