Good morning, good afternoon and good evening, everyone. My name is Jessica Hogan and I will serve as your moderator for today's event. Before we kick off today's agenda, I do have a few housekeeping items to review with you. At the bottom of your screen are application widgets you can use throughout the event. Go to the next slide. There we go. At the bottom of your screen are application widgets you can use throughout the event. They are resizable and movable, so feel free to manipulate them to get the most out of your desktop space. For the best audio quality, please make sure to use your computer. Speakers or headset are adjusted accordingly so you can hear the presenters clearly. If you have questions during the presentations, you can submit them using the Q&A widget on your screen. Please know that we do capture all questions. So that's all I have to share with you today from the technical side. And it's to that aim. It's now my pleasure to introduce our first presenter of the day, Oliver, who will give a presentation on funding your European life science startup, How EIT Health can support you and over to you, Oliver. Awesome. Thanks, Jessica, and hello, everybody. Thanks for joining today's call and I'm very grateful for our host also to host this event. So giving the other speakers myself the opportunity to talk to you today. Quick background on myself before I go into the content of the slides. I myself, I'm a scientist by training and I spent the past seven years in the Silicon Valley working in two biotech startups, one on drug discovery as the scientific lead and one and drug development as the chief of staff, working closely with the CEO on operations and fundraising, etcetera. And so I've been recently, you know, been back to Europe and I thought, I want to take all the learnings that I have from the crazy ride over there with two boom and bust cycles and deploy those, you know, that know how my network and my skills in the European life science ecosystem. And that's why I'm very grateful here to represent you, represent EIT Health to you today and yeah, showcase what EIT Health can do to support you on your, on your journey. And So what is EIT Health and what do we do? So you might have heard of EIT Health, you might have not heard about EIT Health. I before coming back to Europe did definitely not hear about EIT Health before. EIT Health is one of those consortiums, a large private and public EU body that is aimed at fostering, you know innovation in the life science sector in Europe. And it's actually the largest life science consortium in the world. And so our members consists of large corporates, many of which you probably know of universities, startups, venture capitalists, etcetera, etcetera. And we basically as EIT Health as a whole do to three things, right. First one is that we work with the European Union and our stakeholders to understand which areas of innovations are really key for the European Union, right. So that could be therapeutic areas for instance or you know addressing the digital challenge in the life science, hospitals, healthcare providers, etcetera sector. But we also, you know, take the innovation that we're in those key areas that we identified and then accelerate the companies that are breaking ground there, right? So we work closely with startups on accelerating the product market so that the patients in Europe can actually benefit. And then lastly, because all those startups also need people that can actually work for them and with them and you know, because we need new entrepreneurs on a common basis, we also educate, right. So we work closely with the, with the universities to drive education programs and support the system that way. And so you can see where we are, where we have hubs and, and presences, you know, major European countries, of course, but also there's an outreach location in the US. We actually have collaboration with Canada ongoing right now. And we're looking into Japan too. So it's, it's really like Western, Western world plus Japan, all the leading pharma drivers that were connected with OK. And so, you know, just to highlight a couple of members that are within our ecosystem. So you see all the big names here, you see Roche, Sanofi, GSK, Amgen, AstraZeneca, BI, all of those are there. You see some of the key hospitals and University Hospitals here. So it's really players from all parts of the ecosystem that are within our group and where I think the key advantage for us also comes from, right? It's the people that work at the IT health are connected to all those individual players. And by learning more about you as a startup and what you're doing, we can identify the key players within the ecosystem that you might want to be connected with, Right. So we're really considering ourselves a door opener to facilitate innovation. Yeah, OK. On the high impact scale, want to mention a couple of numbers. So we've supported today, this is close to 3000. I know it's probably more than 3000 startups. Those startups have attracted with our help an additional 2.2 billion in funding. So this is European billion, right? So large sum of money, we have 123 healthcare products that were launched through our system at more than half a million of patients in Europe and trained about 65,000 new folks for the industry. And considering the audience that we have here, I hope there's many startups that are joining that are looking into, OK, how can EIT Health be a partner for me? I'm not a large corporate yet, so I'm not interested in that part. I really want to understand what you can do for me on the ground in terms of like getting my product out into the market. And so that piece is really represented through the accelerator piece. And so EIT Health does have a subunit that's pretty large and that's the EIT Health accelerator. And so similar to other accelerators that you might have in your local ecosystem, we provide similar services, but we're doing a pun European scale, right? And working with us, it's really more about, you know, finding a hands on partner that understands the larger European ecosystem very well and can also bridge across countries, right? With the partners that we have on board as an accelerator, we do offer specific services or support pieces, training programs, individual, you know, services as well as access and networking opportunities within different sections. And I just want to highlight a couple of here that I think so far as we've been working with a startups come up and up again, depending on where they are on the journey and which field they're in. So 1 is, you know, working with the startups on market access strategy. We have, since we have so many senior partners in our network and we have people within the organization that have been at those partner companies before. We really have key thought leaders on, you know, that can help you develop your market access strategy, which is something that you initially don't really think about when you're, you know, launching your, you know, your proof of concept and you know, your checking out whether it's working or not. But you should, right. And so having somebody there that can take your hand and do the assessment with you is really key. We also do provide the opportunity to, you know, help you set up strategic partnerships again with those large pharma companies or universities for clinical trials, etcetera, etcetera. We do provide commercialization support. And the last and most, you know, often thought of peace is the, you know, access to finance, we call it, so the access to public and private funding. So we have dedicated unit for that access to finance team that I'm also part of. And so independent of how you interact with the EIC health accelerator, typically things that happen when you engage with us is that, you know, a, we're always eager to learn about what you're doing. You know, we typically will ask you for a non conduct to actually, you know, understand where you're at. And then if you decide, OK, I really want to get closer with EIT Health, I don't want to join one of the programs, you can sign up with us. And then we do an assessment. We identify critical gaps and we provide customized services that actually help you fill those gaps, right? Knowing from my own experience, different companies are very different needs depending on how they're structured and who is in the leadership team. And so we try to fill those gaps so that you don't always have to hire like the next CXO person just to get something done pretty quickly. And then last but not least, when we think you're ready, we'll put you, you know, in front of our partners and our networks and, you know, hope to help you build a successful business that way. OK, I want to highlight one example here because it highlights the journey of a startup from very early, you know, idea inception into, you know, post Series A raise and work on commercialization. Can't name the name of the company, but I can describe it here. So it's a startup that was founded in 2017 and it provided a digital solution that combined cardiac images and electrolytic cardiograms, merged those, you know, with AI technology to deliver a digital twin of the patient's heart that was really good for clinicians to, you know, improve their clinical diagnosis. And so the, as I mentioned, they, they started in 2017, they joined the EIT Health Head Stop program. So that's the first time that we've heard about them. We then you know, they, they worked on their technology on their, on their, on their approach and then they joined the EIT Health Catapult program. That's really the piece where the technology is, you know, driven towards, you know, a solid business case. You start talking to investors, right, we highlight you etcetera, etcetera. And then in 2020 they worked with us on the EIT Health market access program. So they had a training program on how to think about market excess strategy started to initial, you know, potential customers, etcetera. I got customer feedback and then they took that information and applied for the EIC accelerator program. So for many of those, all of those who don't know the EIC, the EIC is the European Innovation Commission and they are one of the largest funding bodies in the European Union that has their own accelerator program that can dish out substantial amounts of funds if you get Co investment with a private investor. And So what EIT Health is doing is we have a special deal with the EIC that if you come through our network and you've been vetted by some of our internal venture capitalist partners, you can fast track that application. And so why is that key is one, that's a very substantial amount of of funding that you can raise there, right? I think it's up to 5 or 7.5 million EIC Co funding, but it's extremely competitive. So the success chance of getting that grant, the Co funding from the EIC is about 4% if you just apply normally. And if you talk to other companies to be here that they apply two or three times before they actually get to a point where they feel like, OK, they have understand the chance. So what we do at the IT health is we, we understand that you want to apply for that. We help you prepare for it. And because we, we've got you and prepare you, we have this deal with the IC that you can fast track your application to the second stage, which immediately boosts your likelihood of getting funding from 4% to 25%. And so from my own experience, as you know, running a start up and trying to fund the start up, the biotech space, you always want, you know, more cash is more is valuable, but the amount of time that you need to invest to apply for some of these grants is substantial and can be very frustrating. So really increasing your chances and having the right partners on the side makes it much easier because it becomes a simple investment decision, right? So it's like how much time and money want to invest now to have the chance of securing, you know, 5 to 15,000,000. And then so they were successful with that. And then the 2023, they were then supported by the access to finance team fundraising directly with us through our VCOE network and they closed out a