Good afternoon, everyone, and welcome to the Summer twenty twenty-four Investor Summit. We have here joining us today, Quang Pham, Chairman and CEO of Cardrenal Therapeutics, and we are thrilled to host him. So without further ado, Quang, over to you.
Thank you. Hello, this is Quang Pham. I am the founder and Chief Executive Officer of Cardrenal Therapeutics. I have personally worked on our lead product candidate, Tecarfen, since twenty seventeen. That makes it over seven years, and I'm especially excited to share with you today about the company's potential to help patients by introducing Tecarfen for patients specifically with implanted heart devices or those with rare cardiovascular conditions to better manage their anticoagulation with our drug candidate. Investment opportunity with you today. Next. First, I must remind you of our forward-looking statements, which I will be making. Next. All right, let's get right into it. Let's talk about Cardrenal Therapeutics. We are a biopharmaceutical company focused on our lead asset, Tecarfen, an enzyme anticoagulation blood thinner called Tecarfen.
We are late stage because Tecarfen has undergone extensive phase one and two and three trials in more than a thousand patients, and the Food and Drug Administration, the FDA, recognizing unmet medical needs, has designated our drug, Tecarfen, with multiple orphan drug and fast track designations. What is Tecarfen? Tecarfen is a vitamin K antagonist class, or VKA, that we are evaluating as a potential anticoagulation or blood thinner that may be safer and more effective in certain patients with implanted cardiac devices or rare cardiovascular conditions. The most common implantable cardiac device is the LVAD, the Left Ventricular Assist Device, which is a mechanical pump for patients with advanced heart failure. Once a patient gets an LVAD, they must be on a lifelong prescribed blood thinner to prevent blood clots, strokes, and heart attacks. Today, no anticoagulant is indicated or approved by the FDA for LVAD patients.
Most of them are prescribed a seventy-year-old drug called warfarin, formerly known as Coumadin, which many of you have probably heard of through your family or friends that have been on it. It is another vitamin K antagonist, but it is far from an effective and optimal and safe blood-thinning drug. Warfarin is famously known for its drug-to-drug interactions and its very challenging metabolism for those with chronic kidney disease, which unfortunately goes hand in hand with heart failure and other cardiovascular issues. Tecarfen was specifically designed to overcome many of the challenges that patients and their providers experience with warfarin. So we are here today because we firmly believe that Tecarfen has the potential to be a more stable and effective anticoagulant for LVAD patients over warfarin.
We are looking to investigate Tecarfen's superiority to warfarin in patients with end-stage kidney disease and atrial fibrillation at the same time, and those with implanted mechanical heart valves who have genetic resistance to warfarin are difficult to control therapeutically, time in therapeutic range, or TTR. That is the time that the patient needs to be in the recommended level of anticoagulation that can be inadequate with warfarin in patients with mechanical heart valves. Next, slide four. Let's do a review of Tecarfen. Tecarfen is the only anticoagulation in the world in development for patients with LVADs and other rare cardiovascular conditions. These are patients who are stuck on warfarin. They have to take an anticoagulant. They have to take a vitamin K antagonist, and the only one that's available is warfarin.
Because the DOAC class of drugs, or the Eliquis class of drugs, are not used and are not approved, and the factor elevens that are being developed today are not being tested in these patient populations, so anticoagulants have been big in the big pharma world for many years, starting with warfarin, brand name Coumadin. About twenty ten, a new class of drug came on the market to challenge warfarin, and they were called the DOACs, direct, acting or direct oral acting anticoagulants, the Eliquis class of drugs, that gave patients a better option for patients who need, you know, lifelong or chronic anticoagulation, but not all, not the patient population that we're focused on, those who are stuck on warfarin. Many of you are now probably familiar with the Eliquis and Xarelto from the endless commercials that are on the internet and on television.
But none of these drugs were not only tested, but ever approved by the FDA for patients with LVAD or certain rare cardiovascular conditions, such as end-stage kidney disease with AFib. Eliquis was after it was approved, Eliquis was studied in mechanical heart valve patients, but the clinical trial ended early when patients began to experience worse outcomes. Same with Eliquis and patients with end-stage kidney disease and AFib. A big study was suspended back in 2019 called the RENAL-AF. Finally, the Eliquis and Xarelto class of drugs will be going off patent soon, and they're prescribed for the larger anticoagulation indications. While use of the blood thinner for 20 million patients, warfarin is the one that's being prescribed because it's the only one available, but it has significant drawbacks. These patients have no other options.
That's why I refer to them as those who are stuck on warfarin. They often bleed too much, too often, and have impaired quality of life. And there are certain patient factors that make the controlling of the quality of anticoagulation very difficult. Age, weight, body mass index, and race, smoking status, existing medical conditions, drug-drug interactions due to taking multiple drugs to control, perhaps diabetes, high cholesterol, hypertension, and other diseases, genetic polymorphism, kidney impairment, and pharmacokinetic profile. And finally, the ability to manage dosing. So once you get on warfarin, it has to be carefully and closely managed by the providers, as well as have to be very attentive by the patients. The DOACs of the Eliquis, Eliquis class of drugs are not approved for these indications that we have received orphan drug designations and are pursuing.
