Q2 2022 Nanobiotix SA Earnings Call
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[music].
Okay.
Good day, and thank you for standing by.
First half 2022, corporate and financial update conference call.
This time all participants.
No.
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Nicole over to Kate.
Macneal Senior Vice President of Investor Relations.
Yeah.
Thank you operator, good afternoon, and good morning, and welcome to the antibiotics conference call to discuss our first half 2022 financial and operational results. Joining me on the call today, a lot maybe co founder and Chief Executive Officer and Barb.
I liked your financial officer.
As a reminder, today's call is being webcast and will be available on our web site for replay.
To remind you that this call will include forward looking statements, which may include statements regarding the progress success and timing of our ongoing and planned clinical trials cooperation regulatory filings data presentation.
Research and development efforts among other things.
Forward looking statements are based on current information assumptions and expectations that are subject to change they are subject to significant risks and uncertainties that could cause the company's actual results to differ materially from our current expectations.
Accordingly, you are cautioned not to place undue reliance on forward looking statements.
To review the full description of risk factors that can be found in the documents, we file with the IMF impressed and SSE in United States, including the RFS and 6K filed yesterday and our most recent E R&D and 20-F.
Each of which are available in the Investor Relations section of our website along with the press release issued yesterday, highlighting our corporate and financial results for the period.
In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date, while we may elect to update these forward looking statements at some point in the future and antibiotics undertakes no obligation to update them to reflect subsequent events or future circumstances.
With that said I'd like to turn the call over to Dr. Miller. Please go ahead.
Thank you Kate.
I would like to welcome everyone participating via conference call and webcast today.
Keith mentioned, we issued a press release yesterday, highlighting the company's operating activity and financial results for the first half 2022.
Before we open the call for Q&A I would like to take a moment bolster review our recent progress and outline how we plan to continue our Atkins.
The development of <unk> and drive shareholder value.
In the near term and long term.
Since inception, we have generated a substantial body of evidence pointing to the novel potential <unk> III to play a critical role in cancer care.
Leveraging evident both local and these tend to have more control we have focused our development effort on the main page.
Patients with locally advanced and treatment resistant recurrent metastatic head and neck cancer.
With this focus we believe we can build a comprehensive at nexon Charles that could offer a meaningful improvement to current standoff care. Both in terms of treatment effect and quality of life and serve as a <unk>.
Although two replicated across additional study to more indication in the future.
During the first half of 2022, we made significant progress towards these goals.
Year to date, most defining moment clinical program at <unk> initiation of patient enrollment in <unk>.
Since then with the support of our partner <unk>.
We have activated approximately.
Key sites across 13 countries include.
Including the initial site activation and first patient in Jan Bios territory, a few weeks ago.
Having also recently initiated clinical site activation in the U S. I'm pleased to report that underwrites each well is now actively recruiting patients in each of the three core territory that will drive the study Europe U S and Asia.
These achievements reflect the odd work of our entire <unk> team as well as our collaborators at <unk> and the impressive support of investigators and patients.
This hard work has including nimble response in a phase of multiple regional challenges as we discussed in March <unk> was initially intended to include certain sites in Russia and Ukraine.
In light of the ongoing war in that region. The team set about rapidly assessing alternative strategy for achieving our patient enrollment goal and have already identified replacement sites in that country.
Because of the Swift action, we do not currently anticipate an impact on the overall study timeline. So we did see some shift in early enrolment tariffs as a result.
Further while the world continue to make significant progress in battling the pandemic the effect of COVID-19 continue to reveal themselves in different way across different territories, including a recent surge in cases in China, continuing shortage of clinical research staffing at the center in the U S.
While this process is not a simple one under the best of the competencies I am very proud of how our team has proven itself capable of rising to the challenge is laid before Ben.
Purpose for the patients we hope to serve.
With each of our key territories no activity in the city, we look forward not only to continuing to add new sites, but to beginning to capture data that we can use to validate and refine or underlining assumption about recruitment enrollment unexpected even trade target patient population.
We anticipate that it will take approximately four to six months of global equipment to provide that are driven validation of our anticipated steady time rates, including our planned futility analyses anticipated in 'twenty, three and a planned interim efficacy.
That is anticipated in H 224.
As we still met our suite will kick off and ramp up during the first half of 2022, we were equally pleased to complete annual mentioned as Judy why don't you are dose escalation and expansion study similar head and neck cancer population.
This study has provided incredibly valuable information regarding the activity of <unk> III in head and neck cancer, and indeed was a key driver in our decision to pursue registration in head and neck cancer as our first global registration pathway, having reported median overall survival of $17 nine malls.
