Monopar Therapeutics: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 12 August 2026: press release. Guidance figures: 1 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Net loss increased versus last year: The company reported a net loss of $5.3 million, or $0.62 per share, for the second quarter of 2026, compared with $2.5 million, or $0.35 per share, a year earlier. Source
• Rolling NDA submission authorized by FDA: The FDA authorized the rolling submission, so completed sections can be submitted and reviewed while the remaining sections are finalized. Source
• Rare pediatric designation for ALXN1840: The company said the designation provides the potential, at NDA approval, to receive a pediatric Priority Review Voucher. Source
• Pivotal Phase 3 met primary endpoint: The pivotal Phase 3 trial met its primary endpoint, with copper mobilization significantly greater than standard of care over 48 weeks in both previously treated and treatment-naive patients. Source
• R&D expenses rose $3.0 million: R&D expenses were $4,766,832, against $1,730,000 a year earlier, an increase of $3,036,831 attributed to contractor and consulting costs and personnel expenses including stock-based compensation. Source
• Cash and investments at quarter end: Cash, cash equivalents and investments were $134.3 million at June 30, 2026. The first-quarter release reported $137.5 million at March 31, 2026. Source
• Funds expected to last into 2028: Current funds are expected to support regulatory and potential commercial activities for ALXN1840, continued MNPR-101 development and internal research through at least December 31, 2027. Source
• Commercial lead preparing potential launch: Susan Rodriguez, who joined in March 2026 as Chief Commercial and Strategy Officer, is leading preparations for a potential launch of ALXN1840. Source

“The Company anticipates completing the NDA submission within the next few months.”

Monopar Therapeutics, press release

Guidance

What changed from last quarter

• Guidance kept: The cash runway date is unchanged at December 31, 2027. Source
• New: The company initiated a rolling NDA submission for ALXN1840; the first-quarter release had said it intended to initiate the submission. Source
• New: The FDA granted Rare Pediatric Disease designation to ALXN1840 on June 30, 2026. Source
• New: Nicole Sweeny, former Chief Commercial Officer of KalVista Pharmaceuticals, was appointed to the Board of Directors. Source
• New: Sharon Funk and Daniel Olmstead were added as Senior Vice Presidents for sales and marketing, and for market access, distribution and patient services. Source

Results and net loss

• Net loss increased versus last year: The company reported a net loss of $5.3 million, or $0.62 per share, for the second quarter of 2026, compared with $2.5 million, or $0.35 per share, a year earlier. Source
• Interest income rose on Treasury holdings: Interest income was $1,299,205, against $780,769 a year earlier. The company attributed the increase to Treasury securities, commercial paper and higher bank balances in 2026. Source
• Other income from vendor invoice: Other income was $32,158, compared with $0 a year earlier, which the company attributed to an adjustment to a vendor invoice recognized in the current period. Source

Pipeline and regulatory progress

• Rolling NDA submission authorized by FDA: The FDA authorized the rolling submission, so completed sections can be submitted and reviewed while the remaining sections are finalized. Source
• Rare pediatric designation for ALXN1840: The company said the designation provides the potential, at NDA approval, to receive a pediatric Priority Review Voucher. Source
• FoCus analyses presented at EAN: Analyses from the Phase 3 FoCus trial were presented at the 12th Congress of the European Academy of Neurology, reporting greater neurologic benefit and global clinical improvement versus standard of care. Source
• Phase 2 liver data presented at EASL: Phase 2 ALXN1840-WD-205 data presented at EASL 2026 reported that ALXN1840 can stabilize liver disease and improve neurological symptoms and quality of life in treatment-experienced patients. Source
• Radiopharmaceutical programs in development: Radiopharmaceutical programs are MNPR-101-Zr in Phase 1 for imaging advanced cancers, MNPR-101-Lu in Phase 1a, and MNPR-101-Ac in late preclinical for treating advanced cancers. Source

“Susan Rodriguez, who joined as Chief Commercial and Strategy Officer in March 2026, is leading preparations for a potential commercial launch.”

Monopar Therapeutics, press release

Pivotal data and disease context

• Pivotal Phase 3 met primary endpoint: The pivotal Phase 3 trial met its primary endpoint, with copper mobilization significantly greater than standard of care over 48 weeks in both previously treated and treatment-naive patients. Source
• Program follow-up across 266 patients: Across the ALXN1840 program, the company reported clinical improvement and tolerability across 645 patient-years of follow-up in 266 patients, with a safety profile it described as well-characterized. Source
• Copper balance study published: Hepatology Communications published the Phase 2 ALXN1840-WD-204 copper balance manuscript, reporting a rapid, statistically significant and sustained improvement in daily copper balance. Source
• Wilson disease prevalence and cause: Wilson disease is described as affecting about 1 in 30,000 people worldwide, caused by mutations in the ATP7B gene that impair the body's ability to excrete copper. Source

Operating costs and spending

• R&D expenses rose $3.0 million: R&D expenses were $4,766,832, against $1,730,000 a year earlier, an increase of $3,036,831 attributed to contractor and consulting costs and personnel expenses including stock-based compensation. Source
• Contractor costs drove most of R&D rise: R&D contractor and consulting expenses rose $2,026,851, R&D personnel expenses including stock-based compensation rose $721,228, and other R&D expenses rose a net $288,752. Source
• G&A expenses rose $373,536: G&A expenses were $1,877,831, against $1,504,295 a year earlier, an increase attributed to G&A personnel expenses including stock-based compensation and G&A contractor and consulting expenses. Source

Cash and funding

• Cash and investments at quarter end: Cash, cash equivalents and investments were $134.3 million at June 30, 2026. The first-quarter release reported $137.5 million at March 31, 2026. Source
• Funds expected to last into 2028: Current funds are expected to support regulatory and potential commercial activities for ALXN1840, continued MNPR-101 development and internal research through at least December 31, 2027. Source
• Higher balances from 2025 raise: The company cited net proceeds of approximately $91.9 million from its September 2025 capital raise as the source of higher bank balances in 2026. Source

Commercial readiness and leadership

• Commercial lead preparing potential launch: Susan Rodriguez, who joined in March 2026 as Chief Commercial and Strategy Officer, is leading preparations for a potential launch of ALXN1840. Source
• Former KalVista commercial head joins board: The company described commercial readiness as further strengthened by the appointment of Nicole Sweeny to the Board of Directors. Source
• Sales and market access leaders added: Sharon Funk joined as Senior Vice President of Sales and Marketing, and Daniel Olmstead as Senior Vice President of Market Access, Distribution and Patient Services. Source

Coming up, as management said on 12 August 2026

• NDA submission to be completed: The company anticipates completing the rolling NDA submission within the next few months, with remaining sections still being finalized. Source
• Commercial launch preparations continue: Preparations for a potential launch are led by Susan Rodriguez, with Sharon Funk and Daniel Olmstead added as Senior Vice Presidents. Source
• Priority review voucher if approved: If approved, the company could receive a pediatric Priority Review Voucher, usable for priority review of a later application or sold or transferred to another sponsor. Source

Figures management reported

Earlier plans management reported on

• On track: The first-quarter release said the company remained on track to submit the NDA to the FDA in mid-2026.

Other quarters

• Q3 FY2026 earnings call
• Q1 FY2026 earnings call
• Q4 FY2019 results
• Q3 FY2019 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.