There are no other FDA-approved alternatives for patients with these rare cardiovascular conditions. Tecarfen has a really great opportunity to fill this void in the marketplace, and that's why we're excited, our investors are excited, the team's excited, our key opinion leaders, our scientific advisory board. We're excited because we are doing something to make a difference when there is no alternative for these patients. Slide five. Let's not wait. Let's talk about the investment highlights for Tecarfen opportunity. We're extremely optimistic, not only about the near-term potential, but also the long term. So these are the key points. The current standard of care for these patients is sorely inadequate. High level of unmet need with no approved anticoagulation therapy for these rare cardiovascular conditions. That's an important point.
We spoke with physicians about this, and they are frustrated with the warfarin outcome and data, but yet there's no option, and the DOAC class of drugs did not solve these problems. The Tecarfen sounds like warfarin. Same class of drug, vitamin K antagonist, has the same proven mechanism of action. With phase 2/3 clinical data showing its effectiveness as a reversible oral anticoagulant, providing more stable anticoagulation across multiple key patient subgroups. This is what's so exciting. As mentioned, we announced in April, in addition to the orphan and Fast Track designation for Tecarfen for end-stage kidney patients who have atrial fibrillation, we received a second orphan drug designation for LVAD patients. These designations are very significant for several reasons, right?
First, the FDA provides incentives to companies that are developing treatments for orphan or rare diseases or conditions that affect less than two hundred thousand patients in the United States. These incentives include tax credits, but most importantly, seven years of market exclusivity from the date of approval and other benefits to accelerate our path to commercialization. Now, from a competitive standpoint, you may have heard or you will hear about the new class of anticoagulants called the factor elevens. They are in development, but a number of years away still, but they are not being studied or pursued in these orphan diseases or rare cardiovascular conditions that we are expected to fill the void in the years to come in these markets. Key opinion leaders and researchers and providers expect strong adoption of Tecarfen, given the gap and no alternative treatment for these patients and payers.
We've done the payer study. Expect access and coverage for Tecarfen for these patients. Putting this into context, it is very unusual for a company with our market cap in the large cardiovascular market with these four. These orphan drug designations to have only one trial to go before we put our new drug application together, send to the FDA for their consideration and review for approval. One pivotal trial or one phase three trial remaining. We have a very experienced management team that has commercially taken drugs to market, and we have an acceleration plan and value-added initiatives, which I'll share with you shortly, the composition of the team.
This includes working with our business development advisors and sharing with potential partners and letting them know the value of assisting and partnering with us to take Tecarfen across the end zones in completing this final requirement of a phase three. Slide six. So here's the leadership team, from clinical to commercial expertise to get Tecarfen to the market, underscoring our ability to not only accelerate the time to market. We are lean, we are focused, and we are building sustainable value for shareholders and new shareholders that are considering us. We have the skin in the game. As I said, I've been working on Tecarfen since 2017 and are very big shareholders ourselves. Both of our C-suite and our board are highly engaged and motivated to deliver. Slide seven. Our scientific advisors all have deep experience in cardiovascular drug development and commercialization.
Deep experience in cardiology, in the clinic, in research, as well as in kidney disease and specifically in anticoagulation drug development. Slide eight, please. These leading key opinion leaders have made the problem very clear. Certain rare cardiovascular conditions lack effective anticoagulation, which causes the clinicians, those who take care of the patients, to be very frustrated with the seventy-year-old drug warfarin, and the lack of data of the Eliquis class of drugs have been shown efficacy and safety to be used in these patients. This is a big problem. With LVADs, physicians have no choice except to put their patient on the seventy-year-old warfarin, despite getting state-of-the-art LVAD, such as the HeartMate 3 by Abbott. Knowing that there are high frequency of hemorrhagic events, such as strokes, caused by a brain bleed with warfarin and multiple dose adjustments, which are very frequent and common.
With the Eliquis class of drugs that are NOACs, the high reversal cost and time make them far from ideal solutions for these high-risk advanced heart failure patients. Therefore, the LVAD populations have always been excluded from DOAC studies and are not recommended in the clinical guidelines for this patient population. We feel that this is a very significant and underappreciated market opportunity. Newly published data from the ARIES trial, recently completed and funded by Abbott, underscores that warfarin and warfarin in combination with aspirin remain inadequate for controlling the measurement of the quality of anticoagulation, which is globally known as the time in therapeutic range, or TTR, in patients with implanted LVADs. The quality of VKA management, as measured by TTR, appears to correlate with, you know, the risk of bleed.
