Monopar Therapeutics Inc Stock Price, News & Analysis

Monopar Therapeutics (Nasdaq: MNPR) announced the publication of a peer-reviewed Letter to the Editor in the Journal of Hepatology regarding ALXN1840's effectiveness in treating Wilson disease. The letter addresses previous methodological limitations in copper balance analysis from the Phase 2 ALXN1840-WD-204 study.

The new analysis demonstrates that ALXN1840 significantly improved copper balance in patients, with key findings showing a mean daily difference of -0.367 mg (p=0.005) during the 15 mg/day treatment period. The overall treatment period showed a mean daily difference of -0.289 mg (p=0.023), with a cumulative mean change from baseline of -6.08 mg.

Monopar Therapeutics (Nasdaq: MNPR) will present new long-term data for its investigational therapy ALXN1840 in Wilson disease at the 150th American Neurological Association Annual Meeting. The analysis combines data from four clinical trials with 266 patients and a median treatment duration of 2.6 years.

Key findings include statistically significant neurologic improvements sustained over 6 years, measured by UWDRS Parts II and III. Patients who switched from standard of care to ALXN1840 showed additional neurological improvement. The drug demonstrated a favorable safety profile with less than 1% of patients experiencing drug-related neurological serious adverse events across more than 645 patient-years.

Monopar Therapeutics (Nasdaq: MNPR) announced that its abstract on ALXN1840 (tiomolybdate choline) for Wilson disease treatment has been selected for both oral and poster presentations at the 150th American Neurological Association Annual Meeting in September 2025.

The abstract, focused on long-term neurological benefits in Wilson disease patients, received the prestigious Abstract of Distinction designation, which will be featured in the Annals of Neurology. Dr. Matthew Lorincz from the University of Michigan will present the findings on September 14-15, 2025, with presentations available on Monopar's website.

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.

Monopar Therapeutics and EDNOC have received FDA authorization for an Expanded Access Program (EAP) for MNPR-101-Zr and MNPR-101-Lu in advanced cancers. The program, now open for enrollment at EDNOC in Houston, Texas, targets aggressive cancers including triple-negative breast, pancreatic, and colorectal cancer. EDNOC, recognized as a Radiopharmaceutical Therapy Center of Excellence by SNMMI, will conduct the program under Dr. Ebrahim S. Delpassand's supervision. This development follows Monopar's Phase 1 clinical trials initiation in Australia last year for both investigational agents. The EAP provides compassionate use access to these radiopharmaceutical therapies, targeting uPAR-expressing solid tumors as a new approach in radioligand therapy.

Monopar Therapeutics (MNPR) announced its upcoming inclusion in the Russell 3000® Index and Russell 2000® Index, effective after market close on June 27, 2025. This inclusion follows announcements made on May 23 and May 30, 2025, as part of the annual Russell U.S. Indexes reconstitution. The Russell 2000® Index, a subset of the Russell 3000®, tracks small-cap U.S. equity performance. The inclusion automatically places MNPR in relevant growth and value style indexes for one year. The Russell U.S. Indexes serve as benchmarks for approximately $10.6 trillion in assets as of May 2025. CFO Quan Vu attributed this milestone to the company's transformation and growing recognition of their late-stage ALXN1840 drug candidate for Wilson disease.

Monopar Therapeutics (MNPR) reported Q1 2025 financial results and recent developments. The company presented promising long-term data for ALXN1840, a potential treatment for Wilson disease, showing sustained clinical benefits across 255 patients over 2.63 years with a favorable safety profile. The company plans to submit an NDA to FDA in early 2026. MNPR currently has two active Phase 1 trials for MNPR-101 radiopharmaceuticals in Australia. Financially, MNPR reported $54.6 million in cash and investments as of March 31, 2025, expected to fund operations through December 2026. Q1 2025 net loss was $2.6 million ($0.38/share) compared to $1.6 million ($0.51/share) in Q1 2024. R&D expenses increased to $1.64M from $966K, while G&A expenses rose to $1.58M from $757K year-over-year.

Monopar Therapeutics (Nasdaq: MNPR) presented late-breaker data at EASL 2025 on ALXN1840, their drug candidate for Wilson disease. The analysis pooled data from three clinical trials (n=255) for efficacy and included a fourth trial for safety analysis (n=266), with median treatment durations of 2.63 and 2.58 years respectively.

Key findings showed sustained improvements in patient-reported and clinician-assessed symptoms (UWDRS), increased copper mobilization, better CGI-I scale results compared to standard care, and improvement in the New Wilson Index. The drug demonstrated strong safety with less than 5% of patients experiencing drug-related serious adverse events and no renal/urinary system SAEs. Patients reported higher convenience and effectiveness compared to standard treatment.

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.