I declare this annual general meeting of Immutep Limited open, and thank you for attending. My name is Russell Howard, and I'm the chair of the company. It gives me great pleasure to welcome you here today and to share with you our progress over the last 12 months. I would like to begin today's meeting by acknowledging the traditional owners of the land on which we meet today, the Gadigal people of the Eora Nation. I pay my respect to elders past and present and extend that respect to my Aboriginal and Torres Strait Islander people standing or attending at this meeting. I would now like to introduce you to the company's board of directors: Marc Voigt, our Managing Director and CEO, Liz Boyce, our other Australian-based Non-Executive Director, Dr. Frédéric Triebel, our CSO and Executive Director, and Pete Meyers, our U.S.-based Non-Executive Director who is attending remotely.
I also welcome Jason Hayes, our audit partner from PwC, and Deanne Miller, our COO and Company Secretary. The company's constitution specifies a quorum of two members present, in person or by proxy. As there are more than two members present, I declare that the meeting is open with a quorum. When you arrived at the meeting this morning, you would have registered with our share registry Boardroom, and you would have been allocated a card. If there is anybody present who has not registered or received an admission card, would you please do so now? All shareholders who are present in person or by proxy who are entitled to vote should have a green card. Non-voting shareholders will have been allocated a red card and are not entitled to vote in any of the resolutions. However, they are able to ask questions.
Visitors received a white admission card, which allows you to attend the meeting but not ask any questions. If I call on you, please raise your green voting or red non-voting card prior to speaking to identify yourself as a shareholder. If you're acting as a proxy, please state clearly who you are appointed to represent when introducing yourself to the meeting. Voting today will be conducted by way of a poll on all resolutions. You can complete your voting cards during the meeting and submit these to the company's registry staff present today at the meeting. All members and appointed proxies entitled to vote were given a green card upon admission to the meeting. Members attending the meeting who have also voted by proxy must be using their voting card as their proxy votes are rendered illegible by their attendance. That is a terrible sentence.
Please clearly mark either for, against, or abstain on the front of the card next to the resolution being used under the poll, voted under the poll. The returning officer for the poll will be Marc Duckmanton from Boardroom. Once you have marked your vote, it will be collected by the returning officer staff, and I declare the poll opened. Notice of Meeting. Notice of this annual general meeting has been given to shareholders in accordance with the company's constitution, the Listing Rules of the ASX, and the Corporations Act. A copy of the Notice of Meeting has been lodged with the ASX and posted to all shareholders. Unless there's any objection, I propose that the Notice of Meeting be taken as read. Before we commence the formal aspects of today's AGM, I would like to say a few words. Now I have larger font.
Dear fellow shareholders, on behalf of the board of directors, I'm pleased to welcome you to Immutep Limited's annual general meeting for the 2024 financial year. Thank you to all our shareholders who have joined us both in person and virtually. It's my pleasure to provide you with an overview of Immutep's progress during the last financial year, a year of notable achievements and advancements in our clinical trials, significant regulatory achievements, and continued strong financial management. This has put our company in a very strong position to continue to advance our lead candidate, eftilagimod alpha, or FD, towards market approvals in Europe and the US, and in addition to progress our autoimmune candidate, IMP761, through early clinical trials following its recent early entry into the clinic.
As you may know, FD is a soluble LAG-3 fusion protein with a unique mechanism of action as an MHC Class II agonist. It is the only LAG-3 product that activates both the adaptive and innate immune system to drive a broad immune response to fight cancer. Another key differentiator is FD's strong safety profile, which enables it to be paired with a variety of other cancer therapies, including anti-PD-L1 therapies, radiotherapy, and chemotherapy, without generating a new safety signal from combined therapy. Its versatility, with exceptional promise in multiple oncology indications, opens up multiple strategic opportunities for Immutep. Immutep's strategic options include the opportunity to partner with one of our existing collaboration partners or to partner with the owner of any of the other cancer therapies FD is already being tested with, or we could potentially pursue commercialization ourselves.
Delivering the best outcome for patients and shareholders will be the key determinant for our eventual pathway. In financial year 2024, we made significant strides advancing FD in later stage clinical trials in three large oncology indications. Our lead indication is first line non-small cell NSCLC cancer. We're also evaluating FD in first line head and neck squamous cell carcinoma, HNSCC, as well as advancing it in metastatic breast cancer. In addition to these later stage studies, earlier stage trials in soft tissue sarcoma and urothelial cancer are also underway with clinical collaborators. Before I take you through the highlights of this work, I would like to extend the board's appreciation to Immutep's team, whose dedication has enabled us to achieve so many milestones this year. Immutep has welcomed a number of new team members this year.
