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

Honestly, when you look at a Phase 3 biotech like Tenax Therapeutics, Inc. (TENX), the business model isn't about sales yet; it's a high-wire act of capital deployment and clinical execution. Right now, their entire structure is built around successfully navigating the LEVEL and LEVEL-2 trials for TNX-103, a potential first-in-disease oral therapy for PH-HFpEF. Here's the quick math: they are funding this intensive work-which saw Research and Development (R&D) costs hit $10.3 million in Q3 2025-using their war chest, which stood at $99.4 million in cash as of September 30, 2025. It's a capital deployment story, pure and simple. Dive into the nine building blocks below to see exactly how Tenax Therapeutics, Inc. is managing this make-or-break phase, from securing global intellectual property (IP) to managing investor expectations.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Key Partnerships

You're building a Phase 3 company, so your key partnerships aren't just vendors; they're the engine driving your registrational data. The structure Tenax Therapeutics has put in place for TNX-103 is capital-intensive and relies heavily on external expertise to navigate the complex PH-HFpEF space.

For clinical guidance, Tenax Therapeutics actively engages with the top minds in the field. They recently scheduled a virtual Key Opinion Leader (KOL) call for Thursday, November 13, 2025, featuring leading experts to discuss the physiology of PH-HFpEF and the differentiation strategy for TNX-103. This partnership with KOLs is crucial for shaping the clinical narrative and trial execution.

The global reach required for the second registrational trial, LEVEL-2, necessitates a vast network of investigative sites. As of the third quarter of 2025, Tenax Therapeutics reported that over 160 investigative sites new to the program, spanning 15 countries, have been qualified to support the LEVEL-2 study. This site network is the operational backbone for generating the global safety database needed for regulatory submissions.

Intellectual property protection is a non-negotiable partnership with government bodies. The European Patent Office (EPO) notified Tenax Therapeutics in September 2025 of its Intention to Grant a key patent covering the use of levosimendan in PH-HFpEF. This patent term is set to run until December 2040, and it may even qualify for European patent supplementary protection certificates (SPC) that would extend that protection further. On the U.S. side, Tenax Therapeutics has previously received a Notice of Allowance from the USPTO for similar claims, also targeting protection through December 2040. This IP scaffolding is what underpins the long-term commercial value.

Financing these global trials is where institutional healthcare investors become critical partners. The momentum for the dual Phase 3 strategy was significantly bolstered by a major financing event. Specifically, new investor BVF Partners LP led an oversubscribed private placement in August 2024, which brought in approximately $100 million in gross proceeds. This capital, combined with a subsequent March 2025 private placement of approximately $25 million gross proceeds from RTW Investments, is intended to fund operations through 2027, well past the expected topline data readout for the first Phase 3 trial, LEVEL, in the second half of 2026. The scale of this investment supports the operational costs, as evidenced by the Q3 2025 R&D expenses hitting $10.3 million.

Here's a quick look at how these partnerships align with the clinical development needs:

The reliance on external Clinical Research Organizations (CROs) is implicit in running a global Phase 3 study like LEVEL-2, which is designed to satisfy requirements for both U.S. and other geographies. While specific CRO contracts aren't public, the scale dictates the use of established global CROs to manage the logistics across the 15 countries involved in LEVEL-2. The R&D expense for Q3 2025 was $10.3 million, much of which flows directly to these operational partners.

You should track the cash position closely; Tenax Therapeutics reported cash and cash equivalents of $99.4 million as of September 30, 2025. This is the financial buffer supporting these critical external relationships.

• KOL engagement is scheduled for November 13, 2025.
• LEVEL-2 has qualified sites in 15 countries.
• The EPO patent provides protection until at least December 2040.
• The August 2024 financing secured $100 million, led by BVF Partners LP.
• Q3 2025 R&D spend was $10.3 million.

