Monopar Therapeutics 8-K, filed Feb 16, 2021
Monopar Therapeutics (MNPR)
8-K
2021-02-16
For: 2021-02-01
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on February 16, 2021, reporting on events of February 1, 2021.
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): February 16, 2021
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 February 16,
2021, Monopar Therapeutics Inc. (“Monopar”) issued a
press release announcing the first patient dosed in its Phase
2b/3 VOICE trial of Validive® for the
prevention of chemoradiotherapy-induced severe
oral
mucositis in patients
with oropharyngeal cancer
(VOICE).
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: February 16,
2021
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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 First Patient Dosed in its Phase 2b/3 VOICE Trial
Evaluating Validive® for the
Prevention of Chemoradiotherapy-Induced Severe Oral Mucositis (SOM)
in Oropharyngeal Cancer (OPC)
There are currently no FDA-approved drugs to prevent or treat
chemoradiotherapy-induced SOM
WILMETTE, Ill., February 16, 2021 – 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 it has dosed the first patient in its Phase 2b/3
VOICE trial of Validive® for the
prevention of chemoradiotherapy-induced severe
oral
mucositis in patients
with oropharyngeal cancer
(VOICE).
Validive’s mucoadhesive buccal
tablet formulation allows for prolonged and enhanced local delivery
of drug to the regions of mucosal radiation damage, and its easy
application under the upper lip allows for convenient once-daily
self-administration in the patient’s home
setting.
“With this important milestone accomplished we are excited to
be one step closer to bringing Validive to the approximately 40,000
OPC patients per year in the US that have no effective options for
preventing or treating their chemoradiotherapy-induced SOM,”
said Chandler Robinson, MD, Chief Executive Officer of Monopar.
“SOM is a painful and debilitating severe adverse effect of
chemoradiotherapy (CRT) treatment and can have significant
negative impacts on clinical outcomes as well as quality of life in
both the short and long term.”
“The number of newly diagnosed individuals with oropharyngeal
cancer is growing,” said Andrew Mazar, PhD, Chief Scientific
Officer of Monopar. “CRT is the standard of care for OPC, but
unfortunately 60-70% of OPC patients undergoing CRT will develop
severe oral mucositis in the course of their
treatment.”
The completed Validive Phase 2 trial showed that administering a
single, once daily 100µg
Validive tablet resulted in a 40% reduction in the incidence of SOM
compared to placebo in OPC patients undergoing CRT
treatment. Up to approximately
260 patients will be enrolled in the current multi-center,
randomized, double-blind, placebo-controlled, adaptive design Phase
2b/3 VOICE trial.
Further information about the Validive Phase 2b/3 VOICE trial is
available at www.ClinicalTrials.gov
under study identifier
NCT
04648020.
About Validive
Validive
(clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal
tablet (MBT) formulation. The mucobuccal tablet provides for
prolonged and enhanced local delivery of clonidine to the regions
of oral mucosal radiation damage in OPC patients. The tablet is
self-administered once daily in the patient’s home setting
with the patient placing it under the upper lip where it adheres to
the gums and dissolves over several hours, continuously releasing
clonidine into the saliva. Clonidine agonizes the alpha-2
adrenergic receptor on macrophages (white blood cells present in
the immune tissues of the oropharynx), decreasing the
macrophages’ expression of the destructive cytokines they
release in response to radiotherapy. A completed double-blind,
randomized, placebo-controlled Phase 2 clinical trial of Validive
showed reduced incidence compared to placebo (absolute decrease of
26%, relative decrease of 40%) in OPC patients treated with
Validive 100 µg, a safety profile similar to placebo, and a
high rate of treatment compliance (over 90%).
About Severe Oral Mucositis
Severe oral mucositis (SOM) is a painful and debilitating
inflammation and ulceration of the mucous membranes lining the oral
cavity and oropharynx in response to insults such as chemoradiation
treatment (CRT). SOM is the most frequent major side effect
experienced by oropharyngeal cancer patients, experienced by a
majority of those undergoing CRT. SOM impacts both quality of life
and clinical outcomes for these patients. SOM prevents patients
from drinking and/or eating, and can lead to severe weight loss,
opiate usage, and the use of feeding tubes as well as intravenous
supplementation to keep alive. Patients who develop SOM can become
hospitalized, and symptoms can force patients to prematurely stop
cancer treatment, reducing treatment efficacy and long-term
survival.
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 whether Monopar will successfully
continue to enroll its Validive Phase 2b/3 VOICE clinical trial;
whether Validive will benefit OPC patients in the VOICE trial;
whether the VOICE trial will yield results similar to the Phase 2
clinical trial in OPC patients; and whether the incidence of OPC
will continue to grow and continue to be treated with CRT. The
forward-looking statements involve risks and uncertainties for
Monopar including, but not limited to, the requirement for
additional capital to complete the VOICE trial beyond the interim
analysis and for potential commercialization; the VOICE trial not
yielding statistically significant results; if successful, not
being able to ensure volumes of Validive 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 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.
CONTACT:
Monopar Therapeutics Inc:
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
kimtsu@monopartx.com
Follow Monopar on social media for updates:
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@MonoparTx
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Monopar
Therapeutics
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