Monopar Therapeutics 8-K, filed Aug 10, 2020
Monopar Therapeutics (MNPR)
8-K
2020-08-10
For: 2020-08-10
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on August 10, 2020.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 8.01: Other events
- 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): August 10,
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
August 10, 2020, Monopar Therapeutics Inc. (“Monopar”)
issued a press release announcing, in collaboration with NorthStar
Medical Radioisotopes, LLC (“NorthStar”), a partnership
with IsoTherapeutics Group, LLC (Angleton, TX)
(“IsoTherapeutics”), to develop and manufacture
Radio-Immuno-Therapeutics (“RITs”) for the potential
treatment of severe COVID-19. IsoTherapeutics will modify
Monopar’s proprietary urokinase plasminogen activator
receptor (“uPAR”) targeted antibody, MNPR-101, by
making conjugates that will allow the attachment of therapeutic
radioisotopes supplied by NorthStar, creating a platform of
uPAR-targeted RIT (“uPRIT”) candidates to be evaluated
as treatments for severe COVID-19.
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: August
10, 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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Monopar and NorthStar Partner with IsoTherapeutics for the
Manufacturing of Potential Therapeutic for Severe
COVID-19
WILMETTE, IL, BELOIT, WI, and ANGLETON, TX, August 10, 2020
- Monopar Therapeutics Inc. (Nasdaq: MNPR)(Wilmette, IL) and
NorthStar Medical Radioisotopes, LLC (Beloit, WI), who are
collaborating on the development of Radio-Immuno-Therapeutics
(RITs) to treat patients with severe COVID-19, today announced a
partnership with IsoTherapeutics Group, LLC (Angleton, TX), to
develop and manufacture a RIT for the potential treatment of severe
COVID-19.
IsoTherapeutics
will modify Monopar’s proprietary urokinase plasminogen
activator receptor (uPAR) targeted antibody, MNPR-101, by making
conjugates that will allow the attachment of therapeutic
radioisotopes supplied by NorthStar, creating a platform of
uPAR-targeted RIT (uPRIT) candidates to be evaluated as treatments
for severe COVID-19. The plan is for IsoTherapeutics to then
advance a clinical candidate identified from this platform through
GMP manufacturing for Monopar and NorthStar to take into its first
in human trials.
Recent
publications have implicated uPAR-expressing immune cells in the
development of severe lung injury, multiple organ failure, and
death in severe COVID-19 patients. “A treatment that
specifically targets and eradicates these over-activated immune
cells could significantly improve patient outcomes in severe
COVID-19,” said Andrew Mazar, Ph.D., Chief Scientific Officer
of Monopar.
“We
are excited to partner with Monopar and NorthStar,” said Jim
Simón, Ph.D., Chief Scientific Officer of IsoTherapeutics.
“A uPAR-targeted RIT has great therapeutic potential, and we
are proud to contribute our expertise in radiopharmaceutical
research and manufacturing to ensure its rapid and effective
development.”
James
T. Harvey, Ph.D., Senior Vice President and Chief Science Officer
of NorthStar, said “We have successfully worked with
IsoTherapeutics on a previous project that led to an FDA approval,
and we value their expertise. This is a crucial step in the
development of a uPRIT for severe COVID-19.”
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.
About NorthStar Medical Radioisotopes, LLC
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.
About IsoTherapeutics Group, LLC
IsoTherapeutics
Group is a radiopharmaceutical company that provides research and
development services, including animal studies and early stage
manufacturing for the purpose of aiding customers and collaborators
in the development of radionuclide-based drug and device products.
IsoTherapeutics scientists hold over 100 patents for novel
chemistry and radiopharmaceutical formulations. For more
information, visit: http://isotherapeutics.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 IsoTherapeutics’ ability to
create a platform of uPAR-targeted RIT (uPRIT) candidates based
upon MNPR-101 and a therapeutic radioisotope from NorthStar;
IsoTherapeutics’ ability to advance a clinical candidate
identified from this platform through GMP manufacturing for Monopar
and NorthStar to take into its first in human trials; that a
treatment that specifically targets and eradicates these
over-activated immune cells could significantly improve patient
outcomes in severe COVID-19; that a uPAR-targeted RIT has great
therapeutic potential; and that IsoTherapeutics’ expertise in
radiopharmaceutical research and manufacturing will ensure rapid
and effective development of uPRIT candidates. The forward-looking
statements involve risks and uncertainties including, but not
limited to, the lack of any clinical activities to date with
respect to MNPR-101 and that preclinical 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, IsoTherapeutics
not being able to couple MNPR-101 to a therapeutic radioisotope,
the conjugate not being able to kill aberrantly activated
cytokine-producing immune cells, the conjugate not being able to
use uPAR to gain entry into these cells and deliver cytotoxic
payload to kill these cells while sparing normal 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. 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, NorthStar and
IsoTherapeutics 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,
NorthStar’s and IsoTherapeutics’ 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
For IsoTherapeutics Group, LLC.:
Lance
Cooper
Director
of Business Development
lancecooper@isotherapeutics.com