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NeuroBo Pharmaceuticals, Inc. (NRBO)·Q2 2024 Earnings Summary

Executive Summary

  • R&D execution accelerated in Q2: DA‑1726 (obesity) Phase 1 SAD completed enrollment (45 subjects) with top-line due in Q3 2024; MAD dosed first patient with top-line in Q1 2025. DA‑1241 (MASH) Phase 2a Part 1 and Part 2 completed enrollment; top-line due in Q4 2024 .
  • Balance sheet de-risked: closed $20M upfront of up to $70M financing, lifting cash to $27.9M at 6/30 and extending runway into Q2 2025; potential $20M from Series A warrant exercise in H1 2025 if milestones met .
  • Operating spend ramped materially as trials advanced: R&D rose to $8.07M vs $2.36M YoY and $4.90M QoQ; net loss increased to $10.05M (EPS $(1.85)) from $(0.73)M YoY and $(6.71)M QoQ (EPS $(1.32)) .
  • Differentiation claims for DA‑1726 strengthened by ADA data: superior weight loss vs survodutide and lipid‑lowering vs tirzepatide in preclinical models, supporting a potential best‑in‑class profile pending human data .
  • No Street consensus available; no earnings call transcript posted for Q2—stock catalysts hinge on Q3 SAD readout (DA‑1726) and Q4 DA‑1241 readout; financing-driven runway extension reduces near‑term dilution risk if warrants exercise .

What Went Well and What Went Wrong

What Went Well

  • Completed key study enrollments and stayed on clinical timelines: DA‑1726 SAD fully enrolled (45 participants) with Q3 readout; MAD initiated; DA‑1241 Phase 2a Part 2 enrollment completed; top-line for both programs in Q4 2024/Q1 2025 as guided .
  • Strengthened DA‑1726 narrative with new ADA preclinical data: “DA‑1726…demonstrated superiority in weight loss, retention of lean body mass, and lipid‑lowering…compared to survodutide…[and] is also more effective than tirzepatide in lowering cholesterol” .
  • Balance sheet fortified and runway extended: $20M upfront closed as part of up to $70M financing; cash $27.9M; runway into Q2 2025; potential $20M Series A warrant exercise in H1 2025 .

What Went Wrong

  • Operating burn increased sharply with clinical progress: R&D $8.07M (vs $2.36M LY; $4.90M LQ) drove total op‑ex to $10.08M (vs $3.81M LY; $6.88M LQ) .
  • Other income normalized (no large warrant liability gains): $0.03M vs $3.07M LY; reducing P&L cushion and contributing to wider net loss .
  • Ongoing control environment remediation: disclosure controls “not effective” due to material weaknesses, with remediation in progress as of Q2 filing .

Financial Results

Metric (USD)Q2 2023 (oldest)Q1 2024Q2 2024 (newest)
Research & Development Expense ($MM)$2.364 $4.904 $8.074
General & Administrative Expense ($MM)$1.442 $1.977 $2.010
Total Operating Expenses ($MM)$3.806 $6.881 $10.084
Other (Income) Expense, net ($MM)$(3.072) $(0.167) $(0.031)
Net Loss ($MM)$(0.734) $(6.714) $(10.053)
Loss per Share (Basic & Diluted)$(0.15) $(1.32) $(1.85)
Cash & Equivalents ($MM, end of period)$15.988 $27.934

Notes:

  • Revenue: Company is pre‑commercial; financial statements report operating expenses and loss—no product revenue line disclosed .
  • No Street estimates available for comparison (S&P Global data unavailable for NRBO; see Estimates Context).

KPIs – Clinical & Operational

KPIPrior Periods (Q4’23 / Q1’24)Current (Q2’24)Forward Timing
DA‑1726 Phase 1 SAD enrollmentIND cleared; first patient dosed Apr’24 Enrollment completed; 45 participants Top‑line Q3 2024
DA‑1726 Phase 1 MADPlanned/initiating H2’24 First patient dosed Jun’24 Last patient visit Q4 2024; top‑line Q1 2025
DA‑1241 Phase 2a Part 1 (MASH)Enrollment completed Apr’24 (~49 pts) Top‑line Q4 2024
DA‑1241 Phase 2a Part 2 (MASH combo)Enrolling Enrollment completed (~37 pts) Top‑line Q4 2024
Cash runwayInto Q4 2024 (pre‑financing) Into Q2 2025 Potential $20M Series A warrants H1 2025

