Christine Wolosin
Chief Commercial Officer at 4BASEBIO PLC
Replay available
Investor Presentation hosted by 4basebio (LSE:4BB) on Investor Meet Company, held 2026-06-29.

On 6ix: 6ix.com/event/4basebio-plc-4bb-investor-presentation
Automated transcript · Written by software from the replay's audio. It can mishear names and figures; the replay is the record.
0:00 Good afternoon, and welcome to the 4BASEBIO PLC investor presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and could be submitted at any time via the Q and A tab situated on the right hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to Amy Walker, CEO. Thank you very much. So I'd like to start off today with 4BASEBIO's mission statement, and that's really through our enzymatically produced DNA, we enable clinical and commercial biomanufacturing for advanced therapeutics, empowering safer, faster, more cost effective treatments to improve outcomes for patients worldwide.
0:53 I'd also like to take the opportunity to introduce the new leadership team here at 4BASEBIO. So so people might remember me. My name is Amy Walker. I'm the chief executive officer, and I was appoint appointed as CEO, in February of this year, formerly serving as as chief operating officer. Next to me on the slide is Christine Willison. Chrissy will join me for this call today, and Chrissy serves as our chief commercial officer. She has a wealth of experience over a range of different CDMO businesses, including Trilink and Thermo Fisher as well. As we move across, we have Scott Lorimer, who was appointed as chief operating officer earlier this year. And like Chrissy, he has a wealth of experience in the industry leading global operations for a number of companies, including Catalent, Sanofi Genzyme, and Patheon as well.
1:41 And finally, we recently appointed Richard Bunge as our chief financial officer, and Richard will be joining the company, in early July. So maybe just to remind everyone a little bit about what 4BASEBIO does. So our technology platform is an essential DNA manufacturing solution across the breadth of of cell and gene therapy and and vaccine applications. Really, the objective there is to deliver highly pure, scalable, enzymatically produced DNA and supply this DNA as a critical starting material or a GMP drug substance into clinical trial applications. The way that we manufacture DNA is faster and more cost effective than the traditional plasmid and bacterially derived methods, and this is really this incumbent technology that we wish to to displace.
2:33 And as I mentioned, we really want to support a wide range of therapeutics across the broader gene and cell therapy market and capitalizing on that strong growth in genetic medicine market currently validate val valuated at an excess of 20,000,000,000 per annum. As a reminder, the company was established in 2020, and to date, we've served over 125 customers. The IP is governed by 33 patent families. And very critically, last year, we received our GMP certification from the MHRA, which really allows us to build DNA that can feed into clinical trial applications. And, you know, to that end, we have supported four INDs and CTAs so far. The the furthest advanced of our clinical assets is a phase two asset. We really position ourselves as leading the revolution of cell free DNA manufacturing, and I think some of these stats attest to that.
3:28 So today, we're working with six out of the top 10, tier one pharma companies, as it stands. And throughout 2025, we were able to support 52 global customers who purchased DNA from 4BASEBIO. We currently have two customers with phase one two clinical trials running, and we have familiarity and acceptance from three regulatory agencies where we have been approved for clinical use. That's really from the FDA, here in EMA and in The UK and also in Australia. So we've really been focusing on the manufacture of DNA since 2020. And you can see here a very brief timeline of our history. 4BASEBIO spun out of our parent company, Expedia, after it was sold to ABCAM at the back end of twenty nineteen.
4:16 And it was at that point in time that I joined the the company as as the first employee. You'll be reminded that we are an AIM listed company. We were listed on AIM in 2021. And you can see that over the course of our first years of development, we really focused on building out the infrastructure and the GMP labs that are required for our manufacturing processes. And, really, that early stage of development was focused on scaling up this platform, our enzymatic DNA platform, from the bench and ultimately into clinic. You can see a very significant milestone in 2024 when our first patients were dosed with our synthetic DNA technology. And 2024 was also a pivotal year from a corporate development perspective when we were able to bring in a $90,000,000 strategic investment led by Patient Square Capital through Elvage Medical Technologies and also M and G here in The UK.
