Good morning, ladies and gentlemen. I declare this annual general meeting of Immutep Limited open, and thank you for attending this meeting. My name is Russell Howard. I'm the chair of the company, and it gives me immense pleasure to welcome you here today and to share in our progress over the last 12 months. I'd 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 any Aboriginal and Torres Strait Islander people attending the meeting. I would now like to introduce you to the company's board of directors: Marc Voigt, our managing director and CEO; Lis Boyce, our other Australian-based non-executive director; Dr.
Frédéric Triebel, our CSO and executive director, and Pete Meyers, our US-based non-executive director, are both attending virtually. I also welcome Jason Hayes, our auditor 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 a quorum is present and the meeting is open. When you arrived at the meeting, you would have registered with our share registry Boardroom, and you would have been allocated a card. If there is anybody present who is 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, you 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 those 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 use their voting card as their proxy votes are rendered ineligible by their attendance. Please clearly mark either for, against, or abstain on the front of the cards next to the resolution being voted on under a poll. The returning officer for the poll will be Mark Dakamangi 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 this annual general meeting has been given to shareholders in accordance with the company's constitution, the listing rules, 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 is any objection, I propose that the notice of meeting be taken as read.
Before we commence the formal aspects of today's AGM, I'd like to say a few words. Fellow shareholders, on behalf of the board of directors, I'm delighted to welcome you to Immutep Limited's Annual General Meeting for the 2025 Financial Year. Thank you to everyone who's joined us today, both in person and virtually. It's my pleasure to provide you with an overview of Immutep's progress during the financial year, a pivotal one for our company as we made the successful transition into a phase III biotechnology company. We saw strong execution across our clinical programs and maintained strong financial management. We continue to build on our leadership in lymphocyte activation gene three, or LAG-3 immunotherapy, delivering on key milestones and generating compelling clinical data across both oncology and autoimmune disease pipelines.
Our lead immuno-oncology candidate, eftilagimod alpha, or efti, advanced into the TACTI-004 KEYNOTE F9/1, a registrational phase III trial in first-line non-small cell lung cancer, or 1L NSCLC, with the first patient dosed in March 2025. TACTI-004 is among a select few global phase III studies in first-line NSCLC. It's a study evaluating combination therapies with KEYTRUDA. TACTI-004 is targeting one of the broadest patient populations in this large indication. The trial, conducted in collaboration with MSD, who is supplying KEYTRUDA pembrolizumab for the study, represents our most significant program to date. As reported in October, this global trial has enrolled and randomized over 170 patients. This level of patient enrollment represents an important milestone since 170 patients is above the number needed to conduct a futility analysis. Futility analysis remains on track for completion in the first quarter of calendar year 2026.
There are now over 100 clinical sites open for enrollment, and 24 countries have delivered regulatory approval. In September, Immutep presented a trial-in-progress poster presentation for TACTI-004 at the IASLC 2025 World Conference on Lung Cancer, WCLC, in Barcelona, Spain. Feedback from physicians at this conference and several others I won't enumerate, as well as at the European Lung Cancer Congress, or ELCC, and the American Society of Clinical Oncology, or ASCO, meeting earlier in the year has been very encouraging. We receive a common view from these clinicians on efti as a safe, easy-to-administer immunotherapy that has shown strong efficacy across two trials in first-line non-small cell lung cancer, TACTI-002 and INSIGHT-003.
Efti is unique, the only immunotherapy that activates antigen-presenting cells, that is, dendritic cells, directly via the MHC Class II pathway, thereby facilitating the transport of tumor antigenic fragments to the lymph nodes for presentation to T cells and driving a broad immune response to fight cancer. In August, Immutep received positive and constructive feedback from the U.S. Food and Drug Administration, or FDA, regarding future late-stage clinical development of efti in first-line treatment of head and neck squamous cell carcinoma patients, 1L HNSCC, who have PD-L1 expression below one, that is, a CPS less than one. Based on its review of the encouraging data from TACTI-003 in first-line HNSCC with a CPS less than one, the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this patient segment and is supportive of the combination's further development.
