Tenax Therapeutics, Inc. · NASDAQ:TENX
Tenax Therapeutics — Investor Presentation (January 2020)
22 slides from Tenax Therapeutics's investor presentation, Jan 13, 2020
Slide 1: Tenax Therapeutics January 2020
TENA THERAPEUTICS "NASDAQ: TENX — TENX January 2020
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but
Slide 3: Mission Statement
Mission Statement Specialty pharmaceutical company focused on identifying and developing therapeutics that address diseases with high unmet medical need with an initial therapeutic focus on Cardio- Pulmonary diseases Pulmonary
Slide 4: Levosimendan and Active Metabolite; non-protein bound plasma concentrations
Levosimendan and Active Metabolite; non-protein bound plasma concentrations —-— Levosimendan —@— 0r-1896 Free plasma concentration (nM) 0 24 48 72 96 120 144 168 192 216 240 264 288 312 336 360 384 Time (H)
Slide 5: Levosimendan History
Levosimendan History =Levosimendan is a calcium sensitizer/K-ATP channel activator =First approved in Sweden (Orion) in 2000 for acute decompensated heart failure "Approved/marketed in >60 countries = To date >1.5 million patients have been treated with levosimendan = Not Approved in US or Canada
Slide 6: Scientific Advisory Board
Scientific Advisory Board PH-HFpEF Development Plan Guided by World Recognized Experts in Pulmonary Hypertension and HFpEF Professor of Medicine, Northwestern University Feinberg School of Medicine Director, Pulmonary Vascular Disease Program, Bluhm Cardiovascular ™ Northwestern Medicine’ Institute
Slide 7: Levosimendan in PH-HFpEF
Levosimendan in PH-HFpEF = PH-HFpEF (pulmonary hypertension) represents a potential $Billion US opportunity = >2 million US PH-HFpEF patients = High mortality and poor quality of life = No effective therapies = Phase 2 Trial of Levosimendan in PH-HFpEF is ongoing (HELP Study) = Levosimendan is an NC
Slide 8: Pulmonary Hypertension Prevalence and Market Size
Pulmonary Hypertension Prevalence and Market Size Estimated Prevalence by WHO Group Pharmaceutical Sales >$5 billion in 2016 (primarily in Group 1) oe WHO Group 1 roup 5 3% 3% WHO Group 4 2% Pfizer $285M Bayer $279M Source: Pulmonary Hypertension Assocation Strange G etal. Heart. 2012;98(24:1805-11
Slide 9: PH-HFpEF Represents a Large Unmet Medical Need
PH-HFpEF Represents a Large Unmet Medical Need Estimated PH-HFpEF US Prevalence >2 Million Patients (1,2,3) PAH (WHO Group 1) PH due to Left Heart Disease| (WHO Group 2) PH due to Chronic Lung Disease (WHO Group 3) CTEPH (WHO Group 4) PH due to unknown causes (WHO Group 5) @ Misc
Slide 10: Poor PH-HFpEF Patients Outcomes
Poor PH-HFpEF Patients Outcomes PH-HFpEF + Right Ventricle Dysfunction Associated with Highest Mortality s S 2 J 3 € PH-HFpEF Patients Normal RV 8 & PH-HFpEF Patients w/ RV Dysfunction 20, Ps0.0001 0) : 1 1 : 1 1 2 3 4 Ss Years —— __PASP<47mmbg normal RV function ---- PASP<47mmHg RV dysfunction ———
Slide 11: Comparison of HELP Study to Other Multicenter Phase Trials in PH-HFpEF
Comparison of HELP Study to Other Multicenter Phase 2 Trials in PH-HFpEF Trial BADDHY MELODY DILATE HELP Sponsor Actelion/J&J Actelion/J&J Bayer Tenax Product Bosentan Macitentan Riocigaut Levosimendan Approved ADHF- Bie PAH PAH PAH/CETPH A Indication M Outside US Patients (#) 20 63 39 36 Design Ran
Slide 12: Levosimendan Mechanism of Action
Levosimendan Mechanism of Action Molecular targets Mechanisms of action Pharmacological effects Therapeutic effects Selective binding to the saturated form of cardiac troponin C Icium- Opening of sarcolemma Karp channels on smooth-muscle cells in vasculature Opening of mitochondrial Ky channels in c