5:12 The following year, we were able to receive our GMP certification from from the MHRA also here in The UK. And you can see that ultimately in 2026, I became appointed CEO, and we built out the the new leadership team at the company. Here, you can see the 4BASEBIO cap table as it stands today, and, really, that is nicely split between our core shareholders through to invest, holding around 33% of the cap table through through various groups in Germany. And then we have Allevage Medical Technologies and M and G comprising another 30% of the cap table. And then the remaining is really held around senior management, board members, and then a free float and long term holders comprising the the last section of the cap table.
6:01 I want to comment on the strong patent portfolio that we have across the breadth of the DNA manufacturing technology. So I mentioned already, we have 33 patent families that really govern the process, and you can really see this as end to end. So it starts with the enzymes that we use to manufacture our DNA. It runs through all of the different manufacturing steps. And very importantly, we're starting to have product claims granted as well. So these are really the products that we make with our manufacturing process and how we deploy them in downstream applications. I would position ourselves as a global company. At this point in time, our headquarters remains to be in Cambridge, UK, where we have a couple of sites that I'll talk a little bit about. But I think throughout 2025 and into 2026, we have significantly expanded our global commercial team that is led by Chrissy. She's based in The US as are a lot of her BD and marketing executives.
6:56 And we have a growing sales team here in Europe and The UK as well. You might recall that one of the differentiating factors about 4BASEBIO is that we manufacture the enzymes that we use within our manufacturing process, and this happens in Madrid and Spain where we have our manufacturing facility, and that was really where our technology was invented, rolling circle amplification was invented. If you look at some of our workforce stats, you can see that 28% hold a bachelor's, 43% hold a master's, and 12% of our of our team and our workforce hold a PhD, representing 23 different nationalities. So we have an incredibly scientifically minded workforce which really serves the company. I'm also pleased to announce, that we are moving into a new headquarter facility, here again in Cambridge UK, and this new facility will augment the capacity that we already have in our GMP manufacturing suites by allowing us much higher capacity in those earlier stage research grade DNA batches in addition to allowing us to serve very exciting personalized cancer vaccines where we're really making therapies for n of one medicines, whether that's for a vaccine or or an exciting gene editing technology.
8:10 So we're hoping to be moved into this building before the year end of 2026, and we're really excited about the substantial capacity that this will enable for the company alongside remaining to foster our IP strategies and all of that development that goes into to the process. So now moving on to the market and the opportunity. So some stats here. Really critical starting materials for genetic medicines is primed for disruption. So you can see here a number of statistics. The global plasmid market size in 2025 is estimated to be over 2,400,000,000, and this is really the the market opportunity that 4BASEBIO sees, the total addressable market, and ultimately what we want to disrupt with our synthetic DNA.
8:56 Very critically, you can see that 86% of that plasma DNA market is is revenue associated with GMP grade plasmid. So GMP grade plasmid is the sort of plasmid that can be used in clinical trials and beyond, and that's why it's of utmost importance that we now have our license and are able to penetrate into these opportunities as well. And we really see this demand growing and expected to to increase as as the years develop. If we look at the right hand side, perhaps unsurprisingly, the largest market remains to be North America, and the fastest growing market is is perhaps again unsurprisingly, APAC. And we really position there to be a significant opportunity with delivery mechanisms for genetic medicines to advance through the clinic.
9:43 And so on the left hand side here, we are looking specifically at viral vector applications. So this could be AAV therapies, lentivirus therapies, for example. And you can see that there's a growing number of assets that are evolving through from phase one through phase three and all of that clinical development. If we look to the right hand side, there still remains to be double digit growth within this market with a 12% CAGR year on year through 2030, and that North America really leads the viral vector market share and has done so since 2025. So you might remember the different flavors of of DNA that we can manufacture, and this is very important for 4BASEBIO. It is a significant differentiator as compared to our peers or indeed the incumbent technology being plasmid.
