Brad, over to you.
All right, thanks. Yeah, a great overview. A lot to dig in there. I think I want to start at the higher level, and actually, we can do that by I want to have you kind of explain the AI and what that has to do with the business, the way it develops, the way it helps the efficiency of the company and the development of these treatments, b ut also there's some great news this morning that was just released that you can talk about during that response.
Yeah.
And that one of your platforms has another update. I want to just kind of start there because that, I think, is at the core of what you guys do.
Yeah. No, happy to, Brad. A nd as you say, it is the core of what we do, right? That's what the company was founded based upon. We were founded, as I said, as an AI-first company, and then we have been building all the other capabilities around the platform. And as I say, we have two parts of the business. One is the cancer and the other is the infectious disease side of things.
In essence, this is about being fast and being effective in terms of developing novel vaccines. For instance, if you look at the infectious disease side of business, reverse vaccinology, it takes three years to identify a vaccine target, and then actually, many of those targets identified with reverse vaccinology, they turn out not to be effective targets. With our AI immunology platform and the two modules we have for infectious diseases, we can actually design and discover a target in just 24 hours, i.e., significantly faster than what you do with conventional methods.
What's also important is we can also discover targets which you can't find with conventional methods. We have shown how we can outcompete reverse vaccinology. A nd this is only possible because of the high amount of data that we have been collecting, the training of our AI model, that we have been enabling a high degree of predictability and ability to predict and select the right targets.
Then the cancer side of the thing, of the business, then we're talking about personalized cancer vaccines. And here, of course, if you have to design a cancer vaccine for the individual patient, then speed is of essence. When you get cancer, you want to have a therapy as quickly as possible, and if you have to spend a lot of time in designing a therapeutic with conventional methods, then that's not gonna enable an effective therapy for cancer patients.
With our PIONEER model, which is the prediction model we're using for cancer, we also here in 24 hours can identify the exact right targets that needs to go into a personalized cancer vaccine. So in essence, it enables speed, it enables high degree of accuracy, and it enables predicting and selecting the right targets.
And that links back to the news that we had out today, which is around the platform which is called or the model which is called EDEN, which is a model we use for bacterial infectious diseases. We have just today, at a conference in Finland, launched an upgraded version of this EDEN model, aiming at one thing, being able to predict the right targets even better but also being able to predict toxins. Toxins are a very important target for infectious diseases or bacterial infectious diseases, and now we have expanded the model to also cover this target.
That's what we have been doing during the past 15 years. We have constantly been developing and maturing the models and actually also spending a lot of time on validating the model both from a clinical point of view but also from preclinical point of view. It is about doing these constant learning loops where you feed the model with new data, with proprietary data, with public data, with the objective of increasing the predictive capabilities of the model.
Yeah. A nd that's I think I want to go back to something you said at the beginning and just point that out, that this company isn't just from the last year or two when the AI has really gotten a lot of press. This is 14 years ago, and these models have been developed, and like Christian said, that's they learn. We all know that, AI models, one of their features is that they learn from going through these things.
So they've had 14 years of experience and data and everything else, s o I do wanna. There's two questions on this, and then we'll get to more specific treatments, b ut one is: S o with partnerships, is that, since you have a lot of data already in there, are other companies looking to use your AI models? Are they looking to use your data? Are you looking to combine data? Are they looking to run their data through your model? Is there? O r how is that, or is it all of the above?
I would say the main interest we're seeing, and that's also where we're focusing, is twofold. It's either on new target discovery collaborations, just as the one that we have with Merck, where we are using our platform to discover and design new vaccine candidates.
Again back to your point from just before that we have been training and working with the model for many years, and also on top of that, as I also said in the beginning, we do have our own lab. We do have our own animal facility. That also means that we have a very efficient process for generating our own proprietary data.
Whenever the AI team makes some predictions for a novel vaccine candidate, we can go straight into the lab, design the vaccine. W e can go straight into the animal facility and test it out. A nd that has meant that we have this process where we are able to, on a continuous basis, to feed our models the new proprietary data.
