Monopar Therapeutics 8-K, filed May 26, 2021
Monopar Therapeutics (MNPR)
8-K
2021-05-26
For: 2021-05-26
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on May 26, 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): May 26,
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 May 26, 2021, Monopar
Therapeutics Inc. issued a press release announcing the filing of a
provisional composition of matter patent titled
“Urokinase Plasminogen Activator Receptor-Targeted
Radiopharmaceutical” covering a radiotherapeutic consisting
of Monopar’s proprietary antibody MNPR-101 bound to
Actinium-225 (Ac-225) via the metal binding agent PCTA
in collaboration
with NorthStar Medical Radioisotopes, LLC.
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: May 26,
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 and
NorthStar Announce Filing of Composition of
Matter
Patent Protecting
MNPR-101 Radiotherapeutic
WILMETTE, Ill. and BELOIT, Wis., May 26,
2021 – Monopar Therapeutics Inc. (Nasdaq: MNPR)
and NorthStar Medical Radioisotopes, LLC, today announced the
filing of a provisional composition of matter patent titled
“Urokinase Plasminogen Activator Receptor-Targeted
Radiopharmaceutical” covering a radiotherapeutic consisting
of Monopar’s proprietary antibody MNPR-101 bound to
Actinium-225 (Ac-225) via the metal binding agent PCTA. This
Radio-Immuno-Therapeutic (RIT) demonstrated a 98% radiochemical
purity and has the potential to be a highly selective, potent
treatment for a variety of cancers, severe COVID-19, and other
diseases characterized by aberrant urokinase plasminogen activator
receptor (uPAR) expression.
RITs are an emerging class of drugs
formed by attaching a radioactive element to an antibody for the
purpose of targeting and killing specific cells. Actinium is
quickly becoming a premier radioisotope of choice for RITs;
however, its full potential is presently constrained by its price
and scarcity. On May 24, 2021, Monopar and NorthStar announced the
filing of a provisional patent which may enable them to manufacture
antibody-PCTA-Ac225 conjugates using less antibody and less Ac-225
starting material, and may also confer efficacy and safety
advantages while also improving supply chain
logistics.
“We are excited about working
with Monopar to develop MNPR-101 as a radio-immuno-therapeutic, and
advancing it further toward the clinic,” said James Harvey,
PhD, Chief Scientific Officer of NorthStar.
“The binding of Actinium-225 to
PCTA-MNPR-101 with 98% yield is highly encouraging,” said
Andrew Mazar, PhD, Monopar’s Chief Scientific Officer.
“If issued, this composition of matter patent could
significantly expand the MNPR-101 patent
estate.”
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; and a preclinical stage uPAR targeted
antibody MNPR-101 for advanced cancers and severe COVID-19. For
more information, visit: www.monopartx.com.
About NorthStar
Medical Radioisotopes, LLC
NorthStar Medical Radioisotopes is a global
innovator in the production and distribution of radioisotopes used
for medical imaging and therapeutic purposes. NorthStar is a
company committed to providing the United States with reliable and
environmentally friendly radioisotope supply solutions to meet the
needs of patients and to advance clinical research.
NorthStar’s first product is the RadioGenix® System
(technetium Tc 99m generator), an innovative and flexible platform
technology initially approved by the U.S. Food and Drug
Administration in February 2018. For more information,
visit: www.northstarnm.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
MNPR101-PCTA-Ac225 has the
potential to be a highly selective, potent RIT for the treatment of
a variety of cancers, severe COVID-19, and other diseases
characterized by aberrant urokinase plasminogen activator receptor
(uPAR) expression; that the previously announced provisional patent
filing may enable Monopar and NorthStar to manufacture
MNPR101-PCTA-Ac225 using less antibody and less Ac-225 starting
material and may also confer efficacy and safety advantages and
improve supply chain logistics; that the RIT may move further
toward the clinic; and that, if issued, this composition of matter
patent could significantly expand the MNPR-101 patent estate.
The forward-looking statements involve
risks and uncertainties including, but not limited to:
this and/or the previously announced
provisional patent filing not resulting in issued patents;
RITs not becoming an emerging class of drugs; Actinium not becoming
a premier radioisotope of choice for RITs; whether RITs’ full
potential continues to be constrained due to its price and
scarcity; whether MNPR101-PCTA-Ac225 uses less antibody and less
Ac-225 starting material and confer efficacy and safety advantages
and improve supply chain logistics; whether the RIT will be
successfully preclinically and clinically developed, if at
all; the lack of any clinical activities to date with
respect to MNPR-101 and related conjugates; the requirement for
additional capital to complete preclinical and clinical development
of RITs and if successful, 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 and NorthStar undertake 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 and NorthStar’s views only as of the date
hereof and should not be relied upon as representing its views as
of any subsequent date.
CONTACTS:
For Monopar
Therapeutics Inc.
Investor Relations:
Kim R. Tsuchimoto
Chief Financial
Officer
kimtsu@monopartx.com
For NorthStar Medical
Radioisotopes, LLC
Investor Relations:
Paul Estrem
Senior Vice President and Chief Financial
Officer
pestrem@northstarnm.com
Lisa Holst
Vice President Sales and
Marketing
678-471-9027
lholst@northstarnm.com
Media:
Priscilla Harlan
781-799-7917
pharlan@shiningrockllc.com