10:31 And what that enables us to do is to manufacture application specific molecules depending on the downstream application. So if we are partnering with an mRNA client, for example, they may receive a molecule like the right hand side of this schematic. Likewise, if we're partnering with a viral vector client, they would receive another flavor of DNA. And, really, these different modifications on the DNA help us convey downstream benefit as compared to plasmid. The end market opportunity is is huge, and you can see here some of the sorts of clients that we work and partner with, on a day to day from 4BASEBIO. And, really, just to highlight some of the reasons why our partners, whether that's biopharma or biotech or even our CDMO partners, are starting to choose and recognize enzymatic cell free DNA as odd competing plasmid.
11:24 For me, the most important, and I'll talk a little bit about this, is actually the enhanced purity and safety profile. So being an enzymatic process, this is completely devoid of any bacterial fermentation. And so all of those impurities that are historically and typically associated with plasma DNA are just not there in our manufacturing process. We have incredibly reliable quality within our DNA, so that means the purity of the molecules is really good. And when our customers use that in their downstream drug substance development, they can really see benefits. Because of the way that we make DNA, it is completely devoid of any bacterial sequence, and really that means that we are only encoding a gene of interest for our partners when we make our enzymatic DNA, and this allows them to significantly reduce the dose required in their downstream application.
12:15 So if we think of a viral vector therapy, for example, typically, our partners are using 30% less DNA when they switch to synthetic as compared to the incumbent technology. The last two points I would mention here are the reduced turnaround times. We are able to manufacture, GMP grade DNA in a matter of weeks rather than several months up to half a year, And that's really important when we think of some of the applications that we're serving, be that a personalized cancer vaccine where that needle to needle time is is of utmost importance, or be that for a seasonal flu vaccine, for example, when you really need need speed on your side. The last point I would mention here is the scalability and cost. So one of the benefits of a cell free manufacturing process is that we are not in a large scale bioreactor for manufacturing, and so we don't need hundreds or even thousands of liters to produce our DNA. We need milliliters and liters.
13:10 And what this allows us to do is to tailor the batch size depending on our clients' needs. So if they have a large patient public population, of course, we can scale that up and manufacture substantial amounts and quantities of DNA, but perhaps they have a population of one. Maybe it's a personalized medicine, a personalized cancer vaccine, and as such, we can accommodate that with a much smaller batch, and that really resonates with our partners. I did say I was going to go in a little bit on safety. This is the only piece of science in the in the deck, but, essentially, the safety profile of DNA starting materials remains a high focus of drug developers and certainly for regulators as well. And you can see on the left hand side here a Nature Medicine paper that was published earlier this year where they saw contaminating plasmid sequences within liver biopsies of pediatric patients that had been dosed with an AAV gene therapy.
14:05 In addition to that, you can see a quote from the FDA here that says the presence of these impurities may have adverse effects on product quality and safety and that they recommend that we optimize our manufacturing processes to reduce non vector DNA contaminants. So, of course, for a synthetic DNA company, we think that this is really incredibly important because we don't have that contaminant, and so there's no risk of that being incorporated into genomes of of patients ultimately dosed with these therapies. Finally, if you look at the the top right hand side, we are looking at two orthogonal methods to quantify any of that bacterial contamination or that plasmid contamination. And you can see here on the left hand side, when we look at that when the AAVs have been made with plasmid, there's upwards of 5% contaminating DNA that is present in that AAV therapy.
14:57 And when you switch over to a cell free process, a four base bioprocess, you can see that you cannot detect that contamination. And we see this as a significant growth driver in our pipeline as people can increasingly recognize the safety benefits of using an enzymatic approach as compared to plasmid. So to talk briefly on our go to market strategy, and and Chrissy will be able to talk a little bit more detail of our of our pipeline on our progress over the last twelve months, you can really see here on the left hand side where does 4BASEBIO play. And when we were first commercializing our technology back in 2022 and 2023, really, the people that we were working with were doing early incredibly early stage evaluations, and they were looking at research grade material to see how we competed against plasmid within their workflows.
