Monopar Therapeutics (MNPR)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 delivered a larger net loss ($3.44M; $0.48 EPS) on accelerated R&D and G&A spend tied to ALXN1840 manufacturing, personnel, and Board stock-option grants; cash and investments rose to $143.7M after the September offering, extending runway to at least December 31, 2027 .
• EPS missed Wall Street consensus (actual -$0.48 vs -$0.40 consensus), while revenue remained $0; interest income increased to $655K, partially offsetting higher OpEx, but not enough to prevent the miss . EPS consensus values retrieved from S&P Global*.
• Strategic momentum: new copper-balance data at AASLD showing rapid and sustained improvement on ALXN1840; NDA targeted for early 2026; FDA-cleared IND for MNPR-101-Lu Phase 1 dose-escalation trial .
• Capital actions: $126.9M gross raised (net ~$91.9M after a $35M related-party share repurchase), improving liquidity but introducing governance sensitivity; share count increased, contributing to higher EPS loss per share vs prior year .

What Went Well and What Went Wrong

What Went Well

• Strengthened liquidity: Cash, cash equivalents, and investments reached $143.7M; management guides runway at least through 12/31/2027, enabling NDA preparation and radiopharmaceutical trials .
• Clinical/regulatory progress: FDA cleared IND for MNPR-101-Lu Phase 1 dose-escalation study; expanded access program remains active, and MNPR-101-Zr Phase 1 continues enrollment .
• ALXN1840 evidence base: New AASLD data showed rapid, sustained improvements in copper balance with increased fecal excretion; management reiterated NDA submission in early 2026 (quote: “Rapidly Improved Cu Balance…” oral presentation by Prof. Aftab Ala) .

What Went Wrong

• Operating cost inflation: R&D rose to $2.59M (+$1.61M YoY) on ALXN1840 manufacturing and personnel; G&A climbed to $1.50M (+$0.91M YoY) largely from Board options and personnel costs .
• EPS miss vs consensus: Actual -$0.48 vs -$0.40 consensus, driven by higher OpEx; interest income (+$556K YoY) was insufficient to offset increased burn* . EPS consensus values retrieved from S&P Global*.
• Governance optics: $35M buyback from a significant holder linked to the CEO (minority owner and non-controlling Managing Member) amid the capital raise may invite scrutiny despite enhanced runway .

Financial Results

Income Statement Highlights (USD)

Note: Company reports no revenue; margins not meaningful given zero sales .

Sequential Trend (USD)

KPIs and Balance

Estimates vs Actual (Q3 2025)

Values retrieved from S&P Global*.

Guidance Changes

No revenue/margin/OpEx/tax/dividend guidance provided .

Earnings Call Themes & Trends

Note: No Q3 earnings call transcript available; themes derived from the quarter’s filings and press releases.

Management Commentary

• “Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline” oral presentation highlighted rapid and sustained improvement in daily copper balance, primarily via increased fecal excretion, supporting ALXN1840’s potential as a therapeutic option .
• New ANA data emphasized sustained neurologic improvement (UWDRS) and psychiatric benefit (BPRS) with very low neurological SAE rates (<1%), underscoring multi-year efficacy and safety .
• Management reiterated intent to submit ALXN1840 NDA in early 2026 and outlined continued progress across MNPR-101 programs (Zr imaging, Lu therapy, Ac preclinical), supported by strengthened liquidity .

Q&A Highlights

• No Q3 2025 earnings call transcript was available; guidance clarifications and strategic updates were communicated through the 8-K earnings release, 10-Q, and press releases .

Estimates Context

• EPS missed consensus due to higher operating expenses (ALXN1840 manufacturing, personnel, Board options) despite a meaningful increase in interest income; revenue remains $0, in line with consensus given the pre-commercial stage . EPS and revenue consensus values retrieved from S&P Global*.
• Near-term estimate revisions may tilt lower for EPS if R&D intensity and Board-related G&A persist; conversely, higher interest income from larger treasury holdings provides a partial offset .

Key Takeaways for Investors

• Liquidity inflection: Post-September financing, cash/investments at $143.7M extend runway to end-2027, de-risking the ALXN1840 NDA and radiopharmaceutical trials as near-term execution priorities .
• Regulatory catalyst: Early-2026 ALXN1840 NDA submission is a key stock driver; multi-modal data (EASL/ANA/AASLD) strengthen the dossier’s efficacy and safety narrative .
• Clinical advancement: FDA-cleared MNPR-101-Lu IND and ongoing MNPR-101-Zr Phase 1/EAP broaden optionality in oncology radiopharmaceuticals, adding pipeline depth .
• Expense trajectory: Elevated R&D and G&A drove the EPS miss; monitor OpEx discipline versus milestone timelines to gauge path toward consensus alignment .
• Governance watchpoint: $35M related-party share repurchase alongside an outsized raise improves per-share economics but may attract scrutiny; expect investor focus on Board actions and capital allocation .
• Valuation sensitivity: With zero revenue pre-NDA, shares will trade on binary regulatory outcomes and clinical readouts; interest income offers an incremental buffer to EPS while trial costs scale .
• Execution focus: Maintain attention on NDA assembly, CMC readiness, and trial enrollment cadence; any timeline slips vs early-2026 target would be a negative narrative inflection .

Values marked with * are retrieved from S&P Global.

Citations:

• Q3 2025 8-K earnings release and details
• Q3 2025 10-Q financials and narrative
• Q2 2025 8-K earnings release
• Q1 2025 8-K earnings release
• AASLD copper balance data press and 8-K
• ANA long-term neurological data 8-K