Hello, welcome to the full year 2022 financial results and business update conference call. Please note this call is being recorded, for the duration of the call, your lines will be on listen only. However, you will have the opportunity to ask questions at the end of the call. This can be done by pressing star one on your telephone keypad to register your question. If you require assistance at any point, please press star zero and you'll be connected to an operator. I will now hand you over to your host, Mr. Hedi Ben Brahim, CEO, to begin today's conference. Thank you.
Yeah. Thank you. This is actually Lucie. I'm director of II. Just to say that today we're indeed with Hedi Ben Brahim, CEO of Transgene. We provide you an update on the remarkable progress we've made in 2022, the prospect for 2023. After this, Jean-Philippe Del, our CSO, Éric Quéméneur, our CSO, Maud Brandely, our CMO, and Steve Bloom, our CFO, will be available to answer your questions. Before I turn the call over to Mr. Ben Brahim, I'd like to remind everyone that today's discussion will contain forward-looking statements which are subject to a number of risks and uncertainties. If you're listening to this webcast via the Internet, you will not be able to ask questions. If you wish to do so, please make sure that you join us via one of the numbers, phone numbers that are available in today's press release. With this short introduction, I now turn over the call to Hedi Ben Brahim.
Thank you, Lucie, and welcome everyone. Thank you very much for joining today's update call. 2022 has been a truly exciting year for Transgene. We have made remarkable progress and built the foundation for 2023, a year that will see us realize a number of critical milestones. We have seen, and we continue seeing, a growing interest on both the pharma and biotech and medical community in the potential of therapeutic cancer vaccines and oncolytic viruses. With our approach based on the right vector, the right target, and the right patient population, we are in strong position to deliver improved clinical benefits and to position our candidates as potential game changers to the current standard of care in solid tumor treatments. Before I go through our portfolio of exciting assets, I wanted to highlight that Transgene will be very visible at this year's AACR Congress next month.
We are scheduled to present eight posters. We will also have a Transgene booth where we intend to share our clear missions in the solid tumor immunotherapy space based on the promising data we have generated to date. Let's start with our individualized neoantigen vaccine TG4050. What is the status of that project? We are in two ongoing phase I that are generating promising data on TG4050 as a single agent. In these two trials, our aim is to extend the remission period of the patients. We have the ability to generate data on TG4050 as a monotherapy. New data were presented at AACR and ASCO 2022 were very robust and showed potential important advantages to competing approaches. TG40 has been well tolerated. TG4050 is a perfect example of how we apply our right vector, right target, right indication approach.
The MVA is a fantastic vector and differentiates from the competition, in particular because it can induce a very broad immune response, mobilizes innate immunity, CD8+ T- cell, and also memory cells. The vaccine display generates very strong immunogenicity. The induction of immune responses is particularly efficient with 100% of patients evaluated at the data cut-off date showing a specific similar response. Critically, these immune responses are clearly associated with disease progression. We are also very pleased these progress data have been validated using ctDNA analysis. Enrollment has been completed in these two phase I trials, underlining the attractiveness of the candidate and the strong support we have received from the CRO involved in these studies. In the head and neck cancer trial, almost all patients have been randomized.
At the last cut-off, which is end of August 2022, no patient treated with TG4050 had relapsed, while two patients in the control group who have not received the treatment have seen the disease progress. An update on the clinical data will be provided at AACR next month in Orlando. We are also working on the planning for a phase II trial in head and neck cancer. The data from the study, if positive, could be used to file a conditional approval for TG4050. We intend to provide a further full update in a press release on April 18th after our poster presentation at AACR. We will also organize a conference call on the back at AACR. Stay tuned.
Now let's move to our HPV vaccine TG4001. What is the status of the program? TG4001 is our most advanced asset in our immunotherapy portfolio and a great example of the potential of our virvector-based approaches in the treatment of cancer. We are in an ongoing randomized phase II trial. Which is designed to demonstrate the contribution of TG4001 plus avelumab versus avelumab alone in population of patients that do not receive prior therapy, which checkpoint blockers. We announced late last year that following a pre-planned interim analysis, TG4001 plus avelumab was shown to deliver improved progression-free survival compared to avelumab alone. The trial now intends to randomize a total of 120 patients overall, which is a meaningful reduction versus the initial plan of 150.