15:46 What I'm incredibly encouraged by is actually the significant uptake that we're seeing in much later stages of development, be that late preclinical for for high quality grade demands or even into the clinic and ultimately into commercial. And we're very encouraged that we're able to, increase and accelerate adoption of these later stages of development. You may have seen one of our most recent press releases with a with a biotech company that is taking our product directly into a phase two clinical trial. They had previously used plasmid in their phase one and for a number of reasons were frustrated with that plasmid provider, and so they recognized the safety and speed benefits of switching to synthetic DNA, and so we're incredibly encouraged by news like this. And you can really see some of our solution offering, be that DNA development and manufacturing, be that mRNA manufacturing services, and really thinking and fostering our multichannel growth and commercial strategy, whether that's direct to innovator or within a partner ecosystem.
16:48 I'd like to highlight two case studies. The first is a US based biotech that's been working on an mRNA vaccine. And you can see that in early twenty twenty two, we were able to introduce ourselves and have a CDA executed. And, really, in over the course of a number of weeks, they had signed an MTA. They were which is a material transfer agreement that can govern the transfer of materials. We had quoted, and we had received a PO for some of that earlier stage research grade material that I was talking about just a short time ago. Over the course of '23, we did an extensive amount of work with this client where they tested our product, where they scaled it up within their workflows. And, ultimately, by q three of twenty twenty three, we were able to quote them for this high quality critical starting material that is required for their clinical trial.
17:39 In 2024, we were audited by the client's quality team, and we were able to scale up their manufacturing sufficiently for initiation of their phase one clinical trial, and the first patients were dosed at in March 2024. So you can really see how by converting from a plasmid technology to a synthetic DNA alternative can accelerate clinical timelines. And here in this example, the material quote to patient dosing was less than eighteen months. On the other end of the scale, I mentioned that we're working with several six out of 10 tier one pharma clients, and this is one of those case studies. So this is a multinational company with a strong incubator program, and we actually had initial outreach from this, opportunity from their CDMO partner who recognized the benefits of 4BASEBIO's DNA technology alongside this pharma client, and they wanted to run some evaluations to see how our product would stack up against plasma DNA.
18:43 And so throughout 2025, we were able to run a number of comprehensive studies and scaled up studies with this pharma partner and their CDMO, and we were able to deliver material in massively accelerated turnaround times such that they could continue their development. Fast forward to 2026, we have really finalized that proof of proof of concept. We are validated with respect to a CMC perspective of of how you can use our DNA in these viral vector programs, and we're currently scaling up that process alongside, organizing an audit and understanding how we can work into clinical programs with this partner. In addition to that, and very encouragingly, because we were successful in this particular, drug application area, it's opened up a number of other opportunities, orthogonal opportunities within that broader pharma.
19:35 And so we're actively working on programs that are clinically, advancing both in gene editing applications and also with mRNA applications. So I think this highlights why those pharma partnerships are so incredibly important because they can be be under one umbrella but have multi assets across multiple different downstream modalities. Okay. Next, we're gonna touch briefly on the competitive landscape. And so I think when people consider, synthetic DNA, there are a number of different players there. If we look to the right hand side here, you can see the synthesizers. So these might be companies like Twist or IDT, DNA Script, for example. And then you can see another company that we bucket as assemblers. So this could be a Ribbon. It could be an Evenetics, etcetera.
20:24 And, actually, these are upstream partners to 4BASEBIO. So, yes, they are synthetic DNA providers, but, actually, they are more in a high throughput, low quantity manufacturing scale. And so we actually use these guys as an upstream template provider, and then we feed that into our amplification manufacturing process. Critically, both the synthesizers and the assemblers are research grade only, and they're not suitable with respect to their quality or their scale for clinical application. When we think about people in our space, we really position ourselves and another UK based company, Touchlight, as the GMP ready, GMP certified players in this space that can disrupt the incumbent technology by producing gram scale GMP certified material.
