Avenue Therapeutics, Inc. (ATXI): Business Model Canvas [Dec-2025 Updated]

You're looking for the real story behind Avenue Therapeutics, Inc.'s (ATXI) current setup, especially after their Nasdaq delisting in March 2025 and the focus on IV tramadol. Honestly, their business model right now is a masterclass in lean survival: they are running on $724,000 in Q3 2025 operating costs, holding just $3.7 million in cash, all while pushing a single, late-stage asset toward the FDA. The key to their near-term survival hinges on securing capital and hitting milestones from the Axsome deal, which could total up to $84.5 million down the line. Dive into the nine blocks below to see exactly how this specialty pharma firm is structuring its path forward, from its OTC market presence to its minimal R&D spend.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Key Partnerships

You're looking at the structure of Avenue Therapeutics, Inc. as it stands in late 2025, specifically focusing on the external relationships that drive its operations and value capture. These partnerships, or the wind-down of them, are central to the current financial picture.

Axsome Therapeutics for BAER-101 Program Acquisition and Milestones

Avenue Therapeutics finalized the sale of its majority-owned subsidiary, Baergic Bio, to Axsome Therapeutics in November 2025, transferring global rights to BAER-101, now called AXS-17. This transaction provided an immediate, albeit small, cash infusion, but the bulk of the value is tied to future performance metrics. Avenue Therapeutics expects to receive approximately 74% of all future payments and royalties from this deal. The deal aligns the former Baergic stockholders, including Avenue, with Axsome's development success for AXS-17, which Axsome plans to develop for epilepsy treatment.

The financial structure of the BAER-101/AXS-17 contingent consideration is as follows:

Fortress Biotech, Inc. as the Founding Entity and Potential Strategic Partner

Fortress Biotech, Inc. (Nasdaq: FBIO) is the founding entity of Avenue Therapeutics, Inc. This relationship establishes the initial corporate structure and strategic backing for Avenue's focus on developing and commercializing therapies for neurologic diseases. The connection is foundational to Avenue Therapeutics' corporate history.

Contract Research Organizations (CROs) for Clinical Trial Execution

Execution of clinical trials relies on external partners, though specific CRO contracts aren't detailed in recent filings. The prior Phase 1b/2a study for AJ201 involved clinical trial execution across six sites in the United States in 2023. A key financial indicator related to R&D activities is the reported reduction in operating expenses, which fell to $724,000 for the quarter ended September 30, 2025, down from $3.2 million in the same period last year, primarily due to reduced research and development costs. This suggests a shift in the scale or nature of ongoing external trial commitments.

Financial Institutions for Securing Additional Capital Funding

Avenue Therapeutics continues to focus on securing additional funding to support operations, including a potential Phase 3 safety study for its IV tramadol product candidate. The company has been trading on the over-the-counter market since March 2025 following a Nasdaq delisting. While specific late-2025 institutional partners for new capital are not explicitly named, a prior financing event in January 2023 closed with aggregate gross proceeds of approximately $3.25 million from a registered direct offering and concurrent private placement.

The company's need for capital is underscored by its financial position, though recent operational changes have improved the bottom line:

• Net loss for the quarter ended September 30, 2025: $683,000.
• Net loss for the same period last year: $3.1 million.

AnnJi Pharmaceutical Co. Ltd. (Former Licensee for AJ201)

The exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. for AJ201 terminated in April 2025, resulting in a License Termination and Program Transfer Agreement. This transition shifted global development and commercialization back to AnnJi, but established a stream of potential future payments for Avenue. Avenue reported other revenue of $1.4 million for the nine months ended September 30, 2025, which is related to this terminated agreement. The potential future consideration Avenue is eligible to receive from AnnJi is structured as follows:

• Development and regulatory milestone payments: Up to an aggregate of $5 million.
• Commercial sales milestone payments: Up to an aggregate of $17 million.
• Royalty on net sales: A 1.75% royalty.
• Subsequent Sublicensing Payments: 15% of payments AnnJi receives from third parties, capped at $7.5 million, with a minimum of $4 million upon U.S. New Drug Application approval.

