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AVENUE THERAPEUTICS, INC. (ATXI)·Q4 2023 Earnings Summary

Executive Summary

  • Avenue reported FY 2023 results alongside its Q4 2023 update: cash and cash equivalents were $1.8M at 12/31/2023 and FY 2023 net loss was $10.5M ($0.98 per share), reflecting higher R&D and the AJ201 license expense .
  • The quarter’s narrative was driven by pipeline execution: AJ201 Phase 1b/2a enrollment completed (25 patients), FDA alignment finalized on the Phase 3 IV tramadol safety study, and BAER-101 preclinical data presented across multiple venues .
  • No formal financial guidance was issued; management highlighted near-term clinical catalysts (AJ201 topline data in Q2 2024) and reiterated financing needs to progress BAER-101 and IV tramadol .
  • Q4 2023 EPS was reported as $0.56 by third-party coverage; the company reported no revenue for the quarter per those sources; S&P Global consensus data was unavailable for validation, and the company’s press release did not provide quarterly revenue .

What Went Well and What Went Wrong

What Went Well

  • AJ201 program execution: completed enrollment of 25 SBMA patients in the Phase 1b/2a trial; topline data expected Q2 2024. “We remain on track to report topline data for AJ201 in the second quarter of 2024…” — CEO Alexandra MacLean, M.D. .
  • Positive BAER-101 preclinical readouts: fully suppressed seizure activity in GAERS model at 0.3 mg/kg PO, fast onset and stable effect; presented at AES and ASENT, and in Drug Development Research .
  • FDA alignment on IV tramadol Phase 3 safety study design and statistical plan; non-inferiority vs IV morphine in post-bunionectomy patients, ~300 patients, with potential 12-month completion timeline post-initiation .

What Went Wrong

  • Liquidity tightened: cash fell to $1.8M at year-end from $6.7M prior year; company completed a warrant inducement in Jan 2024 for $5.0M gross proceeds .
  • Elevated operating spend: FY 2023 R&D was $6.1M plus $4.2M license acquisition expense; G&A $4.2M, contributing to FY net loss of $10.5M .
  • Listing/compliance risk: Nasdaq Hearings Panel granted extension through May 20, 2024 to evidence compliance with bid price and stockholders’ equity requirements .

Financial Results

Quarterly snapshot (Q2–Q4 2023)

MetricQ2 2023Q3 2023Q4 2023
Cash and Equivalents (period-end, $USD Millions)$1.571 $0.161 $1.783
R&D Expense ($USD Millions)$3.027 $0.907 n/a (not disclosed)
G&A Expense ($USD Millions)$0.896 $1.161 n/a (not disclosed)
Net Income (Loss) ($USD Millions)$(4.016) $0.513 n/a (not disclosed)
Diluted EPS ($USD)$(0.52) $0.06 $0.56

Notes:

  • The company’s Q4 press release provided FY figures and balance sheet at 12/31/2023 but did not disclose Q4 R&D, G&A, or net income detail .
  • Third-party coverage reported Q4 EPS and “no revenue,” but ATXI did not provide quarterly revenue in its filings or press releases; S&P Global estimates were unavailable .

Annual comparison (FY 2022 vs FY 2023)

MetricFY 2022FY 2023
Cash and Equivalents (period-end, $USD Millions)$6.708 $1.783
R&D Expense ($USD Millions)$2.698 $6.131
R&D – Licenses Acquired ($USD Millions)$0.000 $4.230
G&A Expense ($USD Millions)$5.345 $4.179
Net Loss ($USD Millions)$(3.603) $(10.488)
Diluted EPS ($USD)$(1.63) $(0.98)

KPIs / Operational milestones

KPIQ2 2023Q3 2023Q4 2023
AJ201 clinical progressFirst patient dosed in Phase 1b/2a; ~24 planned enrollment Enrollment on track; trial-in-progress posters presented Enrollment completed (25 patients); topline data expected Q2 2024
BAER-101Preclinical GAERS model: full seizure suppression at 0.3 mg/kg PO; fast onset, stable effect AES poster acceptance; reiteration of preclinical efficacy Presented at AES/ASENT; publication in Drug Development Research
IV tramadolFDA agreement on Phase 3 safety study design/statistics Alignment on key elements of Phase 3 design Final agreement on protocol/statistics; ~300-patient study; aim to initiate pending financing

