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Moleculin Biotech, Inc. (MBRX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally on track: first patient dosed in the pivotal, adaptive Phase 3 MIRACLE trial for Annamycin (naxtarubicin) in R/R AML; EMA approved the CTA across nine EU countries, expanding recruitment capacity; interim readout (n=45) remains targeted for 2H 2025 .
  • Financially, Moleculin reported no revenue and a net loss of $6.44M (–$0.69 EPS); cash was $7.72M, funding operations into Q3 2025 .
  • Wall Street consensus for Q1 2025 EPS was –$0.56*, so the reported –$0.69 was a miss of $0.13; revenue consensus was $0.00*, matching actual $0 .
  • Management reiterated the primary CR endpoint at ~day 35 and explained EMA’s GLP preclinical condition for Part B, while CFO highlighted an expected ~$15M raise to extend runway into Q1 2026 and beyond the initial interim readout .
  • Potential near-term catalysts include H2 2025 unblinding (n=45) in MIRACLE and final MB‑107 STS lung mets data (targeted by end of June), plus ongoing WP1066 progress (GBM trial recruitment, IV formulation work at Emory) .

What Went Well and What Went Wrong

What Went Well

  • “We are pleased with the continued progress of our pivotal, adaptive Phase 3 MIRACLE trial… EMA approval… positions us to continue building momentum and remain on track with our expected enrollment and data milestones.” — CEO Walter Klemp .
  • MIRACLE trial site selection and approvals are broadening: 38 sites selected globally, with EU CTA approval in nine countries; patient dosing began; first data unblinding planned H2 2025 .
  • Pipeline breadth: WP1066 GBM investigator-sponsored trial recruiting (7 patients), and MB‑107 STS lung mets final data targeted by end of June; WHO approved “naxtarubicin” as Annamycin’s INN, advancing branding/readiness .

What Went Wrong

  • EPS missed consensus by $0.13 (–$0.69 vs –$0.56*), with volatility driven by warrant-related fair value changes, issuance losses, and transaction costs within other income lines (gain of $9.05M, offset by –$7.80M issuance loss and –$1.79M transaction costs) .
  • Limited cash runway: $7.72M at 3/31/25, sufficient into Q3 2025; management anticipates raising ~$15M to fund into Q1 2026 and beyond interim MIRACLE readouts .
  • EMA condition requires appropriate nonclinical GLP studies before initiating Part B in EU, adding execution steps that could affect timing if studies take longer than expected (management does not expect timeline impact) .

Financial Results

Income Statement and EPS

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$0.00 N/A (company reported full-year only)$0.00
Net Loss ($USD Millions)$(10.59) N/A (company reported full-year only)$(6.44)
EPS ($USD)$(2.85) N/A (company reported full-year only)$(0.69)

Notes: Q4 2024 press release provided fiscal year data rather than quarter-specific figures .

Operating Expenses

Metric ($USD Millions)Q3 2024Q1 2025
Research and development$4.93 $3.44
G&A and depreciation$2.20 $2.51
Total operating expenses$7.14 $5.94

Cash and Balance Sheet Items

Metric ($USD Millions)Sep 30, 2024Dec 31, 2024Mar 31, 2025
Cash and cash equivalents$9.41 $4.28 $7.72
Warrant liability (long-term)$9.93 $5.23 $13.75
Total liabilities$15.92 $10.95 $20.97
Stockholders’ equity$7.48 $5.98 $0.04

Estimates vs Actual (EPS and Revenue)

MetricQ4 2024Q1 2025Q2 2025
EPS Consensus (USD)$(1.28)*$(0.56)*$(0.40)*
EPS Actual (USD)N/A$(0.69) N/A
Revenue Consensus ($USD Millions)$0.00*$0.00*$0.00*
Revenue Actual ($USD Millions)N/A$0.00 N/A
  • Q1 2025 EPS: Miss of $0.13 vs consensus (–$0.69 vs –$0.56*) — bold miss.
  • Disclaimer: Values marked with * are “Values retrieved from S&P Global”.

KPIs (Clinical and Operational)

KPIQ3 2024Q4 2024Q1 2025
MIRACLE sites selected (global)Interest from 60 sites, 17 targets ~25 sites selected, ~45 in process 38 sites selected (5 in US); dosing commenced
EMA approval (EU countries)N/AFirst EU country approval EMA approved CTA across 9 EU countries (Belgium, Czechia, France, Germany, Italy, Lithuania, Poland, Romania, Spain)
MIRACLE first patient dosedN/A“on track Q1 2025” First patient dosed; April 1 announcement
Interim readoutsPlanned Q4 2025 (n=45) 2H 2025 (n=45); 1H 2026 (n=75–90) 2H 2025 (n=45); 1H 2026 (n=75–90)
WP1066 (GBM)Initiated investigator-sponsored Phase 2 combo RT; recruitment underway Continued updates 7 patients recruited; IV formulation work at Emory underway
MB‑107 (STS lung mets)Database lock; clinical study report in process Final data by end of April 2025 Final data targeted by end of June 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
MIRACLE first patient treatedQ1 2025“On track Q1 2025” Achieved; first patient dosed Raised (achieved milestone)
MIRACLE interim unblinding (n=45)2H 2025Q4 2025 2H 2025 Pulled forward (calendar framing)
MIRACLE second unblinding (n=75–90)1H 20261H 2026 1H 2026 Maintained
EU participation (CTA approval)2025First EU country approval 9 EU countries approved CTA Raised (broadened EU scope)
MB‑107 final dataH1 2025“End of April” “By end of June” Deferred (timing update)
Cash runway2025/Q3 → 2026/Q1Cash sufficient into Q3 2025 Plan ~$15M raise to reach Q1 2026 New financing need clarified

