Conference Transcript - CVKD 2026-05-28

Robert Bloom, Analyst — Managing Partner, Lithium Partners

All right. Hello, everyone, and thank you for continuing to join us throughout the day here at the Lithium Partners Spring 2026 Investor Conference. My name is Robert Bloom, Managing Partner here at Lithium. And up next, we welcome Kadrenal Therapeutics, ticker symbol of CVKD on the NASDAQ, and the company's chief medical officer, Terry Ferguson. Terry, thanks so much for your participation today.

Terry Ferguson, Other

Thanks, Robert. It's really a pleasure to join you.

Robert Bloom, Analyst — Managing Partner, Lithium Partners

Fantastic. Well, we're going to do this in a bit of a quick 15-minute fireside chat session, try to get to as many topics as we can. Start with a high-level overview on the company.

Terry Ferguson, Other

So, Cadrenal Therapeutics is focused on advancing novel therapies for life-threatening immune and thrombotic conditions. Our current lead program is CAD1005, which is a first-in-class 12-LOX inhibitor that's intended for the treatment of heparin-induced thrombocytopenia, HIT, which is a deadly immune-mediated thrombotic disorder.

Robert Bloom, Analyst — Managing Partner, Lithium Partners

Talk really about how big a problem HIT is for everybody.

Terry Ferguson, Other

Yeah, HIT is a, you know, heparin is a parenteral anticoagulant that's commonly used in hospital. There's probably 12,000, 12 million people every year in the United States that have heparin administered. And there is a rare but devastating immune reaction to that. It's estimated that it occurs in about one in every 1,500 hospital admissions. It works out to probably between a half and 1% of people who have heparin administered have a reaction to it. And it's, you know, if you give enough heparin, you're going to see it. And I think that the important thing about HIT, it is that it is an incredibly devastating disease. It is something that It is associated with thrombotic events throughout the body, strokes, heart attacks, arterial occlusion, venous occlusion, amputation, even death. And in some series, up to about 20% of people, mortality is as high as 20%. So it is a real problem with people who receive heparin. It's rare, but it's devastating.

Robert Bloom, Analyst — Managing Partner, Lithium Partners

What does current therapy look like?

Terry Ferguson, Other

Current therapy for HIT basically revolves around administering anticoagulants. The problem with HIT is clots that form throughout the body. And the natural response to that, well, let's just give blood thinners. And let's give a blood thinner that's not heparin, so you're not reinforcing the problem. The problem with that is you're working downstream and you're treating the complications after they've happened and after this whole immune process has revved up. So direct thrombin inhibitors like argatriban and bivalirudin, DOACs, fondoparanox, a variety of other non-heparin anticoagulants are what standard therapy is now. But the simple fact of the matter is that what we have now is not good enough. There are still devastating complications that occur with HIT despite the use of anticoagulants. Now, talk a little bit about the LEAD program, CAD-1005. What does it do that others do not? Yeah, that's a great question. So CAD-1005 is a 12-LOX inhibitor, 12-lipoxygenase. And why 12-lipoxygenase is so important is that it's part of the signaling process around immune-mediated platelet activation. And the whole problem in HIT is that there is an immune response to heparin and that immune response starts to activate platelets. And then those activated platelets go on and release more factors and you create this vicious cycle. 12-LOX is important because it is the signaling pathway between the immune mediated receptors on the surface of the platelets and the whole platelet activation process. So you are turning off the immune response that engenders the whole HIT cascade.

Robert Bloom, Analyst — Managing Partner, Lithium Partners

Talk about how big this market is.

Terry Ferguson, Other

Yeah. In the U.S., it's estimated that somewhere between 240,000 and 280,000 patients every year have at least suspected HIT. The diagnosis of HIT is a little bit challenging because there's, if you will, a sequence of tests that are done. Once you suspect HIT, then it is absolutely crucial that you stop all heparin-containing products, administer whatever else you need to from a non-heparin standpoint. So the treatment of HIT is initiated when you suspect it. Then there are confirmatory assays that are sent out, the serotonin release assay. And again, SRA confirmed hit is probably around 50,000 patients per year in the United States. So it is not an insignificant problem, and there is a lot of attention being paid to it. The other challenge with HIT is not only the fact that it increases the rate of amputation, it increases thrombotic events. It increases mortality. It also substantially increases hospital costs. So that this is a problem that hospitals face. Once a patient has developed hit, you are now talking about at least $75,000 to $140,000 more in hospital cost as a consequence of all of these complications. So that from a marketplace, there is a lot of HIT out there and it is expensive. So that our estimates would be that for a revenue standpoint for this therapy in the treatment of HIT is somewhere north of a billion dollars. And I think that that sort of holds up as you look at the consequences of hospital costs and the opportunities to reduce greatly elevated hospital costs associated with HIT.

