Resverlogix Corp. (RVX) Earnings Call Transcript & Summary

Thank you for joining the 2026 Annual Meeting of Resverlogix Corp. Shareholders. The meeting will begin momentarily. [Operator Instructions]

Good afternoon, and welcome to the Annual Meeting of Resverlogix Corp. The meeting will now come to order. My name is Don McCaffrey, Chairman, President and CEO of Resverlogix, and I will chair today's meeting. Upon conclusion of the formal part of the meeting, I will provide a report on the company's activities. In order to ensure that the meeting covers the required business in an efficient manner, we have prearranged with designated shareholders to move and second the motions of business. With your approval, I ask Brad Cann to act as Secretary of the meeting and Donald Santini of Computershare to act as scrutineer. Before we proceed, I would ask Brad Cann, Chief Financial Officer of Resverlogix, to confirm receipt of the declaration of mailing and report on attendance of shareholders at the meeting.

Computershare has provided me with a declaration as to mailing indicating that shareholders of record on May 11, 2026, were mailed a copy of the notice of meeting and information circular, together with the accompanying form of proxy or the notice and access form and the form of proxy as the case may be. And I direct a copy of the declaration as to mailing to be kept with the records of this meeting.

Thank you.

The scrutineer has provided me with a report that shows that the shareholders present or represented by proxy at the meeting constitute a quorum for purposes of this meeting.

Thank you, Brad. I now declare the meeting regularly constituted for the transaction of business. With your approval, I recommend that the reading of the minutes from the prior Annual Meeting of Shareholders held on June 30, 2025, be dispensed with. If there are no objections, we will proceed. Anyone wishing to review these minutes should contact the company's Chief Financial Officer. Being no objective. The first item of business is to table the audited financial statements of the company for the year ended December 31, 2025, together with the report of the auditors. A copy of the December 31, 2025 audited financial statements and MD&A have been mailed to the registered shareholders and beneficial shareholders who responded to the mail list request form. The next item of business is to fix the number of directors to be elected at the meeting at 5 members. I will now ask someone to make a motion in this regard.

Mr. Chairman, I so move.

Mr. Chairman, I second the motion.

All those in favor, please signify by raising your hand. [Voting]

Opposed, if any? [Voting]

I declare the motion carried. The next item of business is the election of directors, and I declare the meeting open for nominations.

Mr. Chairman, I nominate Don McCaffrey, Kelly McNeill, Ken Zuerblis, Dicky To and Bradley Glass for election as directors of the company.

Thank you. Are there any other nominations? Is anyone opposed to closing -- the close of the nominations? [Voting]

If there are no further nominations, I declare nominations closed.

Mr. Chairman, I move that the persons nominated as directors of the company be individually elected as directors for the ensuing year.

Mr. Chairman, I second the motion.

All of those in favor of individually electing the nominees as directors of the company as aforesaid, please signify by raising your hand. [Voting]

I declare that I, Don McCaffrey, Kelly McNeill, Ken Zuerblis, Dicky To and Bradley Glass are the duly elected directors of the company, each to hold office until the next annual meeting or until their successor is elected or appointed, unless their office is either vacated in accordance with the company's bylaws. We will proceed with the appointment of auditors. I will ask someone to move that RSM Canada LLP, Chartered Professional Accountants of Toronto, Ontario, be appointed as auditors of the company until the next Annual Meeting of Shareholders at such remuneration as may be fixed by the Board of Directors and that the directors be and are hereby authorized to fix such remuneration.

Mr. Chairman, I so move.

Mr. Chairman, I second the motion.

All those in favor, please signify by raising your hand. [Voting]

I declare the motion carried. Termination of meeting. If there is no other business, may I have a motion to terminate this meeting. [Voting]

Mr. Chairman, I so move.

Mr. Chairman, I second the motion.

You've heard the motion. All of those in favor, please signify by raising your hand. [Voting]

Opposed, if any? [Voting]

