Tenax Therapeutics, Inc. · NASDAQ:TENX
Tenax Therapeutics — Technical Presentation (September 2026)
41 slides from Tenax Therapeutics's technical presentation, Sep 9, 2026
Slide 1: LEVEL Clinical Trial Results
LEVEL Clinical Trial Results September 09, 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 may include information concerning our clinical data, our regulatory plans, ou
Slide 3: LEVEL Results Update
LEVEL Results Update Topline results made public: 10 August 2026 Comprehensive results update: 09 September 2026
Slide 4: PH-HFpEF is a complex disease
PH-HFpEF is a complex disease, combining the excessive volume overload (or preload) of the left ventricle with the increased PA pressure (or afterload) of the right ventricle. This challenging combination of targets explains why a treatment for PH-HFpEF has been so elusive. An ideal therapy would ta
Slide 5: LEVEL Results Highlights: Key Scientific Updates
Key Scientific Updates following receipt of the full statistical analysis & ESC Late Breaker (both week of 24 Aug): Efficacy: < Median Baseline 6MWD population and 6MWD results comparable to HELP, both with >25m ∆6MWD Efficacy: NT-proBNP at baseline associated with exercise improvement Efficacy: RVS
Slide 6: Interpretation of the LEVEL Primary Endpoint Result
Interpretation of the LEVEL Primary Endpoint Result The neutral LEVEL result was not due to an ineffective drug, but to a protocol design flaw: the inclusion of too many patients who walked too far at baseline, with little room to improve. LEVEL-2 will not face this obstacle. The degree to which a p
Slide 7: LEVEL Study Recap
LEVEL Study Recap
Slide 8: 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 arterial pressure. 1mg oral
Slide 9: 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 10: 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 11: 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 12: Baseline 6MWD was the Strongest Predictor of Clinical Response
Baseline 6MWD was the Strongest Predictor of Clinical Response
Slide 13: Patients with Greater Exercise Limitation Demonstrated a Large Treatment Effect
Patients with Greater Exercise Limitation Demonstrated a Large Treatment Effect +26.3 M LS Mean Difference *Prespecified analysis 6MWD: 6-minute walk distance; LS: least squares; SE: standard error; CI: confidence interval. Multi-variable analyses identified baseline 6MWD as the strongest predictor
Slide 14: 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-value 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
Slide 15: 6MWD Treatment Effect: Comparison of LEVEL and HELP
6MWD Treatment Effect: Comparison of LEVEL (12-week ∆) & HELP (6-week ∆) 9
Slide 16: Lower 6MWD Greatest Benefit
Lower 6MWD Greatest Benefit Inverse linear relationship between baseline 6MWD and treatment effect In LEVEL, levosimendan-treated patients whose baseline 6MWD matched HELP and CADENCE (274-285 m) had a ~20-meter placebo-adjusted improvement in 6MWD 333 m CADENCE: HELP: Shaded area represents 95% CI
Slide 17: RVSP Reduction Greatest in Patients with Baseline 6MWD <Median
RVSP Reduction Greatest in Patients with Baseline 6MWD <Median (<333M) 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 this
Slide 18: Echocardiographic Measures Point to RV & LV Functional Enhancement
Echocardiographic summary provided by Northwestern University core lab Echocardiographic Measures Point to RV & LV Functional Enhancement ECHOCARDIOGRAPHY CONDUCTED AT BASELINE AND WEEK 12
Slide 19: Treatment Effect Appears Magnified in Older Patients
LEVEL Treatment Effect Appears Magnified in Older Patients (<333M Baseline) THE PATIENTS WHO NEED THE DRUG THE MOST BENEFIT THE MOST + 43.1M LS Mean Difference *Post-hoc analysis 6MWD: 6-minute walk distance; LS: least squares; SE: standard error; CI: confidence interval. Difference in change from b
Slide 20: TNX-103 Benefited Patients on State-of-the-Art Therapy
TNX-103 Benefited Patients on State-of-the-Art Therapy PATIENTS WHO WILL BENEFIT THE MOST: BASELINE 6MWD <MEDIAN (333M) AND ON GLP-1s & GUIDELINE-DIRECTED MEDICAL THERAPY (GDMT) Difference in change from baseline LS Mean Difference (SE) 35.9 (12.17) 95% CI for LS Mean Difference 12.1, 59.8 Differenc
Slide 21: Treatment Effect by Baseline NT-proBNP
