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Anebulo Pharmaceuticals, Inc. (ANEB)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 FY2025 narrowed losses sequentially and beat the single-analyst EPS estimate: EPS of $(0.04) vs $(0.05)* consensus and $(0.09) in Q2; OpEx declined to $1.9M from $2.6M in Q2 .
  • Strategic focus sharpened on pediatric IV selonabant: FDA acknowledged unmet need and Anebulo now targets initiating the Phase 1 SAD in healthy adults in Q3 calendar 2025 (a shift from prior 1H25) .
  • Liquidity: Cash was $13.3M at 3/31/25 (down from $15.0M at 12/31/24); loan availability reduced to ~$3M following LSA amendment in Feb’25 (vs $10M availability disclosed in Q1) .
  • Near-term stock catalysts: Phase 1 SAD start in Q3 CY2025; progress on pediatric observational study (amended to focus on pediatric patients) .

Values with an asterisk (*) are retrieved from S&P Global.

What Went Well and What Went Wrong

  • What Went Well

    • EPS beat vs consensus and improved sequentially: $(0.04) vs $(0.05)* and vs $(0.09) in Q2 *.
    • Cost discipline: Total operating expenses fell to $1.9M from $2.6M in Q2 .
    • FDA engagement and program clarity: “We anticipate initiating our Phase 1 SAD study of intravenous selonabant in healthy adults aged 18 to 25 years in the third quarter of calendar 2025” . Management emphasized “a significant and growing unmet medical need” for pediatric cannabis toxicity treatment .
  • What Went Wrong

    • Timeline slippage: Start of Phase 1 SAD moved from “1H25” to “Q3 calendar 2025” .
    • Liquidity trend: Cash declined to $13.3M (3/31/25) from $15.0M (12/31/24), and loan capacity was cut to ~$3M (from $10M previously) .
    • Mix shift in OpEx: G&A rose YoY to $1.254M from $0.916M, partially offset by lower R&D .

Financial Results

Quarterly comparison (oldest → newest):

MetricQ3 FY2024Q2 FY2025Q3 FY2025
Revenue ($USD Millions)N/A (no revenue reported) N/A (no revenue reported) N/A (no revenue reported)
Net Loss ($USD Millions)$(1.654) $(2.463) $(1.676)
EPS (Basic & Diluted)$(0.06) $(0.09) $(0.04)
Total Operating Expenses ($USD Millions)$1.664 $2.588 $1.892
R&D Expense ($USD Millions)$0.748 $1.221 $0.638
G&A Expense ($USD Millions)$0.916 $1.368 $1.254
Cash & Cash Equivalents ($USD Millions)$15.0 (12/31/24) $13.3 (3/31/25)

Q3 FY2025 vs Estimates (S&P Global):

MetricConsensusActual
EPS (Primary)$(0.05)*$(0.04)
Revenue$0.0*N/A (no revenue reported)

Values with an asterisk (*) are retrieved from S&P Global.

Notes:

  • Company is pre-revenue; statements of operations present operating expenses and other income items but no revenue line .
  • No non-GAAP metrics were provided in the releases .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
IV selonabant Phase 1 SAD – start timingInitial clinical start1H25 (Q2 PR) Q3 calendar 2025 (Q3 PR) Lowered/Delayed
Loan facility availabilityLiquidity$10M availability (Q1 PR) ~ $3M availability post-amendment (Feb’25) Lowered
Development focusStrategicPrioritizing IV pediatric path (Q1/Q2) Reaffirmed priority; pediatric focus and Phase 1 SAD plan (Q3) Maintained
Observational study focusClinical opsED cannabis toxicity – general Amended to focus on pediatric patients Refined/Narrowed