The multicenter INSIGHT-003 investigator-initiated trial, which is evaluating efti in combination with KEYTRUDA and chemotherapy in first-line non-squamous NSCLC, continued to deliver pleasing results. Data presented at the European Society for Medical Oncology, or ESMO, Congress in 2025 in Berlin, Germany, showed a high 62.7% objective response rate and 90.2% disease control rate across all PD-L1 expression levels. The results were most impressive in patients of high unmet need with PD-L1 expression below 50%. Importantly, INSIGHT-003 is evaluating the same immunotherapy-chemotherapy combination being used in the pivotal TACTI-004 phase III in first-line NSCLC. In metastatic breast cancer, we completed enrollment in the phase II portion of our AIPAC-003 trial, evaluating efti in combination with chemotherapy. We continue patient follow-up throughout the year. This study helped determine the optimum biological dose of 30 mg for efti while addressing an underserved patient population that has exhausted endocrine therapy sessions.
An update will be provided at the San Antonio Breast Cancer Symposium in San Antonio, Texas, USA , in December 2025, and we look forward to sharing further data. In September, the company announced the launch of an investigator-initiated phase II trial evaluating neoadjuvant efti as monotherapy in combination with chemotherapy prior to surgery in early-stage HR-positive HER2-negative breast cancer patients. We also reached a significant milestone in the investigator-initiated EFTISARC-NEO trial in soft tissue sarcoma, with completion of patient enrollment and announcement that the trial had met its primary endpoint. This phase II trial demonstrated a marked increase in tumor hyalinization, a surrogate marker of long-term survival when efti was added to radiotherapy and anti-PD-1 treatment. Data from this trial was the subject of a proffered paper oral presentation at the ESMO Congress 2025 last month.
Moving on to autoimmune diseases, our first inhuman phase I trial of IMP761, a first-in-class LAG-3 agonist antibody, progressed through multiple dose cohorts. Encouragingly, at the highest dose tested to date, IMP761 showed a favorable safety profile and a promising 80% reduction in T cell activity in skin tissue. These early results support IMP761's potential to selectively silence overreactive memory T cells and restore immune balance without broadly and unnecessarily suppressing the immune system. Immutep's leadership in LAG-3 immunotherapy continues to be recognized through its continuing partnerships and growth of our intellectual property estate. In financial year 2025, we were granted 17 new patents across 10 territories for both efti and IMP761. Also, in financial year 2025, landmark research from our collaboration with Monash University was published in Science Immunology.
Pleasingly, we reached a significant corporate milestone by being added to the S&P/ASX 300 Index in the September 2024 review, which we believe is a strong indicator of investor confidence in our trajectory and growth. This milestone is a testament to the tireless work over many years undertaken by Marc and the team across multiple jurisdictions. Financially, we maintained a strong balance sheet throughout the year. We ended financial year 2025 with a cash and term deposit balance of AUD 129.7 million, providing a cash runway through to the end of calendar year 2026. This prudent financial management is crucial for driving success in clinical trials, avoiding delays from unforeseen costs, and enabling us to progress our trials on schedule. Looking back at the year, I'm particularly proud of the extensive progress that the Immutep team has made, considering the complex challenges currently impacting the biotechnology sector.
Our strong clinical data and the quality of our leadership and operational skills mean we are well-placed to navigate the challenges and hurdles presented in the changing global regulatory world. Supply chain disruptions also present hurdles affecting everything from access to critical raw materials to the overall cost structure, including heightened tax implications due to shifting international regulations. Geopolitical instability further compounds these issues, influencing market access, investment flows, and collaboration opportunities globally. As we navigate these unpredictable conditions, our focus remains on execution and completion of our clinical trials, with priority on our global registration phase III trial, where we're eager to see efti validated clinically and, with success, provide a meaningful benefit to cancer patients. On behalf of the board, I would like to acknowledge a number of key leadership changes during the year. I would like to thank Dr.
Stephan Winckels for accepting the role of Chief Medical Officer of Immutep and congratulate Christian Mueller on his promotion to Chief Development Officer. We're fortunate to have people of Dr. Winckels and Mr. Mueller's caliber and experience helping to steer our company. Their deep knowledge of our clinical programs and long-standing involvement with efti will be invaluable as we navigate the next stages of our development. As we look ahead, financial year 2026 promises to be another year of meaningful progress. You can expect continued momentum for TACTI-004, data updates from AIPAC-003, INSIGHT-003, and EFTISARC-NEO, and further advancement in our autoimmune portfolio with IMP761. Our team remains focused on our mission to develop and commerciaLise innovative immunotherapies that offer new hope to patients with cancer and autoimmune diseases.
