Monopar Therapeutics 8-K, filed Aug 19, 2020
Monopar Therapeutics (MNPR)
8-K
2020-08-19
For: 2020-08-17
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on August 19, 2020, reporting on events of August 17, 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): August 19,
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
19, 2020, Monopar Therapeutics
Inc. (“Monopar”) issued a press release
announcing a partnership with Aragen Bioscience, Inc., in
collaboration with NorthStar Medical Radioisotopes, LLC on the
development of urokinase plasminogen activator receptor targeted
radio-immuno-therapeutics (uPRITs) for the potential treatment of
patients with severe COVID-19. Aragen will perform studies aimed at selecting a
lead candidate uPRIT to advance into IND-enabling development 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 19, 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
Aragen for Testing of Novel Potential Therapeutic for Severe
COVID-19
WILMETTE, IL, BELOIT, WI, and MORGAN HILL, CA, AUGUST 19,
2020 – Monopar Therapeutics Inc. (Nasdaq:
MNPR)(Wilmette, IL) and NorthStar Medical Radioisotopes, LLC
(Beloit, WI), who are collaborating on the development of
urokinase plasminogen activator receptor targeted
radio-immuno-therapeutics (uPRITs) for the potential
treatment of patients with severe COVID-19, today announced a
partnership with Aragen Bioscience,
Inc. (Morgan Hill, CA), a leading contract research organization
focused on accelerating preclinical biologics product development.
Aragen will perform studies aimed at selecting a lead candidate
uPRIT to advance into IND-enabling development for severe
COVID-19.
“Aragen’s expertise in this specific area of
preclinical research should accelerate selection of a lead uPRIT
based on the MNPR-101 antibody scaffold to advance toward the
clinic,” said Andrew Mazar, PhD, Chief Scientific Officer of
Monopar.
“We are pleased to partner with Aragen on this important
phase of the uPRIT program,” said James T. Harvey, PhD,
Senior Vice President and Chief Science Officer of NorthStar.
“Using rigorous criteria to select the uPRIT candidate to
advance into IND-enabling studies is a crucial part of our COVID-19
program.”
“uPRIT has great therapeutic potential for severe COVID-19
patients” said Axel Schleyer, PhD, MBA, Chief Executive
Officer of Aragen. “We are excited to partner with Monopar
and NorthStar on this important endeavor.”
The aim of this partnership is to identify the uPRIT with the
optimal urokinase plasminogen activator receptor binding profile,
enabling selective delivery of a cytotoxic radioisotope to just
those aberrantly activated immune cells that produce the
“cytokine storm” that causes severe lung injury,
multiple organ damage, and death in severe COVID-19
patients.
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 Aragen Bioscience, Inc.
Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a
leading contract research organization based in the San Francisco
Bay Area. Aragen Bioscience offers a diverse set of
in vitro
and in vivo services for the discovery, cell line development,
production, characterization, activity and efficacy assessment and
development of biologic and diagnostic products. For more
information, visit: www.aragenbio.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 Aragen’s ability to select a lead candidate
uPRIT, based on the MNPR-101 antibody scaffold, into IND-enabling
development and toward the clinic for severe COVID-19, that uPRIT
has great therapeutic potential for severe COVID-19
patients, and the partnership’s ability to
identify the uPRIT with the optimal
binding profile that enables selective delivery of a cytotoxic
radioisotope to just those aberrantly activated immune cells that
produce the “cytokine storm” that causes severe lung
injury, multiple organ damage, and death in severe COVID-19
patients. 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, the
requirement for additional capital to complete preclinical and
clinical development, potential for 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, NorthStar and Aragen 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 Aragen’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
For Aragen Bioscience, Inc.:
David
Lustig
dlustig@aragenbio.com