My name is Paul Hopper, and I'm the Executive Chairman of the company, and I'd like to welcome you to the 2024 Annual General Meeting for Imugene Limited. Before we commence, I'd like to acknowledge the traditional owners of the land on which we meet today, the Gadigal people of the Eora Nation, and I pay my respects to Elders past, present, and emerging. I also acknowledge the traditional custodians of the various lands on which you are joining me today, and the Aboriginal and Torres Strait Islander people who may be participating in the meeting. It's now a little after 9:00 A.M. Sydney time, and there being a quorum present, I declare the meeting open for our business, and I declare and confirm that the meeting has been properly constituted.
The company considers it appropriate to hold this AGM as a hybrid meeting, and that's a manner in which is consistent with the requirements of the Corporations Act and our company's constitution. So to start with, I'd like to introduce the board and management team who are in attendance. The first person, I guess maybe the most important, is Leslie Chong, our CEO and Managing Director. Jacob Dupont, I think, is a regret for today. I'm not sure where he is. Probably traveling somewhere. I've got Kim Drapkin on the East Coast, a non-executive director. Dr. Jens Eckstein, non-executive director, also from the East Coast. Leslie Russell, who I think is down maybe in Florida. We have Mike Tonroe, the company secretary and CFO. And then Adrian Atkinson from Automic is here, and she'll be the returning officer for today's meeting.
And then Michael Cunningham, who's our auditor and partner at Grant Thornton. The virtual component of this meeting is being held via Automic's online meeting platform. This platform enables you, as shareholders and proxy holders, to participate in this live event of the meeting, as well as you being able to ask questions and submit votes. So you can put your questions in at any time. And to ask a question, you press the Q&A icon. This will open a new screen. At the bottom of that screen, there's a section for you to type your question. Could you start your question by typing your shareholder SRN or HIN? This will allow the moderator to identify you as a shareholder.
If you'd like to ask your question verbally, put in your SRN and HIN, and then type, "I'd like to speak." And once you finish typing, hit Enter on your keyboard to send. Please note that while you can submit questions from now on, I'm only going to address them at the relevant time in the meeting, if you wouldn't mind including the agenda item to which your question relates. Now, please note that if we receive multiple questions on the same topic, we may combine them together. And if we run out of time, which I don't expect will be a problem, we will answer your questions in due course via email. So all the questions should be addressed to me as the chair. I'll deal with the question personally or ask someone else on the team who's better placed to respond.
Could I ask you to keep your questions short? So we have a lot of attendees today on this call, so could I ask you to keep your questions short so we can get through as many as possible? When we reach the formal part of the meeting, voting on all resolutions will be conducted by a poll. And shareholders attending virtually and wishing to vote on the resolutions being put to the meeting, you can do that through the Automic Investor portal. If you've not already logged in, how you can do so is found in the notice of meeting. If you have any problem registering your shareholder with Automic, please call the support number shown on the screen. So to allow shareholders time to log in, I now declare the poll open.
Online voting is now open and will remain open until I declare it closed at the end of the formal business. Your votes have to be submitted prior to the portal being closed for them to count. Now, before we move to the agenda, I'd like to announce that Dr. Jens Eckstein will be stepping down from the board today following our meeting. And on behalf of the board and the team, I want to thank Jens very much for his dedication and commitment to Imugene over the past five years. His contributions have always been invaluable, and of course, we wish him very well for his future agendas. We have an unusual situation here this morning because at 10:00 A.M., the building where the meeting is being held live has advised us that there's a fire evacuation drill.
Obviously, we're not going to participate, but there may be some noise, and I trust the meeting will be concluded by then. So the agenda for today's meeting is what we're going to do is we're going to, because of the fire drill, we'll do the formal part of the meeting first and get that out of the way. And then Leslie will do a short presentation at the end of the meeting, and then there'll be an opportunity for questions and discussions. So let's now move to the formal part of the meeting, of the formal business as set out in the notice of meeting, and that was distributed to everyone on the 14th of October 2024 and is to be taken as read.
