Tenax Therapeutics, Inc. · NASDAQ:TENX
Tenax Therapeutics — Investor Presentation (October 2026)
39 slides from Tenax Therapeutics's investor presentation, Oct 8, 2026
Slide 1: Corporate Presentation October 2026
Corporate Presentation October 2026 Exhibit 99.1
Slide 2: Forward-Looking Statements Disclaimers
Forward-Looking Statements Disclaimers Except for historical information, all of the statements, expectations and assumptions contained in this presentation are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding our expectations about t
Slide 3: Evidence-Driven Phase 3 Program
Evidence-Driven Phase 3 Program LEVEL DATA ENHANCES HELP TRIAL PROOF OF CONCEPT TO DE-RISK ONGOING PHASE 3; WELL-ESTABLISHED SAFETY PROFILE PH-HFpEF: pulmonary hypertension in heart failure with preserved ejection fraction; MOA: mechanism of action. TNX-103, or Oral Levosimendan, is a potential firs
Slide 4: Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Slide 5: Group 2 Pulmonary Hypertension (Left Heart Disease)
Group 2 Pulmonary Hypertension (Left Heart Disease) PH: pulmonary hypertension; PH-HFpEF: pulmonary hypertension in heart failure with preserved ejection fraction; WHO: World Health Organization. Strange G, et al. Heart (British Cardiac Society) vol. 98,24 (2012): 1805-11. PH-HFpEF is the most commo
Slide 6: The Fundamental Role of the Splanchnic Reservoir
The Fundamental Role of the Splanchnic Reservoir Gelman S and Mushlin PS. Anesthesiology vol. 100,2 (2004): 434-9. 35% of circulating blood is in the systemic veins 35% of circulating blood is in the systemic arteries 30% of circulating blood is in the splanchnic vascular reservoir
Slide 7: Blood Volume Distribution in Healthy vs PH-HFpEF
LA, left atrium; LV, left ventricle; RA, right atrium; RV, right ventricle; PH-HFpEF, pulmonary hypertension in heart failure with preserved ejection fraction. Gelman S, et al. J Am Soc Anesthesiol. 2004;100(2):434-439.; Fudim M, et al. Eur J Heart Fail. 2021;23:1076-1084.; Yaku H, et al. J Cardiol.
Slide 8: Oral Levosimendan (TNX-103)
Oral Levosimendan (TNX-103)
Slide 9: Levosimendan's MOA is Uniquely Suited to Treat PH-HFpEF
Levosimendan’s MOA is Uniquely Suited to Treat PH-HFpEF NOVEL, POTENTIAL FIRST-IN-CLASS K-ATP CHANNEL ACTIVATOR AND CALCIUM SENSITIZER MOA: mechanism of action; K-ATP: potassium adenosine triphosphate-sensitive. Pataricza J, et al. The Journal of pharmacy and pharmacology vol. 52,2 (2000): 213-7. Do
Slide 10: Phase 3 LEVEL Trial Design
Phase 3 LEVEL Trial Design PHASE 3 REGISTRATIONAL TRIAL IN U.S. AND CANADA BID: twice a day; TID: three times a day; 6MWD: 6-minute walk distance; RHC: right heart catheterization; PCWP: pulmonary capillary wedge pressure; mPAP: mean pulmonary artery pressure; RAP: right atrial pressure. 1 mg oral c
Slide 11: We Believe LEVEL Confirms the Biological Thesis
PH-HFpEF: pulmonary hypertension in heart failure with preserved ejection fraction; RVSP: right ventricular systolic pressure; LV: left ventricle; RV: right ventricle; 6MWD: 6-minute walk distance; NT-proBNP: N-terminal pro B-type natriuretic peptide; AE: adverse events. We Believe LEVEL Confirms th
Slide 12: Patient Demographics
Patient Demographics BASELINE CHARACTERISTICS WERE BROADLY BALANCED ACROSS TREATMENT ARMS BMI: body mass index; 6MWD: 6-minute walk distance; eGFR: estimated glomerular filtration rate; NYHA: New York Heart Association. Characteristic TNX-103 (N=120) Placebo (N=121) Overall (N=241) Age, years, mean
Slide 13: Safety
Safety TOLERABILITY DIFFERENCE BETWEEN ARMS; SERIOUS EVENTS AND CLINICAL WORSENING BALANCED CWE: clinical worsening event; AE: adverse event; CV: cardiovascular; IV: intravenous. Adverse event summary TNX-103 (N=120) Placebo (N=121) Any adverse event, n (%) 104 (86.7) 87 (71.9) Treatment-related adv
Slide 14: Treatment Emergent Adverse Events
Treatment Emergent Adverse Events BALANCED BETWEEN TNX-103 AND PLACEBO IN THE ≥ AND < MEDIAN BASELINE 6MWD SUBGROUPS TNX-103 Placebo System Organ Class (SOC) Preferred Term (PT), n (%) Overall (N=120) BL 6MWD < Median (N=62)* BL 6MWD ≥ Median (N=58)* Overall (N=121) BL 6MWD < Median (N=57)* BL 6MWD