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
MIRACLE trial progressSite interest (60), early visibility via adaptive design; endpoint CR vs HiDAC ~17–18%; derisking via early unblinding 38 sites selected; first patient dosed; dosing underway; unblinding timeline affirmed Strengthening execution
EMA CTA approval & EU scopeInitial EU approvals; global design EMA approval in nine EU countries; minor protocol differences, GLP condition for Part B Expanded footprint; execution step added
Endpoint and trial designCR at ~day 35; two annamycin doses (190/230 mg/m²); adaptive Part A, Part B Endpoint reiterated; single cycle comparison likely lowers placebo CR vs prior trials Consistent, nuanced
Financing and cash runwayCash $9.4M (Q3 2024), plan raises; burn guidance Cash ~$8M; plan to raise ~$15M to reach Q1 2026 and beyond interim readout Clearer funding path
WP1066 (GBM)Trial initiation; MD Anderson sponsored research 7 patients recruited; IV formulation work at Emory; update expected by year-end Advancing
STS MB‑107Data lock; CSR writing; H1 2025 readout Final data targeted by end of June Slight timing adjustment
Branding/IPPatent portfolio growth WHO approved “naxtarubicin” INN; two new US patents granted Strengthened assets

Management Commentary

  • “We are pleased with the continued progress of our pivotal, adaptive Phase 3 MIRACLE trial… remain on track with our expected enrollment and data milestones.” — Walter Klemp (CEO) .
  • “We expect the initial readout of safety and efficacy data on the first 45 subjects around the end of 2025… EMA approved our CTA in all 9 countries we submitted.” — John Paul Waymack (Senior CMO) .
  • “We ended the quarter with about $8 million… to get us well into the first quarter of 2026, we will need to raise approximately $15 million.” — Jonathan Foster (CFO) .
  • “Durability is not a primary endpoint… CR rate is the primary; durability, OS will be secondary trends.” — Management during Q&A .
  • “We think naxtarubicin is positioned to possibly become the first ever non-cardiotoxic anthracycline… key milestones coming quickly this year.” — Walter Klemp .

Q&A Highlights

  • EMA GLP nonclinical condition for Part B: Management does not expect timeline impact; continued recruitment outside EU can proceed during GLP work .
  • R&D run rate and CMC: R&D likely rises into 2026 with GLP and manufacturing as Part B approaches; enough drug on hand for Part A now .
  • Endpoint clarity: Primary is CR at ~day 35; durability/OS secondary; single-cycle design likely reduces placebo CR vs prior multi-cycle HiDAC trials .
  • Stratification: Data will be stratified by age/mutations; company believes efficacy is agnostic to venetoclax failures and elderly patients based on Phase 2 data .

Estimates Context

  • Q1 2025 EPS: –$0.69 actual vs –$0.56 consensus*; miss of $0.13 driven by non-cash warrant-related items (gain from warrant liability fair value $9.05M, offset by issuance loss –$7.80M and transaction costs –$1.79M) affecting net loss and per-share dynamics .
  • Revenue: consensus $0.00*, actual $0.00; in line .
  • Forward consensus: Q2 2025 EPS –$0.40*, Q4 2025 –$0.26* (pre-revenue profile) — estimates likely to be sensitive to financing timing and non-cash items; no revenue expected*.

Disclaimer: Values marked with * are “Values retrieved from S&P Global”.

Key Takeaways for Investors

  • Near-term catalysts: H2 2025 interim MIRACLE unblinding (n=45) is pivotal; positive CR delta vs placebo could materially rerate the stock; monitor patient recruitment pace and GLP completion status .
  • Funding overhang: With $7.72M cash at quarter-end and plan to raise ~$15M, expect capital markets activity that could pressure shares near term; positive interim data could improve terms .
  • Execution in EU/US sites: EMA’s approval across nine countries should accelerate enrollment; watch announcements of site initiations and enrollment cadence .
  • Risk/Reward: Adaptive design with early unblinding and strong Phase 2 efficacy (50% CR) vs HiDAC’s ~17–18% precedent reduces efficacy risk; single-cycle CR measurement may widen delta vs placebo .
  • Pipeline optionality: WP1066 (GBM) and MB‑107 STS lung mets provide non-AML upside; MB‑107 final data and WP1066 IV formulation progress could add catalysts .
  • Branding/IP strengthening: WHO’s “naxtarubicin” INN and extended US patents enhance commercialization readiness and moat .
  • Trading implications: Post-call stock reaction showed pressure; focus on recruitment updates and H2 2025 interim milestone as key narrative driver .