Good day, and thank you for joining the PHAXIAM Therapeutics business update and financial highlights full year 2023 results 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, you will need to press star one one on your telephone. 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, Thibaut du Fayet, Chief Executive Officer. Please go ahead. Ladies and gentlemen, good, good morning to all of you. Thank you for joining us for this conference call and webinar to present to you PHAXIAM business update and 2023 financial results. If you can go to slide number three. I'm here with Eric Soyer, the COO and CFO of PHAXIAM, and Pascal Birman, our Chief Medical Officer. We are all of us to present this update, and we'll be available for any Q&A afterwards. We have disclosed last Wednesday post-market press release presenting a general business update and financial results. This press release, as well as this presentation, can be found on the IR page on our website. If you can go to slide number four, please. Before starting, as usual, I would like to draw your attention to the disclaimer to remind you that today's call includes forward-looking statements. And as you know, they all involve risk and uncertainties that could cause actual timings and results to differ materially. If you go to slide five, as an agenda, we propose to you the following points: presentation of market highlights, a business update related to PHAXIAM's clinical development mainly, then third, 2023 PHAXIAM financial results presentation. If you can go to slide six. Phage therapy attractiveness has very recently been reinforced by the financial commitment of top-tier U.S. investors. Deerfield and OrbiMed, two major U.S. life science funds, have contributed to an important private placement of around $50 million, concurrently with a merger between BiomX, an Israeli biotech, and APT, U.S. biotech, these two companies being PHAXIAM competitors. In parallel to this, Innoviva, another U.S. life science fund, which is an Armata main shareholder, has refinanced the company with a capital increase of around $35 million. These two very recent investments are positive for the field, for the technology—I mean, I'm alluding here to the phage therapy—and demonstrate this growing attractiveness of the phage therapy to leading investors. Now, if we can move to slide seven, regarding our business update. Over the past 12 months, PHAXIAM has been developing a new ambitious clinical strategy structured around different items. The first one is that we target high-value indications corresponding to a very severe resistant infection having unmet medical needs, either chronic like PGI, prosthetic joint infection, or vital infection like endocarditis infection or ventilator-associated pneumonias. These infections may be associated with higher mortality rates to be decreased, and that's the case of endocarditis, with mortality rates reaching around 60 sorry, 30%-40%, or, you know, chronic high-budget impact indication like PGI, with very high costs of surgery or and rehabilitation. These critical claims can justify to get high price. That's, that's why we are targeting this high-value indication. The second aspect, the second point, is that, we pursue with our strategy to accelerate our path to registration, considering that the compassionate use of our phage and associated generated clinical data allow us to move faster to registration study. As a consequence, the purpose is really to prepare and launch the first global Europe-U.S. randomized phase II proof-of-concept study in PGI patients, patients having a DAIR, you know, which is a debridement, which is a standard of care we want to improve. And following this major global phase II, the objective is to be in a position to leverage on a potential early access pathway in Europe, after phase II data, if generated clinical data are robust enough. And such a process could enable us to anticipate commercialization early on. And we anticipate to start this early commercialization early semester 1, 2027. That's the second aspect. The third aspect of our clinical strategy is that beyond this lead indication, which is strategic to us, and I will come back to this, the objective is to gradually diversify our portfolio to other high-value indications beyond prosthetic joint infection, like endocarditis infection, for example, or ventilator-associated pneumonias, and also using other pathogens, like Pseudomonas aeruginosa or E. coli, you know, other phage portfolio. If you can move to the slide number eight now, I want to explain here why PGI is considered as a strategic indication for PHAXIAM. The first reason is that it's an attractive indication. PGI incidence in Europe-U.S. amounts to around 50,000-60,000 patients, considering on top of this incidence potential high cost of treatment. In the U.S., a DAIR, an integrated cost, amounts to around $150,000. In Europe, it's in the range between EUR 60,000-EUR 70,000. This incidence and this level of price are probably sufficient to sustain a value-creative business model. That's the first aspect. The second aspect is that for PGI, there is a very high unmet medical need, considering that there is still a failure rate of around 50% for the DAIR, which remains the standard of care, sorry. There is also, with this standard treatment, still a high risk of reinfection, around 60%, risk of amputation, mortality rate at five years still amounts to 55%. It's been that there is very important unmet medical need in this indication. The third aspect, which is of high importance, is that PHAXIAM can build on a very strong competitive position in this indication, in PGI, as the most as being the most advanced player in clinical development and being probably the first to market if clinical data are sufficient, to be at the end of this phase II. That's a very important aspect, comparing to APT Armata. Armata is probably 18 months behind PHAXIAM. Currently, APT, Adaptive Phage Therapeutics, our other main competitor in the U.S., put this trial in PGI on hold. It means that we are increasing our advance in this indication. The fourth aspect, it's also very high important, is that we consider that in this indication, we can maximize the probability of success of the proof of concept