Historically, under the original 2023 agreement, Avenue issued shares worth up to 19.99% of its total outstanding common stock to AnnJi, which were to be repurchased under the termination agreement. AnnJi had previously paid Avenue an upfront fee of $3 million under the initial deal, with potential milestones up to $250 million plus royalties.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Key Activities

You're looking at the core things Avenue Therapeutics, Inc. (ATXI) absolutely has to do right now to keep the lights on and push its main asset forward. Given the recent delisting from Nasdaq in March 2025, the focus on cash preservation and strategic asset monetization is intense. Here's the breakdown of the key activities as of the Q3 2025 report.

Advancing IV tramadol through the Phase 3 safety study protocol

The primary operational activity centers on getting the final confirmatory study for intravenous (IV) tramadol underway. This is the make-or-break for the lead asset, which is being developed for acute post-operative pain in a medically supervised setting. You should know that Avenue has already reached a final agreement with the U.S. Food and Drug Administration (FDA) on the protocol and statistical analysis approach for this Phase 3 safety study. This agreement is crucial because it addresses the theoretical risk of opioid-induced respiratory depression compared to IV morphine.

Here are the hard numbers for that study design:

Honestly, the study initiation is entirely dependent on securing external funding; that's the current bottleneck.

Securing additional capital to fund operations and clinical trials

Cash management is a top-tier activity, especially since the company ended Q3 2025 with only $3.7 million in cash on the balance sheet. The Q3 2025 net loss was $0.7 million, an improvement from the $3.1 million loss in Q3 2024, but management has explicitly stated that current cash is insufficient to fund operations beyond 12 months without new capital. The delisting from Nasdaq in March 2025 definitely complicates traditional financing routes.

The company has been actively generating non-operating cash flow from asset restructuring, which is a key activity supporting the runway:

• Termination payment from the AJ201 license agreement received in the first nine months of 2025: $1.4 million.
• Upfront payment from the BAER-101 sale to Axsome Therapeutics: $0.3 million.

The focus is definitely on finding a strategic partnership or new financing to bridge the gap to the IV tramadol study readout.

Regulatory engagement with the FDA for drug approval pathway

The most significant regulatory activity was the successful negotiation with the FDA to finalize the Phase 3 safety study protocol. This engagement, which took place over the preceding year, resulted in an agreed-upon plan that Avenue believes will support a safe profile for IV tramadol and address the previous Complete Response Letter (CRL). The goal of this activity is clear: a positive outcome from the final study could support the submission to the FDA to potentially gain U.S. approval for IV tramadol.

Managing intellectual property and licensing agreements

Avenue Therapeutics has been actively managing its intellectual property (IP) and licensing portfolio to streamline focus and generate non-dilutive cash. This involved two major recent actions:

• Terminating the license agreement for AJ201 with AnnJi Pharmaceutical, which resulted in a $1.4 million cash inflow for the nine months ended September 30, 2025.
• Divesting the BAER-101 program to Axsome Therapeutics. This deal structure includes an upfront payment of $0.3 million, potential milestone payments up to $84.5 million, and tiered royalties, with Avenue retaining approximately 74% of future payments.

These moves represent a strategic pivot, shedding non-core assets to concentrate resources.

Exploring strategic alternatives for remaining pipeline assets

The sale of BAER-101 and termination of the AJ201 agreement are direct results of exploring strategic alternatives. The company is clearly prioritizing IV tramadol, which has the potential for significant near-term value upon approval, over the other CNS assets. The net loss for the nine months ended September 30, 2025, was $2.2 million, a significant reduction from the $10.11 million loss in the prior year period, reflecting this strategic pruning of non-core development costs.

For the nine months ended September 30, 2025, R&D expenses fell to support this focus, dropping to a level where the Q3 2025 R&D expense was only $0.2 million, a 92% decrease year-over-year.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Key Resources

You're looking at the core assets Avenue Therapeutics, Inc. (ATXI) holds as of late 2025 to drive its strategy forward. These are the tangible and intangible things the company must have to make its business model work.

The primary Key Resource is the IV tramadol drug candidate, positioned for acute post-operative pain management in the U.S. This asset has data from two Phase 3 trials involving over 700 patients, showing a strong safety and efficacy profile at the 50mg dose level against placebo. To put that in context, IV tramadol has seen use in Europe for 30 years, accumulating approximately 370 million doses administered between 2010 and 2019.