And for the purposes of the poll, I'm going to appoint Adrian Atkinson of Automic, the company share registry, to act as the returning officer and conduct the poll. So people entitled to vote are all the shareholders, representatives, and attorneys of shareholders and proxy holders who have yellow voting cards. If you're attending in more than one of those capacities, you will have been issued with as many voting cards as you have separate capacities. If anyone believes they are entitled to vote but they don't have a yellow voting card, please raise your hand now, and a member of our registry team will assist you. At the appropriate time, I will ask that you mark your vote for the resolution on the yellow voting card.
If you're a shareholder and wish to cast all of your votes for a resolution, please place a mark in either the for, against, or abstain box next to that resolution. If you are a proxy holder, a summary of the votes to which you are entitled has been attached to the voting card. If the summary of votes includes discretionary votes, these are yours to cast at your discretion. If you wish to cast the discretionary votes, please place a mark in the corresponding for, against, and abstain boxes. If your summary of votes does not have any discretionary votes, you do not need to mark your voting card and will simply need to hand it to the returning officer at the end of the resolutions.
After all resolutions have been read and voted upon, please place it in one of the ballot boxes that will be circulating there in the room. Are there any questions in relation to the voting process? Let me just check if anything's come in on that. Okay. So let's now, there aren't any questions relating to that. The proxies have been inspected, and all those validly lodged have been accepted. Let us go. Proxies have been received representing a bit over two billion shares or 27% of the capital of the company. All undirected proxies or open votes that have been nominated the chair of the meeting as their proxy will be cast in favor of each resolution in the notice of meeting. So now let's proceed to the resolutions set out in the meeting. So the first one is the financial statements.
And the first item of business in this meeting is to receive the annual financial statements for the year ended 30th of June 2024. The financial report and reports of the directors and the auditors are now laid out before the meeting. There actually won't be a vote on this item and is a discussion item only. The company's auditor for the year, Michael Cunningham, is here and is able to take questions relevant to the conduct of the audit and the preparation and content of the independent auditor's reports. Are there any questions relevant to the conduct of the audit and the preparation and content of the auditor's report to be put to Michael? And I see there's none online, so I'll proceed to the resolutions set out in the notice of meeting.
So, resolution one, that to consider and, if thought fit, to pass with or without amendment, adoption of the remuneration report as a non-binding ordinary resolution. The proxies are now shown on the screen. As you can see, they're 63% for, 36% against. I now put forward the motion for those of you attending in person. Please mark your voting instruction for this resolution on your voting card. For those attending virtually, please vote via the online portal, although you're reminded, do not click on next until selecting your vote on all the resolutions. All right, resolution two is as follows. That Dr. Leslie Russell, a director who retires by rotation in accordance with Listing Rule 14.4 and Rule 19.3 of the company's constitution, and being eligible, be re-elected as a director of the company.
I now put forward the motion for those attending in person today. Please mark your voting instruction for this resolution on your yellow voting card. For those attending virtually, please submit your vote via the online portal, so what we have received so far is 82% in favor, 14.3% against. All right, let us move to resolution three, and that resolution is that for the purposes of Listing Rule 7.4 and for all other purposes, shareholders ratify the previous issue of 87.9 million fully paid shares to Precision BioSciences as part settlement of deferred consideration pursuant to the Precision agreements on the terms that are set out in the explanatory memorandum. I now put forward the motion, and the proxies will be on the screen in just a moment. For those attending in person today, please mark your voting instruction for this resolution on your yellow voting card.
For those of you attending virtually, please submit your vote via the online portal. The votes or proxies received so far, 95.6% in favor, 3.69% against. So let us move now to resolution number four, and that is for the purposes of Listing Rules 10.14, shareholders approved the granting of 3.5 million. I beg your pardon, on this resolution, since it's related to myself, I'd like to hand the resolution to Leslie to manage. Thank you, Leslie.
Thank you, Paul. The proxies received in relation to this resolution are on the screen. I now put forward the motion for those attending in person today, please mark your voting instructions for this resolution on your yellow voting card. For those attending virtually, please submit your vote via the online portal. As a resolution four currently stands, four, we have 57.53% and against 41.78%.