series, Series A of 11,000,023. And so you know, it's quite, quite the time frame, but I think it gives you an understanding of all the different pieces of how EIT Health can be supportive you at your different stages. And I think right now they're working with the market access team again from EIT Health to actually execute the market access program they initially, OK. So overall that's it for the accelerator. I think what the key take away here is we have strong partnerships with key European bodies like the European Commission, the EC, the European Investment Fund, the EIF and the EIC, the European Innovation Council. All of those are large funding bodies that can distribute capital, but that typically lack the experience within the individual, individual sectors like life science. So we are there partner of choice for the life science sector, right. So we make that connection happen between the European bodies and the the local ecosystem players, venture capitalists. And so we got plenty of recognition for you know, the approaches that we're taking there. So we're proud of that. So we got the number one world's top public private business accelerator award from Ubi in 2023. And then for the P Gallian in the US, the Venture Center of Excellence program that we have at the Access to Finance unit has been finalist twice in 2023. I don't know what the position was, but I think 2 weeks ago for 2024 we got second place out of 55. So that's pretty good. So recognition is definitely there. And speaking from my own experience, you know, having raised in the USI think it's cool to see that you're does have these institutions that can support the ecosystem, particularly because the risk capital is of course not as available in Europe as you as in US. OK, so that's the part for the accelerator. Let me transition into access to finance and particularly the partnering on the fundraising. So at the access to Finance team, that's the team that I'm working with with my colleagues, we understand that raising capital is tough. It's particularly tough right now and it's been tough for quite some time. We hope it's going to be less tough in the future. But nonetheless, asking, you know, for lots of cash without actually generating a revenue, as you know many of the therapeutic company companies out there will experience is always going to be a challenge, right? So the way that we think we are the perfect partner for you there is because one, of course we have the fundraising expertise because ourselves we have a enormous private investor network that is not only consisting of European investors, but also US investors and Japanese investors. And we have that link to the European funding. So we can really, you know, manoeuvre those pieces to make the matchmaking go faster because we have the leverage through a network and our experience. And so that's what we utilize on a day-to-day basis. So I see tons of start-ups flying on my desk that are like, hey, I want to raise capital. I'm like, OK, show me a story. That's my day-to-day business basically. And then we work with them to figure out their, the strategy for fundraising. There are of course a couple of requirements that you need to, you know, fulfill in order to specifically work with access to finance. So in the accelerator path, we're practically one of the last units that you'll work with because we're typically focused on Series A launches. So we're not doing lots of education anymore, not not business plan development or any of that. We do fundraising, right. And so we do that with companies that want to raise, raise at least three million. But typically the companies work with our Series A, Series B financing rounds and that 10 to 20 or more, right? So right now we see a lot of companies that want to raise 60 to 80 million to actually fund the clinical development of their of their preclinical candidates all the way through phase one, Phase 2. So phase one plus phase two. And there's some investor sentiment that that can be attractive for the right in the right requirement. But saying that, OK, so you need the round you want to raise needs to be large enough to be eligible to apply to our programs. There's other requirements. You need to be European, a privately held company. Understand that in this audience there might also be some US firms. What we've have seen is that many firms, particularly in the drug development space, have a European headquarter, US headquarter. There is maneuverability there. Come speak to us. We'll see how that goes. But the key here is you need to be growing and addressing a European market too, because we have a mandate to support the European patient cohorts. Of course, transformational technology in healthcare. I think that's a given for most of the biotechs that that I see on my desk at least. And then very importantly, as always, you can't have a commitment with another firm at the given point in time because there's typically exclusivity agreements that you need to sign off on those. So that would prevent us from engaging with you. And in terms of financing, the timing for the financing, my personal rule is always if I fundraise, I want to have the term sheet at least 1-6 months before I run out of cash. And the reason for that is I want that, I want to have that, you know, 6 month buffer. So I have negotiation leverage. Something that I've seen a couple of Times Now is companies coming to us and they're like, Oh yeah, I'm running out of cash end up here. So that gives me two months to try to figure out, close the round, get a term sheet and seal a deal. That's not going to give you a lot of leverage, right? So start this early and there's a famous saying from the German soccer soccer universe that says after the game is before the game. And I think that works very well for fundraising too. After the fundraisers for the fundraise. And all the CEO's probably know that you're constantly fundraising. So make sure that if you're thinking about, you know, you closed your seed, you know, plan A and come talk to us, right? Because if you have two years of runway financing rounds, putting that together can take nine months, 12 months, right now you want to have six months of buffer, you're already in 18 months, right? So come talk to us early so we can prepare you and you know, engage investor interest, understand where the investors are in their investment cycle, etcetera, etcetera. So help us help, help us help you by, you know, reaching out early. OK, so all these, you know, check out, get in touch and then we can assess whether you want to sign on or not. And if you want to sign on, then we do the thing that I mentioned before, we do the assessment where we look at what's missing, you know, is positioning, right? Is that something that we can spin to to, you know, create, you know, create a more attractive message for the investors. You then help you support, help you with the filling in the gaps and then we do the active promotion as soon as we think you're ready. So why do we do only act motion when we think that you're ready? We have a reputation here to lose where the VC's trust our judgments and they will consider companies that they see a lot of companies preferentially from the stuff that we sent them, right? So whatever we send them needs to be good. So we only do active promotion, you know, after we've we've done these OK, that's it for access to finance. One thing that I think I want to highlight here is an example of what I think is a, an attractive, a special call that's open. So as you're probably aware, right, all these European bodies they have, they do open calls and run programs and that should be timed and limited and they have a certain amount of funding associated with them. So one of them that is active right now that EIT Health just launched is a we call the transformative Health instrument call and that's a €500,000 grant to option to equity fund. And So what you can do with that is you know you can apply for those 500,000 if you have a project planned that would see the the 500,000 spent within the next 10 months. So why I think this is relevant for this audience, I'm thinking about, you know, running in vivo studies. So you might be in your, you know, IMD enabling studies right now you have, you know, two or three studies that you would like to run. You might have to rerun one 500,000 can become very handy there. The requirements for you to get that money would be that you need to do a 30% Co founding Co funding for the for the project. So if you want to get the 500 K, you would need to invest 165 K yourself. As mentioned, it's a grant to options to equity single beneficiary, so only you as a company can apply. But it also makes it a lot easier because there's no coordination with VCs or other partners involved. And the last requirement is that you would need to have raised €4,000,000 in the last round with a new investor in 2023 or 2024. So you must have gotten capital within the last year or two and you're looking to deploy, you know, 500K or more, presumably you're going to, you know, invest a million or two moving forward with a project there. So then you, you know, you would be eligible and you can click on, you know, I can share the link here later on or you can reach out to me request that link to learn more about the requirements and, and the timeline. Timeline, roughly speaking, is it's a short call. So this one opened last week and the final submission is January 7th. So that's right before or right around the time of JP Morgan. So perfect to get that done before you head to JP Morgan. And then there's the evaluation happening and you'll know about your, whether you're being selected or not by end of February and then you can start. So for me, this is something that I would love to have had back in the days when, when, when I was in, in Silicon Valley in the start-ups, because I think it's, it is one of those rare opportunities where it's easy access to quick cash that is not as cumbersome as the usual applications that OK. And with that, I'm done with my presentation and I would love to Thanks again our hosts and you for your attention. As always, You can reach me via the e-mail that I printed out here. You can ask me questions in the chat. You can, you know, hit me up on LinkedIn, always happy to talk and you know, see where, where I can help or EOT Health can help. And yeah, apply for that thi instrument call and good luck. That's it. Awesome. Thank you very much Oliver for that great presentation. And as a reminder to our audience right now it's not too late to submit any final questions you have for Oliver using the Q&A widget on your screen. So we can take a couple seconds to let a couple questions come through. Now we do have one question that has come through Oliver and it was the question is, are all these schemes accessible to the UK based startups? So maybe we could start you with that question and we have an applause to so great job on your presentation. But maybe we can we can get started with that question and see if any others come through for now. Yeah. So the background information for that question is that this program was initiated under the Horizon 2020 framework. So back in the days the UK chipped into that program too. So I think so most of those programs, UK based startups are also little. I would need to double check because I as I said, I'm still new with the organization and a very large organization. But I think yes, because the UK was part of that program, definitely reach out and we can check easy as that. Very good. Thank you very much there. I still don't see any other questions in the chat. So right now I can leave it to you, Oliver, if you have any other additional information you wish to share maybe with the audience or we have a couple more minutes. So another one came through. OK, let's see. A minimum of 30% cofunding, yeah, so. OK. So the question is, could I clarify what is meant by a minimum of 30% cofunding for this thi background? So that would mean so we can chip in up to 500,000, but you would need to Co invest 30% of that total sum, right? So if you if you want the 500,000, then you need to invest 165,000 yourself on top of that, right. So the total project volume would be 665. I'm doing the math correctly. 