Monopar Therapeutics 8-K, filed Jun 3, 2021
Monopar Therapeutics (MNPR)
8-K
2021-06-03
For: 2021-06-03
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on June 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): June 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 June
3, 2021, Monopar Therapeutics Inc. issued a press release
announcing a
collaboration agreement
with the Cancer Science Institute of Singapore (CSI Singapore)
at the National University of Singapore (NUS) to evaluate the activity of MNPR-202 and
related analogs in multiple types of cancer. MNPR-202 was designed
to retain the same potentially non-cardiotoxic backbone as
camsirubicin but is modified at other positions which may enable it
to work in certain cancers that are resistant to camsirubicin and
doxorubicin.
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: June 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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Monopar Announces New Drug
Candidate, MNPR-202, and Enters into
Collaboration Agreement with the
National University of Singapore for Preclinical Evaluation in
Cancer
Development of novel Camsirubicin analog expands Monopar’s
therapeutic pipeline
WILMETTE,
IL, June 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 it
has entered into a collaboration agreement
with the Cancer Science Institute of Singapore (CSI Singapore)
at the National University of Singapore (NUS) to evaluate the
activity of MNPR-202 and related analogs in multiple types of
cancer. MNPR-202 was designed to retain the same potentially
non-cardiotoxic backbone as camsirubicin but is modified at other
positions which may enable it to work in certain cancers that are
resistant to camsirubicin and doxorubicin. Monopar recently
announced a composition of matter U.S. patent (US10,450,340)
covering MNPR-202 and related analogs. While we expect camsirubicin
to enter a dose escalation run-in clinical trial in advanced soft
tissue sarcoma in the second half of this year, CSI Singapore will
explore how the immune system
recognizes cancer cells treated with MNPR-202 and related analogs
in order to guide the rational design of immunotherapy-chemotherapy
combinations for the treatment of cancer.
CSI Singapore
is one of Asia’s premier cancer research centers and NUS is
consistently ranked as one of the world's top
universities. Anand Jeyasekharan, MBBS MRCP (UK) PhD, of CSI
Singapore, NUS is an expert in the molecular and biological
responses of cancer cells to chemotherapy. Through this
collaboration, we hope to gain fundamental insight into how
MNPR-202 and related analogs alter the DNA of cancer cells and how
the immune system then identifies and eliminates these cells,
resulting in immunogenic cell death (ICD). The relationship between
chemotherapy and ICD constitutes a prominent pathway for immune
system activation against various cancers, including cancers that
are considered to be “cold” and poorly responsive to
checkpoint inhibition alone. A deeper understanding of ICD response
may reveal additional indications where MNPR-202 and related
analogs could have significant potential as anticancer
therapies.
“By
expanding our understanding of MNPR-202 activity against
chemotherapy-resistant tumors and working with Dr. Jeyasekharan to
assess immunogenic potential, we may be able to inform and refine
our development strategy toward indications where MNPR-202 could be
most impactful,” said Andrew Mazar, PhD, Chief Scientific
Officer of Monopar.
“We
believe MNPR-202 has the potential to disrupt the current
chemotherapy landscape and impact a broad range of cancers,”
said Dr. Anand Jeyasekharan, who will be the Principal Investigator
at CSI Singapore. “We are pleased to collaborate with Monopar
to further our current research and hope to aid in the advancement
of MNPR-202 toward the clinic.”
“We are
very excited to work with Cancer Institute of Singapore at the
National University of Singapore and Dr. Jeyasekharan on
MNPR-202,” said Chandler Robinson, MD, CEO of Monopar.
“A world-class reputation paired with deep expertise on the
relationship between chemotherapy and immune cell activation make
Dr. Jeyasekharan and CSI Singapore a great research
partner.”
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; 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.
About the Cancer
Science Institute of Singapore (CSI Singapore)
The Cancer Science Institute of
Singapore (CSI) is one of only
five Research Centres of Excellence established by the Government
of Singapore with funding from the National Research Foundation and
the Ministry of Education. Its mission is to better
understand the causes of human cancer across Asia, and thereby
improve its detection, treatment and prevention for the benefit of
the patients. The
CSI’s outstanding researchers and
excellent scientific facilities create an energetic environment for
ground-breaking research and world-class training. The CSI
is internationally recognized
for its innovative research on the biology of cancers prevalent in
Asia, and for taking new methods for cancer treatment from the
laboratory to the clinic. Through its local and global
partnerships, the CSI works with leading minds from multiple
scientific and clinical disciplines in Singapore, the USA and
Europe, both in academia and in industry. For more information on CSI Singapore,
visit https://www.csi.nus.edu.sg/web/.
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 MNPR-202 will retain the same
potentially non-cardiotoxic backbone as camsirubicin or increase
potency and circumvent drug resistance pathways in cancer cells;
whether Monopar will commence a camsirubicin dose escalation run-in
clinical trial in advanced soft tissue sarcoma in the second half
of this year; and whether the collaboration with Cancer Science
Institute of Singapore (CSI Singapore) at the National University
of Singapore (NUS) will result in positive data or the successful
development of MNPR-202 and related analogs, if at all. The
forward-looking statements involve risks and uncertainties
including, but not limited to Monopar’s inability to raise
additional capital to complete future preclinical and clinical
development; negative or inconclusive data from the studies of
MNPR-202 and related analogs conducted in the collaboration with
CSI at the NUS; if successful, the potential for commercialization,
including uncertainties about levels of demand of MNPR-202 and
related analogs; 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