Good day, and thank you for standing by. Welcome to the Phaxiam Therapeutics Business Update and Financial Highlights of H1 2023 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star one one on your phone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, the CEO, Thibaut du Fayet. Sir, please go ahead. Yes, good morning to all. Thank you very much for joining us for this conference call to update—to discuss about Phaxiam's business and the financials update. If you go to slide number two, I'm with Eric Soyer, you know, our... I mean, Phaxiam CEO and CFO. We will both present this update, and we will be available at the end of this presentation for any Q&A. This presentation will be uploaded also on the investor page for our company. If you please go to slide number three. Before starting, I would like just to draw your attention to the disclaimer to remind you that today's call include, of course, forward, forward well looking statement. As you know, they all involve risk and uncertainties that could cause actual timing and results potentially to differ. As for the agenda, if you are moving to slide number four, we have four sections. First, we would like to present the Phaxiam strategy, then to make a business update, mainly related to clinical development. Then, a financial update on the Phaxiam H1 financials, and then a short conclusion. Please move to slide number five. Phaxiam's ambition is to be a global phage therapy player and leader. This strategy relies on different axes. The first one is to expand our clinical portfolio in high-value indication, and I will come back to this in a minute. Then second point, to position the company as a global player through increased international development, and the idea here is mainly to leverage on previous Erytech and team expertise. It's also opening new clinical and new clinical sites in Europe and in the US. What we have already done in Europe with our PhagoDex trial, we have, beyond France and Spain, we have validation in Germany, Netherlands. It's why we are becoming more and more, through our clinical development, a European player. The third point relates to research. We intend to boost our R&D capabilities and expand our phage platform. It means identifying new targets like, for instance, Klebsiella as a pathogen that we have disclosed a few days ago. To prepare also future development programs likely to move to development. We're also working on the extension of our phage portfolio for E. coli pathogen, for Pseudomonas pathogen. Of course, it's also to develop a drug-based bacteriophage program, developing potentially endolysin as proteins, very much complementary to phage. And that's also an expertise that Erytech brought to the collaboration, to the merger. And all this to boost our research, leveraging on strategic research alliance and with an open innovation approach, so that we complement our internal research portfolio. The fourth point, the purpose is really to implement a global manufacturing strategy, by developing a global strategy consistent with our international development and mainly regarding the U.S. And I would say that the short and medium-term aspect is really first to consolidate our industrial partnership that we have already in place with MB Pharma, a European industrial partner, that we consider being as a major competitive advantage. And beyond this, implementing supply backups plan also. The last point, the purpose is to intensify BD activities and market access strategy. BD activities is establishing research collaboration in human health, but also beyond human health, to leverage on our phage technology platform and consider strategic alliance, you know, with biotech, with complementary biotech, but potentially also with pharmas, with which we are more and more discussing. In terms of market access, we, we, you know, we, we have-- we got in Europe for program, which stands for AAC, auto regulation, like say, compassionate. It's a kind of protocolized way for compassionate access, for which we are generating revenues, and the idea is to extend this validation and also to prepare for early access pathways, because this regulatory validation gives us an opportunity for being granted early access pathway and to be in a position to commercialize early our products. These are the most important points. If we are moving to slide number six, that's the first point of our corporate strategy that I would like to dig into. We have an ambitious clinical strategy, which is really the cornerstone of this corporate strategy. First of all, we target high value indication corresponding to severe resistant infection, having high medical need. It means, you know, potential indication, having high mortality rates to be decreased. That's the case, for instance, for endocarditis infection or ventilator-associated pneumonias, you know, in the respiratory tract infection, for which mortality rate could be decreased, and enabling us to claim for high price. I take the example of endocarditis, as mortality rate reach 30%-40%. That's why, even a 10% decrease in this mortality rate could enable to get reimbursement and high pricing. The second aspect is potentially high project impact indication, like PJI, prosthetic joint infection, for which we are very much positioned in our current development. This indication is associated to very high cost of surgery and rehabilitation, in the U.S. and in Europe. It could also justify, you know, to get high price. The second point beyond this high value indication positioning is really to accelerate our path to registration, considering that and, mainly, and first of all, for PJI, considering that we have collected so far, you know, compassionate data associated with clinical data, for our, mainly for our, for the PJI indication. That's an argument to move faster to registration. As a consequence, the purpose is to prepare and launch the