Monopar Therapeutics 8-K, filed Mar 30, 2021
Monopar Therapeutics (MNPR)
8-K
2021-03-30
For: 2021-03-30
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on March 30, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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): March 30, 2021
MONOPAR
THERAPEUTICS INC.
(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 60091
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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 March 30, 2021, Monopar Therapeutics Inc.
(“Monopar”) issued a press release announcing
the publication
of a peer-reviewed study
titled “Engineered Antibody Fragment
against the Urokinase Plasminogen Activator for Fast Delineation of
Triple-Negative Breast Cancer by Positron Emission
Tomography.”
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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99.1
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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: March 30,
2021
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By:
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/s/
Kim
R. Tsuchimoto
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Name: Kim
R. Tsuchimoto
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Title:
Chief
Financial Officer, Secretary and Treasurer
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Monopar’s uPA Antibody Fragment
Radiotracer Shows Potential for PET Imaging of Breast Cancer in
Preclinical Study
WILMETTE, Ill., March 30, 2021 -- Monopar Therapeutics Inc.
(Nasdaq: MNPR), a clinical-stage biopharmaceutical company
primarily focused on developing proprietary therapeutics designed
to extend life or improve the quality of life for cancer patients,
today announced the publication of
a peer-reviewed study titled “Engineered Antibody Fragment against the
Urokinase Plasminogen Activator for Fast Delineation of
Triple-Negative Breast Cancer by Positron Emission
Tomography.” Urokinase plasminogen activator (uPA) is
an established biomarker in current breast cancer clinical practice
guidelines and its presence is used to select appropriate drug
treatment. This study demonstrates the potential to identify breast
cancers with uPA overexpression and monitor uPA activity during
treatment using PET imaging and Monopar’s uPA antibody
fragment radiotracer. Monopar has a panel of proprietary antibodies
and antibody fragments to uPA and its receptor uPAR (such as
MNPR-101).
uPA and
its receptor uPAR work together to drive aggressive tumor invasion,
leading to metastasis, morbidity, and mortality in breast and other
cancers. However, uPA is difficult to measure and currently
requires a substantial amount of fresh frozen tissue.
Monopar’s antibody fragment (ATN-291 F(ab’)2) conjugated to a
copper radiotracer enabled rapid PET visualization of tumors with
uPA overexpression in a human breast cancer model in mice. PET
imaging may expand the current application of uPA as a breast
cancer biomarker and enable the monitoring of tumor uPA expression
during treatment.
“The
publication demonstrates the potential utility of Monopar’s
uPA antibody fragments as imaging agents in a model of aggressive
triple negative breast cancer,” said Andrew Mazar, PhD, Chief
Scientific Officer of Monopar and a co-author of the study.
“Same-day PET imaging may guide treatment decisions for
breast cancer, and potentially other solid cancers, given the
established role of uPA in this disease.”
“We
are pleased with the results of this peer-reviewed study,”
said Chandler Robinson, MD, Chief Executive Officer of Monopar,
“and we look forward to exploring the potential of our
versatile panel of uPA/uPAR targeted monoclonal antibodies in
cancer imaging, cancer treatment, and other possible
applications.”
About Monopar Therapeutics Inc.
Monopar
Therapeutics is a clinical-stage biopharmaceutical company
primarily focused on developing proprietary therapeutics designed
to extend life or improve the quality of life for cancer patients.
Monopar's pipeline consists of Validive® for the prevention of
chemoradiotherapy-induced severe oral mucositis in oropharyngeal
cancer patients; camsirubicin for the treatment of advanced soft
tissue sarcoma; and a late-stage preclinical antibody, MNPR-101,
for advanced cancers and severe COVID-19. 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 the potential for same-day PET
imaging of breast cancer, including aggressive triple negative
breast cancer, using Monopar’s uPA-targeted antibody fragment
(ATN-291 F(ab’)2), whether PET
imaging may expand the current application of uPA as a biomarker
for breast cancer and enable the monitoring of tumor uPA expression
during treatment, and the potential of Monopar’s versatile
panel of uPA/uPAR targeted monoclonal antibodies in cancer imaging,
cancer treatment, and other possible applications. The
forward-looking statements involve risks and uncertainties
including, but not limited to: the lack of any clinical activities
to date with respect to Monopar’s uPA targeted antibody
fragments; that Monopar’s MNPR-101 and related compound
preclinical development activities to date have been focused on the
treatment of cancers and not imaging medical devices; the
requirement for additional capital to complete preclinical and
clinical development of a medical device utilizing Monopar’s
uPA antibody fragments, and if successful, commercialization; if
funding is available, not being able to successfully develop
Monopar’s antibody fragments for use as uPA imaging agents in
triple negative breast cancer detection, or any other uses or
indications; not being able to ensure volumes of ATN-291
F(ab’) 2) conjugates or
its derivatives can be manufactured and scaled up to meet potential
demand; uncertainties about levels of demand if and when a medical
device is available for commercialization and the significant
general risks and uncertainties surrounding the research,
development, regulatory approval and commercialization of medical
devices. 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