Monopar Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and investments totaled $129.4 million as of September 30, 2026.
• Net loss for the third quarter of 2026 was $6.2 million ($0.72 per share), compared to a net loss of $3.4 million ($0.48 per share) in the third quarter of 2025.
• Research and Development (R&D) expenses increased to $4,436,543 in Q3 2026 from $2,589,749 in Q3 2025, a rise of $1,846,794 driven by increases in contractor/consulting expenses ($1,772,461) and personnel expenses including stock-based compensation ($909,699), partially offset by a decrease in manufacturing activities related to ALXN1840 ($709,250).
• General and Administrative (G&A) expenses rose to $3,031,302 in Q3 2026 from $1,503,326 in Q3 2025, an increase of $1,527,976 attributed to higher personnel expenses including stock-based compensation ($973,753), contractor/consulting expenses ($353,963), and other G&A expenses ($200,260).
• Interest income increased to $1,271,370 in Q3 2026 from $655,473 in Q3 2025, resulting from higher bank balances following a September 2025 capital raise of approximately $91.9 million and earnings on U.S. Treasury securities and commercial paper.
• The company expects current funds to support operations through at least March 31, 2028.

Guidance and Future Outlook:

• The company is on track to complete the New Drug Application (NDA) submission for ALXN1840 within the next several weeks following the initiation of rolling submission on July 22, 2026.
• The company is preparing for potential FDA approval of the NDA for ALXN1840.
• Future operational focus includes regulatory and potential commercial activities for ALXN1840, continued development of MNPR-101 programs, and internal research and development.

Business Segments and Product Lines:

• ALXN1840 (Wilson Disease):
  • Presented baseline findings from the Phase 3 FoCus study at AASLD 2026, the largest randomized controlled trial in Wilson disease, characterizing residual disease burden in treatment-experienced patients.
  • Baseline cirrhosis rates were 39% for treatment-experienced and 30% for treatment-naïve patients; neurologic symptoms were 79% and 83% respectively; psychiatric symptoms were 75% and 70% respectively.
  • Among evaluable patients, 73% had at least two of these manifestations.
  • Only 47% of treatment-experienced patients were within the guideline-recommended copper target range, and 31% of those on standard-of-care therapy for over 12 months had 24-hour urinary copper excretion above that range.
  • Presented data at AASLD showing neutral molybdenum balance and lack of molybdenum toxicity over six years of treatment, with serum uric acid remaining within normal limits.
  • 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.
  • Clinical data across the development program showed durable clinical improvement and favorable tolerability over 645 patient-years of follow-up in 266 patients.
• MNPR-101 Programs:
  • MNPR-101-Zr is in Phase 1 for imaging advanced cancers.
  • MNPR-101-Lu is in Phase 1a for the treatment of advanced cancers.
  • MNPR-101-Ac is in late preclinical for the treatment of advanced cancers.
• Leadership:
  • Jeffrey D. Kent, M.D., FACP, FACG, was appointed Executive Vice President, Head of Medical Affairs on August 19, 2026, bringing over 20 years of experience in medical affairs, clinical development, and regulatory strategy.

Market and Competitive Landscape:

• Wilson disease affects approximately 1 in 30,000 people worldwide.
• ALXN1840 is a first-in-class albumin tripartite complex (ATC) activator designed to mobilize and sequester excess copper, suppressing redox reactivity and blocking transport across the blood-brain barrier.
• ALXN1840 improves copper balance by increasing fecal copper excretion.

Risks and Challenges:

• Risks include the ability to complete the NDA submission within the anticipated timeframe.
• Uncertainties exist regarding whether the FDA will accept the NDA for filing, require additional information or studies, or approve ALXN1840.
• The timing of FDA review remains uncertain.
• Changes in operating plans, development or commercialization costs, or the timing and amount of contractual milestone payments could shorten the expected cash runway.
• General risks surround the research, development, regulatory approval, and commercialization of imaging agents and therapeutics.

Management Commentary and Tone:

• Management highlighted the significance of the Phase 3 FoCus study as the largest randomized controlled trial ever conducted in Wilson disease.
• The company expressed confidence in the long-term safety profile of ALXN1840 based on six years of treatment data showing neutral molybdenum balance.
• The appointment of Dr. Kent signals preparation for potential FDA approval and commercialization readiness.

Other Key Points:

• The company raised approximately $91.9 million in net proceeds from a capital raise in September 2025, which contributed to higher interest income in Q3 2026.
• The NDA for ALXN1840 was authorized for rolling submission by the FDA on July 22, 2026.
• The press release includes detailed financial information available via SEC filings at the company's investor relations website.