500% of that come from the IT health, 30% would be from probably the math wrong there, but it's basically the investment, right that you need to do. So if you have a smaller project, you know you would still need to do with the core and Co funding, but of course the Co funding would be smaller. And then the contribution from right now we're planning on deploying about 6,000,000 of capital that way. So if everybody taps the 500,000, then that would be 12 startups that get supported. That way if we get additional traction from, you know, capital from the from the European Union, that might be more or if startups actually apply for less money, we might be able to support more startups depending on, you know, how the situation. Great, that makes sense. And we did we, we have one more question that's come through the chat. And the question is any funding support for earlier stage than ACE then Series A for example precede? Yeah. So that's a great question. So the answer to that is yes, slightly different though, right. So as I mentioned for us at the access to finance team, we we start actually working at latest stages a lot of large amount of capital, but there are support infrastructures that EIT Health is offering for pre seed companies. We also do have an investor network that does invest into seed stage companies, right, particularly regional hubs with VCs that are, you know, more specific on a specific focus on a specific region tend to do smaller check sizes. So yes, one program I want to flag there is probably the Catapult program and then deep tech mention we just launched, but that's probably even earlier than that. So I mean, if you reach out to me directly, I'm happy to point you at the people that coordinate the programs that might be a better fit for your for your company. So yes, I hope so. Wonderful, wonderful. Thank you for that response, Oliver. And I don't see any other questions coming through the chat. So with that, we want to thank you again, Oliver, for your great presentation and your insights today. And thank you for those questions to the audience. Thank you for submitting those questions. And with that, we'll be moving on to our next presenter. But thank you again, Oliver, Have a. Great rest of your day. Thanks. Great. So moving on to our next presenter. Stephen Majors is the Vice President of Global Communications at Alliance at Alliance for Regenerative. Oh, excuse me, I'm going to move to the right slide now to get started. Here we go. All right, so moving on to our next presenter. Stephen Majors is the Vice President of Global Communications at Alliance for Regenerative Medicine. Today, Stephen will be presenting on cell and gene therapy, the state of the industry. And with that, Stephen, welcome to the symposium. Please feel free to begin your presentation. Great. Thank you so much, Jessica, and thanks to our host for inviting me to present today. And good morning and good afternoon to everyone. I'm going to spend the next 2025 minutes or so talking about selling gene therapy, where we are currently with the industry and where we expect to be going forward and some of the trends we're seeing. So looking forward to talking to you with you all today. So first, a little bit about the Alliance for Regenerative Medicine. We consider ourselves the global voice of the cell and gene therapy sector. We have a wide range of members. We have small biotech companies as members, large pharmaceutical companies as members, patient advocacy organizations, and academic and medical institutions. Most of our members are in the US and Europe, but we do have members from all over the world as well. And so basically we convene the sector to tackle the sector's biggest problems and biggest challenges. We work closely with regulators and policy makers to make sure that regulation and policy is fit for purpose for selling gene therapy. And we spent a lot of time kind of trying to modernize healthcare systems both in the US and Europe to ensure that all of these wonderful scientific advancements that we're seeing in selling gene therapy can ultimately reach patients and make a difference in their lives and the lives of their families. So taking a step back, this slide I think really shows where we are in the growth of the cell and gene therapy sector. You'll see we have about 3000 developers worldwide. These are again small companies, large companies. This also includes academic and medical research institutions who are driving innovation forward. We're just under 2000 clinical trials globally and, and, and in Q2 we had about $3.8 billion and and total investment. And so we've really seen of course is continued steady growth of the industry, though of course, we're seeing some funding challenges, particularly for the biotech sector. Cell and gene therapy is not immune to that. And it's particularly sensitive to interest rate changes as we'll get to more in a moment. But you'll see that most of the development that we're seeing is occurring in North America. We've really seen a lot of growth in Asia Pacific, Europe. We've seen a little bit of a stagnation in recent years, but we're also working hard in Europe to make sure that all the great innovation that continues to happen there can ultimately get translated into therapies that will benefit patients. And so let's take a little closer look at the investment picture. As you as you see, there is a huge boom in investment in 2020 and 2021, which was largely driven by the pandemic, the increasing interest that we saw in biotech around the development of COVID vaccines, which had a knock on effect for other types of of innovations including cell and gene therapy. And of course, we saw interest rates drop extremely low given the growth challenges that we had at the time in the amount of funding flowing in from government spending. And so that after that, there's a little bit of a pullback. There are a lot of selling gene therapy companies that were out there, a lot of IP OS that occurred. And now in the last few years, we've really seen a bit of a retrenchment. But what we're seeing now is a little bit of a recovery in the first half, at least through the first half of this year. And particularly, we're seeing strength and follow on finances, financings for established companies that have shown clinical data and we're still waiting for an uptick in some of those earlier stages. And then venture financing for companies that are coming out with new ideas. But we're hopeful we're going to see more of that going forward. But really we're seeing financing return to what it was pre pandemic. So it's not like it's it's, it's dropped off a Cliff. But again, we hope to see this recovery continue going forward. And so now we'll move into some of the clinical successes that we've seen. So we look back at last year, we really see this as the year of gene therapy. And so if you look and then this is really focused on on the US, if you look at the years 2017 through 2022, you saw gene therapy kind of jump onto the scene. You saw the first few of approvals occur on the back of multiple decades of research and ups and downs. And so you saw a breakthrough 2017 and kind of what I'll call incremental approvals from 2017 through the end of 2022. And so we saw during that span, 5 approvals of gene therapies for rare genetic disease. And then going looking at last year and specifically, we saw 5 approvals for rare genetic disease in a single year. And so we really see this as a remarkable burst of innovation and kind of a sign of things to come in the field of gene therapy. And importantly, we saw approvals for hemophilia and we saw two approvals for sickle cell disease, including the first ever CRISPR based therapy for any type of disease. And so again, this is really a huge uptick that we're seeing. And then on the European side, traditionally we've seen several gene therapies be approved, first in Europe before being approved in US, which was an encouraging sign for for Europe. For the last couple years, we've seen a little bit of slow down in approvals in Europe and that's something that we're certainly keeping an eye on as an organization. And so let's Fast forward to this year. Last year was the year that we're seeing of the year of gene therapy. So we're really seeing this year is the the year of cell therapy. And so there's a number of of key milestones that have occurred. Importantly, earlier this year we saw the first ever adoptive cell therapy approved for a solid tumor. This was a tumor infant infiltrating lymphocyte therapy that was approved for metastatic Melanoma. So that was a a huge breakthrough when it comes to solid tumors. We also saw the first ever approval of ATCR cell therapy to treat solid tumor in recent months. And importantly, we've continued to see CAR T therapies go forward as and be approved as earlier line treatments as they have demonstrated growing success against the current standard of care. And so that's happened in both the US and Europe and it's happened with multiple CAR T therapies. And just kind of A to skip forward a little bit, we've now seen one CAR T therapy submitted for approval as a first line therapy here in the US. And so you can you continue to see CAR T therapies move earlier in lines of treatment, which should improve access and give more patients the opportunity to receive these therapies. And then in general, we're seeing kind of an uptick in overall approval rates for cell therapy, which is another reason why we see 2024 is a really a breakthrough year for cell therapy. Another reason it's been a breakthrough year for cell therapy is, is some of the financings that we're seeing, some of the largest financings that we've seen going back to what I was talking about earlier have occurred in the area of cell therapy. So we've seen 300 plus, you know 200 million dollar, 300 million, $200 million raises for a range of different types of cell therapies, including for things like autoimmune disease, which is really a captured a lot of attention. There's several companies who are pursuing CAR T technology against lupus and other types of autoimmune diseases that have been resistant to other types of treatment. And so that's a huge area of focus and promise on the horizon for the field that we're seeing. And let's look at the approvals pictures. So a lot has changed in the past week since I developed this presentation, of course. But we have seen 4 new therapies approved in the US, 2 new therapies approved in Europe. And we're actually expecting some news here today. There's what's called a PDUFA date for ABSTASA, a gene therapy for a neurodegenerative disease that has already been approved in Europe. There's a PEDUCA date today for that same therapy in the US There's also multiple decisions pending in both the US and Europe where either Biologic License Applications or MAAS have been submitted and accepted. And then we've also got next year's pipeline also starting to build. We have two Paducah dates already on the horizon in the US and then we have submissions pending for a range of other therapies. And so I think the the key take away here is we're continuing to see steady growth year after year and the number of therapies approved. And then we we're seeing the replenishing of the pipeline coming behind it with applications being submitted. And some, some of you may recall back in 2019, the FDA made a prediction and the EMAI think mirror this prediction that it expected to approve between 10 and 20 new cell and gene therapies each year by the year 2025. At the time, it seems really ambitious because this was back when we'd only see maybe one or two approved a year. We, of course then had the pandemic. But now when we look at the pipeline, we can see that prediction within reach, which is is pretty remarkable given what we came through with the pandemic and given how much attention that took from regulators as opposed to selling gene therapy. So that's another positive sign for the sector that we're watching closely. And then here at ARM, there are a few key sector issue that were issues that were really spending a lot of