demonstration. It's where we have the highest probability because this indication is de-risked on the one side, on the other hand, by real-life compassionate data that we have generated, and Pascal will come on this. But another aspect, on the other hand, we consider that the route of administration that we use is of low risk because it's a local administration. It's been that for all these reasons, we consider that PHAXIAM, this indication is absolutely strategic for our development and that PHAXIAM has a unique and leadership position in this strategic prosthetic joint infection indication. And now I'm to hand over to Pascal so that he can present to you some real-life clinical data. Thank you, Thibaut. So, on slide number nine, the data which are presented on this slide are coming from about 100 patients treated under a compassionate process. All but three patients, two in Switzerland and one in Sweden, were treated in France after agreement with the French medical agency, Agence Nationale de Sécurité du Médicament en France. Phages against Staphylococcus aureus and/or against Pseudomonas aeruginosa were administered to these patients for different indications: osteoarticular infections, pulmonary infections, or vascular infections, using various routes of administration: local administration intra-articular for PGI, for osteoarticular; nebulization for pulmonary infections; IV intravenous for vascular infections. These treatments were for patients with severe infections, mostly in therapeutic impact. No side effects were reported after administration. The main indication which has been used was prosthetic joint infection, PGI. In the 42 patients which were treated under compassionate, no relapse of infection was reported by the prescribing physicians three months after PHAXIAM phage treatment, which was administered between one to three-weekly intra-articular administration. This was reported in 80% of the cases, no relapse after three months. With all the limitations due to the compassionate process, these are very encouraging results, which justify performing clinical trials to confirm the safety and efficacy of phages in this indication. If we move now to slide 10. As a whole, we have a balanced clinical portfolio with a strong focus on Staphylococcus aureus program with the PGI and endocarditis study, for which we have the highest competitive advantage in terms of clinic but also in terms of pharmaceutical robustness, as we have worked a lot on the stability of the formulation, the ability to store the formulation at 5 degrees in the fridge, and the process scale-up. The strategic focus for PHAXIAM is clearly PGI with our upcoming phase II study, and I will come back to that. The other sponsored clinical trial in endocarditis is also preparing future potential registration trials with a high-value indication. After the small phase I trial that will start very soon, we will consider a registration trial. Also, complementary to our sponsored portfolio, we have two additional investigator-sponsored studies that are performed by academic centers and are likely to create additional value and clinical evidence. The first one is called PhagoPied, and it's targeting diabetic patients with foot ulcer due to Staphylococcus aureus infection. The first patient is expected during the first half of this year. The second one is called PIOCADED, targeting patients with Pseudomonas aeruginosa ventilator-associated pulmonary infections, VAP, having a mortality rate of about 30%. The clinical trial is under preparation for a submission, which is filed for the second half of 2024. On the slide number 11. Through the preparation of a phase II proof of concept study, which is a multi-center randomized double-blind study assessing the efficacy and safety of phage therapy in patients with hip or knee PGI, who have an open surgery debridement, which is called DAIR, in combination with antibiotics, through this preparation, we are accelerating our clinical development in this PGI indication. So what is the rationale to accelerate our plan? First, thanks to the merger between Pherecydes and ERYTECH to become PHAXIAM, we have a higher clinical ambition targeting high-value indications up to registration. We also have available compassionate real-life clinical data, which I presented just before in about 100 patients, already demonstrating safety and very promising clinical benefit in a hard-to-treat population without any more therapeutic solutions available. In addition, we've had, at the end of last year, regulatory interactions with FDA for pre-IND and with the European agency, the EMA, with a scientific advice, which are helping us to refine another strategy for registration trial, reducing our level of risk. In addition, we have a pilot study, PhagoDAIR, for which the results will be available at the end of this year, which will bring to this global phase II study additional safety evidence in addition to supportive clinical data in terms of efficacy. We will target also a larger population with this phase II compared to PhagoDAIR, which is too restricted when compared with real-life. For all these objective reasons, we do consider that we have a leading competitive position in this PGI indication, and we are contemplating to initiate this first global pilot or clinical study in PGI and in phage therapy. On slide 12, this study, which is called GLORIA, will include clinical sites worldwide, so in the European Union, France, Germany, Spain, the Netherlands, Sweden, Italy, but also in the U.K. and in the United States. Regulatory submission will start with the FDA in the United States in the summer of this year, and it will be followed by submission in the EMA and in the European countries and then in the U.K. Our objective is to get a first regulatory approval before the end of this year for a first patient in the first quarter of next year. On slide number 13, about the PK endocarditis study, this is a phase I study, which will include 12 subjects who have infective endocarditis due to Staphylococcus aureus with an indication for surgery. These patients will be recruited in five French hospitals. This study will allow to assess the safety of intravenous administration and will provide PK data in the blood and also data