21:12 Of course, the natural competition is the incumbent DNA plasmid, and you can see the logos here whether that's Aldevron, whether that's Thermo Fisher, and that's really where we want to play and how we want to displace that plasmid for a synthetic DNA alternative. And, really, when you think about the amplification and the people that play in that space, we truly believe that 4BASEBIO is well positioned to lead in that space from a cost, from a fidelity, and from a scalability perspective. Ultimately, we want to decouple genomic innovation from manufacturing volatility. And if we look at this table, we think some of these features, whether that is speed to clinic, whether that's the purity profile and the regulatory risk, or whether that's sequence complexity, we believe that our enzymatically produced DNA can offer timelines of six to ten weeks, can offer enhanced purity with no risk of those bacterial impurities that we typically see with plasmid, and we can really scale this process for NF one medicines to much, much larger patient applications.
22:15 We want to replace the foundation with an enzymatic process designed specifically for the safety and clinical speed. So I'll touch briefly on our financials from 2025. We delivered strong foundation for expected future growth, and you can see here that we've accelerated our revenue growth with a year on year increase of 81% and an expectation to continue to accelerate that rapidly in 2026 and beyond. I think very critically that revenue is expanded across multiple downstream applications, so it's not so around one or more of these therapeutic modalities. Actually, it's much more broad, and and Chrissy can talk to that in her section as well. We closed the year with a strong balance sheet. We had cash at 17,800,000, and we're well placed and well resourced to deliver on our group strategy with this cash on balance sheet.
23:08 We additionally drew down €7,000,000 from the to invest facility in April 26 to further strengthen that balance sheet. And, ultimately, we have a stabilizing cost base to underpin significant and substantial revenue growth, really supported by this disciplined cost base and fully enabling the commercial readiness through the headcount and the infrastructure that we have today. If we look at the accelerated adoption of 4BASEBIO's DNA in clinical applications and consider that, I think this is amplified and shown in our in our revenue by product rate. So, of course, we're starting by from a low base in 2023, but what you can see here is a year on year growth of upwards of 80% between '23, '24, and '25.
23:56 From my perspective, what's much more interesting here is actually you can see that the research grade material, so those much smaller POs that are used in earlier stage applications, it remains pretty steady across the year on year. And you can see that all of the revenue growth is actually associated with either high quality DNA or GMP grade DNA, and that's really the DNAs that can serve our clinical trial partners. And so this is a a trend that we continue to see and that we hope to promote and really foster that that adoption in later stage, higher value opportunities here through that clinical stage DNA. The twenty twenty five cost base fully establishes commercial readiness and is reaching mature levels, and you can see here how that's divided through the total operating expenses, administrative operating costs, and commercial costs, and how that grows and evolves as we as we expand the organization and make sure our departments are fit for purpose to foster the growth of the company as it needs.
24:57 And you can see that reflected in our head count per function as well. And, naturally, as we've grown and expanded, our quality teams have got bigger, our operations teams have got bigger to to facilitate that GMP readiness being ready to manufacture that clinical stage DNA. And, of course, our commercial team has significantly expanded as we've brought on and onboarded this much bigger team to really serve our our commercial traction that we anticipate. Ultimately, we we closed 2025 with a strong cash position. In '25, we had a cash burn of 16,800,000. I mentioned already that we drew down another €7,000,000 from our facility with Deutsche Balaton. And finally, just to mention that we have a cash runway into late twenty twenty seven.
25:45 So with that, I will kindly hand over to Chrissy who will talk through her commercial strategy and why we're very excited about that at 4BASEBIO. Thank you, Amy. Good afternoon, and thank you for the opportunity to be here today. By way of background, I bring over 25 of experience in the life sciences space. And in the last decade, I've really been focused on leading global commercial teams in the CRO and CDMO space, and also bringing new capabilities in those sectors to market. Over the next few minutes, I'm gonna walk through the markets we serve, our commercial priorities, and why we believe that 4BASEBIO is positioned to lead the shift from plasmid based manufacturing to synthetic DNA based drug manufacturing.
