Tenax Therapeutics, Inc. · NASDAQ:TENX
Tenax Therapeutics — Investor Presentation (April 2023)
31 slides from Tenax Therapeutics's investor presentation, Apr 13, 2023
Slide 1: Tenax Therapeutics Corporate Presentation
\ IERAPEUTICS ‘e Presentation
Slide 2: Safe Harbor Statement
Safe Harbor Statement Disclaimer Except for historical information, all the statements, expectations and assumptions contained in this presentation are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important fact
Slide 3: Tenax Strategy Reset
Tenax Strategy Reset Current Company Strategies/Priorities A Advance Streamline Transform : Execute Levosimendan Streamline Company Gain new IP for IV & Advance Levosimendan Focus on Execution Operations Oral Levosimendan in PH-HFpEF + Initiate first Phase 3 PH- * Focus on mission-critical * Prosecu
Slide 4: 2023 Strategy Reset Transforms the Tenax Value Proposition
2023 Strategy Reset Transforms the Tenax Value Proposition - New IP Transforms the Company » Potential new TNX-102 (oral levosimendan) IP protection expected to create substantial value - New Clinical Development Strategy: » Prioritize levosimendan development _pleatal Jor two sequential Phase 3 tri
Slide 5: Levosimendan IP Transformation
Levosimendan IP Transformation 2018 2019-2021 Levosimendan transformation Multiple Levosimendan patent based on paradigm shift ’ applications filed © PH-HFpEF vs HFrEF © Chronic PH vs Acute HF | * PH-HFpEF Use (IV) + PH-HEpEF Use (oral) ‘+ Outpatient vs Hospital/ICU | + SC Use/Formulation * SC/Oral
Slide 6: Multiple Patent Filings: Levosimendan Use in PH-HFpEF
Multiple Patent Filings: Levosimendan Use in PH-HFpEF Provides Potential Exclusivity Beyond 2040 IP Protection for Oral Levosimendan Use in PH-HFpEF would be Transformative (2002 T2023 [2024 [2025 [2026 [2027 [2028 [2029 [ 2030 | 2031 [_2032 | 2033 [2034 [2035 | 2036 [_2037 | 2038 [ 2039 [2080 [2001
Slide 7: American Heart Association: Call to Action
American Heart Association: Call to Action PH-HFpEF Represents a Large Unmet Medical Need AHA SCIENCE ADVISORY Elucidating the Clinical Implications and Pathophysiology of ment of PH and particularly pulmonary vascu- lar disease (which distinguishes functional pressure elevation from vascular dysfun
Slide 8: PH-HFpEF — A Very High Unmet Medical Need
PH-HFpEF — A Very High Unmet Medical Need - A devastating diagnosis with no approved therapy Progressive, relentless worsening over time Limits lifestyle to avoiding all levels of exercise Not a single treatment is even suggested by the current guidelines
Slide 9: Overview: Pathophysiology of PH with HFpEF
Overview: Pathophysiology of PH with HFpEF The venous circulation has now been discovered to be the source of the problem PH-HFpEF has recently been described to follow this course: ( EXCESSIVE VENOUS BLOOD VOLUME ) (INCREASED CENTRAL VENOUS PRESSURE (creasen PULMONARY VENOUS PRESSURE ) C PULMONARY
Slide 10: Levosimendan Mechanism of Action is Unique
Levosimendan Mechanism of Action is Unique Levosimendan is a unique K+ATP channel activator and calcium sensitizer’ No other drug shares these properties Levosimendan has strong vasodilatory effects on venous beds** Causes a marked reduction in central venous pressure (CVP) Causes a marked reduction
Slide 11: TNX-103 (levosimendan) improves CVP and PCWP at rest and with Exercise