In the old treated population and 23 months median survival in the Evaluable patient population as of February of this year. We made the decision to modify the protocol for this study truly meet the required follow up to a minimum of 12 months.
Based on deck of enrollment decision impact the planned follow up for only four of the 74 patients enrolled in the study and no position us to report to mature and robust final data from study one or two in mid 'twenty three while reducing the overall expenses of this trial.
The first half of 2022 and also some significant progress in our immunotherapy program.
I am very pleased to now be able to say that what started as exploratory study evaluating <unk> in combination with anti PD, one immune checkpoint inhibitor.
Compelling evidence of activity and the identification of a set on planned registration program for patients with local regional recurrent a recurrent metastatic head and neck cancer that are resistant to PD one therapy.
As we reported two weeks ago following enrollment of 29 patients across three cohort of patients with advanced Mckesson I'll keep you can see we have completed the dose escalation phase of the study 11 and trade and as a reminder, our recommended phase II dose to be 33% of gross to more volume for all patient cohort.
If those will now be further evaluated in the dose expansion part study 11 grade as you will recall in the first half of 2022, we modified the true expansion cohorts in the study for a more robust data collection target population of patients with head and neck cancer resistant to prior immunotherapy.
As we advance the dose expansion part of study 11 in trade, we're looking forward to providing everyone with an updated look at data from the dose escalation phase at a medical Congress in the fourth quarter.
Based on previous data generated by <unk> 11, and trade, we initiated discussion with FDA earlier this year to better assess what the potential registration pathway for this patient population could look like.
This dialog Westbury pharmacy and has put us in a strong position to develop a potential phase III protocol that we intend to submit for agency review and come in by Q1 2023.
I would like now to turn the call over to Bob to briefly discuss our financial results for the patios box.
Thank you Laurel.
The focus execution of our clinical development programs. During the first half of 2022 were matched by a similar focus on strengthening our financial position and the successes equally apparent.
This time last year we.
We reported that our capital resources were expected to fund operations into Q1 of 2023.
Since that time, we've undertaken several initiatives intended to improve our financial flexibility.
And extend our operating runway.
First we implemented cost control initiatives intended to drive a double digit reduction in 2020 to SG&A expenses.
And in the second quarter of this year, we expanded on these initiatives by prioritizing R&D expense supporting our late stage development programs.
Adding back all the clinical preclinical and manufacturing expense, while reducing our infrastructure cost to achieve the target reduction in operating cost of approximately 12% to 50 million Euro.
2023.
<unk> included.
These efforts collectively added nearly two quarters to our anticipated operating runway.
Second we announced our intention to restructure our existing debt obligations and I'm pleased to report that earlier. This month, we reached an agreement in principle to restructure.
$37 million Euro and outstanding debt obligations related to the company's 2018 loan agreement with the European investment Bank.
As detailed in our prior press release and filings yesterday.
This restructuring aligns the repayment schedule with our anticipated commercial timelines and the first majority of our principal payments due in 2022 and 2023.
We anticipate that this agreement will be finalized in the next several weeks and resulted in an additional quarter of operating runway in 2023.
Finally during the second quarter of 2022, we secured access to flexible equity financing line through cutoff rate.
Significantly.
We are not committed to issue shares now or anytime in the future nor are we obligated to do so at any price.
Through this structure and <unk>.
Alex has the full authority to activate or suspend access to capital through this facility.
At its sole discretion.
However.
It would ensure that that'll build ex us guaranteed access to capital to extend this operating runway by approximately one quarter.
These initiatives combined with the $63 million and cash and cash equivalents reported as of June 32022 are expected to support our planned clinical development programs into the first quarter of 2024.
As Kate mentioned yesterday after the close of the U S markets than <unk> reported financial results for the six months ended June 32022.
As both our release and associated filings with the SEC and Ams detail the financial results for the periods.
I will refer you to these documents for a more complete breakdown of our financial results.
However, I will note that the operating cost for the period decreased from $31 1 million Euro for the six months of 2021 to $27 2 million Euro quarter first six months of 2022.
Operating cost shorter periods reflect an increase of approximately $1 1 million euro in R&D expense, primarily driven by cost associated with the initiation of our global Phase III study.
The decrease of approximately half a million euro and SG&A expense due to increased efficiencies.
And a decrease of nearly $4 5 million Euro and all of our operating income and expenses related to the pharma and John contract termination in 2021.
Net loss attributable to common shareholders for the first six months ended June 32022 was $26 4 million.
Or euro 76 per share compared to a net loss of $30 4 million euro for the comparable periods in 2021.