time on. And these are really thorny challenges for the sector that require a lot of attention. And so I'm just going to touch on the four of them at a high level and then really delve into this conversation around pricing and value, because that is something that that continues to get a lot of attention from external stakeholders. But there's a lot to think about in terms of CGT pricing and value. Of course, everyone's focused on the very high list prices and launch prices for these therapies, but these are are brand new. They're going after high unmet medical need. The standard of care for the diseases they're targeting is often subpar or nonexistent. And so it's important to educate everyone about the types of diseases that are being targeted and really have a full conversation around the value that selling gene therapy is providing and then getting that balance right among innovation, access and sustainability for the sector and for healthcare systems going forward. The next thing we're really focused on is what we're calling the industrialization of selling gene therapy. And so we've now seen the first set of therapies come online, the 1st generation therapies. And of course, most of these therapies are only available in the US and in Europe and perhaps a few other developed high income markets. And of course, we all want to see these therapies be available to patients in all across the world. And of course, we know that the vast majority of sickle cell patients do not reside in the US or Europe. And so how are we thinking about the industrialization of the field and the advances that will need to occur to bring down the cost of goods and to increase access across the world? There's also some unique challenges when it comes to ultra rare diseases. A lot of the sector has been focused on rare diseases and there's there's thousands of diseases out there that could potentially be targeted with the technology that we now have. But the commercial case just isn't in isn't there given the small number of patients for a lot of these diseases. And so we're all trying to work together as a sector to figure out the right kind of models that will work for these ultra rare or in of 1 diseases. And lastly, there of course some ethical issues when it comes to changing people's DNA. And So what is the appropriate guardrails that what are the appropriate guardrails that should be in place for frontier technologies germline editing? What is the right line there when it comes to changing the the genome? And so these are a lot of the issues or some of the key issues that arm is addressing on behalf of the sector. And then next, I will dive a little bit more into this conversation about pricing and value. And so this is a framework that we developed last year for gene therapy, specifically for and gene therapy for rare diseases. And so the first idea is that the gene therapies that have been improved for rare genetic diseases, these are all devastating, often deadly diseases. And one of the, the statistics that that comes to mind to illustrate this is that if you take the life expectancy for the diseases targeted by gene therapy without gene therapy, the life average life expectancy for the those diseases there's approved gene therapies is below 40 years. And so that shows the, the seriousness of some of the diseases that are being targeted by gene therapy. Another important point is that some of these are really expensive diseases in terms of the drain and the current healthcare system. So if you look at severe haemophilia patients, that can be $20 million or so in lifetime cost. Severe sickle cell disease can be 4 to $6 million in lifetime cost for the US healthcare system. And so when people think about gene therapy and how expensive it is, it's important to keep in mind what is currently spent with the standard of care. Next point is that gene therapies are highly effective and we know this because the new DIGS organization out of Tufts University came out with a study last year looking at the clinical success rates for gene therapy and other type and other CGTS in comparison to the average drug that's approved. And one example of that data is they found that orphan gene therapies are 3.5 times more likely to be approved as the average drug as studied by BIO and IQVIA and in terms of overall success rates. And so these therapies have much greater success moving through the clinic, which should give investors and others in the sector encouragement about where the sector is going. Next point is that with Value for Healthcare systems, I serve the Institute for Clinical and Economic Review, which is sort of a quasi HTA body here in the US Generally, they do not find that US drug pricing is justified for lots of different pharmaceuticals. However, when they've looked at gene therapies, more often than not, they have, they have found that these are, are, have very high value given that the diseases that they're targeting. And lastly, we're looking at kind of the sustainability of the field. There's a lot of discussion about, well, society can't afford gene therapies because they're too expensive and they're going to overwhelm healthcare systems. But when you look at the projected revenue for for you for gene therapy in 20-30 in the United States, you're looking at about 7 1/2 billion dollars according to touch new digs. That is about 110th of 1% of projected healthcare spending in the US. And so there may be some challenges of course, for some smaller papers pay payers, but writ large, these therapies are, are can be easily digested in the overall healthcare budget, not even taking into account the value that they provide that I discussed earlier. We also did a framework for CAR T therapy and I'll move through this one a little bit faster. But the first point is that CAR T therapy of course, provides a lifeline for patients for blood cancer, patients with lymphoma, leukemia, other types of diseases who have no alternatives. They've exhausted all, all their treatment options. And so CAR T therapies, there's been numerous documented cases of therapy saving the lives of of patients including Emily Whitehead, who's now more than 10 years cancer free, who was the first pediatric patient to be treated with a CAR T patient. As I mentioned earlier, CAR T is increasingly moving up and lines of treatment. There's been more studies of CAR T against the standard of care and moving from third into second. And now the application for first line treatment is happening based on those therapies effectiveness head to going head to head against the standard of care. In many cases CAR T just like gene therapy does provide an opportunity to potentially replace or reduce a standard of care that is expensive and toxic. Multiple myeloma of course requires multiple drug cocktail that can be hundreds of thousands of dollars over the course of a few years where is and that that puts the CAR T therapy around $400,000 in context. CAR T therapies are also sustainable for the healthcare system similar to what I mentioned with gene therapy. And then all the last point with CAR T therapy is that they're driving revolutions in healthcare systems. And so when you look at CAR T success against blood cancers, there's also numerous clinical trials ongoing to test CAR T against solid tumors. And then as as I also mentioned, autoimmune diseases. And so you can really see the progression and the future promise that CAR T is driving and the in the world of cell therapy. And if anyone's interested to hear more about these value frameworks of value narratives, I just wanted to stop briefly on this slide to let you take a picture of the QR codes that will take you to our full reports on these topics. OK. And so we're also doing some work then this is actually should say moderate modernizing healthcare systems in general, because I'm going to talk about both US and Europe, but ARM is doing a lot of work to make sure that the healthcare systems can accommodate these therapies and help deliver this innovation to patients. And so this is both on the regulatory side and development and on the access side when it comes to reimbursement and payment and access. So one key thing of note is that a division of the Center for Medicare and Medicaid last year released a plan that would help pay for the new therapies for sickle cell disease using outcomes based agreements. So essentially all of the US states run their own Medicaid programs with funding from the federal government. And so this would enable groups of states to band together with the assistance of CMS to enter into outcomes based agreements with the manufacturers of the two sickle cell therapies. And so this in our view, if done properly, is really a sign that the US government recognizes that these are different types of therapies that need different types of payment models. And so we're going to be watching this closely to see how it works going forward. But it's a, it's a really positive step forward for movement in this area. And then turning over to Europe, some of you may be familiar that starting in January for the first time, there will be a joint clinical set assessment at the EU level. And this clinical assessment will then inform how each individual European Member State decides their reimbursement. And so this is going to start off with selling gene therapy products as well as oncology products. And one of the key things we've been focusing on is the fact that initially the methodology that was going to be applied in this joint clinical assessment with disregard evidence from single arm trials. This is a great concern for gene therapy because they're often targeting rare diseases and ultra rare diseases where it is not possible for ethical or practical reasons to conduct a randomized clinical trial. So if this process is going to require randomized clinical trial, we have concerns that there will it will not fully capture the value or we'll discount the value of gene therapies as they go into that individual member state reimbursement process. So we've been working hard with the HTA coordination group to be more accepting of single arm trials and and justified cases and we're seeing some positive signs in those regards. But we want to see practical implementation of this flexibility as this joint clinical assessment process starts come January. And then turning to the FDA and FDA on the regular side, regulatory side we're seeing more positive sign. So the FDA of course established new office of therapeutics therapeutic products called OTP. This is a super office within the Center for Biologics Evaluation and Research. The new head, Nicole Verdun is now about a year over a year into her her tenure, she's hired a deputy. They've really tried to hire to keep pace for the coming wave of selling gene therapy applications. And importantly, we're seeing more focus on using the accelerated approval pathway for gene therapies. We've seen the FDA kind of really lean into that as an appropriate pathway as a way to get therapies to patients faster. So that's a positive sign. And we're also seeing things like the START program, which is designed to promote more early communication with companies who have are developing rare disease therapies for rare disease gene therapies and then some more signs of kind of modernization and collaboration. We are arm is host is hosting FDA scientific exchanges to tackle some complex issues. For example, we have one coming up a week from today that's going to focus on gene editing as a platform technology. So that instead of going back to the drawing board with every new gene therapy, gene editing therapy that comes along, there can be some agreement on the development of a process. And so that each therapy that comes after it doesn't have to go through each of those same steps. There's also been a lot of collaboration around CMC issues. And we've also done some horizon scanning to really help FDA understand the types of therapies and innovation that's coming forward, so they can get ready for that for those from a regulatory perspective. And then I'll just end on this slide, which is really about the reasons to believe in selling gene therapy, which we