We now have 46 talented professionals across the globe, experts in research, development, and regulatory affairs in our key markets. During the year, we were pleased to sign our third and most important clinical trial collaboration and supply agreement with MSD, also known as Merck & Co. in the US. This clinical trial will assess FD in combination with Merck's anti-PD-1 therapy, Keytruda, plus chemotherapy as a first line treatment for metastatic NSCLC. This pivotal phase III trial is called TACTI-004. MSD's Keytruda became the world's top selling drug in 2023, and lung cancer was estimated to represent over 35% of Keytruda's $25 billion in sales last year. Success with TACTI-004 would provide our company with significant commercial leverage. The TACTI-004 trial will enroll approximately 750 patients irrespective of PD-L1 expression to address the full scope of the first line NSCLC market eligible for anti-PD-L1 therapy.
We were delighted to receive positive feedback from the U.S. Food and Drug Administration on this trial following the end of the financial year, completing the preparatory regulatory interactions needed to start the trial. In other areas, our TACTI-003 trial for first-line HNSCC has made strong progress, completing recruitment and reporting initial clinical results. This phase IIb trial has reported promising efficacy across all levels of PD-L1 expression, especially of interest in the PD-L1 negative cohort. Remarkably, these results have been achieved without chemotherapy in a PD-L1 negative HNSCC population, a patient subgroup traditionally challenging to treat. Immutep continues to track patient outcomes and looks forward to providing an update on HNSCC patients with negative PD-L1 expression in a few weeks at the ESMO Immuno-Oncology Conference. The APEX-003 phase II/III study in metastatic breast cancer is also progressing well. Patient recruitment continued through the financial year.
In October 2024, we announced the phase II portion was fully enrolled. Early data from the safety lead-in phase was encouraging. We look forward to reporting further data and determining FD's optimal biological dose, which will be either 30 or 90 milligram dose, in light of the Project Optimus guidance from the FDA. Our new collaboration with MSD builds on previous collaborations, including the TACTI-002 trial in NSCLC and HNSCC, where we've reported compelling improvements in patient survival and response rates. In part A of TACTI-002, we've shown FD is enabling deep, durable responses for patients regardless of PD-L1 expression. We have a favorable safety profile in line with anti-PD-1 monotherapy, and most importantly, this treatment drives a relatively high median overall survival benefit for our patients.
Finally, Immutep recently reported promising interim results from the INSITE-003 trial in first-line non-small cell lung cancer, NSCLC, and from the EFTISARC-NEO phase II trial in soft tissue sarcoma, or STS. We're excited about the excellent data in NSCLC and STS, and it represents an area of high unmet need. These advancements across Immutep's broader clinical programs underscore FD's potential to improve therapeutic outcomes for a variety of patients facing challenging cancer types. Financial year 2024 has also been a pivotal year for regulatory achievements. Both the European Medicines Agency, or EMA, and the U.S. FDA provided positive feedback on FD's development pathway. The EMA confirmed additional toxicology studies are not required for the anticipated potential marketing authorization application, or MAA, while the FDA offered similar support regarding the potential biologics license application, or BLA. This strengthens the regulatory pathway for FD.
On the manufacturing front, Immutep secured regulatory approval for FD made under its commercial 2,000-liter scale process, a process designed for clinical use in multiple European countries as well as in the US. The manufacturing milestone this represents positions us to meet future demand as the company advances towards commercialization. Immutep's second program with IMP761, the world's first LAG-3 agonist designed for autoimmune diseases, has also made significant progress. The initiation of first-in-human trials started mid this year. The first healthy participant was successfully dosed, subsequent to the financial year end, and the trial is progressing well. IMP761 holds great promise due to its potential to address the underlying causes of autoimmune disorders, and it's an exciting emerging part of our development pipeline.
Throughout all this clinical activity, Immutep's financial position has remained very robust, thanks to the ongoing and strong support we have received from our shareholders. During financial year 24, new and existing shareholders enabled Immutep to raise AUD 100.2 million, that's $63 million, via a fully underwritten issue of new equity. We closed financial year 24 with a strong balance in cash, cash equivalents, and term deposits of approximately AUD 181.8 million. Our financial strategy has been disciplined and growth oriented, ensuring we can expect a strong runway to the end of calendar 2026. Immutep's share price and market capitalization is often affected by the broader biotech and pharma market, as well as the global forces that are always changing.
Following our recent INSITE-003 data, we are more confident than ever in our path to conduct our pivotal phase III study, TACTI-004, that study for the largest global cancer market of NSCLC. We believe FD can add significant clinical benefit to the standard of care for patients receiving the world's commercially most successful drug, Keytruda, and that our combination trial will translate into tremendous value for Immutep and its partners and will well reward our longstanding shareholders. Looking ahead, financial year 2025 is poised to be another year of meaningful progress. Our primary focus will be to develop FD in first line NSCLC via the TACTI-004 phase III trial. We anticipate initiation of the trial in late 2024 or early 2025.
In addition, we will continue to explore the paths forward for first-line HNSCC and metastatic breast cancer, and we are eagerly awaiting results from the first-in-human study of our autoimmune candidate, IMP761. We are grateful for the continued support of our shareholders, whose trust enables us to advance these life-changing LAG-3 therapeutics. Thank you for your ongoing confidence in Immutep as we work to make a lasting difference in the lives of patients and their families worldwide. Get rid of some of this. Thank you. Now we will turn to the formal business part of today's meeting. A summary of valid proxies and directed votes received prior to the AGM for all resolutions contained in this year's AGM notice of meeting appears on the slide shown on the screen. Now to the financial statements, which we'll table.
