Avenue Therapeutics, Inc. (ATXI): History, Ownership, Mission, How It Works & Makes Money

Avenue Therapeutics, Inc. (ATXI) is a specialty pharmaceutical company focused on neurologic diseases, but how does a firm with a market capitalization of just $2.26 million as of late 2025 manage to progress a Phase 3 asset like IV tramadol? You might be surprised to see the company reported a net loss of only $683,000 in Q3 2025, a substantial improvement from the $3.1 million loss a year prior, largely due to reduced operating expenses and a $1.4 million revenue from a terminated license deal. This improved financial picture is defintely a positive sign, but with the stock trading over-the-counter (OTC) since its Nasdaq delisting in March 2025, the real question for investors is whether management can secure the necessary funding to move its core pipeline forward. Let's dive into the history, the unusual ownership structure-where retail investors hold roughly 84% of the stock-and the business model that will determine if Avenue Therapeutics, Inc. can truly transform patient outcomes in acute pain management.

Avenue Therapeutics, Inc. (ATXI) History

Avenue Therapeutics, Inc. is a specialty pharmaceutical company that was spun out of Fortress Biotech, Inc. to focus initially on acute pain management, specifically with an intravenous (IV) formulation of tramadol for post-operative use. The company's history is one of strategic pivots, moving from a single-asset pain focus to a portfolio of central nervous system (CNS) disease therapies, a shift that has been punctuated by significant regulatory and financial challenges.

You need to understand that this company's trajectory is a classic biotech story of high-risk, high-reward drug development, complicated by the financial realities of a small-cap entity navigating the public markets. Here's the quick math: they raised a good chunk of capital early on, but the failure to secure FDA approval for their lead asset forced a complete strategic change.

Given Company's Founding Timeline

Year established

The company was incorporated on February 9, 2015.

Original location

Avenue Therapeutics, Inc. was founded in New York, New York, but its current headquarters is in Bay Harbor Islands, Florida.

Founding team members

Avenue Therapeutics was founded by Fortress Biotech, Inc. (Nasdaq: FBIO) as a subsidiary. Key individuals involved from the start in 2015 included Lindsay Allan Rosenwald, who serves as an Executive Director, and Neil Herskowitz, a Non-Executive Independent Director.

Initial capital/funding

The company's first major capital infusion came from its Initial Public Offering (IPO) on June 27, 2017, which raised a total of approximately $37.95 million, including the underwriters' overallotment option, by selling 6,325,000 shares at $6.00 per share.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's history is defintely defined by two major transformative moments: the regulatory failure of its lead drug and the subsequent strategic pivot to a new portfolio.

The first major blow was the 2020 Complete Response Letter from the FDA for IV tramadol, which effectively ended the company's initial mission. That forced a scramble to find new value.

• Shift to CNS Pipeline: Following the IV tramadol setback, the company pivoted entirely from acute pain to central nervous system (CNS) diseases, acquiring and licensing new assets like AJ201 for spinal and bulbar muscular atrophy and BAER-101 for epilepsy and panic disorders. This was a survival move.
• 2025 Financial Streamlining: For the nine months ended September 30, 2025, the company reported a net loss of only $683,000 for the quarter, a substantial improvement from the $3.1 million loss in the same period last year, largely due to operating expenses dropping to $724,000 from $3.2 million. This shows a significant cost-cutting effort to extend runway after the delisting in March 2025.
• The Baergic Bio Transaction (November 2025): The sale of Baergic Bio to Axsome Therapeutics, Inc. is the most recent and critical moment. While the upfront cash is small-just $0.3 million-the deal includes eligibility for up to $82 million in future milestone payments and royalties. This transaction validates the new CNS strategy and provides a non-dilutive path to potential future revenue, which is crucial for a micro-cap company.

This latest deal gives Avenue Therapeutics a clear financial shot at funding its remaining pipeline, but they still need to secure additional capital for the potential Phase 3 safety study for IV tramadol, which remains an open question. You can dive deeper into the current financial standing and what this means for the future by reading Breaking Down Avenue Therapeutics, Inc. (ATXI) Financial Health: Key Insights for Investors.

Avenue Therapeutics, Inc. (ATXI) Ownership Structure

Avenue Therapeutics, Inc. (ATXI) is a publicly traded specialty pharmaceutical company, but its ownership structure is heavily influenced by its founder, Fortress Biotech, Inc., which maintains a significant stake and close operational ties, so control is concentrated despite its public status.

The company's common stock is currently traded on the OTC Markets (OTCPK: ATXI), as it lost its eligibility and was delisted from the Nasdaq Stock Market earlier in 2025. This move to the over-the-counter market can affect liquidity and capital access, which is a key risk to monitor, especially given the company's Q3 2025 net loss of $0.7 million and cash balance of $3.709 million as of September 30, 2025.

