Imugene investor update and FAQ webinar. Joining us from Imugene today, we have the Executive Chairman, Paul Hopper, who will lead the session, and he's joined by CEO and Managing Director, Leslie Chong, and Chief Operating Officer, Dr. Bradley Glover. In terms of format, there will be an initial discussion from the team based on the most common questions that have been sent through over the last week. Following this, we'll take further live questions that have not already been addressed. If you'd like to submit a live question, you can do so using the Q&A panel within Zoom. I'll hand it over to Paul to commence.
Thank you, Matt, and good morning, everybody. As Matt noted, I'm the Chairman. I'm joined today by Leslie and Brad, Brad in California. What we'd like to do is give you an update on where we're at, to be quite frank. Given the volatility of the markets over the past few weeks and the continued dreadful weakness in our share price, we thought it would be appropriate to hold a forum in which, you know, our two senior people could share with you an update on the activities and what we've been doing. Now, some of you have written in with questions, and you've obviously raised concerns about what's going on. Look, we can't always answer those questions, not because we don't want to, but if it's not been released to the market under the selective disclosure rules, we're not permitted to do so.
Now, some of the questions that came in related to board matters, which we obviously can't disclose here, but we've collated all of the email questions over the last week, and I think we've covered most of them and maybe even a bit more. We have broken the webinar into three sections, being the three people who are talking, me and Leslie and Brad. As we go through, I will direct the topic or question to Leslie or Brad to answer. Initially, let's get into something that's on everyone's mind, of course, which is the share price. I'll also talk about other capital items and related subjects. We understand the frustration around our current share price, especially after such a massive decline from the peak valuation a few years ago.
Look, the management and the board share your concerns, and we're all shareholders in the company, and that does not just include the three of us; it includes pretty well everyone else in the company as well. Look, while we cannot control market trading or short positions, we do acknowledge the lack of major licensing announcement and slower-than-expected data. We acknowledge these as contributing factors. You know, capital needs in biotech are significant, really. It is not a cheap business to be in, I do not have to tell you, especially with three active programs. We are disciplined in our funding and cash flow strategy, and we are serious about getting a return to the previous share price levels that we had. Let's just talk for a minute about the share price.
Look, for many shareholders, the share price is the measurement of how the company's doing, and we understand that. That's the barometer. When the share price is high, everyone thinks the company's fine and there's no problems. When the price is depressed and people are losing money on their investment, anxiety levels rise and questions are raised about what's wrong with the company. There must be something wrong if it's worth AUD 0.025. When you have a company that was valued at $3 billion several years ago and it's now only worth $200 million, it's only natural to ask what is wrong and to blame the board and the CEO. We become the lightning rod, and we understand that and we recognize the negative sentiment, but I remind you that we are investors in the business as well.
Look, some of you are worried about the company's performance and the future prospects, and I can assure you we are deeply focused on getting results, and we want to get a return to a share price which better reflects what we really think the business is worth. From a practical perspective, we do not have any direct control over the daily trading in the shares. You have to admit it is a pretty brutal market that when you announce four complete responses, that means no more cancers in the patient, that the share price goes down. I mean, it is unbelievable, but again, what can we do about it? I am not going to give you platitudes and blame external factors such as the last three difficult years for biotech companies globally, nor am I going to blame the recent market turmoil created by the Trump tariff disaster.
We're not going to blame those for the share price. They may have an impact, but let's leave them aside. We admit that we don't know exactly why we've been hit so hard with the negative share price, but let me be transparent with maybe some explanations. The first thing that I would say is, yes, we've done no licensing deals or we haven't had a lot of progress with any other parties on any of the programs, particularly HER-Vaxx. Now, we've not signed a deal with the programs, and BD or licensing, it's a very slow process, and you have to remain confidential until the deal is signed. Let me assure you, lack of news doesn't mean we're doing nothing. We are, but at the moment, we don't have anything good or bad to report.