think there are many and here's just a few. There's a lot of promising near term commercial opportunities where there's all already 2 individual billion dollars CGT products. And we're expecting that by the end of next year that will double to become four. There's a lot of discussion about Big Pharma's involvement. And so when you look at the top 15 pharma companies in the world by market cap, 13 of those 15 had significant involvement in cell and gene therapy, either in terms of development or and or commercialization. Like I mentioned before, there's a lot of pioneer pioneering work going on in solid tumors and autoimmune disorders and the science is adapting really fast. We're seeing tons of great developments and prevalent diseases like wet AMD are on the high horizon just a couple years from now. And so we're moving like they're still very much focused on rare disease, but we're moving increasingly into more prevalent diseases as well, which of course will reach more patients. So I think that is the end. Sorry, one last thing, just a nice story here. Jimmy Olahare is a sickle cell disease patient who participated in the CRISPR Vertex clinical trial, trial for sickle cell disease. He received the therapy back in 2020 and I think there's probably no other indication to to show how well he's doing than the fact that he recently climbed Mount Kilimanjaro. We think he's the first ever sickle cell patient to be able to accomplish that. And so I just wanted to leave you with that to show you just the immense power of the sector and what what is achieving with patients. Thank you. Great. Thank you so much, Steven for your presentation and your perspective. This is definitely a very interesting topic and thank you for sharing that story at the end. That's that's truly amazing. So we did have one question that came through in the chat. And the question is what's your take on the FDA's off off quoted message on 10 approvals annually by 2025? Would you say that this is still realistic? Yes. So the, as I mentioned the presentation back in 2019, they made the prediction that they could approve to 10 to 20 therapies each year by 2025. I think last year there were seven therapies approved. This year I think there could be 8. And so when you look at the pipeline going forward it it's possible in 2025, I'm not going to tell you that it's definitely going to happen because it's hard to to to know like election what's going to happen with pipelines, but that prediction certainly looks to be within reach and reasonable. Great, great. Thank you for that response. And we do have a couple minutes. So I just want to let the audience know that if, if you have any final questions for Steven to please put them into the Q&A widget right now. So we'll give the audience a second or two. And I have seen another question come through the chat and it looks like investments in CGT has started to rebound in 2024. Can you discuss this in a little bit more detail? And you might have already gone into this, but maybe you can just add another just point or two regarding this. Sure. So we're already on track this year. It's significantly surpassed last year's financing. So that's obviously positive sign and I think what we're seeing is continued confidence in established companies that have good clinical data and strong management teams. And what we're hoping to see going forward is a little bit more funding flowing from venture capital into early stage companies and Series A through C financing. And so we're hoping to see an uptick in that as well, which will really propel the set the sector forward. Great, wonderful. And we did have one more question come through the chat and I think we only have time for just this last one. So I'll ask this last one and then we'll wrap things up. The question was what will make AAV accessible in low and middle income countries? Just manufacturing efficiency or policy or other? I think we're looking at this for now as. Lowering the cost of goods, more manufacturing efficiency, but also perhaps most importantly the development of in vivo therapies. Because as you may know, ex vivo is the is the current approach for the sickle cell therapies, which is a very intensive long process that requires a lot of infrastructure around it. But there is more and more development going on for sickle cell and other diseases and for with using in vivo technology and vivo AAB technology. So that's going to be a big driver of whether we can get these therapies outside the US and Europe into other into lower middle income countries. Great, great. Thank you so much, Steven. And I think that's all the time we have for today. So we want to thank you so much again, Steven for your presentation and sharing your insights with us. What a really interesting topic. And now audience, we have hit the point in our agenda where we will take a short 10 minute break. So be sure to check your watches and join us back here in 10 minutes. We'll see you soon. Welcome back, everyone. And now it's time to move on to our next presentation. I'd like to introduce you to David Owens, Founding Partner at Bauman's Tower Venture Partners. Thank you, Jessica. Well, thank you Jessica, and also for the, the sponsor and the host for allowing me to talk today, inviting me to, to speak. I'm going to have a, a presentation that's going to be very practical. We're not going to talk about science. We're not going to talk about market conditions. We're going to talk about building the critical advisors to help you succeed as an early stage entrepreneur. And what gives me the ability to do this is that I'm introducing myself into my partners is that I've spent 25, the 1st 25 years of my life as a pharmaceutical executive. I started my career at Merck and then a little company at the time that had no products in the market called Genentech called me and I was able to transition to the West Coast of of the United States and launch the first 3 products at Genentech. Went back into the larger farm again, then back into biotech with Genzyme and then back into the larger farmer. And in 2009 I actually semi retired. I became an early stage investor. I have now for 15 years have made an early stage seed investments, founding investments in in companies, early stage drug development companies. I've been a board director and a board director and an entrepreneur. I've made 8 investments in some of these into these companies and four of them have accident. So I've been an operator at the pharmacide, I've been an operator on the entrepreneurial side, I've been a investor, I've been a founder and I've also sold companies. Bonus Tower Venture Partners is a group of similar people. We are investors, founders, operators, boards of members of board of directors and have spent our careers in the Pharmaceutical industry but have decades of experience and have a passion still for helping build companies. What we do as a group, and there's about 30 of us, we advise and invest in early stage life science companies by providing mentorship, strategic guidance, operational support when you need it, and also the seed capital through our network of investor consultant experts. What I'm going to talk to you today about are trying to understand how to choose those people that can help you with your journey into building a company. If you're a scientist. I am not a scientist, I'm a pharmacist. I've been an operational person for my whole career, but I have been at the company formations. I've managed billion dollar businesses. I've advised companies, I've been there to raise the money. I've been an investor and I've been there to sell to companies. So I've been at the negotiating table to sell companies to larger pharma companies. My other partners of that, several of them are here, are also in a very similar type of situation. They tend to be Cpas, attorneys, MD's that have managed clinical groups and business development people that who for the last several years of our careers have decided that what we want to do and what interests us most is helping entrepreneurs succeed in building businesses. So I'm coming to you today to speak to you about some of the practical applications of who to find to help you in the journey in building your business. And it really begins with the scientist. You've identified a unique top technology or, or some kind of technology that you think had meets a commercial need, an unmet medical need or a market need. And you're deciding, what am I going to do with this now? How am I going to build it into a company? How am I going to develop an investable business plan? What are the best ways for me to get funding into the future? And how do I get the people to help me and help me navigate things that I'm not familiar with and new challenges that I haven't done before? I want to become an entrepreneur. I've been a scientist my whole life, and now I want to start something new. That's where it all begins. And that's the type of situation that we walk into. In thinking that through, you may already know the science. I mean, you've come up with these great ideas. That's your your core competency. But there's so much more into building a company. How do you develop the business plan? What does it need to look like? What are all the critical elements? How can I make it convincing to investors? That's a true test and it's a true art, something that not everybody can succeed with. You have to be thinking about the corporate entity. How what kind of company am I going to be building here? Is this going to be a company that is going to be structured as an LLC or limit? And every every country has its own specifics to that. Is it going to be AC Corp? What do I do about record keeping? What do I do from regulatory requirements? Are there governance structures that have to go into place where I have to have a board of directors, scientific advisors and so forth? All of that should be thought through as early as you can in the development of a company. In addition, there are practical issues such as staffing, equipment, space. Do I hire right away or do I start to look for contractors or advisors? How do I acquire capital needs the such as equipment leases where the physical space is needed? I just heard a presentation before about incubators. I have worked with several different incubators across the East Coast of the United States. Very familiar with them. They're a great opportunity, but as you expand and grow, you may need to meet do something quickly very differently. In addition. Then there's the whole investment in financial, financial management. Once you start asking for other people's money, not your own money, but other people that are investing, you got to be thinking about all the different ways that you're going to manage that capital. You're going to report on that capital and you're going to live up to the expectation of those investors. Those are the kind of things that should be thought through as quickly as possible so that you can create the structures and the the people and the, and the infrastructure that will help you manage those needs. Let me start with one of the first decisions you'll need to make, and that has to do with legal services. One size does not fit all. There are a lot of companies that will start off with a corporate attorney and realize very quickly that that person may or may not fit all the needs that they have in this organization. They're usually the group that helps sets the company up, gets the articles of incorporation, figures out some of the basic legal documentation and protocols, and could be a daily advisor to you on many issues as you start to build a company. But they aren't necessarily going to be a patent attorney. You need to find a patent attorney that's going to help you through the freedom to operate, opinions, the intellectual property and so forth as you move on. And so looking for a corporate attorney that has has patent experience may not be the right choice for you. In addition, it's just a matter of time that you're going to have to have an employment attorney looking at contracts, looking at policies, helping develop as you build an organization to how to best serve the needs of your