Monopar Therapeutics 8-K, filed Aug 3, 2021
Monopar Therapeutics (MNPR)
8-K
2021-08-03
For: 2021-08-03
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on August 3, 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): August 3,
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
August 3, 2021, Monopar Therapeutics Inc. issued a press release
announcing clearance from the US Food and Drug Administration to
proceed under its IND with an open-label Phase 1b dose-escalation
trial evaluating camsirubicin plus growth factor support
(pegfilgrastim) 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 August 3, 2021 |
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 3, 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 Announces FDA Clearance to Proceed with Camsirubicin
Clinical Trial Targeting Advanced Soft Tissue Sarcoma
WILMETTE, Ill., August 3, 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 clearance from
the US Food and Drug Administration (FDA) to proceed under its IND
with an open-label Phase 1b dose-escalation trial evaluating
camsirubicin plus growth factor support (pegfilgrastim) in patients
with advanced soft tissue sarcoma (ASTS). The Company anticipates dosing the
first patient in the trial in the fourth quarter of this
year.
“By giving concomitant growth factor support to overcome the
dose-limiting toxicity of this class of drug, we hypothesize
camsirubicin could be dosed even higher and longer than
doxorubicin, yielding the chance to demonstrate efficacy
superiority over doxorubicin,” said Octavio Costa, MD,
Monopar’s Chief Medical Officer.
“We eagerly await reaching each higher dose level in this
trial,” said Andrew Mazar, PhD, Monopar’s
Chief Scientific Officer. “Camsirubicin
is a novel analog of doxorubicin, and doxorubicin is known to work
through a dose-dependent mechanism, where higher quantities yield
more anti-cancer effect.”
“If successful in ASTS, there are 13 other potential cancer
indications for camsirubicin where doxorubicin is already
FDA-approved,” said Chandler Robinson,
MD, Monopar’s Chief Executive Officer.
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 Phase
2b/3-stage Validive® for the
prevention of chemoradiotherapy-induced severe oral mucositis in
oropharyngeal cancer patients; Phase 1b-stage
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: the Company anticipating dosing the first
patient in the fourth quarter of this year; that camsirubicin could
be dosed even higher and longer than doxorubicin, yielding the
chance to demonstrate efficacy superiority over doxorubicin; and if
successful in ASTS, there are 13 other potential cancer indications
for camsirubicin where doxorubicin is already FDA approved. The
forward-looking statements involve risks and uncertainties
including, but not limited to: not dosing the first patient in the
Phase 1b clinical trial in the fourth quarter of this year, if at
all; that camsirubicin may cause unexpected serious adverse effects
or lacks meaningful efficacy; the potential for the FDA to put the
Phase 1b trial on clinical hold at any time; whether giving
concomitant growth factor support will overcome the dose-limiting
toxicity of this class of drug and whether camsirubicin will be
able to safely achieve any dose level higher than the starting dose
level for this Phase 1b trial; camsirubicin not being superior to
or as effective as doxorubicin; if successful, camsirubicin not
being effective in 13 other cancer indications; 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:
Twitter: @MonoparTx
LinkedIn:
Monopar Therapeutics