TNX-103 (levosimendan) improves CVP and PCWP at rest and with Exercise in PH-HFpEF Patients 50, Levosimendan Group 59, Levosimendan Group |—e— Baseline |—e— Baseline 40|77—24 Hr Levo Infusion 40. |—s— 24 Hr Levo Infusion 3 3B = = E 30. =” a 2 20 & 20. = o oO 10 2 40 0 r 0. Legs Legs 25 Down Up Watts
Slide 12: Levosimendan IP Supported by HELP Study Discoveries
Levosimendan IP Supported by HELP Study Discoveries Levosimendan Improves Exercise Capacity in PH-HFpEF Patients after 6 Weeks 29 meter improvement on 6-minute walk distance p=0.033 ‘AG Minute Walk Distance (m) So $8 Placebo Levosimendan https://www.medscape.com/viewarticle/938671 Barry Borlaug, May
Slide 13: Levosimendan Efficacy in PH-HFpEF Is Unique
Levosimendan Efficacy in PH-HFpEF Is Unique All PAH Approved Drugs Studied in PH-HFpEF have Failed » Bosentan - (BADDHY Trial.) - FAILED in PH-HFpEF » “Six-minute walk distance (6MWD) did not change in the Bosentan group” » Macitentan - (MELODY Trial:) - FAILED in PH-HFpEF » “The mean treatment effe
Slide 14: Open Label Extension: Transition from IV to Oral Levosimendan
Patients in the Open Label Extension study of HELP were transitioned from IV to oral Levosimendan Previous IV Week 0 Week 2 Week 4 Week 6 Infusion (Office) (Home) (Home) (Office) 0.10 img QD img BID img TID ug/kg/min (41mg total daily (2mg total (3mg total Fun dose) daily dose) daily dose) evaluated
Slide 15: Improvements in Efficacy Measures in Patients Transitioned to Oral
Improvements in Efficacy Measures in Patients Transitioned from IV to Oral Levosimendan » 6MWD (exercise capacity) « Improved a further 7 meters - BNP/NT pro-BNP (measure of cardiac function) » Improved by 23% » KCCQ (patient reported symptoms) » Improved in 6 of 7 different domains TENAX 15
Slide 16: Clinical Development Strategy
Clinical Development Strategy: Advance Levosimendan in PH-HFpEF Prioritize levosimendan based on new IP in PH-HFpEF Long runway and lack of competition (recruitment) allows incremental development approach IP covers use in patients with PH-HFpEF (no approved therapies) - Address large, unmet need, a
Slide 17: FDA Guidance: Phase 3 Levosimendan Development in PH-HFpEF
FDA Guidance: Phase 3 Levosimendan Development in PH-HFpEF FDA meeting minutes record agreements on key details of potential Phase 3 program: + Two phase 3 trials (p<0.05) with 6MWD as the primary endpoint would be sufficient + Safety database requirement: 300 patients followed for 6 months, and 100
Slide 18: Leverage Phase 2b (HELP) Study Results to Design Phase 3
Leverage Phase2b (HELP) Study Results to Design Phase 3 Hemodynamic Entry Criteria (SBV Sox Fespnder fate 6MWD, 29m, p=0.03 1V-to-Oral Transition: improvement in Reduction) BNP, KCCQ, 6MWD Initial Phase 3 PH-HFpEF Trial Hemodynamic Entry Criteria Primary Endpoint = 6MWD ~152 patients, 90% Power, p<0
Slide 19: Levosimendan in PH-HFpEF Phase 3 Study Design
Levosimendan in PH-HFpEF Phase 3 Study Design (Initial Study) Double-blind final Randomization evaluation (12 wks + Levosimendan ——> _ : Open-label Screening —-_- 1:1 ratio laiceiroaiatan extension = Placebo —= Img oral capsule BID, Weeks 1-3; titrated to Img TID Weeks 4-12 Primary Endpoint: change
Slide 20: Projected Development Timelines-TNX-103 (Oral Levosimendan)
Projected Development Timelines-TNX-103 (Oral Levosimendan) Phase 3 PH-HFpEF Study Phase 3 Initiation e First Patient Enrolled eo Last Patient Enrolled e Topline eo