Finance: review the burn rate against the $99.4 million cash on hand as of September 30, 2025, focusing on CRO contract milestones.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Key Activities

You're looking at the core engine driving Tenax Therapeutics right now-the actual work required to get TNX-103, their oral levosimendan, across the finish line. It's all about execution in the clinic and securing the legal moat around the drug.

Executing two registrational Phase 3 trials (LEVEL and LEVEL-2) for TNX-103

The company's primary activity centers on advancing TNX-103 for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). The ongoing Phase 3 LEVEL study is progressing, with high rates of continuation reported through both blinded and open-label extension stages. The goal for this trial is firming up the data needed for a potential regulatory filing.

The second registrational trial, LEVEL-2, is the global expansion of this effort. You need to track the start-up costs and site qualification, which are clearly hitting the operating expenses now. Honestly, the ramp-up for a global study like this eats cash fast.

Here's the quick math on the trial timelines and associated R&D spend:

Securing and maintaining global intellectual property (IP) for levosimendan

Protecting the core asset is a non-negotiable activity. Tenax Therapeutics has been actively building out its IP portfolio, which is critical for market exclusivity, especially as they prepare for a potential launch in Europe via LEVEL-2.

A major step was the September 2025 notification from the European Patent Office (EPO) of its Intention to Grant a key patent.

• This European patent covers the use of TNX-103 (oral levosimendan), TNX-102, TNX-101, and transdermal levosimendan for PH-HFpEF.
• Once granted, protection is secured in Europe through at least December 2040.
• The patent may qualify for European patent supplementary protection certificates (SPC) extending protection beyond 2040.
• This builds upon multiple patents already issued in the U.S. and Canada.

Managing regulatory interactions with the FDA and other global bodies

The FDA interaction is a gating item for US commercialization. You saw direct evidence of this activity in March 2025 when the FDA completed its review of the updated Phase 3 development plan for TNX-103. This included both the amendment to the ongoing LEVEL study and the protocol for the upcoming LEVEL-2 study. Regulatory consulting costs are a component of the operating expenses, noted in the R&D spend increase in Q1 2025.

Raising capital through private placements and investor relations

Sustaining two registrational trials requires significant capital stewardship. Tenax Therapeutics has been successful in tapping the private markets to fund this extended timeline, which management believes covers operations through 2027.

Key financing events include:

• Aggregate gross proceeds from private placements in 2024 and early 2025 totaled approximately $125 million.
• Specifically, a private placement in March 2025 raised approximately $25 million in gross proceeds.
• The cash position as of March 31, 2025, was $111.4 million.
• Cash and cash equivalents stood at $99.4 million as of September 30, 2025.

The company maintains a lean structure, with an employee count of 13 as of 2025.

Developing and manufacturing the oral levosimendan (TNX-103) drug product

This activity covers the non-clinical development and scale-up required for TNX-103, the oral formulation of levosimendan. Tenax Therapeutics is also developing TNX-101 (IV) and TNX-102. The costs associated with advancing the clinical program are captured in the R&D line item, which saw a significant jump in Q3 2025 to $10.3 million, partly due to increased personnel costs from headcount growth in 2025. The R&D spend for the full year 2024 was $12.7 million.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Key Resources

You're looking at the core assets Tenax Therapeutics, Inc. is banking on to bring their cardiopulmonary therapies to market. Honestly, the financial footing right now is solid, giving them room to execute on their late-stage trials. As of September 30, 2025, the firm held $99.4 million in cash and cash equivalents. This level of liquidity is projected to fund the Company's operations through the end of 2027.

Here's a quick look at some of the hard numbers defining the current resource base:

Intellectual property forms a critical part of the value proposition, centered around the levosimendan franchise for PH-HFpEF. You should note the breadth of this protection:

• Global rights to levosimendan, covering specific formulations: TNX-103 (oral), TNX-102 (subcutaneous), and TNX-101 (IV).
• Protection also extends to transdermal levosimendan and the active metabolites OR1896 and OR1855.
• Levosimendan already has market authorization in 60 countries for its intravenous use in acutely decompensated heart failure.

