Monopar Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Updates
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Monopar Therapeutics (Nasdaq: MNPR) reported a third-quarter 2026 net loss of $6.2 million and progress toward completing its ALXN1840 regulatory application. The loss was $0.72 per share, versus $3.4 million, or $0.48 per share, a year earlier. Research and development expenses rose to $4,436,543 from $2,589,749; general and administrative expenses increased to $3,031,302 from $1,503,326. Interest income rose to $1,271,370 from $655,473.
Cash, cash equivalents and investments totaled $129.4 million at September 30, 2026. Monopar expects funding to support operations through at least March 31, 2028, and completion of its rolling FDA application for ALXN1840 in Wilson disease within several weeks. A November 5 presentation reported neutral molybdenum balance, no molybdenum toxicity and normal serum uric acid over six years of treatment. Jeffrey D. Kent was appointed head of medical affairs in August.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point$129.4 million in cash, cash equivalents and investments held at September 30, 2026.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Funding runway expected through at least March 31, 2028, including regulatory and potential ALXN1840 commercial activities.
- Moderate point. Forward-looking: it has not happened yet and may not happen.ALXN1840 rolling FDA application initiated July 22; Monopar expects completion within the next several weeks.
- Minor pointALXN1840 safety findings included neutral molybdenum balance, no molybdenum toxicity and normal serum uric acid over six years.
- Minor pointInterest income increased to $1,271,370 in third-quarter 2026 from $655,473 a year earlier.
Negative
- Moderate pointNet loss widened to $6.2 million, or $0.72 per share, from $3.4 million, or $0.48, year over year.
- Minor pointR&D expenses rose to $4,436,543 in third-quarter 2026 from $2,589,749 a year earlier.
- Minor pointG&A expenses rose to $3,031,302 in third-quarter 2026 from $1,503,326 a year earlier.
Details
News Market Reaction – MNPR
On Nov 12, the day this news came out, MNPR closed 1.32% above the previous close. Argus tracked a peak move of +8.5% during that session. Argus tracked a trough of -2.5% from its starting point during tracking. Our momentum scanner recorded 9 alerts for this stock that day. That session’s volume was 2.3x the stock’s average daily volume.
Data tracked by StockTitan Argus for the Nov 12 session.
Key Figures
- Cash, cash equivalents and investments
- $129.4 million
- As of September 30, 2026
- Expected operating runway
- Through at least March 31, 2028
- Includes ALXN1840 activities, MNPR-101 programs, and internal R&D
- Net loss
- $6.2 million vs. $3.4 million
- Third quarter 2026 vs. third quarter 2025
- Net loss per share
- $0.72 vs. $0.48
- Third quarter 2026 vs. third quarter 2025
- R&D expenses
- $4,436,543 vs. $2,589,749
- Third quarter 2026 vs. third quarter 2025
- G&A expenses
- $3,031,302 vs. $1,503,326
- Third quarter 2026 vs. third quarter 2025
Previous Earnings Reports
-
Q2 report established comparable cash runway and quarterly loss alongside ALXN1840 filing progress.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
new drug application regulatory
rolling submission regulatory
randomized controlled trial medical
primary endpoint medical
24-hour urinary copper excretion medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
WILMETTE, Ill., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced third quarter 2026 financial results and provided business updates.
Recent Program Developments
ALXN1840 for Wilson Disease
On November 8, 2026, Monopar presented baseline findings from the Phase 3 FoCus study of ALXN1840 (tiomolibdate choline, TMC), the largest randomized controlled trial ever conducted in Wilson disease, characterizing residual disease burden in treatment-experienced patients at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2026. Baseline rates in treatment-experienced and treatment-naïve patients were
On November 5, 2026, Monopar presented a poster at AASLD 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. These findings are consistent with ALXN1840’s known albumin tripartite complex (ATC) mechanism and provide further evidence supporting its long-term safety profile.