We're at all the major industry conferences around the world, and we've got direct contact and direct dialogue with all the pharmaceutical companies who are involved in the same technology space as Imugene. We're talking to them. Look, let's be realistic here. There are very, very few licensing and commercialization deals done by Aussie biotechs. They are few and far between. We're not alone here. It'd probably be a worthwhile exercise to count how many of those deals have been done in the last five years, but it'd be, I don't know, I'm guessing under 10 out of 140 biotechs. These are deals that are not easy to achieve.
I think the other thing is that there's been a lack of regular and good news on CF33 and OnCAR programs, and it is correct that the data readouts are a little slower than expected, and Brad and Leslie can talk to those programs shortly. The other thing which hits us, I think, share price-wise, is there's a perception that we are a high-cash-burn business, and the reality is that, in fact, we are, because drug development, particularly CAR-Ts, costs very large sums of money. This is not like prosecuting a small molecule or an antibody through the clinic. CAR-Ts cost big dough, and the specialist medical and scientific teams that you need to manufacture the drugs and run the programs are not cheap. I think, you know, either you're in the game or you're not, and unfortunately, we're in high-burn businesses, and it requires cash to do it.
The other thing which I think has had a serious effect is the short position in the company, and I think this has had a knock-on effect to other sellers and investors who probably correctly view a short position as an expectation that the share price will fall, and I think that's dragged other sellers into the stock, and we don't have any control over that. That's a difficult one. In terms of raising money and diluting shareholders, you know, we've talked about cost. This is a business which is long-dated negative cash flows. It's got high capital needs. It's high risk, and it's zero revenues, and running three technology platforms isn't cheap. Azer-cell is a cell therapy trial which costs a lot to make the drug and run the trial.
You know, apart from the convertible note we announced earlier this year, the last time we raised money, I think, was back in August or September 2023, and only about 9% of that money comes from retail shareholders. Are we going to raise additional capital? Yes, we will. We look at the markets carefully, and we stay in touch with a bunch of Australian brokers, and we are very close to a bunch of very respectable, credible bankers in the U.S. who are interested in our business, and I think that reflects well on the quality of the company and the technology and the people. I need to remind you that we do not dictate to the bankers and investors at what price we will raise money at. I mean, the benchmark for pricing a capital raise is the share price at that time.
It's pretty rare for anyone to get a premium or any substantial premium on their share price when they're raising money. Look, we will announce a capital raise when it's complete and not before, as I'm sure you'd understand. We do get questions about Nasdaq and are we going to consolidate the shares, and the answer to that is that both those items are under regular review by the board, and an announcement will be made if and when a decision to proceed is reached. Just before I hand over to Leslie, there's been a question asked about how the turmoil from the tariff issues and stock volatility, whether it'll affect the runway and the clinical trials, and the short answer to that is we do not expect it to have a material impact on our business at this time.
I just would remind, just going back to the share price and all that, I remind you that we've not had a clinical trial failure across any of our trials. None. That further complicates as to why we're getting punished so much in our share price, but all of our technology is still proceeding, and there have been some pretty spectacular clinical trial failures in recent times which are catastrophic. We've not had those. Could I, Leslie, could I hand over to you to just talk about just an introductory comment on the pipeline of the programs?
Thank you, Paul. That's correct. We have not had anything negative happen in our clinical trials, and I just want to set some strategic context here before we start addressing some of your very important questions. I want to be clear, all our programs are in clinical trials. Now, they're not preclinical. They're not in a Petri dish. Actually, we're treating real cancer patients and many of them who have failed multiple prior therapies. We are seeing early signs of clinical activity. In fact, we are seeing complete response in some of our therapies across multiple programs, but our strategic focus has not changed from day one. Our strategic focus is on advancing assets with near-term value and clear partnering potential.
I'll say that again because I think that's important, that our capital and resources are always being prioritized towards programs with strong clinical signals and defined paths to commercialization or pharma collaboration. Those are our two goals: assets that will get us to commercialization, to marketing, or pharma partnering. I am going to hand it over to Dr. Brad Glover to talk about our very important program, azer-cel.