Slide 15: Primary and Key Secondary Endpoints
Primary and Key Secondary Endpoints *N=120 and N=121 for TNX-103 and placebo arms, respectively. 6MWD: 6-minute walk distance; LS: least squares; SE: standard error; SD: standard deviation; KCCQ-TSS: Kansas City Cardiomyopathy Questionnaire-Total Symptom Score; NYHA: New York Heart Association; NS:
Slide 16: Mean Change in 6MWD by Baseline 6MWD Quartile
Mean Change in 6MWD by Baseline 6MWD Quartile INVERSE LINEAR RELATIONSHIP BETWEEN BASELINE 6MWD AND TREATMENT EFFECT Q1 ≤264 M (N=61) Q2 >264-333 M (N=61) Q3 >333-384 M (N=59) Q4 >384 M (N=60) *Post-hoc analysis 6MWD: 6-minute walk distance; LS: least squares. Levosimendan produced a large and clini
Slide 17: Drug Response Correlates with Baseline 6MWD
Drug Response Correlates with Baseline 6MWD *Prespecified analysis 6MWD: 6-minute walk distance; LS: least squares; CI: confidence interval. LS Mean Difference in Δ6MWD (95% CI) Levosimendan N / LS Mean (95% CI) Placebo N / LS Mean (95% CI) LS Mean Difference (95% CI) Baseline 6MWD Below Median (<33
Slide 18: Patients with Greater Exercise Limitation Demonstrated Large Treatment Effect
Patients with Greater Exercise Limitation Demonstrated Large Treatment Effect +26.3 M LS Mean Difference *Prespecified analysis. #For patients with a baseline 6MWD >333 M, the change in 6MWD was -17.6 M (95% CI -36.9, 1.7; nominal p-value 0.0744) 6MWD: 6-minute walk distance; LS: least squares; SE:
Slide 19: LEVEL Patients with Baseline 6MWD <Median: Improvement Similar to HELP
LEVEL Patients with Baseline 6MWD <Median: Improvement Similar to HELP +26.3 M LS Mean Difference +29.3 M LS Mean Difference p = 0.0329 *Prespecified subgroup 6MWD: 6-minute walk distance; LS: least squares; SE: standard error; CI: confidence interval. Difference in change from baseline LS Mean Diff
Slide 20: 6MWD Treatment Effect: Comparison of LEVEL and HELP
6MWD Treatment Effect: Comparison of LEVEL (12 Weeks) & HELP (6 Weeks)
Slide 21: Lower 6MWD, Greatest Benefit
Lower 6MWD, Greatest Benefit Data presented by Dr. Sanjiv Shah at ESC Congress 2026 on August 29, 2026. 6MWD: 6-minute walk distance. 333 M CADENCE: HELP: Shaded area represents 95% CI Inverse linear relationship between baseline 6MWD and treatment effect In LEVEL, levosimendan-treated patients whos
Slide 22: RVSP Reduction Greatest in Patients with Baseline 6MWD <Median
RVSP Reduction Greatest in Patients with Baseline 6MWD <Median (<333 M) LEVOSIMENDAN EFFECTIVELY LOWERS RVSP ACROSS THIS PULMONARY HYPERTENSION POPULATION *Prespecified subgroup 6MWD: 6-minute walk distance; CI: confidence interval. Physiologic improvement in RVSP aligns with 6MWD improvement in thi
Slide 23: Echocardiographic Measures Point to RV & LV Functional Enhancement
Echocardiographic Measures Point to RV & LV Functional Enhancement ECHOCARDIOGRAPHY CONDUCTED AT BASELINE AND WEEK 12 Echocardiographic summary provided by Northwestern University core lab
Slide 24: TNX-103 Benefited Patients on State-of-the-Art Therapy
TNX-103 Benefited Patients on State-of-the-Art Therapy PATIENTS WITH BASELINE 6MWD <MEDIAN (333 M) AND ON GLP-1s & GUIDELINE-DIRECTED MEDICAL THERAPY BENEFIT MOST Difference in change from baseline LS Mean Difference (SE) 35.9 (12.17) 95% CI for LS Mean Difference 12.1, 59.8 Difference in change fro
Slide 25: LEVEL Study 6MWD Change by Baseline NT-proBNP
LEVEL Study 6MWD Change by Baseline NT-proBNP *Post-hoc analysis 6MWD: 6-minute walk distance; NT-proBNP: N-terminal pro B-type natriuretic peptide; LS: least squares; SE: standard error; CI: confidence interval. Difference in change from baseline LS Mean Difference (SE) 16.7 (9.72) 95% CI for LS Me
Slide 26: Change in 6MWD by Type of Qualifying RHC Hemodynamic Assessment
∆6MWD by Type of Qualifying RHC Hemodynamic Assessment BY SUBGROUP WITH BASELINE 6MWD < MEDIAN (<333 M) Difference in change from baseline LS Mean Difference (SE) 29.9 (14.12) 95% CI for LS Mean Difference 2.2, 57.6 Difference in change from baseline LS Mean Difference (SE) 21.4 (15.15) 95% CI for L
Slide 27: PAH Studies with Best Results in Lowest 6MWD Cohort