I now hand the chair back to Mr. Paul Hopper.
Thank you, Leslie. So let's move to resolution five, please. And that resolution is for the purposes of Listing Rule 10.14, shareholders approved the granting of 19.3 million performance rights, vesting in equal parts over four years to Leslie Chong, director or her nominee, under Imugene's ESOP on the terms set out in the explanatory memorandum. The proxies received in relation are now on the screen. There are 63.79% in favor, 35.6% against. I now put forward the motion for those attending in person today. Please mark your voting instruction for this resolution on your yellow voting card. For those attending virtually, please submit your vote via the online portal. Thank you. Let's now go to resolution six.
This resolution is that for the purposes of Listing Rule 10.14, shareholders approve the granting of two million restricted stock units vesting in equal parts over four years to Dr. Jacob Dupont, Director, or his nominee, under Imugene's ESOP on the terms set out in the explanatory memorandum. So I now put forward the motion. For those of you attending in person, please mark your card, your yellow voting card, and for those attending virtually, please submit your vote. All right, let us now go to resolution seven, please. Resolution seven, and that is for the purposes of Listing Rule 10.14, shareholders approve the granting of two million restricted stock units vesting in equal parts over four years to Jens Eckstein, Director, or his nominee under Imugene's ESOP plan on the terms set out in the explanatory memorandum.
I now put forward, sorry, the proxies are shown on the screen, 67.4% in favour, 32% against. I now put forward the motion. For those attending in person, please mark your voting cards with the yellow card. For those attending virtually, submit your vote via the online portal. Thank you. Resolution eight is that for the purposes of Listing Rule 10.14, shareholders approved the granting of two million restricted stock units vesting in equal parts over four years to Leslie Russell, director or her nominee under Imugene's ESOP plan on the terms set out in the explanatory memorandum. The proxies received in relation to this resolution on the screen, 67.4% in favour, 32.0% against. I now put forward the motion. For those attending in person today, please mark your yellow card. For those attending virtually, submit your vote via the online portal.
Let us now move to resolution nine, and that is for the purposes of Listing Rule 10.14, shareholders approved the granting of 2 million restricted stock units vesting in equal parts over four years to Kim Drapkin, Director or her nominee under Imugene's ESOP plan on the terms set out in the explanatory memorandum. The proxies received in relation to this resolution are on the screen, 68.36% in favor, 31.0% against. I now put forward the motion. And for those attending in person today, please mark your yellow card. And for those attending virtually, submit your vote via the online portal. All right, let's go to conducting the poll and the Q&A. That concludes the resolutions to be voted today. As noted, we are conducting upon all the resolutions, and I draw your attention that the poll is already open.
If you have any questions in relation to votes, please put them through on the Q&A function now. There are a number of, there are a couple of questions that have come through. So what I'm going to do is I will proceed as earlier advised, whereby Leslie will present a report on the company, and then we can open up to the questions and respond to them from that. We're going to ask all shareholders now to finish off their voting. We'll leave another minute or two before we close it. If there's anybody attending in person who wants to vote, I ask the Automic staff now to collect the cards. Are there any people in the room for whom cards need to be collected, Automic?
So those cards are being collected now, Paul.
Thank you, Mike. M ike, if you could let us know when you're done there, please.
Okay, we're done here. Thanks. All collected.
All right, thank you very much for that. So I now declare the poll closed. The staff of Automic will now process the poll, and the results will be announced to the ASX once they are available. I'd now like to hand over to Leslie Chong to give the CEO update. And if you'd like to submit any other questions whilst Leslie is speaking, we'll address those at the end of her presentation. So thank you, Leslie. Over to you.
Thank you so much, Paul. I just want to also acknowledge that Dr. Jacob Dupont is on the call with us.
Okay, thank you.
Is everyone seeing the presentation mode?
Yes, Leslie.
Great. Thank you. Imugene is a clinical stage cancer company developing three drug candidates in CAR T cellular therapy and as well as oncolytic virus.
