Monopar Therapeutics Reports Second Quarter 2024 Financial Results and Recent Developments
09 Agosto 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 second
quarter 2024 financial results and summarized recent developments.
Recent Developments
MNPR-101 for Radiopharmaceutical Use
- MNPR-101 is a uPAR-targeting antibody being developed as a
precision radiopharmaceutical for both imaging and treatment of
various cancers.
- MNPR-101-Zr is a cancer imaging agent radiolabeled with
Zirconium-89, a positron emission tomography (PET) imaging isotope.
Preclinical imaging studies have shown selective, high, and
enduring tumor uptake across multiple uPAR-expressing cancers
including pancreatic, colorectal, and triple negative breast
cancers. An open-label Phase 1 imaging and dosimetry clinical trial
of MNPR-101-Zr was recently initiated and is currently active and
enrolling patients.
- An open-label Phase 1 clinical trial for Monopar’s therapeutic
radiopharmaceutical MNPR-101-RIT is on track to initiate as early
as Q4 2024. Preclinical in vivo studies of therapeutic
radioisotopes, such as actinium-225 and lutetium-177, bound to
MNPR-101 have shown near complete elimination of uPAR-expressing
tumors after just a single injection.
- Monopar’s MNPR-101-RIT abstract was selected as a Top-Rated
Oral Presentation at the European Association of Nuclear Medicine
(EANM) 2024 Annual Congress that will be held in Hamburg, Germany
in October 2024.
- A long-term supply agreement with NorthStar Medical
Radioisotopes LLC was entered into under which NorthStar agreed to
provide actinium-225 for Monopar’s development stage and potential
future commercial stage programs.
- The NorthStar collaboration agreement was amended, with one
primary impact being Monopar gaining full ownership and title to
its lead MNPR-101 radiopharmaceutical platform.
Reverse Stock Split
- On August 5, 2024, the stockholders approved the reverse stock
split proposal at the Annual Meeting of Stockholders, which
provided the Board of Directors with authority to effect a reverse
split within the range of ratios approved by stockholders.
Subsequently, the Board of Directors approved a reverse stock split
of 1 for 5 shares of the Company's common stock in an attempt to
regain compliance with the Nasdaq's continued listing requirements.
The Company expects that the reverse stock split will become
effective at 5:00 pm on Monday, August 12, 2024, and its common
stock will begin trading on a split-adjusted basis at the open of
trading on Tuesday, August 13, 2024.
Results for the Second Quarter Ended June 30, 2024
Compared to the Second Quarter Ended June 30, 2023
Cash and Net Loss
Cash, cash equivalents and short-term investments as of June 30,
2024, were $7.1 million. Monopar projects that its current funds
will be sufficient to continue operations at least through August
31, 2025, including to continue to conduct and conclude our
first-in-human clinical trial with our MNPR-101-Zr
radiopharmaceutical imaging program and to advance our MNPR-101-RIT
program into the clinic. We are in the process of winding down the
camsirubicin Phase 1b clinical trial and the preclinical
development of MNPR-202 due to focusing our finite financial
resources on our radiopharmaceutical programs. We will require
additional funding to further advance our clinical and preclinical
programs, and we anticipate that we will seek to raise additional
capital within the next 12 months to fund our future
operations.
Net loss for the second quarter of 2024 was $1.7 million, or
$0.10 per share, compared to net loss of $2.2 million, or $0.16 per
share, for the second quarter of 2023.
Research and Development (R&D) Expenses
R&D expenses for the quarter ended June 30, 2024 were
$1,131,000, compared to $1,595,000 for the quarter ended June
30, 2023. This represents a decrease of
$464,000 attributed to (1) a decrease of $636,000 in
Validive clinical trial-related expenses due to the closure of the
trial in March 2023, and (2) decrease in camsirubicin manufacturing
costs of $138,000. These decreases were partially offset by a
net increase of $310,000 due to other R&D expenses
attributable to MNPR-101 for radiopharma use.
General and Administrative (G&A)
Expenses
G&A expenses for the quarter ended June 30, 2024 were
$658,000, compared to $733,000 for the quarter ended June 30, 2023.
This represents a decrease of $75,000 primarily attributed to (1) a
decrease in stock-based compensation to the board of directors of
$64,000 as no equity awards were issued to the board of directors
to-date in 2024, and (2) a net decrease in consulting, tax services
and other G&A expenses of $11,000.
Principal Effects of the Pending Reverse
Stock Split
The number of shares authorized remains at 40,000,000. After
effectiveness of the anticipated reverse stock split, the unaudited
proforma number of shares issued and outstanding will be
approximately 3,520,366. The par value will remain unchanged at
$0.001 per share.
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, as well as early development programs against solid
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: that Monopar is on track to initiate
a Phase 1 clinical study in advanced cancers with its therapeutic
radiopharmaceutical MNPR-101-RIT as soon as Q4 2024; that NorthStar
will provide actinium-225 for Monopar’s development stage and
potential future commercial stage programs; that current funds will
be sufficient for Monopar to continue operations at least through
August 31, 2025, including 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; and that the
Company expects that the reverse stock split at a ratio of 1 for
5 shares of common stock will become effective at 5:00 pm on
Monday, August 12, 2024 and its common stock will begin trading on
a split-adjusted basis at the open of trading on Tuesday, August
13, 2024. 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 preclinical data to date; not enrolling sufficient patients
in the MNPR-101-Zr Phase 1 clinical trial; 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; the effects of general
economic and market conditions on Monopar’s operations and ability
to raise funding; whether the Company effects the reverse stock
split as expected and whether the Company is able to regain
compliance with Nasdaq’s requirements within required timeframes or
at all; 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 Karthik Radhakrishnan Chief
Financial Officerkarthik@monopartx.com
Follow Monopar on social media for
updates:Twitter: @MonoparTx LinkedIn: Monopar
Therapeutics
Monopar Therapeutics (NASDAQ:MNPR)
Gráfica de Acción Histórica
De Sep 2024 a Oct 2024
Monopar Therapeutics (NASDAQ:MNPR)
Gráfica de Acción Histórica
De Oct 2023 a Oct 2024