Q2 2023 ERYTECH Pharma SA Earnings Call
Speaker 1: You.
One.
Good day and thank you for standing by. Welcome to the Faxium, 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 11 on your phone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again.
Please be a vibe that today's conference is being recorded. And I would now like to hand the conference over to you or speak today, the CEO , Tivo Jufayet. Sir, please go ahead.
Yes, good morning to you. Thank you very much for joining us for this conference call.
to discuss about tax yams business and the financials update.
If you go to slide number two, I'm with Eric Swaye, I mean, fact, I'm CO on CFO , and 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 MVC.
and this top page for our company.
If please go to slide number three. Before starting, I would like just to draw you attention to the disclaimer to remind you that today's goal include, of course, for the world-looking statement. And as you know, they are all involved with and uncertainties that could cause actual timing and results.
Potentialy to different.
As an agenda, if you are moving to slide number four, we have four sections. First, we would like to present the FACTIAM strategy then to make a business update, mainly related to clinical development, then a financial date on FACTIAM H1 financials, then a short conclusion.
Please move to slide number five.
Um.
Fakciam's ambition is to be a global global fetched rapid player and leader. This rapidity relies on different axis. 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, position the company as a global player through increased international development, and the idea is mainly to leverage on previous heavy tax.
U.S. presents and T-Mexportized.
And it's also opening new clinical sites in Europe and in the US. What we have already done in Europe with our Fagodeth trial, we have beyond France and Spain, we have validation in Germany, in Netherlands, it's why we are becoming more and more through our clinical development, Europe and player.
The third point relates to research. We intend to boost our erandic abilities and expand our Fetch platform. It means identifying new targets, like for instance, Klepp Tiela as a pathogen that we have disclosed a few days ago. To prepare for future...
development programs likely to move to development. We are also working on the extension of our FH portfolio for Ecoli Pathogen for pseudomonas Pathogen.
Of course it's also to develop a drug based bacteria of age.
Program and developing potentially endolygene as proteins very much complementary to phage.
And that also an expertise that every text wrote to the collaboration to the merchant.
And all these to boost our research, leveraging on strategic research alliance and within open innovation approach 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 US.
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, which is 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 busy activities and market access strategy.
be the activities establishing research collaboration in human health but also beyond human health to leverage on our phage technology platform and consider strategic alliance with biotech, with complementary biotechs but potentially also with pharmas with which we are more and more discussing. h
In terms of market access, we got in Europe
We have a third position for our program which stands for A-A-C, Autoregation D'Accé Compassionnel. 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 to us an opportunity for being granted early access pathways 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.
We entered 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 rate to be decreased. That the case, for instance, for endocarditis infection or ventilated acquired pneumopaties, you know, in respiratory tract infection, for which mortality rate could be decreased and anything has to claim for high price.
I take the example of endocarditis as mortality rate reaches 30-40%.
That's why even a 10% decrease in this mortality rate could enable to get...
and high pricing. The second aspect is potentially high project impact indication like PGI, 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 US and in Europe . It could also justify to get high price.
The second point beyond this high value indication positioning is ready to accelerate our path to registration.
considering that and mainly and first of all for PGI considering that we have collected so far you know compassionate data associated with clinical data for mainly for the PGI indication
And of course that's an argument to move faster to registration. And as a consequence, the purpose is to prepare and launch the first global Europe-US pivotal randomized phase-to-be.
Three.
for PGI 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 after we get phase IIB part data if the terms that generate the 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 PGI, the objective is really to gradually diversify our clinical portfolio to other eye value indications.
like endocarditis infection or complex urinary tract infection and to speak about in a minute. But the idea is ready to target to other high value indication Majin.
If we move to slide 7, here we want to explain why PGI, prosthetic joint infection, is considered as an high value indication.
as an attractive indication.
First of all, the standard of care is insufficient as it remains very challenging to treat every dose of systemic antibiotics in addition to long, to surgeries and for a long duration, sometime months but potentially years.
There is a...
There is an abuse and demonstrated I am ethmetical either.
considering that today the dare treatment, debridement, which is the standard of care that we are targeting to be replaced.
has a failure rate of around 50% to 55%, feel very high.
Conserving 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 modality rate for this indication is around 25%. In that, as a whole, there is a very important unmet medical need.
We consider that the PGI incidence in US and in Europe amounting to 60 to 70 K patients.
It's probably sufficient to sustain a valuable creative business model. Of course, we are not in huge incidence indications, but it's probably sufficient as we are targeting severe resistant infection without pricing.
And for PGI we have also very high PGI times match according to what I was describing. There is substantial economic burden in the US.
The treatment cost is amounting to around 150k dollar in Europe in the range of 50 to 70k euro.
savings to be done for the healthcare system.
That's why we consider that DJI is really matching these criteria and can be considered as the high value indication.
