Monopar
Therapeutics Reports Fourth Quarter and Full-Year
2020
Financial Results and Recent Business Updates
Validive®
Phase 2b/3 VOICE Clinical Trial
Commenced
Camsirubicin Phase 2 Clinical Trial Anticipated to Start in Q2
2021
MNPR-101-Conjugate
Data Published in European
Journal of Cancer
Wilmette,
IL, March 25, 2021 – 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 fourth quarter and full-year 2020
financial results and recent business updates.
Recent Business Updates
Lead Product Candidate Validive
●
Monopar’s
Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl
mucobuccal tablet) for the prevention of severe oral mucositis
(SOM) in patients undergoing chemoradiotherapy (CRT) for
oropharyngeal cancer (OPC) dosed its first patient in February 2021
and is actively recruiting patients and initiating additional
clinical trial sites. There is no FDA-approved prevention or
treatment for CRT-induced SOM.
●
The U.S. Patent and
Trademark Office (USPTO) allowed patent claims for Validive,
covering “Clonidine and/or clonidine derivatives for use in
the prevention and/or treatment of adverse side effects of
chemotherapy.” This patent
expands coverage on the potential use of Validive in cancer
patients beyond earlier allowed claims specifically for the
prevention of oral mucositis in patients receiving
CRT.
Camsirubicin
●
The
Phase 2 clinical trial of camsirubicin is anticipated to commence
enrollment in the second quarter of 2021. Monopar’s clinical
development collaborator, Grupo Español de Investigación
en Sarcomas (GEIS), 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 an open-label 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.
●
The
USPTO allowed patent claims covering compositions of matter
(2-pyrrilino camsirubicin) for a novel family of camsirubicin
analogs. This patent expires in 2038, not including any patent term
extensions. The patent broadens Monopar’s camsirubicin
portfolio and covers a pipeline of compounds designed to retain the
potentially favorable non-cardiotoxic chemical backbone of
camsirubicin along with the potent broad-spectrum antitumor
activity of doxorubicin. Preclinical evidence suggests that this
new family of 2-pyrrilino camsirubicin analogs could be active
against doxorubicin-resistant tumor cells which may enable use in
cancer types beyond those treatable with camsirubicin.
MNPR-101 and Related Compounds
●
Progress continues in the Monopar/NorthStar
Medical Radioisotopes collaboration focused on developing a novel
treatment for severe COVID-19 by partnering with (i)
IsoTherapeutics Group, LLC to develop and manufacture humanized
urokinase plasminogen activator receptor radioimmunotherapeutics
(uPRITs), (ii) Aragen Bioscience, Inc. which performed studies to
enable the selection of a lead candidate uPRIT along with back-up
candidates to potentially advance into IND-enabling development,
and (iii) The University of Texas Health Science Center at Tyler
and its Texas Lung Injury Institute (TLII) to
perform in vitro and in vivo studies and to participate in the clinical
development of uPRITs.
●
The European Journal of
Cancer published a
peer-reviewed preclinical study which shows the potential utility
of MNPR-101 conjugates as uPAR imaging agents to improve surgical
outcomes in bladder cancer and for surveillance
post-resection.
Results for the Fourth Quarter and Year Ended December 31, 2020
Compared to the Fourth Quarter and Year Ended December 31,
2019
Cash and Net Loss
Cash and cash equivalents as of December 31, 2020
were $16.7 million. Monopar anticipates that its current cash and
cash equivalents, which includes an additional $10.9 million of net
proceeds raised in the first quarter of 2021 under the
Company’s Capital on Demand®
Sales Agreement with JonesTrading
Institutional Services, at an average gross price per share of
$10.20, will fund the Company’s planned operations at least
through March 2022. Planned operations include funding and
completing the Phase 2b portion of the Validive “VOICE”
clinical trial and commencing of the Phase 3 portion; the funding
of the run-in portion of the GEIS Phase 2 camsirubicin clinical
trial; and continuation of the development of the COVID-19
uPRIT program along with other MNPR-101 related compounds. The
Company plans to raise additional funds or engage a partner in the
next 12 months to complete the VOICE clinical program and continue
the GEIS camsirubicin clinical trial beyond the run-in
phase.
Net
loss for the fourth quarter of 2020 was $2.1 million or $0.19 per
share compared to net loss of $1.2 million or $0.13 per share for
the fourth quarter of 2019. Net loss for the year ended December
31, 2020 was $6.3 million or $0.58 per share compared to net loss
of $4.2 million or $0.45 per share for the year ended December 31,
2019.
Research and Development (R&D) Expenses
R&D
expenses for the fourth quarter of 2020 were $1.6 million compared
to $0.6 million for the fourth quarter of 2019. This increase of
$1.0 million is primarily attributed to increases in expenses of
$0.5 million for the planning of the GEIS camsirubicin Phase 2
clinical trial including manufacturing, $0.2 million for the VOICE
clinical trial planning and manufacturing costs, and $0.3 million
for R&D personnel salary and benefits.
R&D
expenses for the year ended December 31, 2020 were $4.1 million
compared to $2.0 million for the year ended December 31, 2019. This
represents an increase of approximately $2.1 million primarily
attributed to increases in expenses of $1.1 million for the
planning of the GEIS camsirubicin Phase 2 clinical trial including
manufacturing, $0.1 million for the VOICE clinical trial planning
and manufacturing costs, and $0.9 million for R&D personnel
salary and benefits.
General and Administrative (G&A) Expenses
G&A expenses for the fourth quarter of 2020 were $0.6 million,
equal to $0.6 million for the fourth quarter of 2019.
G&A expenses for the year ended December 31, 2020 were $2.4
million, equal to $2.4 million for the year ended December 31,
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 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 in the second quarter of 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 March 2022. The forward-looking statements involve risks
and uncertainties including, but not limited to, not successfully
recruiting patients and initiating additional clinical trial sites
for the VOICE clinical trial or the Phase 2 GEIS-sponsored
camsirubicin clinical trial within expected timeframes, if at all;
the Company’s inability to raise sufficient funds or engage a
partner to complete the Phase 3 portion of the VOICE clinical trial
and continue the GEIS camsirubicin 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