Avenue Therapeutics, Inc.'s Current Status

Avenue Therapeutics, Inc. is a small-cap, publicly-traded entity focused on developing therapies for neurologic diseases, though it is currently navigating significant financial challenges. Its status as a public company allows for retail investment, but the low market capitalization of approximately $2.39 million and the shares outstanding of 3,183,558 as of November 12, 2025, mean the stock can experience high volatility and low trading volume.

This is a micro-cap stock, which means you defintely need to do your homework before buying. For a deeper dive into the stakeholders, you should check out Exploring Avenue Therapeutics, Inc. (ATXI) Investor Profile: Who's Buying and Why?

Avenue Therapeutics, Inc.'s Ownership Breakdown

The company's ownership is split primarily between institutional funds, insiders, and the general public. As of the 2025 fiscal year data, the majority of the common stock is held by retail investors and the public float, but the insider and institutional holdings, especially those tied to Fortress Biotech, Inc., dictate the strategic direction.

Avenue Therapeutics, Inc.'s Leadership

The leadership team is a mix of long-tenured medical experts and executives with close ties to Fortress Biotech, Inc., the company's founder. This structure ensures a consistent strategic vision, but it also links Avenue Therapeutics, Inc.'s operational decisions closely to its parent company's interests.

• Chief Executive Officer (CEO): Dr. Alexandra MacLean. Appointed in August 2022, her total compensation for the 2025 fiscal year was $840,100.
• Chairman of the Board: Jay Kranzler, MD, PhD. He has been a board member since 2017 and Chairman since March 2023. His 2025 compensation was $174,530.
• Interim Chief Financial Officer (CFO) and Chief Operating Officer (COO): David Jin. He holds both roles and also serves as CFO and Head of Corporate Development at Fortress Biotech, Inc.
• Interim Chief Medical Officer (CMO): Scott A. Reines, MD, PhD. He has served in this role since January 2016, bringing deep experience in CNS and pain drug development from companies like Johnson & Johnson.
• Executive Director: Lindsay Rosenwald, MD. He is also the Chairman and CEO of Fortress Biotech, Inc., underscoring the strong affiliation between the two companies.

The average tenure for the management team is considered experienced at 3.4 years, which provides stability in a high-risk biotech environment.

Avenue Therapeutics, Inc. (ATXI) Mission and Values

Avenue Therapeutics, Inc. (ATXI) centers its purpose on addressing significant unmet patient needs in neurologic diseases, a mission recently validated by the strategic sale of its subsidiary, Baergic Bio, which promises to accelerate therapy development. Their cultural DNA is built on a lean, opportunistic model of sourcing and commercializing high-impact therapies.

For context, the company's financial activity in the first half of the year was minimal, reporting an actual Q2 2025 revenue of only $1.40M, which underscores that their value is tied to pipeline development and strategic transactions, not existing sales volume. Breaking Down Avenue Therapeutics, Inc. (ATXI) Financial Health: Key Insights for Investors

Avenue Therapeutics' Core Purpose

The company's core purpose is defintely two-fold: advancing therapies for complex neurologic conditions and, concurrently, creating meaningful long-term shareholder value through strategic development and out-licensing.

Here's the quick math: when a specialty pharma company with a small team-reported at just 2 employees in late 2024-executes a deal like the Baergic Bio acquisition by Axsome Therapeutics (announced November 2025), the mission is clear. It's about being a high-leverage development engine, not a large-scale commercial operation. That transaction alone makes Baergic shareholders eligible for up to approximately $82 million in potential milestones and royalties, a huge validation of their model.

Official Mission Statement

While Avenue Therapeutics does not publish a traditional, flowery mission statement, its operational focus serves as its mandate:

• Develop and commercialize high-impact therapies for neurologic diseases.
• Source and develop therapies that address large unmet medical needs.
• Create meaningful opportunities for long-term shareholder value.

The entire strategy is built around identifying promising, de-risked assets-like the former IV tramadol for acute pain or the recent BAER-101 for epilepsy-and moving them toward commercialization or a strategic exit. They are a focused asset incubator.

Vision Statement

The vision is less about market share and more about clinical impact and efficient capital deployment. It maps directly to their recent actions.

• Accelerate the progression of targeted therapies for patients suffering from conditions with high unmet need, such as epilepsy.
• Leverage the expertise of larger partners (like Axsome Therapeutics) to speed up development timelines.
• Establish a repeatable model for generating returns by licensing or selling promising drug candidates.

The vision is to be the catalyst that gets a promising drug to the patient faster. That's a good vision for a small-cap biotech.

