Every 8-K that Monopar Therapeutics Inc. (MNPR) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow MNPR and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full MNPR filings page.
Monopar Therapeutics reported second quarter 2026 results and highlighted regulatory progress for its lead Wilson disease candidate ALXN1840. On July 22, 2026, the company initiated a rolling New Drug Application (NDA) submission to the FDA for ALXN1840, and on June 30, 2026, the FDA granted Rare Pediatric Disease (RPD) designation, which could make Monopar eligible for a pediatric Priority Review Voucher if the NDA is ultimately approved.
Additional clinical data from Phase 2 and Phase 3 ALXN1840 studies were presented at major neurology and liver conferences, and a peer-reviewed Phase 2 manuscript was published, underscoring copper balance and clinical benefits in Wilson disease. Cash, cash equivalents and investments totaled $134.3 million as of June 30, 2026, and Monopar expects this to fund operations through at least December 31, 2027, including regulatory and potential commercial activities for ALXN1840 and continued MNPR-101 development.
Net loss for the quarter was $5.3 million, or $0.62 per share, compared with $2.5 million, or $0.35 per share, a year earlier, mainly driven by higher research and development spending. R&D expenses rose to $4,766,832 from $1,730,000, while G&A expenses increased to $1,877,831 from $1,504,295. Interest income increased to $1,299,205, reflecting earnings on U.S. Treasury securities, commercial paper and higher cash balances following a prior capital raise of approximately $91.9 million.
Monopar Therapeutics Inc. has begun a rolling submission of a New Drug Application to the U.S. Food and Drug Administration for ALXN1840 (tiomolibdate choline), a first-in-class albumin tripartite complex activator being developed to treat Wilson disease.
The FDA has authorized this rolling process and the first sections of the application have been submitted. In a pivotal Phase 3 trial, ALXN1840 met its primary endpoint, showing rapid and sustained copper mobilization significantly greater than standard of care over 48 weeks. Across the clinical development program, durable clinical improvement and favorable tolerability were observed over 645 patient-years in 266 patients. ALXN1840 holds Fast Track, Orphan Drug and Rare Pediatric Disease designations, which provide the potential, at the time of NDA approval, to receive a pediatric Priority Review Voucher.
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 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 Inc. is highlighting new Phase 3 data for ALXN1840 (tiomolibdate choline) in Wilson disease. Analyses from the randomized controlled FoCus trial showed greater neurologic improvement and significantly less worsening versus standard of care through Week 48 in patients with neurologic symptoms at baseline, with durable benefit over multiple years of treatment. These results, presented at the American Academy of Neurology 2026 meeting in a late-breaker oral and poster session, support Monopar’s plan to advance ALXN1840 toward a New Drug Application submission to the U.S. Food and Drug Administration in mid-2026.
Monopar Therapeutics reported fourth-quarter and full-year 2025 results and provided an update on its drug programs. Cash, cash equivalents and short-term investments were $140.4 million as of December 31, 2025, and the company expects this to fund operations through at least December 31, 2027.
Net loss was $5.2 million, or $0.61 per share, for Q4 2025 and $13.7 million, or $1.85 per share, for full-year 2025, both lower than in 2024. R&D expenses fell mainly because 2024 included one-time ALXN1840 in-licensing costs, while G&A expenses rose due to higher personnel and patent expenses.
Monopar plans to submit a New Drug Application for ALXN1840 for Wilson disease in mid-2026 and is advancing its MNPR-101 radiopharmaceutical programs. The leadership team was expanded with a new Chief Commercial and Strategy Officer to support a potential ALXN1840 launch.
Monopar Therapeutics filed an 8-K to share that it has appointed seasoned biopharma executive Susan Rodriguez as Chief Commercial and Strategy Officer, effective immediately. She will lead commercial strategy and infrastructure as the company prepares a planned NDA submission in the first half of 2026 for ALXN1840, its late-stage investigational therapy for Wilson disease.
