Monopar Therapeutics Reports Second Quarter 2021
Financial Results and Recent Business Updates
Camsirubicin Phase 1b Clinical Trial Anticipated to Start in the
U.S. in Q4 2021
Validive®
Phase 2b/3 VOICE Trial on Track for
Reaching Interim Analysis in H1 2022
Wilmette,
IL, August 12, 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 second 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 successfully reached its target of 20
activated clinical trial sites for the Phase 2b portion of the
trial. Monopar plans to activate additional clinical trial sites,
potentially including sites outside of the U.S. There is no
FDA-approved prevention or treatment for CRT-induced SOM. The VOICE
trial is on track for reaching interim analysis in the first half
of 2022.
Camsirubicin and MNPR-202 and Related Analogs
●
The
U.S. Food and Drug Administration cleared Monopar to proceed under
its Investigational New Drug (IND) application with an open-label
Phase 1b dose-escalation clinical trial evaluating camsirubicin
plus growth factor support (pegfilgrastim) in patients with
advanced soft tissue sarcoma (ASTS). Monopar anticipates dosing the
first patient in the fourth quarter of 2021.
●
Monopar
entered into a collaboration agreement with the Cancer Science
Institute of Singapore, one of Asia’s premier cancer research
centers, at the National University of Singapore (consistently
ranked as one of the world's top universities) to evaluate the
activity of MNPR-202 and related analogs in preclinical models of
multiple types of cancer. MNPR-202, a camsirubicin analog, was
designed to retain the same potentially non-cardiotoxic backbone as
camsirubicin but is modified at other positions which may enable it
to be efficacious in certain cancers that are resistant to
camsirubicin and doxorubicin. MNPR-202 and related analogs are
covered under a newly issued U.S. composition of matter patent
(US10,450,340).
MNPR-101 RIT and Related Compounds
●
Monopar
and NorthStar Medical Radioisotopes, LLC (NorthStar) filed a
provisional patent application with the U.S. Patent and Trademark
Office (USPTO) titled “Bio-Targeted Radiopharmaceutical
Compositions Containing Ac-225 and Methods of Preparation.”
Radiopharmaceutical therapy is a promising approach to treat cancer
and other diseases using radioactive metals bound to
proteins/antibodies to target and kill cells. Actinium-225 (Ac-225)
is emerging as a radioactive isotope of choice for
radiopharmaceuticals due to favorable properties such as its long
half-life and selective induction of localized tumor cell
death.
●
Monopar and NorthStar filed a provisional
composition of matter patent application titled
“Urokinase Plasminogen
Activator Receptor-Targeted Radiopharmaceutical” covering a
radiotherapeutic consisting of Monopar’s proprietary antibody
MNPR-101 bound to Ac-225 via the metal binding agent PCTA. This
radioimmunotherapeutic (RIT) has demonstrated 98% radiochemical
purity and high stability, and has the potential to be a highly
selective, potent treatment for a variety of cancers, severe
COVID-19, and other diseases characterized by aberrant urokinase
plasminogen activator receptor expression.
Additions to Monopar’s Executive Management Team
●
Monopar
appointed Andrew Cittadine, MBA, as its Chief Operating Officer.
Mr. Cittadine is an experienced healthcare executive and serial
entrepreneur who has founded or led multiple healthcare businesses
from concept through acquisition by Fortune Global 1000 firms.
These include founding two successful diagnostic imaging companies,
Sensant Corp. and American Biooptics, where he also served as CEO,
and led both through stock or asset acquisitions by Siemens and
Olympus, respectively. He also served as CEO of a critical care
company, SonarMed, which was acquired by Medtronic. Mr. Cittadine
brings to Monopar considerable leadership experience, including
managing manufacturing and quality systems implementation,
executing multi-center clinical trials, and achieving regulatory
clearances for new technologies in both the U.S. and
Europe.
●
Monopar appointed Octávio Costa, MD, as its
Chief Medical Officer. Dr. Costa joined Monopar with over 30 years
of experience overseeing clinical development, clinical operations,
development strategy and global medical affairs. He has extensive
Phase 1 through Phase 4 clinical development expertise and related
regulatory experience. Dr. Costa’s previous roles include
positions of increasing responsibility in clinical development at
Merck, Celgene, Novartis and most recently as Chief Medical Officer
at Rafael Pharmaceuticals. He has played an important role in the
development and life-cycle management of significant marketed
oncology products, including the blockbuster product
REVLIMID®
(lenalidomide) in Latin
America.
Results for the Second Quarter Ended June 30, 2021, Compared to the
Second Quarter Ended June 30, 2020
Cash and Net Loss
Cash
and cash equivalents as of June 30, 2021, were $24.3 million.
Monopar anticipates that its current cash and cash equivalents will
fund the Company’s major programs at least through September
2022, including: completing the Phase 2b portion of the VOICE
clinical trial and commencing of the Phase 3 portion; funding the
camsirubicin Phase 1b clinical trial; continuing advancement of the
MNPR-101 RIT program including related compounds; continuing the
development of MNPR-101 and related technologies in cancer; and
developing MNPR-202 and related analogs in various cancers. 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 Phase
1b clinical trial.
Net
loss for the second quarter of 2021 was $2.1 million or $0.17 per
share compared to net loss of $1.4 million or $0.14 per share for
the second quarter of 2020.
Research and Development (R&D) Expenses
R&D
expenses for the second quarter of 2021 were $1.4 million compared
to $0.8 million for the second quarter of 2020. This increase of
$0.6 million was primarily attributed to increases of (1) $0.3
million for VOICE clinical trial expenses, (2) $0.2 million for
R&D personnel expenses, and (3) $0.1 million for planning of
the Phase 1b camsirubicin clinical trial including regulatory and
manufacturing-related expenses.
General and Administrative (G&A) Expenses
G&A expenses for the second quarter of 2021 were $0.6 million,
essentially the same as the G&A expenses for the second 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; a late-stage preclinical antibody,
MNPR-101, for advanced cancers and severe COVID-19; and an
early-stage camsirubicin analog, MNPR-202, for various cancers.
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 plans to activate
additional clinical trial sites potentially including sites outside
of the U.S.; that the VOICE trial is on track for reaching interim
analysis in the first half of 2022; that Monopar anticipates dosing
the first patient in its Phase 1b camsirubicin clinical trial in
the fourth quarter of 2021; and that Monopar’s cash and cash
equivalents will fund major programs at least through September
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 Phase 1b 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
camsirubicin clinical program beyond the Phase 1b clinical trial;
not successfully developing the MNPR-101 RIT or MNPR-202 with the
Company’s development collaborators; not successfully
developing MNPR-101 and potential technologies in cancer; and the
significant general risks and uncertainties surrounding the
research, development, regulatory approval, and commercialization
of therapeutics. 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
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