Tenax Therapeutics, Inc. · NASDAQ:TENX
Tenax Therapeutics — Investor Presentation (September 2022)
24 slides from Tenax Therapeutics's investor presentation, Sep 20, 2022
Slide 1: Tenax Therapeutics September 2022 Corporate Presentation
TENAX THERAPEUTICS September 2022 | Corporate Presentation 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: Tenax Investment Opportunity
Tenax Investment Opportunity * Therapeutic Focus: Pulmonary Hypertension (PH) Pulmonary Arterial Hypertension (PAH): Orphan PH w/Heart Failure with preserved Ejection Fraction (PH-HFpEF): >1.5M US patients, no approved therapies » Pipeline: Two Phase 3-Ready Product Candidates ‘TNX-201 Imatinib (Mod
Slide 4: Pulmonary Hypertension: Large Addressable Market
Pulmonary Hypertension: Large Addressable Market World Health Organization (WHO) has Classified PH into 5 Groups* PAH (WHO Group 1) Tenax pipeline addresses the majority cad of PH patients m= PH wlLeft Heart Disease (includes HFpEF) (WHO Group 2) @ PH w/Chronic Lung Disease (WHO Group 3) @ CTEPH (WH
Slide 5: Pulmonary Hypertension is a Neglected Disease
Pulmonary Hypertension is a Neglected Disease: High Age-Associated Prevalence with Increased Mortality * Estimated prevalence by screening Mortality of pulmonary hypertension is a echocardiography in adults of all ages in continuum of risk and even borderline PH is Australia is 9.4%. associated with
Slide 6: Commercially Attractive Markets with Significant Unmet Medical Need
Commercially Attractive Markets with Significant Unmet Medical Need Extraordinary Market Opportunity TNX-201 (imatinib) - PAH (Orphan) TNX-103/102 (levosimendan) — PH-HFpEF Pulmonary Arterial Hypertension (PAH) Market >$5B* (no disease-modifying treatments) Pulmonary Hypertension with HFpEF Market >
Slide 7: Two Phase 3-Ready Assets with Compelling Clinical Data
Two Phase 3-Ready Assets with Compelling Clinical Data TNX-201 Mies : IMPRES Phase 2/3 Initiate in 2023 +32M 6MWD (p=0.002) TNX-103 (Oral and SC PH-HFpEF Initiate 2023 Levosimendan) +29M 6MWD (p=0.03)
Slide 8: TNX-201 (imatinib)
TNX-201 (imatinib) Development Prog (WHO Group 1)
Slide 9: Overview of PAH: The Pathology
Overview of PAH: The Pathology As the pulmonary artery narrows, the pulmonary pressure increases.
Slide 10: Imatinib Targets the Pathophysiology of PAH
Imatinib Targets the Pathophysiology of PAH — D> Endothelial cell vy, >| <DD> smooth muscle cell Ff oe y © crowth factors N y| vow NORMAL GROWTH FACTORS VESSEL PROLIFERATES INVADE THE AND GROWS INWARD VESSEL Because imatinib blocks the growth factors that cause the disease, it has the potential to h
Slide 11: 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 12: Learnings from IMPRES Study Informed Phase IMPROVE Design
Learnings from IMPRES Study Informed Phase 3 IMPROVE Design IMPROVE Efficacy was established in PAH 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 the most common, novel formu
Slide 13: TNX-201 (imatinib) Development Timelines
TNX-201 (imatinib) Development Timelines Precision medicine approach, built on the efficacy established in IMPRES TNX-201 (oral, modified release imatinib) TNX-201 tablet formulation development ri (it Phase 1 comparative PK study conduct @e Phase 1 comparative PK topline results e FDA Review of Pha
Slide 14: TNX-103 & TNX-102 (levosimendan)
TNX-103 & TNX-102 (levosimendan) Heart Failure with preser Ejection Fraction (WHO G
Slide 15: Overview: Pathophysiology of PH with HFpEF