entire organization, employees. And at some point there may be litigation. I've started, as I said, eight different companies. We in four of them we have been sued at some point in time by an employee. So those are the kind of things that you look at is legal services that you've got a fraction out there who are the various types of legal sources that you need at what points in time, tips and thoughts about that. There are a number of law firms that actually are known for providing early stage or emerging company service. They generally have special pricing and benefits to early stage companies. They may offer discounted rates. They look for where they can provide additional help and paralegal services and associates to work on the account to help lower the overall cost. But when you want to look for those kind of people, you want to look for those that are geographically reputable. I always look for legal services that are local in the area of which I'm operating a company I'm not looking for. We're on the East Coast of the United States. I rarely will look for a West Coast law firm to help us in the early stages of starting up companies. So you need to be thinking about those kind of companies that can help you that are specifically needed for your needs. You can have friends that are lawyers. I don't suggest that. I suggest looking for those kind of attorneys that really understand the emerging life science space. Selecting those type of attorneys can take time. I look for getting requests for proposals from several different firms. I talked to the trade organizations and the and the others so that I'm involved with for recommendations, other entrepreneurs and trying to find out who, which firms they like and which ones that they've had good success with. And I interview them. What's really important is chemistry between you and your legal services is critical. You're going to talk to them almost every day. They're going to have to be someone that you trust and also that you have good chemistry with. And they represent not just you, the entrepreneur, they represent the company and the board of directors. So it's an important criteria by which you select your attorney and counsel. Another critical early advisory services is financial. You don't need ACFO right away. In fact, I've played CFO at a number of companies in the very beginning and I'm the furthest thing from a CFO. But what you need to do depends on the source of capital that you get. If you're bootstrapping your company yourself, you can do a lot of this yourself. However, it gets burdensome and you have to be thinking about setting up chart of accounts and using Quicken and all different kinds of payment services for your vendors. So that sometimes gets old and weary very quickly. Another way of doing this if you have, especially if you're getting grant money or other non dilutive capital, is using bookkeeping services that can help you with all the setup of accounts and chart of accounts and help follow the flow of money and take that as a burden off of you. A lot of times, as I said, with investors where you have other people's money or OPM, they're going to require certain types of financial accounting requirements. And if your business gets more complex, you're probably going to have to find yourself in hiring ACFO or controller that'll help you manage all of the bill process. And also the the, the capital needs a book. So it really looks like a bookkeeper, CPA firm, controller, CFO or the continuum in which you're going to look for financial advisors. In addition, you're going to need a tax accountant and people that will help you with your tax taxes. If you don't, if you have a bookkeeping service, they won't do your taxes. So you're going to have to find a tax account to help you do that. And many times I found that payroll companies, depending on the geography that you're in can make all of this so much easier, especially if you have an, you're starting to grow the number of employees you have to more than just a couple. So looking for those financial services that help meet your growing needs as you as you build your company is going to be really critical. Some thoughts on how to do that. Well, a lot of this work is transactional. It's paying your bills, it's paying your taxes, it's paying your payroll. These are not complicated processes, but you need an expert to do it. So very similar to what you do with the with the legal firms is go out and do request from a Pope, request for proposals from several different firms. Talk to the companies that are similar to yours in an area and trade associations for recommendations, but be clear and interview with them on what you need and how your business might grow. You're going to need to be thinking about cash flow all the time. That's the cash in and the cash out. So find those experts can help you figure that out and look for banks that can be friendly to start up organizations. You're likely not going to get a line of credit right away, but there will be a point in time where you're going to look for a line of credit to help with cash flow. So reasonable local regional banks are sometimes the best way of going. I don't go with large banks nationwide. I look for local regional banks that are willing to help invest in early stage companies. This slide is important. This is the one I'd like to try and spend the most time on, but it's the business planning and government aspect of your company. There's really three to four different groups. You should start very early in getting those experts that can help you with your business. That's the role that we play at Bonus Tower Venture Partners, looking for strategic advisors that can help you build the business plan, help you develop the business model and help you in the fundraising so that you can be quick and strategic and how you're going to X source your capital and successful in doing so. Those sometimes are hard to find. You have to be looking around for those types of groups of experts. A lot of times a lot of venture groups will help you do this. In fact, they're about, it's become a growing trend within the BC market to actually start that type of advice to early stage companies from the very beginning, especially those that are coming out of university settings. But look for those type of strategic advisors that can help you that aren't necessarily scientists, but are the people that have built companies, the people that understand how to get financing, the people that can build a business plan that can help be convincing to you to raising capital. That's a key aspect that that would be beneficial in helping you build your business. A board of directors, this is something that comes up quite frequently too. Ultimately you're going to have to have a board of advisors, especially as you start raising capital from outside of, of yourself and and other what I should call non dilutive capital in that you're not looking for necessarily people that are going to be your friends. You're looking for people that can complement your capabilities, individuals that can understand what it takes to build a company that can provide you the issue or can provide you good solid guidance in guiding strategic decisions, financial decisions, governance decisions, employment decisions. All of those things that have are going to be critical as you start to raise your awareness of your business and raise the complexity of your business. What I look for and I'm I'm, I'm on four boards right now. I don't always get along with the CEO, but we respect one each other because we respect our differences of opinion and we respect the value that each brings to the team. So look for those people that you can trust that can be able to help you build your company, that can approve the actions that are important to the shareholders of the company. Equally, a scientific Advisory Board is also is critical. We look to scientific advisors to help us understand where we are going with our business that are broader than what we have specifically with just the internal staff within the organization. So looking for those key scientific advisors that can help you. And lastly, I know I'm running short on time, is the employment services somewhere along the line, you're going to build a staffing plan. I suggest that you find yourself a human resources advisor that can help you, that can give you guidance, and they can help you put together all those compensation and benefits analysis and everything that you have to do to build an organization that you want to attract quality people. So what's left? Well, there's obviously something such as IT and website, insurance, lab space and furniture. All of those things are something you shouldn't have to do yourself, but you should be helping get finding people that can help you do it. So the key takeaways for my short period of time here is that you should focus as a scientist. Focus on what you do best, your core competency, but build that team around you that can help you do all the other things that are important to building a business, an ongoing entity. Chemistry is going to be important and all those people that you pick. So people find people that you trust, find people that can that you can afford, incentivize them to help you build a business and by that meaning giving them some shares in your organization. And with that, I think you'll find yourself in a better position to attract capital, build a solid business and with any success, be able to form an exit and sell your asset to off to A to a strategic acquirer. And with that, I'll allow it for questions. Thank you so much, David for your insights on this crucial aspect of establishing a solid foundation for the long term success and growth of an emerging company. Your background is impressive and you've definitely give them some very helpful pointers and tips for for how to get started. And with that, this is we've now moved into the Q&A session. And if there are any final questions for David, please submit them now using the Q&A widget on your screen. So audience Q&A is open. Please submit your questions now and David will wait for some. We don't have a question yet, so we can just wait for a question to see if it comes through. That's fine. But in the meantime, as we wait, if there's any questions, if there are any final pointers or pieces of advice from your past experiences that you would like to leave us with, we can. We can maybe if you would like to add that, I still don't see a question. We have another minute before we go to our next presenter. So if you have anything else to add, feel free, David, or maybe you've covered everything. I think you give a very clear presentation. So I don't think we had too, too many. Any questions? Oh, very good. Well, I hope. I wish everybody success in their endeavors and hopefully I'll read all about you and in the in the on your success. Thank you. Wonderful. Thank you so much again David for for your time today. And with that, we're going to be moving on to our next presenter and our actually our final presenter of the day. And so we welcome Arda who will be giving a presentation on the state of biopharma and funding innovation. And with that, Arda, I turn things over to you. Thank you very much, Jessica, and I hope everybody's having a great day so far, great presentations to follow through. So I'll try to build on the, you know, practical advice as well as this LNG therapy deep dive as well as what Oliver started with the funding access. I'll try to capture it all and then hopefully it's going to be a helpful take away for everybody. So views are expressed belong to me, not EUI. And you know, maybe 10 seconds about my background. So I've been 30 years into business, 20 of which I was in the industries, a large pharma companies running businesses for them and a biotech startup, which is I think relevant for all of our audience today, which we took public and then got acquired and finally a Med tech company. I ran two of their businesses but also was head of strategic marketing and then flipped to the consulting side of things. And I'm accountable for Eli, America's life sciences sector for the last four