Monopar Extends Cash Runway to March 2028

The Tip Desk · November 12, 2026 · 4 min read

Cash, cash equivalents and investments were $129.4 million as of September 30, 2026, and the company said it is on track to complete a rolling ALXN1840 NDA within several weeks.

Monopar Therapeutics Inc. (MNPR), a clinical-stage biopharmaceutical company, said it is on track to complete a rolling New Drug Application for ALXN1840 within the next several weeks, after telling investors in the prior quarter that it anticipated finishing the filing within the next few months.

The company also said cash, cash equivalents and investments of $129.4 million as of September 30, 2026, are expected to support operations through at least March 31, 2028, covering regulatory and potential commercial activities for ALXN1840, continued development of MNPR-101 programs, and internal research and development. That runway is later than the at-least-December 31, 2027 horizon it had given after the second quarter.

On July 22, 2026, Monopar initiated a rolling NDA submission to the FDA for ALXN1840, a first-in-class albumin tripartite complex activator for Wilson disease. The FDA authorized the rolling process so completed sections can be reviewed while remaining sections are finalized.

Net loss for the third quarter ended September 30, 2026, was $6.2 million, or $0.72 a share, compared with $3.4 million, or $0.48 a share, a year earlier.

Research and development expenses were $4,436,543, up from $2,589,749. The company attributed the $1,846,794 increase primarily to a $1,772,461 rise in R&D contractor and consulting expenses and a $909,699 rise in R&D personnel expenses including stock-based compensation, partly offset by a $709,250 decrease in manufacturing activities related to ALXN1840 and a $126,116 net decrease in other R&D expenses.

General and administrative expenses were $3,031,302, compared with $1,503,326. The $1,527,976 increase was led by a $973,753 rise in G&A personnel expenses including stock-based compensation, a $353,963 rise in G&A contractor and consulting expenses, and a $200,260 net increase in other G&A expenses.

Interest income was $1,271,370, compared with $655,473. The company attributed the increase to interest earned on U.S. Treasury securities and commercial paper and to higher 2026 bank balances from about $91.9 million of net proceeds from a September 2025 capital raise.

Cash, cash equivalents and investments declined from $134.3 million at June 30, 2026.

On November 8, 2026, Monopar presented baseline findings from the Phase 3 FoCus study of ALXN1840, which it described as the largest randomized controlled trial ever conducted in Wilson disease, at AASLD – The Liver Meeting 2026. Among treatment-experienced patients, baseline rates were 39% for cirrhosis, 79% for neurologic symptoms, and 75% for psychiatric symptoms; among treatment-naïve patients, 30%, 83%, and 70%, respectively. Among evaluable patients, 73% had at least two of those manifestations. Only 47% of treatment-experienced patients were within the guideline-recommended copper target range, and among patients on standard-of-care therapy for more than 12 months, 31% had 24-hour urinary copper excretion above that range.

On November 5, 2026, the company presented a poster reporting neutral molybdenum balance and lack of molybdenum toxicity in subjects treated with ALXN1840, with serum uric acid remaining within normal limits over six years of treatment. It said the findings are consistent with ALXN1840’s known ATC mechanism and provide further evidence supporting its long-term safety profile.

On August 19, 2026, Monopar appointed Jeffrey D. Kent, M.D., as Executive Vice President, Head of Medical Affairs. The company said Dr. Kent is leading the medical affairs organization as Monopar prepares for potential FDA approval of the ALXN1840 NDA.

The company said the pivotal Phase 3 trial met its primary endpoint, demonstrating rapid and sustained copper mobilization significantly greater than standard of care over 48 weeks in both previously treated and treatment-naïve patients. Across the ALXN1840 program, it said durable clinical improvement and favorable tolerability were observed across 645 patient-years of follow-up in 266 patients.

Forward-looking statements in the release include that Dr. Kent is leading medical affairs as Monopar prepares for potential FDA approval of the NDA, that the company is on track to complete the NDA submission within the next several weeks, and that Monopar expects its current funds to support operations through at least March 31, 2028. The company listed risks including whether the FDA will accept the NDA, require additional information or studies, or approve ALXN1840, the timing of FDA review, and the risk that changes in operating plans, development or commercialization costs, or milestone payments could shorten the expected cash runway.