We'll table the financial statements, the director's report, and auditor's report for the company and its controlled entities for the year ended 30 June 2024. Copies of the annual report have been sent to all shareholders, and additional copies are available here. I would like to invite shareholders to ask questions on the reports and the conduct of the audit. At this time, please limit your questions to matters concerning the financial and other reports and the content of the audit, as there will be time for other questions at times throughout and at the conclusion of the meeting. I now turn to resolution one. The resolution reads that for the purposes of section 250(r)(2) of the Corporations Act 2001 and for all other purposes, the company adopt the remuneration report for the financial year ended 30 June 2024.
Details in respect of resolution one were set out in the explanatory notes accompanying the notice of the 2024 annual general meeting. This is an ordinary resolution requiring a simple majority approval. This resolution is required by the Corporations Act 2001, and the vote on the resolution is advisory only and does not bind the directors of the company. As stated in the AGM notice of meeting, the board recommends that you vote in favor of resolution one. I inform the meeting the proxy votes on the resolution are as presented on the slide, and I note that no questions were submitted on this resolution in advance of the meeting. Are there any questions from the floor about this resolution? Does anyone wish to speak for or against the resolution or make comments on the remuneration report?
There being no further discussion, I put the resolution to the vote, and please complete your voting card. Now to resolution two. It reads that Dr. Frédéric Triebel, who's retiring in accordance with the Constitution and who offers himself for re-election, is re-elected as the director of the company. This is an ordinary resolution, again requiring a simple majority approval. As stated in the AGM notice of meeting, the board, with Dr. Triebel abstaining, recommends that you vote in favor of resolution two. Frédéric, before I see questions or comments from members, would you like to say a few words, please?
Yes. Stand up for just a few words. I should say that. Or not to be on the board of Immutep. Hopefully, you're receiving a lot of confidence today. I'll explain. We're facing exciting times.
There will be certainly a few announcements before the end of the calendar year, and in 2025, I think we will be positioned as a recognized phase three company working with a respected partner with a lot of experience, MSD, and there will be a lot of work on the to be prepared for the BLA on the manufacturing, on the regulatory, on SAP. So many news to come, and we hope that will help the shareholders in a sense. Also, not to forget, we have this very interesting LAG-3 agonist for autoimmunity, IMP761, and we will release shortly results about safety, which is the main point first, but maybe as important efficacy results in terms of looking at immunosuppression in these healthy subjects.
So this is a randomized placebo control, I mean, real good stuff, and we hope that this proof of concept in human will certainly help us to design a good phase two, possibly with a partner the year after that. So that's where we are, and thank you very much. Thank you, Frédéric.
I inform the meeting the proxy votes on the resolution are as presented on the slide. I note no questions were submitted on the resolution in advance of the meeting. Are there any questions from the floor about this resolution, and does anyone wish to speak for or against the resolution? Thank you. There being no further discussion, I put the resolution to the vote, and please complete your voting card.
The third resolution reads that for the purposes of ASX listing rule 7.4 and for all other purposes, shareholders ratify the issue of 189,470,507 shares on the terms and conditions set out in the explanatory memorandum. This is an ordinary resolution requiring a simple majority approval. As stated in the AGM notice of meeting, the board recommends that you vote in favor of resolution three, and I inform the meeting that proxy votes on the resolution are as presented on the slide. I note no questions were submitted on this resolution in advance of the meeting, and are there any questions from the floor on this resolution? Does anyone wish to speak to it, please?
Yeah, I'm just Alex Maxwell from Home Investments. I just have a question about the timing of the raising. You were raising it just a few months ago.
It was shortly before the announcement of some clinical trial results for an update, at least I think it was TACTI-3, which had a mixed reception by the market. My question is, why didn't you wait for the release of that? I think what that's led to is some new shareholders who probably weren't in the stock for the right reason, looking at those results their own way in a short-term with a short-term focus, and has led to some disappointment and share price retreating as a result. My question is, why didn't you wait for those results to be announced and then do the raising, even if that meant doing a raising at a lower price?
Marc, I will let you answer the question.
I can maybe comment on that. First of all, it's of course a good and important question.
So we have been entering into an agreement with MSD for a very large clinical trial, TACTI-004, 750 patients, and of course you have financial requirements for such a clinical trial, requirements you need to cover. So you sign an agreement which is also requiring from you that you have the capability in terms of your own resources, including financial resources, to execute on that. So the key trigger has been the plan for TACTI-004. At that time, we knew that the cohort B of TACTI-003, preliminary data, I believe, has been released in April, has been positive. We didn't know final results of cohort A, which has been having a mixed reception, is an euphemism, I would say. It has been not received very well and has been leading to a disappointing share price reaction. That's simply as a matter of fact.