The clinical evidence supporting TNX-103's potential is anchored in the Phase 2 HELP study results. Specifically, levosimendan demonstrated a statistically significant reduction in pulmonary capillary wedge pressure (PCWP) compared to baseline (p=<0.0017) and placebo (p=<0.0475) when measurements at rest, with legs up, and during exercise were combined. Furthermore, the trial showed a statistically significant improvement in 6-minute walk distance (6MWD) of 29 meters (p=0.0329) over placebo. The current Phase 3 LEVEL study, which is being upsized to 230 patients, anticipates completing enrollment around the end of 2025, with topline data expected in the middle of 2026.

The operational capacity is supported by specialized R&D and clinical operations personnel, evidenced by the Q3 2025 R&D expense of $10.3 million. This team is managing two registrational Phase 3 studies in parallel: the expanded LEVEL trial in Canada and the U.S., and the globally footprinted LEVEL-2 study, which Tenax Therapeutics planned to initiate in 2025. The company is defintely investing heavily in personnel to drive these complex programs forward.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Value Propositions

You're looking at the core reason Tenax Therapeutics, Inc. exists: to bring the first-in-disease oral therapy to patients with Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). This is a major value driver because, honestly, there are no drugs approved for this indication right now. The burden is clear: PH in HFpEF affects about 47.2% of the HFpEF population, and this subtype carries a one-year mortality of 20-29% and a 30-day all-cause readmission rate of 21%. That's the massive unmet need TNX-103 is targeting.

The primary value proposition of TNX-103, which is oral levosimendan, centers on improving functional capacity and, by extension, the quality of life for these patients. The ongoing Phase 3 LEVEL study is designed to measure this efficacy, using the Six-Minute Walk Distance (6 MWD) as a key endpoint. The commitment to robust data is evident; the LEVEL study has been expanded to at least 230 patients, boosting the statistical powering to over 95%. We expect to see topline data from this pivotal trial in the second half of 2026.

What makes this different is the mechanism. Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer. This differentiated approach is what key opinion leaders are discussing, as it targets the underlying physiology differently than current standard-of-care, which focuses on comorbidities and volume management. The early data supports its tolerability; as of late February 2025, >95% of randomized patients remained on therapy in the LEVEL study.

Tenax Therapeutics, Inc. isn't just betting on one delivery method; they own the North American rights to multiple levosimendan formulations, which broadens the potential patient reach and utility. This flexibility is a strong component of the overall value. The company is advancing these in parallel, with the second global Phase 3 study, LEVEL-2, set to commence in 2025. The intellectual property is also locked down, with patent protection for the oral formulation extending through at least 2040.

Here's a quick look at the development pipeline and supporting financials as of late 2025:

The company's investment reflects this focus; R&D expenses for the third quarter of 2025 were $10.3 million, up from $3.1 million in Q3 2024, driven by these Phase 3 studies. Still, with a cash position of $99.4 million as of September 30, 2025, management believes they are funded through 2027. The market is pricing this potential at a stock price of $7.04 as of November 11, 2025, giving a market cap of $32.1M. This valuation hinges entirely on delivering on the promise of TNX-103 as a first-in-class therapy.

The value propositions are centered on addressing a critical gap in care:

• First-in-disease oral therapy for PH-HFpEF, a condition with no approved drugs.
• TNX-103 aims to improve functional capacity, measured by 6 MWD.
• Differentiated mechanism as a K-ATP activator/calcium sensitizer.
• Multiple levosimendan formulations (oral, IV, subcutaneous) for varied patient needs.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so you know the focus is razor-sharp: keeping investigators happy and investors confident while the science plays out. Here's the breakdown of how Tenax Therapeutics, Inc. handles its key customer groups as of late 2025.