If we move to sign number 8
It's why we consider that there is a It's very valuable to consider this GDI to accelerate our chemical development plan and it's
It's the reason why we are considering in this indication to prepare an integrated Phase IIB3
multi-centric, randomized, comparative, double-blind study to assess the efficacy and the safety of face therapy in PGIs patients.
many hip and knee PGI patients.
having this open surgery debridement which is called the DEAR in combination with antibiotics.
Why is it rational to accelerate our plan?
First, thanks to the merger we have done with Eretec, increasing our clinical ambition.
to target high value education but also to move faster, to move faster to registration, leveraging on all these expertise that we get from ARITEC in the US with regulatory expertise but also clinical operation expertise. And it's why this hourly indication, it's a good indication to accelerate to our registration.
The second point is that we have prepared over the last few months a briefing package that we have signed to FDA in August for a pre-IND meeting and to EMA for scientific advice and we will 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 its authority on this plan.
The third point is the 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. Our administers are not to the targeted population for our phase 3 trial but for more advanced patients. We are to treat in a therapeutic deadlock with no more available treatment. Most of them are in line 2 or line 3 antibiotics.
With this real-life data, we are in a way securing and de-risking our clinical approach.
The first point relates to FAGODER, our FAGODER trial, our pilot study. We will break to this phase 3.
safety evidence, which is already demonstrated so far, in addition to super-tip clinical data in terms of efficacy. And this data will come in 24.
Probably around Q scoop, 20?ite.
the pitchspinds,
is related to the targeted population. We need to go faster to a larger population to target, according to guidelines when compared with Fagoda. And the intent of this phase to be free is to address a larger targeted population.
For all this objective reason, we do consider that we are believing in competitive position in pitch-i indication and it's why we are contemplating to initiate this first global pivotal study in both in pitch-i but also in fibroauthority.
If we move to the slide number nine, I would like to add some elements. On the top of this face to be three studies that we are considering in PTI, we are preparing two other sponsored trial of IELTRED. The first one, the phase one.
PK study, targeting on the cardiology infection, associated with staff for reuse, which is a high value medication. Again, considering this, I am not a deteriorated with alluding too.
Under-candidate infection patients have registered infection to cardiac chambers and valves.
The outfage will be administered ID, and independently, 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 phase, it will be both for this clinical positioning, but also for either other sorry, IV education. And the idea will be potentially to move to registration study right after this phase one PK study. We expect...
to enroll the first patient in the 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 one P case study targeting complex urinary tract infection associated with Econine, which is also of a very high value indication considering that the population that we are targeting are post-phromatic patients having final injury.
And for this patient, for this study, Fage will be administered locally into the bladder and the rational that we expect, the evidence that we are looking for, it should demonstrate the efficacy of intra bladder routes of administration.
Before moving to a potential registration study that we could initiate right after this phase one PK.
Sterling.
For this study, in particular, we expect to file the CCA in Europe before end of year 2023, for a trial that could be initiated around mid-next year, I would say, H2, H2, next year.
This is important to see that these forms of studies are expanding our clinical portfolio with a very consistent strategic approach as they are targeting a value indication.
If we are moving to the slide number 10, I just, as a whole, to describe a bit our clinical portfolio, which is a bit balanced. And I would like to insist on our staff for this program, for which we are mainly focusing our development, with PTI and our faculty 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, adding the PGI development, but also extending to undergradity.
12, which is of a unique positioning down, not any other similar trails, but 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, being stable. We are already working on the skinning of the manufacturing process. And it's why, otherwise, this staff of this program is our most strategic program, too.
still priority is increased by our face to be free trial. The two other sponsor trial that we are also preparing for future registration trial, on the cardity trial and complex urinary trial and infection trial are complementing this approach. And the top of this, I would like to highlight also two more one aspect which is a bit more tactical but complementary to this sponsor portfolio. We have two other additional and vestigate or sponsor studies that are likely to create
additional value and generates more clinical evidence. The first one is called phagopie, it's not on the slide, but targeting diabetic patients with a foothold serenfection. And this one is of high importance for the US because due to the prevalence of diabetes too in the US and this trial, for this trial, we expect the FBI to append in H124 and potentially into one 24. The second one is pure fanab, targeting patients with abdominal, original, original, ventilated, acquired pneumopathies. And this indication is also of high value as a mortality rate amounts to around 30%. And for this study, the CTA is under preparation and for a filing plan in H124.
It's why we have again a large and balanced portfolio with very strategic program around staff or restaurant. And I would say potential or the indication, I value education for which we could like on localities infection and complex your running track and fiction for which we could consider future registration trial.
I would now end of earth to Eric for this line number 11.
Thank you, TiBo. Good morning, everyone. I'm Eric Sawyer, I'm the Chief Operating and Chief Financial Officer of Facial DiEM, or indeed on line number 11.