or five years. And Eli as you know is, you know, 50 plus billion dollar company with almost 400,000 people around the world. And specific to this audience, I think what you may want to be paying attention to is the IPO readiness or access to capital markets, commercialization, market access and audit. If that's something you need. Those are the things that in our company offers. But with that, let's dive in and and please do connect with me on LinkedIn. You will see my opinions coming through there as well as happy to connect with you if you got any questions or perspectives. So let's talk about, you know, how the industry is shaping up in 2024. We obviously are in a very interesting time just you know at the end of an election. And some of these areas that you're seeing will be affected as a result of that. But there are many secular trends right now shaping the life sciences industry. I'll just hit some of them and then some of them I'll drill down deeper. But just to start with the obviously the big, big word is Gen. AI and how the use cases are picking up quickly. I think that can be our next opportunity to seize as an industry to get through some of the challenges. I'll, I'll explain in a second where the, you know, patent explorations are hitting the top 25 pharma companies really hard and that's going to be the case for next couple of years. Then maybe tax operations and strategy are becoming more and more complex. I think the, if there will be tariffs coming up that's going to make things even more complex with inbound active product ingredients or the OR the suppliers you will be hiring to work with. Similar to a technological advances, cyber security and data privacy risks are becoming something to be really on on top of then supply chains are reshaping as a result of that. You're seeing a lot of the China based manufacturing moving to Latin America, parts of Mexico and we'll talk about the workforce and how it's changes over the years separately, but also regulatorily. There is quite a quite a few things that are shaping up our industry with the Inflation Reduction Act and how it's shaping our you know, small molecule versus monoclonal antibody investment upfront because of the exemptions in there. Bio Secure Act will come to play in, you know, eight years because of the lobbying efforts and that will define who to work with, who to pick as a, as a supplier and of course the FTC in a new, new administration, we will see change to the FTC and that will have impact probably on the M&A and I will drill down on some of those. And finally, last but not least, the Fed's moves to start lowering the rates has some favorable impacts because of the high cost of capital will be, you know, kind of gone to to make it easier for M&A as well as running businesses. I'll come to those two bottom boxes in a few minutes, but let's start with the big picture first. As I kind of tried to explain, it's a very multifaceted and complex environment. So what makes this environment even more complex? Starting, you know in 2023 to 2028, you see the percent of revenue which is at risk due to loss of exclusivity wave that we are living through is going to be in a fairly large. You're talking about 2028 because of the Keytruda and others, 6.7% of the revenue will be just washed down. So this certainly creates a person a certain pressure on the industry. But let's kind of step back for a second and take a look at the big picture. And when you look at this graph, what this shows you is the imbalance between the, you know, top line and then the pipeline. And then if the if the number is over one, then your pipeline is supporting your top line. And historically speaking, I think you see that dashed lines about 1.6 times has been historical median for for this. So how to interpret this? We go back to 2010 were the small molecules patent Cliff hit the industry in a pretty steep way because it was easy to change the prescriptions to overnight mail services. And with that the industry kind of got its first hit. While the small molecules that you all live through treating mostly general population diseases have been wiped out. And then came this, you know, steady upswing with the monoclonal antibodies that helped the industry get back to its historic leverages. And in 2020 to 23, we saw any, you know, abnormality because of the pandemics impact. If the pandemics impact was deducted, excluded, then you would see the dashed white curve as opposed to the yellow solid line. So with or without it, I think the industry now is on this downward slope because of this $300 billion impact that I talked about in the prior slide. So the industry is in an ominous place to replace all that innovation with new innovation. And we'll talk about some of that in the next several slides. What is it that's going to help us because the small molecules was replaced by monoclonal antibodies. So what will replace monoclonal antibodies? And then one might speculate it's probably AI because the science coming through the pipeline is not, you know, is necessary but not sufficient in terms of numbers. We are talking about South. One cautionary advice that's helping us all is that the prescriptions will continue to increase. The volume of prescriptions are not at any mercy of any recessionary periods over the years. So that's, I mean ageing population, we all get sicker. So that's certainly not changing. But that alone is not going to be sufficient I think for the industry to replace its top line and everybody's innovating something on this call and that will be necessary but not sufficient. So we need something else. So that's why I think the AI component will be very important to, to watch closely. And then that's why you saw a lot of capital funding flowing into the AI enabled companies. So if you look at the AI pictures, overall, what you see is absolutely a stunning kegger between 22 and 32 / 20%. And then technology itself certainly is a, is a massive driver there with the GPT and, and other now multimodal actually AI come into place. There is voluminous data, especially on the imaging side of the house. It's going to make really easy for a pathologist and a radiologist to interpret data with AI support and also the kind of connecting with the patients and commercialization with the, you know, actions like next best action, how to engage the as your professionals will be very important. And then there's some challenges. The technology requires a lot of processing. If you are kind of looking at this space, you see a Google search versus, you know, Google's Gemini source takes about 17 times more energy. So we need to really, you know, build an infrastructure to support the energy, the big data, how much processing can be done on, on the cloud, regulatory and ethical issues like how do you make sure that the there are no biases in the AI and then the kind of LLN, the large language models are trained in the right way. So you don't get a lot of these hallucinations. And financially, of course, we need to find those in ROYS and then business cases early on. So that's I think an interesting way to look at it. But I think one may speculate that AI will certainly help us, you know, help the industry get back to its growth pattern over the years. Other areas, not just looking externally, but also looking internally. If you look at the SGNA overall over the last 10 years, it's about stock like 28%, which is amazing because you would think that with all the productivity increases and all, you would just be able to run a company at that much efficient way with the SGNA, but it's about 28% and stuck there. So as you know here we have a lot of opportunities for AI to take cost out and and also the other element is the R&D expenses. These are the number of clinical trials that are captured in the clinicaltrials.gov. You have about 500,000 now and look at the steep increases over there. So clearly the R&D expenses, which is about 18% of the industry's revenue increase from 12% or 20 years ago. So I think about the the picture that I tried to paint, you have the top line not supported by the pipeline, you have the SG and a stuck at 28% and your R&D expenses are increasing because the targets that are to be picked are already picked. So this kind of puts you know a big challenge and opportunity on the industry, how we will be bringing up the performance and then innovation at the right level. This also obviously brings workforce challenges. If we drill down on the workforce and workforce specifically has been discussed in the post COVID environment, what's to return to office policies and how are we going to find the right talent? How are we going to upskill our talent with the, you know, AI? These are, you know, front and center issues for large companies and small companies alike. And this is the breakdown of the workforce in four categories based on Bureau of Labor statistics. As you can tell, at the bottom, the sales force has been about 80,000 stabilized. And I think the AI certainly will help the sales force to be more efficient and effective by guiding them what should be their next action when they're discussing their science with the clinicians. And then the other thing that is worthwhile to observe here is the top layer, which is the R&D with all these clinical trials. You clearly need, you know, kind of a very skilled and and global workforce to be able to sustain that clinical development and supply chain is certainly not getting smaller as percentage as well as in in kind of large numbers. So these are, I think not only isolated to business challenges, but also to people challenges as well. So if you have questions, please and fire them away. I will try to take them as much as I can. So I think I tried to pick paint the picture like how the business is run and and the people's skills. Let's talk about now capital markets and what it means to in the next era of lower interest rates, how it's going to all pan out. In fact, there were probably 2 uncertainties before the markets a couple weeks ago. The first uncertainty was the Feds direction and I think it's becoming clear that they will start lowering the rates through the June time frame. Our economist unit is projecting the rate will be probably around 3.4% by June. But that's helpful for the industry, which has been stuck and not gaining access to capital over the last two years. And so this is all welcome news. And if you look at the EXPI and ERG indexes, how they responded to inversely responded to the treasury bond yield, you will probably see that it's a helpful way for everyone who is looking for capital. Because in the COVID years, which I call the like the the sugar high years, if I kind of joke sometimes if a if a founder and a dog walking to the VC and a dog talking an idea, they would get funding. That's not the case anymore. They're looking for really strong management team with record of success. They're looking for science that is de risked the amount of dollars flowing into the late stage assets have been, you know, historically much more now than than in prior years. And there has been also some normalization of some of the investment in Sal and gene. Steven did a great job in explaining the Sal and gene therapy. So the the amount of you know, the amount of scrutiny going into that has been also higher given the paucity of assets actually plenty of assets a paucity of access to to capital. So this is the picture for how the funding changed between the IPOs and follow on offerings and the venture capital which David did a great job explaining and pipes which is the private investment into public assets. So if you, if you look at the, the pipes in the last two quarters, in the first quarter second, you see a bump there and that is the preference for liquidity because the, the markets have not been for the except with the exception of the last couple months, the markets have been very, you know, unpredictable and tight in terms of the venture capital exits. And because there are no IP OS, the IP OS have been typically 100 and 10110 IP OS went you know kind of public in the, in the sugar high time post pandemic. But then this year alone is like 23 only. And then the