Tenax Therapeutics, Inc. · NASDAQ:TENX
Tenax Therapeutics — Investor Presentation (March 2022)
32 slides from Tenax Therapeutics's investor presentation, Mar 24, 2022
Slide 1: Tenax Therapeutics Corporate Presentation
TENAX THERAPEUTICS March 2022 | Corporate Presentation www.tenaxthera.com NASDAQ TENX
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: Specialty pharmaceutical company focused on cardio-pulmonary diseases
ent 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: Tenax Therapeutics underwent a transformation in 2021
Tenax Therapeutics underwent a transformation in 2021 New Leadership and a Stronger Intellectual Property Position New leadership at the Director level Five physician entrepreneurs on the Board of Directors New leadership at the Scientific Advisory level New leadership at the Executive International
Slide 5: Scientific Advisory Boards
Scientific Advisory Boards World Recognized Experts in Pulmonary Hypertension and Heart Failure TNX-103 & TNX-102 (levosimendan) consultants Sanjiv Shah, MD Professor of Medicine, Northwestern University Feinberg School of Medicine Director, Northwestern HFpEF Program, Bluhm Cardiovascular Institute
Slide 6: Two therapies poised to have a major impact on patient lives
Two therapies poised to have a major impact on patient lives & 5 TNX-201 (Novel, coated form of imatinib mesylate) - BCR-AbI, PDGFR, and c-Kit tyrosine kinase inhibitor Pulmonary Arterial Hypertension ss grams Addressing Both O Significant Unr with TENAX
Slide 7: Extraordinary Market Opportunities
Extraordinary Market Opportunities Orphan Disease and Large Patient Population Markets With Significant Unmet Medical Need TNX-201 (imatinib) TNX-103, TNX-102 (levosimenda: Pulmonary Arterial Hypertension (PAH) Pulmonary Hypertension Due To Left Heart Disease PAH market >$5B*, yet no disease-modifyi
Slide 8: Global PAH Market
$7,000,000,000 $6,000,000,000 $5,000,000,000 $4,000,000,000 $3,000,000,000 GLOBAL PAH MARKET $2,000,000,000 $1,000,000,000 $- US/EU5/JAPAN Market Estimate 2020-2030 Disease Modifying Agents have Potential to Drive Growth 2020 Tenax market estimates 2030 ™PDES Inhibitors Potential Disease Modifying A
Slide 9: TNX-201 (imatinib) Development Program for Pulmonary Arterial Hypertension
TNX-201 (imati Development Pr« for Pulmonary Arterial (WHO Group 1)
Slide 10: Overview of Pulmonary Arterial Hypertension (PAH)
Overview of Pulmonary Arterial Hypertension (PAH) The Disease: WHO Group 1 Pulmonary Hypertension 57% survival at 5 years* Large unmet clinical need Progressive, fatal orphan } \ with current | with no disease-modifying treatments available disease with no cure J \ therapies y * Vanderpool, Rebecca,
Slide 11: Overview of PAH: The Pathology
Overview of PAH: The Pathology As the pulmonary artery narrows, the pulmonary pressure increases. Company and Products Overview | March 2022 12
Slide 12: Overview of PAH: The Solution: TNX-201 (imatinib mesylate)
Overview of PAH The Solution: TNX-201 (imatinib mesylate) Considered one of the greatest breakthroughs Disease reversal demonstrated Developed by Novartis | | | as the first curative } \ in cancer research, treatment of chronic / \ operates by targeting / leukemia (Gleevec®) J key growth factors / |
Slide 13: Imatinib Targets the Pathophysiology of PAH
Imatinib Targets the Pathophysiology of PAH Endothelial disruption PASMC proliferation and migration PAEC = pulmonary artery endothelial cell PASMC = pulmonary artery smooth muscle cell imatinib blocks GF = growth factors BCR-Abl, PDGFR, c-Kit and reverses
Slide 14: Proof of Concept IMPRES Study
Proof of Concept IMPRES STUDY Imatinib is Proven Effective in Treating PAH 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 15: Proof of Concept
Proof of Concept Imatinib Efficacy and Safety Data From IMPRES Study Provides Guidance for Phase 3 Even though efficacy was established, Novartis withdrew the NDA and abandoned the patent for PAH Excessive dropouts in the IMPRES trial, mostly related to early onset side effects from imatinib, requir
Slide 16: Phase 3 Clinical Trial Protocol Design
Phase 3 Clinical Trial Protocol Design TNX-201 (unique, modified-release imatinib mesylate) for PAH Strong FDA agreement with Tenax’ clinical trial design to both minimize risks and increase likelihood of success: » Unique oral formulation: - Novel modified release formulation to minimize gastric ex
Slide 17: Other routes: development risks of inhaled imatinib
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 RISK: Inhalation is subject to unpredictable bioavailability, which varies f
Slide 18: TNX-201 Program Summary