High-touch engagement with clinical investigators and sites for trial compliance

The relationship with clinical investigators is all about execution fidelity for the TNX-103 program. The ongoing Phase 3 LEVEL study, which is being conducted in the United States and Canada, is nearing its target enrollment of 230 patients, with completion anticipated in the first half of 2026. Tenax Therapeutics is clearly maintaining engagement, reporting high rates of study and therapy continuation through both the blinded and open-label extension stages of LEVEL. Furthermore, the second registrational Phase 3 study, LEVEL-2, is set to initiate in 2025 with a global footprint. To support this, over 160 investigative sites new to the program, across 15 countries, have been qualified for the LEVEL-2 study as of the third quarter of 2025.

Investor relations via conferences and webcasts for capital market confidence

Maintaining capital market confidence is crucial, especially while funding two Phase 3 trials. Tenax Therapeutics reported a cash position of $99.4 million as of September 30, 2025. This follows a March 2025 private placement that brought in approximately $25 million in gross proceeds. Management projects this cash, which stood at $111.4 million on March 31, 2025, will fund operations through 2027. The company actively engages through investor events, with announcements for participation in conferences like the 8th Annual Evercore Healthcare Conference on December 2, 2025, and the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, 2025. Analyst sentiment, based on data from May 2025, showed a consensus brokerage recommendation of 1.3 from 4 brokerage firms, where 1 signifies Strong Buy.

Here's the quick math on recent capital activity:

• Cash as of September 30, 2025: $99.4 million
• Cash as of March 31, 2025: $111.4 million
• Gross Proceeds from March 2025 Private Placement: $25 million
• Projected Cash Runway: Through 2027

Direct communication with Key Opinion Leaders (KOLs) to shape clinical defintely strategy

Engaging KOLs directly helps validate the clinical strategy for TNX-103 in treating Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). Tenax Therapeutics hosted a Virtual KOL Call on Thursday, November 13, 2025, at 4:30 p.m. ET. This event featured members of the management team joined by recognized key opinion leaders in cardiovascular medicine to discuss the treatment landscape and the late-stage development program for TNX-103.

Patient support programs within the clinical trial framework

For patients enrolled in the TNX-103 trials, the relationship is managed through the structure of the trials themselves, emphasizing continued participation. The high rates of study and therapy continuation observed in the Phase 3 LEVEL study serve as a key metric for the effectiveness of the support framework provided to trial participants. The goal is to maintain this engagement until enrollment completion, targeted for the first half of 2026.

Finance: review Q3 2025 R&D spend of $10.3 million against site activation milestones by next Tuesday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Channels

You're looking at how Tenax Therapeutics, Inc. gets its science and corporate story out to the world-from the research sites running the trials to the investors watching the stock. It's all about execution and communication in the clinical development phase.

Global Network of Clinical Trial Sites (US, Canada, Europe, etc.)

The primary channel for clinical data generation is the network of investigative sites running the two registrational Phase 3 studies for TNX-103 (oral levosimendan) in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF).

• The ongoing Phase 3 LEVEL study is currently being conducted in the United States and Canada.
• Enrollment for LEVEL, targeting 230 patients, is expected to be completed in the first half of 2026.
• The second registrational Phase 3 study, LEVEL-2, which has a global footprint, was on track to initiate in 2025.
• As of the third quarter of 2025, over 160 investigative sites new to the program, across 15 countries, have been qualified for the LEVEL-2 study.

Regulatory Submissions (NDA, MAA) to the FDA and European Medicines Agency (EMA)

Regulatory engagement is a critical channel for product approval. Tenax Therapeutics, Inc. has been actively communicating its development plan to the U.S. Food and Drug Administration (FDA).

The FDA completed its review of the updated Phase 3 development plan for TNX-103, which included the amendment for the LEVEL study and the protocol for LEVEL-2, in March 2025. The company expects to file for approval in the U.S. and other geographies upon successful completion of both registrational studies.

