Cadrenal Therapeutics, Inc. · NASDAQ:CVKD
Cadrenal Therapeutics — Investor Presentation (March 2023)
32 slides from Cadrenal Therapeutics's investor presentation, Mar 27, 2023
Slide 1: Cadrenal Therapeutics, Inc.
1 CREATE A COVER SLIDE Cadrenal Therapeutics, Inc. NASDAQ: CVKD March 2023
Slide 2: Cautionary Statement Concerning Forward Looking Statements
2 Cautionary Statement Concerning Forward Looking Statements This document contains forward - looking statements. In addition, from time to time, we or our representatives may make forward - looking statements orally or in writing. We base these forward - looking statements on our expectations and p
Slide 3: Agenda
3 UPCOMING MILESTONES CLINICAL DATA MANAGEMENT, PRINCIPAL INVESTIGATOR & SCIENTIFIC ADVISORY BOARD TECARAFIN OPPORTUNITY AGENDA
Slide 4: Cadrenal Investment Case
4 4 CADRENAL Investment Case 1. Based upon 2019 study, adjusted for inflation. CADRENAL THERAPEUTICS’ asset , tecarfarin POSITIONED FOR FINAL, CONFIRMATORY PHASE 3 STUDY to establish the indication of prevention of systemic thromboembolism in patients with end - stage renal disease and atrial fibril
Slide 5: Tailored Regulatory Pathway for Patients with ESRD + AFib
5 Tailored Regulatory Pathway for Patients with ESRD + AFib 5 Broad Label, All OAC Indications Broad Label, All OAC Indications With “Enriched Population” Orphan Drug Designation For ESRD Patients With AFib Regulatory Pathway For Tecarfarin 2006 - 2017 2017 - 2019 2019 - Current • ARYx Therapeutics
Slide 6: The Problem
6 6 THE PROBLEM No effective anticoagulant treatment options for patients with End - Stage Renal Disease AND Atrial Fibrillation ESRD + AFib
Slide 7: CKD or AFib increases risk of thromboembolic outcomes
7 7 The presence of either chronic kidney disease (CKD) or AFib increases the risk of serious thromboembolic adverse clinical outcomes, such as stroke and death Trevor Mace - Brickman et al, The Risk of Stroke and Stroke Type in Patients With Atrial Fibrillation and Chronic Kidney Disease, Canadian
Slide 8: Warfarin does not reduce stroke risk in ESRD
8 HR (95% CI) Normal Kidney eGFR≥90m L/m in/m 2 No anticoagulation 1.00 (ref) Warfarin treatment 0.57 (0.43 - 0.76) ESRD eGFR <15m L/m in/m 2 No anticoagulation 1.00 (ref) Warfarin treatment 1.18 (0.58 - 2.40) 8 Bonde AN, et al. Renal Function and the Risk of Stroke and Bleeding in Patients With Atr
Slide 9: Warfarin is difficult to control in ESRD patients
9 9 Warfarin (most common treatment) is difficult to control in ESRD patients due to metabolism via cytochrome P450 pathway 1 THE PROBLEM | No effective treatment options for patients with ESRD + AFib 14 11 18 36 0 10 20 30 40 50 eGFR ≥60 eGFR 45-59 eGFR 30-44 eGFR <30/Dialysis 1. Mandeep S. et al,
Slide 10: Most ESRD with AFib patients are not given warfarin
10 10 Despite the significantly increased risk of stroke in ESRD with AFib, most patients are not given warfarin due to the lack of evidence of benefit 1. Yoon CY, Noh J, Jhee JH, et al. Warfarin Use in Patients With Atrial Fibrillation Undergoing Hemodialysis: A Nationwide Popul ati on - Based Stud
Slide 11: Our Solution: Tecarfarin
11 11 OUR SOLUTION Tecarfarin PHASE 3, FAVORABLE SAFETY PROFILE TARGETS Different metabolic pathway than the most commonly prescribed drugs for the treatment of thrombosis and AFib • Established similar MOA to warfarin • Elimination from body was not affected by severe kidney dysfunction • Demonstra
