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AVENUE THERAPEUTICS, INC. (ATXI)·Q3 2024 Earnings Summary

Executive Summary

  • Avenue reported Q3 2024 GAAP net loss attributable to common stockholders of $(3.08) million, or $(1.92) per share; no product revenue was reported as the company remains development-stage .
  • Cash and equivalents fell to $2.60 million at 9/30/24 from $4.92 million at 6/30/24 (burn of ~$2.32 million QoQ), underscoring the need for additional financing to progress programs .
  • Pipeline milestones remain the primary catalysts: AJ201 (SBMA) topline Phase 1b/2a data now expected “around year-end 2024”; IV tramadol Phase 3 safety study ready to initiate pending financing, with 12-month completion timeline post-start; BAER-101 Phase 2a also contingent on financing .
  • Year-over-year comparison is noisy: Q3 2023 showed net income primarily due to a large non-cash warrant liability fair value gain; Q3 2024 reverted to operating-loss profile as expected for a pre-revenue biotech .

What Went Well and What Went Wrong

What Went Well

  • AJ201 progressed to the “last patient visit complete” milestone; management reiterated confidence and timing for topline readout “around year-end 2024,” framing AJ201 as a potential best-in-class disease-modifying therapy in SBMA .
  • FDA alignment achieved on IV tramadol Phase 3 safety study protocol and statistical approach; the company believes the study can be completed and submitted to FDA within 12 months of initiation, providing a clear regulatory execution path once funded .
  • G&A operating discipline: Q3 2024 G&A fell to $0.83 million vs. $1.16 million in Q3 2023, indicating cost control outside of R&D .

Management quote: “We have generated considerable momentum this past quarter in advancing our pipeline of innovative treatments for neurologic diseases… We are looking forward to sharing topline clinical data in the coming months.” – CEO Alexandra MacLean, M.D. .

What Went Wrong

  • Liquidity draw: Cash declined to $2.60 million at quarter-end from $4.92 million at Q2, highlighting near-term funding needs to advance trials (especially IV tramadol and BAER-101) .
  • R&D spend re-accelerated QoQ with Q3 R&D at $2.33 million vs. $1.36 million in Q2, reflecting program activity and putting added pressure on limited cash resources .
  • Going-concern risk explicitly cited among risk factors in forward-looking statements, reinforcing financing overhang and execution dependence on capital markets/partners .

Financial Results

Note: Avenue is a development-stage company and did not report product revenue in these periods .

MetricQ1 2024Q2 2024Q3 2024
R&D Expense ($MM)$2.39 $1.36 $2.33
G&A Expense ($MM)$1.32 $1.46 $0.83
Loss from Operations ($MM)$(3.71) $(2.82) $(3.16)
Change in FV of Warrant Liabilities ($MM)$(0.12) $0.26 $0.02
Net (Loss) Income Attributable to Common ($MM)$(4.34) $(7.19) $(3.08)
Diluted EPS ($)$(15.40) $(6.43) $(1.92)
Weighted Avg Shares (000s)562.0 1,117.8 1,600.2

KPIs and Balance Sheet Items

KPIQ1 2024Q2 2024Q3 2024
Cash & Equivalents ($MM)$3.19 $4.92 $2.60
Common Shares Outstanding (Period End, 000s)590.2 1,189.7 1,604.2

YoY context (Q3 2024 vs. Q3 2023): Q3 2023 showed net income of $0.53 million (EPS $4.86) driven largely by a $2.57 million non-cash gain from warrant liabilities; Q3 2024 reverted to a typical operating loss absent such gains .

Estimates: S&P Global consensus estimates for ATXI were not available for Q3 2024 (no comparisons to Street possible).

