Q4 2023 PHAXIAM Therapeutics SA Earnings Call

Okay.

Good day and thank you for joining the vaccine 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.

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Be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today Tivo do you find any chief Executive Officer. Please go ahead.

And ladies and gentlemen, and good morning to all of you.

Thank you for joining.

As for this conference call and we'd be now to present to you.

In fact, some business updates in 'twenty three financial results. If you can go to slide number three.

I'm here with our <unk>, the T O and CFO Sherman Pascal BMO.

<unk> Medical officer.

Well all of us to present, this update and will be available for Q&A afterwards.

We have just closed last Wednesday post market press release, presenting a general business update.

And our financial results. This press release as well as the presentation can be found on them.

Page on our website. She 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 four well looking statements.

As you know.

They all involve risks and uncertainties that could cause actual timings and results to differ materially.

If you go to slide number five as an agenda.

We proposed to you following Barnes presentation of market highlights the business update related to Frac sand clinical development mainly.

And so.

2023 facts Sham financial results presentation.

If you can go to slide number six.

Yeah.

Phage therapy attractiveness.

It's been a.

Very recently been reinforced by the financial commitment.

Top tier U S investors.

Do you feel and I'll be met two major.

Our U S life science phones.

Contributed to unimportant.

Private placements of around 50 million U S dollar.

Concurrently with the merger between <unk>, and Israeli and second E. P T.

Our U S. Biotech is two company being a fraction compared to dose and in parallel to this.

Veeva.

Another U S and there's a lifestyle choice phone.

Which is I'm at our main shareholder as refinance the company with the capital increase of around 35 billion U S. Dollar.

These two very recent investments are positive for the field.

For the technology, I mean, you didn't need to use of phage therapy.

And demonstrate the growing attractiveness of the French therapy, two leading investors.

Okay.

Now we can move to slide seven.

Regarding our business updates.

Over the last 12, the last past 12 months.

Sam has been dropping.

New ambitious clinical strategy strip.

Structured around different items. The first one is that.

We target new indication.

Corresponding to this very severe resistant infection, I think I unmet medical needs.

Chronic like P. G. I positive jaws infection are vital infection like olive garden disinfection fluctuated quite nimble batches.

And this infection.

Maybe associated with iron mortality rates to be decreased and that is the case upon localities.

Mortality rates reached around 60, sorry, 30% to 40% off.

You know chronic I forget impact indication like Picciano with very high cost of surgery.

Rehabilitation.

These critical claims cant justify to get I price. That's that's why we're targeting this.

One indication.

There's still going to expect the second point is that we.

We we pursue with our strategy to accelerate.

Pass through registration considering that the compassionate use of phage.

And I appreciate it generated clinical desktop.

Oh, no west to move faster to registration study and as a consequence. The purpose is really to prepare and launched the first global Europe U S.

Well optimized phase II proof of concept study.

In Pgi patience.

Patient testing of debt, which is a debridement, which is a standoff care, we want to improve and then and following two days following this.

<unk> a global phase II.

The objective is to be in a position to leverage and on a potential early access pathway in Europe.

After phase II desktop if generated clinical that are robust enough.

In such a process could enable us to anticipate commercialization early on and we anticipate to start this.

This early commercialization early so Mr at 127.

That's the second aspect understood aspect of a clinical strategy that beyond its lead indication, which is strategic to us and I will come back to this the objective is to gradually diversifying our portfolio to other I bet you indication beyond prosthetic joint infection like although colleges infection for example.

<unk>.

Well that's related to quite a number of parties.

And also using other pathogen like Pseudomonas.

Oh equalize although.

But for <unk> portfolio.

If you can move to the slide number eight now I want to explain.

Why pgi is considered as a strategic allocation for fracture. The first reason is that it's an attractive indication pitch.

P J incidents in Europe U S amounts to around 50, 60 K patient.

Considering.

On the top of this incidence potential iqos of trade spend in the U S.

Yeah.

Greater cost amounts to around 150 kilowatt hour in Europe. It's in the range of between 60 to 70 care Euro.

This incident in this level of price are probably sufficient to sustain value creative business model.

That's the first aspect the second aspect is that for pitch. Yeah. There is a very high unmet medical need considering that there is still the failure rate of around 50% for the day on which remains at the dock.

On the health care sorry.

There is also where these stand on treatment still at high risk of infection around 60% risk of amputation mortality rates at five years see the mountains to.

It amounts to 55%.

Is very important.

And met medical need in this indication the south aspect, which is important is that section can built 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. It.

Clinical data are sufficient.

Which.

At the end of this phase II.

And that's that's a very important aspect comparing to EBIT.

Madame amortize, probably 18 months behind our affection and currently.

That just fits rapid seek out other main competitor in the U S put this trial in pgi as an old.