I would like to thank all our shareholders for their continued support as we work to deliver long-term value and transformative outcomes for patients and their families. Now we can turn to the formal business 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. I will now table the financial statements, director's report, and auditor's report for the company and its controlled entities for the year ended 30 June 2025. 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 conduct of the audit, as there will be time for other questions at times throughout and at the conclusion of the meeting. Are there any questions at this time? Please.
Are there copies of the annual report here?
Yes, we do. It will be available to you.
Sorry, I just relied on the start.
No, sure. Please ask one of the people here. Any other questions, please? Good. Okay, let's move on now with the resolutions. If you could go to the first slide, please. Trust. Is it we have to do it ourselves? How about that? There we go. Very good. Here is the first resolution, Resolution One. This resolution is describing that the company adopted the remuneration report for the financial year ended 30 June 2025.
The details are set out in the explanatory notes accompanying the notice of the meeting, and you can see the full resolution on the screen. This is an ordinary resolution requiring a simple majority approval. This resolution is required by the Corporations Act of 2001. 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 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. Are there any questions from the floor about this resolution? Thank you. Does anyone wish to speak for or against the resolution or make comments on the remuneration report?
There being no further discussion, I'll put the resolution to the vote. Please complete your voting first. I take it that the resolution is carried. People collect later. We'll collect later. Yeah. On with the next. Resolution Two. Thank you. This resolution concerns the reelection of Mr. Pete Meyers, who was a non-executive director of the company in the United States, that he be reelected as a director of the company. This is an ordinary resolution requiring a simple majority approval, and the full resolution can be seen on the screen. As stated in the notice of the meeting, the board, with Mr. Meyers abstaining, recommends that you vote in favor of this resolution. Pete, who is online with us, I would like to see comments or questions from you and any comments that you would like to make before we proceed. Pete, are you available online?
Yes, thank you, Mr. Chairman. I want to thank our fellow shareholders for their support along this journey. I also want to thank our dedicated employees who, under Marc's leadership, have driven the development of the pipeline. The pivotal phase III trial evaluating efti in treating first-line non-small cell lung cancer is now well underway, and critical catalysts are now on the near-term horizon. I'm eager to continue to serve my fellow shareholders as Deputy Chairman. With that, I'll turn it back over to the Chairman.
Thank you, Pete. I inform the meeting that proxy votes on the resolution are as presented on the slide. I note no questions were submitted to this resolution in advance of the meeting. Are there any questions from the floor about the resolution, and does anyone wish to speak for or against this resolution? Thank you.
There being no further discussion, I put the resolution to the vote, and please complete your voting card. Now on to Resolution Three. This resolution concerns remuneration for Mr. Pete Meyers and particular performance rights to him, with the full resolution shown on the slide. It's an ordinary resolution requiring a simple majority approval. The full resolution can be seen there. As stated in the notice of meeting, as each non-executive director has an interest in his or her proposed allocation of performance rights referred to on the notice, the board as a whole abstains from making a recommendation in relation to this resolution. I inform the meeting that proxy votes in the resolution are as presented on the slide, and I note no questions were submitted in 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. As the next resolution concerns my own remuneration, I ask my fellow director, Lis Boyce, to take the chair for this IT business. Thank you, Lis.
Thank you, Russell. This resolution concerns the issue of performance rights to Dr. Russell Howard, and the full resolution is on the screen. This is an ordinary resolution, so it requires a simple majority vote. As stated in the notice of meeting, as each non-executive director has an interest in his or her proposed allocation of performance rights, the board as a whole is abstaining from making recommendations on any of the performance rights resolutions.
The proxy votes on the resolution can be seen on the screen. We did not receive any questions ahead of time on this resolution, so are there any questions from the floor about this particular resolution? I see no hands going up. Does anyone wish to speak for or against the resolution? No hands going up. As there is no further discussion, I put the resolution to the vote. Please complete your voting card, and I will now hand back to Dr. Howard for the remainder of the meeting.
Thank you, Lis. Resolution Five is shown up there. This is a resolution that concerns performance rights on the terms and conditions set out in the explanatory memorandum for Ms. Lis Boyce as a non-executive director of the company. This is an ordinary resolution requiring a simple majority approval, and the full resolution is shown on the screen.
As stated in the notice of meeting, as each non-executive director has an interest in his or her proposed allocation of performance rights referred to in the notice, the board as a whole abstains from making a recommendation in relation to this resolution. I inform the meeting that proxy votes on the resolution are as presented on the slide, and I note no questions were submitted in 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. Close of polls. I now declare the poll closed and thank you for your participation.
