Form 8-K Monopar Therapeutics For: Dec 08
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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): December 8, 2021
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MONOPAR
THERAPEUTICS INC.
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(Exact name of
registrant as specified in its charter)
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Deleware
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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
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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
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Registrant’s
telephone number, including area code
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N/A
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(Former name or
former address, if changed since last
report)
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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
December 8, 2021, Monopar Therapeutics Inc. issued a press release
announcing the positive recommendation from its safety review
committee to escalate to the second dose level in its camsirubicin
Phase 1b trial in patients with advanced soft tissue
sarcoma.
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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Press Release Dated December 8,
2021
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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: December 8,
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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Exhibit
99.1
Monopar Advances Dosing of Camsirubicin to Higher Level Than Tested
In Any Previous Clinical Trial
WILMETTE, Ill, December 8, 2021 – Monopar Therapeutics Inc.
(Nasdaq: MNPR), a clinical-stage biopharmaceutical company
focused on developing proprietary therapeutics designed to extend
life or improve the quality of life for cancer patients,
today announced the
positive recommendation from its safety review committee to
escalate to the second dose level in its camsirubicin Phase 1b
trial in patients with advanced soft tissue sarcoma (ASTS). This
decision was made following a review of safety data from the
patients in the first dose cohort and will allow evaluation of
a higher dose level of
camsirubicin than has been administered in any prior clinical
trial.
“Camsirubicin belongs to a class of drugs, anthracyclines,
that have repeatedly demonstrated a dose-dependent anti-tumor
response,” said Andrew
Mazar, PhD, Monopar’s Chief Scientific Officer.
“Camsirubicin has already shown potential signs of anti-tumor
activity in a traditional all-comer advanced cancer Phase 1 and in
a pilot Phase 2 study in ASTS, so the ability to achieve a higher
dose than previously used in those studies is an important
milestone for the company.”
“We are pleased with the swift progress accomplished to date,
rapidly moving from regulatory trial allowance to first site
activated to clearing the first dose level in only a few
months,” said Chandler Robinson, MD, Monopar’s Chief
Executive Officer. “We are eager to continue evaluating
progressively escalating dose levels of camsirubicin, which may
demonstrate increasing anti-tumor activity.”
Further information about this actively enrolling,
open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov
under study identifier
NCT
05043649.
About Camsirubicin
Camsirubicin
is a novel proprietary analog of the widely used cancer drug
doxorubicin. It has been investigated in ASTS patients in a Phase 1
and a single-arm Phase 2 clinical trial. In these studies, no
camsirubicin-treated patients developed the irreversible
cardiotoxicity common to doxorubicin at higher cumulative doses.
The most frequent adverse event observed in the Phase 1 study was
neutropenia, which was mitigated in the Phase 2 study using
prophylactic G-CSF. Based on encouraging clinical results to date,
the current Phase 1b trial is designed to test camsirubicin at
progressively higher doses than previously administered while using
concomitant prophylactic G-CSF to prevent neutropenia.
About Soft Tissue Sarcoma
Soft tissue sarcomas (STS) are a diverse type of cancer that
typically develop in the connective tissue of the body. According
to the American Cancer Society, in 2021, an estimated 13,460
new STS cases will be diagnosed in the US alone, and about 5,350
people will not survive their disease. These tend to be the
advanced cases; those with sarcomas that are unresectable and/or
have metastasized. The average life expectancy from time of
diagnosis for those patients with advanced disease (ASTS) is about
12 to 15 months. Doxorubicin is the current standard of care
in the 1st-line setting for
ASTS, and has been for decades, since there have been no
1st-line
therapeutic advancements that have improved overall survival for
this patient population.
About Monopar Therapeutics Inc.
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; a late-stage preclinical antibody,
MNPR-101, for advanced cancers and severe COVID-19; and an
early-stage camsirubicin analog, MNPR-202, for various cancers. 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: that we will be able to continue
evaluating progressively escalating dose levels of camsirubicin,
which may demonstrate increasing anti-tumor activity. The
forward-looking statements involve risks and uncertainties
including, but not limited to: whether the Phase 1b camsirubicin
trial will successfully enroll sufficient patients to accomplish
trial goals; whether camsirubicin will show comparable anti-tumor
activity to doxorubicin without any signs of irreversible heart
damage; that camsirubicin may not prove to be clinically
efficacious; that the Company will need to raise additional funds
in 2022 to develop camsirubicin beyond Phase 1b; 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
Follow Monopar on social media for updates:
Twitter: @MonoparTx
LinkedIn:
Monopar Therapeutics
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