Based on the data we have seen, we aim to continue the development of TG4001 with a potentially registrational trial to support conditional approval of this novel cancer vaccine in patients. We are already working on the design of this trial. This scenario is one that we as Transgene are confident we can execute successfully. After this complete update on the therapeutic vaccine, what about the oncolytic viruses? Well, we have also achieved great progress with our two clinical candidates, and we have also expanded our pipeline with TG6050, an exciting new drug candidate, which is due to enter the clinic later this year. TG6002 has continued to demonstrate the attractiveness of our patented virus backbone, which is the basis of our in vivo platform.
We are very pleased that the clinical work we have done in the last 12 months with TG6002 has clearly shown that our oncolytic viruses could be administered intravenously. That is the key competitive advantage. Regarding the intravenous administration trial, new data was presented at ESMO last year. It has shown that the virus is well-tolerated, even at very high doses or intensive administration schedules. It is able to reach the tumor, replicate, and express its payloads. That confirms the mechanism of action. We are very happy that further data will be presented at the AACR next month. This program is particularly important with regard to our collaboration with AstraZeneca and the company's future developments. Demonstrating the efficacy with the intravenous route would considerably extend the potential addressable market of oncolytic viruses. Based on the comprehensive data package that we are putting together, we will assess the best way forward with TG6002 against the background of our overall plan to generate value from our oncolytic virus pipeline.
Let's move to BT-001. That's our oncolytic virus co-developed with BioInvent. We have also demonstrated very promising data over the year 2022. In the ongoing phase I, we assessed IV administration of a single agent, BT-001. The initial data was good. We had good safety. We had persistence and replication of the virus in the tumor. With expression of the anti-CTLA-4 antibody in the tumor, we had first signs of efficacy, and so the last patient is about to be dosed. The plan is to start the part B of the phase I study in combination with pembrolizumab in the second half of 2023. That is done within the frame of clinical collaboration with MSD. This great collaboration with our colleague at BioInvent aims at demonstrating that vaccinia viruses are ideal cargos to bring immune modulators within the tumor, restore immune competence of the tumor microenvironment, increase and improve the responses to anti-PD-L1 therapy. We intend to communicate data on the single agent part of this exciting phase I trial in the first half of 2023.
Let's have a few words on our novel and promising oncolytic virus, TG6050. You know it's the latest addition to our clinical stage portfolio. What is the challenge that we are addressing with TG6050? This is the administration of IL-12 at the heart of the tumor, and we want to answer the two key questions for the industry. How do we deal with the safety profile of IL-12 and ensure good safety for patients? How do we make sure that IL-12 reaches the tumor? TG6050 is designed to answer that themselves, because with a selective replication in tumor cells, oncolytic viruses are ideal cargos to induce the expression of IL-12 in the tumor and only in the tumor. The first patients are expected in the coming weeks. That's an exciting development in non-small cell lung cancer, fully capitalizing on intravenous administration data generated by TG6002.
A word on finance. P&L in 2022 is in line with our expectations and reflects the acceleration of our clinical trials. The net cash burn of EUR 22.8 million in 2022 compared to EUR 10 million in 2021, excluding capital increase. At the end of December, we had EUR 26.8 million in cash and cash equivalents. In addition, Transgene still holds Tasly BioPharmaceuticals shares reevaluated at EUR 14.3 million at the end of December 2022. The financial visibility is now until early 2024, which means we can deliver our near term anticipated milestone. This overview has clearly highlighted the potential of our immunotherapy pipeline and in particular, our strong belief in TG4050, TG4001 and TG6050. I believe that Transgene has a very exciting future and is well positioned to deliver for all of its key stakeholders. We'll be very happy to take your questions.
Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star one on your telephone keypad. To withdraw your please press star two. The first question comes from the line of Brandon Folkes calling from Cantor Fitzgerald. Sorry. Please go ahead.
Hi. Thanks for taking my questions and congratulations on all the progress. Maybe just from me, just can you elaborate on the, what we should expect at AACR? You know, I did see that you noted that some new data will be released on phase I on TG4050. Just any expectations how we should look at that data? You know, sort of how should we think to frame that data? Additionally, also on the oncolytic virus platform for TG6002.
