Monopar Therapeutics Reports First Quarter 2024 Financial Results and Strategic Focus on its Radiopharma Pipeline
May 09 2024 - 7:00AM
Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR),
a clinical-stage radiopharmaceutical company focused on developing
innovative treatments for cancer patients, today announced
first quarter 2024 financial results and summarized recent
developments.
Recent Developments
The radiopharma space has had numerous positive recent
developments and announcements, from acquisitions to clinical data
to reimbursement rates to commercial demand. Since this past
December alone, four significant acquisitions have been publicly
announced or completed which have had upfront payments ranging from
approximately $1 billion to over $4 billion (BMS/RayzeBio,
AstraZeneca/Fusion Pharma, Eli Lilly/POINT BioPharma, and Novartis/
Mariana Oncology).
Monopar has been generating promising preclinical data, and
recently entered the clinic with its novel, proprietary MNPR-101
radiopharma program targeting the urokinase plasminogen activator
receptor (uPAR). Based on these advances, Monopar has made the
strategic decision to focus its resources on the assets and
capabilities it has been building up in the radiopharma space. As
such, the Company is winding down its non-radiopharma programs,
including camsirubicin (and its Phase 1b clinical trial) as well as
MNPR-202. The Company is targeting launching its second radiopharma
clinical trial as early as the end of this year or the first
quarter of 2025.
MNPR-101 for Radiopharmaceutical
Use – First-in-Human Study with MNPR-101-Zr is Now
Active
- Received clearance and recently initiated a first-in-human
Phase 1 imaging and dosimetry clinical trial with novel
radiopharmaceutical MNPR-101-Zr in advanced cancer patients.
Further information about the MNPR-101-Zr trial is available at
www.ClinicalTrials.gov under study identifier
NCT06337084. This study is being led by
internationally recognized radiopharmaceutical physician Prof.
Rodney Hicks, founder of the Melbourne Theranostic Innovation
Centre (MTIC).
- Optimized imaging and therapeutic MNPR-101 radiopharma
programs, significantly increasing tumor uptake while minimizing
uptake in healthy tissue (link). This work led to in vivo efficacy
studies demonstrating near complete elimination of the tumor after
a single injection of the MNPR-101 radiopharmaceutical agent.
- Imaged the biodistribution of a therapeutic radioisotope bound
to MNPR-101, and demonstrated highly preferential tumor uptake in
the tumor consistent with what is seen with the Zr-89 imaging
radioisotope (link).
- Filed a provisional patent application to protect the recent
advancements and optimizations Monopar has achieved with its
MNPR-101 radiopharma programs.
- Announced that Monopar’s abstract on MNPR-101-Zr radiopharma
program was selected for presentation at the Society of Nuclear
Medicine and Molecular Imaging’s Annual Meeting on June 8-11,
2024.
- Monopar is targeting initiating a Phase 1 clinical study in
advanced cancers with its therapeutic radiopharmaceutical
MNPR-101-RIT as soon as the end of this year or early next
year.
Results for the First Quarter Ended
March 31, 2024, Compared to the First Quarter Ended March 31,
2023
Cash and Net Loss
Cash, cash equivalents and short-term investments as of March
31, 2024, were $8.8 million. Monopar projects that its current
funds will be sufficient to continue operations at least through
June 30, 2025, to continue to conduct and conclude its
first-in-human imaging and dosimetry clinical trial with
MNPR-101-Zr, and to advance the preclinical MNPR-101-RIT
therapeutic program into the clinic. Monopar will require
additional funding to advance its preclinical and clinical programs
beyond that, and anticipates seeking to raise additional capital
within the next 12 months to fund its future operations.
Net loss for the first quarter of 2024 was $1.6 million or $0.10
per share compared to net loss of $2.4 million or $0.19 per share
for the first quarter of 2023.
Research and Development (R&D)
Expenses
R&D expenses for the first quarter of 2024 were $966,000
compared to $1,653,000 for the first quarter of 2023. This decrease
of $687,000 was primarily due to a decrease of $716,000 in Validive
clinical trial-related expenses due to the closure of the trial in
March 2023, partially offset by a net increase of $29,000 in other
R&D expenses.
General and Administrative (G&A)
Expenses
G&A expenses for the first quarter of 2024 were $757,000,
compared to $872,000 for the first quarter of 2023. This represents
a decrease of $115,000 primarily attributed to (1) a decrease in
stock-based compensation to the non-employee directors of $70,000
as no equity awards were issued in the first quarter of 2024
compared to the first quarter of 2023, (2) a reduction of $62,000
in patent expenses related to the closure of the Validive trial,
and (3) a reduction of stock-based compensation expenses to
employees of $16,000 due to the full vesting of the 2020 grants in
the fourth quarter of 2023, partially offset by a net increase in
consulting, tax services and other G&A expenses of $33,000.
About Monopar Therapeutics
Monopar Therapeutics is a clinical-stage radiopharmaceutical
company focused on developing innovative treatments for cancer
patients, including Phase 1-stage MNPR-101-Zr for imaging advanced
cancers and late preclinical-stage MNPR-101
radio-immuno-therapeutic (RIT) for the treatment of advanced
cancers. For more information, and links to SEC filings that
contain detailed financial information,
visit: https://ir.monopartx.com/quarterly-reports.
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
and are not limited to: that Monopar is targeting initiating a
Phase 1 clinical study in advanced cancers with its therapeutic
radiopharmaceutical MNPR-101-RIT as soon as the end of this year or
early next year; and that current funds will be sufficient for
Monopar to continue operations at least through June 30, 2025, to
continue to conduct and conclude its first-in-human clinical trial
with Monopar’s MNPR-101-Zr radiopharmaceutical program, and to
advance the preclinical MNPR-101-RIT therapeutic program into the
clinic. 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 enrolling sufficient patients in the
MNPR-101-Zr Phase 1 clinical trial 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 RelationsKim
R. TsuchimotoChief Financial Officerkimtsu@monopartx.com
Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar
Therapeutics
Monopar Therapeutics (NASDAQ:MNPR)
Historical Stock Chart
From Apr 2024 to May 2024
Monopar Therapeutics (NASDAQ:MNPR)
Historical Stock Chart
From May 2023 to May 2024