Thank you very much, Leslie. Following on what Leslie just said a second ago, I mean, azer-cel continues to deliver encouraging results, including a 57% complete response rate, which means the absence of cancer, and it has strong durability, which is basically how long the treatment lasts, the effect lasts, and this is in a heavily treated patient population. We're actively finalizing the phase II clinical strategy that balances both the scientific rigor and speed to potential registration, including more, and I'll talk a little bit about this, a more rapid path for approval such as CNS lymphoma and expanding to international sites. We received a lot of questions regarding azer-cel, and we can address some of those here now. We got several related to the clinical trial plan for azer-cel. When will it start? What countries will it be in?
We have continued to dose patients with a low-dose IL-2 and have seen the promising results. You probably saw our February 18th release that showed this 57% complete response rate and really good safety signals. We are continuing to dose these patients in this cohort to really build a dataset for phase II. We are considering several trial design strategies that could further explore DLBCL, but also indications, like I just mentioned, in CNS lymphoma that may have a streamlined path to registration, and that translates to less money requirements and a more rapid path to the clinic. We received questions on how much will the trials cost. I mean, several factors go into trial costs, including the number of planned patients, the control arms, CRO contracts, manufacturing, etc., including access to countries outside America, like Australia, like Europe, and other regions.
We anticipate the phase II costs to be greater than $30 million USD , but ultimately, it's going to be driven by the final trial design. Our experienced clinical team has put together a rational scenario set, and we expect our thinking to evolve as we engage our investigators and KOLs in the upcoming couple of months. We have received questions on, you know, how long will this trial take to complete? As mentioned before, the trial design and size are driven by many factors, including the number of arms, XUS readiness, number of patients, etc. It is likely that the phase II azer-cel trial will last two to three years, but again, it's going to depend on the factors we just mentioned above. We are very confident in azer-cel.
We're seeing, we just, Leslie mentioned it, and I mentioned it just a second ago, four out of seven complete responses and patients continuing to be disease-free with the longest coming up on a year. We've had questions around what was the rationale for in-licensing azer-cel? Why did Precision BioSciences not continue with azer-cel? Precision has publicly stated that their focus is on in vivo gene editing versus actively pursuing azer-cel, which is a cell therapy and a different technology. Preclinical biotech companies like Imugene, like ours, we have to prioritize capital, and we have to focus our pipelines to ensure that we can achieve meaningful value inflection points versus spreading our efforts too broadly across multiple programs and increasing cost.
You know, since taking over azer-cel in 2023, Imugene has added such a significant amount of value to this program, and we have really positioned it for continued success. With that on azer-cel, we do have questions on our OV programs, and I'll hand it back over to Leslie.
Thank you, Brad. I've had some questions regarding OnCARlytics. I just want to explain that program a little bit. It's a dose-finding and dose-escalating phase I study in solid tumors. azer-cel is in blood cancers, OnCARlytics, as well as VAXINIA , are in solid tumors. This is a two-arm study in combination with a product called BLINCYTO , which is approved and marketed by Amgen in blood cancers. OnCARlytics is in solid tumors. It's a clever way to bring these neat blood cancer products into the solid tumor setting. Before we could even start the combination, and because OnCARlytics is such a novel product, the FDA made us establish safety with OnCARlytics by itself, both an intratumoral and intravenous route of administration. We had to establish single-agent safety first before we could go into the combination with BLINCYTO.
As you know, we just announced a clearance of intravenous, the IV, in combination with BLINCYTO. The first cohort has cleared, so we have moved on to the second higher dose cohort. We feel that as we dose-escalate, we will likely see stronger clinical signals, meaning CD19 expression with working with BLINCYTO even more. Even at this earlier stage, we are already seeing presence of CD19 expression in the tumors. As we are exploring combination strategies and potential partnership to maximize this particular novel platform and its impact, we will share updates as data matures. I am hoping that it is quite soon as we dose-escalate. For those of you who had asked about OnCAR and where we are, we are currently in the combination in IT and IV with BLINCYTO.
