Form 8-K - Current report
10 Juni 2024 - 2:00PM
Edgar (US Regulatory)
false
0001645469
0001645469
2024-06-10
2024-06-10
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): June 10, 2024
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MONOPAR THERAPEUTICS INC.
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(Exact name of registrant as specified in its charter)
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Delaware
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001-39070
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32-0463781
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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1000 Skokie Blvd., Suite 350, Wilmette, IL
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60091
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(Address of principal executive offices)
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(Zip Code)
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(847) 388-0349
Registrant’s telephone number, including area code
N/A
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, $0.001 par value
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MNPR
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The Nasdaq Stock Market LLC (Nasdaq Capital Market)
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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:
☐ Written communications 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 communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 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 June 10, 2024, Monopar Therapeutics Inc. (Monopar) issued a press release announcing a poster presentation summarizing data from the preclinical development of its novel first-in-class lead radiopharma program MNPR-101-Zr at the 2024 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Toronto, Canada.
The press release is furnished as Exhibit 99.1 to this report and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
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Exhibit No.
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Description
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
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.
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Monopar Therapeutics Inc.
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Date: June 10, 2024
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By:
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/s/ Kim R. Tsuchimoto
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Name:
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Kim R. Tsuchimoto
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Title:
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Chief Financial Officer and Director
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Exhibit 99.1
Monopar Presents Data Showcasing the Appeal of uPAR as a Radiopharma Cancer Target
and of its lead Clinical Program at the 2024 SNMMI Annual Meeting
WILMETTE, Ill, June 10, 2024 – Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, is presenting today data from the preclinical development of its novel first-in-class lead radiopharma program MNPR-101-Zr at the 2024 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Toronto, Canada. SNMMI is the premier educational, scientific, and research event in the radiopharma space. Monopar’s poster presentation can be found at the following link: https://www.monopartx.com/pipeline/mnpr-101/snmmi-poster-june-2024.
Monopar’s poster highlights the potential promise of both the urokinase plasminogen activator receptor (uPAR) as a radiopharma cancer target for solid tumors as well as MNPR-101 as a targeting agent against uPAR. The data presented demonstrate robust, durable tumor uptake of Zr-89 radiolabeled MNPR-101 (MNPR-101-Zr) in human tumor xenograft mouse models of triple-negative breast, colorectal, and pancreatic cancers. Monopar’s optimization of the MNPR-101-Zr construct achieved markedly higher tumor uptake and drug stability while minimizing accumulation in bone and healthy tissue.
Monopar recently initiated a first-in-human Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr. The study is led by internationally recognized radiopharmaceutical physician Prof. Rodney Hicks, founder of the Melbourne Theranostic Innovation Centre (MTIC). Further information about the MNPR-101-Zr trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, including Phase 1-stage MNPR-101-Zr for imaging advanced cancers and late preclinical-stage MNPR-101 radio-immuno-therapeutic (RIT) for the treatment of advanced cancers. For more information, visit: www.monopartx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: promise of both the urokinase plasminogen activator receptor (uPAR) as a radiopharma cancer target for solid tumors as well as MNPR-101 as a targeting agent against uPAR, any implied translation of data from preclinical human tumor xenograft models to human clinical data may not be realized including optimization of the MNPR-101-Zr construct in preclinical models. The forward-looking statements involve risks and uncertainties including, but not limited to: that future preclinical or clinical data will not be as promising as the data to date; not enrolling the Phase 1 clinical trial; that MNPR-101-Zr may cause unexpected serious adverse effects or fail to image; the potential for the Australian regulatory authority (HREC) to put the Phase 1 trial on clinical hold at any time; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
CONTACT:
Monopar Therapeutics Inc.
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
kimtsu@monopartx.com
Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics
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Jun. 10, 2024 |
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MONOPAR THERAPEUTICS INC.
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8-K
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Jun. 10, 2024
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| Entity, Incorporation, State or Country Code |
DE
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| Entity, File Number |
001-39070
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| Entity, Tax Identification Number |
32-0463781
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1000 Skokie Blvd.
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Suite 350
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IL
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847
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| Local Phone Number |
388-0349
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