If you're in the room, please hand your voting cards to the Boardroom representatives who are coming around with ballot boxes now, should you wish. The gentleman is at the back of the room. The results of these votes will be released to the ASX later today and will also be made available on our company's website. I'll wait a few moments until that is completed. Up the front as well. Thank you. Thank you. Thank you, everyone. That business is completed. Our CEO, Marc Voigt, will now present a brief update on the company's activities. Thank you, Marc.
Thank you, Russell, and thank you all for coming here to attend our AGM and also the ones who are attending online or who can't make it today. Thank you all for the support. There have been very supportive results again. Thank you so much for that.
I will now present, as Russell said, the brief, as brief as it could be when I talk, update on the company. First of all, to bring us all back on the same page, the general description, I trust you know Immutep very well. You know that we are active in oncology as well as in autoimmune diseases. You do know that we prefer to work with the big pharmaceutical industry in different partnerships and collaborations, as demonstrated in the past, most notably last year, mid of last year, where we teamed up again with Merck from the United States, called MSD throughout the presentation, for conducting the phase III clinical trial in the most important market in oncology with a high unmet medical need in first-line non-small cell lung cancer.
Also, one update compared to the Chairman's address, which was referring to the end of the financial year, latest figures in terms of cash and cash equivalents last quarter, end of September, is close to AUD 110 million. We continue to have a good balance sheet. We continue to have strong cash reserves to conduct what we have to conduct in research and development. Our pipeline this year sorted a little bit differently. You may notice that sometimes people, our design-related people, get obsessed about it, but it is practically saying the same thing. We have eftilagimod clearly as a value driver of the company. The most notable value driver, say it again, is a phase III clinical trial in first-line non-small cell lung cancer.
If everything else, and we do a number of different other clinical trials, we have a number of different other assets, would fail, but this trial is successful, then we will be a multiple of what we are today. We do other clinical trials in head and neck cancer, metastatic breast cancer, where there will be a data presentation at the San Antonio Breast Conference soon, soft tissue sarcoma, where two presentations took place in November at ESMO in Berlin and also at CTOS at Boca Raton in Florida, United States, and different other assets that I will talk a little bit also about IMP761, the world's first agonist two legs recreated by Frédéric and his team. Let's come to a few key highlights. Of course, I have to talk there about non-small cell lung cancer. It's, as you may recall, the primary cause of cancer death.
It's a terrible disease. Despite all changes which have been done in the past two decades, unfortunately, with a median overall survival expectancy for the patients much below two years. To change this situation, to bring benefits to the patients with a combination, we are testing eftilagimod plus KEYTRUDA plus chemotherapy in phase III. This is our most critical mission at the moment. I believe it's justified to say that we delivered on that promise from an operational perspective. I believe it's also fair to say that we delivered strongly in terms of the performance of the company, bringing our product into phase III when we announced mid of 2024 the collaboration with Merck and managed to get first patient in here in Australia for this global clinical trial by March this year. That is, for many of you, maybe sounds slow.
I can tell it's record-breaking speed, and we got congratulations from our collaboration partner for achieving that. Very often, it takes longer, especially as we had a very thorough approach. We have been discussing our clinical trial protocol with the U.S. FDA, which is critical to get the support, the review of the most important regulatory agency worldwide, but also with other agencies like the German Paul- Ehrlich Institute and the Spanish AEMPS. A very well-planned clinical trial. Also, in October, we press released that we already recruited a sufficient number of patients to conduct the futility analysis. I'm very actually proud to say that the guidance we have been putting out about 12 months prior to study start, nine months prior to study start, remains intact so that we expect the futility analysis to happen by first quarter next year by the standards of our industry.
That's tomorrow. I'm proud of that because very often the clinical reality in our business leads to delays in terms of recruitment, in terms of getting countries and getting hospitals on the study. This trial has great support from the principal investigators, and we have been recruiting within the specified timelines. We got feedback from different events, from key opinion leaders participating, principal investigators, the treating doctors in TACTI-004. I think this is very supportive. They like to treat patients with that combination. We had different events in Paris, in Chicago, typically around the conferences because that limits the cost for the company, also at ESMO in Berlin. We really got a lot of compliments for the mode of action.