A nd that is also what attracts potential partners, that we can be a one-stop shop from the early discussions around a given infectious or a bacterial or a viral infectious disease to discovering a possible target against that and doing all the early development. So that, we're seeing interest from partners in target discovery collaborations.
I think it's also fair, Brad, to say that we are seeing a lot of interest from potential partners in our existing pipeline assets, which are all AI-derived vaccine candidates; as I said, clinical- stage cancer pipeline; and a super exciting preclinical stage infectious disease pipeline.
So it's fairly broad-based, the interest, but I mean we are not as such looking to partner around the data itself. I mean we have, of course, a number of collaborations around data, but it is around the vaccine candidates and all the discovery of novel vaccine candidates that we're focusing from a partnership point of view.
Okay, great. And last question, on the broader AI models. Have you had or has your company had or do you know of discussions with the FDA that would, because of the capabilities of AI, maybe shorten the approval process or, yeah,
I mean [crosstalk].
Require less human trials or something like that, anything like that?
Yeah. I mean we have had multiple discussions with regulatory authorities in different parts of the world. Also, of course, given the fact that we are running EVX-01, that's being run in both Europe and in Australia, just as we have a Fast Track designation from the FDA. So as such, I don't see it necessarily shortens the development of, say, a phase III trial, but there's a lot of interest also from regulatory authorities in how to encompass AI within the current regulatory framework.
I think the general view is also that this is going to be the future, s o we need to make sure that we account for that also from a regulatory point of view, b ut I think, the fact that we have the FDA Fast Track designation for EVX-01, that also shows that, I mean, there's not a concern from, for instance, FDA as to this AI-derived vaccine candidate.
Yeah, the FDA is sometimes slow to come around to these things, but I'm glad you're kind of in the cutting edge of letting them know what's going on, y eah. Any investor that's listening that is involved with this knows that's an understatement, y eah.
S o you've mentioned it a couple of times. S o I kind of don't want to, I've kind of buried the lead here, but there's really exciting news that, from testing, getting more granular and specific treatments that you've had. So do you want to detail the announcement from earlier this week, late last week on EVX-01 and tell investors what that means?
Yeah. No, be happy to. And just to recap, EVX-01, that's our lead candidate. It's a personalized neoantigen vaccine which is in phase II development for metastatic melanoma. And you should see metastatic melanoma, as the first indication, that the concept of a neoantigen-based cancer vaccine would be applicable in many solid tumors.
And then here we have conducted a phase I/II trial, which we reported out last year, which actually showed a very strong data. We had a 67% overall response rate in that phase I/II trial. And we had a strong immune response across the different patients.
Of course, with so strong phase I/II data, you're always a little bit concerned going into your phase II trial and having the first clinical readout, which we presented at a conference in Barcelona this Saturday, but w e actually saw a 69% overall response rate in this phase II trial at the one-year readout, i.e., even better than what we saw in the phase I/II trial. So very encouraging data.
What we also did see is that we saw, in 15 out of the 16 patients, we actually saw a reduction in tumor size. I would say, very strong data which confirms that the concept of a personalized vaccine designed for the individual patient, based upon new antigens, holds up. Of course, you can say, still a smaller population with about 16 patients. For regulatory purposes, you will need a much larger randomized controlled trial, but t his is very strong data indicating a high commercial potential of the EVX-01 in metastatic melanoma.
Yeah, it was great news. A nd yeah, people suffering from cancer are desperate for that great news, so always good to see. Let's see, where do we want to go next? Well, I guess you've had some also some good news recently with the EVX-B2 mRNA vaccine. Do you want to kind of outline that? And the
Yeah.
I believe there's the partnership with that.
Yeah, no, I'd be happy to. That's news we had out mid last week. EVX-B2, that's our preclinical vaccine candidate against gonorrhea. And let's just remind ourselves here that there are no approved vaccines against gonorrhea today, and it is a growing health problem across all parts of the world.