Slide 12: Randomized Controlled Trial Shows Tecarfarin Well-Tolerated
12 600 Patient Randomized Controlled Trial Shows Tecarfarin is Well - Tolerated for Stroke and Thrombus Prevention, with Fewer Hemorrhagic Events 0 0 0 2 2 1 Ischemic Stroke Deep Venous Thrombosis Pulmonary Embolis Tecafarin Warfarin T ecarfarin treated subjects experienced fewer major hemorrhages t
Slide 13: Tecarfarin is Designed to be an Improvement to Warfarin
13 13 OUR SOLUTION Tecarfarin is Designed to be an Improvement to Warfarin Whitlock RP, Fordyce CB, Midei MG, et al. A randomized, double blind comparison of tecarfarin, a novel vitamin K antagonist, wit h warfarin. The EmbraceAC Trial. Thromb Haemost. 2016;116(2):241 - 250. doi:10.1160/TH15 - 11 -
Slide 14: Renal Failure Impact on Warfarin PK vs Tecarfarin
14 44 15 0 5 10 15 20 25 30 35 40 45 50 Warfarin Tecarfarin Percent Increase 20 - 8 -10 -5 0 5 10 15 20 25 Warfarin Tecarfarin Percent Increase/Decrease AUC t 1/2 Renal Failure Had a Significant Impact on Warfarin PK vs Tecarfarin Percent Increase in Exposure for Healthy Volunteer Subjects vs. Chron
Slide 15: Agenda
15 UPCOMING MILESTONES CLINICAL DATA MANAGEMENT, PRINCIPAL INVESTIGATOR & SCIENTIFIC ADVISORY BOARD TECARAFIN OPPORTUNITY AGENDA
Slide 16: Management Team
16 Quang Pham CEO & Founder Espero BioPharma Lathian Systems Genentech Marine Corps Douglas Losordo, MD Chief Medical Officer Cardiologist, Global Head of R&D Director, Longeveron, Inc. (NASDAQ: LGVN) CMO, KBP BioSciences, Inc. CMO, Caladrius Biosciences (NASDAQ: CLBS) Professor of Medicine, NYU Lan
Slide 17: Principal Investigator and Scientific Advisory Board
17 Principal Investigator and Scientific Advisory Board (SAB) Sean Pokorney MD, MBA Principal Investigator Cardiologist, electrophysiologist and researcher specializing in ESRD+AFib Duke University and Duke Clinical Research Institute (DCRI) SCIENTIFIC ADVISORY BOARD Christopher Granger, MD Professo
Slide 18: Agenda
18 UPCOMING MILESTONES CLINICAL DATA MANAGEMENT, PRINCIPAL INVESTIGATOR & SCIENTIFIC ADVISORY BOARD TECARAFIN OPPORTUNITY AGENDA
Slide 19: Planned Phase 3 Study: ACTOR-AF
19 19 Planned Phase 3 Study Expected to be the FINAL STUDY required to seek regulatory approval o ACTOR - AF Study Anti - Coagulation with Tecarfarin on Outcomes in Renal Disease and Atrial Fibrillation o Phase 3 | 492 patients o Randomized, Double - Blind, Placebo - Controlled Outcomes Study – Teca
Slide 20: Tecarfarin vs. Placebo in Patients with ESRD and AFib
20 Tecarfarin vs. Placebo in Patients with ESRD and AFib Randomized, Double - Blind, Placebo - Controlled (no active control) Tecarfarin Phase 3 Trial Design Randomization stratified according to VKORC1 status Tecarfarin (n = 246) Placebo (n = 246) 12 - month follow - up for Primary Endpoint of time
Slide 21: U.S. Annual Market Potential ESRD + AFib
21 21 *Based upon 2019 study, adjusted for inflation U.S. ANNUAL MARKET POTENTIAL ESRD + AFib Orphan Pricing $65 per day (WAC) | $23,400 annually if approved by the FDA 1 UP TO BILLION* $
Slide 22: Targeted Patient Commercialization Opportunity