The unique mode of action, eftilagimod alpha, is something no one else on this planet is doing, but we, and which delivers typically a relatively safe treatment to the patients. Also, of course, the principal investigators have a look at our past results. This is pretty convincing. We have a lot of support from different key opinion leaders around the globe. This is something which is, I believe, very good, especially in line with some key features of our program. It's delivered subcutaneously. It's a push of a syringe. It's not difficult. It's not an intravenous infusion where you have to have a 30, 60, or 90-minute procedure, often with a nurse at the bedside, but really simple route of administration, delivering typically very good results.
Just to remind us on the trial design, I would like to emphasize here again that we jointly designed this clinical trial together with Merck, with industry experts who have been driving now the approval for KEYTRUDA in more than 40 different cancer indications. A very strong team at Merck. We are privileged that we had the chance to team up with them, as I believe, right there to say that as well. They are privileged that they have the chance to test efti together with KEYTRUDA and chemotherapy, as we had also the choice. It is a strong clinical trial with different high-quality design features, one-to-one randomized, of course, multinational, multi-center clinical trial with different stratification factors, where you try to ensure that the readouts are as balanced as they can be for this 756-patient clinical trial.
All in all, we look here at the pharma standard clinical trial, which is robust, where also the statistical core is robust, and not a clinical trial where biotech hopes for the best outcome with a very ambitious trial design, meaning that you would translate your phase II results directly into the phase III. This is something you shouldn't do, but you should apply a significant haircut to all the results you deliver prior to that in order to bring your expectations from the control arm and the active arm together and then drive statistically significant results based on reasonable statistical and medical expectations. This is the whole spirit of the trial. We have now significantly more than 100 hospitals. That's a number from October. Practically every week, we are adding hospitals on site in 24 countries.
The operational performance, as mentioned earlier, is going exceptionally well. Of course, we far, far exceeded the 170-patient number you see there. The trial and a few elements of an outlook here as well, of course, trial taking place in different regions in the world and, of course, North America, South America, Europe, here in Australia, different parts of Asia. It is a global clinical trial where also the region is a so-called stratification factor, so where your design ensures that you have not a trial with predominantly Australian patients, but where you have a good distribution of the patients around the globe. You have here also a trial which is looking at the so-called dual primary endpoint. You look at progression-free survival. This is typically reading out earlier, always reading out earlier, and overall survival.
We have two different endpoints with which we can win. We have also different important milestones we are seeing around the corner, the futility analysis I mentioned already, and also last patient in by third quarter 2026. This guidance is also fully intact. Of course, we are not yet there, but I feel very comfortable to make that statement. This is what we are aiming for, to have this 756-clinical trial, which started in March this year, completed from a recruitment point of view by third quarter next year. Around the corner is the first interim analysis on which we could, if sufficiently positive, of course, potentially file by backend of 2026 to mid-2027. This is a so-called event-driven readout. You need to have enough patients progressing in order to drive that readout.
If we see statistically significant results there, we will file this combination with eftilagimod to the FDA and would have, if everything goes well, a product being approved. Let's assume that's not the case. That's not the case. PFS, for whatever reason, not statistically significant. About a year later, you have actually the first overall survival readout. Let's assume this is also a close shape. Another year later, you have the last overall survival readout. In other words, we created here a clinical trial, protocol FDA reviewed together with one of the best companies and groups in the world. You can design a clinical trial with this dual primary endpoint and different chances to win. The first chance is relatively soon, maybe in about a year, maybe a bit later.
This is also a trial which has been designed to capture the entire first-line non-small cell lung cancer market eligible to anti-PD-1. There are other clinical trials ongoing. Russell pointed to that. We have the broadest trial with KEYTRUDA in the active arm you can think about. Daiichi Sankyo, Gilead, companies which are slightly bigger than we, unfortunately, having also some clinical trials with different concepts. We have a trial which is in the American spirit, I can maybe say, think big, capture the market, especially as our mode of action and the results we saw in other clinical trials are supporting this. You did see with other immuno-oncology approaches like anti-TIGIT, certain segments like TPS greater equal 50%, where the mode of action required to focus on them. That's not the situation here.
We can go broad, and we therefore have here a potential blockbuster drug ahead. Few other remarks in terms of other approaches in phase III and non-small cell lung cancer, as it is commercially the largest cancer indication. It's, of course, also highly attractive. We have here a clear product differentiation compared to everyone else, but there are other classes of products like ADC. You see here PD-1/ VEGF. That's a so-called bispecific TIGIT. Unfortunately, they have not been delivering because we should always hope for the best to bring benefit for patients. Also, Anti-LAG-3 has unfortunately not been delivering so far. There's one bigger clinical trial for TPS 1-49, so one of the segments remaining from Bristol-Meyers Squibb. It has been, for instance, dropped by our collaboration partner, MSD. ADCs is a better form of chemotherapy delivering.