For quick words, on fact, him some of the results out of the end of June this year. The first comment I would like to make is that...
Thanks, my gentleman. I have financial statements in our first panel.
include X-Aritek and X-Furicitis since the merger of both companies, that was in June 23rd this year. As a result, the PNR information which you have in the condensed form on the screen now, the first six months of the year is mostly related to X-Aritek activities since for a satisfactory event, only on June 23rd. And of course, the balance sheet of June 30, the statement of financial position, includes the financial positions of both merge companies.
at these days.
On the PNL side, the net loss for the first six months of 2023 was 12.2 million euro. It's noticeable that...
We had a further shop production in operating expenses. It was minus 50% as converted to the previous year. It's even minus 80% on research and development expenses. And this is a fourth driven by the closing of Princeton operations, which we sold, Iretex sold, in April last year. And also the termination of exerate technical developments and regulatory activity. So a shop production 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 cost related to the merger equating the exception of the year.
Moving to the next slide for words on cash position. So let's slide in the bed 12.
As of June 30 this year, the total cash position of the company was 25.2 million euro, that's approximately 27.5 million dollars, and that compared with 38.8 million euro at the start of the year. So that's a decrease of 13.6 million euro and that decrease in cash position during the first six months of the year, again mostly related to ex-erotic activities and attributable to 12.1 million net cash utilization in operating and investing activities. We also also 1.6 million euro used in financial activities mostly for the repayments of the COVID loan that we...
Start up two years ago in the context of COVID, that was a state guarantee loan with very attractive rates, but we are starting to repay that loan over the next four years. And a very slightly negative change rate of the dollar against the euro, with the impact of the European 3 million euro.
With that, we believe that the company can finance its current 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 catalyst, value catalyst over the next few months.
plus starting with the...
The second half of this year, 2H33, with on the clinical front, Tivo has already mentioned that the start of the phase one, DK, study in endocodities, which an important study because not only that's the first clinical development in that indication and the quality is 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.
So that's for this second half of 20th, most importantly, before the end of the year, the major catalyst is more on the regulatory side with the DFTA.
We are in the meeting to discuss finalization and the validation of the phase 2, 2, 3 study we want to start in prosthetic joint detection.
Then, first up, next year, probably early next year, we should have the feedback from the European Agency, the EMA, the scientific advice, again, on the finalization and validation of the Phase IIB3 trial in PGI, US and EU trial to start next year. And, of course, we should have the data of the Phase I PK in the Codid, a very interesting catalyst. And, towards the second half of next year, we should be able, hopefully, to stop the Phase IIB3 trial in PGI. We also have the clinical data from the ongoing Phase II trial, the FIGOJR trial in PGI, which will be supporting the start of the Phase IIB3 trial. And, finally, we plan to start and initiate another Phase I PK in complex urinary tract infections, with a first patient also expected before the other picture.
So all in all, very active news flow, plan of order, the coming month and we believe we hope that will sustain the company values over the next year month. Well done, everyone.
to summarize, and that will be the last slide of this presentation. The first point is that the merger of forest-solided and erytech is now effective, FACTIM is real, and the FACTIM teams are all focused on swift execution of the strategy, which is assythic, and we already see very active synergies between the two companies on all functional fronts, actually, which have enabled us to
to make a very strong progress, particularly on the regulatory front with two meetings with the FDA and the EMA to happen very soon now.
This is also supporting a
Rainforest upgraded strategic ambition to high value indications in severe resistant infections. She was explaining the critical portfolio to sustain that ambition. The cornerstone of that ambition is the PGI phase 2b3 study which we plan to start next year and 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.
And in the same time, as a complement to our clinical portfolio, again in high value indications, we're sending the portfolio to endocarditis infections with a phase 1 PK trial to start before the end of this year.
Thank you.
All that building on a very favorable competitive position of FAC-CAM. We are the career European leader in the field. We are very well advanced on the strategic trial and clinical development in PGI. Again, PGI is a first indication, we believe that's the first indication of choice to finally have a very valid and compelling proof of concept of clinical proof of concept for phages which is what is lacking in the field and we believe PGI is the exact right choice to start having that and then expand to other indications.
We are clearly there in Europe where we have the advantage, as Thibaut explained, to have some real-life data already from compassionate patients and AIC patients, which are compassionate patients with a specific status, which is also, one, a very strong signal of clinical activity, but also a way to bear risk or clinical development in the field. So 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.
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And speakers, I see no questions in the queue. I would now like to turn the conference back over to Tibo Dufier for closing remarks.
Tr.
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 dynamic in the merger between the two companies, Eritreq and Procider.
Constructulating and leveraging on mutual expertise and mainly on the matter like expertise enabling our new company to
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 to be free to be initiated for next year.