Avenue Therapeutics' Slogan/Tagline

A formal, consumer-facing tagline is absent, which is typical for a business-to-business (B2B) pharmaceutical developer. Their functional tagline, however, is their value proposition:

• High-Impact Therapies, Strategic Value.

The company's history of focusing on products for the intensive care hospital setting, like IV tramadol, shows a consistent, critical-care orientation. They prioritize clinical significance over broad market appeal.

Avenue Therapeutics, Inc. (ATXI) How It Works

Avenue Therapeutics, Inc. operates as a specialty pharmaceutical company focused on developing and commercializing therapies for neurologic diseases, primarily generating value through advancing its lead clinical-stage product, Intravenous (IV) Tramadol, toward U.S. Food and Drug Administration (FDA) approval and monetizing non-core assets to fund operations.

The core business model is centered on reformulating established active pharmaceutical ingredients (APIs) to address unmet needs in acute care settings, aiming to improve safety profiles and reduce opioid exposure, but its current financial health relies heavily on successful clinical development and securing additional capital.

Avenue Therapeutics, Inc.'s Product/Service Portfolio

Avenue Therapeutics, Inc.'s Operational Framework

Avenue Therapeutics follows a lean, capital-efficient operational model typical of a clinical-stage biopharmaceutical company, which means it minimizes in-house infrastructure and defintely outsources key functions.

• Outsourced R&D: The company relies on contract research organizations (CROs) to manage and execute its clinical trials, including the required Phase 3 safety study for IV Tramadol. This approach significantly reduced operating expenses to $724,000 in the third quarter of 2025.
• Asset Licensing and Divestiture: Avenue generates revenue by strategically licensing or divesting non-core pipeline assets, such as the $1.4 million in other revenue reported for the nine months ended September 30, 2025, from a terminated license agreement with AnnJi Pharmaceutical Co. Ltd.
• Funding Strategy: Operations are financed through equity offerings, like the $2.1 million in net proceeds from at-the-market (ATM) stock sales as of June 30, 2025, and through strategic partnerships. Here's the quick math: with cash and cash equivalents of $3.3 million as of June 30, 2025, and a quarterly net loss of $683,000 in Q3 2025, the runway is short without new capital.
• Regulatory Focus: The primary operational bottleneck is securing the necessary funding to initiate the FDA-agreed Phase 3 safety study protocol for IV Tramadol, which is essential for resubmitting the New Drug Application (NDA).

They're essentially a virtual pharma company, focusing on intellectual property and regulatory strategy.

Avenue Therapeutics, Inc.'s Strategic Advantages

Avenue's advantages are rooted in its product profile and its agility in managing a focused, capital-constrained pipeline, though its recent delisting from Nasdaq to the over-the-counter (OTC) market in March 2025 limits its financing options.

• Product Differentiation: IV Tramadol offers a novel, non-traditional opioid mechanism for acute pain management, directly addressing the critical need for pain relief options that carry a lower risk of respiratory depression and abuse compared to traditional intravenous narcotics.
• Regulatory Proximity: The IV Tramadol program is in Phase 3 and has an agreed-upon safety study protocol with the FDA, positioning it closer to potential approval and commercialization than many early-stage biopharma assets.
• Monetization Expertise: The recent successful acquisition of its subsidiary Baergic Bio by Axsome Therapeutics on November 6, 2025, for up to approximately $82 million in potential milestones and royalties, demonstrates the management team's ability to create and monetize asset value to fund its core program.
• Lean Structure: The reliance on outsourced development keeps the fixed cost base low, which is crucial for a company with limited cash and a net loss of $683,000 in Q3 2025.

For more detail on the investor landscape and who is backing this strategy, you should read Exploring Avenue Therapeutics, Inc. (ATXI) Investor Profile: Who's Buying and Why?

Avenue Therapeutics, Inc. (ATXI) How It Makes Money

As a clinical-stage biopharmaceutical company, Avenue Therapeutics, Inc. (ATXI) does not currently generate revenue from commercial product sales; instead, its primary source of income comes from non-recurring licensing agreements, asset divestitures, and external financing to fund its research pipeline.

Simply put, they are in the business of developing and selling intellectual property-drug candidates-not yet selling drugs to patients. That's a critical distinction for any investor to make.

Given Company's Revenue Breakdown

For the nine months ended September 30, 2025, Avenue Therapeutics' revenue was entirely composed of a one-time payment, reflecting the company's pre-commercial stage and its reliance on strategic transactions to generate capital.

Business Economics

The economics of Avenue Therapeutics are typical of a specialty pharma firm focused on developing therapies for neurologic diseases; it's a high-risk, high-reward model with a long cash runway requirement. The company's entire revenue of $1.4 million for the nine months ended September 30, 2025, came from a terminated license agreement with AnnJi Pharmaceutical Co. Ltd.. This is not a sustainable business model, but a necessary capital injection.