Slide 21: PH-HFpEF Market Assumptions
PH-HFpEF Market Assumptions ° PH-HFpEF Prevalence ° 6,700,000 Heart Failure patients in US (:, * 2% Annual Growth Rate (:) » 54% is HFpEF, with HFpEF proportion increasing to 60% by 2040 (1.2.3.2) » 50% of HFpEF is PH-HFpEF .(2,5,.5) 41) Tsa0, Connie W,, et al. "Heart disease and stroke statisties—2
Slide 22: PH-HFpEF Market is Large and Growing
PH-HFpEF Market is Large and Growing Estimated PH-HFpEF Prevalence in the US 2020 2030 Prevalence estimates based on published epidemiology data referenced in prior slide
Slide 23: Estimated Total Addressable PH-HFpEF U.S. Market in 2030
Estimated Total Addressable PH-HFpEF U.S. Market in 2030 2030 Estimated Addressable U.S. Market 2030 Estimated Addressable Patients S4.5 - 6.0 Billion * *Assumes only 35% of patients are addressable and the estimated Annual Value = $6-8K/patient (1) 41) Drugs.com. March 2023 Annual cost/patient bran
Slide 24: New Value Proposition for Investors
New Value Proposition for Investors Short-term and Long-term catalysts ° Short-term — Catalyst rich 2023 with multiple potential events » Patent Notice of Allowance for oral levosimendan use in PH-HFpEF IND (specific to oral levosimendan) approved » Phase 3 trial initiated » First patient enrolled »
Slide 25: TNX-201 (imatinib) for Pulmonary Arterial Hypertension
TNX-201 (imatinib) Development P: for Pulmonary Arteri: (WHO Group 1)
Slide 26: Overview of PAH: The Pathology
Overview of PAH: The Pathology As the pulmonary artery narrows, the pulmonary pressure increases.
Slide 27: Imatinib Targets the Pathophysiology of PAH
Imatinib Targets the Pathophysiology of PAH PAEC = pulmonary artery endothelial cell PASMC = pulmonary artery smooth muscle cell GF = growth factors BCR-Abl, PDGER, c-Kit PASMC proliferation and migration a 2 | SES imatinib blocks and reverses TENAX 7
Slide 28: Proof of Concept IMPRES Study
Proof of Concept IMPRES STUDY Imatinib is Proven Effective in Treating PAH The primary endpoint was change in Phase 3 Clinical Trial: 6-minute walk distance Imatinib Mesylate as Add-On Therapy for z ji 70 Pulmonary Arterial Hypertension: Results of the A ~ 604 + Imatinib — *P<0.05 Randomized IMPRES
Slide 29: Key Learnings from IMPRES Study Informed Phase IMPROVE
Key Learnings from IMPRES Study Informed Phase 3 “IMPROVE” IMPROVE Efficacy was established in PAH PAH VY 02 Adequate dose is critical (400mg) to achieve clinical efficacy 03 Avoid excessive dropouts, mostly related to early-onset_side effects Gastrointestinal side effects are most the common, novel
Slide 30: Imatinib-MR Remains a Very Attractive Therapy Compared to Sotatercept and Seralutinib
Imatinib-MR Remains a Very Attractive Therapy When Compared to Sotatercept and/or Seralutinib Sotatercept (STELLAR) vs. Seralutinib-inhaled (TORREY) vs. Oral Imatinib (IMPRES) Oral Imatinib (IMPRES) + 6-minute walk test + 6-minute walk test + Sotatercept increased by 8.5% + Seralutinib increased by
Slide 31: Tenax Investment Opportunity
Tenax Investment Opportunity * Therapeutic Focus - Pulmonary Hypertension PH-HFpEF (>1.5M US patients, no approved therapies) PAH (Orphan) » Pipeline- (2) Phase 3-Ready Products TNX-103 Levosimendan oral (First in class oral KATP Activator/Ca++ Sensitizer) for PH-HFpEF TNX-201 Imatinib (Modified Rel
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