On August 19, 2026, Monopar announced the appointment of Jeffrey D. Kent, M.D., FACP, FACG, as Executive Vice President, Head of Medical Affairs. Dr. Kent is leading the Company’s medical affairs organization as Monopar prepares for potential U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for ALXN1840, its first-in-class ATC activator drug candidate for the treatment of Wilson disease. Dr. Kent brings more than 20 years of biopharmaceutical leadership experience across medical affairs, clinical development and regulatory strategy, with expertise spanning rare diseases, hepatology and gastroenterology, immunology and specialty therapeutics.
On July 22, 2026, Monopar announced it had initiated the rolling submission of an NDA to the FDA for ALXN1840. The FDA authorized Monopar to submit the NDA on a rolling basis, allowing completed sections of the application to be submitted and reviewed while the Company finalizes the remaining sections. The Company is on track to complete the NDA submission within the next several weeks.
Financial Results for the Third Quarter Ended September 30, 2026, Compared to the Third Quarter Ended September 30, 2025
Cash and Net Loss
Cash, cash equivalents and investments as of September 30, 2026, were
Net loss for the third quarter of 2026 was
Research and Development (“R&D”) Expenses
R&D expenses for the third quarter of 2026 were
General and Administrative (“G&A”) Expenses
G&A expenses for the third quarter of 2026 were
Interest Income (Loss)
Interest income for the third quarter of 2026 was
About Wilson Disease
Wilson disease is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. It is caused by mutations in the ATP7B gene, which impairs the body’s ability to excrete copper. It is characterized by toxic accumulation of copper in the liver, brain, and other organs, leading to progressive and potentially fatal outcomes if untreated.
About ALXN1840
ALXN1840 (tiomolibdate choline, TMC) is a novel first-in-class albumin tripartite complex (ATC) activator under investigation for the treatment of Wilson disease. ALXN1840 rapidly mobilizes and tightly sequesters excess copper in stable ATCs, suppressing copper’s redox reactivity, limiting oxidative damage, and blocking its transport across the blood–brain barrier. Clinical data have also demonstrated that ALXN1840 improves copper balance by increasing fecal copper excretion.
In the pivotal Phase 3 trial, ALXN1840 met its primary endpoint, demonstrating rapid and sustained copper mobilization that was significantly greater than standard of care over 48 weeks in both previously treated and treatment-naïve patients. Across the ALXN1840 clinical development program, durable clinical improvement and favorable tolerability were observed across 645 patient-years of follow-up in 266 patients, with a well-characterized safety profile.
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including MNPR-101-Zr (Phase 1) for imaging advanced cancers along with MNPR-101-Lu (Phase 1a) and MNPR-101-Ac (late preclinical) for the treatment of advanced cancers. For more information, and links to SEC filings that contain detailed financial information, visit: https://ir.monopartx.com/quarterly-reports.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning the following: that Dr. Kent is leading the Company’s medical affairs organization as Monopar prepares for potential U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for ALXN1840; 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 forward-looking statements involve risks and uncertainties including, but not limited to, uncertainties related to the Company’s ability to complete the NDA submission within the anticipated timeframe; whether the FDA will accept the NDA for filing, require additional information or studies, or approve ALXN1840; the timing of FDA review; the risk that changes in operating plans, development or commercialization costs, or the timing and amount of contractual milestone payments could shorten the Company’s expected cash runway; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
CONTACT:
Monopar Therapeutics Inc.
Investor Relations
Quan Vu
Chief Financial Officer
vu@monopartx.com
Follow Monopar on social media for updates:
X: @MonoparTx LinkedIn: Monopar Therapeutics
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When does Monopar expect to complete its ALXN1840 FDA application?
Monopar expects to complete the New Drug Application submission within the next several weeks. The rolling submission began July 22, 2026. FDA authorization allows completed sections to be submitted and reviewed while the company finishes the remaining sections.
How long does Monopar expect its cash to fund operations?
Monopar expects current funds to support operations through at least March 31, 2028. This includes regulatory and potential commercial activities for ALXN1840, continued development of MNPR-101 programs, and internal research and development. Cash, cash equivalents and investments were $129.4 million at September 30, 2026.