I don't develop the clinical part myself. I have a wealth of experienced folks helping me, and of which we have together in some part developed over 17 FDA-approved drugs to market specifically in oncology. We have Dr. Paul Woodard, our CMO, Dr. Bradley Glover, our COO, Ms. Ursula McCurry, CCOO, and Dr. John Byon, our Senior VP of Clinical Development, as well as Dr. Monil Shah as our contract CBO. And our investment highlights are quite busy here. So we have four unique platform technologies, all under a long life patent portfolio. We're not only developing in solid tumors, but we're very specific in a blood cancer type. We have four ongoing clinical studies, and three of our prioritized programs are in allogeneic CAR T cellular therapy that we call azer-cel. This is a CD19-directed CAR T. We also have oncolytic viruses that we call VAXINIA.
That's in a metastatic advanced solid tumor trial study. We have onCARlytics. This is a CF33 or an oncolytic virus that expresses CD19, and it's in a combination with a very powerful anti-CD19 CAR T therapeutics. So I'll briefly go into what is an autologous CAR T therapy. So this is a cancer treatment in which a patient's own T cells are reprogrammed in a laboratory. It takes anywhere between 19 to 42 days to get it reprogrammed and placed back into the patient, and they become something like a guided missile to attack certain proteins, and in this case, CD19, on a cancer cell. CAR T stands for Chimeric Antigen Receptor T Cell, and currently, many CD19-targeted autologous CAR Ts are approved and only in blood cancers.
So again, highly personalized, a patient's own T cells are taken from the patient, then reprogrammed, and like a guided missile, it only goes after the CD19 in blood cancers. Highly personalized, and it has revolutionized how we treat certain kinds of blood cancers. But at Imugene, we think that the future is allogeneic CAR T. So allogeneic CAR T is exactly what our Azer-cel is. Azer-cel is an off-the-shelf or on-demand CD19 CAR T drug. This means when a patient is ready, we can provide Azer-cel. This is derived from healthy donor T cells, where we genetically engineer those, and each batch can be sent to a hospital or a clinic and provide dosing for anywhere between 12 to 15 patients.
The slide is quite busy, but we are very focused on a very late line of diffuse large B-cell lymphoma, a true unmet need in this space, where patients have received autologous CAR Ts and have progressed off those. We're currently in a phase 1B study, and I'm quite proud that we were able to cut data at 10 patients, where six patients were in cohort A and four patients were in cohort B. And out of those 10 patients, we saw three complete responders and two in cohort B, where we added interleukin-2. IL-2 is simply a cytokine that helps the T cells or our Azer-cel live a bit longer in the patient. All these patients have failed autologous CAR T and sometimes bispecifics and other lines of chemo. This patient has come on the study in the cohort B.
They have gone through several rounds of chemo as well as Yescarta and autologous CAR T. They benefited for a few months and then had progressed, took some steroids, but yet progressed off those. And as you can see, on the fifth line of Azer-cel at baseline, the next shows massive tumor growth. And as early as day 28, this patient saw a complete clearance of their tumors and remained cleared at the time of this data cut at day 120. I look forward to coming back and providing more updates. I'll move on to our oncolytic viral therapy, our CF33 VAXINIA. So simply put, our CF33 loves to only infect and invade tumor cells. It replicates at an accelerated rate and then explodes, and then the virus goes on to replicate and infect other cancer cells, and we have seen this in our trial.
At the time of the last study data cut, there were greater than about 40 patients. And what we saw, I just want to remind everyone, this is a dose escalation study whereby the FDA makes you start at a very low dose. And during dose escalation, we saw half the population receive stability of their disease. I remind folks that these patients have gone through anywhere between four to eight lines of prior therapy and have progressed prior to coming onto our study. So giving these patients more than three months of stabilization, as well as some patients going on more than 200 days. And one patient in particular, we were happily able to announce that this patient with biliary tract cancer has lived in complete remission for over two years and continues on. We had a couple of patients also reap benefit for a partial response.