We, in late 2023, entered into a collaboration with South African company Afrigen Biologics to take our peptide-based EVX-B2 vaccine and test it out in an mRNA construct. And what we presented last week was a preclinical proof of concept for the vaccine candidate in an mRNA construct. And if you ask, why is this important? This is important because it shows that our platform, the targets, or the vaccine components that predicts, is working independently of the delivery modality you have.
We already showed the proof of concept or preclinical proof of concept for EVX-B2 in a peptide-based vaccine, and now together with Afrigen, we showed the preclinical proof of concept in an mRNA-based construct. And that confirms that our platform is delivery modality agnostic, i.e., it doesn't matter which delivery modality a potential partner prefers. The targets that we are predicting and selecting based upon the model can be applied in any delivery modality.
And that's of course important when you look at different preferences there are among potential different partners. Some prefer mRNA. S ome prefer DNA. A gain, others prefer peptide-based. So, strong confirmation of the, say, scalability of our AI immunology platform. So very exciting data to get out as well.
Yeah, definitely. Yeah, we're almost out of time. I don't want to bury this because this is a rarity. I cover biotechs, and you might not have heard, but Evaxion's goals. Why don't you talk a little bit about the financials? Everybody's interested in cash burn a nd those kind of things at a company your stage, b ut I thought I heard you say that you're trying to be cash neutral here this year. A nd so if I heard that right, confirm that.
Yeah.
And talk about cash on hand and how you're generating more of it.
Yeah, that's correct, b ut I mean our ambition for 2024 is to generate business development income or getting cash in equal to our annual cash burn. And this would also be a major milestone for the company given that we, for the past many years, have been, of course, a cash- burning company.
But given the strategic pivot we made towards the end of last year and have been focusing on and accelerating and executing upon this year, where we are saying, "Okay, let's monetize on some of the exciting assets we have at hand. Let's partner these." With that come the ambition of being cash neutral. And we have an annual cash burn of around $14 million, and that's what we have the ambition of generating in income.
You can say, of course, business development is always uncertain. Do the deal materialize or not? So it is an ambition, but I say, with the strong interest we're seeing from pharma and other potential partners in our platform and in our pipeline, we see it's a stretched but still realistic ambition. So that's what we're looking to achieve.
And going from being cash consuming to cash neutral would, of course, be a significant milestone for a company like us. So we are executing very hard on our different business development activities in terms of bringing in partners who can take on the assets and bring those forward, w hile we, of course, have a unique ability to bring new assets into the pipeline with the AI immunology platform, where we quickly can discover novel vaccines and bring into preclinical development.
Yeah, thank you. I, I guess, said at the beginning that it's just great to see a company that's using AI for beneficial things. A nd it's really transforming the way that you develop, and I think this is gonna be the wave of the future. And Evaxion is at the cutting edge of this. We are almost out of time. Are there any last words you want to say to investors, leave them with some message about the company?
I would say that, I mean, we are a pioneering TechB io with a truly novel and novel personalized cancer vaccine in phase II. We have the validation of our platform and what we do by having MSD in as both a R&D partner but also as our single largest shareholder.
Then on top of that, we are at what you call a financial pivot in the Evaxion journey, in the sense that it's now we have shifted focus towards monetizing and partnering the assets that we have been developing during the past many years. The fact that we are founded as an AI first has clearly given us a significant head start compared to many of the newer AI companies out there today. All in all, we are in a super exciting point in the Evaxion journey.
Of course, there's always risk and uncertainties, but with the broad pipeline we have developed, with the capability base, I think we are set to execute well on our strategy, which is also evidenced by the number of milestones for this year which we already have achieved.
I agree with that. Thank you. That's a great summary, and yeah. So we have to wrap it up. I will just echo that this company has a huge pipeline. And they're at an inflection point, s o I encourage investors to look into it. They have more treatments that we just didn't have time to go through that are very exciting and promising, and there's news coming out every day, so it's a good company to follow.
And I encourage you, if you want to know more about the company and want to get some time, have other questions, there's gonna be a way, after the call, that you can set up meetings with company management. So having said that, I appreciate everybody's time. Thank you for joining us, and have a great day.