Of course, you could take also the strategy to put your trial at risk, maybe even risking a signature from the partner and waiting for more results to come, and we had quite a few results throughout the year. We believe it's best to secure the support from MSD in the United States to make sure that we can kick off the clinical trial, which is in fact the key value driver for the company moving forward. Head and neck cancer, if you look there at the market potential, it's around about $3 billion, while non-small cell lung cancer is $24 billion, and the clear declared first priority of the company since October 2022 is non-small cell lung cancer. So to have this decisive step also financially adequately secured made the Board to decide to raise that capital.
Can I just say, I think, so are you therefore saying you didn't have confidence that if the results weren't received well, that you could raise that money?
No, results are known. Actually, I personally thought we have a good chance to see good results, and if you look at the results, there are quite good elements also in cohort A, but it's of course unknown at the time how the results will be looked at and how the environment is. But what has been known is you have an agreement signed with a very, very good partner, first time since more than two and a half years that they have been doing such a step, and then you are asked to either move or not practically, and of course you have to have the financial resources at hand.
All I'll say is I accept everything you say.
I'm a supporter of the business. I'm a shareholder. I also think those results were better than the market reaction, so I accept all that, but shareholder confidence is important. Agree. And if you try and be tactical in the way you raise money like that, it can undermine confidence, and what you need going forward is confidence from your shareholders because the share price reaction is quite disappointing. It doesn't bother me so much because I'm supporting your business and I understand that the results are potentially coming, but you also have a duty to shareholders to do the right thing by them. You want their support. You need to do things in a way that makes sense for shareholders as well so that you don't put your money in and find it's worth 25%, 30%, 40% less in two months.
No, I fully agree that confidence is a very important currency in our business. I do believe, however, also if you, for instance, look at the votes, that we have quite a good confidence in terms of what we are doing. The share price has been in the second half of the year, from our perspective, certainly not reflective of the intrinsic value. It's frustrating, let's be honest. It's not good. We have been, however, getting really good support from a variety of investors, stakeholders, and I'm fully aware in terms of the confidence, but we needed to secure at that point in time the bigger picture that we can execute on the key value driver of the company for the next three years, and without the adequate financial support, you cannot start such a clinical trial.
And also, there are sometimes investors who can play against you because they know you will never be able to finance such a big trial, so they may short the stock. So there are different responsibilities, different points of view. I certainly accept yours, and we will keep that in mind as a shareholder. Confidence also, and especially, by the way, also from retail shareholders who can't judge on some of the aspects of immunology or oncology. We have this in our decision-making always in mind. Thank you for the question.
Have I just done three, I believe? So resolution three? You need to go with the four. It's on the four. It's the next. Correct. Okay, let me read resolution four.
That for the purposes of Listing Rule 10.14 and for all other purposes, the company approves and authorizes the issue of 3,600,000 performance rights under the company's executive incentive plan to Executive Director and Chief Executive Officer, Mr. Marc Voigt, and/or his nominee, and the issue of up to 3,600,000 shares on exercise of those performance rights on the terms and conditions set out in the explanatory memorandum. This is an ordinary resolution requiring a simple majority approval. As stated in the AGM notice of meeting, the board, with Mr. Voigt abstaining, recommends that you vote in favor of resolution four. I inform the meeting the proxy votes on the resolution are as presented on the slide, and I note that no questions were submitted on this resolution in advance of the meeting.
Are there any questions from the floor about this resolution, and would anyone like to speak for or against the resolution? There being no further discussion, I put the resolution to the vote, and please complete your voting card. Next to resolution five, it reads, for the purposes of Listing Rule 10.14 and for all other purposes, the company approves and authorizes the issue of 2,700,000 performance rights under the company's executive incentive plan to Executive Director and Chief Scientific Officer, Dr. Frédéric Triebel and/or his nominee, and the issue of up to 2,700,000 shares on exercise of those performance rights on the terms and conditions set out in the explanatory memorandum. This is also an ordinary resolution requiring a simple majority approval. As stated in the AGM notice of meeting, the board, with Dr.
Frédéric Triebel abstaining, recommends that you vote in favor of resolution five, and I inform the meeting the proxy votes on the resolution are as presented on the slide, and I note no questions were submitted on this resolution in advance of the meeting. Are there any questions from the floor about this resolution, and does anyone wish to speak for or against this resolution? There being no further discussion, I put the resolution to the vote, and please complete your voting card. Now to resolution six.
It reads that for the purposes of sections 200B and 200E of the Corporations Act 2001 and the ASX Listing Rule 10.19 and for all other purposes, approval is given for the giving of benefits to each current and future eligible senior executive as described in the explanatory memorandum in connection with the retirement of that person from any office in the company or a related body corporate of the company referred to in section 200B of the Corporations Act 2001. This is an ordinary resolution requiring a simple majority approval, and as stated in the AGM Notice of Meeting, the board recommends that you vote in favor of resolution six. I inform the meeting the proxy votes on the resolution are as presented on the slide, and I note no questions were submitted on the resolution in advance of the meeting.