I declare the motion carried. This Annual Meeting of Shareholders of Resverlogix is terminated. I will now proceed with the management presentation after a brief pause. All right. Welcome, everybody, to the Annual General Meeting Management Update. We'll be brief today, but we'll try to cover the essential points that have happened in the last 12 months and where we're headed. This is a forward-looking statement from the company, as usual, and an introduction to Resverlogix. Some of you listening may not know much about the company, but I am Donald McCaffrey, President and CEO. The company was formed in 2001 in Calgary, Canada and is traded on the Toronto Stock Exchange. With me is Brad Cann, CFO; and we have Dr. Ewelina Kulikowski, Chief Scientific Officer. To date, the company has raised over $500 million in its efforts to work on cardiovascular disease and diabetes. Our lead program is in Phase III, and it has the varied FDA breakthrough therapy designation. Apabetalone works in concert with other drugs, other diabetes drugs such as GLP-1s, SGLT2s, DDP-4s, ACE inhibitors and on. So it's a very lucrative potential. It has cardiovascular benefits in heart failure as observed beyond standard of care. Renally impaired patients and dialysis patients have also showed extreme benefit from this particular program. Now the lead candidate, a lot of people know about it already, but it is orally available. It's well tolerated. It demonstrates cardioprotective program -- benefits in our BETonMACE program, our first Phase III, synergistic benefits with combination drugs such as SGLT2s and it has been suggested GLP-1s going forward as well, which would be a nice new market for us. The priority indications for us are heart failure with diabetics and post-COVID condition. Post-COVID condition is something we're going to talk more about today and in more depth than we usually have. The robust intellectual property gives us protection until 2041. I already mentioned we have FDA breakthrough therapy designation. We have over 40 peer-reviewed publications, including some of the top publications in the world. That's Cell, Nature, JAMA. We have 2 or 3 new publications that will come out in the next 2 or 3 months as well. 4,200 patient-years of FDA testing has been done on safety. We're very, very proud of the safety. And in our post-COVID condition trial, you'll hear more about that today, it's even improved in those patients. And we have detailed proteomics and transcriptomics analysis. We'll be doing further work on that with our analysis of the post-COVID condition patients. This is an old slide that depicts what we were working on during that dreaded COVID-19 period, where we had effectiveness and extremely good effectiveness in early infection, pulmonary phase and hyperinflammatory phase. It seems that that has died out not completely, but the post-COVID condition, which is part of the overall program, is very active still. Apabetalone is targeting that particular window. We will reverse back into those other categories once this disease resurfaces, and it will resurface. 3 rounds of it have already happened with SARS-1, MERS-1, which is Middle East Respiratory, and COVID-19. It's not gone away, and we are ready for it next time it comes back. Now one of the key benefits of what we're working on, we're not trying to create Moderna here in some magical very lucrative, take 4 shots a year kind of program. We want to cure it. We want to fix it right away in a couple of weeks. So this isn't something that is going to take a patient on drug forever. We want patients on drug for a long time for the other conditions that are created. That's MACE, Major Adverse Cardiac Event. 70% increases in patients who've had COVID; heart attack, 40% increases in patients that have had COVID, stroke, heart failure. All of these are actively related to having had COVID. We've had a very good publication, probably our best ever in Cell that we're showing the benefits of our drug in these categories. Now we've been quiet, but we've been active with the apabetalone long COVID study. So post-COVID condition. Recruitment has been completed. Now I might add with a little smile and grin here that it was completed early. We were able to shut it down due to success. So we are moving it along quite fast now, and we will have final data out. I've seen the final data. And yes, I'm pleased with where we're going. Examination of baseline data has showed statistical power would be met at 150 patients. So we stopped at 150 patients. We've stopped in May, and our last patient in will be done in September. So we have less than 90 days, and this data will be out. This data is shareable under CDA with pharmaceutical companies, private investors, and that is a route that we will be following. We cannot disclose it today because if we do, we can't have publications and extra awareness. That's something that is worth waiting 90 days for. So if we were in the middle of COVID, yes, we would probably do it right now. But we're pleased with where we're going with this. And we had 3 different sites all in the Middle East. They were very ready and willing to have COVID testing still going on where most people shy away from it, don't even want to hear the word. However, they understand. They suffered through MERS. Rest of the world did not. They know it's already on the third round and headed for a fourth. They will be prepared and ready next time it comes, so will we. So we were able to work in Jordan, Saudi Arabia and United Arab Emirates. And if you can see my arrow, that happens to be Iran. And yes, it is very close to them. And yes, they have been bombed during this particular clinical trial. So in some respects, that might be an extra reason that it's kind of nice that the trial ended early. So I was over there at times and did see missiles and heard bombings. So, it's nice to move on to the success level of this. Now our clinical outcomes were measured on the new World Health Organization format. We use 2 different standards, one called PASS and one called LCIT, Long-COVID Impact