Monopar Presents Data Highlighting Residual Disease Burden in Treatment-Experienced Wilson Disease Patients and Long-Term Molybdenum Safety Data for ALXN1840 at AASLD – The Liver Meeting® 2026

ALXN1840-treated subjects had serum uric acid within normal limits over six years, alongside reported absence of molybdenum toxicity.

Rhea-AI Summary

Monopar Therapeutics (MNPR) presented Wilson disease trial baseline findings and long-term safety data for investigational ALXN1840 at AASLD’s Liver Meeting 2026.

In the Phase 3 FoCus trial, 47% of treatment-experienced patients were within the guideline-recommended copper target range at baseline. Among evaluable patients, 73% had at least two of cirrhosis, neurologic symptoms or psychiatric symptoms. These were baseline observations, not treatment outcomes.

A separate poster reported neutral molybdenum balance and no molybdenum toxicity in subjects treated with ALXN1840. Serum uric acid remained within normal limits over six years of treatment.

Positive

• Minor pointALXN1840 safety data showed neutral molybdenum balance and no molybdenum toxicity in treated subjects.
• Minor pointSerum uric acid remained within normal limits over six years of ALXN1840 treatment.

Negative

• None.

News Explained

The AASLD presentation adds a measure of residual disease during longer-term standard care: at baseline, 31% of patients receiving standard-of-care therapy for more than 12 months had 24-hour urinary copper excretion above the guideline-recommended range.

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Market Reaction – MNPR

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On Nov 9, the day this news came out, the latest delayed price for MNPR is 1.66% above the previous close. The latest delayed price is $72.61. Relative volume is above average at 1.8x what this stock usually trades by this time of day.

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Key Figures

Cirrhosis at baseline: 39% vs. 30% Neurologic symptoms at baseline: 79% vs. 83% Psychiatric symptoms at baseline: 75% vs. 70% +4 more

Cirrhosis at baseline

39% vs. 30%

Treatment-experienced vs. treatment-naïve patients

Neurologic symptoms at baseline

79% vs. 83%

Treatment-experienced vs. treatment-naïve patients

Psychiatric symptoms at baseline

75% vs. 70%

Treatment-experienced vs. treatment-naïve patients

Patients with at least two disease manifestations

73%

Evaluable patients at baseline

Treatment-experienced patients within copper target range

47%

At baseline

Patients above urinary copper target range

31%

Standard-of-care therapy for more than 12 months

Long-term ALXN1840 treatment observation

Over six years

Neutral molybdenum balance, no molybdenum toxicity, and serum uric acid within normal limits

Historical Context

1 past event · Latest: Nov 02

1 event

1. Nov 02

   Conference presentation

   24h Move

   -5.8%

   Announced the same FoCus baseline and ALXN1840 safety presentations for AASLD.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

randomized controlled trial, cirrhosis, 24-hour urinary copper excretion, serum uric acid

4 terms

randomized controlled trial medical

"the largest randomized controlled trial ever conducted in Wilson disease"

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

cirrhosis medical

"cirrhosis in 39% and 30%"

Cirrhosis is long-term damage to the liver in which healthy tissue is replaced by scar tissue, leaving the organ stiff and less able to do jobs like filtering blood, making proteins and processing nutrients—think of a sponge that has been hardened and can no longer soak or squeeze properly. Investors care because cirrhosis drives demand for medicines, medical devices and hospital care, affects clinical trial populations and regulatory risk, and can influence healthcare costs, insurance liabilities and workforce productivity.

24-hour urinary copper excretion medical

"24-hour urinary copper excretion above the guideline-recommended copper target range"

The total amount of copper measured in urine collected over a 24-hour period; it quantifies how much copper the body is excreting in one day and is reported in mass or molar units (for example, micrograms or micromoles per day). Clinically it is used to detect and monitor disorders of copper metabolism—high values can indicate excessive copper accumulation or breakdown, low values can reflect impaired excretion—but results depend on correct full-day urine collection, recent dietary or supplement intake, kidney function and laboratory methods, so numeric thresholds and interpretation vary by clinical context.

serum uric acid medical

"with serum uric acid remaining within normal limits"

Concentration of uric acid dissolved in a patient’s blood measured from serum; uric acid is the end product of purine metabolism and is reported in mg/dL or µmol/L after a blood draw processed to remove cells. It is measured by standard laboratory assays and used to detect hyperuricemia or monitor treatments that affect purine breakdown or kidney excretion; values can vary with diet, hydration, kidney function, certain medications and whether the sample was taken during an acute illness, and a single result should be interpreted in that context.