Are there any questions from the floor about this resolution, and would anyone like to speak for or against the resolution? There being no further discussion, I put the resolution to the vote, and please complete your voting card, and now to resolution seven. It reads that for the purposes of ASX listing rule 7.2, exception 13B, and section 260(c)(4) of the Corporations Act of 2001 and for all other purposes, approval is given for the issue of performance rights and/or options to eligible participants under the company's executive incentive plan, the terms and conditions of which are set out in the explanatory memorandum. This is an ordinary resolution requiring a simple majority vote and approval. As stated in the AGM notice of meeting, the board recommends that you vote in favor of resolution seven.
I inform the meeting the proxy votes on the resolution Iris presented on the slide, and I note no questions were submitted to the resolution in advance of the meeting. Are there any questions from the floor about this resolution, and would anyone like to speak for or against the resolution? There being no further discussion, I put the resolution to the vote, and please complete your voting card. And now to the final resolution, resolution eight. It reads as follows. That for the purposes of section 648(g) of the Corporations Act and for all other purposes, the proportional takeover provisions contained in clauses 12.6 and 12.7 of the company's constitution be renewed. This is an ordinary resolution requiring a simple majority approval. As stated in the AGM notice of meeting, the board recommends that you vote in favor of resolution eight.
I inform the meeting the proxy votes on the resolution Iris presented on the slide, and I note that no questions were submitted on this resolution in advance of the meeting. Are there any questions from the floor about this resolution, and does anyone wish to speak for or against the resolution? There being no further discussion, I put the resolution to the vote, and please complete your voting card. I now declare the poll closed and thank you for your participation. The results of these votes will be released to the ASX later today and will also be made available on our company's website. The business part of the meeting is therefore closed. Our CEO, Marc Voigt, will now present a brief update on the company's activities. Mark.
Thank you, Russell. Accidentally covered half of the presentation already, but it's worth repeating. It's so good.
Let's start at the beginning. First of all, I would like to welcome you all. Very warm welcome from my side, and thank you for your support, ongoing support despite, as mentioned before, and I would like to expressly mention it again, the frustrating share price in the second half of this year. We have been exposed to the biotech rollercoaster regarding data, but also regarding some macro-environmental reasons, like for instance, the implications of the new administration in the United States and the speculations around it. Also, I would like to thank Piper Alderman for hosting us. Very generous. Thank you. Now I will go through the presentation. First of all, my forward-looking statement so we will cover a number of different topics today.
And as Frédéric and Russell said early on, I believe, especially in terms of the outlook, we can be very confident that this is not a marketing statement, but this is reflected by the truth and our key value drivers moving forward and the chance we have specifically in first-line non-small cell lung cancer. Just to remind ourselves briefly, the company overview. So we have a very strong position, a very strong position in terms of our scientific fundament, where Frédéric dedicated three decades of his life towards it. We have the leadership position. We are pioneering the LAG-3 space. It's a unique immune control mechanism, and it's not fancy science, of course. That is it, of course, as well, but it's also validated.
Besides PD-1, CTLA-4, LAG-3, as many of you know, is validated since 2022, and the approval of the first product in that space from Bristol-Myers Squibb. So we have the products. We also generated the data quite a bit during the course of this year, also quite a bit coming up in 2025, and to the earlier point raised by the question, an important question, we also have the financial means to turn our plans into reality, so we can address it from a financial position of strength, and of course, we have the progress in manufacturing and also intellectual property. So from a holistic point of view, we have a very, very good company, a number of very good assets, I believe, a very dedicated team around the globe working very hard on a trial like TACTI-004 and all other aspects of the business.
If you compare our headcount to some other biotechs, I believe, based on operational excellence, we do not need to hide. Also, here just visualize a little bit a different way. It's often forgotten that we have more than only eftilagimod alpha. We have IMP761, which entered clinical development after years of pre-clinical development, usually a bigger event, mid of this year in a very exciting clinical trial, a phase I clinical trial. Frédéric characterized it already a little bit, which will deliver results before the end of this year and then, more importantly, first half and mid of next year, and beyond that, a few other assets, and there might be updates regarding the one or the other. Most importantly, and the key value driver of the company is indeed what you see on top of this page.
This is to turn the company into a phase three company and first-line non-small cell lung cancer. This in itself is an achievement, but more importantly, we do the final clinical step before potential registration. Of course, sufficiently positive results are important in one of the largest markets you can think of. Total addressable market today, round about $24 billion, expected actually to double till 2031. And we do this step not alone, but together with one of the best partners you can think of, MSD, Merck in the United States, and together with the top-selling drug in the whole pharmaceutical industry. So I believe that's a very strong value proposition, especially also looking at the fact, we will come to that later, that we cover the whole first-line non-small cell lung cancer patient population and not a specific small subsegment with a pharma standard clinical trial.