On the European side, the channel for IP protection is strong:

• In September 2025, the European Patent Office (EPO) notified Tenax Therapeutics, Inc. of its Intention to Grant a patent application.
• This grant provides intellectual property protection in Europe for the treatment of PH-HFpEF with TNX-103 and other levosimendan formulations until at least December 2040.

Investor Relations Website and Financial News Wires for Corporate Updates

You need timely, accurate financial and operational data to assess the company's runway and progress. Tenax Therapeutics, Inc. uses its investor relations webpage and news wires to disseminate this information.

Here are the key figures from the latest reported period, the third quarter ended September 30, 2025:

The last earnings call reporting these figures was held on November 12, 2025. The company also announced participation in the 8th Annual Evercore Healthcare Conference on December 2, 2025.

Peer-Reviewed Publications for Scientific Dissemination (e.g., Journal of Cardiac Failure)

Disseminating the scientific rationale through peer review is vital for establishing credibility with the medical community. Tenax Therapeutics, Inc. has used this channel to support its trial designs.

• A protocol design paper, titled "Oral Levosimendan for the Treatment of Pulmonary Hypertension due to Heart Failure With Preserved Ejection Fraction: Rationale and Design of the LEVEL Trial," was published in the Journal of Cardiac Failure.
• Other relevant scientific literature shared by the company includes a paper in the European Journal of Heart Failure from April 19, 2024.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Customer Segments

You're looking at the core groups Tenax Therapeutics, Inc. (TENX) must satisfy to get TNX-103 (oral levosimendan) to market for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). This isn't just about patients; it's about the entire ecosystem that validates, funds, and approves the therapy.

Patients suffering from Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

This group represents the ultimate end-user, a population with a debilitating, often fatal disease for which no drugs are currently approved in the United States or Canada. The company is advancing TNX-103 through two registrational Phase 3 studies targeting this specific indication. The focus is on improving quality of life and exercise ability for these patients.

Cardiologists and pulmonologists specializing in heart failure and pulmonary hypertension

These specialists are the prescribers and the key opinion leaders (KOLs) who validate the clinical utility of TNX-103. Tenax Therapeutics actively engages them, hosting events like the Virtual KOL Call on November 13, 2025, to discuss the treatment landscape and the product's differentiation. The clinical program requires their participation to enroll and treat patients.

• Phase 3 LEVEL study enrollment completion targeted for the first half of 2026, involving 230 patients.
• LEVEL-2, the second global Phase 3 study, is set to initiate in 2025.
• Over 160 investigative sites new to the program have been qualified for the LEVEL-2 study across 15 countries.
• Patient continuation rates in the LEVEL trial through blinded and open-label extension stages have been reported as high.

Institutional and accredited healthcare investors funding development

These stakeholders provide the necessary capital to fund the expensive, late-stage clinical development. Their confidence, demonstrated through financing rounds, directly impacts the company's operational runway. You need to see the burn rate against the cash reserves to gauge their ongoing support.

Here's the quick math on the capital structure as of late 2025, based on the third quarter results:

What this estimate hides is the timing of the topline data readout, expected in the second half of 2026, which will be the next major inflection point for this segment. Still, the current cash position seems adequate for the near term.

Regulatory agencies (FDA, EMA) as the gatekeepers for market access

The FDA and EMA control whether TNX-103 can be prescribed in major markets. Tenax Therapeutics, Inc. must satisfy their requirements for safety and efficacy data from the ongoing Phase 3 trials. The FDA completed its review of the updated Phase 3 development plan for TNX-103 in March 2025. Defintely, securing intellectual property protection is also key to their market strategy.