We had to start off very low in the dose, and that's one times 10 to the eighth plaque-forming units is the way of measuring the amounts of virus injected. At the higher dose, we think that there's a higher likelihood to begin seeing stronger signals. Even at this low dose, as I mentioned, we're already seeing some CD19 expression. We're exploring cohorts with other combinations using other anti-cancer compounds. Just as you have seen in azer-cel, we had combined it with a low-dose IL-2, which helped the T cells proliferate and make the patient's durability last longer and T cells stronger. We're exploring the same thing with OnCAR. We're, you know, also actively discussing ways we can partner our OnCARlytics platform with other CD19 targeting agents and companies, and we'll update the market at the appropriate time. I'll move on to other CF33, VAXINIA.
VAXINIA, I think, has been, it's particularly in metastatic advanced solid tumors. Again, it's another solid tumor product with our OnCAR, with our OnCARlytic virus CF33. Like OnCARlytics, this is interrogating not only IT, IV, and in combination with KEYTRUDA. Basically, it's a four-arm study. It feels like four studies wrapped in one. As we have announced, there was a biliary tract cancer patient in the single IT arm of this study who has remained in complete remission for over two years. The significance of that is in this biliary tract cancer type, only about 8% typically respond to any therapeutics and only for a few months. We are pretty excited that this patient has been able to live free of cancer for over two and a half years now. We have also had two melanoma patients achieve a partial response.
I'm happy to report we're still dose-escalating. However, we're seeing 60% of all participants, all these patients that have come on to the study, despite being heavily pretreated, I mean, some patients have been on seventh lines of therapy prior to coming on to study. They have achieved the best overall response of stable disease or better, so stability of disease, and some go more than six months. These are promising results and have generated lots of enthusiasm by our oncologists that are participating in the study. We will focus our capital resources on expanding the biliary tract cancer cohort because this is, again, where we see the clearest path, the clinical and regulatory impact. What is happening on CF33? I think I just shared with you we have a four-arm dose-escalation study.
We continue to dose-escalate, but we're really focused on the biliary tract cancer because that gives us an earlier win. Some of you have also asked about Yuman Fong. Professor Fong is still with us and works quite closely with us. He is a shareholder, and we have an ongoing research agreement with him and his team. I know there are lots of questions regarding business and development, so I'm going to hand this back to Brad.
Thank you very much, Leslie. Yes, we did. We got a lot of questions around business development. Let me just start by saying our commercialization strategy is consistent with global biotech norms, basically generating compelling data and pursuing strategic out-licensing or partnerships with biotech or large biotech or pharma. We are in discussions across multiple assets, including HER-Vaxx and PD1-Vaxx, and engaged with numerous companies to drive potential licensing or co-development deals. Again, our strategy is compelling data and pursuing out-licensing or partnerships. Our plan is not to take the drugs through phase III and approval ourselves, but to find a big pharma partner to help us manage this. We have gotten questions around HER-Vaxx related to its out-licensure. We are in discussions with licensing HER-Vaxx, PD1-Vaxx, and both. When we have something material, we will definitely update the markets.
As Paul mentioned earlier, that's not something we can discuss right now. When we have something material, we'll come back, of course. Related to PD1-Vaxx, we've received questions on the status of the Neo-POLEM trial. Neo-POLEM is an investigator-sponsored phase II trial that is preparing to open for patient enrollment. The trial is run by the centers and not by Imugene and has been slow to open. This is a collaboration between Imugene and the University of Southampton in the U.K., with centers opening in the U.K. and in Australia in partnership with AGITG. What is the Neo-POLEM trial? This is for patients who have been diagnosed with operable colon cancer. They're going to be dosed with PD1-Vaxx for a period prior to the standard of care surgery that then removes the tumor. We also had questions about Monil Shah, our colleague.
Monil continues to consult with Imugene, and he's working with us on focused and specific areas related to business development. It's great to continue to work with Monil in those focused ways. We've, again, had several comments about monetizing a partnership or when can we hear about agreements. Again, that's a key focus area for us. We're actively pursuing several partnership opportunities and we're prioritizing agreements. We just don't want to do any agreement. It's really agreements that add capital that validates our cell therapy or oncolytic virus strategy and our B cell vaccine technology externally, and ideally includes like a co-development or commercialization structures that really allow us to retain the upside post-deal. That's an update on business development. I will hand it back over to Paul to talk about a couple of other topics.
