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Monopar Therapeutics (MNPR)·Q4 2024 Earnings Summary

Executive Summary

  • Monopar reported Q4 2024 net loss of $10.9M ($2.23 per share), driven primarily by an $8.6M ALXN1840 in-licensing charge; cash and short-term investments rose to $60.2M following Q4 financings .
  • EPS materially missed S&P Global consensus: Primary EPS consensus was -$0.42*, while S&P actual Primary EPS was -$2.75*; press release GAAP diluted EPS was -$2.23, with the delta largely due to in-licensing expense and metric definition differences *.
  • Strategy execution advanced: first patient dosed with MNPR-101-Lu; MNPR-101-Zr Phase 1 imaging ongoing; ALXN1840 NDA filing targeted for early 2026, expanding rare disease footprint .
  • Liquidity and runway improved: net proceeds >$55M from October and December financings extend runway at least through December 31, 2026, a raise versus prior “first half 2026” projection .

What Went Well and What Went Wrong

What Went Well

  • ALXN1840 acquisition progress and regulatory path: “2024 was a productive year... with the in-licensing of ALXN1840... we plan to submit an NDA... in early 2026,” highlighting strategic expansion into Wilson disease .
  • Radiopharma execution: first patient dosed with MNPR-101-Lu under compassionate use with no serious adverse reactions reported; Phase 1a MNPR-101-Lu and Phase 1 MNPR-101-Zr studies actively enrolling, with prior imaging data validating tumor targeting .
  • Strengthened balance sheet and runway: completed $19.2M offering in October and $40M offering in December; management projects funds sufficient through Dec 31, 2026 .

What Went Wrong

  • EPS miss vs consensus and YoY deterioration: Q4 Primary EPS actual at -$2.75* vs consensus -$0.42*; press release diluted EPS -$2.23 vs -$0.60 in Q4 2023, reflecting investment and licensing costs *.
  • R&D expense spike: Q4 R&D rose to $9.9M from $1.0M (+$8.9M), primarily due to $8.6M ALXN1840 in-licensing; full-year R&D up to $13.0M from $5.6M .
  • Continued pre-revenue profile and clinical risks: no revenue reported; forward-looking cautions include enrollment, dosimetry variability, and potential adverse events or clinical hold risks .

Financial Results

Income Statement and Cash Metrics

MetricQ2 2024Q3 2024Q4 2024
Revenues ($USD Millions)N/A*N/A*N/A*
Net Loss ($USD Millions)$1.72 $1.30 $10.93
Diluted EPS ($USD)$0.10 loss $0.37 loss $2.23 loss
R&D Expense ($USD Millions)$1.13 $0.98 $9.90
G&A Expense ($USD Millions)$0.66 $0.59 $1.20
Cash & ST Investments ($USD Millions)$7.1 $6.0 $60.2

Notes: Revenues N/A reflect clinical-stage status; values retrieved from S&P Global where marked with asterisk.*

EPS vs Wall Street Consensus (S&P Global)

MetricQ4 2024
Primary EPS Consensus Mean ($)-0.42*
Primary EPS Actual (S&P Primary EPS) ($)-2.75*
GAAP Diluted EPS (Press Release) ($)-2.23

Values with asterisk retrieved from S&P Global.

Margins

  • Not meaningful given no reported revenue *.

KPIs (Operating)

  • ALXN1840: license executed Oct 2024; NDA planned early 2026 .
  • MNPR-101-Zr: Phase 1 imaging/dosimetry active and enrolling; positive imaging/dosimetry data presented at EANM 2024 .
  • MNPR-101-Lu: Phase 1a therapeutic trial active; first patient dosed, well-tolerated .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Funding RunwayCorporateSufficient at least into H1 2026 Sufficient at least through Dec 31, 2026 Raised
ALXN1840 NDA TimingRegulatoryNot previously specifiedPlan to submit NDA in early 2026 New
MNPR-101-Lu Trial StartClinical“On track to initiate in Q4 2024” Initiated; first patient dosed Dec 2024 Achieved
MNPR-101-Zr ImagingClinicalInitiated; active and enrolling Ongoing; data presented; continued enrollment Maintained

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was available.

