Tenax Therapeutics, Inc. · NASDAQ:TENX
Tenax Therapeutics — Investor Presentation (January 2022)
33 slides from Tenax Therapeutics's investor presentation, Jan 24, 2022
Slide 1: Tenax Therapeutics Corporate Presentation January 2022
TENAX THERAPEUTICS January 2022 I Corporate Presentation www.tenaxthera.com NASDAQ TENX
Slide 2: Disclaimer / 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 factors that could cause a
Slide 3: Mission Statement
Mission Statement Specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, with an initial therapeutic focus on pulmonary hypertension
Slide 4: New Leadership and a Stronger Intellectual Property Position
New Leadership and a Stronger Intellectual Property Position Tenax Therapeutics underwent a transformation in 2021
Slide 5: Scientific Advisory Boards
Scientific Advisory Boards World Recognized Experts in Pulmonary Hypertension and Heart Failure TNX-103 & TNX-102 (levosimendan) consultants TNX-201 (imatinib) consultants
Slide 6: Tenax Therapeutics Investment Summary
Two therapies poised to have a major impact on patient lives Tenax Therapeutics Investment Summary Two Phase 3-ready Drug Programs Addressing Both Orphan and Large CV Markets with Significant Unmet Need TNX-201 (Novel, coated form of imatinib mesylate) - BCR-Abl, PDGFR, and c-Kit tyrosine kinase inh
Slide 7: Orphan Disease and Large Patient Population Markets With Significant Unmet Medical Need
Orphan Disease and Large Patient Population Markets With Significant Unmet Medical Need Extraordinary Market Opportunities Both PAH and PH-LHD with >50% five-year mortality rate*** PAH market >$5B*, yet no disease-modifying treatments Approximately 1.5M U.S. patients** with no approved drug therapie
Slide 8: TNX-201 (imatinib) Development Program for Pulmonary Arterial Hypertension
TNX-201 (imatinib) Development Program for Pulmonary Arterial Hypertension (WHO Group 1)
Slide 9: Overview of Pulmonary Arterial Hypertension (PAH)
The Disease: Overview of Pulmonary Arterial Hypertension (PAH) WHO Group 1 Pulmonary Hypertension Progressive, fatal orphan disease with no cure Large unmet clinical need with no disease-modifying treatments available * Vanderpool, Rebecca, et al., “Association Between Hemodynamic Markers of PH and
Slide 10: Overview of PAH: The Pathology
Overview of PAH: The Pathology As the pulmonary artery narrows, the pulmonary pressure increases.
Slide 11: The Solution: TNX-201 (imatinib mesylate)
The Solution: TNX-201 (imatinib mesylate) Overview of PAH Developed by Novartis as the first curative treatment of chronic leukemia (Gleevec®) Disease reversal demonstrated with imatinib in animal models of PAH convinced Novartis to seek approval
Slide 12: Imatinib Targets the Pathophysiology of PAH
PAEC = pulmonary artery endothelial cell PASMC = pulmonary artery smooth muscle cell GF = growth factors BCR-Abl, PDGFR, c-Kit Imatinib Targets the Pathophysiology of PAH
Slide 13: Imatinib is Proven Effective in Treating PAH
Imatinib is Proven Effective in Treating PAH Proof of Concept IMPRES STUDY Phase 3 Clinical Trial: Imatinib Mesylate as Add-On Therapy for Pulmonary Arterial Hypertension: Results of the Randomized IMPRES Study Results: After 24 weeks, the mean placebo-corrected treatment effect on 6-minute walk dis
Slide 14: IMPRES Study Provides Guidance for Phase 3
Proof of Concept Imatinib Efficacy and Safety Data From IMPRES Study Provides Guidance for Phase 3 14 04 IMPRES data demonstrated the critical dose of oral imatinib to achieve clinical efficacy, central to our Phase 3 protocol
Slide 15: Strong FDA agreement with our clinical trial design
Strong FDA agreement with our clinical trial design to minimize risks and increase likelihood of success (5/30/2019) New formulation development by Q4 to mitigate gastric intolerance FDA agreement for small single dose PK study Enriched enrollment design to increase treatment effect Patients screene
Slide 16: Other routes: the development risks of inhaled imatinib
2 companies pursuing inhaled formulations of imatinib are conducting Phase 1/2 trials based on unproven claims that this route will have advantages over the oral route Other routes: the development risks of inhaled imatinib . RISK: Whether it is possible for inhaled imatinib to achieve meaningful ef
Slide 17: Program Summary TNX-201
Program Summary TNX-201 (unique, modified-release imatinib mesylate) for PAH Single Phase 3 clinical trial for approval of a drug with established efficacy, planned to begin enrolling 2H 2022 FDA supports Tenax’ enrichment approach: increases efficacy, shortens trial duration, reveals durability Sub
Slide 18: TNX-103 & TNX-102 (levosimendan) Development Program for PH with Left Heart Disease
TNX-103 & TNX-102 (levosimendan) Development Program for Pulmonary Hypertension with Left Heart Disease (WHO Group 2)
Slide 19: Pulmonary Hypertension with Left Heart Disease Overview
Pulmonary Hypertension with Left Heart Disease WHO Group 2 PH is the most common type of PH in the world Progressive, relentless, worsens over time Limits lifestyle to avoiding all activity Not a single treatment is even suggested by the current guidelines Overview 3%
Slide 20: Two Major Forms Of Left Heart Failure
Two Major Forms Of Left Heart Failure Overview Systolic Heart Failure (failure to squeeze adequately) Approved Treatments include: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Mineralocorticoid Receptor Antagonists, Angiotensin Receptor-Neprilysin Inhibitors, If channel inhibitors,
Slide 21: Pathophysiology of PH-LHD
A re-focus on the venous side of the problem Overview: Pathophysiology of PH-LHD VOLUME OVERLOAD LOWER EXTREMITY EDEMA PULMONARY CONGESTION PULMONARY HYPERTENSION Recent studies have identified that the venous circulation is the target