Tools. Now COVID has been very hard to monitor for follow-up because -- let me go back a couple of slides here, because what's the patient? Well, they can be anywhere. They can be a MACE patient, heart attack, stroke or pulmonary. What's the symptoms? What's the biomarkers? So all kinds of COVID trials can range with the smattering of different biomarkers, results, impacts, but the World Health Organization decided, let's ask the patient. Are you well or not? How are your standards of professional life, your social life? So they've collected an approach of using patient monitoring, which I think is smart for something with this many potential medical biomarkers and tools that you could use in clinical trials. How are you ever going to standardize between one trial and another? So these are our key endpoints here. And we believe statistically, we're already there. That's why we've shortened the size of the trial, and we will see those numbers. They will change. We will see those numbers in September, October and very gladly get them out to the public. This sets us up for really moving this forward. To my knowledge, no other company has passed this standard yet. So this could be quite nice for us. Now what else can we do? Well, we can do a lot. We've planned for data collection. These are inflammation markers, COVID-19 markers, proteomics, transcriptomics and metabolomics. So there's a lot of information that comes out of this going forward. We have potential to understand the epigenetics of long COVID, something nobody else can do. We'll have blood samples nobody else will have. Detailed apabetalone treatment responses, mechanisms of action of how the SGLT2 combination is helping us out, very helpful in our patent strategy to 2041, identifying new novel pathways, further characterizing the PK/PD relationships, but also the application of these come in future trials, bolster future submission datasets to the FDA or EMA, strengthen our partnership discussions, and they can speed those up quite a bit. We can also start talking in terms of marketing to any agencies in the Middle East, in particular, who may be interested in stockpiling before any of this goes official, official. So we are doing all of that. That's part of my business trips over there. And going forward, I mentioned earlier about the safety -- data safety monitoring boards. We had to meet 3 times. And each time they agreed to proceed according to protocol, no changes. No new safety issues were identified with this drug. No cases of potentially discontinuing the study from liver function. No cases of ALTs over 5x upper limit. You may recall in BETonMACE2, we had the occasional ones, so do standard drugs like statins. And as far as that goes, the rate of elevated liver tests was 2.7%. Statins are 3.2% and our last trial was 6.4%. So the lower difference is mainly because these patients aren't as sick. And remember, in BETonMACE, they're in BETonMACE because they just had a heart attack or a major cardiovascular event. And as such, they got put on the drug. So they're already compromised health. These patients, post-COVID condition is no joke. Don't get me wrong. It's like having the flu every day continuously, annoying beyond belief. So to be able to terminate that is a very useful program. And it really helps us in our overall because here we are, we're talking about cardiovascular, chronic heart disease, diabetes. We're talking about the key factors of our main program and showing that it works in another indication as well. This is very, very helpful for us in valuation going forward. The rate of serious adverse events or SAEs were lower than BETonMACE. So -- and shorter study and duration of the less at-risk population is the believed reason there. So wrapping it up here a bit, the BETonMACE preparations, BETonMACE2 have all been focused around discussions with the regulators. As we have breakthrough therapy designation, we get their guarantees as to what will be approvable and when. We have a 300 event interim analysis with stopping rule in place. So again, this trial halfway through could be stopped for success. And based on BETonMACE1 results, I'm betting it will be. BETonMACE1 had a reduction of events of 63% with a p-value of 0.0002. That means 2 in 10,000 chance it can't be repeated. Well, what we're looking for here with our FDA-approved study is a 20% reduction in events. So at the halfway point on BETonMACE1, we were clearly over that. And now we believe we will do the same that p-values are very strong. Now one of the main indicators here, if you're looking at the first circle, BETonMACE, the blue is background of the average patient. Some of them were on SGLT2s, some are not. Some had CKD, kidney disease, some did not. So in the next one, we're overlapping to make sure our 2 strongest categories are highly represented in this trial. One, almost double the amount of CKD patients. Two, all patients will be on SGLT2s. So for us, we think we're in a very solid position to move this company forward over the next year or 2. And again, it all comes down to what we've talked about extensively is the financing path. We have been stuck in a bad life science market. And just this year, it seems to be breaking. There is a lot of large dollar financing taking place in biotech. As a matter of fact, it's expected to be a record year. However, most of that is VC-backed money supporting their current investments or their newest investments. So it hasn't trickled down to our level yet, but it could. Regardless, we're sticking with our plan of utilizing Zenith Epigenetics assets to further the ability to raise our own funds. This is a program I have been working extensively on in the last year, and it is coming along. I can't say what will happen with it, but I do have a very warm fuzzy feeling here. So that's where we are today. And I'd like to thank all the people who attended in person as well as those online. This particular presentation will be on our website for the next 30 days. So thank you very much. And any questions, we will have a small Q&A now. Thank you.

