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Monopar Therapeutics reported that the U.S. Food and Drug Administration granted Rare Pediatric Disease (RPD) designation to ALXN1840 (tiomolibdate choline), its late-stage candidate for treating Wilson disease. This designation may allow Monopar, if ALXN1840 is approved, to receive a pediatric Priority Review Voucher, which can shorten FDA review time or be sold to another company.
ALXN1840 is an oral, once-daily, first-in-class albumin tripartite complex activator designed to tightly bind excess copper and improve copper balance. In a Phase 3 pivotal trial over 48 weeks, it met the primary endpoint with copper mobilization greater than standard of care, with durable clinical improvement and a favorable safety profile across 645 patient-years in 266 patients.
Monopar Therapeutics is presenting new analyses from its Phase 3 FoCus trial of ALXN1840 in Wilson disease, showing greater neurologic and overall clinical benefit versus standard of care in patients with neurologic symptoms at baseline.
Across Phase 2 and Phase 3 studies, ALXN1840 was given to 266 patients over 645 patient-years, with a median treatment duration of 2.58 years and maximum exposure of more than 8 years. Drug-related serious adverse events occurred in 4.9% of patients, neurologic serious events in less than 1%, and no treatment-related deaths were reported. Monopar states that these results further support its planned New Drug Application submission to the FDA for ALXN1840 in mid-2026.
Monopar Therapeutics Inc. held its Annual Meeting on June 22, 2026, with 6,698,778 common shares entitled to vote and 5,760,392 shares represented in person or by proxy. Stockholders voted on directors, executive compensation, the 2026 Stock Incentive Plan, and the 2026 auditor.
All six director nominees were elected, with support ranging from 4,203,485 to 4,911,758 votes for each candidate, plus broker non-votes. Stockholders approved the advisory vote on named executive officer pay and the Company’s 2026 Stock Incentive Plan, and ratified BPM LLP as independent registered public accounting firm for the year ending December 31, 2026.
Monopar Therapeutics Inc. filed a current report to share that it presented clinical trial results at a major medical conference. On May 29, 2026, the company presented results from a Phase 2 study (NCT04422431) of ALXN1840 (tiomolibdate choline) in patients with Wilson disease at the European Association for the Study of the Liver International Liver Congress 2026.
The related scientific presentation is furnished as Exhibit 99.1 and is incorporated by reference, providing more detailed information on the Phase 2 study’s evaluation of liver pathology and clinical symptoms in Wilson disease.
Monopar Therapeutics Inc. reported that a peer-reviewed manuscript in Hepatology Communications has published Phase 2 ALXN1840-WD-204 trial results for ALXN1840 (tiomolibdate choline) in Wilson disease. The open-label study in nine patients showed rapid, statistically significant and sustained improvement in daily copper balance, mainly through increased fecal copper excretion.
The publication notes patients had a mean 16 years of prior standard-of-care treatment yet still had substantial residual copper that ALXN1840 mobilized and eliminated. Monopar also references a completed 48-week Phase 3 trial in 266 patients over 645 patient-years, where ALXN1840 demonstrated greater copper mobilization than standard care and a favorable safety profile, while cautioning that future outcomes depend on regulatory processes, market acceptance and funding.
Monopar Therapeutics Inc. ownership disclosure: Saturn V Capital Management LP and Xiaoying Tian report a shared beneficial interest of 345,626 shares of Common Stock, representing 5.20% of the class. The filing cites 6,698,778 shares outstanding as of April 27, 2026.
The report states Saturn V acts as investment manager for pooled vehicles and managed accounts that hold the shares and that both reporting persons disclaim direct beneficial ownership while retaining voting and dispositive power on behalf of those Clients.
Monopar Therapeutics reported a net loss of $3.9M for the quarter ended March 31, 2026, wider than the $2.6M loss a year earlier, as it increased spending on its drug pipeline. Research and development expenses rose to $3.5M from $1.6M, while general and administrative costs were $1.7M.
The company had $137.5M in cash, cash equivalents and investments as of March 31, 2026, and management believes this will fund operations at least through December 31, 2027. Monopar remains a clinical-stage biopharmaceutical company with no product revenue, focused on ALXN1840 for Wilson disease and radiopharmaceutical programs for advanced cancers.
Monopar Therapeutics reported first quarter 2026 results and highlighted progress on its ALXN1840 program for Wilson disease. The company remains on track to submit a New Drug Application to the U.S. Food and Drug Administration in mid-2026 and is preparing for a potential launch, led by its Chief Commercial and Strategy Officer.
Cash, cash equivalents and investments were $137.5 million as of March 31, 2026, and Monopar expects this to fund operations at least through December 31, 2027, including regulatory and potential commercial activities for ALXN1840 and continued development of MNPR-101 programs. Net loss for the quarter was $3.9 million, or $0.46 per share, compared with $2.6 million, or $0.38 per share, a year earlier.
Research and development expenses rose to $3,487,247 from $1,643,375, mainly due to higher contractor, consulting, and personnel costs, while general and administrative expenses increased to $1,738,006 from $1,578,442. Interest income increased to $1,332,203 from $596,845, driven by earnings on U.S. Treasury securities, commercial paper, and higher bank balances following approximately $91.9 million of net proceeds from a September 2025 capital raise.
Monopar Therapeutics Schedule 13G/A: Adage Capital Management, L.P. and affiliated reporting persons report beneficial ownership of 424,195 shares of Common Stock, representing 6.23% of the class, calculated on 6,692,140 shares outstanding as of March 17, 2026. The reported holdings include 115,000 shares issuable upon exercise of warrants held by Adage Capital Partners, L.P.
The filing attributes shared voting and dispositive power over the reported shares to the reporting persons and states their business address in Boston, Massachusetts.