Slide 22: Excessive blood in veins: central venous pressure is the target
22 This patient has excessive blood in her veins (elevated central venous pressure is the target).
Slide 23: Excessive blood in lungs: pulmonary venous pressure is the target
This patient has excessive blood in his lungs (elevated pulmonary venous pressure is the target) Normal Congested lungs
Slide 24: Remarkable Discoveries around TNX-103
Remarkable Discoveries around TNX-103 24 * Rich, Stuart, Burkhoff, Daniel, Pollesello, Piero, Papp, Zoltan. “Levosimendan-induced vendilation is mediated by opening of potassium channels.” ESC Heart Failure. 10.1002 (2021) ** Brener, Michael I., et al. "Changes in stressed blood volume with levosime
Slide 25: TNX-103 (IV levosimendan) Phase 2 trial design
TNX-103 (IV levosimendan) Phase 2 trial design Proof of Concept Open label lead-in phase to evaluate the effects of IV levosimendan on hemodynamics at rest and exercise after 24 hours Patients with an initial response were enrolled into randomized, double blinded treatment with once weekly infusions
Slide 26: Overview of the cause of PH-LHD
Overview of the cause of PH-LHD 26 The increase in PCWP during exercise (red) is the critical feature of PH-LHD that produces disability and death. No treatment has been able to prevent this. Exercise Hemodynamics Confirm the Diagnosis Marc A. Pfeffer, Amil M. Shah, Barry A. Borlaug. “Heart Failure
Slide 27: TNX-103 Improves CVP and PCWP at rest and with Exercise
TNX-103 (levosimendan) Improves CVP and PCWP at rest and with Exercise 27 Burkhoff D, Rich S, et. al. Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF. JACC Heart Fail. 2021; 9:360-370
Slide 28: TNX-103 Improves Exercise Capacity
in PH-LHD Patients after 6 Weeks TNX-103 (levosimendan) Improves Exercise Capacity Effects on 6-minute walk distance Dr. Barry Borlaug, The Mayo Clinic, global HFpEF expert: “…this is the first medicine that has actually improved 6-minute walk distance in any patient population with HFpEF…”,
Slide 29: HELP: One of 2021's most talked about publications in JACC: Heart Failure
HELP: One of 2021’s “most talked about” publications in JACC: Heart Failure Data on online attention according to Altmetric, who according to JACC score each article by original shares online and mentions picked up, from discussions on social media platforms such as Twitter and Facebook, research bl
Slide 30: Successful transition of patients from IV to Oral levosimendan
Successful transition of patients from IV to Oral levosimendan (TNX-103) 30 01 02 03 Patent granted January 2022 for administration of subcutaneous levosimendan (TNX-102) for use in PH-LHD and all other conditions in humans.
Slide 31: TNX-103 & TNX-102 Program Summary
TNX-103 & TNX-102 (levosimendan) Program Summary PH-Left Heart Disease has a high unmet medical need: Estimated prevalence in the US >1,500,000 Most prevalent form of PH worldwide No approved therapies FDA supportive of a single Phase 3 trial Efficacy demonstrated in Phase II attributed to levosimen
Slide 32: Projected Development Timelines
TNX-201 (oral, modified release imatinib) Projected Development Timelines OLE IV Tx IV-to-oral TNX-103 (oral levosimendan) oral * Tenax will proceed with a novel formulation into our single Phase 3 trial, pending the outcome of USPTO examination (est. 2H 2022) of Tena’ claims on oral levosimendan, s
Slide 33: Tenax Therapeutics: Investment Case
Strong FDA agreement with our clinical trial design to minimize risks and increase likelihood of success (5/30/2019) New formulation development by Q4 to mitigate gastric intolerance FDA agreement for small single dose PK study Enriched enrollment design to increase treatment effect Patients screene
Tenax Therapeutics — Investor Presentation (January 2022) on 6ix