Executive Summary

Q2 2025 net loss was $2.5M and diluted EPS was -$0.35, improving sequentially from -$0.38 in Q1 2025; management highlighted continued progress on ALXN1840 toward an early-2026 NDA and active enrollment in MNPR-101 radiopharma trials .
EPS came in better than Wall Street consensus and improved year over year (Q2 2024 EPS was -$0.49); interest income rose materially year over year due to higher balances following Q4 2024 financings, partially offsetting higher R&D and G&A expenses .
Cash, equivalents and investments were $53.3M, with runway guided at least through December 31, 2026 to fund ALXN1840 NDA, MNPR-101-Zr and -Lu trials, and MNPR-101-Ac preclinical-to-clinic transition .
Key pipeline updates in the quarter: IND sponsorship for ALXN1840 transferred to Monopar effective June 6; EASL late-breaker data supported long-term efficacy/safety of ALXN1840; U.S. Expanded Access Program opened for MNPR-101-Zr and -Lu; Russell 3000/2000 index inclusion announced as a corporate visibility catalyst .

What Went Well and What Went Wrong

What Went Well

ALXN1840 regulatory pathway advanced: FDA acknowledged IND sponsorship transfer to Monopar (effective June 6, 2025) and the company reiterated intent to file an NDA in early 2026 .
ALXN1840 clinical evidence: EASL late-breaker presentation showed sustained clinical benefits, favorable safety (<5% drug-related SAEs; no renal/urinary SAEs), and patient-reported convenience versus standard of care across pooled trials, bolstering the NDA case .
Radiopharma execution: MNPR-101-Zr Phase 1 (imaging/dosimetry) and MNPR-101-Lu Phase 1a (therapeutic) were active/enrolling in Australia; the U.S. Expanded Access Program opened at EDNOC, broadening patient access .

What Went Wrong

Operating expenses increased: R&D rose to $1.73M (+$0.60M YoY, driven by personnel and SBC), and G&A rose to $1.50M (+$0.85M YoY, driven by board option grants, personnel, legal, taxes, insurance), pressuring the quarterly net loss .
Year-over-year net loss widened to $2.5M vs $1.7M, reflecting higher OpEx, despite a $0.71M YoY increase in interest income from U.S. Treasuries/higher bank balances after Q4 2024 financings .
No revenue-generating products or segment revenue to offset expenses; absence of formal revenue/margin guidance limits near-term visibility of operating leverage .

Financial Results

Sequential and Period Comparisons

Metric	Q4 2024	Q1 2025	Q2 2025
Net Loss ($USD Millions)	$10.9	$2.6	$2.5
Diluted EPS - Continuing Operations ($)	-$2.23	-$0.38	-$0.35
R&D Expense ($USD Millions)	$9.9	$1.643	$1.730
G&A Expense ($USD Millions)	$1.2	$1.578	$1.504
Cash, Equivalents & Investments ($USD Millions)	$60.2	$54.6	$53.3

Year-over-Year (Q2 2025 vs Q2 2024)

Metric	Q2 2024	Q2 2025
Net Loss ($USD Millions)	$1.7	$2.5
Diluted EPS - Continuing Operations ($)	-$0.49	-$0.35
R&D Expense ($USD Millions)	$1.131	$1.730
G&A Expense ($USD Millions)	$0.658	$1.504
Interest Income YoY Change ($USD Millions)	—	+$0.707

Versus Wall Street Consensus (S&P Global)

Metric	Actual Q2 2025	Consensus Q2 2025	Surprise
Diluted EPS - Continuing Operations ($)	-$0.35	-$0.48333*	+$0.13333 (beat)*
Revenue ($USD Millions)	Not reported	0.0*	n/a*

Values retrieved from S&P Global.*

KPIs (operational)

KPI	Q4 2024	Q1 2025	Q2 2025
Cash Runway (internal guidance)	Through 12/31/2026	Through 12/31/2026	Through 12/31/2026
ALXN1840 Regulatory Milestone	License signed (Oct 2024)	Preparing NDA early 2026	IND transfer acknowledged by FDA; NDA early 2026
MNPR-101 Clinical Status	First patient dosed with MNPR-101-Lu (Dec 2024)	Phase 1/1a active/enrolling (AU)	Phase 1/1a active/enrolling (AU); U.S. EAP opened

