Monopar Therapeutics Reports Third Quarter 2020
Financial Results and Business Update
Validive®
Phase 2b/3 Clinical Trial on Track to
Start Before Year-end
Issuance of New Patents For Validive
Camsirubicin Phase 2 Clinical Trial to Start Late 2020/Early
2021
Wilmette,
IL, November 12, 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 third quarter 2020 financial results and
business update.
Third Quarter Business Update
Lead Product Candidate Validive
●
Monopar’s
Phase 2b/3 clinical trial of Validive (clonidine HCl mucobuccal
tablet) for the prevention of severe oral mucositis (SOM) in
patients undergoing chemoradiotherapy for oropharyngeal cancer
(OPC) is on track to commence before year-end. There currently is
no FDA-approved prevention or treatment for radiation-induced
SOM.
●
The U.S. Patent and
Trademark Office allowed patent claims for Monopar’s lead
product candidate, Validive, covering “Clonidine and/or
clonidine derivatives for use in the prevention and/or treatment of
adverse side effects of chemotherapy.” The recently issued
patents would provide protection should Monopar determine in the
future to conduct additional Validive development and
commercialization activities related to adverse side effects of
chemotherapy beyond OPC.
Camsirubicin
●
The
Phase 2 clinical trial of camsirubicin is anticipated to begin at
the end of 2020 or in early 2021. Monopar has partnered with Grupo
Español de Investigación en Sarcomas (GEIS), which will
lead the multi-country, randomized, open-label Phase 2 clinical
trial evaluating camsirubicin head-to-head against standard-of-care
doxorubicin in patients with advanced soft tissue sarcoma
(ASTS).
●
The
trial will begin with a dose escalation “run-in” prior
to the randomization portion of the trial. The primary endpoint of
the trial will be progression-free survival, with secondary
endpoints including overall survival, response rate, and incidence
of treatment-emergent adverse events.
MNPR-101
●
Forward progress was made on the Monopar/NorthStar
collaboration focused on developing a novel treatment for severe
COVID-19 by partnering with 1) IsoTherapeutics Group, LLC to
develop and manufacture radioimmunotherapeutics targeting uPAR
(uPRITs), 2) Aragen Bioscience, Inc. to perform studies aimed at
selecting a lead candidate uPRIT to advance into IND-enabling
development, and 3) The University of Texas Health Science Center
at Tyler and its Texas Lung Injury Institute (TLII) to
perform in vitro and in vivo studies through the TLII and to participate
in the clinical development of uPRITs.
Third
Quarter Summary Financial Results
Results for the Third Quarter Ended September 30, 2020 Compared to
the Third Quarter Ended September 30, 2019
Cash and Net Loss
Cash and cash equivalents as of September 30, 2020
were $18.0 million, which includes $6.7 million of net proceeds
raised in the third quarter of 2020 under the Company’s
Capital on Demand®
Sales Agreement with JonesTrading
Institutional Services, at an average gross price per share of
$9.66. Monopar anticipates that its current cash and cash
equivalents will fund the Company’s planned operations
through 2021, including the initiation and completion of the Phase
2b portion of its Validive clinical trial and the initiation of the
Phase 3 portion, the funding of the initiation of the GEIS Phase 2
camsirubicin clinical trial, and continuation of the
development of the COVID-19 uPRIT program. The Company will need to
raise funds or engage a partner to complete the Validive Phase 3
clinical trial. Net loss for the third quarter of 2020 was
$1.6 million or $0.15 per share compared to net loss of $0.7
million or $0.08 per share for the third quarter of
2019.
Research and Development (R&D) Expenses
R&D
expenses for the third quarter of 2020 were $1.2 million, compared
to $0.2 million, for the third quarter of 2019. This increase of
$1.0 million is primarily attributed to increases in expenses for
the planning of the camsirubicin Phase 2 clinical trial and
manufacturing expenses of $0.4 million, increases in the Validive
clinical trial planning and manufacturing expenses of $0.3 million,
and increases in R&D personnel salaries and benefits, including
equity grants and salaries and benefits for three new R&D
personnel of $0.3 million.
General and Administrative (G&A) Expenses
G&A expenses for the third quarter of 2020 were $0.4 million,
compared to $0.5 million, for the third quarter of
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 Monopar’s ability to commence its Phase 2b/3
clinical trial of Validive before the end of 2020, whether the
recently issued patents would provide protection for development
and commercialization in potential future indications, GEIS’s
ability to begin the camsirubicin Phase 2 clinical trial at the end
of 2020 or early 2021, whether the Monopar/NorthStar collaboration
will be successful in developing a uPRIT to treat severe COVID-19
with its development partners and whether the Company’s
current cash and cash equivalents will fund the Company’s
planned operations through 2021. The forward-looking statements
involve risks and uncertainties including, but not limited to, not
commencing the Validive Phase 2b/3 clinical trial or the Phase 2
GEIS-sponsored camsirubicin clinical trial within expected
timeframes, if at all, our ability to commence the Validive Phase 3
portion without additional fundraising or a development
partnership, to raise sufficient funds or engage a partner to
complete the Phase 3 clinical trial, and not successfully
developing a COVID-19 uPRIT with the Company’s development
collaborators. 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
Follow Monopar on social media for updates:
@MonoparTxMonopar
Therapeutics