TNX-201 (unique, modified-release imatinib mesylate) for PAH Program Summary * Single Phase 3 clinical trial for approval of a drug with established efficacy, planned to begin enrolling 2H 2022 + FDA supports Tenax’ protocol design: increases efficacy, reduces number of patients, tests improved form
Slide 19: TNX-103 & TNX-102 (levosimendan) Development Program for Pulmonary Hypertension
TNX-103 & TNX-102 (levosimendan) Development Progra for Pulmonary Hypertension Left Heart Disease (WHO Group 2)
Slide 20: Overview: Pulmonary Hypertension with Left Heart Disease
Overview Pulmonary Hypertension with Left Heart Disease PAH (WHO Group 1) @ PH with Left Heart Disease (WHO Group 2) @PH with Chronic Lung Disease (WHO Group 3) = CTEPH (WHO Group 4) PH due to unknown causes (WHO Group 5) WHO Group 2 PH is the most common type of PH in the world Progressive, relentl
Slide 21: Overview: Two Major Forms Of Left Heart Failure
Overview Two Major Forms Of Left Heart Failure Systolic Heart Failure (failure to squeeze adequately) Diastolic Heart Failure (failure to fill adequately) Approved Treatments: ACE Inhibitors, Approved Treatments: Angiotensin Receptor Blockers, Beta Blockers, In the last year, first 2 therapies were
Slide 22: Overview: Pathophysiology of PH-LHD
Overview: Pathophysiology of PH-LHD Are-focus on the venous side of the problem Recent studies have identified that the venous circulation is the target C VOLUME OVERLOAD ) C INCREASED CENTRAL VENOUS PRESSURE +) (ncreaseo PULMONARY VENOUS PRESSURE ) C PULMONARY HYPERTENSION +) ‘Company and Products
Slide 23: Remarkable Discoveries around TNX-103
Remarkable Discoveries around TNX-103 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 in pul
Slide 24: Proof of Concept Study: Phase 2 trial design
Hee. Proof of Concept STUDY TNX-103 (/V levosimendan) Phase 2 trial design Open label lead-in phase to evaluate the effects of IV levosimendan on af ml hemodynamics at rest and exercise after 24 hours ©) Patients with an initial response were enrolled into randomized, double blinded treatment with o
Slide 25: Overview of the cause of PH-LHD
Overview of the cause of PH-LHD Exercise Hemodynamics Confirm the Diagnosis A 40 The increase in PCWP during exercise (red) is the critical Ss feature of PH-LHD that produces disability and death. = 30 No treatment has been able to prevent this. E 20 4 2 40 0 Baseline FeetUp tmin Peak 1 min Exercise
Slide 26: TNX-103 Improves CVP and PCWP at rest and with exercise
TNX-103 (levosimendan) Improves CVP and PCWP at rest and with Exercise STUDY 0, Levosimendan Group 59, Levosimendan Group |—e— Baseline |—e— Baseline 40|7*—24 Hr Levo Infusion 40. |—s— 24 Hr Levo Infusion 3 2 E30 E 30. i = a 20 2 20 = = oO Oo 10 210 TENA 7 eieasese
Slide 27: TNX-103 Improves Exercise Capacity in PH-LHD Patients after 6 Weeks
TNX-103 (levosimendan) Improves Exercise Capacity in PH-LHD Patients after 6 Weeks Effects on 6-minute walk distance ‘AG Minute Walk Distance (m) $8 8 p=0.033 Placebo Levosimendan Dr. Barry Borlaug, The Mayo Clinic, global HFpEF expert: “_..this is the first medicine that has actually improved 6-min
Slide 28: HELP: One of 2021's most talked about publications
HELP: One of 2021’s “most talked about” publications in JACC: Heart Failure © | J AC. Best of 2021 ‘AYear in Review Heart Failure To highiignt our most popular content last year, we have compiled lists of the Journal's most read aftiles, most talked about articles as captured by Altmetric, most popu
Slide 29: Successful transition of patients from IV to Oral Levosimendan
Successful transition of patients from IV to Oral Levosimendan (TNX-103) Oral levosimendan showed further improved efficacy after 2 years in clinical measurements of 6MW, BNP and NT-proBNP, and KCCQ, confirming durability. SS Patent granted January 2022 for administration of subcutaneous levosimenda
Slide 30: 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 * Efficacy demonstrated in Phase 2 attributed to levosimendan’s unique, durable effect on venous circulation Patients safely transitioned to oral formulat
Slide 31: Projected Development Timelines
Projected Development Timelines TNX-201 (oral, modi ied release imatinib) 2022 a1 Q2 a3 a4 TNX-201 Tablet Formulation Development eS oa Phase 1 Comparative PK study conduct @ Phase 1 Comparative PK topline results 4 Phase 3 Initiation Sd TNX-103 (oral levosimendan) , Se 2022 OLE with IV-oral transit
Slide 32: Tenax Therapeutics: Investment Case
Tenax Therapeutics: Investment Case Two potential best-in-class therapies with Phase 3 programs expected to start in 2022-23 FDA has agreed both products are approvable with strong data from a single Phase 3 trial. These trials require 150-350 subjects enrolled, each. TNX-201 (imatinib) in Group 1 P
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