first global Europe-US pivotal randomized phase II-B, III for PJI patients. That's one of the major aspects of our clinical development strategy. Complementary to this, and an additional opportunity, is really to leverage on this potential early access pathway that I've just described. You know, after we get phase II-B part data, if it turns that generate clinical data are robust enough, and enabling us to anticipate commercialization. That's the second aspect of our clinical strategy. The third one is considering that beyond this lead indication, PJI, the objective is really to gradually diversify our clinical portfolio to other high value indication, like endocarditis infection or complex urinary tract infection, and to speak about in a minute. But the idea is really to target to other high value indication. If we move to slide seven, here, we want to explain why PJI, prosthetic joint infection, is considered as a high value indication, as an attractive indication. First of all, the standard of care is insufficient, as it remains very challenging to treat, heavy dose of systemic antibiotic, in addition to long surgeries and for a long duration, sometimes months, but potentially years. There is an obvious and demonstrated high unmet medical need, considering that today, the DAIR treatment, debridement, which is a standard of care that we are targeting to be replaced, has a failure rate of around 50%-55%. It's still very high. Considering also that there is a high risk of reinfection, around 60%, a high risk of amputation, around 10%. On the top of this, the five-year mortality rate for this indication is around 25%. It means that as a whole, there is a very important unmet medical need. We consider that the PJI incidence in the U.S. and in Europe, amounting to 60-70K patients, is probably sufficient to sustain a valuable, creative business model. Of course, we are not a huge incidence indication, but it's probably sufficient as we are targeting, you know, severe resistant infection without pricing. And for PJI, we have also very high-match describing. You know, there is a substantial economic burden in the U.S. The treatment cost is amounting to around $150K. In Europe, it's in the range of EUR 50-70K. There is a lot of savings to be done for the healthcare system. That's why we consider that PJI is really matching this criteria and can be considered as a high-value indication. If we move to slide eight, it's why we consider that there is a, it's very valuable to consider PJI to accelerate our clinical development plan. It's the reason why we are considering in this indication to prepare an integrated phase II-B, III multicenter randomized comparative double-blind study to assess the efficacy and the safety of phage therapy in PJI patients, mainly hip and knee PJI patients. Adding this open surgery debridement, which is called the DAIR, in combination with antibiotics. Why, what's the rationale to accelerate our plan? First, thanks to the merger we have done with Erytech, increasing our clinical ambition to target high-value indication, but also to move faster, to move faster to registration. Leveraging on all this expertise that we get from Erytech in the US with regulatory expertise, but also clinical operation expertise. It's why this, our lead indication, it's a good indication to accelerate towards registration. Second point is that we have prepared over the last few months a briefing package that we have filed to FDA in August for a Pre-IND meeting, and to EMA for scientific advice. We have in Q4 this year, before end of year, interaction with these two agencies to refine, maybe to amend our strategy, and potentially to reduce the level of risk of our plan. That's a second argument. The idea is really to interact with this authority on this plan. The third point is a major competitive advantage that we have. So far, we have gathered more than 90 patient clinical data, real-life clinical data. And we have demonstrated, with our phage, their safety, their tolerance, and also very promising clinical benefits in a very hard-to-treat population. Because we are not... the compassionate treatment are administered, administered not to the targeted population for our phase II-B, III trial, but for more advanced patients, very hard to treat in a therapeutic deadlock with no more available treatment. Now, most of them are in line two or line three antibiotics. But with this real-life data, we are, you know, in a way, securing and de-risking our clinical approach. The fourth point relates to PhagoDAIR, you know, our PhagoDAIR trial, our pilot study. We will bring to this phase II-B, III safety evidence, which is already demonstrated so far, in addition to supportive clinical data in terms of efficacy. This data will come in 2024, probably around Q3 2024. The fifth point is related to the targeted population. We need to go faster to a larger population to target according to guidelines, when compared with PhagoDAIR. The intent of this phase 2b/3 is to address a larger targeted population. For all this objective reason, we do consider that we have a leading competitive position in PJI indication, and it's why we are contemplating to initiate this first global pivotal study, in both in PJI but also in phage therapy. If we move to the slide number nine, I would like to add some elements. On top of this phase II-B, III study that we are considering in PJI, we are preparing two other sponsored trials of high interest. The first one is a phase I PK study, targeting endocarditis infection associated with Staph aureus, which is a high-value indication. Again, considering this high mortality rate I was alluding to. Endocarditis infection patients have resistant infection to cardiac chambers and valves. The outrage will be administered IV, intravenously, through this, and through this study, we expect to demonstrate the efficacy of this route of