It is, of course, always good if you see, let's say, a different tweak to an existing product line. Is it the big new quantum leap? Probably not. We do hope, of course, that chemotherapy can be delivered better to patients. Bispecifics is also something which we need to continue to observe. There is currently no OS data available to an extent that you really can make the comparison to us. It is also practically an older concept. It is bevacizumab, Avastin in the market since 2004, combined with anti-PD1 in one molecule, if you like. It is all important. If our trial is successful, no one can steal the approval. It is a question of market segmentation. For sure, eftilagimod would have a place in the non-small cell lung cancer treatment landscape. You have always different approved standard of care.
It's important to understand that you do not have a winner-takes-it-all concept. That's also not the situation right now. You have always different approved standard of cares. The most predominant standard of care is KEYTRUDA. KEYTRUDA plus chemotherapy is what most patients in first-line non-small cell lung cancer are getting. The numbers are all very strong. It's, of course, a strategic drug for Merck. It's a strategic indication for Merck. It's an important clinical trial for us, but I trust also for our collaboration partner as well as for a number of different other companies in the pharma industry. This is also to be seen in the light, for instance, of intellectual property. At the end of the day, what you are selling is data, intellectual property.
If you're lucky as a biotech product, you can maybe even sell a product, but predominantly it's data and patents. We have a combination patent which is covering eftilagimod plus a class of anti-PD-1, specifically, for instance, KEYTRUDA. That's important as a loss of exclusivity is around the corner starting by 2028 for KEYTRUDA, also OPDIVO in the United States. In Europe, it's by 2031, if I recall correctly. The loss of exclusivity of this class of anti-PD-1 is starting, and KEYTRUDA is the top-selling brand in the whole pharmaceutical industry. It's very, very important. We have other updates at milestones. I think financial year 2025 has been rich in terms of data updates.
INSIGHT-003, and we'll talk about that briefly in the coming slides, EFTISARC-NEO, a trial which is performed by Pawel and Kozak, two brilliant Polish investigators who organized a grant to pay for the clinical trial. We deliver drug, we label eftilagimod , but that's it. We have not big expenses on the trial. It is, of course, very rewarding to see that medical experts, oncologists, are taking the task to organize for money to be able to conduct a trial with eftilagimod . I think that's a great statement in itself. TACTI-003 has been delivering data specifically for CPS below 1. We had also very positive feedback from the FDA for a potential next step. Also, AIPAC-003 in breast cancer will deliver an update, I mentioned, in December, the San Antonio Breast Cancer Conference.
Inside 003, Russell mentioned a few numbers here already, and I will not go through each and every individual line here. It is our second clinical trial in first-line non-small cell lung cancer. The TACTI-002 clinical trial has been showing the data frequently. I will not do it here again. This is the second trial where you see the same pattern, rate improvement of objective response rates of tumor shrinkage according to internationally defined standards for TPS below one. That is a segment where KEYTRUDA, unfortunately, does not work well or suboptimally in 1-49. There is even an improvement for TPS greater or equal to 50, where especially the combination of KEYTRUDA and chemotherapy works very well. Overall survival, progression-free survival has been published earlier. All in all, great results, and they fit very nicely into the results and consistently, actually, in TACTI-002.
The fundament for the phase III trial, two separate phase IIs with a total of 165 patients. No biotech way of cutting corners, 20, 30 patients, but really a robust fundament and obviously also convincing for some other stakeholders. Here you see one single case which illustrates also what can be done and what can be done for patients which have, from a biomarker perspective, a critical setup. This is a patient with a TPS score of zero, so no target for KEYTRUDA around. Not a good situation. KEYTRUDA monotherapy wouldn't work, actually not approved, and would be possibly very inefficient. This patient here has been treated with KEYTRUDA plus chemotherapy and eftilagimod . You see from September 2024 to September 2025 that two massive metastases here and here have been completely or almost disappearing.