Financial resources are lean. As of the end of Q3 2025, Avenue Therapeutics, Inc. reported $3.7 million in cash and equivalents. This figure comes after the company sold its BAER-101 program to Axsome Therapeutics for an upfront payment of $0.3 million and received $1.4 million in termination payments from the AJ201 license agreement with AnnJi Pharmaceutical during the first nine months of 2025. Management noted this cash position is insufficient to fund operations beyond 12 months without new capital.

The intellectual property rights for IV tramadol are central, supported by its unique dual mechanism of action: it functions as an opioid agonist while also inhibiting norepinephrine and serotonin re-uptake. This is backed by a critical regulatory milestone.

The company has reached agreement with the U.S. Food and Drug Administration (FDA) on key elements of the required final Phase 3 safety study protocol. This study is designed as a non-inferiority trial comparing IV tramadol to IV morphine.

The human capital, specifically the management team, is a definite resource, showing deep roots in specialty pharma and drug development. The average tenure for the management team is reported at 3.5 years.

Here's a quick look at the specifics of the key clinical and regulatory resource:

The leadership brings relevant industry tenure and specific drug development successes. Key experience points include:

• Dr. Jay Kranzler started the pharmaceutical practice at McKinsey & Company.
• Dr. Kranzler was CEO of Cypress Bioscience, developing Savella™ for fibromyalgia.
• CEO Alexandra MacLean previously served as General Partner and Principal at TVM Capital.
• CEO MacLean held roles at Imbrium Therapeutics and Purdue Pharma.
• The management team average tenure is 3.5 years.

The intellectual property rights are tied directly to the IV tramadol formulation and its intended use for acute post-operative pain, which is a market with over 100 million reported acute pain cases annually in the U.S..

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Value Propositions

You're looking at the core value drivers for Avenue Therapeutics, Inc. (ATXI) as of late 2025, which is a story of extreme focus driven by acute financial reality. The entire value proposition hinges on one asset, IV tramadol, and the company's recent, drastic actions to preserve capital for its final push.

IV tramadol as a non-opioid alternative for post-operative acute pain

The primary value proposition is delivering an intravenous (IV) formulation of tramadol for managing moderate-to-moderately-severe acute post-operative pain in a medically supervised setting. This is positioned directly against established standards of care in the hospital environment.

• The Phase 3 safety study protocol, agreed upon with the FDA, involves a 300-patient non-inferiority trial.
• The study design compares IV tramadol against IV morphine for pain relief over a 48-hour post-operative period in bunionectomy patients.
• The estimated cost to execute this required Phase 3 safety study is $3 million.

Potential for reduced dependency risks compared to conventional opioids

The clinical argument for IV tramadol centers on its mechanism of action, aiming to offer effective analgesia while mitigating the dependency concerns associated with traditional Schedule II opioids. The FDA's requirement for the new Phase 3 study specifically targets this risk profile.

The value proposition is directly tied to demonstrating a favorable safety profile, particularly concerning opioid stacking risk, relative to a standard like IV morphine. Success here unlocks a market segment actively seeking opioid-sparing options.

Focused development on a single, late-stage asset for clear market entry

Avenue Therapeutics, Inc. has executed a complete strategic pivot, confirming an all-in strategy on IV tramadol. This singular focus simplifies the near-term path, though it concentrates all execution risk onto this one program. Honestly, when cash is this tight, you have to be this focused.

Here's the quick math on the pivot, based on the nine months ended September 30, 2025:

What this estimate hides is the immediate need for financing to even start the required Phase 3 trial, which costs an estimated $3 million.

Monetization of non-core assets (e.g., BAER-101) to fund core program

To fund the IV tramadol path, Avenue Therapeutics, Inc. has monetized its other pipeline assets, specifically through the sale of its subsidiary, Baergic Bio, which held BAER-101 and AJ201. This transaction was announced on November 6, 2025, with Axsome Therapeutics. This action directly converted non-core potential into immediate, albeit small, capital.

• Upfront payment received from Axsome Therapeutics for the Baergic Bio sale: $0.3 million.
• Total potential future milestone payments from the sale: Up to $2.5 million.
• BAER-101 was planned for a Phase 2a trial in focal epilepsy, subject to financing, but is now part of the divested assets.

Finance: draft 13-week cash view by Friday.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Customer Relationships

You're looking at the relationships Avenue Therapeutics, Inc. (ATXI) maintains, which are heavily weighted toward institutional and regulatory bodies given its pre-commercial status as of late 2025. Direct customer interaction, meaning with patients or end-users of their drugs, is minimal right now.

