Monopar Therapeutics 8-K, filed Nov 9, 2020
Monopar Therapeutics (MNPR)
8-K
2020-11-09
For: 2020-11-09
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on November 9, 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): November 9, 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 November 9, 2020, Monopar Therapeutics Inc.
(“Monopar”) issued a press release announcing a series
of recently issued patents for its Phase 2b/3 clinical-stage lead
product candidate, Validive (clonidine HCl mucobuccal tablet),
providing claims covering “Clonidine and/or clonidine
derivatives for use in the prevention and/or treatment of adverse
side effects of chemotherapy”.
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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99.1
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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: November
9, 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 Issuance of New
Patents Broadening Protections For Phase 2b/3 Clinical-Stage Lead
Product Candidate Validive®
Strengthens
Monopar’s Validive IP Portfolio To 2035
WILMETTE, IL, November 9, 2020 – Monopar Therapeutics
Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company
primarily focused on developing proprietary therapeutics designed
to extend life or improve the quality of life for cancer patients,
today announced a series of recently issued patents for its Phase
2b/3 clinical-stage lead product candidate, Validive (clonidine HCl
mucobuccal tablet). These patents, including U.S. Patent No.
10,675,271, provide claims covering “Clonidine and/or
clonidine derivatives for use in the prevention and/or treatment of
adverse side effects of chemotherapy”.
“These
recently issued patents broaden the patent protection for the use
of Validive in cancer patients,” said Andrew Mazar, PhD,
Chief Scientific Officer of Monopar. “Specifically, they
provide protection into 2035 for the potential ability of Validive
to prevent or treat common chemotherapy-associated side effects
such as gastrointestinal disorders, respiratory disorders, fatigue
and headache.”
“According
to the U.S. Centers for Disease Control and Prevention, about
650,000 cancer patients receive chemotherapy each year in the U.S.,
and most of these experience side-effects as a result of their
treatment,” said Chandler Robinson, MD, Chief Executive
Officer of Monopar. “These patents expand the potential use
of Validive beyond the earlier allowed claims for the prevention of
oral mucositis in patients receiving chemoradiotherapy. This in
turn serves to advance Monopar’s mission to develop
treatments that improve quality of life in cancer patients
undergoing treatment.”
Monopar
is currently developing Validive for the prevention of
chemoradiation-induced severe oral mucositis in oropharyngeal
cancer patients (OPC), an indication which currently has no FDA
approved treatment. Monopar’s Phase 2b/3 clinical trial in
OPC patients is on track to start before year-end. The recently
issued patents would provide protection should Monopar determine in
the future to conduct additional Validive development activities
related to adverse side effects of chemotherapy beyond
OPC.
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 remain on track to start the Validive
Phase 2b/3 clinical trial before year-end, the potential for
Validive to prevent or treat common chemotherapy-associated
side effects such as gastrointestinal disorders, respiratory
disorders, fatigue and headache, the potential for Validive to
prevent oral mucositis in patients receiving chemoradiotherapy, the
advancement of Monopar’s mission to develop treatments that
improve quality of life in cancer patients undergoing treatment,
and that Validive patents will
strengthen and provide protection for Monopar’s intellectual
property portfolio. The forward-looking statements involve
risks and uncertainties including, but not limited to the requirement for
Monopar to raise additional capital or engage a partner in order to
complete future clinical development of Validive as
well as potential commercialization (including if Monopar
determines to expand currently contemplated development activities
to other adverse side effects of chemotherapy beyond OPC), 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 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
Follow Monopar on social media for updates:
@MonoparTx
Monopar
Therapeutics