Yeah, thank you, Brad. Let's talk about shareholder communications and investor relations. I'm going to get Leslie to go through in detail what we've done. We take investor communications very seriously, and we are committed to updating the market whenever we can. In fact, under continuous disclosure, we have an obligation to do that. We don't sit on information for the sake of it. I know some people ask, you know, why don't you announce more? Because there's nothing to announce. We are fully compliant in our continuous disclosure obligations. I should share with you that a very large institutional investor asked me the question the other day, do you think, in fact, you put out too many announcements? You seem to have something every moment of the day. I said, well, other people complain that we're not saying enough.
Let me hand over to Leslie to take you through what we've done to highlight the company's merits. Leslie, would you take the meeting through that?
Of course. Thank you so much, Paul. You know, already this year in 2025, we've made 27 ASX releases on a variety of topics, including clinical trials, the kinds that I like, and then the financial matters, as well as investor presentation. In 2024, we made 70 announcements, and of which 24 were price sensitive. We do not set price sensitivity. It's the ASX that sets those. We have published six shareholder newsletters in the last 18 months. We regularly post on LinkedIn and Twitter. I might remind you, continuous disclosure rules, they're instinctive that we have to disclose anything material, positive or negative. If we have any negative results in the study, we have to disclose those. Any conference presentation will be announced or uploaded onto our website when they are presented.
I did receive quite a lot of questions regarding the advertisement of therapies in clinical stage of Imugene at the airport carousel. We actually got a pretty decent deal on that. We got one month's worth, but actually it was up for four months. Would I do it again? Probably not. The reason why we did it was because Sydney Airport sees over 40 million passengers annually. This is including high sophisticated professionals and international travelers. This is an eye-catching ad that can put Imugene on the radar of retail investors who may not know it's a clinical stage company with a global footprint. That's why we did it. I am going to hand it over to Paul for some questions regarding the overheads and the costing of running our business.
Yeah, so thank you, Leslie. This seems to be an area of some interest from some shareholders. I remind you that the overhead and the salaries reflect the nature of a global science-driven business, which works in competitive markets like the U.S. and Australia. Most of our money goes directly into making drugs and running clinical trials. In terms of the salary compensation, we benchmark against industry standards, and we've recently implemented cost-saving measures, which I'll take you through in a moment, including the infrastructure and the headcount, the staffing reductions. Let's talk about how salaries, wages, whatever you want to call them, are determined. We have a REM committee. It's made up of three independent directors, and they are seasoned and senior U.S.-based biotech executives, might call them leaders even. Leslie and I are not on that committee. Those three oversee the remuneration.
How we pay people is very clearly set out in great detail over 14 pages in the annual report that covers everything about salaries, bonuses, performance rights, etc. If you want to go through and work out how that's all calculated, it's there in black and white for you to see. I'd also remind you that at the AGM only four months ago, all seven resolutions to grant performance rights and restricted stock units were passed by a majority of the shareholders. Let me state the obvious. No one in our industry is going to work for a company where their salary is tied to the performance of the share price. We just won't have anyone working for us if that's the case. In the year ending 30 June 2024, salaries made up only 20% of the total spend of the company.
Most of the money went into R&D, which is the heart of what we do, you know, drug manufacturing, clinical trials, etc., etc. At the high point last year, we had up to 100 employees on the payroll. Now, since June last year, which is nine months ago, we've taken big steps to reduce our structure costs and headcount. We now have 25 people, 25 versus 100 at the peak. I put it to you, that is a dramatic reduction in overhead in terms of salary. Excuse me. You know, we mentioned that the people we hire mainly are from biotech clusters like Boston, San Francisco, and San Diego, and they're highly educated, very well-qualified people. You might be interested to know that 50% of our employees have either an MD and/or a PhD or an MBA. It is a very, very well-educated payroll.
When we hire employees, we use current benchmarks from remuneration specialists from a firm like Radford, who are very well-known, and we use that to set compensation for specific roles and geographies. As you know, the salaries in the US are high, and that is the pool for the best talent in terms of the technology we are working in. Leslie leads a competitive US-based team. They work in a very highly competitive space. Having the right leadership is key to running clinical trials. It is key to attracting big pharma partners. It is very, very important to getting new treatments through approval with the FDA and ultimately to patients. We are about to go to questions from everybody, but I just want to finish by saying that we recognize the concern really around share price.