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WILMETTE, Ill., Nov. 09, 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 the presentation of baseline data from the Phase 3 FoCus trial characterizing residual disease burden in treatment-experienced patients with Wilson disease, along with molybdenum balance and long-term uric acid data for ALXN1840 (tiomolibdate choline, TMC), the Company’s investigational therapy for Wilson disease, at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting^® 2026, held Nov. 5–9, 2026, in Denver, Colorado.

Frederick K. Askari, M.D., Ph.D., Associate Professor of Internal Medicine and Director of the Wilson Disease Program at the University of Michigan Health System, delivered an oral presentation of baseline findings from the Phase 3 FoCus study, the largest randomized controlled trial ever conducted in Wilson disease. Key findings included:

• Hepatic, neurologic, and psychiatric disease burden was common in both treatment-experienced and treatment-naïve patients at baseline: cirrhosis in 39% and 30%, neurologic symptoms in 79% and 83%, and psychiatric symptoms in 75% and 70%, respectively.
• Nearly three-quarters (73%) of evaluable patients had at least two of the following at baseline: cirrhosis, neurologic symptoms, or psychiatric symptoms.
• Fewer than half (47%) of treatment-experienced patients were within the guideline-recommended copper target range at baseline.
• Nearly a third (31%) of patients receiving standard-of-care therapy for more than 12 months had 24-hour urinary copper excretion above the guideline-recommended copper target range.

“The substantial disease burden at baseline was striking in both treatment-naïve and treatment-experienced patients. Notably, approximately 80% of patients in both groups had neurologic symptoms, despite treatment-experienced patients having received standard-of-care therapy for a median of more than nine years,” said Dr. Askari. “The findings also highlighted the frequent overlapping hepatic, neurologic, and psychiatric manifestations in both groups. Having this level of detail from the largest randomized controlled trial conducted in Wilson disease gives clinicians a clearer picture of the disease burden patients continue to carry.”

Additionally, Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., presented a poster reporting neutral molybdenum balance and lack of molybdenum toxicity in subjects treated with ALXN1840, with serum uric acid remaining within normal limits over six years of treatment. These findings are consistent with ALXN1840’s known albumin tripartite complex (ATC) mechanism and provide further evidence supporting its long-term safety profile.

The abstracts are available on the AASLD conference website. Copies of the presentations are available in the Investors section of Monopar’s website at www.monopartx.com.

About Wilson Disease

Wilson disease is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. Caused by mutations in the ATP7B gene, the disease impairs the body’s ability to excrete copper, resulting in toxic copper accumulation in the liver, brain, and other organs and potentially fatal outcomes if untreated.

About ALXN1840

ALXN1840 (tiomolibdate choline, TMC) is a novel first-in-class albumin tripartite complex (ATC) activator under investigation for the treatment of Wilson disease. ALXN1840 rapidly mobilizes and tightly sequesters excess copper in ATCs, suppressing its redox reactivity, limiting oxidative damage, and blocking transport across the blood–brain barrier. Clinical data demonstrate that ALXN1840 improves copper balance by increasing fecal copper excretion. In the Phase 3 pivotal trial, ALXN1840 met the primary endpoint by demonstrating rapid and sustained copper mobilization significantly greater than standard of care over 48 weeks in both previously treated and untreated patients. Durable clinical improvement and a favorable safety and tolerability profile were observed across 645 patient-years of follow-up in 266 patients.

About Monopar Therapeutics Inc.

Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage candidate 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, visit: www.monopartx.com.

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. The forward-looking statements involve risks and uncertainties including, but not limited to, uncertainties related to the regulatory and approval process for ALXN1840, 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

Follow Monopar on social media for updates:
X: @MonoparTx | LinkedIn: Monopar Therapeutics

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What long-term ALXN1840 safety findings did Monopar present at AASLD 2026?

ALXN1840-treated subjects had neutral molybdenum balance, no molybdenum toxicity and serum uric acid within normal limits over six years of treatment. ALXN1840 remains an investigational therapy for Wilson disease.

What did Monopar’s Phase 3 FoCus baseline data show about Wilson disease burden?

At baseline, 73% of evaluable patients had at least two of cirrhosis, neurologic symptoms or psychiatric symptoms. Among treatment-experienced patients, 47% were within the guideline-recommended copper target range. These findings describe patients before trial treatment outcomes, rather than demonstrating ALXN1840 efficacy.