And now I will turn the call back to La <unk>.
<unk>.
Thank you Bob.
To close out this call I would like to reiterate are excited we are about our continued clinical and operational progress so far this year.
This disciplined execution of our priority pathways and counsel and management of our resources enable us to continue to invest in our pipeline drive value across our business and ultimately advance our goal of delivering significant innovation and improve outcomes for patients with head and neck cancer.
Looking ahead.
<unk> remains a key operational priority and we look forward to critical advancement in this study hold by the coming months.
Additionally, custody 11, Android continues to offer validation of our Io combination strategy, we look forward to each steps that move us closer to our second phase III Registrational program.
We built Appalachian compete we will know set up to have a dataset supporting our second targeted indication.
Dose expansion phase of <unk>, 11, and <unk> and leveraging our existing data to support development of the phase III protocol submission to FDA by two one off next year.
We look forward to keeping you updated on our programs with IDEXX. This conclude our prepared remarks, we will open the call to question operators.
We will now take the first question.
The next question comes from the line of Mike <unk> from Evercore. Please go ahead. Your line is now open.
Hi, guys. This is actually John Millar on.
With Mike.
I was going to ask about.
Your efforts to extend cash runway it seems like you've made a great deal of progress extending our cash runway potentially adding into 2024, but still not too to potential data readouts for <unk> hundred 12, So I guess.
In the interim when as were seeing more results from Citi 1100, what additional levers are you going to have to pull to further extend that cash runway and get coverage for the pivotal trial.
Okay.
Hi, John This is parks. Thank you for your question.
As you can tell were.
Sensitive to to finance and demands of the pipeline in a product that we have.
We have undertaken numerous internal and external initiatives that have.
<unk> begun to reflect in the H, one 2022 financials, we'll see more of that in the second half.
Of this year.
We're very diligent in every opportunity to drive additional efficiency.
And we're optimistic.
Then we will explore all options, including all the waste at biotechs would consider including BD.
More specifically.
We have a.
Confirms ahead of us with Starwood City, where we will do.
<unk> will be of interest.
In addition.
Whoa.
Look forward to bringing to the markets results on.
The pancreatic.
The study that is ongoing as well as <unk> early in 2023.
Great Hope for this that makes that makes great sense can we focus then on on what we could potentially see it did see that'll be the dose escalation.
I assume for most of the patients in that cohort can you confirm how many additional patients will have there versus prior.
Martin do you share that data.
Hey, John .
Mike.
Good morning, So that's strong speaking.
So for the <unk>.
On France, what we do expect to present is derisking cookie escalation part of this phase one.
We have completed.
Total debt being 28 patients to inject heat and light vehicles to safety.
And feasibility and then we'll be in 10 patients evaluable for efficacy that will be presented.
Also now we started the recruitment in the expansion phase, but it's too early to show to.
The expansion phase.
As we speak.
Awesome awesome that makes sense.
I guess one final one for me.
What is your pathway towards developing further indications I know you've already mentioned pancreatic and esophageal and obviously you have been ongoing.
That ratio with MD Anderson, but given your bandwidth limitations.
Wondering what the opportunity is to.
Start expansion cohorts are start additional.
Early cohorts.
In indications beyond head and neck.
Okay.
So good question.
Right now the company is really focused in this head and neck franchise both sweetie.
Phase III studies ongoing across the world and also.
Also when we are preparing in combination with Io and refractory patients.
Now as you may have noticed the collaboration with Amgen discerns, including already five ongoing trials.
And it's still remaining space and just collaboration to go further.
Not on equal saves wind, but solar so potential phase II randomized trial. So he had a reasonable opportunity at low costs to to move forward into this program.
But I think as we continue to grow and bring new data attuned to the market.
We may have new opportunity racing to develop further indication, but right now all the cash in the company is really focused in just head and neck franchise.
Great. Thanks, so much for the color.
Youre welcome.
Thank you.
Reminder, if you wish to ask a question. Please press star one one on your telephone.
We'll now take the next question.
And the next question comes from the line of cooling Bristow from UBS. Please go ahead. Your line is open.
Hi, This is <unk> on for Colin UBS.
Could you just.
Just wanted to confirm some timelines here so it sounds like it.
B T X.
Part of it might be on the market in 2025, following the completion or the interim analysis.
Manta Ray at 312.
Could you just.
Give me your thoughts on that and then also when might we expect a readout of the expansion phase of the study 1100. Thank you.
Thank you Paul for the question I think as far the.
Time to market as cone salaries, not something we did communicate that will evolve multiple step for that.