This is a very strong result for this 75-year-old male. You see a number of cryptic acronyms practically saying CT1C, that there are still metastases inside the lung, stage IV-B, metastasized, obviously. This patient has had this partial response for the whole treatment, of course, will be followed up. Soft tissue sarcoma, fantastic results, oral presentation at ESMO, as well as another oral at CTOS in November. You see here two beautiful violin charts where the level of hyalinization fibrosis, so where the tissue, the tumor tissue changes to a kind of glassy tissue, so becomes not dangerous, if you like. This occurred practically in almost all patients, and the number of viable tumor cells has been dramatically going down. Versus the historic hypothesis, the study received highly statistically significant results with a p-value of 0.001.
Very strong and very nice results in this orphan drug, very difficult to treat. No immune checkpoint inhibitor like KEYTRUDA is approved in that setting. We had here also the combination together with radiotherapy, which is classically the standard for soft tissue sarcoma. It is also in the neoadjuvant setting, meaning prior to surgery, lung cancer, head and neck cancer. This is at the stage where the tumor has metastasized already. This is done when your primary tumor can be removed by surgery, not metastasized, and you treat in a window of a few weeks prior to surgery. You treat the patients in order to get the immune system up to speed and reduce the risk of the patient of having metastases later and passing away. It is indicative also of a later overall survival, which will be observed as well.
Switching gears, I was more talking about an active immune system, actively fighting cancer. Here, it's very different, practically the opposite. Our body in autoimmune diseases, where 761 is positioned, has been getting out of control. Our T cells are attacking our own organ system, constantly stimulated by the cell peptide. Here, we would like to bring the immune system under control, provide IMP761, and bring the immune system back to the right balance. This program is now in clinical development, actually in a placebo-controlled double-blind phase I clinical trial, where we plan for an update prior to year-end. Besides San Antonio Breast, there will also be an update of this exciting program. It has been showing at 0.9 microgram per kilogram, about 80% T cell inhibition in this so-called KLH challenge. What we do there is to have healthy volunteers.
These healthy volunteers get a local inflammation. This local inflammation is either treated with IMP761 or with placebo. You measure versus placebo, is your drug having an effect or not. A very ambitious setup for a phase I clinical trial where you often go a little bit softer or less ambitious and look more for safety, which we do here, of course, as well. We wanted to see already in this phase I, is there an immunosuppressive effect or not. For the time being, we can see that there is an immunosuppressive effect, which is quite nice. We are right now in so-called part B. This is single ascending dose, 2.5 micro per kg, 7 and 14 micro per kg are the next steps and final steps of the dose escalation.
A bit of financials, a bit more revenues, or to be more precise, predominantly other income we received during the financial year 2025. Annual report has been reviewed, and I'm specifically happy about, what should never be happy about, expensive, but I'm happy about the ratio of G&A versus R&D. We have not been pumping up the water head, if you like, but we have been focusing on what we promised to you, which is focus on research and development and delivering specifically on the phase III clinical trial and all the other clinical and research work we are doing. We have a good cash runway. We have also been expanding the team. I can say it's a ton of work to do, and we are executing as good as we can. This is also a firm promise I can give to every single one of you.
We are executing as good as we can to keep the timelines I have been showing earlier on. We have also seen that we entered during financial year 2025, the ASX 300. It is always, of course, good, helps a little bit with visibility and recognition. We have also a robust intellectual property protection. This often goes under the surface, not so much front and center, but especially James Flinn, our Director of Intellectual Property, who is with us today here in row number two, has been doing a phenomenal job to drive and build and to continue to build our intellectual property. Few upcoming milestones, non-small cell lung cancer. There will be, of course, additional milestones. Quarter one is around the corner of futility analysis. I think it is an important de-risking event for the trial, operational updates, how it is going.
Maybe prior to year-end, we should update you where we stand. Of course, head and neck cancer, what could be next steps, especially in first-line head and neck cancer with CPS below one, metastatic breast cancer, all the other clinical trials, IMP761. We are working on a few additional things we hope come to flotation. Let's see. With that, I can close a hopefully brief enough update. Thank you so much. I should not leave before asking if there are any questions. I will be, of course, also around, so you can either ask a question now or a bit later. Maybe a bit later. Thank you.
Thank you for that update, Mark. Now let me ask another question. Are there any questions or comments on the management of the company?
I note no such questions were submitted in advance of the meeting. I'd like to have an opportunity for that question as well. Okay. As there are no further questions, I now declare the meeting closed, and I encourage everyone to stay for some refreshments and the opportunity for conversation and chat with us for learning lots of secrets we can't tell you. I look forward to talking with you all after the meeting. Thank you.
Thank you.