7 Treatment Effect by Baseline NT-proBNP Placebo-adjusted difference in 12-week change in 6MWD across the range of baseline NT-proBNP; the fitted effect crosses zero at 83 pg/mL *Post-hoc analysis NT-proBNP: N-terminal pro B-type natriuretic peptide; 6MWD: 6-minute walk distance; LS: least squares;
Slide 22: 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 23: ∆6MWD by Type of Qualifying RHC Hemodynamic Assessment
∆6MWD by Type of Qualifying RHC Hemodynamic Assessment BY SUBGROUP WITH BASELINE 6MWD < MEDIAN (<333M) 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 LS
Slide 24: 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) <325M baseline cohort PHIRST Trial (3) (tadalafil) <325M baseline cohort TRIUMPH-1 trial (4) ( treprostinil) <350M baseline cohort PH/HFPEF Studies Reporting Posi
Slide 25: Baseline 6MWD below median subgroup results
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 n=57 -20 0 20 40
Slide 26: 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 (<333M) 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 27: Safety Profile Supports Continued Development
Safety Profile Supports Continued Development
Slide 28: 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 29: Treatment Emergent Adverse Events Balanced Between TNX-103 and Placebo
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 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: Conclusions
Conclusions LEVEL enrolled a broad range of patients with symptomatic PH-HFpEF, with PA pressures by invasive hemodynamics Over 12 weeks, levosimendan did not improve 6MWD or KCCQ-TSS, but NTproBNP by ~50% and RVSP by 3.5 mmHg Largest reduction in NTproBNP to date in a HFpEF RCT Magnitude of NTproBN
Slide 32: Conclusions
Conclusions LEVEL enrolled a broad range of patients with symptomatic PH-HFpEF, with PA pressures by invasive hemodynamics Over 12 weeks, levosimendan did not improve 6MWD or KCCQ-TSS, but NTproBNP by ~50% and RVSP by 3.5 mmHg Largest reduction in NTproBNP to date in a HFpEF RCT Magnitude of NTproBN
Slide 33: Next Steps for Tenax
Next Steps for Tenax
Slide 34: 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. NT-proBNP: N-terminal pro B-type natriuretic peptide; RVSP: right ventricular systolic pressure; HELP: Hemodynamic Evaluation of Levosimendan in Patients with PH
Slide 35: Backup - Slides
Backup - Slides
Slide 36: Oral 2mg & 3mg Dose: Levosimendan & OR-1896 Pharmacokinetics
Levosimendan Dose; 1mg BID Weeks 1-4; titrated to 1mg TID Weeks 5-12 Represents 2 or 3 pulses of levosimendan per day; each dose cleared in ~4.5-5 hours Week 12 plasma levels ranged from 0.12 to 37.7 ng/mL, dependent on time of last dose OR-1896 Active Metabolite Plasma levels increased proportional
Slide 37: Is the Baseline-6MWD Interaction Regression to the Mean?
7 ICC: intraclass correlation coefficient; CV: covariate; SD: standard deviation; CI: confidence interval. Is the Baseline-6MWD Interaction Regression to the Mean? AGREEMENT BETWEEN THE SCREENING & BASELINE WALK TEST IN ALL 241 PATIENTS; ICC 0.91, BIAS +2.3M, 95% LIMITS OF AGREEMENT -66.2M - +70.9M
Slide 38: LS Mean Change in 6MWD by Baseline 6MWD Quartile
LS Mean Change in 6MWD by Baseline 6MWD Quartile* *Post-hoc analysis 6MWD: 6-minute walk distance; LS: least squares; CI: confidence interval.
Slide 39: Impressive Reductions in Exploratory Endpoints
Impressive Reductions in Exploratory Endpoints BIOMARKER AND HEMODYNAMIC REDUCTIONS EVEN MORE PRONOUNCED IN PATIENTS WITH HIGHER DISEASE BURDEN *nominal p-value; #95% confidence interval is -6.010, -1.100; HHodges-Lehmann shift estimate. NT-proBNP: N-terminal pro B-type natriuretic peptide; RVSP: ri
Slide 40: Change in KCCQ Total Symptom Score in LEVEL Patients <Median 6MWD
Change in KCCQ Total Symptom Score in LEVEL Patients <Median (333M) 6MWD MAGNITUDE OF EFFECT IS COMPARABLE TO CHANGES SHOWN BY SGLT-2i & MRAs IN MANY HFpEF TRIALS NS *Post-hoc analysis 6MWD: 6-minute walk distance; KCCQ-TSS: Kansas City Cardiomyopathy Questionnaire-Total Symptom Score; LS: least squ
Slide 41: Three Disease Burden Markers Correlate with Treatment Effect
Three Disease Burden Markers Correlate with Treatment Effect KEY BASELINE CHARACTERISTICS PREDICT RESPONSE By age Δ 6MWD vs placebo 95% CI Nominal p-value Top tertile (> 74 years), N=77 + 37.6 m 14.7, 60.5 0.0013 Above median (> 71 years), N=124 + 27.1 m 9.9, 44.4 0.0021 Below median (< 71 years), N
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