Monopar Therapeutics Reports Third Quarter 2023 Financial Results and Recent Developments
November 09 2023 - 7:00AM
Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR),
a clinical-stage biopharmaceutical company focused on developing
innovative treatments for cancer patients, today announced
third quarter 2023 financial results and summarized recent
developments.
Recent Developments
MNPR-101 for Radiopharmaceutical
Use – First-in-Human Study to Start Potentially As
Early As December of This Year
- Monopar continues to advance its MNPR-101 radiopharmaceutical
program towards a first-in-human study in patients with
advanced solid tumors. MNPR‐101 is a highly selective antibody
against uPAR, a promising target overexpressed in multiple solid
tumors, being developed as a precision radiopharmaceutical for
both imaging and treatment of cancer. Much of the work with
MNPR-101 is being done in collaboration with NorthStar Medical
Radioisotopes LLC.
- Preclinical data with MNPR-101 labeled with zirconium-89
(imaging radioisotope) as well as actinium-225 (a powerful
alpha-emitting therapeutic radioisotope) so far have shown
selective, high, and durable tumor uptake across multiple
aggressive cancers including pancreatic, colorectal, and triple
negative breast cancers. In addition, a strong, dose-dependent
anti-tumor effect has been seen in in vivo pancreatic and
triple-negative breast cancer models with favorable biodistribution
profiles.
Camsirubicin – Phase 1b
Dose-Escalation Trial, Treating Fifth
Dose-Level Cohort (650
mg/m2)
- The Phase 1b open-label, dose-escalating clinical trial of
camsirubicin in patients with advanced soft tissue sarcoma (ASTS)
is in the fifth dose-level cohort (650 mg/m2), which is nearly 2.5x
the highest dose evaluated in any prior camsirubicin clinical trial
(265 mg/m2). We have dosed to date two patients in the fifth dose
cohort, and both experienced tumor size reductions, one of
approximately 18% and the other of approximately 20%.
- At the 2023 Connective Tissue Oncology Society (CTOS) Annual
Meeting, Monopar presented Phase 1b clinical trial results to-date.
So far, 9 out of the 14 enrolled ASTS patients have had stable
disease (SD, as defined by RECIST 1.1 criteria) after camsirubicin
treatment, including all patients in the fourth and fifth dose
cohorts. No dose-limiting toxicity, as defined in the protocol, has
been observed to-date. A medically complex patient in the fifth
dose cohort has an ongoing left ventricular ejection fraction
("LVEF") decrease and is being assessed for potential anthracycline
(camsirubicin) induced cardiotoxicity. This patient has a BMI of
42.5, one kidney, hypertension, a long-standing heart murmur, and a
maternal history of heart failure.
MNPR-202 - Encouraging Preclinical
Results Support Further Research
- MNPR-202 is a camsirubicin analog that retains the same
potentially non-cardiotoxic backbone as camsirubicin but is
modified at other positions which may enable it to work against
cancers that are resistant to doxorubicin, one of the most
commonly-used cancer drugs worldwide.
- In collaboration with Dr. Anand Jeyasekharan at National
University of Singapore, preclinical studies are showing that
MNPR-202 has a similar cytotoxic potency to doxorubicin but that it
works in a distinct way as compared to doxorubicin.
- In a preclinical study using a human iPSC cardiomyocyte
model to evaluate heart toxicity, cells treated with MNPR-202
maintained a greater contractile amplitude and a more consistent
and regular beat rate relative to doxorubicin-treated cells,
indicating that MNPR-202 has a broader therapeutic window than
doxorubicin with respect to cardiotoxicity.
Results for the Third Quarter Ended
September 30, 2023 Compared to the Third Quarter Ended
September 30, 2022
Cash and Net Loss
Cash, cash equivalents and short-term investments as of
September 30, 2023 were $8.5 million. Monopar expects
that its current funds will be sufficient for Monopar to advance
the Company's MNPR-101 radiopharmaceutical program into its
first-in-human clinical trial, 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), and continue preclinical studies
of MNPR-202. The Company estimates its cash, cash equivalents and
short-term investments will fund the Company’s planned operations
at least through November 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 third quarter of 2023 was
$2.0 million or $0.14 per share compared to net loss of
$2.4 million or $0.19 per share for the
third quarter of 2022.
Research and Development (R&D) Expenses
R&D expenses for the three months ended September 30,
2023 were $1,317,000, compared to $1,732,000 for the three months
ended September 30, 2022. This represents a decrease of
$415,000 primarily attributed to a decrease of $673,000 in
Validive clinical trial-related and clinical material
manufacturing-related expenses offset by (1) an increase of
$161,000 in non-clinical studies related to the MNPR-101
radiopharmaceutical program, (2) an increase of $78,000
in camsirubicin clinical trial expenses including patient dosing
and manufacturing-related expenses, and (3) a
net increase of $19,000 due to other R&D
expenses.
General and Administrative (G&A)
Expenses
G&A expenses for the three months ended
September 30, 2023 were $749,000, compared to $675,000 for the
three months ended September 30, 2022. This represents an
increase of $74,000 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; MNPR-101, a
late-stage preclinical antibody for radiopharmaceutical use in
advanced cancers; and MNPR-202, 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 Monopar continues to advance
its MNPR-101 radiopharmaceutical program towards the first-in-human
study in patients with advanced solid tumors; that Monopar
anticipates commencing a first-in-human clinical trial for its
MNPR-101 radiopharmaceutical program potentially as early as
December of this year; and that the Company’s cash, cash
equivalents and short-term investments will be sufficient to fund
planned operations at least through November 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 partner; not regaining Nasdaq
listing compliance; the effects of general economic and market
conditions on Monopar’s operations and ability to raise funding,
including potential ramifications of the threat of or actual
delisting from Nasdaq; 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. TsuchimotoChief Financial
Officerkimtsu@monopartx.com
Follow Monopar on social media for updates:@MonoparTx Monopar
Therapeutics
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