Monopar Therapeutics
Reports First Quarter 2021
Financial Results and
Recent Business Updates
First Patient Dosed in Validive®
Phase 2b/3 VOICE Clinical
Trial
Camsirubicin
Run-in Clinical Trial Now Planned to Start in 2H
2021
Potential
Utility Reported for MNPR-101 as Imaging Agent in Cancer
Surgery
Wilmette, IL,
May 13, 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 first quarter 2021 financial results and recent
business updates.
Recent
Business Updates
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 a new patent with 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 uses of Validive in cancer
patients beyond earlier allowed claims limited specifically to the
prevention and/or treatment of oral mucositis in patients receiving
CRT.
Camsirubicin and Novel Analogs
●
Based
on the Company’s current inability to gain regulatory
approval to initiate the camsirubicin Phase 2 clinical trial in
Spain, Monopar is evaluating alternatives to move the dose
escalation run-in clinical trial forward outside of Spain. Monopar
believes that it will be able to initiate the run-in clinical trial
in the second half of 2021 in the U.S. or another
country.
●
The
USPTO allowed a new patent with claims covering compositions of
matter for a novel family of camsirubicin analogs (2-pyrrilino
camsirubicins). 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 and thereby may
enable use in cancer types beyond those treatable with
doxorubicin.
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 (1) IsoTherapeutics Group, LLC to
develop, optimize and manufacture humanized urokinase plasminogen
activator receptor radioimmunotherapeutics (uPRITs), (2) 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 (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 and to participate in the potential
clinical development of uPRITs.
●
A
peer-reviewed preclinical study that reported the potential utility
of MNPR-101 conjugates as uPAR imaging agents to improve surgical
outcomes in bladder cancer and for surveillance post-resection was
published in The European Journal of
Cancer. This publication builds
on previous studies using conjugates of MNPR-101 and its mouse
analog, ATN-658, for the optical imaging of oral and colon
cancer.
●
A
peer-reviewed study titled “Engineered Antibody
Fragment against the Urokinase Plasminogen Activator for Fast
Delineation of Triple-Negative Breast Cancer by Positron Emission
Tomography” demonstrated
the potential to identify breast cancers with urokinase plasminogen
activator (uPA) overexpression, and monitor uPA expression during
treatment using positron emission tomography (PET) imaging along
with the Company’s uPA antibody fragment
radiotracer.
Results for the First Quarter Ended March 31, 2021 Compared to the
First Quarter Ended March 31, 2020
Cash and Net Loss
Cash
and cash equivalents as of March 31, 2021 were $25.7 million.
Monopar anticipates that its current cash and cash equivalents,
which includes $10.9 million of net proceeds raised in the first
quarter of 2021 under the Company’s Capital on
DemandTM
Sales Agreement with JonesTrading
Institutional Services, at an average gross price per share of
$10.20, will fund the Company’s major programs at least
through June 2022, including: funding and completing the Phase 2b
portion of the VOICE clinical trial and commencing of the Phase 3
portion; funding the camsirubicin run-in clinical trial; continuing
advancement of the COVID-19 uPRIT program; and developing other
MNPR-101 related compounds and technologies. The Company plans to
raise additional funds and/or engage a partner within the next 12
months to complete the VOICE clinical program and continue the
camsirubicin clinical development beyond the run-in clinical
trial.
Net loss for
the first quarter of 2021 was $1.9 million or $0.16 per share
compared to net loss of $1.1 million or $0.10 per share for the
first quarter of 2020.
Research and Development (R&D)
Expenses
R&D expenses for the first
quarter of 2021 were $1.2 million compared to $0.3 million for the
first quarter of 2020. This increase of $0.9 million was primarily
attributed to increases of (1) $0.3 million for the planning of the
GEIS-sponsored camsirubicin Phase 2 clinical trial including drug
product manufacturing, (2) $0.3 million for R&D personnel
expenses, (3) $0.2 million for the VOICE clinical trial and
manufacturing-related expenses, and (4) $0.1 million for other
R&D operating expenses.
General and Administrative (G&A) Expenses
G&A
expenses for the first quarter of 2021 were $0.7 million, a nominal
decrease from $0.8 million of G&A expenses for the first
quarter of 2020.
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, our ability to begin the camsirubicin run-in
clinical trial in the second half 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 major programs through June 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 camsirubicin clinical program 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 camsirubicin
clinical program; not successfully developing a COVID-19 uPRIT with
the Company’s development collaborators and not successfully
developing MNPR-101 conjugates and related compounds for various
potential indications and technologies. 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:
@MonoparTx
Monopar
Therapeutics