PAH Studies with Best Results in Lowest 6MWD Cohort SERAPHIN Trial (1) (macitentan) <300 M baseline cohort SUPER-1 Trial (2) (sildenafil) <325 M baseline cohort PHIRST Trial (3) (tadalafil) <325 M baseline cohort TRIUMPH-1 trial (4) ( treprostinil) <350 M baseline cohort PH/HFPEF Studies Reporting P
Slide 28: Baseline 6MWD Below Median (<333 M) Subgroup
Baseline 6MWD Below Median (<333 M) Subgroup 6MWD: 6-minute walk distance; KCCQ-TSS: Kansas City Cardiomyopathy Questionnaire-Total Symptom Score; NT-proBNP: N-terminal pro B-type natriuretic peptide; RVSP: right ventricular systolic pressure; CI: confidence interval +21.1 -5.2 n=62 -20 0 20 40 TNX-
Slide 29: We Believe Learnings from LEVEL will De-risk LEVEL-2
We Believe Learnings from LEVEL will De-risk LEVEL-2 Strong treatment effect in patients with baseline 6MWD below the median (<333 M) is real: Prespecified subgroup finding supported by multivariable analysis No evidence that regression to the mean explains the finding RVSP reduction aligns with the
Slide 30: Confirming Biological Activity Using NT-proBNP
Confirming Biological Activity Using NT-proBNP NT-proBNP FELL IN OVERALL POPULATION WITH SUBSTANTIAL REDUCTION OBSERVED IN FIRST VISIT AFTER RANDOMIZATION *nominal p-value. NT-proBNP: N-terminal pro B-type natriuretic peptide; LS: least squares; CI: confidence interval. NT-proBNP vs. placebo at Week
Slide 31: LEVEL: Largest Reduction in NT-proBNP To Date in HFpEF
LEVEL: Largest Reduction in NT-proBNP To Date in HFpEF Data presented by Dr. Sanjiv Shah at ESC Congress 2026 on August 29, 2026
Slide 32: NT-proBNP: Predicted Effect on HF Events
↓ NT-proBNP: Predicted Effect on ↓ HF Events Data presented by Dr. Sanjiv Shah at ESC Congress 2026 on August 29, 2026 Activin trap SGLT2i Relaxin agonist MRA PROJECTED Levosimendan HF event rate reduction based on LEVEL results GLP1-RA ARNI ERA
Slide 33: What LEVEL Tells Us
What LEVEL Tells Us KEY LEARNINGS FROM THE FIRST PHASE 3 TRIAL *Prespecified analysis; nominal p-values are not adjusted for multiplicity. PK: pharmacokinetics; NT-proBNP: N-terminal pro B-type natriuretic peptide; RVSP: right ventricular systolic pressure; HELP: Hemodynamic Evaluation of Levosimend
Slide 34: Building on LEVEL: A Data-Driven Enrichment Strategy for LEVEL-2
Building on LEVEL A DATA-DRIVEN ENRICHMENT STRATEGY FOR LEVEL-2 6MWD: 6-minute walk distance; RAVI: right atrial volume index; CI: confidence interval; PH: pulmonary hypertension; HF: heart failure. Multivariable analyses were used to identify a sub-population with strong treatment effects. 6MWD at
Slide 35: Right Atrial Volume Index (RAVI) Identifies Strong Responders
Right Atrial Volume Index (RAVI) Identifies Patients with Strong Response to a Volume-Reduction Strategy The excess blood entering the heart initially enters the right atrium, where the effect of this excess can be measured during a right heart catheterization (RHC) as right atrial pressure (RAP) LE
Slide 36: LEVEL-2 Update: Protocol Amendment Implementation
LEVEL-2 Update: Protocol Amendment Implementation TEMPORARY ENROLLMENT PAUSE; FDA INTERACTIONS FDA: U.S. Food and Drug Administration; PH-HFpEF: pulmonary hypertension in heart failure with preserved ejection fraction. Effective execution of the Amended LEVEL-2 protocol requires a temporary pause in
Slide 37: IP Portfolio Protects Global Rights to Levosimendan Use in PH-HFpEF
IP Portfolio Protects Global Rights to Levosimendan Use in PH-HFpEF United States: US 11,213,524, issued January 4, 2022, expires November 14, 2039 (SC Formulation/Use) US 11,607,412, issued March 21, 2023, expires December 15, 2040 (IV Use) US 11,701,355, issued July 18, 2023, expires December 15,
Slide 38: Evidence-Driven Phase 3 Program
Evidence-Driven Phase 3 Program LEVEL DATA ENHANCES HELP TRIAL PROOF OF CONCEPT TO DE-RISK ONGOING PHASE 3; WELL-ESTABLISHED SAFETY PROFILE PH-HFpEF: pulmonary hypertension in heart failure with preserved ejection fraction; MOA: mechanism of action. TNX-103, or Oral Levosimendan, is a potential firs
Slide 39: Developing a therapy uniquely suited for PH-HFpEF
Developing a therapy uniquely suited for PH-HFpEF
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