22 22 Targeted Patient Commercialization Opportunity 1. Source: DaVita Inc. 2020 Annual Report A study utilizing the Fresenius Medical Care North America ESRD database reported that some patients on dialysis received off - label dabigatran or rivaroxaban shortly after their marketing approval in the
Slide 23: Tafamidis: Cardiovascular Orphan Drug Case Study
23 Tafamidis: Cardiovascular Orphan Drug Case Study 1. Vyndaqel contains the micronized meglumine salt of tafamidis, while Vyndamax contains the free acid form of tafamidis. VYNDAQEL® (tafamidis meglumine) and VYNDAMAX® (tafamidis) are novel oral cardiovascular drugs approved by U.S. FDA in May 2019
Slide 24: Cap Table & Insider Ownership
24 Cap Table Common Shares Outstanding 11,634,575 Preferred Shares Outstanding NONE Debt NONE Warrants - Underwriter 110,500 Stock Options Outstanding 1,100,000 Cap Table & Insider Ownership Insider Ownership (Common Stock) Named Executive Officers and Directors Quang Pham, CEO 6,300,000 Matthew Szo
Slide 25: Summary of Highlights
25 Summary of Highlights PORTFOLIO o Phase 3 orphan drug candidate with IP rights in North America, Europe, Australia, Asia and Africa o 7 - year U.S. orphan drug marketing exclusivity potential upon orphan drug approval R&D o Retrometabolic design eliminates or minimizes the CYP450 metabolism in th
Slide 26: Contact Us
26 26 CONTACT US Quang Pham CEO & Founder quang.pham@cadrenal.com Matthew Szot CFO matthew.szot@cadrenal.com
Slide 27: Agenda
27 UPCOMING MILESTONES CLINICAL DATA MANAGEMENT, PRINCIPAL INVESTIGATOR & SCIENTIFIC ADVISORY BOARD TECARAFIN OPPORTUNITY AGENDA
Slide 28: Retrometabolic Drug Design
28 Retrometabolic Drug Design Tecarfarin design: Metabolic clearance not hindered by the body by eliminating or minimizing its metabolism in the liver, thus avoiding the Cytochrome P450 (CYP450) pathway We believe this may allow elimination by large capacity and non - saturable tissue esterase pathw
Slide 29: Tecarfarin Phase 1 PK Trial in Stage 4 CKD Patients
29 Summary Table % change between Stage 4 CKD patients vs healthy subjects matched for each drug using a randomized crossover design (n=23) Tecarfarin (% change) (S) - Warfarin (% change) AUC +15% +44% C max +6% +7% t 1/2 - 8% +19% This study suggests that tecarfarin does not require any dose adjust
Slide 30: Tecarfarin Shows TTR Above Anticoagulation Control Threshold
30 Tecarfarin Shows TTR Above Anticoagulation Control Threshold 0% 20% 40% 60% 80% 100% Overall (N=607) On CYP2C9 inhibiting drug (N=179) On CYP2C9 inhibitor with genetic variant (N = 55) 72.3% +0.8% △ Warfarin (p = 0.51) 76.5% +7.0% △ Warfarin (p = 0.09) 72.2% +2.3% △ Warfarin (p = 0.15) Tecarfarin
Slide 31: Risk Factors Related to Our Business
31 Risk Factors Related to Our Business Our business is subject to several risks you should be aware of before making an investment decision These risks include the following: o Our success is primarily dependent on the successful regulatory approval and commercialization of our lead product candida
Slide 32: Glossary of Terms
32 Term Abbreviation Atrial Fibrillation AFib Area Under the Curve AUC Chronic Kidney Disease CKD Maximum Serum Concentration C max Chemistry, Manufacturing and Controls CMC End Stage Renal Disease ESRD Half Life t 1/2 International Normalized Ratio INR Journal of the American Medical Association JA
Cadrenal Therapeutics — Investor Presentation (March 2023) on 6ix