We have different modes of action. I will not go too much into detail, but we created over the years unique assets. So there is no second version of eftilagimod, so no biosimilar, for instance. We have created a unique product in terms of eftilagimod, but also in terms of IMP761. It's the world's first LAG-3 agonist. It took Frédéric about a decade to create that program, which is now seeing first tests in human beings. During 2024, and Russell covered quite a bit of that already, we have been seeing very, very good progress. We have been seeing good progress in terms of non-small cell lung cancer, also in terms of head and neck cancer.
I deliberately say that even though the results we have been showing were related to one specific group of patients, not so clear, but we delivered there in terms of the patients who can't work with or where Keytruda is not approved, the so-called cohort B, and also in the CPS greater than or equal to 20 patient population. Also in head and neck cancer, we delivered very exciting results, and I believe it has been overlooked for cohort A that we saw statistically significant differences in terms of the immune system with a combination of eftilagimod and Keytruda versus Keytruda. We have been showing actually that we trigger the immune system in a very powerful way in a randomized setting in a statistically significant way. Also in terms of APEX-003, we finalized recruitment in October this year.
We are now collecting the data, of course, continue to treat the patients, clean the data, and then finally also come to the optimal biological dose, which is either 30 or 90 milligrams. And we delivered also exciting results in soft tissue sarcoma last week by chance to announcement on the same day INSITE-003 and EFTISARC-NEO, but exciting also there in this orphan drug indication and IMP761. We are moving forward, and I will make some comments regarding this phase one in a few minutes. So back to TACTI-004, a decisive clinical trial which will certainly be followed not only by our analysts and stakeholders, shareholders, but also by analysts around the globe covering the anti-PD-1 space or covering Merck. This is an important clinical trial which has a chance to set and improve the standard of care and the most important cancer indication.
Non-small cell lung cancer is the leading cause of cancer death globally. So to make a difference is important for the patients. It's important also commercially. And if everything fails, breast cancer, head and neck cancer, soft tissue sarcoma, IMP761, everything fails. If this program is successful, we will certainly be a multiple of what we are today. So it's the key value driver moving forward. And we are about to start the clinical trial. Our guidance we made earlier this year, end of 2024, Q1 2025 remains intact. Nothing to revise. We are working very hard on it. And we also have here a clinical trial which is not recruiting for, let's say, three years, and then you don't hear anything, and it's a long period, and everyone suffers within.
This is a trial which has a chance, or not only the chance, which is designed to have readouts in between, like the futility analysis in late 2025, of course, subject to the recruitment, so we will see at different points in time how it's going with this clinical trial. It's very important for a biotech company not to hang out there for a long period of time in terms of news flow that's important for the shareholders, for the market, and for the key clinical trial, and this clinical trial has also, if you compare it to smaller randomized settings, some of you may think about TACTI-003, a different risk profile. This trial has 750 patients, meaning the differences you need to see do not need to be stellar, so in small clinical trials, you need to see huge difference in order to detect statistical significance.
In large clinical trials, reasonable improvements will do the job because you have a high number of patients. That's simple statistics, nothing to do with eftilagimod, simple statistics. And we and our collaboration partner have been working hard here on the statistical grid. And actually, we went also to the FDA and we discussed the protocol, and it was great to see also the support from the regulatory side of things. We have been discussing with the German Paul-Ehrlich-Institut. We have been discussing with the Spanish AEMPS. So we took great care that our plans are adequately checked as much as you can prior to starting this clinical trial. And again, we do this together with a very, very big partner. And we also have here two chances. We have a dual primary endpoint, progression-free survival and overall survival. So it's a good clinical trial.
We will have multiple readouts. Recruitment is often a question from the operational performance, and I'm sure this will be asked during the course of next year, but if a trial has a chance to recruit well, then this one. Why? Because the patients do not need to make a compromise. They get best available standard of care. That's Keytruda plus chemotherapy, plus minus eftilagimod or placebo. Eftilagimod known to be very safe to drive overall survival. This is what the data has been showing so far, so the patients do not need to make a compromise. The treating physician does not need to make a compromise, so this is a very strong proposition also for the patients to participate in this clinical trial.
We can be more confident than ever since last week because another trial, I don't discuss TACTI-002, we discussed a number of times, covered it at the last AGM and multiple different other occasions, very strong results. We all know that. INSITE-003, which is looking exactly at the combination of eftilagimod plus Keytruda and chemotherapy, so what we test in TACTI-004 here in non-small cell first-line non-small cell lung cancer has been showing remarkable results. If you look, for instance, at overall survival, the key endpoint, the gold standard, what matters for the patient most, we have been delivering 32.9 months with the first group of mature patients versus historically expected 22 months. In TACTI-004, I made the comment, reasonable improvements. We do not need to see such a result. We do not need to see such a difference.
So there's a huge safety margin to what we would normally expect in TACTI-004 and what we actually saw here in this clinical trial. So it's a very big boost of confidence for the trial to start. And also in soft tissue sarcoma, this is an orphan drug. It's a smaller clinical trial. Overall, we'll see at the end of the day, 40 patients. The investigator is very excited. The pathologist is also very excited about the early results based on first 21 patients here as we tripled practically what you would expect in terms of so-called tumor hyalinization. So you look there at the number of viable tumor cells going down and the tissue changing practically. It's a little bit different setting compared to head and neck or non-small cell lung cancer.