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through 12/31/2026	Through 12/31/2026 (Q1 reiteration)	Through 12/31/2026 (Q2 reiteration)	Maintained
ALXN1840 NDA Timing	Early 2026	Early 2026 (Q1 reiteration)	Early 2026; FDA acknowledged IND transfer (effective 6/6/2025)	Maintained; regulatory step completed
MNPR-101-Zr/Lu Trial Status	Ongoing Phase 1/1a (AU)	Ongoing Phase 1/1a (Q1)	Ongoing Phase 1/1a (AU) and U.S. EAP opened	Expanded access added
Financial Metrics (Revenue/Margins/OpEx)	n/a	n/a	No formal quantitative guidance provided	n/a

Earnings Call Themes & Trends

No Q2 2025 earnings call transcript was available; themes tracked using 8-K and press releases.

Topic	Previous Mentions (Q4 2024, Q1 2025)	Current Period (Q2 2025)	Trend
ALXN1840 Regulatory	License from Alexion; plan to submit NDA early 2026	FDA acknowledged IND sponsor transfer; NDA early 2026 reiterated	Improving regulatory clarity
ALXN1840 Clinical Evidence	Preparing for NDA; EASL late-breaker accepted	EASL late-breaker presented; sustained efficacy/safety across pooled trials	Strengthening dataset
Radiopharma MNPR-101	Phase 1/1a trials initiated; first MNPR-101-Lu patient dosed	Trials active/enrolling; U.S. EAP authorized and opened	Expanded access and enrollment momentum
Capital/Index Visibility	Raised >$55M via offerings	Added to Russell 3000/2000 announced (effective 6/27/2025)	Visibility up; potential ownership broadening
Financing Impact on Interest Income	n/a	+$0.515M YoY in Q1	+$0.707M YoY in Q2, driven by Treasuries and higher balances

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 .
“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 .
“This is an important milestone for Monopar and reflects the significant transformation and growth we have experienced over the past year... driven largely by the growing recognition of our late-stage ALXN1840 drug candidate for Wilson disease.” – Quan Vu, CFO .

Q&A Highlights

No Q2 2025 earnings call transcript or Q&A session was available [List: earnings-call-transcript search returned 0].

Estimates Context

EPS beat: Q2 2025 diluted EPS was -$0.35 vs S&P Global consensus of -$0.48333, a positive surprise of $0.13333 per share; we attribute the outperformance partially to higher interest income from U.S. Treasuries and higher cash balances following Q4 2024 financings, which offset increased operating expenses . Values retrieved from S&P Global.*
Revenue: The company did not report product revenue in the quarter; consensus expected $0.0, consistent with the company’s clinical-stage status . Values retrieved from S&P Global.*

Key Takeaways for Investors

EPS loss narrowed sequentially and beat consensus; interest income is a meaningful offset to OpEx while programs progress toward potential value-inflecting milestones .
ALXN1840 path advancing: IND sponsorship transfer and EASL data support; NDA targeted for early 2026, keeping a clear regulatory timeline in view .
Radiopharma optionality: Active enrollment in AU and U.S. EAP launch provide avenues for patient exposure and real-world feedback while early efficacy/safety data mature .
Balance sheet supports execution: $53.3M in cash and investments with runway guided through end-2026; financing completed in Q4 2024 enhances interest income carry .
Index inclusion (Russell 3000/2000) may broaden investor base and liquidity; monitor potential demand shifts around reconstitution flows .
Near term, stock catalysts include ALXN1840 regulatory interactions and additional MNPR-101 clinical/EAP updates; medium term hinges on NDA submission and potential approval pathway .
With no formal revenue or margin guidance, focus on operating expense trajectory, trial progress, and regulatory milestones to gauge timeline risk and capital needs .

Monopar Therapeutics (MNPR)·Q2 2025 Earnings Summary