What we think is that if the interim readout on the primary endpoint PFS is positive and according to previous discussion we have had with the FDA. We may be eligible for an accelerated approval. So if we assume that edge to 'twenty four would be the readout for this interim.
And we need to have to usual time for getting the data submission and getting approval true true SDA.
No.
That's a possibility, but now let's let's move forward in the trial and get the results and see where they are <unk> to move forward into that the next steps.
So.
That's part a.
<unk> had a next phase III trial ongoing now about your question on the 11 on trade.
Did mention we started recruitment in the expansion phase that will include three cohorts.
Little different from the tree called home Deescalation says because here, we want to look at the patient based on their need for example, number one being head and neck patient refractory to PD, one that could have either <unk> or unmet or local relapse in the head and neck carried out in this call.
This is particularly important because it will pave the way.
Through our pathway to registration with the same.
Same population so no that would be an open label trial. So we will be able to give us along the way some update but we did not define yet when would be the first one but I think as soon as we get.
The number of patient in one of the calls all calls Daniel what are the key stats update.
Okay.
Thank you that's all for me.
Thank you.
We will not take the next question.
One moment please.
And the next question comes from the line of Susan Van.
For today comes from Duncan. Please go ahead your line is open.
Good afternoon guys.
Can you, perhaps elaborate a bit more of a benchmark we should keep in mind for the study 1100 data.
We will be hopeful.
I believe we saw somewhat higher response, we'll conclude now.
Cool.
Eliminate golar dark.
For a small number of patients on <unk>.
Wondering marissa.
That's a little different this constraint between personal have had prior <unk> or those who are taking longer.
And then I have a follow up after that that's fine.
Thank you Susan and thanks for the question. So here in the phase <unk> escalation part there is a mixed population of patients.
It's not.
Direct when.
When you want to make a comparison with what's happening in those patient Nevertheless.
I think looking at what has been a publishing G I O world and especially in the head and neck population could be a good basis to think about it and we could have two different paths for that the first one is for example, keynote <unk> eight which gives a reference in head and neck patients.
Early line getting had PD, one where we see.
Overall response at the end of tourists on there around 15% so that could be a good baseline to look at flow 90 stations, meaning that dazzle around 85% of those patients will not respond being either a primary or secondary refractory patients now looking at the literature. When you look past that.
<unk> PD one is population of an example, you'll see a fairly low response.
Patient regardless of the treatment they will get would it be chemo or other type of treatment, but I think we should assume something around 5% to 7%, maybe but depending on the series. So let's say this could be some of the baseline for for responder.
And from a more broader perspective, I think when you look at ne efficient vessels with factory you see patients that have <unk>.
Different baseline.
Not only being <unk>, but also in time for the disease progression and obviously, we could legitimately ink that we could have a greater effect on naive versus refractory, but for that we need to have to wait and see the data we have generated that as we speak we are extracting at the moment to be ready for <unk>.
<unk>.
Thank you.
We'll now take the next question.
Okay.
And the next question comes from the line of Arthur <unk> from.
<unk> from H C. W. Please go ahead your line is open.
The other one for Kate.
I had two questions one is.
Regarding the.
<unk> III immunotherapy combination.
Trial, so for for the plan to submit to the FDA regarding the registration pathway could you.
Give us more color on that parts and.
Assuming that the folks on the PD one resistant patient population.
So.
Where we are at the moment, having being completed escalation, but we have a recommended phase two dose. So we're able to complete and finalize our proposal to FTA.
For the protocol that we expect to submit for discussion.
Beginning of next year, let's say Q1, that's that's what.
What our plan is.
And.
I am sorry, I am not sure I got the second part of your question.
The second part is the patient population for the potential Registrational path.
<unk> is four.
For the PD, one resistant patient population or also including the PD one naive.
Okay.
So at this stage, what we want to achieve is to assure a big delta in patients that are refractory to PD one that could include both.
Primary or secondary resistance.
Two PD one and this was indeed had a naked metastases setting all local regional.
Resistant setting.
When you look at the cohorts number one overall 11 and drive trial expansion phase.
You should have estimate on population.
Got you thanks for that.
And my second or is there.
Just curious regarding the collaboration with MD Anderson.
For the pancreatic cancer patient.
For those data.
By the end of this year.
Which value, we could expect a phone and.
Yes, that's it.
So what do we expect to get by the end of the year.
E <unk> from the phase one part and assuming the data are positive to be able to move in the expansion part of this trial.
Maybe as a reminder.
Escalation part will add onshore unit vulnerable patients.
Thanks for any cancer patients.