Of course, you look here at the so-called neoadjuvant setting, which is a fancy word and means practically prior to surgery, so in lung cancer and head and neck cancer, we look at metastasized disease where it has been spreading to the liver or to the brain, for instance. Here you look to reduce the primary tumor and to bring the tissue into better shape and then have it removed by surgery. That's the concept here, so you only treat for a few weeks, and we do this here together with Keytruda and radiotherapy. Also, the very first time we combine with radiotherapy and we see excellent results, remarkable results, and we're hopefully going to continue to see that in the next year. We also made progress in terms of manufacturing and in terms of intellectual property.
We have here also in the room, for instance, James Flinn, who is managing our intellectual property, and Claudia Jacobi, a director of manufacturing, being responsible for manufacturing of eftilagimod and IMP761. We made very good progress in terms of getting regulatory clearance for clinical use of the 2,000-liter material. That's commercial scale. We continue to continuously develop and expand our intellectual property. A few remarks in terms of the financial side of things. Most important in biotech, as unfortunately you have typically non-revenue-generating businesses, we have a little bit of an increase, but unfortunately our expenses are much higher. We have a very strong cash position. You see also that our G&A expenses have not been increasing much, but that we really expand on research and development and intellectual property.
Our guidance is unchanged, meaning we expect the cash life to be end of 2026. And this is a very strong position so that we can focus on the execution of our business. Very important is the outlook. I talked about the biotech rollercoaster. We are currently overall seeing, and this is not a specific comment for Immutep, we see a little bit a period of uncertainty more regarding the geopolitical sphere, the Trump administration. There was an article here in Australia the other day regarding, is it negative that Immutep collaborates with the FDA? It's of course an absolute must and it's normal, but we are exposed also to a little bit noise like that. Nothing we can do about it, but of course every uncertainty will settle and the new administration is certainly business-oriented.
That should be good for all businesses, including the biopharmaceutical industry. And we have not finished the year. There will be more news to come. One is publicly known. That is at ESMO IO. Data from cohort B in head and neck cancer. You all are aware that our data regarding cohort B has been strong and has been unanimously strong and well received. So there will be a very important update for that data prior to Christmas. And we will have potentially other news coming. Frédéric mentioned IMP761, potentially some safety and a few other things which we may have in stock. Let's see.
2025, even more so. Therefore, it's important to focus also from a communication point of view, which is sometimes a little bit hard to follow for our shareholders or investors because we have this clinical trial, that clinical trial, this piece of data categorized in multiple different ways. We also have to learn from that and be clearer in terms of our key value drivers and make very clear the value proposition we have for MSD and first-line non-small cell lung cancer. I don't like that term, but it's a very strong bet to make practically in a market we do not need to create because with Keytruda it's there, the market is there, and Keytruda gets seven to eight out of 10 patients in lung cancer. So it's a very strong value proposition which can't be ignored, especially not when the study is started.
It's one thing to theoretically talk about. It's another thing to execute, to see it getting good traction and then also to face value inflection points like the futility analysis, the interim analysis, and so on and so forth. So we have to learn from that. We have to focus, but we are not a one product, one clinical trial company. We have multiple different value inflection points. IMP761, a completely different universe. It's autoimmune diseases, a product which is designed to address potentially more than 90% of autoimmune diseases. You have round about 200. It's a blue sky statement, a little bit of marketing statement, I have to admit, because we need to see clinical reality. But we have very, potentially very exciting data points beyond non-small cell lung cancer.
In the communication, of course, again, we need to focus, but also make clear that the profile of the company is bigger and that we are going to see hopefully very exciting data in the next year. We have also the chance for good regulatory progress. We have the good chance to see also news of other nature, so with that, I would like to close. Hopefully good outlook. Apologies for the biotech rollercoaster. We can't control the data. Unfortunately, we can't control the market. I take the comment from you early on in terms of the confidence, an extremely important point, easily lost, hard to gain and hard to maintain, but we will focus on that and focus on the execution of our clinical trials. Thank you so much.
Thanks for your update, Mark.
Are there any questions to Mark on what he's just shared with you or questions on the management of the company? And I note that no such questions were submitted in advance of the meeting. Any questions, please? Please go ahead.
Sorry, I don't want to dominate the questions. Good question. I just want to talk about your clinical trials. I firstly want to congratulate you on how you design your clinical trials, the breadth of your clinical trial doing six different indications. I think a lot of biotechs can learn a thing or two from you guys about how you do clinical trials. So I think you've done very good quality data. We've got very good quality data in my view. But there's no doubt that TACTI-004 is the company maker, at least in the short term.
