Highest-materiality recent filing
Monopar reports ALXN1840 shows significant neurologic and global benefit in Phase 3 FoCus trial
ALXN1840 achieved significant neurologic improvement on UWDRS Part III (p=0.006) vs SOC (p=0.435) over 48 weeks.
Monopar announces Phase 2 publication: ALXN1840 improves copper balance in Wilson disease
Cumulative mean decrease in copper balance of -6.08 mg over 21 days (95% CI: -10.18 to -1.98 mg).
Monopar Therapeutics Q1 2026 net loss $3.9M; NDA on track for mid-2026
Net loss $3.9M ($0.46/share) in Q1 2026 vs $2.6M ($0.38/share) in Q1 2025.
Monopar Phase 3 ALXN1840 data shows greater neurologic benefit vs SoC in Wilson disease
Neurologic worsening at Week 48: 9% ALXN1840 vs 25% SoC (p=0.038); improvement 45% vs 32%.
Monopar Q4 net loss $5.2M, cash $140.4M; ALXN1840 NDA planned mid-2026
Q4 2025 net loss $5.2M ($0.61/sh) vs $10.9M ($2.23) YoY; full-year net loss $13.7M ($1.85/sh) vs $15.6M.
Susan Rodriguez appointed Chief Commercial and Strategy Officer, effective March 2, 2026.
Monopar raises ~$91.9M net in offering; Wilson disease data published in Journal of Hepatology
Offering of 1,034,433 shares at $67.67 and 960,542 pre-funded warrants at $67.669.
Monopar reports positive long-term neurological data for ALXN1840 in Wilson disease
Pooled efficacy from 3 trials (n=255) showed sustained neurological improvement on UWDRS Part II & III over 6 years.
Monopar Q2 net loss $2.5M, cash $53.3M; ALXN1840 IND transferred, NDA plan for early 2026
Net loss $2.5M ($0.35/share) vs $1.7M ($0.49/share) in Q2 2024; R&D up $599k, G&A up $846k.
Monopar Q1 net loss $2.6M, cash $54.6M; ALXN1840 NDA planned early 2026
Cash $54.6M as of March 31, 2025; expected runway through Dec 2026 for NDA and trials.
Pooled analysis from three trials (n=255) shows sustained improvements in UWDRS Part II/III and copper mobilization.
Monopar Therapeutics reports Q4 2024 net loss $10.9M; cash $60.2M; ALXN1840 NDA planned early 2026
Q4 2024 net loss $10.9M ($2.23/share) vs $1.8M ($0.60/share) in Q4 2023.
Monopar raises ~$37.6M via registered offering and private placement of pre-funded warrants
Registered offering of 798,655 shares at $23.79 per share; concurrent private placement of pre-funded warrants for 882,761 shares at $23.789 each.
Monopar doses first patient with uPAR-targeted radiopharmaceutical MNPR-101-Lu
First patient dosed under US compassionate use protocol for metastatic pancreatic cancer.
Monopar reports Q3 net loss $1.3M; in-licensed Wilson disease drug ALXN-1840; raised $17.7M
Net loss Q3 2024 $1.3M ($0.37/share) vs $2.0M ($0.69/share) Q3 2023.
Monopar Therapeutics prices $19.2M public stock offering at $16.25 per share
Gross proceeds ~$19.2M from offering of up to 1,181,540 shares at $16.25/share.
Monopar acquires exclusive worldwide license for ALXN-1840 from Alexion; pays $4M cash + equity
Monopar gets exclusive worldwide license to ALXN-1840 (bis-choline tetrathiomolybdate) for Wilson disease; Phase 3 trial met primary endpoint, but Alexion terminated after Phase 2 results.
Monopar presents positive uPAR radiopharma dosimetry data at EANM 2024
MNPR-101-Lu shows favorable organ safety at high Lu-177 doses using human Zr-89 dosimetry data.
Monopar initiates Phase 1a trial of MNPR-101-Lu radiopharmaceutical therapy in advanced cancers
Phase 1a open-label dose-escalation study of MNPR-101-Lu in solid tumors now recruiting.
