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AVENUE THERAPEUTICS, INC. (ATXI)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 focused on pipeline execution: last patient visit completed in the AJ201 Phase 1b/2a SBMA study, with topline data now targeted for the second half of 2024, shifting from “mid-2024” in Q1 communications .
  • Financing remained a key theme: Avenue raised $4.4M in gross proceeds in April via warrant exercises and effected a 1-for-75 reverse split; cash increased to $4.9M at quarter-end from $3.2M in Q1 and $1.8M at year-end 2023 .
  • Operating expenses mixed: R&D fell year over year to $1.36M from $3.03M, while G&A rose to $1.46M from $0.90M; Avenue reported a net loss per common share of $(6.43) with 1,118K weighted shares outstanding .
  • Upcoming catalysts: AJ201 topline in H2 2024; Phase 3 IV tramadol safety study ready to start, pending financing or partnership; BAER-101 Phase 2a initiation remains contingent on financing .
  • No Q2 earnings call transcript was available in the document catalog; Wall Street consensus estimates via S&P Global were unavailable for this period.

What Went Well and What Went Wrong

What Went Well

  • AJ201 program progressed: “we completed the last patient visit in our Phase 1b/2a trial…we anticipate reading out topline data…in the second half of this year” — Alexandra MacLean, M.D., CEO .
  • Balance sheet stabilizing: cash and equivalents rose to $4.9M vs. $3.2M in Q1 and $1.8M at year-end, helped by $4.4M in April warrant transactions .
  • Listing compliance achieved: formal notice in May confirmed continued listing on Nasdaq Capital Market, resolving prior listing matters .

What Went Wrong

  • Continued dependence on financing: initiation of Phase 3 IV tramadol study and BAER-101 Phase 2a remain contingent on additional funding or a partnership, delaying timelines vs. rapid execution aspirations .
  • Higher G&A spend: G&A rose to $1.46M vs. $0.90M in Q2 2023, elevating non-R&D cash burn despite R&D decline .
  • Disclosure inconsistency: press narrative cites “net loss attributable to common stockholders…$2.7M,” but financial statements show $(7.19)M and EPS $(6.43) on 1,118K shares (the $(2.70)M aligns with “Net loss” line, not “net loss attributable to common stockholders”) .

Financial Results

MetricQ2 2023Q1 2024Q2 2024
Revenue ($USD Thousands)$0 — pre-revenue $0 — pre-revenue $0 — pre-revenue
R&D Expense ($USD Thousands)$3,027 $2,392 $1,361
G&A Expense ($USD Thousands)$896 $1,316 $1,462
Net Loss ($USD Thousands)$(4,016) $(4,349) $(2,701)
Net Loss Attributable to Common Stockholders ($USD Thousands)$(4,007) $(4,340) $(7,186)
Diluted EPS ($USD)$(38.74) $(15.40) $(6.43)
Weighted Avg Shares (Thousands)103 562 1,118

Notes:

  • Avenue remains pre-revenue; statements present only operating expenses (no revenue lines) .
  • The Q2 2024 press release text references “net loss attributable to common stockholders $2.7M,” but statements of operations show $(7.186)M and $(6.43) EPS; $(2.701)M corresponds to “Net loss,” not “net loss attributable to common stockholders” .

KPIs and Balance Sheet

KPIDec 31, 2023Mar 31, 2024Jun 30, 2024
Cash & Equivalents ($USD Thousands)$1,783 $3,194 $4,919
Total Assets ($USD Thousands)$1,850 $3,310 $4,988
Total Liabilities ($USD Thousands)$1,196 $1,412 $1,161
Total Stockholders’ Equity ($USD Thousands)$654 $1,898 $3,827

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
AJ201 Phase 1b/2a topline readout2024“middle of 2024” “second half of 2024” Timing pushed later (H2 vs. mid-year)
IV Tramadol Phase 3 safety study initiation2024“initiate as soon as feasible; study can be completed & submitted within 12 months of initiation” “aims to initiate pending additional financing or partnership” Maintained initiation goal; clarified financing dependency
BAER-101 Phase 2a initiation2024-2025“plans to initiate subject to financing/partnership” “continues plans subject to financing” Maintained
Nasdaq listing statusMay 2024Seeking compliance extension to May 20, 2024 Compliance evidenced with all criteria in May 2024 Improved (resolved listing matter)

No quantitative financial guidance (revenue, margins, OpEx, OI&E, tax rate, dividends) was provided in Q2 materials .