administration, thanks to the pharmacokinetic data that we are to generate, enabling to measure the concentration of the phage. It will be both for this clinical positioning, but also for either other, sorry, IV indication. The idea would be potentially to move to registration study right after this phase I PK study. We expect to enroll the first patient in this study before end of year, which is pretty soon. The second trial I wanted to speak about, another sponsored trial that we are on which we are working, is again a phase I PK study, targeting complex urinary tract infection associated with E. coli, which is also of a very high value indication, considering that the population that we are targeting are post-traumatic patients having spinal injury. For these patients, for this study, phage will be administered locally into the bladder. The rationale that we expected, the evidence that we are looking for, is to demonstrate the efficacy of intra-bladder route of administration, before moving to a potential registration study that we could initiate right after this phase I PK study. For this study, in particular, we expect to file the CTA in Europe before end of year 2023, for a trial that could be initiated around mid-next year, or I would say, H2, H2 next year. It's important to see that these sponsor studies are expanding our clinical portfolio with a very consistent strategic approach, as they are targeting high value indication. If we are moving to the slide number 10, I just, as a role to describe a bit our clinical portfolio, which is a bit balanced. I would like to insist on the, and make a strong, on our staph program, that for which we are mainly focusing our development, you know, with PJI and endocarditis study, for which we consider that we have a very high competitive advantage in terms of clinic, due to the plan that we are designing, aiding the PJI development, but also extending to endocarditis trial, which is of a unique positioning. There are not any other similar trials. Also beyond clinic in CMC, because we have worked a lot on the CMC plan. You know, in terms of stability of our batches, in terms of formulation, we can store our product at five degrees, with being very stable. We are already working on the scaling up of the manufacturing process. It's why, as a whole, this staph program is our most strategic program, still, still, priority is increased by our phase II, phase III trial. The two other sponsored trial that we're also preparing for future registration trial, endocarditis trial and complex urinary tract infection trial, are complementing this approach. I would like to highlight also two more, one aspect, which is a bit more tactical, but complementary to the sponsor portfolio. We have two other additional investigator-sponsored studies that are likely to create additional value and generate more clinical evidence. The first one is called PhagoP, it's not on the slide, but targeting diabetic patients with a foot ulcer infection. This one is of high importance for the US, because due to the prevalence of diabetes II in the US, and this trial—for this trial, we expect the FPI to attend in H1 2024, and potentially in Q1 2024. The second one is Piofaneb, targeting patients with Pseudomonas aeruginosa, ventilated, acquired pneumopathies. You know, and this indication is also of high value, as the mortality rate amounts to around 30%. For this study, the CTA is under preparation, and for a filing plan in H1 2024. It's why we have, again, a large and balanced portfolio, with very strategic program around staph program. And I would say, potential other indication, high value indication, for which we could, like endocarditis infection and complex urinary tract infection, for which we could consider, future registration trial. I would now hand over to Eric for the slide number 11. Thank you, Thibaut. Good morning, everyone. I am Eric Soyer. I'm the Chief Operating and Chief Financial Officer of Phaxiam. We're indeed on slide number 11. For a quick word on Phaxiam financial results as of the end of June this year. The first comment I would like to make is that Phaxiam's financial statements in IFRS standards include ex-Erytech and ex-Pherecydes, since the merger of both companies, and that was on June 23rd this year. And as a result, the PNL information, which you have in the condensed form on the screen now, for the first six months of the year, is mostly related to ex-Erytech activities, since Pherecydes activities entered only on June 23. Of course, the balance sheet as of June 30, the statement of financial position, includes the financial positions of both merged companies at this date. On the PNL side, the net loss for the first six months of 2023 was EUR 12.2 million. It's noticeable that we had a further sharp reduction in operating expenses. It was minus 50% as compared to the previous year. It's even minus 80% on research and development expenses, and this is, of course, driven by the closing of Princeton operations, which we sold, Erytech sold in April last year, and also the termination of ex Erytech clinical developments and regulatory activity. A sharp reduction in operating expenses to date. In the same time, we had an increase in GNA, which is obviously driven by merger-related expenses. It's true that with this merger of two companies, we had one-time costs related to the merger, quite an exceptional year. Moving to the next slide for a word on cash position. So that's slide number 12. As of June 30 this year, the total cash position of the company was EUR 25.2 million. That's approximately $27.5 million, and that compared with EUR 38.8 million at the start of the year. So that's a decrease of EUR 13.6 million, net decrease in cash position during the first six months of the year. Again, mostly related to ex-Erytech activities, and attributed to EUR 12.1 million net cash realization in operating and investing