I want to assure investors that we are fully focused on driving the business to success. I remind you that we've not had a drug failure to date. The pipeline is moving forward with good clinical activity across the trials, and we are focusing on those trials that will have the strongest near-term potential. We do manage our capital prudently. I know some people think we raise too much money, but that's part and parcel of being in this industry. You have to balance the capital available with cost control, given the platforms that we have. We have responded by, I would think, a pretty dramatic reduction in headcount from 100 to 24. That, I think, obviously gives us a little bit more runway. Finally, we try to be transparent, and we think we do frequent communication with shareholders.
Regrettably, some people think that we're not updating the market, but we don't have any control over how the drug performs. We get the data and we report it. Before we go to questions, I thank you for listening in today, and thank you for your support and your feedback. I am going to go back now to Matt, who I think is managing the Q&A. Matt, are you there?
Yeah, no problem. Paul, did you want me to read these questions back?
No, I think we've got them there. Look, the first one I have here relates to when will any of the drugs move to phase II, and which will they be, and what are the obstacles? Brad, do you just want to give just a—I’ll repeat the question. When will any of the drugs move to phase II, and which are those drugs, and what will be the obstacles?
Yeah. For example, data is the foundation for advancing in a clinical trial. We are advancing azer-cel. I mentioned that. I think that question probably came early on in the presentation before we walked through the azer-cel update, as well as the CF33 and OnCARlytics. For Azercel, as we mentioned, we're amassing more data in the phase 1-B for DLBCL, investigating CNS lymphoma and other indications like that. When we have a data package that our team feels is strong, then we'll move forward and investigate a phase II approach. There are many drivers and considerations in that, as well as the OnCARlytics that is still in dose escalation, as Leslie mentioned. The CF33 program, as Leslie also mentioned, we've done a dose escalation there. We've gotten traction with cholangiocarcinoma, which is a type of biliary cancer.
That's where we're really focusing right now, where we've gotten that traction, that complete response of over two years. When we get enough of a patient data set, then we'll progress into later lines of clinical development.
Thank you, Brad.
Can I add—may I add something? For azer-cel, because it's in a specific type of blood cancers, phase II is all that is required to market. It's not only phase II, it's more like a phase II, III registrational study. That is why we're highly focused and prioritizing azer-cel.
Thank you. We had a question, two questions relating to the payroll, what the 100 people were doing, and is the reduction in headcount related to the manufacturing plant we took on? I'll just answer that quickly. Yes. When we bought azer-cel, we took on 100 people. That was a massive manufacturing plant, a lot of R&D, and we've basically pared that back. You may recall we offloaded a lot of that to another operator in the industry. That accounts for it. We have a question here. I've always wondered why Imugene doesn't do a series on the people that have made a complete recovery and pushed the human aspect to the trial. I just lost it. And pushed the human aspect to the trial to increase coverage and perhaps increase trial participation. Very good recommendation.
A lot of this relates to patient privacy, but it's certainly something we'll take on board. I totally agree. If we could get a patient to come on and do a video or something, that would be great. Thank you for that. Why is the next question probably for you, Brad? I think you touched on this earlier on, but why is the data for CF33 and OnCARlytics later than expected?
Later than expected. I mean, clinical trials and dose escalations take time. You have to walk through patient enrollment. You have to wait to get the response. You have to make sure there's no dose-limiting toxicities, move on to the next cohort. It is really a dose escalation study that just takes time. We have seen results with the cholangiocarcinoma and the melanoma that Leslie mentioned as well. We are seeing progress with our azer-cel. It is clinical development. It is science. It just takes time.