And if we think there is enough signed this year and a good <unk> Dan were little moving towards borderline operable setting. So that's the information we should get by the end of this year.
And you understand based on that we'll decide when data to present those data in a medical Congress, but at this stage, we don't have yet to date for that.
Presentation.
Got you so as of now these try is fully it's about bi and BMS now alright correct.
Got you.
Thanks for taking my question.
Youre welcome.
Thank you.
We will now take a written question it will be Brent <unk>.
Please go ahead.
Yes, Hi, Bart and Lora.
I have a question that's come in from <unk> Prasad.
Question on park, Unfortunately, he's having a little bit of difficulty with her connections that I share with you.
Questions are on two fronts. The first relates to steady through 12, and he is asking about some information about the progression of <unk>.
Enrollment in through 12 as well as what is the biggest location expected in the study in the U S Europe or Asia.
Second question relates to the anticipated phase III and.
Immuno oncology asking if we could please provide more information about the endpoint for the planned study asking if we will watch the PFS likely deal and 312 quite a response rates also will be have a control arm or do we plan to have a control arm in that study as we deal with three trials.
Thank you Kate.
So maybe let's start with <unk>, which is our ongoing phase III protein. So I hope to give you.
Overall view on where we are in the progress. We've made as you know we started injecting patients had the beginning of this year in Europe and we've been pleased to also be able to create the first patients in Asia, a few weeks ago and now U S. How patchy abated sites that also that our crew.
Routine so we see a very good progress in the number of open sites, we mentioned <unk>.
In our press release and as we speak we even have more than 50 site now so we're happy about that no I think to them.
To get a good view on how fast we're going to recruit patients in this trial and to refine the readout timelines saw into rainy months utility.
We will need our guests around four to six months.
Full sites recruiting too to get a good view and especially of the <unk>.
Number of patients that could be recruited per months per site so were progressing.
We are happy about the progress handouts in months, we will be able to give us a bit more visibility patients and in time to two readouts refined based on the actual.
Actual life equipment. So that's that's for the <unk> part.
And on the <unk>, what we expect but of course this is subject to final approval by FDA. Nevertheless, based on the previous discussion we've had with them is that we may go for endpoints linked to overall response rate.
One of the key endpoint along with at the end of overall survival, which is one of the key I.
I think during.
Our last call. We also maintained that during the last interaction we've had with FDA on the matter.
They told us that we could have the possibility to design a trial, where a readout on overall response rate could be used for an accelerated approval. So that's along those lines that we are designing the trial and to your question about the control arm yes.
This trial will need a control arm.
Knowing that in the head and neck without fatigue refractory setting has an example.
It's hard to find another stendhal scan. So here, we're looking at what could be done at the control.
Especially because we have seen in many clinical trial.
Knowledge of that base moved there was another line. That's when you just shows that the Asian Malone.
With a checkpoint inhibitor anti PD one you didn't provide benefits for patients. So I think it will be more a longer more open.
A control arm, then just radiation plus PD one.
Thank you.
We'll now take the next question.
One moment please.
Just a follow up question from Suzanne from Johnson. Please go ahead. Your line is now open.
Alright, Thank you sorry, I got disconnected for a better levy that coupon and already then I apologize.
But I had a follow up regarding the study 11 hunger.
Upcoming data and that's the portion of patients. Thank you our research dicey to checkpoint therapy and I was wondering if there is data available what is seen with pure anti PD one treatment.
Now with patient doomed.
Thank you.
Yes.
Hip hop and thank you for the questions Suzanne.
A very a key question and it's hard to find a data at post failure patients.
Continuing treatment under a PD one.
<unk> alone and what we see in the West part of the answer I was mentioned he areas. When you have patients refractory and non refractory that you treat squeeze radiation plus PD. One you don't add on how's that does not bring a lot of value.
Altogether.
Patients that are refractory to PD, one could get chemo some of them will get continuation of PD, one and some of them. Some other experimental treatments, but there is no predefined.
Treatment for those patients. So these coming months with <unk> seeing data any any standoff care.
Got it thank you very much youre welcome.
Thank you.
There are no more questions at this time I would like to hand back over to Don Lindsay for final remarks.
Thank you.
Was there a good call happy to have answer to your question and interacted with you and we hope to see you soon.
During the different conferences are different causal investor conference that we're planning to attend.
I'm going to issue an excellent day in a very good week. Thank you very much.
That does conclude our conference for today. Thank you for participating you may all disconnect.
The conference will begin shortly to raise Johan during Q&A, you can dial star one one.
Okay.
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Yes.
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Sure.
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Yes.
Okay.