Segment breakdown: Not applicable (single clinical-stage portfolio) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayOperating runwayInto Q4 2024 Into Q2 2025 Raised/extended
DA‑1726 Phase 1 SAD top‑lineQ3 2024Q3 2024 Q3 2024 Maintained
DA‑1726 Phase 1 MAD top‑lineQ1 2025Q1 2025 Q1 2025 Maintained
DA‑1241 Phase 2a top‑line2H 20242H 2024 Q4 2024 Refined (narrowed window)
DA‑1726 Phase 1 Part 3 (obesity)Start/ReadoutsNot previously datedStart 3Q 2025; interim mid‑2026; topline 2H 2026 New disclosure

Earnings Call Themes & Trends

TopicPrevious Mentions (FY’23 and Q1’24)Current Period (Q2’24)Trend
Financing & liquidityFY’23 cash $22.4M; funding into Q4’24; exploring financing in Q1’24 Closed $20M upfront of up to $70M; cash $27.9M; runway into Q2’25; potential $20M H1’25 Improving runway, lower near‑term financing risk
R&D executionIND cleared (DA‑1726); SRC greenlight (DA‑1241); Q1 first patient dosed; Part 1 complete DA‑1726 SAD fully enrolled; MAD initiated; DA‑1241 Part 2 enrollment complete On‑plan/accelerating
DA‑1726 differentiationPreclinical advantage vs semaglutide/tirzepatide cited ADA data: superior weight loss vs survodutide; better lipid‑lowering vs tirzepatide Strengthening narrative (preclinical)
Portfolio optimizationOut‑license NB‑01 (July’24); advisor CMO engaged Streamlining legacy assets
Controls & governanceMaterial weaknesses disclosed, remediation plans (Q1’24) Weaknesses persist with remediation progress (Q2’24) Gradual remediation

Note: No Q2’24 earnings call transcript was available in our document corpus.

Management Commentary

  • “During the second quarter and subsequently, we made remarkable progress advancing the clinical development of our two, next generation cardiometabolic assets and are now well capitalized to execute on our upcoming DA‑1726 milestones following our recent, successful financing of up to $70 million…” — Hyung Heon Kim, CEO .
  • On DA‑1726 profile: “The data suggests that DA‑1726's unique GLP‑1 and glucagon receptor activity ratio may be responsible for its differentiated profile…superior weight loss…while also exhibiting superior glucose lowering and retention of relative lean body mass preservation.” .
  • On development timelines: “We anticipate reporting top‑line data in the third quarter of this year [SAD] and…in the first quarter of 2025 [MAD]…we expect to dose the first patient in Part 3 during the third quarter of 2025, providing an interim data readout in or around mid‑2026 and issuing top‑line results in the second half of 2026.” .
  • On DA‑1241: “We continue to believe that DA‑1241 has the potential to be a safe and effective treatment for MASH and anticipate reporting top‑line results in the fourth quarter of this year.” .

Q&A Highlights

  • No Q2 2024 earnings call transcript was found in available documents; Q&A themes are not available for this quarter.

Estimates Context

  • Wall Street consensus (S&P Global) was unavailable for NRBO at the time of this analysis due to missing mapping; therefore, no comparison vs consensus revenue/EPS could be made. We anchored analysis to company-reported results and filings .
  • Implication: Stock reactions likely hinge on binary clinical catalysts rather than quarterly beats/misses; future inclusion in consensus may follow increased coverage post-readouts.

Key Takeaways for Investors

  • Near‑term catalysts: DA‑1726 Phase 1 SAD top‑line in Q3 2024; DA‑1241 Phase 2a top‑line in Q4 2024; DA‑1726 MAD top‑line in Q1 2025—these will drive fundamental re‑rating potential .
  • Financing reduces near-term dilution: $20M upfront closed; runway into Q2 2025; additional $20M from Series A warrants possible in H1 2025 if clinical milestones achieved .
  • R&D investment inflection: Expect elevated burn as programs progress; Q2 R&D $8.07M vs $2.36M YoY indicates sustained higher run‑rate through data readouts .
  • Differentiation narrative building for DA‑1726: Preclinical superiority vs survodutide and lipid‑lowering vs tirzepatide is encouraging; human safety/PK/PD readouts are the next proof points .
  • Risk management: Control weaknesses remain under remediation; “going concern” language persists despite extended runway—future financing still contingent on milestones and market conditions .
  • Trading setup: With no Street estimates and limited liquidity, price action likely catalyst‑driven around readouts; extended runway reduces financing overhang into 2025 .
  • Strategic optionality: Out‑licensing of legacy NB‑01 and joint research on long‑acting DA‑1726 formulation reflect focus on core cardiometabolic assets and lifecycle planning .

Citations:

  • Q2 2024 8‑K press release and exhibit (financials, milestones, cash/runway):
  • Q2 2024 10‑Q (full financial statements, controls, going concern):
  • Q1 2024 8‑K/10‑Q (trend and prior guidance):
  • FY 2023 8‑K/10‑K (context, pipeline, risks):
  • ADA data press release (DA‑1726 differentiation):