Monopar Therapeutics 8-K, filed Jun 16, 2020
Monopar Therapeutics (MNPR)
8-K
2020-06-16
For: 2020-06-16
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on June 16, 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): June 16,
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 16, 2020, Monopar Therapeutics Inc.
(“Monopar”) issued a press
release annoucing a development collaboration with NorthStar
Medical Radioisotopes, LLC to research and develop potential
Radio-Immuno-Therapeutics (“RITs”) to treat severe
COVID-19 (patients with SARS-CoV-2).
The
press release is furnished as Exhibit 99.1 to this report and
incorporated herein by reference.
Item 8.01 Other Information
On June
15, 2020, Monopar executed a development collaboration agreement
with NorthStar Medical Radioisotopes, LLC
(“NorthStar”), a privately-held commercial producer and
supplier of medical radioisotopes based in Beloit, Wisconsin to
develop a potential treatment for severe COVID-19.
The
agreement combines NorthStar’s medical radioisotope expertise
with Monopar’s expertise in therapeutic drug development and
its pre-IND stage humanized urokinase plasminogen activator
receptor (“uPAR”) targeted monoclonal antibody known as
MNPR-101, along with a proprietary portfolio of related monoclonal
antibodies that target uPAR or its ligand uPA.
Each
company will start out sharing development costs 50/50, and the
initial financial commitment for each company is nominal.
Additional financial contributions will be subject to mutual
agreement of the parties. Each party will retain all existing
intellectual property rights and will grant the other party a
royalty-free, non-exclusive license to the intellectual property
necessary to perform the development activities contemplated by the
agreement. Intellectual property developed in the course of
performance of the agreement that relates to the targeted product
would be jointly owned.
The
agreement provides an initial framework for design and development
activities. It is expected that the first several months of the
collaboration will focus on identifying the linker and radioisotope
to conjugate to MNPR-101 or other Monopar antibodies. Additional
capital would be required to complete preclinical and clinical
development, and if successful, commercialization. If the research
is successful, the agreement provides that the companies would
negotiate a commercialization plan at that time, including the
ongoing contributions of each company and respective revenue
sharing.
The
agreement has a ten-year term, but either party may terminate the
agreement upon 30 days’ written notice.
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 16,
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 Join Forces to Develop
Radio-Immuno-Therapeutics (RITs) Targeting Severe
COVID-19
Chicago, IL and Beloit, WI, June 16, 2020 - Monopar
Therapeutics Inc. (Nasdaq: MNPR) (Chicago, IL) and NorthStar
Medical Radioisotopes, LLC (Beloit, WI) announced today a 50/50
collaboration to develop potential Radio-Immuno-Therapeutics (RITs)
to treat severe COVID-19 (patients with SARS-CoV-2 infection).
Monopar is a clinical-stage biopharmaceutical company and NorthStar
is a commercial producer and supplier of medical radioisotopes.
This collaboration combines NorthStar’s expertise in the
innovative production, supply, and distribution of important
medical radioisotopes with Monopar’s expertise in therapeutic
drug development and its pre-IND stage humanized urokinase
plasminogen activator receptor (uPAR) targeted monoclonal antibody
known as MNPR-101, along with a proprietary portfolio of related
monoclonal antibodies that target uPAR or its ligand
uPA.
The uPA
system (comprised of the serine protease enzyme uPA and its
receptor uPAR) has been demonstrated to be selectively expressed on
aberrantly activated immune cells. In response to coronavirus
infection, these rogue immune cells produce pro-inflammatory
cytokines that can cause runaway inflammation throughout the body,
commonly referred to as a cytokine storm. It is this systemic
hyper-inflammatory state that is thought to be largely responsible
for the severe lung injury and further multiple organ damage that
contributes to poor outcomes and death in patients with severe
COVID-19.
In this
collaboration, Monopar and NorthStar plan to couple MNPR-101 to a
therapeutic radioisotope supplied by NorthStar in order to create a
highly selective agent that has the potential to kill aberrantly
activated cytokine-producing immune cells. By eradicating these
cells with a targeted RIT, the goal is to spare healthy cells while
quickly reducing the cytokine storm and its harmful systemic
effects.
“This
collaboration is a powerful combination of unique scientific and
technical expertise to help combat severe COVID-19,” said
Chandler Robinson, MD, CEO of Monopar Therapeutics. “The
companies will be conducting a development program to determine if
Monopar’s uPA/uPAR monoclonal antibodies can be transformed
into RITs that are effective as treatments against severe COVID-19,
as well as other corona viruses.”
“We
are pleased to work together with Monopar in the battle against
COVID-19,” said Stephen Merrick, CEO of NorthStar Medical
Radioisotopes.” Our hope is that, by joining forces, we can
develop a targeted radiopharmaceutical treatment that has the
ability to prevent patients with severe COVID-19 from being placed
on ventilators and from dying.”
“To
help mitigate the cytokine storm and reduce deaths associated with
COVID-19, our goal is to develop an RIT that selectively eliminates
the rogue aberrantly activated immune cells that produce these
cytokines,” said Andrew Mazar, PhD, Chief Scientific Officer
of Monopar. “uPAR is selectively expressed on these rogue
immune cells but not on healthy cells. An antibody carrying a
therapeutic radioisotope could gain entry into these cells through
uPAR and deliver its cytotoxic payload to kill these cells while
sparing normal tissue.”
“NorthStar will apply its expertise to identify and supply
the optimal therapeutic radioisotope to couple with Monopar’s
uPAR monoclonal
antibodies,” said James T.
Harvey, PhD, Senior Vice President and Chief Science Officer of
NorthStar. “We will deploy the most appropriate development
approaches and production technology to ensure that both
development and, if successful, commercial-scale volumes of this
radioisotope can be supplied in order to meet potential
demand.”
This
targeted therapeutic approach to treating severe COVID-19 is
supported by a recently published study (Rovina et al. 2020)
demonstrating that soluble urokinase plasminogen activator receptor
(suPAR), which is shed by aberrantly activated immune cells that
make uPAR, is an early predictor of severe respiratory failure in
COVID-19 and its presence increases as patients develop severe
COVID-19.
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 late-stage preclinical antibody MNPR-101. For
more information, visit: https://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: https://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
develop a targeted radiopharmaceutical treatment that has the
ability to prevent patients with severe COVID-19 from being placed
on ventilators and from dying. 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 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 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
release this 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 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