How many people in the BETonMACE2 trial?

7,000 [indiscernible] in the last trial.

[indiscernible] did get put through the WHO?

No, I think you sent me that. I read through that, and there are some real key flaws in that program. But that's part of why the WHO has tried to standardize everything. And really -- it really comes down to the patient. Is the patient -- does the patient believe they're healed. And in our case, we think we'll be able to show some pretty strong numbers there. Next question.

You said in regards to the long-COVID data that the pharma and I believe you said [indiscernible] investors will have access to some of this information. At that time, investors are they different than your existing shareholders?

Yes. I'm talking strategic critical investors that can move the company forward. So it's people that can get into a CDA, understand the science and support the company.

It was [indiscernible] million this year will support the company?

No. That doesn't cut it.

We have some questions from online.

Fire away.

So the first question comes from Jerry. Jerry asked, given management's continued confidence in the science, why do you think financing has continued to come primarily from insiders and related parties rather than strategic or institutional investors?

Well, my response to that would be, thank God, it has been supported. To me, it didn't matter where. But going forward, biotech has not been a great investment option for the last 5 years. It's been very low. Out of the 474 publicly traded biotech companies that do not have cash flow, the average drop in price is over 95%. So the institutional level that they're referring to has not existed. So thank God, we had some deep pockets to support us along the way. We have some new programs that hopefully will be announced soon that I think are equally as creative and very beneficial to the company.

Thank you. We have a question from Anthony who's asking, what about other molecules? Is there any potential for molecules develop beyond apabetalone?

There's plenty of potential for that, but we have struggled to keep moving forward with one molecule. So we actually had a meeting on that just yesterday. We will keep it on the front burner, but it takes realistic financing to go down that avenue.

Thanks, Don. There's a question from Alex here. Alex asks, it seems like the lines for financing BETonMACE2 keep getting pushed out longer and longer. At a certain point, is there a hard stop there? Is there a hard deadline?

I would say no until there's a replacement route that it could be financed. So the method we're using in trying to sell an oncology asset. The oncology asset over the last year has greatly improved and shown a lot stronger benefits and potential to the market. So along that path, we get closer and closer, just have to find the right company and the right timing.

Thank you. Another question from Jerry asking, given all of the encouraging scientific results we've seen over the past year, what specific milestones do you think remain before Resverlogix can really attract that -- the pharma partners or the investors that we need? Is there something specific?

Yes. I personally believe they're actually going to be related to the oncology asset where we can internally finance it. Trying to finance a 100 million-plus clinical trial as a penny stock is just not realistic. That's dilution suicide. So for us, the best way to move forward is to encourage the development of the oncology programs to the point that they're valuable, sought-after assets. And that's what we've been doing. We have some great partners on the Zenith Epigenetics side, in particular, Harvard's Dana-Farber Cancer Institute and Eli Lilly supporting our lead program in NUT carcinoma. And in NUT carcinoma, they've been able to increase clinical meaningful events from 0 to at least 60%. So we're moving along nicely, and that is a very nasty disease. So sooner or later, someone will step forward.

Ron asked a question that's a little bit along the same lines, but he's wondering if there are any interested parties lined up or in the hopper for that partnership role that you can talk about? And with all of the positive news in all of these studies, why do you think there hasn't been a large partnership -- sorry, a large pharmaceutical partnership as of yet?

I could say yes and no to the question in that, are they lined up? Yes. Can I discuss it? No. So -- and it's more than one. But each company has its own strict categories, like I'll use a few examples. Pfizer, if a single drug in a single indication cannot do $2 billion a year in sales, they're not interested. It makes no sense to me whatsoever, but it's their policy. Novo Nordisk, if a company's program is not primary data, they're not interested in it. So even though you have gold standard data that has FDA breakthrough therapy designation, an employee can get fired at Novo Nordisk for bringing that data forward. So we have to fit in all of these oddities. It's not that they're great smooth running companies that jump at opportunities. That's far from who we have to deal with here.

There's a question here from Steve related to the Zenith program. He's wondering if you can comment on the IND for ZEN-3694. Is there any updates on that front that you can talk about? The IND filing that was mentioned at the Zenith?

Yes. So Steve, that's basically -- so that we ourselves internally can take it forward into FDA filings instead of our partners at National Institutes of Health and National Cancer Institute. It's us driving the bus. So it's a very, very helpful program for us.

Sorry, just a couple more questions about financing that I think have been largely addressed here...

The financing questions are simple. There hasn't been financing for us or anybody for a very long time. It's loosening up quite nicely now. Companies like ours have worked on ways around it, selling major assets, which have to mature to a certain level before they're sellable. And we're in a good spot on all of that.

There's a question from Paul again on the Zenith asking about the $32 million private placement that was discussed during the AGM there. Can you comment on any progress on that front?

This isn't a Zenith meeting. But there is progress on all kinds of stuff going on right now, but that's inappropriate for this meeting.

And Daniel is asking, would you consider selling Zenith Epigenetics at a much lower price and accept no or less dividends for Zenith Capital in order to expedite BETonMACE2?

I would. We haven't had to, but I would consider it. I don't know if I'd consider it to the point I'd do it, but yes everything is considerable.

Great. And that's it for the online questions. Thanks, Donald.

Thank you very much for attending, everyone.

This concludes our live stream of the 2025 (sic) [ 2026 ] Annual Meeting of the Resverlogix Corp. Shareholders. We thank you for joining us. A replay of the event will soon be available on resverlogix.com under Presentations and Events.