Monopar Therapeutics (MNPR)·Q1 2025 Earnings Summary

Executive Summary

• MNPR delivered a clean quarter typical of a pre‑revenue biotech: net loss of $2.6M (‑$0.38/sh) vs ($1.6M)/(‑$0.51/sh) a year ago; EPS materially beat S&P Global consensus (‑$0.57*) on disciplined OpEx and higher interest income .
• Cash, cash equivalents and investments were $54.6M, with runway “at least through December 31, 2026,” reaffirming funding to reach key ALXN1840 NDA activities and ongoing radiopharma trials .
• Program momentum continued: long‑term ALXN1840 data presented at EASL support efficacy/safety; Phase 1 MNPR‑101 radiopharma trials remained active/enrolling; post‑quarter, MNPR was added to the Russell 3000/2000 and an FDA‑authorized Expanded Access Program for MNPR‑101 opened in the U.S. .
• Sequential loss narrowed sharply vs Q4 due to the non‑recurring ALXN1840 in‑licensing charge in Q4 ($8.6M R&D), a key “why” behind Q/Q improvement despite higher underlying OpEx YoY .

What Went Well and What Went Wrong

• What Went Well
  • EPS beat: Q1 EPS (‑$0.38) was better than S&P consensus (‑$0.57*) on higher interest income and controlled spend; interest income rose $515K YoY given larger treasury holdings following late‑2024 financings .
  • De‑risking data: EASL late‑breaker showed sustained ALXN1840 clinical benefits (pooled n=255; median 2.63 years) and favorable safety (<5% drug‑related SAEs; none renal/urinary), supporting the NDA plan for early 2026 .
  • Capital runway intact: $54.6M in cash & investments and runway through 2026 enable regulatory and clinical execution without near‑term financing .
• What Went Wrong
  • Higher OpEx YoY: R&D rose to $1.643M (+$0.677M YoY) on personnel and trial activity; G&A doubled to $1.578M (+$0.821M) on board option grants, personnel, legal and insurance .
  • Net loss widened YoY: $(2.6)M vs $(1.6)M in Q1’24; while sequentially much improved vs Q4, YoY burn still increased as programs ramp .
  • No revenue and no call: MNPR remains pre‑commercial with $0 revenue and did not post an earnings call transcript for Q1, limiting real‑time guidance/QA detail .

Financial Results

• EPS vs prior periods and estimates

• Net loss vs prior periods

• Operating expenses YoY (Q1)

• Liquidity

Notes: Revenue remained $0.00; margins not meaningful for a pre‑revenue biotech .

S&P Global disclaimer: Values marked with * are from S&P Global consensus.

Guidance Changes

Earnings Call Themes & Trends

Note: No Q1’25 earnings call transcript was posted.

Management Commentary

• “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.” – Chandler Robinson, MD, CEO (Q4’24 release) .
• “This is an important milestone for Monopar and reflects the significant transformation and growth we have experienced over the past year.” – Quan Vu, CFO, on Russell index inclusion (post‑Q1) .
• “We are pleased to provide patients in the United States with access to MNPR‑101‑Zr and MNPR‑101‑Lu… This EAP represents continued progress in our radiopharmaceutical pipeline…” – Andrew Cittadine, COO (post‑Q1) .
• External KOL perspective: “The long‑term efficacy, safety, and convenience profile of ALXN1840 are very encouraging… [with] potential to provide a meaningful benefit to Wilson disease patients’ daily lives.” – Dr. Karl Weiss (EASL presenter) .

Q&A Highlights

• No earnings call transcript was posted for Q1’25; therefore, there were no public Q&A disclosures to extract for this quarter.

Estimates Context

• EPS: Actual (‑$0.38) beat S&P Global consensus (‑$0.57*) for Q1’25, a positive delta of approximately $0.19, driven in part by higher interest income and careful OpEx management .
• Revenue: Pre‑revenue; S&P Global consensus was $0.00* and results tracked in‑line .

S&P Global disclaimer: Values marked with * are from S&P Global consensus.

Key Takeaways for Investors

• The quarter delivered an EPS beat versus S&P consensus with controlled OpEx and higher interest income, while preserving a runway through YE26—sufficient to reach the ALXN1840 NDA and continue MNPR‑101 trials .
• Sequential improvement vs Q4 reflects the absence of Q4’s $8.6M ALXN1840 in‑licensing expense—supporting a clearer view of core burn going forward .
• EASL late‑breaker data further de‑risk ALXN1840 (efficacy/safety durability), reinforcing the early‑2026 NDA timeline and underpinning the medium‑term thesis around a rare‑disease commercial opportunity .
• Ongoing Phase 1 activity across MNPR‑101‑Zr/Lu, plus the post‑quarter FDA‑authorized Expanded Access Program, broadens optionality and clinical visibility for the radiopharma franchise .
• Index inclusion (Russell 3000/2000) may support incremental liquidity and awareness; combined with a strong cash position, near‑term financing risk remains low .
• Watch for regulatory interactions and package assembly milestones for ALXN1840 through 2025, as well as updated human imaging/therapy readouts from MNPR‑101 that could influence sentiment and partnership prospects .
• Risk skew remains regulatory/clinical; absent revenue, shares are sensitive to data cadence and FDA feedback—execution on the NDA path and clean safety in ongoing trials are the key stock drivers .

S&P Global disclaimer: Values marked with * are from S&P Global.