Robert Bloom, Analyst — Managing Partner, Lithium Partners

All right. You recently conducted an end of phase two meeting. Talk about the learnings from that meeting and what the registration pathway looks like going

Terry Ferguson, Other

forward here. Yeah, I think that right now we had a very successful recent end of phase two meeting with the FDA. We brought forward data from a phase two study that showed a very encouraging signal in the reduction of thrombotic events. And the path forward now looks like a single pivotal registration study that would involve about 120 SRA positive patients randomized in a blinded placebo-controlled trial that would be conducted in the U.S. and outside the U.S., and would probably involve enrollment over 18 to 24 months, so that the path forward from a regulatory standpoint is very clear as to what the population is, what therapies need to be used, and what the endpoints are. And again, a lot of the interesting discussion with the FDA revolved around what is the standard of care currently for HIT, and can this be overlaid on whatever people are using right now, which it's not working all that well, and the endpoints that you are looking for in this study. And we have, you know, the discussions with the FDA show alignment around a composite endpoint that looks at multiple thrombotic events, venous and arterial, embolic, non-embolic events, and a composite event that allows us to do a relatively small trial that is doable and is, a clear path forward. There's a lot of excitement in the clinical community about the first new therapy in HIT in more than 20 years and an opportunity to improve outcomes that are not good at present.

Robert Bloom, Analyst — Managing Partner, Lithium Partners

All right. Very good. I want to circle back on something you mentioned a moment ago, just about 12 locks, the importance of it. Are there sort of additional potential targets in other therapeutic areas for 12-LOX? Yeah, that's a great question. And I think that as

Terry Ferguson, Other

you look at 12-LOX, a number of companies looked at 12-LOX in the past, but were unable to develop a selective inhibitor. CAD-1005 is that selective inhibitor without off-target effects, interestingly, in HIT without an increase in bleeding complications. And this now, because of its importance in the immune signaling pathway, opens up a whole lot of other potential areas. Again, not to be distracted, HIT is the perfect indication for this because it is an immune mediated thrombocytopenia with high thrombotic events, but opportunities in the future for where 12 LOX fits in into a lot of potential immune signaling pathways. There's been preclinical work in type 1 and type 2 diabetes and obesity, opportunities to carry forward into acute kidney injury. So that there are a lot of potential areas, but our singular focus right now is on heparin-induced thrombocytopenia. And, you know, we're optimistic that once we show the benefits achievable with this, in this devastating thrombotic condition, there are a host of other opportunities that can be pursued in the future.

Robert Bloom, Analyst — Managing Partner, Lithium Partners

All right. Very good. I know we're sort of getting to the end of the time and it's pretty brief here, but anything that we may not have touched on that I think is important to share with the investors here?

Terry Ferguson, Other

Well, I think that the exciting thing about CAD1005 is its novel new mechanism of action. This is an opportunity to treat HIT in ways that have never been possible before. and it's now possible to address immune-mediated thrombocytopenia at its cause. You're not just treating the complications once they've occurred. You are interrupting the whole vicious cycle of platelet activation and thrombosis, and it's an opportunity to now work upstream, deal with the causes of that by targeting selectively a pathway that has a number of potential applications outside of this, but very encouraging opportunity for us right now.

Robert Bloom, Analyst — Managing Partner, Lithium Partners

All right, very good. Well, Terry, thank you so much for your participation in the conference here today. Thank you to everybody, of course, for watching. If there are any questions or anything I can do to assist, please send me an email. That's bloom, B-L-U-M, at lithonpartners.com. Of course, learn more about lithium make sure you visit our website and stay connected with us on linkedin so you can be alerted on future uh activities and events and webcasts such as the one here with quadrino so uh we hope everybody enjoys the conference has a great rest of the day Again, Terry, thanks so much for your participation.

Terry Ferguson, Other

Thank you, Robert.