High-touch investor relations to manage funding and OTC market presence

Managing investor trust is critical when you are actively seeking financing and trading on the over-the-counter (OTC) market, which Avenue Therapeutics, Inc. (ATXI) has been doing since March 2025. The relationship management focuses on transparency regarding ongoing operational burn and strategic milestones. For instance, the Q3 2025 earnings report showed a net loss of $683,000 for the quarter, an improvement from the $3.1 million loss in the same period last year, which is a key data point for current holders. The Net Income (Loss) for the quarter ended September 30, 2025, was reported as $-2.22 million. As of November 18, 2025, the Current Market Cap stood at $2.42M. This necessitates focused communication around securing additional funding to support operations, like the potential Phase 3 safety study for IV tramadol.

Formal investor communication is structured around key corporate events:

• 2025 Annual Meeting of Stockholders set for December 30, 2025.
• Deadline for stockholders to submit proposals for the proxy statement is November 28, 2025.
• The company is headquartered at 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154 for official correspondence.

The technical sentiment signal as of mid-November 2025 was noted as Sell, underscoring the need for clear, proactive investor engagement to manage expectations around fundamental weaknesses like negative earnings.

Direct, formal communication with regulatory bodies like the FDA

The relationship with the U.S. Food and Drug Administration (FDA) is highly formal and protocol-driven, centered on advancing the IV tramadol program. Avenue Therapeutics, Inc. (ATXI) reached a final agreement with the FDA on the Phase 3 safety study protocol and statistical analysis approach for IV tramadol on January 4, 2024. This agreement dictates the structure of the next critical step for potential approval.

Key parameters of this formal interaction include:

• The study is a non-inferiority design comparing IV tramadol to IV morphine.
• The study will randomize approximately 300 post bunionectomy patients.
• A prior Type C meeting with the FDA regarding IV Tramadol development occurred on March 9, 2023.

The company's CEO noted the collaborative nature of working with the FDA to address the theoretical risk of opioid-induced respiratory depression.

Strategic relationships with potential commercialization partners

This area saw a major recent development in November 2025, shifting the relationship focus from internal development to external commercialization through an asset sale. Avenue Therapeutics, Inc. (ATXI) announced the acquisition of its majority-owned subsidiary, Baergic Bio, by Axsome Therapeutics, Inc. This transaction secures a path for the development of BAER-101 (now AXS-17) for epilepsy.

The financial structure of this strategic relationship is detailed below:

This deal validates the company's model of sourcing high-impact therapies while creating shareholder value through strategic divestiture.

Minimal direct customer interaction in the pre-commercial stage

As a development-stage specialty pharmaceutical company, Avenue Therapeutics, Inc. (ATXI) currently has no revenue from product sales. Customer relationships are effectively non-existent in the traditional sense, as the focus remains on clinical trials and regulatory submissions for assets like IV tramadol and AJ201. The company did report other revenue of $1.4 million for the nine months ended September 30, 2025, but this was explicitly related to a terminated license agreement with AnnJi Pharmaceutical Co. Ltd., not product sales to end-users. The primary 'customers' in the near term are the investigators and patients enrolled in the planned Phase 3 safety study for IV tramadol, which involves approximately 300 patients.

Finance: review cash runway based on Q3 2025 burn rate and Axsome upfront payment by Monday.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Channels

You're looking at how Avenue Therapeutics, Inc. (ATXI) gets its information, its assets, and its potential products to the relevant parties as of late 2025. The channels have definitely shifted, especially given the recent corporate transaction.

Over-the-Counter (OTC) Market for Stock Trading

Avenue Therapeutics, Inc. stock is no longer on a major exchange. Trading was suspended on The Nasdaq Capital Market on March 19, 2025, after the company failed to maintain the minimum stockholders' equity of $2,500,000; the reported equity as of September 30, 2024, was $1,652,000. The stock transitioned to the OTC Markets system on that same date under the ticker OTC:ATXI. The stock price as of November 26, 2025, was $0.76. The market capitalization as of November 18, 2025, stood at $2.42M. This market access is the primary channel for public equity trading now.

