Monopar Therapeutics 8-K, filed Mar 27, 2020
Monopar Therapeutics (MNPR)
8-K
2020-03-27
For: 2019-12-31
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on March 27, 2020, reporting on events of December 31, 2019.
Items reported
- Item 2.02: Financial results
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
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Pursuant to Section 13 or 15(d)
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of The Securities Exchange Act of 1934
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Date of Report
(Date of earliest event reported):
March 27,
2020
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MONOPAR THERAPEUTICS INC.
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(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
(Address
of principal executive offices)
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60091
(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 2.02
Results of Operations and Financial
Condition.
On
March 27, 2020, Monopar Therapeutics Inc. issued a press release
announcing its financial results for the fourth quarter and year
ended December 31, 2019. 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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99.1
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Press Release Dated March 27,
2020
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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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By:
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/s/
Kim R.
Tsuchimoto
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Name:
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Kim R.
Tsuchimoto
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Title: |
Chief Financial Officer |
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Date:
March 27, 2020
Monopar Therapeutics Reports Fourth Quarter and Full-Year
2019
Financial Results and Business Updates
Initial public offering on Nasdaq Capital Market in December
2019
Orphan Drug Designation from the European Commission
for
camsirubicin for the treatment of soft tissue sarcoma
CHICAGO,
IL, March 27, 2020 – Monopar Therapeutics Inc. (Monopar or
the Company) (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 fourth quarter and full-year 2019 financial results
and business updates.
Fourth Quarter and Recent Highlights
Initial Public Offering
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In
December 2019, the Company completed its initial public offering of
1,277,778 shares of common stock, including the underwriters’
exercise of their over-allotment option, at a public offering price
of $8.00 per share before underwriting discounts and
commissions.
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The
shares began trading on the Nasdaq Capital Market on December 19,
2019 under the symbol “MNPR.”
Orphan Drug Designation
o
On
February 18, 2020, the Company announced that the European
Commission has granted Orphan Drug Designation for the
Company’s Phase 2 clinical-stage drug candidate,
camsirubicin, for the treatment of soft tissue sarcomas.
Camsirubicin is being developed under a clinical trial partnership
with Grupo Español de Investigación en Sarcomas (GEIS),
an internationally renowned non-profit organization focused on the
research and development of drugs for sarcoma cancers. The
approximately 170-patient GEIS-sponsored camsirubicin Phase 2
clinical trial for the treatment of advanced soft tissue sarcoma is
anticipated to begin in the second half of 2020.
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European
Orphan Drug Designation benefits include protocol assistance,
reduced EU regulatory filing fees and 10 years of market
exclusivity. Designated orphan medicines are also eligible for
conditional marketing authorization. Camsirubicin has already
received Orphan Drug Designation in the U.S. by the Food and Drug
Administration (FDA), which provides for similar benefits such as
fee reductions and 7 years of market exclusivity.
Fourth Quarter and Full Year Summary Financial Results
Results for the Quarter and Year Ended December 31, 2019 Compared
to the Quarter and Year Ended December 31, 2018
Cash
and cash equivalents as of December 31, 2019 were approximately
$13.2 million, compared to approximately $6.9 million as of
December 31, 2018. The increase in cash and cash equivalents was
driven primarily by the approximately $9.4 million net cash
proceeds from the Company’s initial public offering offset by
approximately $3.0 million of cash used in operating
activities.
Research and Development (R&D) Expenses
R&D
expenses for the quarter ended December 31, 2019 were approximately
$0.6 million, compared to approximately $0.5 million for the
quarter ended December 31, 2018, an increase of approximately $0.1
million.
R&D
expenses for the year ended December 31, 2019 were approximately
$2.0 million, compared to approximately $1.8 million for the year
ended December 31, 2018, an increase of approximately $0.2
million.
General and Administrative (G&A) Expenses
G&A
expenses for the quarter ended December 31, 2019 were approximately
$0.6 million, compared to approximately $0.4 million for the
quarter ended December 31, 2018, an increase of approximately $0.2
million.
G&A
expenses for the year ended December 31, 2019 were approximately
$2.4 million, compared to approximately $1.6 million for the year
ended December 31, 2018, an increase of approximately $0.8
million.
Net
loss was $0.13 per share for the fourth quarter of 2019, compared
to $0.10 per share in the comparable period in 2018. For the year
ended December 31, 2019, net loss was $0.45 per share compared to
$0.35 per share in the same period in 2018.
About Monopar Therapeutics
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. 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 late-stage preclinical antibody
MNPR-101. 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 the potential of camsirubicin and the
timing of the GEIS clinical trial. The forward-looking statements
involve risks and uncertainties including, but not limited to, that
enrollment of the camsirubicin clinical trial will not begin in the
second half of 2020, 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
Chandler
D. Robinson, M.D., MBA, M.Sc.
info@monopartherapeutics.com