Earnings Call Themes & Trends

No Q3 FY2025 earnings call transcript was located; theme tracking below uses Q1–Q3 press releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 FY2025)Trend
Pediatric IV selonabant programFDA meeting acknowledged unmet need; plan to begin Phase 1 SAD in 1H25 Initiation targeted for Q3 CY2025; prioritization reiterated Timeline delayed; priority maintained
Regulatory engagementFDA proposed close collaboration to advance pediatric indication FDA confirmed unmet need; ongoing collaboration implied Stable/constructive
Financing & liquidity$15M private placement (Dec’24); LSA amended to ~$3M availability (Feb’25) Cash $13.3M at 3/31/25; $3M loan availability Liquidity modestly lower QoQ
R&D executionIND-enabling and IV scale-up underway; first volunteer 1H25 Phase 1 SAD now Q3 CY2025; ongoing formulation scale-up Slight delay
Observational studyED cannabis toxicity study ongoing Amended to focus on pediatric patients Sharper pediatric focus
IP/patent estateTwo issued patents; multiple applications IP position reiterated Stable

Management Commentary

  • “We anticipate initiating our Phase 1 SAD study of intravenous selonabant in healthy adults aged 18 to 25 years in the third quarter of calendar 2025.” — Richie Cunningham, CEO .
  • “There is a significant and growing unmet medical need for an emergency antidote to acute cannabis-induced toxicity… children are much more sensitive to the toxic effects of cannabis…” — Richie Cunningham, CEO .
  • FDA “confirmed our belief that there is an unmet need for a treatment for children exposed to cannabis toxicity and suggested a close collaboration with Anebulo to facilitate an efficient development plan” .

Q&A Highlights

  • No earnings call transcript for Q3 FY2025 was available in the document set; commentary is based on the 8‑K/press release disclosures .
  • Key clarifications from disclosures: program timing (Q3 CY2025 Phase 1 SAD start), pediatric focus, and liquidity/LSA changes .

Estimates Context

  • EPS: Single-analyst consensus for Q3 FY2025 was $(0.05); actual was $(0.04), a small beat reflecting lower OpEx QoQ .
  • Revenue: Consensus was $0.0* and the company reported no revenue in Q3 *.
  • Trajectory vs prior quarters: Q1 FY2025 EPS $(0.08) vs $(0.05); Q2 FY2025 EPS $(0.09) vs $(0.08); Q3 FY2025 $(0.04) vs $(0.05)* — sequential improvement in reported EPS through Q3 *.

Quarterly estimates vs actuals (oldest → newest):

MetricQ1 FY2025 ConsensusQ1 FY2025 ActualQ2 FY2025 ConsensusQ2 FY2025 ActualQ3 FY2025 ConsensusQ3 FY2025 Actual
EPS (Primary)$(0.05)*$(0.08) $(0.08)*$(0.09) $(0.05)*$(0.04)
Revenue ($M)$0.0*N/A (no revenue) $0.0*N/A (no revenue) $0.0*N/A (no revenue)

Values with an asterisk (*) are retrieved from S&P Global.

Key Takeaways for Investors

  • Anebulo delivered a modest EPS beat and sequentially lower OpEx, narrowing net loss to $(1.68)M and $(0.04) EPS in Q3 *.
  • The pivotal near-term catalyst is Phase 1 SAD for IV selonabant targeted to begin in Q3 CY2025; any further slippage would likely weigh on sentiment .
  • Liquidity remains adequate for near-term milestones (cash $13.3M at 3/31/25), but the LSA availability reduction to ~$3M and cash decline from $15.0M QoQ reduce flexibility; financing overhang is a watch item .
  • The sharpened pediatric strategy (FDA engagement, observational study amended to pediatric focus) strengthens the regulatory narrative and potential path to approval .
  • Expense mix bears monitoring: G&A is up YoY while R&D dipped, consistent with corporate and regulatory build-out; maintaining OpEx control was a positive this quarter .
  • With no revenue and a single-analyst model driving estimates, stock reaction will be driven by execution milestones (Phase 1 start, pediatric study insights) and balance sheet moves *.
  • Overall, the quarter supports a “show-me” but improving setup: execution on the Q3 CY2025 start and sustained OpEx discipline are key to sustaining momentum .

Values with an asterisk (*) are retrieved from S&P Global.