• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI SuperconnectorNEW
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI SuperconnectorNEW
  • Settings
  • RSS Feeds
PublishGo to AppAI Superconnector
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlertsPublish with Us
    Company
    AboutQuantisnow PlusContactJobsAI superconnector for talent & startupsNEW
    Legal
    Terms of usePrivacy policyCookie policy

    Rezolute Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits

    7/18/25 6:04:28 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $RZLT alert in real time by email
    false 0001509261 0001509261 2025-07-15 2025-07-15 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

     

     

     

    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): July 15, 2025

     

     

    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 7.01 Regulation FD Disclosure.

     

    On July 15, 2025, Rezolute, Inc. (the “Company”) posted a patient demographic poster related to the Company’s Phase 3 clinical study (sunRIZE). The poster is available on the Company’s website at https://rezolutebio.com/wp-content/uploads/2025/07/ENDO-Poster_Final_10July2025.pdf, and a copy of the poster is included as Exhibit 99.1 hereto.

     

    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 poster 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.

     

    Item 9.01Financial Statements and Exhibits.

     

    (d) Exhibits.

     

    Exhibit No.   Description
    99.1   Patient Demographic Poster for Phase 3 Clinical Study
    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:  July 18, 2025 By: /s/ Nevan Charles Elam
       

    Nevan Charles Elam
    Chief Executive Officer

     

     

     

    Get the next $RZLT alert in real time by email

    Crush Q3 2025 with the Best AI Superconnector

    Stay ahead of the competition with Standout.work - your AI-powered talent-to-startup matching platform.

    AI-Powered Inbox
    Context-aware email replies
    Strategic Decision Support
    Get Started with Standout.work

    Recent Analyst Ratings for
    $RZLT

    DatePrice TargetRatingAnalyst
    11/5/2024$12.00Outperform
    Wedbush
    8/27/2024$11.00Buy
    Guggenheim
    7/17/2024$13.00Buy
    BTIG Research
    6/4/2024$14.00Buy
    Craig Hallum
    4/9/2024$8.00Buy
    Maxim Group
    8/2/2022$17.00Buy
    Canaccord Genuity
    6/15/2022$9.00Overweight
    Cantor Fitzgerald
    11/29/2021$30.00 → $17.00Buy
    Canaccord Genuity
    More analyst ratings

    $RZLT
    SEC Filings

    View All

    Rezolute Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Leadership Update, Regulation FD Disclosure, Financial Statements and Exhibits

    8-K - Rezolute, Inc. (0001509261) (Filer)

    8/20/25 6:06:33 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form EFFECT filed by Rezolute Inc.

    EFFECT - Rezolute, Inc. (0001509261) (Filer)

    8/11/25 12:15:18 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Amendment: SEC Form SCHEDULE 13G/A filed by Rezolute Inc.

    SCHEDULE 13G/A - Rezolute, Inc. (0001509261) (Subject)

    8/6/25 12:11:01 PM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $RZLT
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    View All

    Chief Medical Officer Roberts Brian Kenneth bought $10,939 worth of shares (2,500 units at $4.38), increasing direct ownership by 19% to 15,500 units (SEC Form 4)

    4 - Rezolute, Inc. (0001509261) (Issuer)

    6/26/25 9:07:55 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    CFO Evans Daron bought $20,250 worth of shares (5,000 units at $4.05), increasing direct ownership by 2% to 268,900 units (SEC Form 4)

    4 - Rezolute, Inc. (0001509261) (Issuer)

    6/24/25 12:41:19 PM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Director Kim Young-Jin bought $3,999,999 worth of shares (1,230,769 units at $3.25) (SEC Form 4)

    4 - Rezolute, Inc. (0001509261) (Issuer)

    6/23/25 9:38:51 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $RZLT
    Insider Purchases

    Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

    View All

    Chief Medical Officer Roberts Brian Kenneth bought $10,939 worth of shares (2,500 units at $4.38), increasing direct ownership by 19% to 15,500 units (SEC Form 4)

    4 - Rezolute, Inc. (0001509261) (Issuer)

    6/26/25 9:07:55 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    CFO Evans Daron bought $20,250 worth of shares (5,000 units at $4.05), increasing direct ownership by 2% to 268,900 units (SEC Form 4)

    4 - Rezolute, Inc. (0001509261) (Issuer)

    6/24/25 12:41:19 PM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Director Kim Young-Jin bought $3,999,999 worth of shares (1,230,769 units at $3.25) (SEC Form 4)

    4 - Rezolute, Inc. (0001509261) (Issuer)

    6/23/25 9:38:51 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $RZLT
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    View All

    Wedbush initiated coverage on Rezolute with a new price target

    Wedbush initiated coverage of Rezolute with a rating of Outperform and set a new price target of $12.00

    11/5/24 6:25:51 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Guggenheim initiated coverage on Rezolute with a new price target

    Guggenheim initiated coverage of Rezolute with a rating of Buy and set a new price target of $11.00

    8/27/24 7:36:43 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    BTIG Research initiated coverage on Rezolute with a new price target