26:33 Overall, our commercial strategy is built on four pillars. Team, early engagement, and strategic partnerships, and leading into that commercial execution structure needed to to progress our new business. First, we've built a a highly experienced global commercial team positioned across key innovation hubs with all roles now filled. We prioritize talent with deep networks in the cell and gene therapy space, specifically selling clinical manufacturing services. These folks are execution focused and with strong performance background, track records. Second, ensuring that we, meet our entry point of at preclinical and and why that's important is in so that excuse me, is to to assure that we have the greatest success to win and can be embedded in the manufacturing process of clients with multiple asset programs.
27:31 This will enable us to meet our mission of being the partner of choice for DNA critical starting materials. To drive this momentum in the clinic, we've implemented a structured account segmentation and prioritization to strengthen our relationships with these top tier customers across multiple modalities. We're gaining consistent traction in the biotech industry, leading KOLs with academic institutions and their spinouts and also within the top 10 biopharma. We've undergone a six month commercial build out and see momentum serving over a 150 clients and line of sight to multiple clinical assets with the top 10 biopharma. At the same time, we're also building strategic partnerships with global contract development manufacturers who are increasingly using our technology to strengthen and differentiate their own offerings.
28:26 And finally, we're accelerating early customer acquisition through three levers, activating an inside sales function for lead generation, enabling third party ordering channels to navigate those complex procurement processes, and also strengthening our legal support to reduce the friction into purchasing. As mentioned, our commercial organization is strategically deployed across key biotech hubs to drive awareness and enable a faster path to the clinic. This brings together marketing business development, technical proposal writers, and inside sales. Collectively, this group represents over twenty a hundred and fifty years of experience in the life sciences space, strong industry networks, and reputation as trusted advisers with our sponsors.
29:15 Together, they translate deep expertise into these trusted partnerships and are leading to tangible results. Diversification across, both customer segments, and the therapeutic modality considerations is core to our strategy, for supporting long term, growth stability while also enabling scalable growth. You'll see that in 2005, our order volume was most heavily concentrated in biotech, which can which is consistent with the industry dynamics. CDMO was representing the second largest sec segment, and the academics were a much smaller part of the the mix, but very critical to us strategically as they home industry leading KOLs and are a key source to biotech spinouts.
30:05 Our bio our our large pharma and CDMO order volume has been more measured, though adoption cycles and and and rigorous supplier onboarding impacted that. Our current pipeline and existing conversations with sponsors give us line of sight to some great uptake in the remainder of 2026 and 2027. Ongoing evaluations, strategic discussions will also continue to drive the growth across these segments into 2027 and beyond. When you look at the modalities from from that perspective, our platform was initially established in mRNA, and that continues to represent over half of our order volume.
30:51 Despite the headwinds, in infectious disease, mRNA remains highly relevant in our industry. Applications span from personalized medicines, off the shelf cancer vaccines, and also delivery mechanisms for cell therapy and crisp CRISPR based therapeutics. At the same time, we're seeing meaningful diversification in DNA, platforms, and we'll see that, continue to develop over time. And then looking at gene editing and AAV, they represent about a third of the mix and significant growth potential across, both gene therapy and next generation, editing applications. AAV is actually very compelling, as manufacturing typically requires multiple constructs, aka multiple, GMP builds, per program driving, like, a much higher unit demand with six and and seven figure, purchase orders.
31:50 So the takeaway here is, continued diversification will strengthen both our near term resilience and long term growth profile, and that'll help position our business to navigate through industry cycles while also capturing emerging opportunities. Historically, our pipeline has been weighted towards research grade material and also, mRNA focused modalities. In research focused material, you'll you'll see here in that that RUO purple bar, but today, roughly 50% of our pipeline is comprised of high value clinically relevant opportunities, reflecting a meaningful upgrade from the average RUO deal size in the 15,000 doll 15,000 GBP range, to deals in the several hundreds of thousands to millions of pounds, sales dollars.
