Monopar Therapeutics 8-K, filed Aug 12, 2020
Monopar Therapeutics (MNPR)
8-K
2020-08-12
For: 2020-08-12
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on August 12, 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 12,
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
12, 2020, Monopar Therapeutics
Inc. (“Monopar”) issued a press release
announcing that it plans to advance the development of a
test to potentially triage COVID-19 patients into those likely
versus unlikely to progress to severe respiratory failure. The test
would use Monopar’s proprietary monoclonal antibody, ATN-658,
to detect soluble urokinase plasminogen activator receptor (suPAR)
in COVID-19 patient plasma. A suPAR test for COVID-19 patients, if
successful, could identify those at high risk for severe
respiratory failure, facilitating earlier therapeutic interventions
or allowing for the staging of patients to an optimal treatment
based on their disease characteristics.
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 12, 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 Announces Plan to Advance
Development of Novel Triage Test for Severe COVID-19 Utilizing its
Patented Technology
Potential Companion Diagnostic to
Monopar’s uPRIT Program
WILMETTE, IL, August 12, 2020 – Monopar Therapeutics
Inc. (Nasdaq: MNPR) today announced its plan to develop a test to
potentially triage COVID-19 patients into those likely versus
unlikely to progress to severe respiratory failure. The test would
use Monopar’s proprietary monoclonal antibody, ATN-658, to
detect soluble urokinase plasminogen activator receptor (suPAR) in
COVID-19 patient plasma. A suPAR test for COVID-19 patients, if
successful, could identify those at high risk for severe
respiratory failure, facilitating earlier therapeutic interventions
or allowing for the staging of patients to an optimal treatment
based on their disease characteristics.
A
prototype enzyme-linked immunosorbent assay (ELISA) for measuring
blood suPAR levels using ATN-658 has been developed, and Monopar is
currently in discussions with several parties to further develop
and commercialize either an ELISA or other suPAR-based test using
ATN-658. The aim is to clinically validate the suPAR-based test in
COVID-19 patients.
The use
of suPAR for triaging COVID-19 patients is supported by a growing
body of recent studies. Rovina et al. 2020 showed that patients
with elevated levels of suPAR at the time of hospital admission are
17 times more likely to develop severe respiratory failure
(p=.0000000012). Arnold et al. 2020 showed suPAR to have the best
performance in predicting outcome (such as intensive care unit
admission and death) of all the biomarkers examined; and
Eugen-Olsen et al. 2020 showed that low levels of suPAR are
predictive of mild outcome in COVID-19 patients.
“suPAR
is emerging as an important biomarker that predicts outcome in
diseases characterized by rapid and severe systemic inflammatory
responses including COVID-19, certain pneumonias, and
sepsis,” said Andrew Mazar, PhD, Chief Scientific Officer of
Monopar. “This suPAR test may enable the early identification
of patients who will rapidly deteriorate, and thereby could greatly
improve the treatment of COVID-19 patients.”
suPAR
is the cleaved, blood-circulating form of the cell-surface anchored
protein called urokinase plasminogen activator receptor (uPAR).
Monopar recently entered into a collaboration with NorthStar
Medical Radioisotopes, LLC to develop a precision
Radio-Immuno-Therapeutic (RIT) based on the same antibody scaffold
that is used in the prototype ELISA to detect suPAR.
The aim
of the NorthStar collaboration is to develop a uPAR-targeted RIT
(uPRIT) to selectively target and eradicate the aberrantly
activated (“rogue”) immune cells that cause the
cytokine storm and subsequent severe respiratory failure and death
in COVID-19 patients. These rogue immune cells seem to be making
uPAR and shedding it into the blood as suPAR. Fortunately, uPAR is
a protein that is not found much, if at all, on normal healthy
tissue, so there is an opportunity to potentially use a uPRIT to
quickly shut down the cytokine storm by selectively killing the
rogue immune cells while sparing healthy cells.
“If
successful, the suPAR test could serve as a companion diagnostic to
Monopar’s uPRIT. Specifically, the test could identify those
patients who are most appropriate for the potential uPRIT
treatment,” said Chandler Robinson, MD, Chief Executive
Officer of Monopar.
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
Monopar’s ability to develop a test to triage COVID-19
patients into those likely versus unlikely to progress to severe
respiratory failure; ATN-658’s ability to detect soluble
urokinase plasminogen activator receptor (suPAR) in COVID-19
patient plasma; the suPAR test’s ability to enable the early
identification of COVID-19 patients who will rapidly deteriorate
and thereby greatly improve the treatment of COVID-19 patients;
that identification of such high risk for respiratory failure could
facilitate therapeutic interventions earlier or allow for the
staging of patients to an optimal treatment based on their
disease characteristics; the success, if any, of
Monopar’s discussions with several parties to further develop
either an ELISA or other suPAR-based test for COVID-19 patients;
Monopar’s or a future collaborator’s ability to
clinically validate the suPAR-based test in COVID-19
patients; Monopar’s ability to replicate results of
earlier third-party studies of suPAR; that suPAR as a novel
biomarker could predict outcome in diseases; that Monopar’s
collaboration with NorthStar will successfully result in a uPRIT
for the treatment of COVID-19; that a uPRIT could quickly shut down
the cytokine storm through selectively killing the rogue immune
cells while sparing healthy cells; and that the suPAR test could
serve as a companion diagnostic to Monopar’s uPRIT.
The forward-looking statements involve risks and uncertainties
including, but not limited to, the lack of any clinical activities
to date with respect to ATN-658 or MNPR-101; the requirement for
additional capital to complete preclinical and clinical
development, and if successful, commercialization of the suPAR test
and/or the uPRIT; the uPRIT not being able to kill aberrantly
activated cytokine-producing immune cells; the uPRIT 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 chosen radioisotope can be manufactured
and scaled up to meet potential demand; the suPAR test being unable
to detect suPAR with sufficient precision, sensitivity and/or
accuracy; uncertainties about
levels of demand if and when a treatment and/or test is available
for commercialization and the significant general risks and
uncertainties surrounding the research, development, regulatory
approval and commercialization of therapeutics and
diagnostics. 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.
CONTACTS:
Monopar Therapeutics Inc.:
Investor
Relations:
Kim R.
Tsuchimoto
Chief
Financial Officer
kimtsu@monopartx.com