Overview: Pathophysiology of PH with HFpEF A re-focus on the venous side of the problem PH-HFpFF has recently been described to follow this course: ( INCREASED VENOUS BLOOD VOLUME ) ( INCREASED CENTRAL YENOUS PRESSURE ) ( INCREASED PULMONARY VENOUS PRESSURE ) C PULMONARY HYPERTENSION +)
Slide 16: Overview of the Cause of PH-HFpEF
Overview of the Cause of PH-HFpEF Exercise Hemodynamics Confirm the Diagnosis The increase in PCWP during exercise (red) is the critical feature of PH-HFpEF that produces disability and death. No currently available treatments have been able to address the increase in Pulmonary Capillary Wedge Basel
Slide 17: Levosimendan Improves Central Venous Pressure and PCWP
Levosimendan Improves Central Venous Pressure (CVP) and PCWP at Rest and with Exercise Ae Levosimendan Group |—e— Baseline |—=— 24 Hr Levo Infusion Levosimendan Group |—e— Baseline |—s— 24 Hr Levo Infusion & 40. 20. 10. CVP (mmHg) 8 PCWP (mmHg) 8.8 TENAX mn
Slide 18: Levosimendan Improves Exercise Capacity in PH-HFpEF Patients after 6 Weeks
Levosimendan Improves Exercise Capacity in PH-HFpEF Patients after 6 Weeks Dr. Barry Borlaug, The Mayo Clinic, Effects on 6-minute walk distance posal ee expentt “...this is the first medicine that has actually improved 6-minute walk distance in any patient 1.033 peo.0s: population with HFpEF...”, H
Slide 19: Levosimendan: IV to Oral Transition Study
Levosimendan: IV to Oral Transition Study * Oral levosimendan was safe and well tolerated over a 6-8 week period in patients with PH-HFpEF who had been receiving IV levosimendan as an outpatient >2 yrs. + Following transition from weekly IV to daily oral levosimendan, modest improvements were observ
Slide 20: TNX-103/102 Development Timelines
TNX-103/102 Development Timelines Milestones TNX-103 (Oral) HELP Study OLE (IV to Oral Transition) SS HELP Study OLE- TNX-103 (Oral) Saaz a=! FDA Review of Phase 3 protocol od Phase 3 initiation & enrollment* rs TNX-102 (SC) ‘SC Use Patent granted e @ Shape denotes a milestone © Shape denotes a proc
Slide 21: Exclusivity / Intellectual Property Summary
Exclusivity /Intellectual Property Summary na TNX-201: FDA orphan designation granted for imatinib in PAH (Patent to be submitted for novel formulation) SE TNX-102: Patent granted January 2022 for subcutaneous administration of levosimendan in all medical conditions (expires in 2039) 02 0 3 TNX-103:
Slide 22: Commercially Attractive Markets with Significant Unmet Medical Need
Commercially Attractive Markets with Significant Unmet Medical Need Extraordinary Market Opportunity TNX-201 (imatinib) - PAH (Orphan) TNX-103/102 (levosimendan) — PH-HFpEF Pulmonary Arterial Hypertension (PAH) Pulmonary Hypertension with HF pEF Market >$5B* . cas Market > 1.5M U.S. patients** (no d
Slide 23: Financial Highlights
Financial Highlights Through 30 June 2022 * Cash balance: $7.2 million * No debt » No material liabilities: only trade payables and office lease * Common shares O/S, as of 30 June 2022: 25.2 million (as reported) * Common shares O/S, as of 15 Sept 2022: 29.8 million (recent primary investor warrant
Slide 24: Summary - Tenax Investment Highlights
Summary - Tenax Investment Highlights » Therapeutic focus on patients with high unmet need » Pulmonary Hypertension » Pipeline: Two Phase 3-Ready Products » TNX-201 » TNX-103/102 » Efficient Clinical Development Pathway » Both programs only require a single small Phase 3 trial for approval * Signifi
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