Tenax Therapeutics, Inc. · NASDAQ:TENX
Tenax Therapeutics — Investor Presentation (January 2023)
24 slides from Tenax Therapeutics's investor presentation, Jan 4, 2023
Slide 1: Tenax Therapeutics Corporate Presentation
TENAX THERAPEUTICS January 2023 | 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 (Mo
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 of PH patients @ PH wlLeft Heart Disease (includes HFpEF) (WHO Group 2) @ PH wChronic Lung Disease (WHO Group 3) ™ CTEPH (WHO Grou
Slide 5: Estimated prevalence by screening
Estimated prevalence by screening echocardiography in adults of all ages in Australia is 9.4%. (J Am Coll Cardiol 2019;73:2660-72) Prevalence of pulmonary hypertension by echocardiography in adults over age 60yrs in the general papulation is 45%. (Eur Respir J 2022; 59: 2100832) Prevalence of pulmon
Slide 6: Commercially Attractive Markets with Significant Unmet Medical Need
Commercially Attractive Markets with Significant Unmet Medical Need TNX-201 (imatinib) -PAH (Orphan) TNX-103/102 (levosimendan) — PH-HFpEF Pulmonary Arterial Hypertension (PAH) Pulmonary Hypertension with HFpEF Market >$5B* Market > 1.5M US patients** (No disease-modifying treatments) (No approved d
Slide 7: Two Phase 3-Ready Assets with Compelling Clinical Data
Two Phase 3-Ready Assets with Compelling Clinical Data Phase 1 Phase 2 Phase 3 TNX-201 . IMPRES Imatinib CS 2023*** Release! +32M 6MWD (p=0.002) TNX-103 tees TNX-102 WHO Group 2 Complete > ee. Initiate 2023*** (Oral and SC PH-HFpEF Phase 2b Levosimendan) +29M 6MWD (p=0.03) +. Hoeper, Marius M, etal
Slide 8: TNX-201 (imatinib) Development Program for PAH
TNX-201 (imatini Development Prog for Pulmonary Arterial H (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 <> Smooth muscle cell ¢. x q k © Growth factors ee GROWTH FACTORS VESSEL PROLIFERATES INVADE THE VESSEL AND GROWS INWARD Because imatinib blocks the growth factors that cause the disease, it has the potential to halt progression and all
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 Adequate dose is critical (400mg) to achieve clinical efficacy Avoid excessive dropouts, mostly related to early-onset side effects ce, Gastrointestinal side effects are the most common, novel formula
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 Phase 1 comparative PK study conduct Phase 1 comparative PK topline results FDA Review of Phase 3 protoco
Slide 14: TNX-103 & TNX-102 (levosimendan) Development Program
TNX-103 & TNX-102 (levosimendan) Development Progr for Pulmonary Hypertensi Heart Failure with preserved Ejection Fraction (WHO Group TENAX
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-HFpEF has recently been described to follow this course: ( INCREASED VENOUS BLOOD VOLUME ) C INCREASED CENTRAL VENOUS PRESSURE D) ( INCREASED PULMONARY VENOUS PRESSURE ) C PULMONARY HYPERTENSION +) 15
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 Press
Slide 17: Levosimendan Improves Central Venous Pressure and PCWP
Levosimendan Improves Central Venous Pressure (CVP) and PCWP at Rest and with Exercise 50. Levosimendan Group Levosimendan Group Baseli |e— Baseline |—e— Baseline |—s— 24 Hr Levo Infusion |—=— 24 Hr Levo Infusion 3” E 30 E™ a 2 20. Es 3 o oO 10 O10 0. 0. Legs Legs 25 Legs Legs 25 Down Up Watts Down
Slide 18: Levosimendan Improves Exercise Capacity
Levosimendan Improves Exercise Capacity in PH-HFpEF Patients after 6 Weeks Effects on 6-minute walk distance p=0.033 ‘AG Minute Walk Distance (m) 3 0 $8 Placebo Levosimendan Dr. Barry Borlaug, The Mayo Clinic, global HFpEF expert: “...this is the first medicine that has actually improved 6-minute wa
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: 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) TNX-102: Patent granted January 2022 for subcutaneous administration of levosimendan in all medical conditions (expires in 2039) 02 TNX-103: Paten
Slide 21: TNX-103/102 Development Timelines
TNX-103/102 Development Timelines TNX-103 (Oral) FDA Review of Phase 3 protocol ?e Phase 3 initiation & enrollment” r TNX-102 (SC) SC Use Patent granted & @ Shape denotes a milestone * Tenax plans to proceed with a novel formulation into our single Phase 3 trial, pending the outcome of, USPTO examin
Slide 22: Commercially Attractive Markets with Significant Unmet Medical Need
Commercially Attractive Markets with Significant Unmet Medical Need TNX-201 (imatinib) -PAH (Orphan) TNX-103/102 (levosimendan) — PH-HFpEF Pulmonary Arterial Hypertension (PAH) Pulmonary Hypertension with HFpEF Market >$5B* Market > 1.5M US patients** (No disease-modifying treatments) (No approved d
Slide 23: Financial Highlights
Financial Highlights As of September 30, 2022 » Cash balance: $3.8 million » No debt » No material liabilities: only trade payables and office lease * Common shares outstanding as of January 04, 2023: approx. 2.3 million on a post-split basis Increase in shares outstanding in late 2022 was due to wa
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 » Potenti
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