Monopar Therapeutics Reports Second Quarter 2023 Financial Results and Recent Developments
10 Agosto 2023 - 1:00PM
Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR),
a clinical-stage biopharmaceutical company focused on developing
innovative treatments for cancer patients, today announced second
quarter 2023 financial results and summarized recent developments.
Recent
Developments
Camsirubicin –
Phase 1b Dose-Escalation
Trial, Treating
Fifth Dose-Level Cohort
(650 mg/m2)
- As recently reported, both of the advanced soft tissue sarcoma
(ASTS) patients so far in the fifth dose-level cohort (650 mg/m2)
have experienced tumor size reductions – of 18% and 20%,
respectively – after the first two cycles of camsirubicin
treatment. These patients are set to receive additional cycles of
camsirubicin treatment, which may result in further tumor size
reduction.
- Phase 1b clinical trial data continue to support Monopar’s
dose-response hypothesis with camsirubicin. The best response seen
prior to the current 650 mg/m2 dose level was a 21% reduction in
tumor size in a patient after receiving six cycles of camsirubicin
treatment at the immediately prior dose level (520 mg/m2). This
patient’s cancer was unresectable at study entry, but after the
tumor size reduction, the patient was able to undergo a successful
surgical removal of the cancer with clear margins. All three
patients at this prior dose level (520 mg/m2) achieved stable
disease with either a net reduction or no overall change in tumor
size per RECIST 1.1 while on study drug.
- No drug-related cardiotoxicity has been observed in the trial
to date as evaluated by the industry standard left ventricular
ejection fraction (LVEF). This compares favorably to the
well-documented cumulative dose-restricting cardiotoxicity
experienced with doxorubicin, the current first-line treatment for
ASTS.
MNPR101 for
Radiopharmaceutical Use
– Promising
Preclinical Studies
Support First in Human Study
- MNPR-101 is a uPAR-targeting antibody being developed in
collaboration with NorthStar Medical Radioisotopes LLC as a
precision radiopharmaceutical for both imaging and treatment of
cancer. Both the imaging and therapeutic agents are showing promise
in preclinical studies and are advancing toward first-in-human
(FIH) studies potentially as early as the end of this year.
- MNPR-101-Zr is a cancer imaging agent radiolabeled with
89Zirconium, a positron emission tomography (PET) imaging isotope.
Recent preclinical imaging studies have shown selective, high, and
enduring tumor uptake across multiple aggressive cancers including
pancreatic, colorectal, and triple negative breast cancers.
- MNPR-101-RIT is a cancer therapeutic agent radiolabeled with
225Actinium, a powerful alpha-emitting isotope. Preclinical studies
show a favorable biodistribution and a strong, dose-dependent
anti-tumor effect in triple-negative breast cancer models.
- Monopar and the Cancer Science Institute at the National
University of Singapore (NUS) recently announced a collaborative
effort to investigate uPAR expression levels in subtypes of ASTS as
a means to identify the most promising subtypes to pursue in
subsequent human clinical trials using MNPR-101-Zr and
MNPR-101-RIT.
MNPR202
Promising Preclinical
Data Ignite
Further Research
- MNPR202 is a camsirubicin analog designed to retain the same
potentially non-cardiotoxic backbone as camsirubicin but is
modified at other positions which may enable it to work in cancers
that are resistant to doxorubicin, one of the most commonly-used
cancer drugs worldwide.
- In collaboration with Dr. Anand Jeyasekharan at NUS,
preclinical studies are showing that MNPR-202 has a similar
cytotoxic potency to doxorubicin but that it works in a distinct
way and against doxorubicin-sensitive cancers as well as
doxorubicin-resistant ones.
- Preclinical work comparing the cardiotoxic effects of
doxorubicin to MNPR-202 is currently underway using
well-established models of doxorubicin cardiotoxicity.
