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NeuroBo Pharmaceuticals, Inc. (NRBO)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 was a heavy investment quarter: net loss widened to $6.71M driven by R&D ramp on DA‑1241 (MASH) and DA‑1726 (obesity), while cash declined to $16.0M; management expects runway into Q4 2024 and is exploring financing alternatives .
  • NeuroBo accelerated DA‑1726 timelines: SAD Part 1 top‑line now expected in Q3 2024 (previously H1 2025), and MAD Part 2 first‑patient dosing targeted for Q3 2024 with top‑line in Q1 2025 — a clear positive catalyst path for H2 2024/H1 2025 vs. .
  • DA‑1241 Phase 2a Part 1 completed enrollment (~49 patients), Part 2 combination with sitagliptin continues; top‑line results expected in Q4 2024, supporting near‑term data readout potential .
  • No earnings call transcript was available; estimates from S&P Global were unavailable (SPGI mapping missing), so beat/miss vs consensus cannot be assessed.
  • Key upcoming catalysts: DA‑1726 SAD top‑line in Q3 2024 and DA‑1241 Phase 2a top‑line in Q4 2024, both highlighted repeatedly by management .

What Went Well and What Went Wrong

What Went Well

  • Dosed first patient in DA‑1726 Phase 1 SAD and pulled forward SAD top‑line to Q3 2024; MAD Part 2 expected to start in Q3 2024 with top‑line in Q1 2025, tightening the clinical catalyst window .
  • Completed enrollment of DA‑1241 Phase 2a Part 1 (~49 patients) and continued enrolling Part 2 combo arm; Safety Review Committee recommended trial continuation without modification, an early safety signal .
  • CEO tone confident on DA‑1726 tolerability and dual‑agonist profile: “we strongly believe that DA‑1726 may offer a superior tolerability profile compared to currently available GLP‑1 agonists…” and reiterated multiple upcoming data disclosures .

What Went Wrong

  • Operating loss widened materially due to higher R&D (investigational drug manufacturing, non‑clinical/preclinical services, clinical trials, consulting) and increased compensation; net loss rose to $6.71M and EPS to $(1.32) vs $(0.51) YoY .
  • Cash declined to $16.0M (from $22.4M at 12/31/23); while management still sees runway into Q4 2024, it is “exploring various financing alternatives,” implying potential dilution or debt constraints .
  • Disclosure controls were deemed “not effective” due to previously identified material weaknesses (segregation of duties, logical access, supervision/review); remediation is underway but not complete, posing governance/process risk .

Financial Results

Quarterly Snapshot (oldest → newest)

MetricQ3 2023Q4 2023Q1 2024
R&D Expense ($USD Millions)$2.292 $4.904
G&A Expense ($USD Millions)$1.601 $1.977
Total Operating Expenses ($USD Millions)$3.893 $6.881
Net Loss ($USD Millions)$3.818 $6.714
EPS (Basic & Diluted) ($USD)$(0.09) $(1.32)
Weighted Avg Shares (Basic & Diluted)40,606,537 5,089,408
Cash and Equivalents ($USD Millions)$25.837 (as of 9/30/23) $22.435 (as of 12/31/23) $15.988 (as of 3/31/24)

Notes: Q4 2023 quarter-level R&D/G&A/Net Loss/EPS not disclosed in FY 2023 press release or filings extracted above; FY-level metrics were provided but are not used to derive quarterly figures .

YoY Comparison – Q1 2024 vs Q1 2023

MetricQ1 2023Q1 2024Change
R&D Expense ($USD Millions)$0.637 $4.904 +$4.267
G&A Expense ($USD Millions)$1.883 $1.977 +$0.094
Total Operating Expenses ($USD Millions)$2.520 $6.881 +$4.361
Net Loss ($USD Millions)$2.604 $6.714 +$4.110
EPS (Basic & Diluted) ($USD)$(0.51) $(1.32) $(0.81)
Interest Income ($USD Millions)$0.000 $0.237 +$0.237
Cash and Equivalents ($USD Millions)$30.813 (as of 3/31/23) $15.988 (as of 3/31/24) $(14.825)

KPIs (Clinical/Operational)

  • DA‑1726 Phase 1 SAD: first patient dosed (April 2024); SAD targets ~45 participants in 5 cohorts (6:3 randomization); MAD Part 2 targets ~36 participants in 4 cohorts .
  • DA‑1241 Phase 2a: Part 1 (~49 patients) enrolled; Part 2 (100 mg DA‑1241 + 100 mg sitagliptin vs placebo) enrolling; trial designed 16‑week, randomized, double‑blind, placebo‑controlled .
  • Cash runway: expected to fund operations into Q4 2024 .