It's been that we are increasing our advance in this indication.

The first aspect. It's also very importantly 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 derisked.

On the one side.

On the other hand.

By real life compassionate desktop that we have generated and Pascal will jump on this.

Another another aspect on the other hand.

We can see that the route of administration that we use is of low risk because it's a local administration.

And that for all these reasons, we consider that fact.

This application is absolutely strategic for development and that section has a unique leadership position in this strategic prosthetic joint infection allocation.

And now I'm to hand over to Pascal too.

Too so that you can present to you some clinical data.

To tivo.

So on slide number nine.

Data, which are presented on this slide are coming from about 100 patients treated under a compassionate prospects.

All three patients two in Switzerland, and one is we don't work treated in France.

As we announced with the French medical urgency.

Each of them the security community came off.

So sage is against Staphylococcus aureus or against Pseudomonas aeruginosa, well administered to these patients for different indications.

Computer infections.

Preliminary infections or let's grow infections using various routes of administration local administration in particular for GR positive, Australia, liberalization fulfillment or infection.

I mean revenues for vascular infections. These treatments for patients with severe infections, mostly in cathodic impacts.

No side effects were reported.

The 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 were bolstered by depressed.

Prescribing physicians three months after such stage treatments.

Which was administered between one to three weekly intra Keytruda administration and this was reported in <unk>.

80% of the.

Casey no relapse after three months.

With all the limitations due to the combustion process.

These are very encouraging with us which justify.

In clinical trials to confirm the safety and efficacy of <unk> in this indication.

If we move now to slide number 10.

As the award we have a balanced clinical portfolio with.

With a strong focus on Staphylococcus aureus program with the Pgi.

<unk> study.

For which we have the highest competitive advantage.

In terms of peak, but also in terms of pharmaceutical business.

As we have worked a lot on the stability of the formulation yet.

The key to still formulation at fight them in the fleet.

The process scale up.

The strategic focus of perfection is clearly pgi with upcoming phase two study and I will come back to that.

The other sponsored clinical trial in on the value of the car Ts is also preparing future potential registration trials with <unk>.

Five value indication.

After the smooth things one prior that we either stop very soon we will consider a registration trial.

Also complementary to our sponsor portfolio, we have two additional investigator sponsored study.

That are performed by academic centers and are likely to create additional value and clinical evidence.

One is called <unk>.

We start getting diabetes patients with <unk> sales due to statute of coffee sourcing picture on the <unk>.

First patients is expected.

During the first half.

For this year.

And the second one is targeting.

Targeting patients with Pseudomonas Irish user.

Cultivation as we said.

Actions EAP.

Having a mortality rate of about 30%.

The clinical trial is under preparation for submission, which is fine for the second half of 2020.

On the slide number 11.

Through the preparation of the 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 E on Pgi.

Thanks to a very good week months, which is.

In combination with anti Biotics through their disparate direction, we are accelerating our clinical development in these PGA indication.

Speaker Change: So what is the rush in order to accelerate our plan.

First.

And thanks to the merger between.

Further to this <unk> to become fracture.

The higher clinical ambition targeting high value indications to registration.

We also have available compassionate.

That people data, which I presented just before about 100 patients.

Already demonstrating safety and very providing clinical benefit in the tough to treat population.

Thus any marked up with the solutions available.

In addition, we've had at the end of last year regulatory interactions with.

EBITDA for <unk> and with the European Agency EMA with a scientific advice.

Speaker Change: Which are helping us to refi.

Speaker Change: Our strategy for registration prior reducing our level of risk.

In addition, we have a pilot study Banco de <unk>.

For which the results will be available at the end of this year, which will bring to this global phase II study additional safety Ebitdas.

<unk> to ship both to your clinical data in terms of the tickets.

We will target also a larger population with this phase two competitive fiber, there, which is to restricted when compared to <unk>.

For all these objective reasons, we do consider that we have a leading competitive position in the <unk> indication.

And we are.

Templating to initiate these global pivotal clinical study in Pgi and insight with your apps.

On the slide 12.

This study, which is called Nokia will include clinical sites worldwide.

So in the European and U S, France, Germany, Spain, the Netherlands, Sweden, Italy, but also in the UK and in the United States.

Regulatory submissions with staff, we view with the United States in the summer of this year and it will be followed by submission in Europe in <unk>.

European countries and then in the UK.

Our objective is to get our first.

Regulatory approval before the end of this year for our first patient.

In the first quarter of next year.

On the slide number 13.

About the PK Endocarditis study.

This is a phase one study, which will include 12 subjects.

Speaker Change: Infective endocarditis due to secular could be stories with an indication for surgery. These patients will be worked with 35 franchise titles.

This study.

Will allude to assess the safety of intravenous administration.

