With me today, I have Ziccum CEO, Ann Gidner. We will talk with Ann about the company's recently announced evaluation agreement with a major biopharmaceutical company focused on mRNA technology, and what that means for the company going forward. Ann, before we get started on that agreement, could you briefly just describe what Ziccum does and what makes your technology unique? Thank you. Yes. Ziccum is a growth stage biotech company developing drying technology for the pharmaceutical industry, and we have a unique principle of drying, ambient drying by mass transfer, and this enables us to dry biopharmaceuticals, which is normally impossible. And why is drying of importance here? This is a huge topic. Most people in the world basically know that the COVID-19 pandemic brought new therapies, mRNA-based therapies. To have them reach into the body, you have to formulate them in LNP, lipid nanoparticles. These very fragile constructions, they need cryogenic handling, so they need handling at minus 80 degrees, which brought tremendous cost and trouble. It was worth it to make the vaccine effort possible. The whole industry globally is really looking for new ways of managing these delicate particles. That's a key example of biopharmaceutical needing more practical handling in powder form. It's the same for all biopharmaceuticals: proteins, peptides, enzymes. All these treatments would really benefit from dry powder handling, and this is what we are enabling with our unique technology. Does that also mean that once the vaccine is in place, so to speak, that you need to inhale it because it's in powder? You have two options. You have several options, but the two key options really is either to reconstitute. You take the powder and dilute it in water. It's a very simple process because we have such good particle properties. That's very simple. We would dose the powder in patient dosage, and you would just dilute it before administration by injection, in that case, or you can administer the powder itself. This really enables new administration routes. The key one being inhalation, but it could also be like a patch where you have microneedles and powder going through the skin. Just one word on the mRNA as well. It's a huge market, of course, and it's not only COVID-19 here. It's a number of indications. Could you just briefly describe the market opportunity here for you and for mRNA? Indeed, mRNA has been known. I mean, it's a classic part of bio, the biochemistry in the cell, in the body, that you transport genetic information into your cell, and your body can then produce new amino acids and new proteins. It has always been an issue to get it into the cell, into the patient. That is now enabled with a new delivery technology, using really complicated and fragile particles, LNPs. Once the COVID pandemic made the need so urgent and so large, the pharma industry pushed extremely hard to make it happen, to make it possible. Now it has been proven to work. Now, there's a very big market opening up for new indications, new treatments, both, preventive and therapies, both prophylactic and curing. All the, all the big pharma players are really striving very hard to now set new mRNA treatments on the market, because suddenly this is possible, which it wasn't before. There's a very. There are two key limitations to the mRNA therapy area. One is the delivery, which takes these really delicate particles and bringing a lot of issues with it, and the other one is stability. If you listen to key opinion leaders, they say, "If the world can solve delivery and stability, then mRNA will be a platform for new therapies in lots of thinkable areas." That's why Ziccum, we are so well placed here, because our technology allows new delivery forms, and we solve the issue of stability. We are a fantastic enabler here, and we are getting fantastic interest from the pharmaceutical development players. Is there any competition for you out there? I mean, in terms of dry powdering, are you the only one doing this? First of all, I would say it doesn't matter if we are the only one, you know. If you're a strong professional player with excellence, of course, you can compete with others. But in our case, we have an even stronger position because we are the only company, as far as we have found, that is able to dry the really delicate biomolecules, like mRNA, into powder. There are some attempts to tweak old technologies like freeze-drying, lyophilization, and some efforts made and some publications on this. And it's working to some extent, but as far as we can see, it's far more cumbersome, and it has far more limitations than the result we get with our technology. Regarding this agreement, then, it's communicated that it's a fully financed feasibility study. What do you hope to achieve with this study and the partnership? It's a partnership with one of the world's leading mRNA players. It has several components. First of all, it's of course, fantastic for us to be able to work with such a leading company, with authorities and amazing knowledge in the field. We will pick up a lot of knowledge and learnings. The near term goal, of course, is to have successful trials performed, that LaminarPace can successfully drive the specific product of this company, the product they will choose for the experiment. The scope is both for mRNA, LNP materials, and/or vaccines, so several products could come at hand. The near term goal is to prove successful drying with a nice dry powder, manageable both in development stage and going forward. As far as I understand, you have already tried this out in-house successfully. Well, do you foresee any complications in this new environment compared to what you reached in-house? You never know. That is science, right? Yeah. It, this is not mathematics, where you can just predict the outcome. This is science, and this is chemistry and biotechnology. That's the whole reason why you do feasibility trials, that you have to verify that it's working. We already tried on our own. The mRNA is pretty the same, pretty much the same, but the LNP formulation varies in each project. It will be very interesting to see how we succeed with this formulation at hand. We don't this far, we don't foresee any trouble, right? That's why we have signed. Yeah. Yeah. The study is expected to start in May already. For how long will it last, and what are the next steps here? It will last for a couple of months. Okay. Of course, there will be an assessment on both sides, to agree on next steps. You will report something around this project to the market within 2 months. Is that to be expected? We don't comment on that. Okay. We don't comment on when we report readouts. Two months is not a couple of months. Okay. just one question on the term fully financed. Does that mean that your partner will take care of the associated costs, or that you actually will generate revenue from this project already? We are generating revenue here. It's the first commercial revenue for the company. It's a very large milestone for us. We are very pleased and happy about this, of course. Mm-hmm. Ann, is this agreement in any way exclusive, or can you do parallel negotiations with similar companies? That's a good question. No, it's not exclusive. We still have ongoing dialogues. Yeah. Of course, I noticed that you have a new partnering agenda here, which is a new strategy set last year. What are the main milestones, would you say, given that you've set a new strategy, partnering up with companies here going forward? What should investors look for regarding Ziccum? We are putting in very strong efforts to build a pipeline and a full, rich pipeline of many dialogues to go into many feasibility trials. Like mentioned, you know, this is pharma and biotech, and you will not succeed in every collaboration, that's for sure. Even if our technology works perfectly, you still have the risk of the pharma project failing at the project owner side, right? Yeah. I have a very long background in CDMO industry, so I grew up building pipelines, you can say, to, to prevent, you know, the failure associated to attrition rates in drug pipelines, in pharma pipelines. I'm very, very used to it. You have to work very hard to have many dialogues, to have a good number of projects, to then have a number of successes coming out of the pipeline. That's why we are spending so much effort now. I'm traveling a lot, presenting a lot at conferences. Ziccum is very present now in the pharma community, especially for mRNA, but also for other vaccine platforms, to make sure we have enough business activity going on to achieve great projects and great revenue, of course, long term. Long term, we are building. You know, each agreement we land has the potential of future revenue, so we are building the company revenue, of course. In terms of the business model, is that milestone payments or, and upfront payments, or how is it structured in terms of? It's a classical licensing deal. Okay. You would start with a feasibility study, and here, you know, positively, we're getting paid for it because our technology is so attractive, right? This is like an entrance ticket to work with us. Next, as we go forward, we would start negotiate a term sheet, and that includes milestone payments, equipment delivery, and then a royalty once you have a drug on the market. It's a very classical licensing model. Okay, Ann, thank you very much for taking the time today. I wish you all the best for the future here. I hope that we can touch base here going forward with new corporations and new partnerships. Indeed! Good luck for now. Indeed. Thank you so much. Thank you.
Loading workspace