I'm interested to understand how some of your previous clinical trials have informed the trial design for TACTI-004, for example, things you may have learned from TACTI-002 or even in the MBC. Breast cancer, yeah. Yeah, in terms of the optimal dose. How have those previous or current clinical trials informed the biggest shot on goal you've got coming up in the next couple of years?
Y eah, that's a good and important question again. First of all, a comment maybe on the operational side of this. It's important for the team to be hands-on in terms of the clinical trials. Sometimes as a biotech company, you simply work with a clinical research organization called CRO. You pay them and they select all the hospitals, and the company is a relatively hands-off approach. We have a very strong hands-on approach. So we negotiate every contract. We do co-monitoring visits.
So we go together with the CRO. You have to work with such an organization. Otherwise, you would need to have 150 staff or so together to the hospitals. And the design is really done at the company level. And our previous clinical trials have, of course, been informing us in terms of safety, in terms of the addressable patient populations, and other cancer immunotherapies like anti-PD-1, we're more focusing on PD-L1 because this is what the data suggested. In our case, it was obvious that we can go broad. And we prefer to work in collaboration settings because we may not know all. There are also certain statistical points of excellence. A company, as a biotech company, may not know so well. So this is why it's also important then to team up. And many believe we can't do that as Merck, for instance.
We may have the choice regarding different anti-PD-1s. It's not been doing such a collaboration. I mentioned it before since two and a half years. So we learn on the one hand side in terms of the data, and you have been referring to one point. That's the optimal biological dose. This is something which we need to identify based on the data we are collecting as we speak from APEX-003, which has been recruiting. And we will certainly have there also the setup that some jurisdictions or territories will come on trial TACTI-004 earlier than the United States because we will have a discussion with the FDA regarding the optimal biological dose. This is to follow while some others, like for instance, the Europeans, didn't care. At the end of the day, we will have a harmonized dose for the whole clinical trial.
We are not running a risk in terms of the dose because 30 milligram is well established. All the results you saw generated with 30 milligram. And you look at the risk-benefit ratio. So if 90 milligram would drive a better clinical outcome in terms of pharmacokinetics and is, from a safety point of view, not a problem, then we would certainly go with 90 milligram. So it's a very objective way to do that. Our guidance in terms of study start remains in place. So is that dependent on the results of the metastatic breast cancer trial? So you're waiting for those results to determine what the optimal dose for TACTI-004? Correct. Yes. Not only for TACTI-004, by the way, but this informs about the optimal biological dose for the whole program, which is important because we address, we are not treating cancer.
We are treating and helping the immune system to fight cancer. So this is why we need to do this exercise, as agreed with the FDA, only once. If you have more targeted therapies, you need to do it in every indication, and every combination costs a ton of money and takes a lot of time. So we are in a very fortunate position here. And, has the, I noticed the timeline for the futility analysis, which is a value inflection point, has that been brought forward or has it always been 12 months? The timing of the futility analysis depends on the recruitment and the number of patients being on trial and evaluable. This is why it is very important that we are aggressive in terms of recruitment. Stick within the timelines.
We will certainly see in this clinical trial more than 150 hospitals around the globe, more than 20 countries, potentially in Australia as well. So it's event-driven, if you like. But the timing based on our best-informed guess and not marketing guess, because this would haunt us later on, best-informed guess is late 2025 up to early 2026. So that period. And this has not been changed to your question. It has not been changed compared to earlier on. And could have been changing if we learned when you plan for a clinical trial, you have to do also so-called feasibility. Fancy word, but it's practically sending questionnaires to hospitals. So you send it to, let's say, 300 hospitals, and then you decide for the 150 best strong recruiters, those being most interested.
They say, for instance, we expect to have five patients per month being eligible to go into this clinical trial. Then you deduct 30% or 50% from that as a safety margin. Then you model everything out based on the submission timeline. So when the regulatory authorities in a specific territory are granting approval, and then you model it and come to those conclusions. So it's not the thumb in the wind, but it's as precise as you can hopefully do it. And in soft tissue, the highlight results you announced recently, which I thought were very exciting results. Where's recruitment at there? Is that fully recruited yet? Not yet. Quarter one next year is what we have in scope. This is an investigator-initiated trial. And by the way, predominantly paid by the Polish government.
So we as shareholders do not need to invest other than eftilagimod and labeling and things like this. So we believe first quarter next year, I can say, and Paweł would certainly not object. The investigator is extremely excited about it, as well as a pathologist. Very remarkable results. Let's see what it leads to. More questions? Yeah, please. You have me here, so. Yeah, exactly where you are. Maybe one last comment then. If you happen to have questions, also your very first question regarding timing of the capital raise, please don't be shy to write an email to us, to me personally or to our IR guys or to the team. We are always happy about feedback, even if the feedback is negative or is appropriately disgruntled or frustrated. We can only learn from that and also deliver some more clarity then on points we can explain.
Thank you so much again. Thank you, Mark.
If there are no further questions, I declare the meeting closed and I encourage everyone to stay for refreshments, more questions, please, and conversation with members of the board and senior management. It's great to see you today. Thank you. Thank you.