32:51 Importantly, this pipeline is now balanced across mRNA and DNA therapeutic modalities, and and viral vector programs continue to gain momentum. These programs are particularly valuable and and will will continue to to to feed our our our final growth objectives for 2026. Okay. So, drug innovators are continuing to see the the benefits of our enzymatically produced DNA, and the clinical numbers speak to that. We currently have a very balanced, number of RUO process development opportunities to g m to high quality GMP, and that reflects, the those RUO based, opportunities or those process development opportunities we discuss that feed into, again, six and seven figure, deal size shift from from the RUO space, our our business historically represented.
33:58 40% of our our pipeline really falls within that clinical high dollar value or GBP value, deal size. And and and what does that that mean? Again, this paradigm shift is here for 4BASEBIO. Synthetic is is now in 2026. And and in closing, we, again, we we've had a commercial build out ranging, you know, over the six six to nine months. And looking back at the historical, pipeline, value of our of our pipeline here at 4BASEBIO, our strategic objectives, and those fill four pillars that we discussed, team, early engagement, strategic partnerships, and that commercial execution infrastructure to bring new business, wins to to our ecosystem is, is working, and we'll continue to to develop new, new capabilities to continue that that diversification of our portfolio for for long industry relevance.
35:07 And with that, I'll pass it over to Amy for for closing. Thank you so much, Gracie. So I just like to highlight our disruptive technology equals better patient outcomes. And we really think at 4BASEBIO, we can par the next generation of safe, cost effective genetic medicines through our proprietary and disruptive technology, our world class scientific and commercial teams, our well invested clinical infrastructure for manufacturing, and proven leadership driving our next phase of growth. So with that, I will conclude the formal presentation, and we'd be really happy to take any questions from the audience here today. That's great. Thank you very much for your presentation. And if I may just bring back up your cameras. Ladies and gentlemen, please do continue to submit your questions just by using the Q and A tab situated on the right hand corner of your screen. Just while the company take a few moments to review those questions submitted today, I'd like to remind you that recording of this presentation, along with a copy of the slides and the published Q and A, can be accessed via investor dashboard.
36:08 As you can see, we have received number of questions throughout today's presentation. Can I please ask you to read out the questions and give responses where appropriate to do so? And I'll pick up from you at the end. Thanks so much, Lily. So I'll take a stab at the first couple of questions here. Coming in from Jonathan e, the question is, what is the current status of the project with the tier one vaccine company for an mRNA flu vaccine? Was that phase one, two trial successfully concluded, and what is the likelihood of another phase two or phase three clinical trial? So that trial is still ongoing. We know that they've dosed several hundreds of patients. And if everyone recalls, that is a trial run under the FDA. So this is really a US focused market. I will, comment on the headwinds that we have received with respect to an anti vaccine sentiment within The US and with this particular administration.
37:00 So I think, ultimately, with this pharma partner, it remains to be seen whether they will continue to progress this trial into phase three. What I can say, however, and very encouragingly, is that because we are now familiar with a particular pharma client, you know, they've audited the facility. We have agreements in place for clinical supply that are not exclusive to flu vaccines, for example. We have a lot of traction across other modalities with that same pharma partner, and we anticipate several clinical entries with that partner in the next year and and certainly into 2027. So I'll move on to the next question also from Jonathan e, which talks to you and comments on the need or requirement for additional manufacturing facilities. And, really, that that that question comments on the the capacity of our current GMP suites.
37:49 So I think with respect to, the additional facility that we're gonna bring live this year, it's very important to note that that augments our current GMP certified facility. So we do not anticipate that GM certified material will be coming out of the new headquarters, and rather that facility will focus on those earlier stages of development, those research use only, and those CEDAR those CEDAR programs that will ultimately translate into high quality and GMP. So that is the additional capacity that we anticipate. I think there's another question there with respect to, that facility being fully utilized and a commentary on the sort of batches that we might make in that facility. And I think this is a really important question. So that facility is currently suited for those n of one medicines, but it is also suited for much, much larger patient populations through phase one, phase three, and beyond, which could have, you know, several hundreds of patients, even several thousands of patients. So it really is agnostic to that batch size.