on the concentration of phages in the infected valve and will allow to move to other studies requiring also IV administration and also for endocarditis into a registration study. This phase I study has already obtained regulatory approval at the end of last year, and a first patient is expected imminently. I will now hand over to Eric Soyer, our Chief Financial Officer. Thank you, Pascal, and good morning, everyone. Now, a few words on the key financial results for the full year 2023. We're on slide number 14 of this presentation, and we're starting with key highlights on the P&L. My first comment is that in the context of the ERYTECH-Pherecydes merger, PHAXIAM's consolidated financial statements include ex-Pherecydes financial results as from the date of the merger, which was June 23, 2023. So consequently, PHAXIAM's P&L information for the full year 2023 includes 12 months of ex-ERYTECH activities and only six months of the second half of 2023 for ex-Pherecydes activities. With that, P&L highlights are still very much in line with the comments we already shared throughout 2023, which are a strong reduction of operating expenses, which are EUR 25 million for the full year 2023, were EUR 8.8 million lower or -26% than in the previous year. The decrease was driven by the reduction of ex-ERYTECH R&D expenses, mostly related to the closing of Princeton operations and the termination of clinical development activities, while new ex-Pherecydes development activities were integrated in the P&L as of the second half of 2023. Overall, R&D expenses were reduced by EUR 9 million, which is -45% year-over-year. PHAXIAM's G&A expenses in the full year 2023 were stable year-over-year, plus EUR 0.2 million or it's +1%. That includes one-off expenses related to the merger and post-merger integration activities. Finally, net loss for the full year 2023 was EUR 23.5 million compared with a net loss of EUR 0.2 million for the same period of 2022, which benefited from the EUR 24.4 million net gain on the sale of the Princeton facility in April 2022. That was, again, an exceptional gain, in 2022. All in all, a difficult comparison of 2023 versus 2022 because both years had very exceptional one-off and significant unusual transactions. We're now moving to the next slide. It's number 15 of the presentation and to the cash position. As of December 31, 2023, PHAXIAM had cash and cash equivalents totaling EUR 10.5 million, which is approximately $11.6 million. And that's compared with EUR 38.8 million as of December 31, 2022. That's a EUR 28.3 million decrease in cash position during the 12 months of 2023. And that was the results of a EUR 24.3 million net cash utilization in operating and investing activities and EUR 3.7 million used in financing activities, which were mostly related to the reimbursements of the PGE COVID loan. And the variation of the U.S. dollar against the euro led to a EUR 0.3 million negative currency exchange impact. That was marginal. We've been gradually decreasing the cash burn of the company, and this is still continuing in 2024 with, for instance, the decision to delist from NASDAQ recently, and that was earlier this year. With that, we believe that the current cash position can fund the company's program and planned operating expenses into September 2024. Not surprisingly, in that context, we are, at this stage, reviewing a number of options to further extend the cash runway and refinance the company. That includes for the launch of the phase II proof of concept study in PGI that Pascal has just explained. Finally, a quick summary of our key strategic priorities for the coming month and upcoming key milestones. This is slide number 16 of the presentation. Again, the key program of PHAXIAM is with anti-Staph aureus phages for PGI. As explained earlier, the plan is to accelerate the transitioning of PGI clinical development efforts into the new and more ambitious global phase II proof of concept study, the GLORIA study. We're currently working on the pre-preparation of that study in view of regulatory approval from the European and U.S. agencies in Q4 this year and then the actual launch in early 2025. And at the same time, as part of this transitioning process, we plan to provide data from the PhagoDAIR pilot study in PGI at the end of this year. Closer in time, we are launching now the phase I PK study in severe endocarditis infections. The sites have been opened, and we expect the first patients anytime now. We plan to provide interim data from the first cohort of patients in the second half of this year and full results in the first half of 2025. So to summarize, quite a significant news flow for PHAXIAM over the coming months, so please stay tuned. With that, I would like to thank you all already for your kind attention, and I will now hand the call over to our operator to open the Q&A session. Abigail, it's over to you. Thank you. At this time, we'll conduct the question-and-answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for our first question. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. I'm showing no questions at this time. I would like to turn the call back to Thibaut du Fayet for closing remarks. Yes, thank you, Abigail. I mean, if you can move on the slide 17, please, for a few takeaways just for the conclusion. First of all, there are promising signs of growing effectiveness for the phage therapy, as we have seen these leading investors going to this field. In this context, PHAXIAM has been developing a strategic ambition, a strategy is targeting high-value indication in severe resistant infection, mainly around PGI and endocarditis infection, being the cornerstone indication. Point number three, PHAXIAM is a phage therapy clear European leader and gains a very strong competitive position in prosthetic joint infection, as already explained, and with the different reason that justifying this strategic choice. And as explained by Eric, you should keep in mind that for the upcoming 12 months, we can anticipate major clinical and regulatory catalysts, likely to create value for PHAXIAM. I would like to thank you for your attention, and we are concluding our call today. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
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