• FDA completed review of updated Phase 3 development plan for TNX-103 in March 2025.
• European Patent Office (EPO) notified Tenax of Intention to Grant a patent in September 2025.
• The granted European patent covers TNX-103 (oral levosimendan) and other formulations for treating PH-HFpEF.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Cost Structure

You're looking at the expense side of Tenax Therapeutics, Inc.'s operations as they push their lead program through late-stage trials. The cost structure is heavily weighted toward clinical execution, which is typical for a Phase 3 company. Honestly, the numbers reflect a significant ramp-up in activity compared to the prior year.

For the third quarter ended September 30, 2025, the total operating expenses are clearly dominated by the push to complete the LEVEL study and initiate LEVEL-2. The reported net loss for the quarter was $15.8 million, a substantial increase from the $4.0 million net loss in the third quarter of 2024. This burn rate is being funded by their cash position, which stood at $99.4 million as of September 30, 2025, a figure management believes supports operations through 2027.

Here's the quick math on the major expense categories for Q3 2025:

The increase in R&D expenses, which rose by 232% year-over-year, is directly tied to advancing the clinical pipeline. You can see the breakdown of where that money is going, defintely.

• Costs driven by the ongoing Phase 3 LEVEL study execution.
• Start-up activities for the second global Phase 3 study, LEVEL-2, in anticipation of patient enrollment.
• Increased personnel costs due to an increased R&D employee headcount during 2025.

Stock-based compensation is a notable non-cash component inflating both R&D and G&A figures. The G&A costs, specifically, saw a massive jump to $6.5 million in Q3 2025 from $1.5 million in Q3 2024, largely due to this compensation.

The non-cash stock-based compensation expense breakdown for Q3 2025 is as follows:

• R&D Non-Cash Stock-Based Compensation: $1.1 million.
• G&A Non-Cash Stock-Based Compensation: $4.5 million.

The execution timeline for the clinical trials is a major cost driver. Tenax Therapeutics expects to complete enrollment of the 230 patients in the LEVEL study in the first half of 2026, with topline data expected in the second half of 2026. Furthermore, the company remains on track to initiate the global LEVEL-2 study within 2025, which involves qualifying over 160 investigative sites across 15 countries.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Tenax Therapeutics, Inc. (TENX) as of late 2025. For a Phase 3 development-stage company, the current revenue picture is exactly what you'd expect: it's entirely dependent on capital markets, not product sales.

Currently, Tenax Therapeutics has zero product revenue. As a Phase 3, development-stage pharmaceutical company, the focus remains on clinical execution rather than commercial sales. The reported revenue for the third quarter ending September 30, 2025, was $0.0. This aligns with the company's status as it seeks approval for its lead candidate, TNX-103.

The primary source of operational funding right now is equity financing. This is how you keep the lights on and the trials running when you don't have a product on the market. Tenax Therapeutics successfully executed a significant capital raise to support this late-stage development.

Here's a look at the most recent financing event that underpins the current operations:

This capital infusion helped bolster the balance sheet. As of September 30, 2025, Tenax Therapeutics reported cash and cash equivalents of $99.4 million. Management has stated that this cash position is expected to fund the Company through 2027. That runway is critical for reaching key data milestones without immediate pressure to raise again.

Future potential revenue streams are entirely contingent on the clinical success and subsequent regulatory approval of TNX-103, which is being evaluated for pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF).

The path to commercial revenue involves two main components:

• The potential for revenue from commercial sales of TNX-103 following any potential U.S. Food and Drug Administration (FDA) approval.
• The potential for future licensing or partnership revenue, specifically for ex-US commercialization efforts.

To be fair, Tenax Therapeutics significantly expanded its commercial potential in September 2025 by securing the exclusive worldwide development, commercialization, and manufacturing rights for orally-administered levosimendan. This move solidifies their control over the asset globally, which is key for structuring any future international deals that would generate partnership revenue.

Here's a quick look at the current financial standing relative to operations:

The entire revenue model for Tenax Therapeutics pivots on the data expected mid-2026 from the Phase 3 LEVEL study. Finance: review the cash burn rate against the $99.4 million balance by next Tuesday.