Results for
the Second
Quarter Ended June
30, 2023
Compared to the
Second Quarter
Ended June 30,
2022 Cash and Net Loss
Cash, cash equivalents and short-term investments as of June
30, 2023 were $10.2 million. Monopar expects that its current funds
will be sufficient for Monopar to obtain topline results from its
ongoing open-label Phase 1b camsirubicin clinical trial by
mid-2024 (but this may not be the case if camsirubicin reaches even
higher dose levels than anticipated and topline results are
deferred as dosing continues beyond mid-2024), advance the
Company’s MNPR-101 radiopharmaceutical program into its
first-in-human clinical trial, and close out Monopar’s terminated
Validive Phase 2b/3 (VOICE) clinical program. The Company estimates
its cash, cash equivalents and short-term investments will fund the
Company’s planned operations at least through September 2024.
Monopar will require additional funding to advance its clinical and
preclinical programs beyond that and anticipates seeking to raise
additional capital within the next 12 months to fund its future
operations.
Net loss for the second quarter of 2023 was $2.2 million or
$0.16 per share compared to net loss of $2.8 million or $0.22 per
share for the second quarter of 2022.
Research and
Development (R&D)
Expenses
R&D expenses for the three months ended June 30, 2023
were $1,595,000, compared to $2,078,000 for the three months ended
June 30, 2022. This represents a decrease of $483,000
primarily attributed to (1) a decrease of $606,000 in camsirubicin
clinical trial expenses and manufacturing-related expenses, and (2)
a decrease of $68,000 in Validive clinical trial and
manufacturing-related expenses. These decreases were partially
offset by (1) a $99,000 increase in non-clinical studies
related to MNPR-101-Zr and MNPR-101-RIT activity, and (2) an
increase of $112,000 in R&D personnel and consulting
expenses.
General and
Administrative (G&A)
Expenses
G&A expenses for the three months ended June 30, 2023 were
$733,000, compared to $685,000 for the three months ended June 30,
2022. This represents an increase of $48,000 primarily attributed
to an increase in G&A salaries and benefits.
About Monopar
Therapeutics
Monopar Therapeutics is a clinical-stage biopharmaceutical
company focused on developing innovative treatments for cancer
patients. Monopar's pipeline consists of camsirubicin (Phase 1b)
for the treatment of advanced soft tissue sarcoma; MNPR101, a
late-stage preclinical antibody for radiopharmaceutical use in
advanced cancers; and MNPR202, an early-stage camsirubicin analog
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: that both Phase 1b camsirubicin
patients are set to receive additional cycles of camsirubicin
treatment, which may result in further tumor size reduction; that
both the MNPR-101 imaging and therapeutic agents are showing
promise in preclinical studies and moving toward first-in-human
studies potentially as early as the end of this year ; the timing
and cost of the Phase 1b camsirubicin clinical trial, MNPR-101
radiopharma program and MNPR-202; and that the Company’s cash, cash
equivalents and short-term investments will be sufficient to fund
planned operations at least through September 2024. 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 camsirubicin
Phase 1b clinical trial within expected timeframes, if at all; the
camsirubicin trial data being inconclusive or negative; the
Company’s inability to raise sufficient funds or engage a partner
to continue the camsirubicin clinical program through and beyond
the Phase 1b clinical trial and to further develop MNPR-101-Zr and
MNPR-101-RIT with its collaboration partners; the effects of
general economic and market conditions on Monopar’s operations and
ability to raise funding, including potential ramifications due to
recent instability in the banking industry; whether the Company
will remain in compliance with Nasdaq listing standards with regard
to its stock price and if the Company becomes non-compliant,
whether the Company will regain compliance within Nasdaq’s time
limits and requirements and its effect on the Company’s ability to
raise funds; and the significant general risks and uncertainties
surrounding the research, development, regulatory approval, and
commercialization of therapeutics and imaging agents. 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.
ContactKim R. Tsuchimoto Chief
Financial Officerkimtsu@monopartx.com
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