And we'll provide PK data in the blood and also data on the concentration of the concentration of sages.

In sectors that.

And we don't know to move to other studies, requiring also IV administration and also on the guidance into a registration study.

This phase one study is already obtained regulatory approval at the end of last year.

First patient is expected imminently.

Speaker Change: I will now hand over to Eric <unk>, Chief Financial Officer.

Yes.

Thank you Albert and good morning, everyone.

Now a few words on the key financial results for the full year 2023 on slide number 14 of this presentation was talking with key highlights on the P&L.

And my first comment is that in the context of the <unk> merger.

<unk> consolidated financial statements.

<unk> X two decided financial results as from the date of the merger, which was June 'twenty three 'twenty two 'twenty three so consequently, <unk> P&L inflation for the full year 'twenty. Three includes 12 months of aerotech activities in only six months of the second half of 'twenty three.

So ex tourist activity.

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 25 million euro for the full year of 2023.

$8 8 million euro lower or minus 26%.

Speaker Change: Then in the previous year.

The decrease was driven by the reduction of R&D.

R&D expenses, mostly related to the closing of Princeton operations and determination of clinical development activities.

While new extra side its development activities were integrated in the P&L as of the second half of 2023 overall R&D expenses were reduced by $9 million, which is minus 45% year over year.

G&A expenses in the full year 2003 was stable year over year.

2 million euro or.

Plus 1%.

And that includes one off expenses related to the merger and post merger integration activities.

And finally net loss for the full year 2003 was $23 5 million euro compared with a net loss of <unk> 2 million Euro for the same period of 'twenty, two which benefited from $24 4 million net gain on the sale of the Princeton facility in Asia.

For last year so.

On April 32, so that was again.

An exceptional gain in 'twenty two.

So all in all a difficult comparison after 'twenty three versus 22, because booth here had a very exceptional one off.

And significant unusual transactions.

We're now moving to the next slide number 15 of the presentation and to the cash position.

As of December 31, 2023 text him with cash and cash equivalents totaling $10 5 million Euro, which was approximately $11 6 million.

And thats compared with $38 8 million as of December 31, 22.

That's a $28 3 million decrease in cash position during the 12 months of 'twenty three and that was the result of a $24 3 million net cash utilization in operating and investing activities and.

And $3 7 million used in financing activities, which were mostly related to the reimbursement of the PG COVID-19 loan.

And the variation of the U S dollar against the Euro led to a 31 3 million negative currency exchange impacts so that was margin.

Been gradually decreasing the cash burn of the company and this is still continuing in 2024, which for instance, the decision to notice from NASDAQ recently this was earlier this year.

Speaker Change: 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 in that.

At this stage are reviewing a number of options to further extend the cash runway and refinance the company and that includes for the launch of the phase II proof of concept study in Pgi that Pascal is just expense.

Finally, a quick summary of our key strategic priorities for the coming months and upcoming key milestones. This is slide number 16 of the presentation.

Again, the key program affection is with anti staph aureus FHA for Pgi as explained earlier the plan is to accelerate the transitioning of fiduciary 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 preparation of <unk>.

That study in view of regulatory approval from the European and U S agencies agencies in Q4. This year and then the actual launch in early 'twenty five.

At the same time as part of this transitioning process with <unk>.

Planned to provide data from the fact that their pilot study in pgi at the end of this year.

Closer in time.

We are launching now the phase one.

PK study in severe and oncologists 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.

Speaker Change: Full results in the first half of 'twenty five.

So to summarize quite a significant news flow for fact, Sam over the coming months. So please stay tuned.

Speaker Change: With that I would like to thank you all already for the kind of attention and I will now hand, the call over to our operator to open the Q&A session.

So over to you.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

One moment for your first question.

Speaker Change: As a reminder to ask a question you will need to press star 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 <unk> for closing remarks.

Yes, Thank you Abigail.

You can move on to slide 17 cases fall a few takeaways.

For the confusion first of all they.

There are promising signs of growing effectiveness for the phage therapy.

As we have seen this leading and vessels going to this field.

In this context, thanks, Jim has been developing our strategic ambition.

Yes.

<unk> is targeting high value indication.

In severe resistant infection, mainly around pgi and look anticipation being the cornerstones indication.

Finally number three facts Xiaomi is a French directly.

Here, Europe, and leader and gates are very strong.

Competitive positioning positive joint infection as already explained.

The different reason that.

Speaker Change: As defined these strategic choice.

And as explained by Rich you should keep in mind that for the upcoming 12 months, we cannot anticipate made sure clinical.

<unk> catalyst.

Speaker Change: Likely to trade value for fiction.

I'd like to thank you for your attention.

And we're going to see now.

Our call today.

Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Thank you bye bye.

Yes.

Okay.

Okay.

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