Monopar Therapeutics 8-K, filed Jun 30, 2020
Monopar Therapeutics (MNPR)
8-K
2020-06-30
For: 2020-06-30
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on June 30, 2020.
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): June 30,
2020
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 June 30, 2020, Monopar Therapeutics Inc.
(“Monopar”) issued a press
release announcing that, in collaboration with NorthStar Medical
Radioisotopes, LLC, a provisional patent application entitled
“Precision Radioimmunotherapeutic Targeting of the Urokinase
Plasminogen Activator Receptor (uPAR) for Treatment of Severe
COVID-19 Disease” has been filed with the U.S. Patent and
Trademark Office. This application covers novel compositions and
uses of cytotoxic radioisotopes attached to antibodies that bind to
uPAR, thereby creating precision targeted radiotherapeutics for the
treatment of severe COVID-19 and other respiratory
diseases.
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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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 30,
2020
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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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 |
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Monopar and NorthStar Announce Filing of Provisional Patent
Protecting Development and Use of Radio-Immuno-Therapeutics (RITs)
Targeting Severe COVID-19 Through uPAR
Chicago, IL and Beloit, WI, June 30, 2020
- Monopar Therapeutics Inc. (Nasdaq:
MNPR) (Chicago, IL) and NorthStar Medical Radioisotopes, LLC
(Beloit, WI) announced today that a provisional patent application
entitled “Precision Radioimmunotherapeutic Targeting of the
Urokinase Plasminogen Activator Receptor (uPAR) for Treatment of
Severe COVID-19 Disease” has been filed with the U.S. Patent
and Trademark Office (USPTO).
This application covers novel compositions and uses of cytotoxic
radioisotopes attached to antibodies that bind to uPAR, thereby
creating precision targeted radiotherapeutics (uPRITs) for the
treatment of severe COVID-19 and other respiratory diseases.
Advanced COVID-19 patients frequently develop severe,
life-threatening, pulmonary inflammation as a result of a viral
induced cytokine storm. The development of this cytokine storm is
associated with a high rate of mortality in severe COVID-19
patients, even with oxygen support and mechanical ventilation.
uPRITs have been designed with the goal of selectively destroying
the aberrantly activated white blood cells responsible for causing
the cytokine storm. If successful, healthy tissue would be spared
in the process as the uPAR target is primarily only present on this
unique class of white blood cells and not in healthy tissue. The
co-inventors of the provisional patent application are James
Harvey, Chief Scientific Officer of NorthStar, and Andrew P. Mazar,
Chief Scientific Officer of Monopar.
If granted, the patent would offer exclusivity to Monopar and
NorthStar for the development and potential use of uPRITs in the
treatment of severe COVID-19 and other respiratory diseases. This
provisional patent application leverages the therapeutic
radioisotope expertise of NorthStar and the translational expertise
of Monopar to create a novel, targeted radioimmunotherapeutic. On
June 16, 2020, Monopar and NorthStar announced a 50/50
collaboration to couple Monopar’s MNPR-101 uPAR targeting
monoclonal antibody to a therapeutic radioisotope provided by
NorthStar.
About Monopar Therapeutics Inc. (Monopar)
Monopar
Therapeutics is a clinical-stage biopharmaceutical company 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 preclinical stage uPAR targeted antibody
MNPR-101 for advanced cancers and severe COVID-19. For more
information, visit: www.monopartx.com.
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar
Medical Radioisotopes is a global innovator in the production and
distribution of radioisotopes used for medical imaging and
therapeutic purposes. NorthStar is a company committed to providing
the United States with reliable and environmentally friendly
radioisotope supply solutions to meet the needs of patients and to
advance clinical research. The Company’s first product is the
RadioGenix® System (technetium Tc 99m generator), an
innovative and flexible platform technology initially approved by
the U.S. Food and Drug Administration in February 2018. For more
information, visit: www.northstarnm.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 collaboration’s ability to
create precision targeted radiotherapeutics (uPRITs) for the
treatment of severe COVID-19 and other respiratory diseases; and
that the patent may be granted. The forward-looking statements
involve risks and uncertainties including, but not limited to,
whether or not the patent will be granted, the lack of any clinical
activities to date with respect to MNPR-101 and that pre-clinical
development activities to date have been focused on the treatment
of cancers, the requirement for additional capital to complete
preclinical and clinical development, and if successful,
commercialization, not being able to couple MNPR-101 to a
therapeutic radioisotope, the uPRITs may not selectively destroy
the aberrantly activated white blood cells responsible for causing
the cytokine storm while sparing healthy tissue, not being able to
ensure
volumes of this radioisotope can be manufactured and scaled up to
meet potential demand, uncertainties about levels of demand if and
when a treatment is available for commercialization and the
significant general risks and uncertainties surrounding the
research, development, regulatory approval and commercialization of
therapeutics. Actual results may differ materially from
those expressed or implied by such forward-looking statements.
Monopar and NorthStar are not making any express or implied claims
that uPRITs have the ability to eliminate or mitigate severe
COVID-19 at this time. 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 and NorthStar
undertake 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 and NorthStar’s views only
as of the date hereof and should not be relied upon as representing
its views as of any subsequent date.
CONTACTS:
For Monopar Therapeutics Inc.:
Investor
Relations:
Kim R.
Tsuchimoto
Chief
Financial Officer
kimtsu@monopartx.com
For NorthStar Medical Radioisotopes, LLC
Investor
Relations:
Paul
Estrem
Senior
Vice President and Chief Financial Officer
pestrem@northstarnm.com
Corporate:
Lisa Holst
Vice President Sales and Marketing
678-471-9027
lholst@northstarnm.com
Media:
Priscilla Harlan
781-799-7917
pharlan@shiningrockllc.com