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Monopar Announces ALXN1840 Data Selected for Late-Breaker Presentation at EASL Congress 2025

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Monopar Therapeutics announced that their ALXN1840 drug candidate for Wilson disease has been selected for a prestigious late-breaker presentation at the EASL International Liver Congress 2025 in Amsterdam.

The presentation will focus on long-term efficacy and safety data of tiomolybdate choline (ALXN1840). The selection as a late-breaker abstract is significant, as these slots are reserved for the most recent and impactful research findings that could substantially influence the field.

The presentation titled "Sustained long-term clinical improvement in Wilson disease patients on tiomolybdate choline" will be delivered by Dr. Karl Heinz Weiss on May 7, 2025. The poster will be made available on Monopar's website the same day.

This selection underscores the potential importance of the research, as late-breaker abstracts must meet strict criteria including presenting latest findings, demonstrating significant potential impact, and featuring prospective clinical studies.

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Positive

  • ALXN1840 data selected for prestigious late-breaker presentation at EASL 2025, indicating significant research findings
  • Study data met rigorous selection criteria for late-breaker status, suggesting potentially impactful results
  • Long-term efficacy and safety data to be presented, showing sustained clinical improvement in Wilson disease patients

Negative

  • None.

Insights

Monopar's Wilson disease treatment data accepted for prestigious EASL conference validates scientific significance and suggests positive clinical outcomes.

The acceptance of Monopar's ALXN1840 (tiomolybdate choline) data as a late-breaker presentation at the European Association for the Study of the Liver (EASL) Congress 2025 represents a significant scientific endorsement. Per the article, EASL late-breaker spots are reserved for "the most recent and significant findings" with "potential to impact the field in a substantial manner" - making this acceptance particularly noteworthy.

The presentation title "Sustained long-term clinical improvement in Wilson disease patients on tiomolybdate choline" strongly suggests positive durability in treatment outcomes, which is critical for chronic conditions requiring lifelong management. The abstract underwent what EASL describes as a "rigorous review" process with an acceptance rate "lower than regular abstracts" - providing external validation from hepatology experts regarding the data's significance.

For clinical-stage biopharmaceutical companies like Monopar, acceptance at prestigious medical conferences serves multiple strategic purposes: establishing scientific credibility, increasing visibility among potential partners and investors, and building momentum toward potential regulatory submissions. The selection of Dr. Karl Heinz Weiss as presenter adds further credibility, as he is recognized in the Wilson disease research community.

While specific efficacy metrics aren't disclosed in this announcement, the May 7th presentation will likely provide investors with important insights into this candidate's clinical profile and potential competitive positioning in the Wilson disease treatment landscape.

Late-breaker acceptance for tiomolybdate choline data suggests meaningful clinical advancements for Wilson disease patients with unmet needs.

Wilson disease represents a significant unmet medical need despite being a rare genetic disorder. This autosomal recessive condition affects approximately 1 in 30,000 individuals worldwide, causing toxic copper accumulation primarily in the liver and brain. Current standard treatments (chelating agents like penicillamine and zinc therapy) have limitations including serious side effects, adherence challenges, and variable efficacy.

The EASL International Liver Congress acceptance of Monopar's tiomolybdate choline data as a late-breaker abstract is particularly meaningful given the congress's criteria requiring that research "is considered highly significant with the potential to impact the field in a substantial manner." For Wilson disease patients, the presentation title suggesting "sustained long-term clinical improvement" addresses a critical aspect of disease management - these patients require lifelong treatment, making durability of effect and long-term safety essential therapeutic considerations.

The article specifies that qualifying clinical studies must be prospective rather than retrospective analyses, suggesting this data comes from well-designed forward-looking investigations rather than historical case reviews. This methodological rigor strengthens the potential clinical relevance of the findings.

While we must await the actual presentation for specific efficacy and safety metrics, this acceptance signals that independent hepatology experts view these findings as potentially advancing the standard of care for a condition with significant quality-of-life implications and life-threatening complications when inadequately managed.

WILMETTE, Ill., April 29, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, today announced that data on the long term efficacy and safety of its ALXN1840 (tiomolybdate choline) drug candidate for Wilson disease has been accepted for a late-breaker poster presentation at the European Association for the Study of the Liver (“EASL”) International Liver Congress 2025. EASL is recognized as one of the premier events in the hepatology space and will be held in Amsterdam, Netherlands from May 7 – 10, 2025.

Late-breaker provides an opportunity to present “the most recent and significant findings,” according to EASL. Criteria for late-breaker abstracts include: (1) they present the latest, up-to-date research findings; (2) the research is considered highly significant with the potential to impact the field in a substantial manner; and (3) clinical studies should be prospective. Late-breaker abstracts undergo a rigorous review, and the acceptance rate is lower than regular abstracts with only the most compelling abstracts selected.

Details of the EASL Congress 2025 late-breaker poster presentation are as follows:

Title: Sustained long-term clinical improvement in Wilson disease patients on tiomolybdate choline
Abstract Number: LB25251
Session: Late-breaker Posters
Date and Time: Wednesday, May 7, 8:30 a.m. CET
Presenter: Karl Heinz Weiss, M.D.
Location: Amsterdam, Netherlands

The poster to be presented at EASL 2025 will be available online at www.monopartx.com on May 7, 2025.

About Monopar Therapeutics Inc.

Monopar Therapeutics is a clinical-stage biotechnology company with late-stage ALXN1840 for Wilson disease, and radiopharma 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-Ac225 for the treatment of advanced cancers. For more information, visit: www.monopartx.com.

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

When will Monopar (MNPR) present ALXN1840 data at EASL Congress 2025?

Monopar will present ALXN1840 data on Wednesday, May 7, 2025, at 8:30 a.m. CET in Amsterdam, Netherlands, as part of the Late-breaker Posters session at EASL Congress 2025.

What is ALXN1840 and what disease does it treat?

ALXN1840 (tiomolybdate choline) is Monopar's drug candidate designed to treat Wilson disease. The presentation will showcase long-term efficacy and safety data for this treatment.

Why is Monopar's ALXN1840 late-breaker presentation significant for MNPR stock?

The late-breaker selection is significant because EASL only accepts the most compelling and recent research findings that have potential to substantially impact the field. Late-breaker abstracts undergo rigorous review with lower acceptance rates than regular abstracts.

Where can investors view Monopar's EASL 2025 ALXN1840 presentation?

The ALXN1840 poster presentation will be available to view online at www.monopartx.com on May 7, 2025.

What are the criteria for EASL late-breaker abstract acceptance?

EASL late-breaker abstracts must present the latest research findings, show significant potential to impact the field substantially, and for clinical studies, must be prospective.
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