Monopar Therapeutics Reports Second Quarter 2025 Financial Results and Recent Developments
Rhea-AI Summary
Monopar Therapeutics (Nasdaq: MNPR) reported its Q2 2025 financial results and key developments. The company ended Q2 with $53.3 million in cash, expected to fund operations through December 2026. Notable developments include the transfer of ALXN1840's IND from Alexion Pharmaceuticals, with plans to submit an NDA in early 2026 for Wilson Disease treatment.
The company reported a Q2 2025 net loss of $2.5 million ($0.35 per share), compared to $1.7 million ($0.49 per share) in Q2 2024. R&D expenses increased to $1.73 million, while G&A expenses rose to $1.50 million. Their MNPR-101 radiopharmaceutical program continues with active Phase 1 trials in Australia and an Expanded Access Program in the U.S.
Positive
- Strong cash position of $53.3 million, sufficient through December 2026
- Successfully acquired ALXN1840 IND from Alexion Pharmaceuticals
- Multiple active clinical trials for MNPR-101 radiopharmaceutical program
- Decreased loss per share from $0.49 in Q2 2024 to $0.35 in Q2 2025
- Significant increase in interest income from higher cash balances
Negative
- Net loss increased to $2.5 million from $1.7 million year-over-year
- R&D expenses increased by $599,023 compared to Q2 2024
- G&A expenses more than doubled to $1.50 million from $657,806 year-over-year
News Market Reaction
On the day this news was published, MNPR gained 14.55%, reflecting a significant positive market reaction. Argus tracked a peak move of +7.5% during that session. Argus tracked a trough of -5.4% from its starting point during tracking. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $27M to the company's valuation, bringing the market cap to $216M at that time.
Data tracked by StockTitan Argus on the day of publication.
WILMETTE, Ill., Aug. 12, 2025 (GLOBE NEWSWIRE) -- 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, today announced second quarter 2025 financial results and recent developments.
Recent Developments
ALXN1840 for Wilson Disease
On June 6, 2025, Alexion Pharmaceuticals officially transferred sponsorship of the investigational new drug (“IND”) application for ALXN1840 to Monopar. The U.S. Food and Drug Administration (“FDA”) acknowledged this change on July 29, 2025, confirming that the transfer was effective as of June 6, 2025. Monopar is now fully responsible for the program, including its commercial advancement and compliance with all applicable federal regulations.
Monopar is preparing to submit a New Drug Application (“NDA”) to the 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, and the Company’s Expanded Access Program (also referred to as compassionate use) for MNPR-101-Zr and MNPR-101-Lu is active and enrolling in the U. S. Monopar continues its preclinical work with MNPR-101-Ac (therapeutic) with plans to enter the clinic in the future.
Financial Results for the Second Quarter Ended June 30, 2025, Compared to the Second Quarter Ended June 30, 2024
Cash and Net Loss
Cash, cash equivalents and investments as of June 30, 2025, were
Net loss for the second quarter of 2025 was
Research and Development (“R&D”) Expenses
R&D expenses for the second quarter of 2025 were
General and Administrative (“G&A”) Expenses
G&A expenses for the second quarter of 2025 were
Interest Income
Interest income for the three months ended June 30, 2025, increased by
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac for the treatment of advanced 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 is responsible for advancing the program commercially; that Monopar is preparing to submit an NDA to the FDA in early 2026; that Monopar continues its preclinical work with MNPR-101-Ac with the plan to enter the clinic in the future; and that Monopar expects that its current funds will be sufficient to continue operations at least through December 31, 2026. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar’s ability to raise sufficient funds in order for the Company to support continued preclinical, clinical, regulatory, precommercial and commercial development of its programs and to make contractual milestone payments, as well as its ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and 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.
CONTACT:
Monopar Therapeutics Inc.
Investor Relations
Quan Vu
Chief Financial Officer
vu@monopartx.com
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FAQ
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