On August 10, 2023 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported second quarter 2023 financial results and summarized recent developments (Press release, Monopar Therapeutics, AUG 10, 2023, View Source [SID1234634233]).
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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.