normal IPO, you want to see about 50 and we are seeing more inbound requests for IPO readiness preparation. So that's a good sign. And I hope that IP OS will come back to about 30 this year and then hopefully will normalize around 50 moving forward in 2025 and onwards. So this is a picture in terms of how the about US biotech funding over the last five years have been shaping up and we would like to believe we will come back to a more healthy environment in the 2025. I think JP Morgan will be an interesting point to to observe how the sentiment is shifting. So the other one to watch out in the in the in the IP OS and then the interest rates is you see the very much inverse correlation over here. So if you look at the number of IP OS per month, how you saw that sugar high period of two years and then how it's really kind of leveled out at almost 01.7 per month. So we hope that IP OS should come back with some backlog, strong backlog in in 2025. And finally what I wanted to talk about here is on the deal making side, how the M&A is is happening. And then what you see for both methic and biopharma 2023 from a value perspective, you see a little look at a mad dash towards the end of it, but it did not follow through end of 2024 with the macro conditions not supporting the expectation that the rates will be lowered sooner. But I think now we are finally there with the rates moving in the right direction and the uncertainty on the political outlook has been also to an extent kind of extinguished. Obviously many more to come to see especially for the HHS and FDA appointments. But it looks so far all systems go for a strong healthy 2025 capital markets. Again, it has to be a a de risk asset and and and experience management team. So here I would like to point towards a tale of two cities picture for the biotechs because what you see on the left side is the premium paid one day post deal. And as you can tell, the 83% and 75% are remarkable premiums that are paid for deals in the acquisition scenario. But on the right side, about 1/3 of the biotechs for the last two years don't have cash to run their operations for about a year. So a really big economy here and then it's probably going to continue to cause mergers, reverse mergers or bankruptcies of some of the biotechs who extended their means to do the cash burn. And then they will need to kind of rein it in or do some other creative strategies to do so. I'm also involved in multiple incubators as advisor. So you kind of get to see it first hand how disciplined approaches will help those biotechs with the management team. So I've been there before and helps how to move forward. So this obviously all predicated by what you bring to market, which is innovation and FDA approvals thankfully have been really healthy and we wish that this you know sustained performance by the FDA responding to the PDUFA dates Cedar or Sieber will continue. As you can tell the last 10 years to 15 years average has been about 60 meeting approvals including all there was a discussion about this you know car T and and S LNG therapies about 10 to 25. I think those are the innovations that kind of keep that numbers at 60 and it's all healthy. I think outlook as long as the innovation is happening, it's going to you know get to the market. The question of course the market access and commercialization and the value proposition of all each of those therapies, where are the therapeutic areas is the question here. And if you look at the, you know, biopharm MNA deal value over the last, you know, five years, yellow being the 2009 and then the amber being on the real right side, the year to date third quarter to 2024, you see how the accumulated value shaped up. But you see oncology to be by far. In fact, if you look at immunology and inflammation, rare disease and CNS combined is not more than oncology. And of course oncology has a lot of unmet medical need, easier reimbursement patterns. So it continues to lead the way and as we I think Steven talked about the saline gene and the new modalities that's been offered, especially the antidrug conjugates, the bispecifics, radioligand therapies and also the approach of CAR T's to solid tumors. Not only which is the majority of the cancers as well as the use of autoimmune diseases like lupus and myasthenia gravis, which have a lot of unmet medical need will continue to drive the products in the oncology towards new heights as well as the immunology and inflammation. Rare diseases have been discussed I think earlier as well. While there's a massive unmet medical need, about 70% of the rare diseases actually there are 7000 rare diseases, 80% of the rare diseases are, are gene related and 80% of those are monogenic. So if you can fix that problem with a gene editing capability, which is now in the market, you know, thanks to also Nobel laureates having, you know, brought those, you know, CRISPR technologies to market into patients, the technologies there. The question is access and reimbursement and and potentially supply chain kind of scale. So this is the picture and then not to ignore of course other like ophthalmology, cardio, cardiovascular and metabolic diseases. This picture does not capture or does justice to GLP ones. You see even small changes in the GLP ones, you know, to clinical trials can swing a large company market cap valuations, you know, fundamentally and for those reasons, I think the the market is missing primary care products and, and maybe with the GLP ones, we will be able to balance this very specialty heavy picture that I'm showing here with some primary care opportunities as well. So let me kind of conclude and then potentially open up for questions as well. Let me conclude with a good, good picture. So when you track pharmas, biopharmas, top 25 pharmas firepower, we have reported this over the last couple of years. And then we started talking about, you know, 1.2 trillion, this is all in in 2013 and they kind of leveled up around the trillion and then with COVID it started increasing and now it's reached $1.6 trillion on all time high. And it's a key driver for, for absolutely, you know, M&A. So this I think is also a good picture to to leave you with. And what I can maybe conclude this conversation is the market was waiting for two big challenges. One was the Feds rates because you saw the relevance and relationship of the Fed rates to IP OS in the markets and, and fundraising. And the other one was the elections, especially the uncertainty around it, which is now behind us. So of course it introduces new uncertainties within itself like who's going to run HHS or how is the FDA's behavior going to change, if at all, or how is the relationship with China will regulate the inbound technologies or the OR the vendor uses for the CR OS and CDM OS. All of those of course are not going away, if not exacerbating, but the, you know, direction of travel at least suggests that we are as an industry in a good spot, whether you are, you know, trying to sell your grow your technology or managing a business, multiple billion dollar business. So you, I think 2025 plus finally is there for us to have a, you know, positive outlook after two years of uncertainty and cautious optimism. I think that we can't drop the cautious and then I think the optimism will kick in. So with that, I'm, I'll open up any questions that Jessica, that you may have seen or asked the audience to type in their questions now. I hope this was a helpful summary of where the state of affairs are at the, you know, 30,000 foot level where the industry is. Thank you so much, Arda for your presentation and your insights today. This is extremely helpful and very impressive. And now I open this up to the Q&A. So I'll just go over to the Q&A slide. So audience, if you have any questions for Arda, please submit them now using the Q&A widget on your screen. Great. And we do have a question, Arda for you. So with the first question, what will be the implications of the elections outcome on the business? You touched a little bit about this, but I'm not sure if maybe you had another point or two to add. I think, I think it is not de minimis the some of the trends I tried to indicate in the like big picture slide for example in the regulatory side I can specifically drill down on 2/1 is the Bio secure Act and the other one is the Federal Trade Commission changes which I didn't spend enough time. Bio Secure Act is a bipartisan for non-us audience here. It's an act that was passed in a bipartisan fashion in August and it just limits the enrollment of some of the China based companies in the CR OS and CDM OS in dealing with the drug development because of the, you know, privacy and patient patient data and and and just being, you know, lowering the risk of doing business. So while that may make sense from a just AUS government perspective, sciences global and there were many, many clinical trials who are being done in China inexpensively and efficiently and fast. So many companies chose to use Chinese vendors for those to get their technologies faster to market. So for that reason, I think there's an 8 year time frame now for the transition to happen. So that certainly introduces and and uncertainty and challenge to the business because those CR OS and CDM OS now need to be replaced by by others in either locally or by other companies by other countries, I should say. So it will pass is the general belief because of either in the lame duck session or post, you know, January 20 when the new administration takes place. And then the second one is the Federal Trade Commission has been historically more lenient on M&A deals in the in the pharmaceutical business. I think that with the revamping of the FTC, which is the expected revamping of the FTCI, think the approach will be more, you know, back to the historical normal, which is, you know, kind of obviously not giving a card plush to to anyone who wants to merge. But I think the scrutiny will be less on especially deals below the Hartscott, Rodino threshold. So I think those two will help the FTC rather will help with the M&A and acquisitions. So this is probably for for the industry, it's good news. And then probably those are the 2 immediately relevant changes. And of course, the biggest change is who's going to run HHS and Human Health and Human Services and FDA, assuming that will not be disruptive and credible assignments will come to place. That will be, you know, great news to the industry because this industry is is is global in nature and probably the most impactful on human life. And that needs to continue to allow to innovate. So I hope this answers the question that came on the elections. Great, great. And I think we have time for one more question. So another question we have is, should we expect more IP OS in 2025? I think the answer is I would say so. I would think so. The IP OS will be back because of the funding. There is is quite a few and there's private equity funding in addition to the public funding. It's an all time high over $3 trillion are also with the private equity. So the IP OS I tried to depict their relationship with the IP OS, with the capital, access to capital. And if we believe the historical nature of the IP OS, I think there should be more and that there is frankly more mature technologies available to come out of the backlog and into capital markets. And you know, happy to, of course, you know, go one-on-one if anyone is interested. But interesting times, I think a good exciting positive outlook, Jessica for 2025 S thanks for having me and more questions. Please connect with LinkedIn and happy to stay informed on what we do. Perfect. Thank you so much, Arda, and thank you again for your presentation and for your time today. We've really enjoyed having you here. And thank you again to all of our experts for their presentations and to those of you in our audience for your attendance at our symposium. Thank you again. Day 2 will begin tomorrow at 10:00 AM Eastern, the same time again as today. So that's all for today, folks, and thank you again for joining us, and we look forward to seeing you at tomorrow's event. Have a great rest of your day. _1733345837982

  _1733345838228