activities. We have also EUR 1.6 million used in financing activities, mostly for the repayments of the COVID loan that we set up two years ago in the context of COVID. That was a state-guaranteed loan with very attractive rates, but we are starting to repay that loan over the next four years. And a very slightly negative exchange rate of the dollar against the euro, with an impact of EUR 0.3 million. With that, we believe that the company can fund its current programs and plans operating expenses into the second quarter of next year, second quarter of 2024. In that context, I would like also to remind that we have very important value catalysts over the next few months, starting with the second half of this year, 2H 2023, with, on the clinical front, Thibaut has already mentioned that the start of the phase I PK study in endocarditis, which is an important study because not only that's the first clinical development in that indication, endocarditis, a very high value indication, but also the opportunity to validate the intravenous application of phages, which can then open the way to additional implications of similar ways of administration. That's for this second half of 2023. Most importantly, before the end of the year, the major catalyst is more on the regulatory side with the FDA pre-IND meeting to discuss the finalization and the validation of the phase II-B, III study we want to start in prosthetic joint infection. Then next year, first half of next year, probably early next year, we should have the feedback from the European agency, the EMA. It's a scientific advice, again, on the finalization and validation of the phase II-B, III trial in PJI, so US and EU trials to start next year. And of course, we should have the data of the phase I PK in endocarditis. So, a very interesting catalyst. Towards the second half of next year, we should be able, hopefully, to start the phase II-B, III trial in PJI. We'll also have the clinical data from the ongoing phase II trial, the PhagoDAIR trial in PJI, which will be supporting the start of the phase II-B, III trial. Finally, we plan to start and initiate another phase I PK in complex urinary tract infections, with a first patient also expected before the end of next year. All in all, a very active news flow planned over the coming months, and we believe, we hope, that will sustain the company values over the next few months. To summarize, and that will be the last slide of this presentation. The first point is that the merger of Pherecydes and Erytech is now effective. Phaxiam is real, and the Phaxiam teams are all focused on swift execution of the strategy, which is absolutely key, and we already see very active synergies between the two companies on all functional fronts, actually. Which have enabled us to make a very strong progress, particularly on the regulatory front, with those two meetings with the FDA and the EMA to happen very soon now. This is also supporting a reinforced, upgraded strategic ambition to high-value indications in severe resistant infections. Thibaut explained the clinical portfolio to sustain that ambition. The cornerstone of that ambition is the PJI phase II-B, III study, which we plan to start next year. The next catalyst in that field will be already this year with the feedback from the regulatory agencies, the FDA first and the EMA after it. In the same time, as a complement to our clinical portfolio, again, in high value indications, we're extending the portfolio to endocarditis infections with a phase I PK trial to start before the end of this year. All that building on a very favorable competitive position of Phaxiam. We are the clear European leader in the field. We are very well advanced on the strategic trial and clinical development in PJI. Again, PJI is a first indication. We believe that's the first indication of choice to finally have a very valid and compelling proof concept, of clinical proof concept for phages, which is what is lacking in the field. We believe PJI is the exact right choice to start having that and then extend to other indications. We are clearly there in Europe, where we have the advantage, Thibaut explained, to have some real-life data already from compassionate patients and AAP patients, which are compassionate patients with a specific status. It is also a very strong signal of clinical activity, but also a way to de-risk clinical development in the field. Again, very well positioned to create, that's our ambition, a global leader in phage therapy. With that, I would like to thank you already for your kind attention, and I am handing the call over to our operator, Chris, who will open the line for questions. Chris, over to you. Thank you. As a reminder, to ask a question, please press star one one on your phone and wait for your name to be announced. To withdraw your question, please press star one one again. Stand by as we compile the Q&A roster. Again, to ask a question, please press star one one on your phone. Again, to ask a question or make a comment, please press star one one on your phone. Speakers, I see no questions in the queue. I would now like to turn the conference back over to Thibaut du Fayet for closing remarks. Okay. First of all, I would like to thank you for your kind attention today for our webinar. I would like maybe just to highlight two points. The first one is that, as said, there is a very promising dynamics in the merger between the two companies, Erytech and Pherecydes. cross-fertilizing and leveraging on mutual expertise, and I would say mainly on the Medilac expertise. enabling our new company to increase and to have this increased ambition in clinical development. Which is the demonstration of our plan, as we are now preparing this phase II- B, III to be initiated for next year. Thank you very much for your attention again. Thank you. Bye-bye. This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.