With that biliary tract trial, with those biliary tract patients, we were able to expand into a biliary tract trial and were able to announce that we had three patients in the first cohort, and now we can open up to the other patients so that we can quickly take a look to see if we need to go into a phase two trial in biliary tract cancer. The FDA has been on notice that we have fast-track orphan drug designation for biliary tract cancer for our VAXINIA trial. We have another CF33 sort of cousin or brother, as it were. So onCARlytics, this is a CD19 expressing oncolytic virus. We know that our CF33 loves to infiltrate into only solid tumors, shuttles up, or flags a solid tumor with CD19. CD19 is a protein that doesn't occur in solid tumor, but only in blood cancers.
As I said earlier, there are many CD19-directed therapeutics. So to be in that combination, we obliterate solid tumor. This is revolutionary. There is nothing like it in the cancer landscape. So we have high anticipation for this. We're currently in an onCARlytics combined with blinatumomab. This is an approved product by Amgen. So it's a CD19-directed therapeutics. With onCARlytics, we were able to pass the IV intravenous and its intra-tumoral monotherapy cohort and clear that for safety. We're currently in combination, not only intravenous combination with blinatumomab, but also intra-tumoral combo. Azer-cel 2024 was a very good year in that we were able to announce three complete responses. Then in our homeland, we were able to open up our first Australian site.
With VAXINIA, we had positive news with that one complete responder in biliary tract cancer going on more than two years, and then two partial response. And again, I'll remind you, this is a dose escalation study where you're looking for an optimal biological dose. We were able to receive orphan drug designation as well as combining with that fast-track designation. We are currently in a biliary tract cancer trial expansion. We have some key catalysts, and all those that happened in 2024 lays a nice groundwork and baseline to achieve other main key catalyst points at the rest of 2024 as well as well into 2025. With Azer-cel continuing on with that IL-2 combination in that diffuse large B-cell lymphoma, the late line lymphoma patients in phase 1B, we hope to report back with some interim data.
We continue to target the regulatory meetings with FDA and hopefully start our phase two study. OnCARlytics, IT and IV combination continues, and we hope to read out on some early data, and then establishing that optimal biological dose so that we can move into a phase two. IVAXNIA is still ongoing with the hope that we can open up a second indication and establish an optimal biological dose there as well and start our phase two study. Imugene continues to the commercialization strategy, and we want to reap on the multiple value realization pathway. Our company can be acquired. We can partner with Big Pharma. We can license the technology separately as well as develop and commercialize independently. Thank you so much for your attention.
Right. Thank you, Leslie. So let us now move to questions. Several questions have come in.
Let me start with the first one, which I think I'll direct to you, Leslie, which is, when will the next data cut and release for the MAST study and oncolytics be?
So the data cut encompasses quite a lot of time. You want at least three months to pass for each patient that come in. And so 2025, I imagine that we will provide a further update.
Thank you. Then there's a question about the licensing negotiations with the B-cell platform. So licensing negotiations are continuous on this particular platform. Naturally, we can't make announcements regarding something which is not concluded. And in particular, when dealing with parties interested in technology, the last thing they want is someone like Imugene announcing to the market that they're close to doing a deal. So that is work in progress.
When the company is in a position to announce something solid, we will do so. A question about the R&D refund. The R&D refund will be announced shortly. We had some extra questions which we had to answer in terms of the audit and that, but we expect an announcement on the refund fairly shortly. There's a question about raising funds for the company in addition to how many quarters cash are left. Look, we obviously don't spend time telling the market what the board strategy is in relation to capital. If you look at the history of this company in the last four or five years, it's always been extremely well supported when it's needed money. The board watches the cash position carefully, and when we have news, we will make an announcement on that.
There's a question about whether a share consolidation is being considered, and the answer is no. That comes up from time to time, but we rarely get a question from investors, particularly U.S. investors, about whether we should consolidate the stock. But it is something that sits there, but we are not thinking about it at the moment. A question about the board members about them being there to secure funding and selling assets. I think that's a misconception. The board is comprised of a multitude of experience and expertise, and they don't have a particular role to raise money or to sell assets. And then further, the question about licensing and Big Pharma. Yes, they are interested, but like all of these technologies, you need to produce very profound, definitive data before they sign up.