Monopar reports positive early human data for MNPR-101-Zr tumor targeting
MNPR-101-Zr PET image at 168h post-dose in first cancer patient shows high preferential uptake in metastatic tumors.
Monopar receives HREC clearance in Australia for Phase 1 trial of MNPR-101-Lu in advanced cancers
HREC clearance in Australia to commence Phase 1 therapeutic trial of MNPR-101-Lu (Lu-177 with anti-uPAR antibody).
Monopar doses first patient in Phase 1 MNPR-101-Zr trial; favorable safety and biodistribution data
First patient dosed in open-label Phase 1 imaging trial of MNPR-101-Zr; well-tolerated with no serious adverse reactions.
Monopar reports Q2 net loss $1.7M, initiates 1-for-5 reverse split to regain Nasdaq compliance
Net loss for Q2 2024 was $1.7M ($0.10/sh) vs $2.2M ($0.16/sh) in Q2 2023; cash $7.1M sufficient through Aug 31, 2025.
Monopar CFO Kim Tsuchimoto retiring; Karthik Radhakrishnan appointed successor
CFO Kim Tsuchimoto retires effective June 30, 2024 after 35+ years; remains on Board.
Monopar Q1 net loss $1.6M; pivots to radiopharma pipeline, winding down other programs
Net loss $1.6M ($0.10/shr) vs $2.4M ($0.19/shr) in Q1 2023.
Monopar initiates Phase 1 dosimetry trial for MNPR-101-Zr in advanced cancers
Trial open for enrollment at Melbourne Theranostic Innovation Centre; led by Prof. Rodney Hicks.
Monopar receives additional 180-day Nasdaq extension to Aug 26, 2024 to meet $1 bid price rule
Nasdaq granted Monopar extension to August 26, 2024 to regain compliance with $1.00 minimum bid price requirement.
MNPR-101 targets uPAR, expressed in majority of triple-negative breast, colorectal, and pancreatic cancers.
HREC clearance in Australia to commence Phase 1 dosimetry trial of MNPR-101-Zr for advanced cancers.
Monopar Q3 net loss improves to $2.0M; MNPR-101 radiopharma on track for first-in-human Dec 2023
Net loss $2.0M ($0.14/share) vs $2.4M ($0.19) YoY; cash and equivalents $8.5M.
14 patients enrolled across 5 dose cohorts; 9 of 14 had stable disease per RECIST 1.1.
Monopar receives Nasdaq notice for bid price deficiency; 180 days to regain compliance
Nasdaq notified Monopar on Aug 28, 2023 that bid price closed below $1.00 for 30 consecutive days.
On February 28, 2025, Karthik Radhakrishnan’s employment with Monopar Therapeutics Inc. (the “Company” or “Monopar”) terminated.
On February 27, 2025, the Company’s Board of Directors appointed Quan Vu, age 53, to succeed Mr. Radhakrishnan as Monopar’s Chief Financial Officer, principal accounting officer and principal financial officer effective March 3, 2025.
On February 21, 2025, the Company’s Board appointed Lavina Talukdar to the Board.
Michael J. Brown has resigned from his position as a member of the Monopar Therapeutics Inc. (the” Company”) Board of Directors (the “Board”) effective February 19, 2025.
Effective June 30, 2024, after a career spanning more than 35 years, Kim R. Tsuchimoto, the Chief Financial Officer of Monopar Therapeutics Inc. (“Monopar” or the “Company”), will be retiring.
On May 23, 2024, the Company’s Board of Directors appointed, Karthik Radhakrishnan, age 53, to succeed Ms. Tsuchimoto as Monopar’s Chief Financial Officer, principal accounting officer and principal financial officer effective July 1, 2024.
Dr. Andrew P. Mazar, the Company’s Co-Founder, Executive Vice President of Research and Development, Chief Scientific Officer and Board Member, will be resigning from his position with the Company and as a member of the Company’s Board of Directors effective April 8, 2022.
Max materiality 0.75 · Median 0.60 · Most common event other_material