Here's the quick math: the company's nine-month net loss was $2.2 million, meaning the $1.4 million revenue only partially offset the operating burn. This is why the company's stock now trades on the over-the-counter (OTC) market after being delisted from Nasdaq in March 2025, which can defintely constrain future capital access.

• Pricing Strategy: Future revenue from its lead candidate, intravenous (IV) tramadol for acute post-operative pain, would likely follow a specialty pharmaceutical pricing model, commanding a premium due to its unique delivery method and target market (medically supervised healthcare settings).
• Capital Dependence: The business fundamentally relies on external financing-either new equity raises or strategic partnerships-to fund the Phase 3 safety study for IV tramadol and other pipeline assets.
• Asset Divestiture: The recent sale of its subsidiary Baergic Bio to Axsome Therapeutics for an upfront payment of $0.3 million plus potential milestones shows a strategy of monetizing non-core assets to extend the cash runway and focus on IV tramadol.

For a deeper dive into the company's strategic direction, you should review Mission Statement, Vision, & Core Values of Avenue Therapeutics, Inc. (ATXI).

Given Company's Financial Performance

While still operating at a loss, Avenue Therapeutics has shown a significant reduction in its cash burn, a key metric for any clinical-stage company. The focus now is on liquidity and the ability to secure the necessary funding to move its lead product forward.

• Net Loss Improvement: The net loss for the third quarter of 2025 was $0.7 million, a substantial improvement from the $3.1 million loss reported in the same quarter last year. This was achieved by cutting operating expenses, which fell sharply to $0.7 million in Q3 2025 from $3.2 million previously.
• Cash Position: As of September 30, 2025, the company held $3.709 million in cash and cash equivalents. This is the critical number that determines their operational runway.
• Expense Allocation: Research and Development (R&D) expenses were only $0.18 million in Q3 2025, a sign that major clinical work is currently on hold pending new financing, as R&D is the lifeblood of a biotech.
• Going Concern Warning: Management explicitly stated there is substantial doubt about the company's ability to continue as a 'going concern' without securing additional financing, which is the most critical risk factor you need to consider right now.

What this estimate hides is the true cost of a Phase 3 trial; the current cash balance is nowhere near enough to initiate the planned IV tramadol safety study, so new capital is a must-have, not a nice-to-have.

Avenue Therapeutics, Inc. (ATXI) Market Position & Future Outlook

Avenue Therapeutics is currently a pre-commercial specialty pharmaceutical company focused on a single key asset, intravenous (IV) tramadol, for post-operative acute pain. The company's future outlook is defintely tied to its ability to secure financing for the required Phase 3 safety study for IV tramadol, as it faces a significant 'going concern' risk with cash reserves of only $3.709 million as of September 30, 2025.

The recent sale of its subsidiary Baergic Bio to Axsome Therapeutics in November 2025 for a $0.3 million upfront payment, plus eligibility for up to approximately $82 million in potential milestones and royalties, acts as a crucial, near-term capital infusion and a long-term value driver from a non-core asset.

Competitive Landscape

Avenue Therapeutics' IV tramadol competes in the multi-billion dollar post-operative acute pain market, which is dominated by established generics and large pharmaceutical companies. The non-opioid pain treatment market is valued at approximately $51.86 billion in 2025, and the post-operative pain segment is one of the largest indications.

ATXI's competitive advantage hinges on IV tramadol's profile as a centrally-acting, non-opioid analgesic that is effective against moderate-to-moderately severe pain, positioning it between traditional IV NSAIDs (nonsteroidal anti-inflammatory drugs) and high-potency opioids.

Opportunities & Challenges

The company's strategy is a high-risk, high-reward play on IV tramadol's potential to capture a share of the acute post-operative pain market, driven by the ongoing shift away from highly addictive opioids. Here's the quick math: the global non-opioid pain treatment market is estimated at $51.86 billion in 2025, so even a tiny slice is a huge win.

Industry Position

Avenue Therapeutics is positioned as a micro-cap, single-asset biotech company with a market capitalization of approximately $2.39 million as of November 2025.

• Focus Narrowed: The company's strategic focus is now almost entirely on IV tramadol, following the sale of BAER-101 and the termination of the AJ201 program.
• Liquidity Constraint: The company reported a net loss of $0.7 million in Q3 2025 and ended the quarter with only $3.709 million in cash, making it highly dependent on external funding for its clinical path.
• High Barrier to Entry: Competing against established, low-cost generic IV analgesics like Ketorolac and IV Acetaminophen, plus new, novel non-opioid entrants like Journavx.

To understand the investor sentiment and ownership structure around this high-risk profile, you should be Exploring Avenue Therapeutics, Inc. (ATXI) Investor Profile: Who's Buying and Why?