Surely I can introduce the answer, and Maud Brandely, our CMO, will complete first. I really would like to remind you that we have eight posters at AACR. That's quite amazing. I'm very proud of what the team has done, both at pre-clinical and clinical level. Indeed, probably the one that we'll hear more about are the posters on the TG4050 and TG6002, where we already have very strong data. Now it's about confirming and going a step further in the IV administration for TG6002, sorry. About the immunogenicity and the clinical sign of activity for TG4050. Maud Brandely?
Yes. With respect to TG4050, we have organized now 32 patients who we will provide in this poster more data regarding the immunogenicity of our vaccine. About the clinical data we have derived, that's the benefit we have derived from our vaccine. I cannot tell more because of course, it will be delivered at the moment of the AACR. Regarding TG6002, to be very specific, we have demonstrated, as Hedi mentioned, the clear benefit of the IV administration, but we are also exploring local regional administration. We will have a poster describing the administration of TG6002 by using intra-arterial hepatic route in patients with metastatic liver lesion from colon cancer. Very exciting route of administration which as you know is used for chemotherapy, and other, products. On the top of that, of course, as Hedi mentioned, we have a lot of other posters on the, on the research.
Great. Thank you very much. I look forward to the posters at AACR.
Thank you, Brandon.
We currently have no question coming through, so as a final reminder, if you'd like to ask a question, please press star one now. It seems that there are no further questions, so I will hand it back to your host to conclude this conference.
It seems Brandon has a question again.
Well, in this case, please, Brandon, if you can, dial again or I think I will be able to unmute you again. Yeah, that's fine. Please go ahead.
Hi, can you hear me?
Yes.
Okay. Yeah, you know, maybe just a couple follow-ups. On these phase II trials, you know, the head and neck cancer on TG4050, do you think we'll get a flavor for the trial design in the near term? What are you thinking just in terms of communicating a trial design for the phase II? How conservative do you wanna be there? That's it from me. Thank you.
Well, as you know, we have, from the very beginning, designed the trial, even in phase I, using a randomized design. Meaning that, from the very beginning, we compare, the vaccine, used as a single agent after, standard treatment, standard curative treatment, including surgery and adjuvant therapy versus, observation. So we are in a position to determine the rate of relapse in the patients who receive the vaccine immediately versus the ones who receive the vaccine at the time of relapse. So, the phase II is quite natural in that setting because we can, we are considering actually, amending the protocol so that we can, enlarge the sample size, by selecting the same patient.
As you know, in that setting, the anti-PD-1 and more specifically, zimberelimab has failed to show any benefit in the adjuvant setting. It's very interesting to propose for the benefit of the patient a new adjuvant treatment. For that purpose, we will pursue by enlarging the number of patients enrolled, the comparison between the patients treated with the vaccine versus observation.
Fantastic. Very helpful. Congrats on all the progress. That's it from me. Thank you.
Sure.
Okay. We have another question now, calling, coming from Dominic Rose, coming from Intron Health Research . Please go ahead.
Thank you very much. This is Dominic from Intron Health Research. I've got two questions. Question one is on TG4050. I just wondered whether you think it could be a drug that at some point in the future is eligible for FDA Breakthrough Therapy designation. The reason I'm asking is because of Moderna's mRNA-4157, which recently got that award. My second question is on your financial visibility. Apologies if I missed this on the call. Do the Tasly shares, do they count towards the guidance, or would that be extra runway if you sold those in the middle of the year? Thanks.
I will answer your first question and Jean-Philippe will answer the question regarding our finance. Breakthrough Therapy, you know, is a very, very interesting designation. And this is something of course we will consider as soon as we will get a sufficient follow-up of our patients and demonstrate in a significant manner that we have bring benefit to the patient versus observation. This is something of course we are considering.
Regarding the Tasly share. I confirm that the cash guidance that we are providing includes the sale of this share that we expect to occur in mid-2023.
Okay. Thanks very much. That's clear.
There are no further question, so I will hand it back to you, host, to conclude today's conference. Thank you.
Thank you. Thank you for listening to us today and your stimulating questions. To conclude, I believe that we have a very attractive proprietary product portfolio. As a result, Transgene is ideally positioned to deliver multiple milestones in the 12 to 18 months, and be seen as a key innovator in immuno-oncology space. We are very confident that by successfully delivering our programs and our strategy, we will be able to generate multiple improved treatment options that will significantly improve the standard of care for patients with solid tumor, at the same time, create significant values for our shareholders. With this, I would like to conclude today's call. Thank you very much and goodbye.