    BTIG Research initiated coverage of Rezolute with a rating of Buy and set a new price target of $13.00

    7/17/24 7:55:53 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $RZLT
    Leadership Updates

    Live Leadership Updates

    View All

    Rezolute Appoints Seasoned Commercial Executive Sunil Karnawat as Chief Commercial Officer

    REDWOOD CITY, Calif., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced the appointment of Sunil Karnawat as Chief Commercial Officer, effective August 18, 2025. "We're thrilled to welcome Sunil to our leadership team at such a pivotal point as we advance ersodetug through Phase 3 studies for both congenital and tumor hyperinsulinism," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "His proven track record of successfully bringing therapies to patients across multiple therapeutic areas, including four ultr

    8/20/25 7:30:00 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Rezolute Reports Third Quarter Fiscal 2025 Financial Results and Provides Business Update

    sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended March 31, 2025. "The Phase 3 sunRIZE study in congenital HI is on track to complete enrollment this month and we are p

    5/13/25 4:05:00 PM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Rezolute Announces Appointment of Rare Disease Commercial Leader Erik Harris to its Board of Directors

    REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, announced the appointment of Erik Harris to its Board of Directors, effective immediately. Mr. Harris, who currently serves as Chief Commercial Officer and Executive Vice President at Ultragenyx, brings more than 20 years of biopharmaceutical expertise to Rezolute. "We are thrilled to welcome Erik to our board. He is a recognized rare disease commercial expert, and his insights will be invaluable as we advance our lead programs through clinical development and prepare for p

    3/26/25 7:30:00 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $RZLT
    Press Releases

    Fastest customizable press release news feed in the world

    View All

    Rezolute Appoints Seasoned Commercial Executive Sunil Karnawat as Chief Commercial Officer

    REDWOOD CITY, Calif., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced the appointment of Sunil Karnawat as Chief Commercial Officer, effective August 18, 2025. "We're thrilled to welcome Sunil to our leadership team at such a pivotal point as we advance ersodetug through Phase 3 studies for both congenital and tumor hyperinsulinism," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "His proven track record of successfully bringing therapies to patients across multiple therapeutic areas, including four ultr

    8/20/25 7:30:00 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Rezolute to Participate in the BTIG Virtual Biotechnology Conference

    REDWOOD CITY, Calif., July 22, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced that management will participate in the BTIG Virtual Biotechnology Conference, taking place July 29-30, 2025. Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their BTIG representative. About Rezolute, Inc. Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia c

    7/22/25 7:30:00 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Rezolute Announces Presentation of Participant Baseline Data from its Fully Enrolled Phase 3 Study of Ersodetug in Congenital Hyperinsulinism at the Upcoming Annual Meeting of the Endocrine Society (ENDO 2025)

    REDWOOD CITY, Calif., July 09, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced that the abstract titled "Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress" has been selected for a late-breaking presentation at ENDO 2025 taking place July 12-15, 2025 in San Francisco, CA, USA. "We are excited to share baseline data from the sunRIZE study, which will offer important insights into this population and its comparabilit

    7/9/25 7:30:00 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $RZLT
    Financials

    Live finance-specific insights

    View All

    Rezolute Reports Second Quarter Fiscal 2024 Results and Provides Business Update

    Phase 3 clinical study of RZ358 underway in patients with congenital hyperinsulinism (cHI); topline results expected in mid-2025 Benefit shown in individual patient cases with RZ358 for tumor-associated hyperinsulinism (taHI) under Expanded Access Program (EAP); drives alignment with FDA on unmet need and potential to move into late-stage clinical development to further evaluate RZ358 in this population REDWOOD CITY, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial re

    2/13/24 4:05:00 PM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Rezolute Reports First Quarter Fiscal 2024 Results

    REDWOOD CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial results for the first quarter of fiscal 2024 ended September 30, 2023. "We are on track to commence our Phase 3 study for RZ358 to treat congenital hyperinsulinism prior to year-end and are delighted to have recently obtained PRIME eligibility from the European Medicines Agency for this indication," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We also anticipate completing enrollment this quarter for our o

    11/13/23 4:05:00 PM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Rezolute Reports Full Year Fiscal 2023 Results and Highlights Company Progress

    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 20

    9/14/23 4:05:00 PM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $RZLT
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    View All

    Amendment: SEC Form SC 13G/A filed by Rezolute Inc.

    SC 13G/A - Rezolute, Inc. (0001509261) (Subject)

    11/14/24 6:59:50 PM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Amendment: SEC Form SC 13G/A filed by Rezolute Inc.

    SC 13G/A - Rezolute, Inc. (0001509261) (Subject)

    11/14/24 10:04:23 AM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Amendment: SEC Form SC 13G/A filed by Rezolute Inc.

    SC 13G/A - Rezolute, Inc. (0001509261) (Subject)

    11/13/24 5:31:40 PM ET
    $RZLT
    Biotechnology: Pharmaceutical Preparations
    Health Care