Monopar Therapeutics Reports First Quarter 2023 Financial Results and Recent Developments
May 11 2023 - 7:00AM
Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR),
a clinicalstage biopharmaceutical company focused on developing
proprietary therapeutics designed to extend life or improve the
quality of life for cancer patients, today announced first quarter
2023 financial results and summarized recent developments.
Recent
Developments
Camsirubicin –
Phase 1b DoseEscalation
Trial, Currently
Enrolling Fifth
DoseLevel Cohort
- Phase 1b data to date show an improvement in median progression
free survival in patients with advanced soft tissue sarcoma (ASTS)
from what was observed in the prior camsirubicin Phase 2 trial (265
mg/m2). This is supportive of our doseresponse hypothesis with
camsirubicin. Additionally, one of the three patients in the 520
mg/m2 dose-level cohort recently went from having what was
initially determined to be an unresectable cancer to, after several
cycles of camsirubicin treatment and a corresponding 21% reduction
in tumor dimensions, being determined to be resectable. This
changed the course of treatment for this patient, who recently did
undergo surgical resection of the cancer.
- Monopar is currently enrolling patients into the fifth
doselevel cohort (650 mg/m2), which is nearly 2.5x the highest
dose evaluated in any prior camsirubicin clinical trial
(265mg/m2).
- To date, no drugrelated cardiotoxicity has been observed with
camsirubicin treatment as evaluated by the industry standard left
ventricular ejection fraction (LVEF). This compares favorably to
the welldocumented doserestricting cardiotoxicity experienced
with doxorubicin, the current firstline treatment for ASTS.
- 75% of camsirubicin patients in this trial have experienced no
hair loss. Of the 25% with any hair loss, only 8% experienced
>50% hair loss and only 17% experienced low grade hair loss.
This compares favorably to the approximately 50% of doxorubicin
treated patients in recent ASTS clinical trials reporting some
amount of hair loss, with the majority of these patients
experiencing >50% hair loss.
- Only 8% of camsirubicin patients in
the trial have experienced low grade, mild oral mucositis. This
compares favorably to the roughly 3540% of doxorubicin treated
patients in recent ASTS clinical trials that experienced
mildtosevere oral mucositis.
MNPR101 for
Radiopharmaceutical Use
– Promising
Preclinical Studies
Support FIH
Study
- Based on promising preclinical imaging results with MNPR-101-Zr
showing high uptake across multiple tumor types, and with
preclinical therapeutic efficacy and biodistribution studies
utilizing the radioisotopes Ac-225 and Lu-177, Monopar and its
collaborator, NorthStar Medical Radioisotopes, committed to
additional funding with the aim of initiating a first-in-human
(FIH) imaging study with MNPR-101-Zr as early as end of this
year.
- MNPR101Zr is a zirconium89 labeled version of MNPR101 (a
highly selective antibody against the urokinase plasminogen
activator receptor, also known as uPAR). Positron emission
tomography (PET) imaging of preclinical mouse models for
triplenegative breast, colorectal, and pancreatic tumors displayed
high and selective uptake of MNPR101Zr in these uPARexpressing
tumors.
- Preclinical triple negative breast cancer mouse model studies
with Ac-225 and Lu-177 radiolabeled MNPR-101 showed a promising
dose-dependent-anti-cancer-effect and favorable biodistribution
profile. The imaging and therapeutic preclinical results to date
demonstrate the potential utility of MNPR101 as a precision
targeting agent for both imaging and treatment in multiple cancer
indications.
MNPR202 Promising
Preclinical Data
Ignites Further
Research
- MNPR202 is designed to retain the same potentially
noncardiotoxic backbone as camsirubicin but is modified at other
positions which may enable it to work in certain cancers that are
resistant to camsirubicin and doxorubicin.