38:45 And maybe just a clarifying point there, Jonathan e also mentioned, the the individualized nature of some of these cancer therapies. Our most recent clinical supply agreement is an oncology asset, but that is not an individualized treatment. That is a a treatment that would be suitable for a much broader range of patients, and it is not individualized. So, naturally, the batch size is much larger because it has to cater to to all of these patients. Moving on to a question from Tobias. It says that we are producing at a scale suitable for scientific research. And do we plan to scale up production, or will we generate revenue through licensing? So, again, we are well suited to be able to produce material for research grade and development.
39:32 Those are much smaller quantities of materials, so that could typically be somewhere in between one milligram and maybe a 100. And that sort of material does not come out of our GMP certified facility. That is for research use only, so it's much earlier stage. On the other end of the scale is actually our capability and capacity to be able to manufacture multi gram batches that are suitable for clinic, and that sort of material would come out of our GMP certified facility. The end of that question, comments on whether we would generate revenue through licensing. I think that's a great question. Historically and and even today, 4BASEBIO have not licensed our technology out to any of our partners. We have established CDMO relationships, but those are critically, based on a supply agreement whereby they would purchase DNA from 4BASEBIO and feed it into their drug substance manufacturing.
40:24 So licensing isn't on the table today, and it will remain that way. Another question from Bruno r, what do we think are unique selling points versus our competitors in the amplifiers category? A great question. I didn't fit much science into this into this deck, but I think there's a number of differentiators, which I think are important. One of these really starts from the enzymes that we use within our manufacturing process. So you'll recall that the map that I showed, which shows our our different headquarters and their geographies, we have an enzyme manufacturing facility in Madrid in Spain. And that enzyme manufacturing facility manufactures all of the enzymes that we use within our manufacturing process. This is important for a number of reasons.
41:09 One is a cost of goods consideration. And so having that control and that supply chain control allows us to be competitive with respect of cost of goods. The second of those points I would mention is actually a quality consideration. So when we benchmark our enzymes versus something that you can get off the shelf, we can see a higher quality of DNA, and that's really coming from all of that extensive knowledge and production that we have situated in Madrid and the enzymologist that we have there. Finally, on the on the enzyme side, we have proprietary enzymes. So those enzymes are not what we call wild type. Actually, those enzymes have been engineered. And and one of the ways in which they have been engineered is to enhance their fidelity to make sure and ensure the sequences that we make are correct and they comply to our customers' expectations.
41:56 So that's one piece definitely on the on the enzyme side that I position as a differentiator. And I think the second piece that I would highlight there is the different flavors of DNA that we make. So you might recall this slide that I showed different configurations of DNA, whether that was single stranded, double stranded. And we have this sort of flexibility within our manufacturing process that allows us to confer downstream benefits if they use that particular modality. And that's something that we have unlike our other amplifier competitors or indeed the incumbent technology being plasma DNA. Perfect. That's great. Thank you for answering those questions you have from investors. And, of course, the company can review all questions submitted today, and we'll publish those responses on the investor meet company platform.
42:42 Just before redirecting investors to provide you with their feedback, which I know is particularly important to the company, Amy, could I please just ask you for a few closing comments? Yes. Thank you so much, Lily. So thank you everyone for joining today. I I hope it's come across that both Chrissy and I remain incredibly excited about what we can achieve at 4BASEBIO. We think this is just the beginning and and watch this space. That's great. Thank you for updating investors today. Can I please ask investors not to close this session as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations? This will only take a few moments to complete, and I'm sure be greatly valued by the company. On behalf of the management team, we'd like to thank you for attending today's presentation, and good afternoon to you all.
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Chief Commercial Officer at 4BASEBIO PLC
Chief Executive Officer at 4BASEBIO PLC