Monopar Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Updates
Rhea-AI Summary
Monopar Therapeutics (Nasdaq: MNPR) reported Q1 2026 results and business updates. The company highlighted new Phase 3 FoCus trial analyses showing greater neurologic benefit of ALXN1840 versus standard of care in Wilson disease and confirmed plans to submit an NDA to the FDA in mid-2026.
Cash, cash equivalents and investments were $137.5 million as of March 31, 2026, expected to fund operations at least through December 31, 2027. Q1 2026 net loss was $3.9 million versus $2.6 million a year earlier, with higher R&D and G&A expenses partly offset by increased interest income.
Positive
- Cash and investments of $137.5 million as of March 31, 2026
- Runway expected to fund operations at least through December 31, 2027
- ALXN1840 NDA submission to FDA remains on track for mid-2026
- Phase 3 FoCus analyses show greater neurologic benefit of ALXN1840 vs standard of care
- Interest income rose to $1.33 million from $0.60 million year-over-year
- Chief Commercial and Strategy Officer appointed in March 2026 to lead launch readiness
Negative
- Net loss increased to $3.9 million from $2.6 million year-over-year
- R&D expenses rose to $3.49 million from $1.64 million
- G&A expenses increased to $1.74 million from $1.58 million
News Market Reaction – MNPR
In the May 14 session, MNPR declined 0.73%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 27 | Q4/FY 2025 earnings | Positive | -0.8% | Reported $140.4M cash, 2025 results, and reaffirmed mid-2026 ALXN1840 NDA plans. |
| Nov 13 | Q3 2025 earnings | Positive | +5.4% | Q3 2025 results, strong cash of $143.7M, and progress toward ALXN1840 NDA. |
| Aug 12 | Q2 2025 earnings | Positive | +14.6% | Q2 2025 results, $53.3M cash, and IND transfer for ALXN1840 with NDA plans. |
| May 13 | Q1 2025 earnings | Positive | -3.6% | Q1 2025 results plus encouraging long-term ALXN1840 data and MNPR-101 trials. |
| Mar 31 | Q4/FY 2024 earnings | Positive | -9.7% | Q4/FY 2024 results, over $55M raised, ALXN1840 in-licensing and Phase 1 starts. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings updates often feature positive cash and ALXN1840 progress, but price reactions have skewed negative or muted in 3 of the last 5 reports.
Over the past year, Monopar’s earnings releases have consistently emphasized building a cash runway and advancing ALXN1840 toward an NDA. Cash rose from $54.6M as of Mar 31, 2025 to $143.7M by Q3 2025 and $140.4M at Dec 31, 2025, supporting operations through at least Dec 31, 2027. Price reactions have been mixed, with notable gains after the Q2 2025 report but declines after several other earnings updates, suggesting investors react selectively to financial and pipeline details.
Key Terms
new drug application regulatory
nda regulatory
u.s. food and drug administration regulatory
phase 3 medical
randomized controlled medical
standard of care medical
stock-based compensation financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
WILMETTE, Ill., May 14, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced first quarter 2026 financial results and provided business updates.
Recent Program Developments
ALXN1840 for Wilson Disease – NDA Submission on Track for Mid-2026
In April 2026, Monopar presented new analyses from the randomized controlled Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline, TMC) at the American Academy of Neurology (AAN) Annual Meeting 2026. The late-breaker oral and poster presentation, titled “Greater clinical benefit with tiomolibdate choline versus standard-of-care in neurologic Wilson disease patients in the Phase 3 FoCus Trial,” demonstrated greater neurologic benefit of ALXN1840 versus standard of care (“SoC”) in Wilson disease patients with neurologic symptoms at baseline.
These results from the FoCus trial will also be presented in a poster at the 12th Congress of the European Academy of Neurology (EAN) in Geneva, Switzerland, June 27-30, 2026. Dr. Aurélia Poujois, MD, PhD, of the Adolphe de Rothschild Foundation Hospital, a leading authority in Wilson disease, will present on June 28 at 12:50 CEST.
Monopar will also present at the European Association for the Study of the Liver (EASL) Congress 2026, a leading global forum for liver disease research. The presentation, titled “Tiomolibdate choline stabilizes liver disease and improves neurological symptoms as well as quality-of-life in treatment-experienced Wilson disease patients,” will be presented by UC Davis Professor Dr. Valentina Medici, MD, MAS, FAASLD. EASL Congress 2026 will take place in Barcelona, Spain, from May 27-30, 2026, with Dr. Medici presenting on May 29 at 08:45 CEST.
The Company remains on track with its plans to submit the New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in mid-2026. Susan Rodriguez, the Company’s Chief Commercial and Strategy Officer who joined in March 2026, is leading commercial readiness activities in preparation for a potential launch.
Financial Results for the First Quarter Ended March 31, 2026, Compared to the First Quarter Ended March 31, 2025
Cash and Net Loss
Cash, cash equivalents and investments as of March 31, 2026, were
Net loss for the first quarter of 2026 was
Research and Development (“R&D”) Expenses
R&D expenses for the first quarter of 2026 were
General and Administrative (“G&A”) Expenses
G&A expenses for the first quarter of 2026 were
Interest Income
Interest income for the first quarter of 2026 was
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including MNPR-101-Zr (Phase 1) for imaging advanced cancers along with MNPR-101-Lu (Phase 1a) and MNPR-101-Ac (late preclinical) 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 the Company remains on track with its plans to submit the New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in mid-2026; that Susan Rodriguez is leading commercial readiness activities in preparation for a potential launch; and that Monopar expects its current funds to support operations at least through December 31, 2027. 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, including the submission of the NDA to the FDA, 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, pre-commercial 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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