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was available in the catalog; themes sourced from Q4 FY2023, Q1, and Q2 press releases .

TopicPrevious Mentions (Q4 2023, Q1 2024)Current Period (Q2 2024)Trend
AJ201 (SBMA)Enrollment completed; topline expected Q2 2024 Last patient visit complete; topline in H2 2024 Timeline slipped from mid-2024 to H2 2024
BAER-101 (epilepsy)Positive preclinical data presented; Phase 2a subject to financing/partnership Plans to initiate remain subject to financing; reiteration of seizure suppression profile Awaiting financing; narrative consistent
IV Tramadol (acute post-op pain)Final FDA agreement on Phase 3 safety study design; initiation as soon as feasible Aims to initiate pending financing/partnership; ~300 post-bunionectomy patients Financing dependency emphasized
Capital/ListingJan/May warrant exercises; reverse split planned; Nasdaq extension through May 20 $4.4M April warrant proceeds; 1-for-75 reverse split; Nasdaq compliance achieved Balance sheet improved; listing concern resolved

Management Commentary

  • “We continue to make meaningful progress advancing our pipeline of innovative treatments for neurologic diseases…AJ201 is the most advanced investigational treatment in development for SBMA in the U.S.” — Alexandra MacLean, M.D., CEO .
  • On IV tramadol: “final agreement with the FDA on the safety study protocol and statistical analysis approach…aims to initiate the Phase 3 safety study pending additional financing or a partnership” .
  • On BAER-101: “plans to initiate a Phase 2a clinical trial…subject to the receipt of additional financing…preclinical mouse models have demonstrated BAER-101…fully suppress seizure activity” .

Q&A Highlights

  • No Q2 2024 earnings call transcript was found in the document catalog; Avenue’s investor communications for the quarter were via press releases and the 8‑K furnishing of Exhibit 99.1 .
  • Key clarifications from disclosures: AJ201 topline timing shift to H2 2024; IV tramadol initiation contingent on financing; BAER-101 progression remains financing-dependent .

Estimates Context

  • Wall Street consensus estimates (EPS and revenue) via S&P Global were unavailable for Q2 2024 and Q1 2024 in our session due to data access limitations. We did not identify any externally reported consensus figures in the company documents.
  • Given Avenue is pre-revenue and focused on development-stage assets, near-term estimate frameworks typically center on cash runway, OpEx trajectory, and clinical milestones rather than revenue/EPS; any update to AJ201 topline timing (H2 2024) may prompt modest adjustments to timelines embedded in investor models .

Key Takeaways for Investors

  • AJ201 remains the near-term value driver; topline H2 2024 is the critical catalyst. A positive readout could materially alter the company’s partnership optionality and funding pathway .
  • Financing is the gating factor for IV tramadol Phase 3 and BAER-101 Phase 2a; monitor capital raises or strategic deals as triggers for program starts .
  • Operating discipline: R&D down year over year while G&A up; watch Q3/Q4 OpEx mix and potential cost controls to extend cash runway .
  • Balance sheet improved with April warrant proceeds and reverse split; Nasdaq compliance achieved, reducing technical listing risk .
  • Disclosure precision matters: reconcile EPS/share and “net loss attributable to common stockholders” with the statements; rely on the financial tables and EPS math rather than narrative shorthand .
  • Near-term trading setup: catalyst-driven; stock likely sensitive to AJ201 data timing updates and any financing/partnership headlines for IV tramadol/BAER-101 .
  • Medium-term thesis hinges on AJ201 clinical efficacy/safety, regulatory path clarity for IV tramadol, and demonstration of BAER-101’s translational potential in humans .