- Monopar’s collaborator at the National University of Singapore,
Cancer Science Institute, has reported data from blood cancer
preclinical studies showing that MNPR202:
- has a similar cytotoxic potency to doxorubicin
- generates increased DNA damage in the cancer cells compared to
doxorubicin
- has a unique immune activation
profile versus doxorubicin
- demonstrates increased apoptosis
(programmed cell death) compared to doxorubicin
- causes a distinct set of genes to be
upregulated and downregulated versus doxorubicin and
- may also be superior to doxorubicin
in certain combination treatment regimens.
- A combination drug screen with 183 compounds was performed,
revealing distinct differences in the synergy profile between
doxorubicin versus MNPR202 when used along with other compounds.
For example, MNPR202 demonstrated a more favorable synergy profile
with the experimental anticancer agent volasertib compared to
doxorubicin.
Validive Clinical Update
On March 27, 2023, the Company discontinued its Validive Phase
2b/3 VOICE trial based upon its independent Data Safety Monitoring
Board’s determination that the trial did not meet the pre-defined
threshold for efficacy of a 15% absolute difference in severe oral
mucositis prevention between Validive and placebo. Other than
clinical site close-out related expenses to be incurred in Q2 2023,
the Company will not incur any license or royalty obligations and
is not anticipating any significant expenses beyond Q2 2023 related
to Validive.
Results for
the First
Quarter Ended
March 31, 2023,
Compared to the
First Quarter
Ended March 31,
2022 Cash and Net Loss
Cash, cash equivalents and shortterm investments as of March
31, 2023, were $11.7 million. Monopar expects that its current
funds will be sufficient for Monopar to obtain topline results from
its ongoing openlabel Phase 1b camsirubicin clinical trial as
planned by the end of 2023 (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 2023),
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 June 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 first quarter of 2023 was $2.4 million or $0.19
per share compared to net loss of $2.5 million or $0.19 per share
for the first quarter of 2022.
Research and
Development (R&D)
Expenses
R&D expenses for the first quarter of 2023 were $1,653,000
compared to $1,678,000 for the first quarter of 2022. This decrease
of $25,000 was primarily due to a decrease of $120,000 in R&D
personnel costs, partially offset by an increase of $79,000 in
Validive and camsirubicin clinical trial-related and clinical
material manufacturing-related expenses.
General and
Administrative (G&A)
Expenses
G&A expenses for the first quarter of 2023 were $872,000
compared to $779,000 for the first quarter of 2022. This increase
of $93,000 was primarily due to (1) an increase in G&A salaries
and benefits and (2) an increase in accounting and audit fees.
About Monopar
Therapeutics
Monopar Therapeutics is a clinicalstage biopharmaceutical
company focused on developing proprietary therapeutics designed to
extend life or improve the quality of life for cancer patients.
Monopar's pipeline consists of camsirubicin (Phase 1b) for the
treatment of advanced soft tissue sarcoma; MNPR101, a latestage
preclinical antibody for radiopharmaceutical use in advanced
cancers; and MNPR202, an earlystage 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 forwardlooking statements
include statements concerning: that Monopar and its collaborator,
NorthStar Medical Radioisotopes, are aiming to initiate a
firstinhuman imaging study with MNPR101Zr as early as end of
this year; that preclinical results to date demonstrate the
potential utility of MNPR101 as a precision targeting agent for
both imaging and treatment in multiple cancer indications; that
MNPR-202 may be superior to doxorubicin in certain combination
treatment regimens; that Monopar is not anticipating any
significant expenses beyond Q2 2023 related to Validive; the timing
and cost of the Phase 1b camsirubicin clinical trial; and that the
Company’s cash, cash equivalents and short-term investments will be
sufficient to fund planned operations at least through June 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 with
its collaboration partner if its first-in-human trial is
successful; the effects of general economic and market conditions
on Monopar’s operations and ability to raise fundings, including
potential ramifications due to recent instability in the banking
industry; 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.
ContactKim R. Tsuchimoto Chief
Financial Officer kimtsu@monopartx.com
Follow Monopar on social media for
updates:@MonoparTx Monopar Therapeutics
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