That is the target for us to achieve in order to be able to do licensing. I mentioned the B-cell platform previously. That has been marked for out-licensing, and we've been very clear about that. And as I mentioned earlier on, we are in the process of talking to people about it, and when we are able to do something, we'll make an announcement. There's a question about. There are three products under clinical trial. What about B-cell HER-Vaxx? Leslie, just want to take that one quickly, please.
Sure. So HER-Vaxx, as Paul alluded to, is in BD process. PD1-Vaxx is under what's called an investigator-sponsored trial called the NeoPOLEM. This is handled by an Australian group as well as the U.K., the United Kingdom group. And so there's a joint effort in moving PD1-Vaxx forward in a clinical trial.
Because we are not the sponsor, we really can't say much about it because they're sponsoring the clinical trial on our behalf.
Thank you, Leslie. Can you comment whether there's a risk of graft-versus-host disease with the allogeneic CAR T?
No. There has been because azer-cel has been genetically modified to specifically avoid this. The TK locus is knocked out. Therefore, we have not seen this in roughly more than 90 patients that we have dosed.
Right. Can you speak to the foreseeable timeframe for the FDA regulatory meeting in the start of the phase two study for azer-cel?
We would like to amass some confidence in our data so that we are not going back and forth with the FDA.
So we're amassing this data in the phase 1B currently, and we will have a meeting with the FDA regarding our data as soon as we have a comfort level and a confidence interval with our phase 1B data in azer-cel.
Thank you. There's a question on our efforts to increase revenue so we can have more than three quarters of cash flow to give us more time to hopefully see significant results in various trials. Look, as I mentioned earlier on, the board monitors the cash position very closely. When you say what the question said to increase revenue, I'm assuming you mean to raise money rather than revenue because, as you know, biotechs don't have revenue. So the board monitors the market pretty carefully. We're in touch with all our bankers and investors.
And at the appropriate time, we'll let the market know as to our efforts or outcomes to raise money. And I think I'm just going through. I think that covers all the questions. Some of them I've amalgamated. All right. If there are no more questions, then I guess that brings us to the end of the meeting today. Any on the floor? No questions from the floor or yes?
So there's a question.
Yes, Mr. Chairman, I have three questions. The first one is, what competition does the company face for the three products you are endeavoring to produce?
Sure. So almost every cancer technology under development throughout the world has competition. So if you pick something like breast cancer, there's probably hundreds of technologies out there. So competition, if you want to refine it a little bit, competition in the CAR T space is reasonably intense.
We do believe that in the case of azer-cel, we have a fairly unique product. There are some that are related, I guess, but we do believe it's pretty unique. In terms of the oncolytic viruses, we also think they have a pretty unique status, though there are other oncolytic virus companies out there. So there's always going to be some sort of competition against the three technologies, but we believe ours are unique and have their own special features.
Okay. Question number two. Will the company's product be the first of its kind on the market?
Well, I guess that's sort of related to your first question. Well, CAR T drugs, for example, there are seven or so blood cancer CAR Ts, and there are many solid tumor CAR Ts in development. So I guess in that case, it's a bit of a race to the finish.
In the case of the oncolytic viruses, we could be. It's not a very crowded space, oncolytic viruses, but there are a number of them out there. So I guess, again, it's just really a question of who gets to the finish line first.
Question number three is, does the company's product or any of them have orphan drug status?
Yes. Leslie, do you want to take that one?
Yes. So the IVAXNIA or the CF33 parental virus has received just two months ago orphan designation.
So does that mean it's not for the mass market then? It's not a mass market drug, but for a fairly small demand.
No.
What that means is because it's a very highly unmet need and it happens to be a niche area, the FDA will allow for efficiencies such as seven-year dominance over first-in-class when you are able to market it. So there are great advantages to allow for those unmet need patients to receive the drug for a longer amount of time.
Sorry. Which product has got orphan status?
The CF33, the oncolytic virus that we call VAXINIA.
Thank you.
Mike, do we have any more questions from the floor? No more questions for. All right. Thank you very much. Well, look, since the questions are finished, I think that brings us to the end of the meeting today. Thank you for your interest and suport of Imugene and for your attendance in today's meeting. Thank you.