Monopar Therapeutics 8-K, filed Aug 6, 2020
Monopar Therapeutics (MNPR)
8-K
2020-08-06
For: 2020-08-06
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on August 6, 2020.
Items reported
- Item 2.02: Financial results
- 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 6,
2020
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 2.02
Results of Operations and Financial
Condition.
On
August 6, 2020, Monopar Therapeutics Inc. issued a press release
announcing its financial results for the second quarter ended June
30, 2020. A copy of this press release is attached hereto as
Exhibit 99.1.
The
information in this Item 2.02 and the exhibit hereto are being
furnished and shall not be deemed to be “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), or otherwise subject
to the liability of that section, nor shall they be deemed
incorporated by reference in any filing under the Securities Act of
1933, as amended, or the Exchange Act, except as expressly set
forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
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Exhibit No.
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Description
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SIGNATURE
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Monopar
Therapeutics Inc.
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Date: August 6, 2020
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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 Therapeutics Reports Second Quarter 2020
Financial Results and Business Updates
Collaboration Formed to Develop COVID-19 Therapeutic
with
Monopar’s Proprietary MNPR-101 Technology
CHICAGO,
IL, August 6, 2020 – Monopar Therapeutics Inc. (Monopar or
the Company) (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 second quarter 2020 financial results and
business updates.
Second Quarter and Recent Highlights
Collaboration with NorthStar Medical Radioisotopes to Develop
Potential Therapeutic for Severe COVID-19 and Other Respiratory
Diseases
o
Monopar and
NorthStar entered into a 50/50 collaboration to develop potential
Radio-Immuno-Therapeutics (RITs) to treat severe
COVID-19.
o
Monopar will
provide its pre-IND stage humanized uPAR targeted monoclonal
antibody, known as MNPR-101, and NorthStar will supply a cytotoxic
radioisotope. The aim is to create a highly selective agent that
has the potential to kill aberrantly activated cytokine-producing
immune cells thought to be largely responsible for the severe lung
injury that contributes to poor outcomes and death in patients with
severe COVID-19.
o
Provisional patent
has been filed that covers novel compositions and uses of cytotoxic
radioisotopes attached to antibodies that bind to uPAR,
thereby creating precision targeted radio-immuno-therapeutics
(uPRITs) for the treatment of severe COVID-19 and other respiratory
diseases.
Validive Phase 2b/3 Clinical Trial and Camsirubicin Phase 2
Clinical Trial Continue on Schedule
o
Monopar’s
two clinical-stage programs both continue to be on schedule for
first patient dosing in the second half of 2020.
Second
Quarter Summary Financial Results
Results for the Quarter Ended June 30, 2020 Compared to the Quarter
Ended June 30, 2019
Cash
and cash equivalents as of June 30, 2020 were $12.5 million. Net
loss for the three months ended June 30, 2020 was $1.4 million or
$0.14 per share compared to net loss of $0.9 million or $0.10 per
share for the three months ended June 30, 2019.
Research and Development (R&D) Expenses
R&D
expenses for the three months ended June 30, 2020 were $0.8
million, compared to $0.3 million, for the three months ended June
30, 2019. This represents an increase of $0.5 million primarily
attributed to increases in camsirubicin and Validive clinical trial
planning and materials manufacturing costs and increases in
personnel expenses for three new R&D employees and higher
salary and stock-based (non-cash) compensation for
2020.
General and Administrative (G&A) Expenses
G&A
expenses for the three months ended June 30, 2020 were $0.6
million, compared to $0.6 million, for the three months ended June
30, 2019.
About Monopar Therapeutics
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. The Company'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,
and links to SEC filings that contain detailed financial
information, visit: https://ir.monopartx.com/quarterly-reports.
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 the potential for NorthStar Medical
Radioisotopes’ development collaboration to develop a
COVID-19 uPRIT and the Company’s ability to dose first
patients in the Validive and camsirubicin clinical trials in the
second half of 2020. The forward-looking statements involve risks
and uncertainties including, but not limited to, not successfully
developing a COVID-19 uPRIT with the Company’s development
collaborator, and not commencing the Validive Phase 2b/3 clinical
trial and Phase 2 GEIS-sponsored camsirubicin clinical trial in the
second half of 2020, if at all, and not commencing the Validive
Phase 3 portion subject to fundraising and partnership efforts, if
at all. 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
Kim
R. Tsuchimoto
Chief Financial Officer
kimtsu@monopartx.com