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Radiopharma ExecutionMNPR-101-Zr Phase 1 initiated & enrolling; MNPR-101-RIT on track for Q4 start MNPR-101-Lu Phase 1a launched; MNPR-101-Zr positive imaging data; pipeline IP expanded First MNPR-101-Lu patient dosed; imaging trial ongoing Accelerating
ALXN1840 / Wilson DiseaseN/AExclusive license signed; Phase 3 completed; assemble regulatory package NDA filing targeted for early 2026 Advancing to regulatory
Financing & RunwayReverse split; liquidity plan; runway through Aug 2025 $17.7M raise post-Q3; runway into H1 2026 $55M net proceeds in Q4; runway through Dec 31, 2026 Strengthened
R&D FocusShift to radiopharma; winding down legacy programs Focus on uPAR radiopharma; expanded IP (linkers) Elevated R&D due to ALXN1840 in-licensing and trial execution Scaling investment
Regulatory/Clinical RisksEnrollment and clinical hold risks highlighted Similar forward-looking cautions Similar; plus dosimetry consistency and NDA uncertainty Persistent risk factors

Management Commentary

  • CEO framing: “2024 was a productive year for Monopar, with the in-licensing of ALXN1840, the initiation of two first-in-human radiopharma Phase 1 clinical trials, and the strengthening of our balance sheet with net proceeds of over $55 million from financings.”
  • On MNPR-101-Lu: “We are thrilled to have dosed this patient... believe this may be the world’s first dosing of a patient with a uPAR-targeted therapeutic radiopharmaceutical.”
  • On ALXN1840 and Wilson disease: “ALXN-1840... met its primary endpoint... Monopar will be assembling a regulatory package and initiating discussions with the FDA...” ; “Plan to submit NDA... in early 2026.”

Q&A Highlights

  • No Q4 2024 earnings call transcript available; therefore, no Q&A highlights or clarifications to report [ListDocuments search returned none].

Estimates Context

  • EPS: S&P Global Primary EPS consensus -$0.42* vs S&P actual Primary EPS -$2.75*; press release diluted EPS -$2.23. The variance reflects the $8.6M ALXN1840 in-licensing expense and differences between Primary EPS and GAAP diluted EPS definitions; reverse split mechanics may also impact per-share comparability across periods * .
  • Revenue: Consensus $0.00*; actual revenue not reported (clinical-stage).
  • Target Price: S&P Global Target Price Consensus Mean $111.77* (contextual only; not a quarterly metric).

Values with asterisk retrieved from S&P Global.

Key Takeaways for Investors

  • EPS miss is investment-driven: The Q4 EPS shortfall versus consensus primarily reflects ALXN1840 in-licensing ($8.6M) and stepped-up R&D as radiopharma and Wilson disease programs progress, not deterioration in core operations .
  • Runway extended through year-end 2026: October and December financings meaningfully de-risk near-term funding, enabling NDA preparations and clinical execution across MNPR-101 programs .
  • Radiopharma milestones approaching: Early data and first MNPR-101-Lu dosing set the stage for initial readouts; uPAR-targeting may offer differentiated precision oncology potential; watch enrollment pace, dosimetry consistency, and safety signals .
  • Rare disease optionality: ALXN1840 brings late-stage asset potential; regulatory dialogue and NDA preparation are key catalysts over the next 12–18 months; monitor FDA feedback and any need for additional data .
  • Expect continued P&L volatility: Without revenue, quarterly results will be driven by R&D and licensing costs; expense cadence may remain elevated as trials scale; consensus EPS may need recalibration post ALXN1840 accounting *.
  • Trading implications: Near-term stock moves likely tied to clinical updates (MNPR-101-Lu/Zr safety and imaging efficacy), regulatory milestones for ALXN1840, and any partnership/royalty disclosures; financing overhang reduced .
  • Risk management: Persistent clinical and regulatory risks (enrollment, dosimetry, adverse events, NDA uncertainties) warrant position sizing discipline; liquidity mitigates funding risk, but execution is paramount .

Additional source citations:

  • Q4 earnings 8-K and press release: .
  • Q3 earnings 8-K press release: .
  • Q2 earnings 8-K press release: .
  • ALXN1840 license: .
  • MNPR-101-Lu first dosing: .
  • October and December financing releases: .

S&P Global disclaimer: Values marked with asterisk (*) are retrieved from S&P Global.