Thank you. There's a question about, it seems we're relying heavily on Big Pharma for commercialization of our product. Look, I'll just answer that very quickly. That is the standard strategy for small biotech. Nobody wants to go out and run a massively expensive phase III clinical trial, hire 60-foot soldiers to wander around America selling approved drug to physicians and hospitals. I guess if you don't find a partner, then the alternatives would be to run a phase III clinical trial. That happens sometimes. Is Trump putting tariffs on the cancer drugs from Imugene? No, none of our drugs are approved. These are still experimental. I think that's the end of the questions. Is one open? I think the question about readouts on the trial have been handled by you, Brad, just a moment ago.
That's all the questions in the list, Paul.
Okay. All right. That brings us to the end of the—oh, hang on. I just got a couple more. Let's finish them off. Yeah. Can you give a broad brush overview of the various phases? Drug development is sort of linear. You do a phase I, you do a phase2 , you do a phase 3, then you apply to the FDA for approval, and then you market the drug. In CAR-Ts, you only need to get to phase III. The timeline, that depends on recruitment, how fast you get patients on, etc., etc. Anything you want to add to that, Brad?
No, I think that's well answered.
Okay. Another question. Are we in discussions with Chinese Big Pharma? The answer to that is we can't give you an answer. I'm sorry. That goes back to the question of, you know, we'll make announcements when they're done. Justin asked a question. Would you consider selling azer-cel to fund the other trials? No. And then another question. On a scale of 1 to 10, how confident are you at selling Her-Vaxx? That's a prediction I don't think we can make. How long before you run out of cash? We've given guidance. The last guidance we gave was the end of the year. I got a question about, are we talking five years, but I'm not sure what that question is in relation to which topic, which drug. Have we had any issues recruiting patients?
Brad, maybe you could just explain some of the headwind you face when you open a trial in terms of getting recruitment done.
Sure. It's opening sites in different regions. For azer-cel, for example, we have sites in the United States that are open, ones in Australia. It just takes time. Building relationships, our clinical team does a fantastic job of building those relationships, ensuring the right types of conversations happen to make sure we recruit as fast as possible. It's a complicated nexus of indications, diagnoses, and all that. We support the sites really closely.
Thank you. We have another question here. Moving forward, can the quarterly activities report include basic status updates for the clinical trials, perhaps additional patients enrolled, which cohorts we are at, and number remaining? Basically, items so we can remain engaged with the progress, not giving away material facts. Also, update on some of the questions today. Yes, we can certainly do that, and we take that on board seriously. Leave it with us. Do you consider the cholangiocarcinoma poster data as immaterial? Why was it not announced to the market?
We have announced status on that particular patient, and there's still ongoing complete response.
Yes, I'm not sure. I think the question said poster data. Did we announce the poster data, or I don't recall?
Oh, I'm not sure which poster.
Do you consider the cholangiocarcinoma poster data as immaterial? Why wasn't it announced to the market?
We did announce to the market of the status of that patient.
Okay. Last question I've got is, what key catalysts are you excited for in the first half of 2025?
Leslie, you want to take that?
Can you repeat the question? Sorry.
What key catalysts are you excited for in the first half of 2025 to December this year?
We gave a brief on four out of seven in azer-cel in a phase I study. Paul, there was a question regarding just the phases of clinical trials. Clinical trials generally go from phase I, where you look for safety and safety only so that you can move to a phase II trial. To see activity and efficacy data in phase I is a bit of exciting news, really. For azer-cel, four out of seven so far that we've reported to the market. With the VAXINIA and the MAST study, we have one biliary tract cancer patient that is still ongoing, past two and a half years and ongoing, with two partial responses as well as the stability of disease. OnCARlytics, this is a very exciting and novel program. This could be considered first in class.
We hope to update the market on as we dose escalate to a higher dose level because the FDA made a start at a very low dose. As we dose escalate and get to a higher dose, we anticipate higher clinical activity and therefore an announcement out of that. Those are the three things that I'm looking forward to.
Thank you, Leslie. Somebody else commented that relating to the poster question, the poster was posted on Twitter and the Imugene website on the 11th of April. The questioner, I believe, is asking why an ASX announcement wasn't generated.
We didn't think that that was an ASX announceable material because we had already announced on the complete response as well as the other response and the stability of disease. That poster was reiterating previous announcements.
