Monopar Reports Fourth Quarter and Full-Year 2023 Financial Results and Recent Developments
March 28 2024 - 7:00AM
Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage
biopharmaceutical company focused on developing innovative
treatments for cancer patients, today announced fourth quarter and
full-year 2023 financial results and summarized recent
developments.
Recent Developments
Novel MNPR-101 Radiopharmaceutical Program targeting
uPAR – Phase 1 dosimetry clinical trial to commence in the coming
weeks
- MNPR-101-Zr Phase 1 dosimetry clinical trial has Human Research
Ethics Committee (HREC) clearance in Australia and is on track to
initiate at the Melbourne Theranostic Innovation Centre (MTIC)
within the next few weeks.
- Will enroll patients with advanced cancers, aiming for those
most likely to have uPAR expression, which include a majority of
all triple-negative breast, colorectal, and pancreatic
cancers.
- Will utilize state-of-the-art positron emission tomography
(PET) imaging to assess tumor uptake, normal organ biodistribution,
and safety.
- Internationally recognized radiopharmaceutical physician,
Professor Rodney Hicks, will be the lead investigator for the
trial.
- Positive preclinical data support the potential of a MNPR-101
based radiopharmaceutical to provide a very meaningful clinical
benefit to patients.
- In February 2024, Monopar shared preclinical biodistribution
and efficacy data using imaging and therapeutic radioisotopes
conjugated to MNPR-101. Imaging with MNPR-101-Zr in a pancreatic
cancer human tumor xenograft mouse model showed high specificity
and durable tumor uptake. With the therapeutic radioisotope
actinium-225 (Ac-225) conjugated to MNPR-101, near complete
elimination of tumor was achieved after a single injection in a
triple negative breast human tumor xenograft mouse model.
- In March 2024, Monopar shared biodistribution data using the
therapeutic radioisotope Lutetium-177 (Lu-177) conjugated to
MNPR-101. The images show highly preferential uptake in tumor,
helping explain the near complete elimination of tumors observed
after a single injection of therapeutic radioisotopes bound to
MNPR-101.
Camsirubicin – Phase 1b Dose-Escalation Trial, Currently
enrolling the Fifth Dose-Level Cohort (650
mg/m2)
- Monopar is presently enrolling patients at the fifth dose
level, which is over twice the highest dose reached in any prior
camsirubicin clinical trial (650 mg/m2 versus 265 mg/m2).
Results for the Fourth Quarter and Year Ended December
31, 2023, Compared to the Fourth Quarter and Year Ended December
31, 2022
Cash and Net Loss
Cash, cash equivalents and short-term investments as of December
31, 2023, were $7.3 million. Monopar expects that its current
funds, which include an additional $3.2 million from the net
proceeds of its at-the-market facility in Q1 2024, will be
sufficient for Monopar to continue operations at least through June
30, 2025, to conduct and conclude its first-in-human clinical trial
with Monopar’s MNPR-101-Zr radiopharma program and continue the
Company’s other pipeline programs.
Net loss for the fourth quarter of 2023 was $1.8 million or
$0.12 per share compared to $2.9 million or $0.22 per share for the
fourth quarter of 2022. Net loss for the year ended December 31,
2023 was $8.4 million or $0.61 per share compared to $10.5 million
or $0.83 per share for the year ended December 31, 2022.
Research and Development (R&D) Expenses
R&D expenses for the fourth quarter of 2023 were $1.0
million compared to $2.1 million for the fourth quarter of 2022.
This decrease of $1.1 million was primarily due to (1) a decrease
of $0.9 million for Validive clinical trial expense, (2) a decrease
of $0.2 million in camsirubicin manufacturing costs, and (3) a
decrease of $0.1 million in R&D salaries, partially offset by
an increase of $0.1 million in MNPR-101 radiopharmaceutical program
development activities.
R&D expenses for the year ended December 31, 2023 were $5.6
million compared to $7.6 million for the year ended December 31,
2022. This decrease of $2.0 million was primarily due to (1) a
decrease of $1.4 million for Validive clinical trial
and manufacturing costs, (2) a decrease of $0.9 million
in camsirubicin clinical trial and manufacturing costs, (3) a
decrease of $0.1 million in R&D salaries, partially offset by
an increase of $0.4 million in MNPR-101 radiopharma activity.
General and Administrative (G&A)
Expenses
G&A expenses for the fourth quarter of 2023 were $0.9
million, compared to $0.8 million for the fourth quarter of 2022.
This increase of $0.1 million was primarily due to an increase in
G&A personnel expenses.
G&A expenses for the year ended December 31, 2023 were $3.2
million, compared to $2.9 million for the year ended December 31,
2022. This increase of $0.3 million was primarily due to an
increase in G&A personnel expenses.
About Monopar Therapeutics Inc. Monopar Therapeutics
is a clinical-stage biopharmaceutical company focused on developing
innovative treatments for cancer patients. Monopar's pipeline
consists of Phase 1b-stage camsirubicin for the treatment of
advanced soft tissue sarcoma; Phase 1-stage MNPR-101 for
radiopharmaceutical use in various advanced cancers; and an
early-stage camsirubicin analog, MNPR-202. For more information,
visit: www.monopartx.com.
Forward-Looking StatementsStatements 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:
that Monopar’s Phase 1 dosimetry clinical trial will commence in
the coming weeks; that Professor Rodney Hicks, will be the lead
investigator for Monopar’s MNPR-101-Zr Phase 1 dosimetry clinical
trial; that Professor Hicks will enroll patients at MTIC in
Australia; that positive preclinical data to date support the
potential of a MNPR-101 based radiopharmaceutical (MNPR-101-RIT) to
provide a very meaningful clinical benefit to patients and that
Monopar expects that its current funds, including the net proceeds
from its at-the-market facility in Q1 2024, will be sufficient for
Monopar to continue operations beyond June 30, 2025. The
forward-looking statements involve risks and uncertainties
including, but not limited to: that we may expend available funds
sooner than anticipated or require additional funding due to change
in circumstances or unanticipated events; that future preclinical
or clinical data will not be as promising as the data to date; not
initiating and enrolling the MNPR-101-Zr Phase 1 clinical trial in
the coming weeks or at all; that MNPR-101-Zr and/or MNPR-101
conjugated to a therapeutic radioisotope may cause unexpected
serious adverse effects or fail to image or be effective against
the cancer tumors in humans; and the significant general risks and
uncertainties surrounding the research, development, regulatory
approval, and commercialization of imaging agents and 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:
Monopar Therapeutics Inc.Investor
Relations Kim R. Tsuchimoto Chief Financial
Officer kimtsu@monopartx.com
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Twitter: @MonoparTx LinkedIn: Monopar Therapeutics
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