Here's a quick look at the public trading structure as of mid-November 2025:

SEC Filings and Press Releases for Investor Communication

Investor communication flows through mandatory regulatory disclosures and corporate announcements. Avenue Therapeutics, Inc. has set its 2025 annual meeting of stockholders for December 30, 2025. The deadline for shareholders to submit proposals for inclusion in the proxy statement under Rule 14a-8 was November 28, 2025. The company filed an 8-K on November 18, 2025, detailing corporate governance matters. The most recent material event reported via an 8-K on November 12, 2025, concerned the definitive agreement to sell its majority-owned subsidiary, Baergic Bio.

Key recent regulatory filing dates include:

• Filing of 10-Q (Quarterly Report): November 13, 2025.
• Filing of 8-K (Material Event): November 18, 2025.
• Last reported financial results (Q3 2024 10-Q): November 14, 2024.

Clinical Trial Sites and Investigators for Drug Development

The development pipeline relies on clinical sites and investigators to generate data. For the AJ201 Phase 1b/2a trial in Spinal and Bulbar Muscular Atrophy (SBMA), 25 patients were enrolled across six clinical sites in the U.S. The company thanked trial investigators for completing this study on schedule in May 2024. For the IV tramadol Phase 3 safety study, the plan involved randomizing approximately 300 post bunionectomy patients.

The broader ecosystem supporting these activities shows significant market scale:

• Clinical Trial Investigative Site Network Market Size (2024): USD 8.5 Bn.
• Predicted Clinical Trial Investigative Site Network Market Size (2034): USD 17.5 Bn.
• Therapeutic Areas of Focus: Central Nervous System (CNS) and Pain & Inflammation.

Future Pharmaceutical Sales Force (Likely Partnered) for Commercialization

Commercialization channels for Avenue Therapeutics, Inc.'s assets are largely structured through partnerships following recent divestitures. Axsome Therapeutics obtained worldwide commercial rights to BAER-101 (re-designated as AXS-17) as part of the Baergic Bio sale. Avenue Therapeutics, Inc. is positioned to receive value through milestones and royalties from this partner, meaning Axsome will manage the ultimate sales force channel.

The potential financial upside channel from the AXS-17 agreement includes:

• Upfront payment received: $0.3 million (less fees).
• Development/Regulatory Milestones (First Indication): Up to $2.5 million.
• Commercial Sales Milestones: Up to $79 million.
• Royalty Structure: A tiered mid-to-high single-digit royalty on potential global net sales.
• Avenue Therapeutics, Inc. expected share of all future payments/royalties: Approximately 74%.

For IV tramadol, the path to commercialization was previously noted as subject to obtaining necessary financing, potentially through a strategic partnership. The company is headquartered in Miami, FL.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Customer Segments

You're looking at the customer base for Avenue Therapeutics, Inc. (ATXI) as of late 2025. Given the company's current financial posture-a cash balance of just $3.7 million as of September 30, 2025, and a market capitalization of $2.42 million-the focus is intensely narrow, directly impacting how they approach each segment.

Hospitals and surgical centers managing acute post-operative pain.

This segment represents the primary commercial target for the company's lead asset, IV Tramadol, intended for use in a medically supervised healthcare setting for moderate-to-moderately-severe pain management following surgery. The company's entire operational focus is currently channeled toward this product, evidenced by the dramatic 87% collapse in research and development expenses-down to $0.8 million for the first nine months of 2025.

The immediate requirement to serve this segment hinges on securing funding for the final regulatory step:

• Estimated cost for the required new Phase 3 safety study: $3 million.
• The study protocol involves a 300-patient non-inferiority trial.

Pain management specialists and anesthesiologists.

These are the prescribers and administrators who would utilize IV Tramadol for rapid, effective acute pain relief. Their adoption hinges on the clinical profile of the IV formulation versus existing standards of care. The company's ability to engage this segment commercially is entirely dependent on successfully navigating the financing hurdle to complete the necessary safety trial.

The company's strategic pivot confirms this focus:

• R&D spend dropped from $6.1 million to $0.8 million for the nine months ended September 30, 2025.
• The company is obligated to pay Fortress Biotech a 2.5% Annual Equity Fee, which accounted for $0.7 million in G&A expense for the first nine months of 2025, diverting scarce capital.

Institutional and retail investors in the specialty pharmaceutical sector.

This segment is currently characterized by high risk due to the company's liquidity crisis and recent delisting from Nasdaq in July 2025. The investment thesis is now almost entirely tied to the successful financing and subsequent approval of IV Tramadol, or the realization of contingent value from prior asset sales.