Segment breakdown: Not applicable (clinical‑stage; no revenue segments reported).

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
DA‑1726 Phase 1 SAD top‑lineQ3/Q4 timingH1 2025 top‑line Q3 2024 top‑line Accelerated
DA‑1726 Phase 1 MAD Part 2 – first patientStartH1 2024 initiate Q3 2024 first patient Deferred to Q3
DA‑1726 Phase 1 MAD Part 2 top‑lineQ1/Q2 timingH2 2025 Q1 2025 Accelerated
DA‑1241 Phase 2a full enrollmentQuarterH2 2024 Q3 2024 Clarified earlier
DA‑1241 Phase 2a top‑lineQuarterH2 2024 Q4 2024 Narrowed window
Cash runwayHorizonInto Q4 2024 Into Q4 2024 Maintained

Earnings Call Themes & Trends

Note: No Q1 2024 earnings call transcript available in the filings database window; themes inferred from Q3 2023 and FY 2023 releases and Q1 2024 8‑K/10‑Q.

TopicPrevious Mentions (Q3 2023)Previous Mentions (Q4 2023/FY)Current Period (Q1 2024)Trend
R&D executionFirst patient dosed in DA‑1241 Phase 2a; DA‑1726 IND submission expected YE’23 IND cleared for DA‑1726; first site IRB approved; SRC approval to continue DA‑1241 Phase 2a DA‑1726 Phase 1 SAD first patient dosed; DA‑1241 Phase 2a Part 1 enrollment completed; Part 2 enrolling Execution advancing
RegulatoryIRB approvals and IND prep for DA‑1726 FDA IND clearance for DA‑1726; SRC recommendation on DA‑1241 Continued IRB approvals and dosing initiation for DA‑1726 Positive momentum
Cash/runway$25.8M cash; runway into Q4 2024 $22.4M cash; runway into Q4 2024 $16.0M cash; runway maintained into Q4 2024; exploring financing Runway steady, cash lower
Obesity program profilePreclinical suggests weight‑loss efficacy vs semaglutide/tirzepatide Reiterated superior weight loss in preclinical models Emphasizes tolerability via GLP1R/GCGR balance; clinical initiation and near‑term SAD readout Confidence, timelines pulled forward
MASH programDA‑1241 mechanism (GPR119) and prior safety/efficacy signals SRC positive, combo sitagliptin synergy; Part 2 enrollment opened Part 1 enrolled (~49), Part 2 enrolling; top‑line Q4 2024 Advancing to readout

Management Commentary

  • “During the first quarter and subsequently, we continued to diligently advance the clinical development of our two, next generation cardiometabolic assets… we strongly believe that DA‑1726 may offer a superior tolerability profile compared to currently available GLP‑1 agonists…” — Hyung Heon Kim, President & CEO .
  • “Additionally… we fully enrolled Part 1 of the Phase 2a clinical trial for DA‑1241… Part 2 of this trial… continues to enroll patients… 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.” — Hyung Heon Kim .
  • “Cash was approximately $16.0 million… expected to fund operations into the fourth quarter of 2024 and we are currently exploring various financing alternatives.” — Company statement .

Q&A Highlights

  • No public Q1 2024 earnings call transcript was available; no Q&A themes to report from a call. Strategy and timelines are drawn from the Q1 2024 8‑K press release and 10‑Q .

Estimates Context

  • S&P Global/Capital IQ consensus estimates for EPS and revenue were unavailable for NRBO due to missing SPGI mapping, so we cannot assess beats/misses vs Street for Q1 2024. Values retrieved from S&P Global were unavailable.

Key Takeaways for Investors

  • Near‑term catalysts: DA‑1726 SAD top‑line in Q3 2024 and DA‑1241 Phase 2a top‑line in Q4 2024; MAD Part 2 top‑line Q1 2025 — these events can re‑rate clinical probability and sentiment .
  • R&D ramp is intentional; operating expenses will remain elevated as both programs progress; monitor cash burn and financing updates given runway only into Q4 2024 .
  • DA‑1726 timeline acceleration is a significant positive; confirmation of safety/tolerability in SAD and dosing initiation in MAD will be important for differentiation vs existing GLP‑1/GIP classes .
  • DA‑1241 combination strategy (with sitagliptin) and SRC endorsement reduce execution risk; Q4 top‑line will be a pivotal read on mechanism and combo benefits .
  • Governance/process risk: disclosure controls not yet effective; remediation underway — keep an eye on progress to reduce non‑operational risk .
  • Without Street estimates, trading may be catalyst‑driven rather than numbers‑driven; positioning into Q3/Q4 events should consider financing overhang and potential dilution .