Thank you. Somebody has said, "You have recruited extremely talented and qualified leading staff. How are we ensuring to keep this talent together?" Look, I'll make a couple of comments on that. Leslie leads a really, really incredible team, highly motivated, very devoted to see that one day we might have a cure for cancer from one of our drugs. They work very hard. We keep in touch with them. I mean, it's a contact sport at the end of the day. We see them regularly in the states. We work hard, and then we socialize well. They're an inspirational lot. I think they see the extraordinary promise in our programs. I mean, they're well paid. I can tell you, most of these people are not motivated by money.
I mean, they obviously want to be well paid, but their goal, their vision is a place someday where one of these drugs is on the market and making changes. Now, we already know we're making changes. We've got four people that are alive today just in azer-cel who would have passed away without that CAR-T. The drivers in a lot of the people in this industry are quite different from people who work in banks or investment banks or anything else. I think Leslie does a very good job keeping the team together and motivated and very enthusiastic.
Thank you.
Just one last one. I'm sorry to be indulgent here. I'm going to say from one commentator, "Well done, guys. Keep up the good work. Don't worry about the doubters. Block out the noise." That's a nice comment. Thank you. I see we've got one more. Let me just—any discussion with the FDA for products of FDA fast-tracking program?
I can answer that. Fast-track does give us more frequent visits with them and conversations with them, and it's fast-track for a reason. We will take advantage of that and go to the FDA with aze-rcel because, again, that's near term to a registrational phase two. We're going to start engaging. We really want to have those meetings with the FDA, they are so valuable. We don't want to waste it. We're very clear on the amount of data that we want and what we would like for them to answer and give us sort of an approval and a nod because that way, when we actually conduct the study and we've already had those conversations and a lame way to get to the end, which is the approval, we've already had those conversations.
I think the five-year comment earlier was about how long will it take to commercialize a product. We're hoping that Azercel, along with the fast-track and along with other designations that we'll get, it will be—as a team, we're quite excited to get approval or get into a registrational study as fast as we can. I think five years, we want to beat that.
Yeah.
All right. Which of our platforms do you think has the biggest chance of accelerated approval?
Azer-cel?
Okay. Thank you.
OnCARlytics is, again, a very novel product, but it needs to go through the dose escalation.
Right. Another question. Were there any issues raising capital last time, which was in—I am assuming that is probably a 2023 question. No, there was not. We got two large institutional investors come in, and then we offered—I think it was a share purchase plan to the shareholders who came in as well. We have actually not really had much issue raising capital in the last four years, even when the markets were in total turmoil in 2023 and early 2024. The company has always been of interest to institutional investors, which has been good. I have been asked, "Would you please highlight the key milestones in the second half of 2023 and 2024?" I guess January to June next year. Leslie and Brad, do you guys want to take that?
I mean, it's going to continue to be the same. I mean, as Paul mentioned earlier, we've really focused the organization for clinical efficiency, reduced overhead, staffing, infrastructure to really focus on the clinical delivery. And with azer-cel, we mentioned earlier, it's going to be continually dosing patients in the DLBCL, exploring some additional rare indications like CNS lymphoma that would perhaps give us a faster track. All that's rolling out through 2025, as well as our dose escalation with OnCARlytics and the new combinations that we're doing there to help boost some of those outcomes that Leslie talked about earlier. It's really clinical execution and hopefully seeing the data come as well.
Thank you. I'm being asked how much of the decline in share price is due to share dilution from a large institutional capital raise. I'm not sure I understand the link between dilution and a capital raise. I mean, obviously, if you have a capital raise, it dilutes the equity. I'm sorry that I would need more clarity on that. Otherwise, I can't answer it. All right. That brings us to the end. There's no more open questions. Thank you, everybody, for your attention. Really appreciate it. The Imugene shareholder email line is open, and we'll answer any questions that come in to the best of our ability and within our ability to do so without spilling the beans. Thank you for your support. We do understand it drives us mad as well. We talk about it constantly.
We ask ourselves all the time, "What are we doing wrong?" I just hope that the drugs are going to prove themselves, and this will all look like a bad dream. Thank you very much. We appreciate your time today.