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial guidance (Revenue, EPS, margins, OpEx)FY/Q4 2023NoneNoneMaintained (no formal guidance)
AJ201 topline data timingQ2 2024“First half 2024” “Second quarter of 2024” Narrowed timing window (clarified)
IV tramadol Phase 3 initiation2024“As soon as feasible pending financing” “Aims to initiate as soon as feasible pending financing; 12 months to complete post-initiation” Maintained timing; added completion expectation

Earnings Call Themes & Trends

Note: No Q4 2023 earnings call transcript identified in filings or on the investor site; themes are derived from press releases .

TopicPrevious Mentions (Q2 2023)Previous Mentions (Q3 2023)Current Period (Q4 2023)Trend
R&D execution (AJ201)First patient dosed; ~24 planned Enrollment progressing; trial posters Enrollment completed (25); topline Q2 2024 Positive execution momentum
Regulatory (IV tramadol)FDA agreement on Phase 3 design/statistics Alignment on key elements; submitting plan Final agreement; ~300 patients; aim to initiate pending financing Advancing toward pivotal safety study
Preclinical efficacy (BAER-101)GAERS model: full suppression at 0.3 mg/kg AES presentation planned Presented at AES/ASENT; published Strengthening external validation
Liquidity/financingCash $1.6M at Q2; no offering mentioned Cash $0.2M; raised ~$5M gross in Nov 2023 Cash $1.8M at FY-end; $5M warrant inducement in Jan 2024 Ongoing financing need
Listing/compliance——Nasdaq extension to May 20, 2024 Improvement contingent on equity/bid price

Management Commentary

  • “We remain on track to report topline data for AJ201 in the second quarter of 2024, an incredibly exciting milestone…” — Alexandra MacLean, M.D., CEO .
  • “We have progressed BAER-101… presenting preclinical data… We have also advanced IV tramadol, reaching final agreement with the FDA on the safety study and statistical analysis approach…” .
  • “Pending additional financing, we look forward to progressing BAER-101 and IV tramadol…” .

Q&A Highlights

  • No Q4 2023 earnings call transcript or Q&A was identified; disclosures were made via press releases and SEC 8-K filings .

Estimates Context

  • We attempted to retrieve S&P Global consensus for Q4 2023 EPS and revenue; data was unavailable for ATXI at the time of query. As such, estimate comparison is not provided, and any third-party estimate references are not S&P Global-sourced .
  • Given the company’s pre-revenue status and limited coverage, investors should focus on clinical/regulatory milestones and financing cadence as the primary drivers of near-term estimate revisions .

Key Takeaways for Investors

  • Near-term catalyst: AJ201 Phase 1b/2a topline data in Q2 2024; successful readout could be a material stock driver given lack of approved treatments in SBMA .
  • IV tramadol pathway clarified: final FDA agreement on Phase 3 safety study design; study initiation and completion timeline hinge on financing and operational execution .
  • BAER-101 strengthening story: reproducible preclinical efficacy and selective receptor targeting may support entry into Phase 2a; watch for partnering or funding updates .
  • Balance sheet and listing compliance are watch items: cash $1.8M at FY-end; Nasdaq extension through May 20, 2024 underscores urgency to bolster equity capital .
  • Operating trends: quarterly EPS improved from $(0.52) in Q2 to $0.06 in Q3 and third-party reported $0.56 in Q4; swings are influenced by non-cash warrant liability fair value changes rather than revenue growth .
  • Strategy: With no formal financial guidance, trade the pipeline timeline and regulatory events; monitor capital raises and any strategic partnerships to de-risk development execution .
  • Action: Position sizing should reflect financing and listing compliance risks; catalysts in 2024 may drive binary outcomes, requiring disciplined risk management .