Here are the key financial metrics defining the current investor landscape for Avenue Therapeutics, Inc. (ATXI):

Patients requiring moderate-to-moderately-severe pain management.

This segment represents the ultimate beneficiary of the product, requiring prompt relief in acute settings. While direct patient volume statistics for the target indication are not publicly detailed for Avenue Therapeutics, Inc. (ATXI), the product's positioning is to offer a novel treatment option for patients undergoing surgical procedures or suffering from severe acute conditions.

The company's focus on IV administration suggests a target population where rapid onset of action is critical, such as:

• Patients in the immediate post-operative recovery phase.
• Patients in emergency or acute care settings needing immediate analgesia.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Cost Structure

You're looking at the cost side of Avenue Therapeutics, Inc. (ATXI) as of the third quarter of 2025. For a clinical-stage biotech, the cost structure is almost entirely focused on development, compliance, and keeping the lights on while pursuing financing. Honestly, the numbers show a very lean operation for the period.

The Total Operating Expenses for the three months ended September 30, 2025, were reported at $724,000. This figure is significantly lower than the $3,156,000 reported for the same period in 2024, reflecting a major shift in spending priorities or program status.

Here's a breakdown of the key components of that cost structure for Q3 2025, in thousands of US dollars:

The Research and Development (R&D) spend for the quarter was $177,000. This is a sharp drop from the $2,327,000 in R&D costs seen in Q3 2024. This lower R&D spend reflects the company's current stage, especially concerning the IV tramadol program, which is contingent on securing additional financing or a partnership before initiating the Phase 3 safety study.

General and Administrative (G&A) expenses for the quarter were $547,000. While lower than the $829,000 in Q3 2024, G&A remains a critical, fixed-like cost base for a public pharmaceutical company.

Costs associated with initiating and running the IV tramadol Phase 3 trial are currently deferred, as the initiation of the Phase 3 safety study, which involves approximately 300 post-bunionectomy patients, is pending financing or a partnership. However, past costs are embedded in the R&D line item. For instance, for the six months ended June 30, 2025, R&D expenses decreased by $3.2 million compared to the prior year, which included a $0.1 million decrease in IV tramadol supply costs.

Legal and defintely regulatory compliance costs are a constant in this industry, and for Avenue Therapeutics, Inc., these are captured within the G&A structure. These costs cover:

• Professional fees for legal and consulting services.
• Costs associated with seeking potential regulatory approval and commercialization.
• Costs related to public reporting company requirements.
• Compliance with federal and state healthcare laws, including fraud and abuse regulations.

To be fair, maintaining Nasdaq listing compliance also drives certain administrative and legal overhead, which you see reflected in the $547,000 G&A spend for the quarter.

Finance: draft 13-week cash view by Friday.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Revenue Streams

The Revenue Streams for Avenue Therapeutics, Inc. as of late 2025 are primarily non-product related, stemming from asset divestitures and licensing agreements, as the company focuses on its IV tramadol development.

No product revenue was reported by Avenue Therapeutics, Inc. in the third quarter of 2025. The company's current financial structure relies heavily on contingent payments from prior transactions to fund its ongoing operations, especially following its delisting from Nasdaq in March 2025.

The primary expected future income streams are tied to the sale of its majority-owned subsidiary, Baergic Bio, to Axsome Therapeutics, Inc., which holds the rights to BAER-101 (AXS-17).

The company also has potential future revenue from the terminated AJ201 agreement with AnnJi Pharmaceutical, though the $1.4 million received in the first nine months of 2025 appears to be a key component of that settlement.

The potential future payments from the AnnJi termination include:

• Payments up to $5 million in aggregate for development and regulatory milestones for AJ201.
• Payments up to $17 million in aggregate for commercial sales milestone events for AJ201.
• A 1.75% royalty on net sales of AJ201.
• Up to $7.5 million from 15% of payments AnnJi receives from any subsequent third-party licenses.
• A minimum of $4 million owing under a specific mechanism if a New Drug Application is approved in the U.S. for AJ201.

To bridge the gap until potential milestone or royalty payments are realized, Avenue Therapeutics, Inc. relies on proceeds from equity financing. Management has noted that current cash levels are insufficient to fund operations beyond 12 months without additional capital, underscoring the importance of these financing activities to sustain operations.