Segment breakdown and margins: Not applicable; the company reported no product revenue and no reportable segments in these periods .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
AJ201 topline Phase 1b/2a readout (SBMA)2024“Middle of 2024” (Q1 PR) → “Second half of 2024” (Q2 PR) “Around year-end 2024” (Q3 PR) Slid later within 2024 window
IV Tramadol Phase 3 safety study initiationUpon financing“Aims to initiate as soon as feasible; 12 months to completion and submission after start” (Q1 PR) “Aims to initiate pending additional financing/partnership; 12 months to completion and submission after start” (Q3 PR) Maintained, financing-dependent
BAER-101 Phase 2a initiationUpon financing“Plans to initiate subject to financing/partnership” (Q1 PR) “Plans to initiate subject to additional financing” (Q3 PR) Maintained, financing-dependent

Earnings Call Themes & Trends

No Q3 2024 earnings call transcript was available; themes below reflect public disclosures (press releases/8-Ks).

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2024)Trend
AJ201 (SBMA) clinical timelineLast patient visit complete (May 2024); topline expected 2H24 Topline “around year-end 2024” Slightly later timing within 2024
IV Tramadol regulatory pathFDA agreement on Phase 3 safety study design/statistics; aims to initiate when feasible Ready to initiate pending financing; 12-month completion once started Path intact; gating factor is funding
BAER-101 plansPreclinical efficacy presented; Phase 2a planned subject to financing Phase 2a planned subject to financing Unchanged; financing-dependent
Liquidity/CapitalRaised $9.4mm gross via warrant exercises YTD through May; Nasdaq listing compliance regained Cash fell QoQ to $2.6mm, highlighting funding need Deteriorated QoQ; higher urgency
Risk disclosures—Going-concern risk cited among forward-looking risk factors Heightened attention to financing risk

Management Commentary

  • “We have generated considerable momentum this past quarter in advancing our pipeline of innovative treatments for neurologic diseases… We are looking forward to sharing topline clinical data in the coming months.” – Alexandra MacLean, M.D., CEO .
  • “AJ201 is a potential best-in-class asset that would bring a disease-modifying therapeutic option to patients with significant unmet medical need in Kennedy’s Disease.” – Alexandra MacLean, M.D. .
  • Q2 reinforcing message: “We continue to make meaningful progress advancing our pipeline… [AJ201] last patient visit… anticipate reading out topline data… in the second half of this year.” – Alexandra MacLean, M.D. .
  • Q1 framing across programs: Agreement with FDA on IV tramadol Phase 3 safety study design/statistics; progressing BAER-101 toward Phase 2a subject to financing .

Q&A Highlights

  • Not applicable; no Q3 2024 earnings call transcript was available in the company’s disclosures for this period.

Estimates Context

  • We were unable to retrieve S&P Global consensus for Q3 2024 revenue or EPS for ATXI; coverage appears limited for this development-stage micro-cap. As a result, we cannot provide vs-Consensus comparisons for this quarter.

Key Takeaways for Investors

  • Liquidity is the swing factor: cash of $2.60 million at 9/30/24 vs. ~$2.32 million QoQ burn implies urgency to secure financing or partnerships to maintain program momentum .
  • Near-term binary-like catalyst: AJ201 Phase 1b/2a topline data “around year-end 2024” could reset sentiment depending on safety/PD biomarker signals in SBMA .
  • IV tramadol offers a defined regulatory path: with FDA-agreed design and 12-month completion timeline post-initiation, funding is the gating item to re-activate the asset .
  • Operating discipline visible in G&A, but R&D needs will ebb/flow with trial activity; expect expense variability around catalyst windows .
  • YoY optics are distorted by 2023 warrant liability gains; focus on underlying operating trajectory and financing runway rather than GAAP YoY compares .
  • With no product revenue and no Street consensus, the stock is likely to trade on clinical/regulatory headlines and financing outcomes rather than quarterly P&L .
  • Strategic partnering (AJ201, IV tramadol, BAER-101) could be a key de-risking lever, potentially mitigating dilutive capital needs while enabling execution .

Sources:

  • Q3 2024 press release and financial statements .
  • Q3 2024 8-K (Item 2.02, Exhibit 99.1) .
  • Q2 2024 press release and financial statements .
  • Q1 2024 8-K, press release, and financial statements .