On May 13, 2025 Monopar Therapeutics Inc. ("Monopar" or the "Company") (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, reported first quarter 2025 financial results and recent developments (Press release, Monopar Therapeutics, MAY 13, 2025, View Source [SID1234652983]).
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Recent Developments
ALXN1840 for Wilson Disease
On May 7, 2025, Monopar presented long-term efficacy and safety data for ALXN1840 (tiomolybdate choline) at the European Association for the Study of the Liver ("EASL") International Liver Congress 2025, a leading global conference in liver disease.
The data support ALXN1840 as a potential treatment for Wilson disease, a rare genetic disorder that causes toxic copper buildup in organs like the liver and brain. Pooled results from three clinical trials (n=255) showed sustained clinical benefits over a median treatment duration of 2.63 years. Safety data, which included an additional Phase 2 study (n=266), confirmed a favorable safety profile with fewer than 5% of patients experiencing a drug-related serious adverse event ("SAE") and no renal or urinary system SAEs.
Sustained neurological improvement as assessed by the physician as well as the patient using the Unified Wilson Disease Rating Scale ("UWDRS") was observed, as was sustained increased copper mobilization. Patients reported greater convenience and effectiveness when treated with ALXN1840 compared to standard of care, and improvement in the New Wilson Index (a prognostic indicator of the status of the liver) was also observed.
The Company is preparing to submit a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") in early 2026.
MNPR‐101 for Radiopharmaceutical Use
The Company’s MNPR-101-Zr Phase 1 (imaging and dosimetry) and MNPR-101-Lu (therapeutic) Phase 1a clinical trials in advanced cancers are active and enrolling in Australia. Monopar continues its preclinical work with MNPR-101-Ac (therapeutic) with plans to enter the clinic in the future.
Financial Results for the First Quarter Ended March 31, 2025, Compared to the First Quarter Ended March 31, 2024
Cash and Net Loss
Cash, cash equivalents and investments as of March 31, 2025, were $54.6 million. Monopar expects that its current funds will be sufficient to continue operations at least through December 31, 2026, in order to: (1) assemble a regulatory package and file an NDA for ALXN1840; (2) continue to conduct and conclude its first-in-human imaging and dosimetry clinical trial with MNPR-101-Zr; (3) continue to conduct its first-in-human therapeutic clinical trial of MNPR-101-Lu; (4) advance its preclinical MNPR-101-Ac program into the clinic; and (5) invest in internal research and development projects to expand its radiopharmaceutical and rare disease pipeline.
Net loss for the first quarter of 2025 was $2.6 million or $0.38 per share compared to net loss of $1.6 million or $0.51 per share for the first quarter of 2024.
Research and Development ("R&D") Expenses
R&D expenses for the first quarter of 2025 were $1,643,000, compared to $966,000 for the first quarter of 2024. This represents an increase of $677,000 attributed to (1) a $611,000 increase in R&D personnel expenses including stock-based compensation and (2) a $69,000 increase in clinical trial site activity related to MNPR-101 for radiopharmaceutical use, partially offset by (3) a net decrease of $3,000 in other R&D expenses.
General and Administrative ("G&A") Expenses
G&A expenses for the first quarter of 2025 were $1,578,000, compared to $757,000 for the first quarter of 2024. This represents an increase of $821,000 primarily attributed to (1) a $416,000 increase in Board compensation resulting from the grant of stock options during the quarter ended March 31, 2025 (no stock options were granted during the quarter ended March 31, 2024), (2) a $291,000 increase in G&A personnel expenses including stock-based compensation, (3) a $73,000 increase in legal fees and (4) a $41,000 increase in insurance expenses.
Interest Income
Interest income for the first quarter of 2025 increased by $515,000, compared to the first quarter of 2024. The increase is attributed to interest earned on U.S. Treasury securities and higher bank balances in 2025, resulting from over $55 million of funds raised in the fourth quarter of 2024.