Rodriguez brings over 30 years of leadership experience, including senior roles at Avadel Pharmaceuticals, Ardelyx, Tolmar Pharmaceuticals, and Abbott. Her background spans launching rare disease therapies, building commercial organizations, and contributing to Avadel’s acquisition by Alkermes for over $2 billion. The filing also highlights Monopar’s broader pipeline of radiopharmaceutical programs targeting advanced cancers.
Monopar Therapeutics (MNPR) reported that it furnished a press release announcing its financial results for the third quarter ended September 30, 2025. The notice was made via an 8-K under Item 2.02, with the press release attached as Exhibit 99.1. The company states this information is being furnished and is not deemed “filed” under Section 18 of the Exchange Act, nor incorporated by reference except if specifically referenced.
Monopar Therapeutics (MNPR) furnished an 8‑K under Regulation FD announcing it issued a press release about presenting new data and analyses from the Phase 2 ALXN1840‑WD‑204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2025. The press release is included as Exhibit 99.1 and incorporated by reference.
Monopar Therapeutics entered into an underwriting agreement to sell 1,034,433 shares of common stock at $67.67 per share and pre-funded warrants to purchase 960,542 shares at $67.669 per pre-funded warrant, with immediate exercisability and ownership caps tied to a 9.99% threshold (adjustable to 19.99% with notice). The offering is being made from a shelf registration declared effective September 9, 2025, and is expected to close on September 25, 2025. The company also agreed to repurchase 550,229 shares from existing significant stockholder Tactic Pharma at $63.6098 per share; Chandler D. Robinson, the CEO, is a managing member of Tactic Pharma. After giving effect to the repurchase, net proceeds are expected to be approximately $91.9 million, before estimated offering expenses. A peer-reviewed letter about the company’s investigational therapy ALXN1840 was published in the Journal of Hepatology and disclosed via press release.
Monopar Therapeutics reported that it presented new long-term neurological efficacy and safety data for its investigational therapy ALXN1840 (tiomolybdate choline) for Wilson disease at the 150th American Neurological Association Annual Meeting held on September 14-15, 2025. The company furnished a press release, a poster presentation, and an oral presentation as Exhibits 99.1, 99.2, and 99.3 to the report and incorporated them by reference. The filing announces the dissemination of these materials but does not include detailed efficacy or safety results within the 8-K text itself. The disclosure is intended to satisfy Regulation FD requirements by making the presentations and release publicly available.
Monopar Therapeutics Inc. (MNPR) filed an 8-K reporting that on August 12, 2025 the company issued a press release announcing its financial results for the quarter ended June 30, 2025. The press release is attached to the report as Exhibit 99.1. The filing also lists an Inline XBRL cover page as Exhibit 104, and provides the company headquarters in Wilmette, Illinois and Nasdaq listing information.
The 8-K explicitly states the Item 2.02 disclosure and the exhibit are being furnished, not filed, and therefore are not subject to Section 18 liability or incorporation by reference except as expressly stated in another filing. The report is signed by Quan Vu, Chief Financial Officer, dated August 12, 2025. The filing text does not include the press release content or numeric financial results.
Monopar Therapeutics Inc. (MNPR) filed an 8-K to disclose the results of its 17 June 2025 Annual Meeting of Stockholders. Of the 6,115,214 shares entitled to vote, 82.6% (5,048,394) were represented in person or by proxy.
- Director elections: All six nominees—including CEO Chandler D. Robinson and Chair Christopher M. Starr—were elected. Support ranged from 78.7% to 99.9% of votes cast, with 655,826 broker non-votes recorded for each nominee.
- Say-on-pay: Executive compensation was approved with 4,382,795 votes for (99.8%), 2,933 against, and 6,840 abstentions.
- Say-on-pay frequency: Shareholders selected an annual advisory vote, receiving 4,383,765 votes, dwarfing biennial (1,247) and triennial (1,212) options.
- Auditor ratification: BPM LLP was ratified as independent accountant for FY-2025 with 5,044,817 votes for (99.9%).
No other matters were submitted. The outcome signals continued shareholder support for current governance, compensation practices, and audit oversight. No immediate financial impact or strategic change was disclosed.