This data reinforces why timing is critical for Tecarfen to address a significant unmet need for patients with LVADs. In end-stage kidney disease and atrial fibrillation, the warfarin data shows that there is a higher risk of bleeding. Those adjustment challenges exist. They continue to exist, as well as drug interactions in patients with co-morbidities. And with the NOACs, the Eliquis, there is very limited evidence and no guideline and guidance and ambiguity in dosing recommendations. Slide nine, please. Abbott is the only maker of the LVADs in the United States at this point. The HeartMate 3 is considered the best LVAD ever, and this market, the LVAD market, is a double-digit growth market. Next. As I mentioned two slides earlier, the recent ARIES-HM3 study in the HeartMate 3 with warfarin versus warfarin and aspirin.
Recent clinical evidence published late last year and presented earlier this year documented the consequences of suboptimal anticoagulation with warfarin in LVAD patients, those with the HeartMate 3 by Abbott. Abbott was the sponsor. Time in therapeutic range, or TTR, correlated directly with clinical outcomes, and the FDA has accepted TTR as a proxy for clinical outcomes. Let's go to slide 11 and look at the ARIES-HM3, HeartMate 3 study. The ARIES-HM3 study. Abbott has shown its leadership and its caring for patients in sponsoring and executing this study, which is very important learning for us as we have announced an initiation of a collaboration with Abbott to advance Tecarfen. The rate of severe bleeding events significantly increase with uncontrolled TTR, time in therapeutic range. Next. The solution, Tecarfen, is an elegant solution to address these significant problems.
We're aiming to overcome warfarin's major challenges and fill the market void still left by the DOACs. Those patients stuck on warfarin. The current treatment are unreliable, challenging to control, metabolize through the CYP450 pathway, and have significant variability in their pharmacokinetic profiles. Tecarfen was specifically designed to address these challenges with this differentiated metabolism, thereby decreasing the risk of stroke and bleeding while providing a reliable and stable PK profile. Tecarfen's rational metabolic drug design provides for a more stable anticoagulation than warfarin, thereby decreasing the risk of stroke and bleeding, which has been proven in eleven clinical studies and over a thousand subjects.
Unlike warfarin, Tecarfen is metabolized by tissue esterases throughout the body, so it is not metabolized by the cytochrome P450 system, thereby avoiding the CYP450-mediated drug-drug or drug-food interactions, as well as genetic variations that have plagued patients for decades. Next. Given these advances from the current standard of care, Tecarfen, Tecarfen potentially represents an attractive market opportunity with a robust addressable market of $2 billion just in the U.S. alone. Next. The Tecarfen development pipeline on the screen here demonstrates an accelerated pathway to commercialization, with two of our programs involving receiving orphan drug designation and one getting the Fast Track designation. So the end-stage kidney disease with AFib has Orphan and Fast Track. The LVAD program has Orphan. Future milestones include trial initiation and enrollment, data readouts and publications, as well as updates on strategic partnership opportunities.
Next. Why do we believe that Tecarfen could be successful in the LVAD patients? Obviously, it comes from this key study, a phase 2/3 study with Tecarfen versus warfarin, and Tecarfen showing stable anticoagulation with greater than 72% of time in therapeutic range, or TTR overall, across multiple subgroups of patients. This was a large, well-controlled study of 607 patients. Tecarfen demonstrated numerically fewer major bleeding events compared to warfarin and no thrombotic events. Next. A financial summary of Cardrenal Therapeutics. We are exploring strategic partnership, as I had mentioned, prior to entering our phase 3 clinical trials for each of the indications that we have talked about. Cardrenal has no debt and a simple capital structure. We used approximately $3.4 million in operating activities during the first half of 2024.
The insiders own a large portion of the company, 47%. I am the largest shareholder, and incentives are aligned with all shareholders. Next. So why Cadrenal now? We believe we offer an underappreciated investment opportunity today. Our data has further validated that the current standard of care and the new class of drugs fail to achieve stable anticoagulation. We are aggressively pursuing business development opportunities, meetings, including our announcement recently regarding our discussions with Abbott, the sole maker of LVAD in the United States, who has a deep interest in also funding the ARIES-HM3 trial. The MFR is clear: the FDA has not approved a drug for these indications. They're just using warfarin because they need to, and they're stuck on warfarin, even though it's not approved for LVAD patients, and the DOAC class of drugs are contraindicated. Tecarfen has been de-risked.
Once again, eleven clinical trials, over a thousand patients, safety database, has a proven mechanism of action with well-supported efficacy and improved safety profile, an accelerated regulatory pathway with Orphan and Fast Track designations, making Cardrenal Tecarfen one study away from review and approval consideration by the FDA, then on to commercialization. A $2 billion commercial market in the United States alone that has seven years of exclusivity, potentially from the date of approval, led by a seasoned team of drug development through commercialization, and we do have several catalysts in the near term as well. Last slide. Here's how you can reach us. Here's how you can reach me directly. Thank you for listening and for your time today.
Thank you very much. This does conclude today's conference. You may now disconnect. The next session will begin shortly. Please consult the conference agenda for the next presenting company. Thank you.