Monopar Therapeutics 8-K, filed May 7, 2020
Monopar Therapeutics (MNPR)
8-K
2020-05-07
For: 2020-03-31
View Original
Added on
April 10, 2026
About this 8-K
Monopar Therapeutics filed this 8-K on May 7, 2020, reporting on events of March 31, 2020.
Items reported
- Item 2.02: Financial results
|
|
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 7,
2020
|
||
|
MONOPAR THERAPEUTICS INC.
|
||
|
(Exact
name of registrant as specified in its charter)
|
||
|
Delaware
|
001-39070
|
32-0463781
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification No.)
|
|
1000 Skokie Blvd., Suite 350, Wilmette, IL
(Address
of principal executive offices)
|
|
60091
(Zip
Code)
|
|
|
(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:
|
|
|
Title
of each class
|
Trading
Symbol(s)
|
|
Name
of each exchange on which registered
|
|
|
Common
Stock, $0.001 par value
|
|
MNPR
|
|
The
Nasdaq Stock Market LLC
(Nasdaq
Capital Market)
|
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
May 7, 2020, Monopar Therapeutics Inc. issued a press release
announcing its financial results for the first quarter ended March
31, 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.
|
Exhibit
No.
|
|
Description
|
|
99.1
|
|
Press Release Dated May 7,
2020
|
SIGNATURES
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.
|
|
Monopar
Therapeutics Inc.
|
|
|
|
|
|
|
|
|
Date: May 7,
2020
|
By:
|
/s/
Kim R.
Tsuchimoto
|
|
|
|
|
Name: Kim R.
Tsuchimoto
|
|
|
|
|
Title:
Chief
Financial Officer
|
|
Monopar Therapeutics Reports First Quarter 2020
Financial Results and Business Updates
Validive clinical trial design adapted for
current COVID-19 pandemic challenges
CHICAGO,
IL, May 7, 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 first quarter 2020 financial results and business
updates.
First Quarter and Recent Highlights
Validive Phase 2b/3 Clinical Trial
o
Monopar,
in response to the current COVID-19 pandemic and its effects on
clinical trials, has modified the original adaptive design Phase 3
clinical trial to be a Phase 2b/3 clinical trial to better fit the
types of trials which can enroll patients in the current
environment.
o
The
primary endpoint, absolute incidence of severe oral mucositis,
remains the same, but the touch points with the healthcare system
have been minimized.
o
The
Validive program will now consist of a randomized Phase 2b/3
clinical trial anticipated to start in the second half of 2020,
which will have an unblinded data readout after the Phase 2b
portion (estimated to be in the second half of 2021), and shortly
thereafter the Phase 3 portion will commence subject to the
Company’s ability to raise additional funding or find a
suitable pharmaceutical partner.
Camsirubicin Phase 2 Clinical Trial
o
Camsirubicin
clinical program continues to make progress with its collaboration
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, which is
sponsoring the approximately 170-patient camsirubicin Phase 2
clinical trial for the treatment of advanced soft tissue sarcoma,
anticipated to begin in the second half of 2020.
“We are
excited to move our clinical development programs forward,
especially in light of the challenges that the COVID-19 pandemic
has created for many biopharmaceutical companies. Addressing the
needs of oncology patients is our highest priority and we look
forward to entering the clinic in the second half of this
year,” said Andrew Mazar, Ph.D., Monopar’s Chief
Scientific Officer.
First Quarter Summary Financial Results
Results for the Quarter Ended March 31, 2020 Compared to the
Quarter Ended March 31, 2019
Cash
and cash equivalents as of March 31, 2020 were $12.6 million. Net
loss for the three months ended March 31, 2020 was $1.1 million or
$0.10 per share compared to net loss of $1.4 million or $0.15 per
share in the comparable period in 2019.
Research and Development (R&D) Expenses
R&D
expenses for the three months ended March 31, 2020 were $0.3
million, compared to $0.8 million, for the three months ended March
31, 2019. This represents a decrease of $0.5 million primarily
attributed to a decrease in Validive clinical trial planning and
accrued material costs.
General and Administrative (G&A) Expenses
G&A
expenses for the three months ended March 31, 2020 were $0.8
million, compared to $0.6 million, for the three months ended March
31, 2019. This represents an increase of $0.2 million primarily
attributed to increases in professional fees and G&A cash and
stock-based (non-cash) compensation.
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,
and links to SEC filings that contain detailed financial
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 clinical development timing of
Validive and 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, 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,
not obtaining the Validive Phase 2b unblinded data readout in the
second half of 2021, 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
Chandler
D. Robinson, M.D., MBA, M.Sc.
Chief Executive Officer, Monopar Therapeutics Inc.
info@monopartherapeutics.com