Slide 13: Levosimendan and Active Metabolite; non-protein bound plasma concentrations
Levosimendan and Active Metabolite; non-protein bound plasma concentrations —-— Levosimendan —@— 0r-1896 Free plasma concentration (nM) 0 24 48 72 96 120 144 168 192 216 240 264 288 312 336 360 384 Time (H)
Slide 14: Levosimendan Phase 2 for PH-HFpEF
14 Levosimendan Phase 2 for PH-HFpEF =Multi-center, double-blind placebo-controlled study “Enroll 36 evaluable patients at 12-15 sites = PAP 235, PCWP 220, NYHA Class IIb/III, LVEF 240% =Primary Endpoints: = Change from baseline PCWP with bicycle exercise (25Watts) at Week 6 = 80% power to detect a
Slide 15: Levosimendan Phase 2 Study Design
Levosimendan Phase 2 for in PH-HFpEF Study Design Open-Label Lead-In Chronic Phase Week 6 24 hours 5 weeks Final Evaluation (0.1 ug/kg/min) -——* Levosimendan n=18 -—— > Responders _n=36 | weekly infusion through Week 5 Levosimendan —— L__4 enrolled patients Placebo n=18 ‘——» Non-Responders
Slide 16: Preliminary Open Label Data from the HELP Study are Very Encouraging
16 Preliminary Open Label Data from the Help Study are Very Encouraging = 85% Responder rate during lead-in infusion (23/27) = 23 Randomized patients (target 36) = Encouraging and consistent open-label hemodynamic improvements = Reduced PCWP = Reduced RAP = Reduced mPAP = Increased cardiac output =
Slide 17: A Positive HELP Study Would Represent a Breakthrough in PH-HFpEF
A Positive HELP Study Would Represent a Breakthrough in PH-HFpEF PCWP Change vs Baseline (mm Hg) BADDHY(1) MELODY (2) DILATE(s) Bosentan/J&J Macitentan/J&J — Riociguat/Bayer Rest PCWP Rest PCWP Rest PCWP — —— ee Previous Failed PH-HFpEF Trials HELP() Open-Label Levosimendan Rest PCWP HELP(s) Open-La
Slide 18: PCWP Pre vs Post Lead-in Infusion
PCWP mmHg 35 30 & 8 15 10 PCWP — Pre vs Post Lead-in Infusion Open Label Levosimendan Responders (n=22) PCWP Rest (legs down) 60 32 55 50 +29 28 « #0 = p3 E a5 1 2 2 30 Ly 8 25 16 20 15 10 i Pre-Levo Ml Post-Levo P<0.0001 PCWP Exercise (25 watts) i Pre-Levo Ml Post- Levo P<0.0000001 Data is from inv
Slide 19: RAP Pre vs Post Lead-in Infusion
RAP — Pre vs Post Lead-in Infusion Open-Label Levosimendan Responders (n=22) RAP Rest (legs'down) RAP Exercise (@ 25 watts) 30 é 27 , 743 25 0 35 20 30 2 rs E 15 25 S F3 20 10 1s ° 10 +3 oO 5 i Pre-Levo Ml Post-Levo Hi Pre-Levo Ml Post-Levo P<0.0001 P<0.001 Data is from investigator reported hemodyn
Slide 20: mPAP Pre vs Post Lead-in Infusion
mPAP -— Pre vs Post Lead-in Infusion Open-Label Levosimendan Responders (n=22) mPAP Rest (legs down) mPAP Exercise (@25Watts) 70 90 67 65 65 60 80 55 70 v0 Py 50 : i E 4s E 60 ¢ z = 40 € 35 50 30 40 ce 24 21 20 30 1 Pre-Levo Ml Post- Levo [i Pre-Levo Il Post-Levo P<0.007 P<0.006 Data is from investi
Slide 21: Cardiac Output
Cardiac Output Open-label Levosimendan Responders (n=22) Cardiac )output (L/min) 9.0 8.0 7.0 6.0 5.0 4.0 3.0 2.0 Cardiac Output Exercise(@25Watts) 14.0 Cardiac Output- Rest- (Legs Down) 8.6 712.8 12.0 10.0 ag ° Cardiac Output (L/min) ~ 6 4.0 2.0 1 Pre-Levo Ml Post-Levo @ Pre-Levo Ml Post-Levo P<0.00
Slide 22: Summary: The Opportunity for Levosimendan in PH-HFpEF
Summary: The Opportunity for Levosimendan in PH-HFpEF "Area of high unmet medical need = High mortality (up to 50% at 5 years) = Poor quality of life (poor exercise capacity) = No approved therapies in PH-HFpEF =Commercially attractive market = Large potential market - Estimated PH-HFpEF prevalence
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