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Nanobiotix S.A. (NBTX)

Q3 2022 Earnings Call· Fri, Nov 11, 2022

$33.18

+0.21%

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Transcript

Kate Mcneil

Management

Thank you, operator. Good afternoon and good morning, and welcome to Nanobiotix Conference Call to discuss our Third Quarter 2022 Financial and Operational results. Joining me in the call today, are Laurent Levy, co-Founder and Chief Executive Officer, and Bart Van Rhijn, Chief Financial Officer. As a reminder, today's call is being webcast and will be available on our website for replay. I would like 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 collaborations, regulatory filings, data presentation, and future research and development efforts, among other things. These 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. This review the full description of risk factors that can be found in the documents we filed with the AMF in France and SEC in the United States, including our most recent URD and 20-F, each of which are available in the Investor Relations section of our website, along with a 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, Nanobiotix 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 around the Laurent. Laurent, please go ahead.

Laurent Levy

Management

Thank you, Kate. I would like to welcome everyone participating to this call. As Kate mentioned, we've been releasing yesterday our third quarter operational and financial update. I would like for this particular call to focus on our priority pathway, which is developing our product in head and neck cancer. As you know, we intend to build a franchise in head and neck cancer patients in order to bring this product into market with this indication and then expand it into other indications. Within the occasion during our last call to talk about the advancement of our global Phase 3, and today, we're going to spend a bit more time about the 1,100 trial, which is taking care of recurrent and metastatic head and neck patients and others, but this time in combination with immunotherapy. As you know, we have started beginning of this year, our global Phase 3 that is a randomized Phase 3 that will encompass 500 patients across the world. And the first patient that's been injected beginning of this year later, our Strategic partner, LianBio started to enroll patients in Asia, and we also have initiated clinical sites in the United States. What we see in this trial is a ramp-up, both in the site activation across the world, but also in the patient recruited. And at the next step, we expect to have a first patient enrolled in US beginning of the Q4. But today, I think we should take this opportunity to really focus on our priority pathway number two, which is taking care of patients having recurrent or metastatic head and neck cancer. Here, we're talking about the study 1,100 dose escalation, and we've been completing the enrollment for those escalation and determine the recommended Phase 2 dose. Later today, I will be…

Bart Van Rhijn

Management

Thank you, Laurent. We continue to prioritize and execute across our initiatives to improve our financial flexibility and extend our operating runway. As indicated, in our press release yesterday, cash and cash equivalents were €53.5 million for the first three months ended September 30th, 2022 compared to €83.9 million as of December 31, 2021. In October, we were pleased to execute a final agreement with the European Investment Bank to realign approximately €30.7 million in outstanding debt obligations with the company's expected development and commercialization time lines. The cash and cash equivalents as of September 30th, 2022, combined with the executed debt restructuring and existing equity line is expected to fund development programs into Q1 2024. And now I will turn the call back to Laurent, Laurent?

Laurent Levy

Management

Thank you, Bart. I have to conclude the first part by tell you what's in the front of us and give you some milestones that we expect to achieve in the coming months and years. Let's start with the head and neck locally advanced station. Our Phase 3 that has started. Now, we were expecting to get the futility analysis H2, 2023 and as planned the interim on PFS on H2 2024. Also, the completion of the 102 Study that was the Phase 1/2, will present the final data midyear next year. Now focusing on the IO pathway with the head and neck recurrent and metastatic cancer patients, we've been establishing the RP2D, as you've just seen and started to look at some data and have initiated the dose expansion part of this trial. We'll take the opportunity to future medical and scientific conference to give you update on this expansion part of the trial. Now as far as the registration path is concerned, we are going to submit Q1 of next year, the protocol to FDA to continue the discussion we have initiated with them in order to pave our registration path for this product in head and neck metastatic cancer patients. For other solid tumor indication, our partner, MD Anderson continue to make good progress. We expect to reach the RP2D in the pancreatic cancer Phase 1 that is currently ongoing and hopefully to move into the expansion part of this trial. For the Phase 1 in esophageal cancer, we should expect next year the first results coming out are scientific complaints. And a bit later, the first results of the Phase 1 in non-small cell lung cancer. So as you see, we have a rich news flow in the front of us, and we'll be happy to discuss that in future calls with you. On that, this concludes the first part of the call, and now we will open the floor for questions. Operator?

Operator

Operator

Thank you. [Operator Instructions] Now we're going to take our first question. And the first question comes from the line of Mike DiFiore from Evercore. Your line is open. Please ask your question.

Mike DiFiore

Analyst

Hi, guys. Thanks so much for taking my questions. This is Mike on with John. Congrats on the data. Just a simple question for me. Today's study 1100 data set was flagged as an important value driver for the company, especially with regards to extending cash runway beyond 1Q 2024. So my question is this. Just given today's study 1100 results, where the ORR seems to have decreased from 50% at ASTRO last year to 31% this year. Are you more or less confident in your ability to do that, meaning kind of have the study prove valuable in terms of potentially attracting additional capital, or -- and are there any additional levels to be able to pull to get you through NANORAY-312 in 2024? Thank you.

Laurent Levy

Management

Thank you, Mike. So good question. I think what we see in this Phase 1 is the first step of our development in immuno-oncology. The data we have established in the completion of the escalation, give us confidence that we can find a path forward. Now we need to dig much deeper to see how we're going to define pivotal trial, we intend to submit to FDA in Q1. But we think the signal we see for Phase 1 is very strong. So that's something we're going to work on in order to define the right population to be treated in the Phase 3. Now until we get the feedback from the FDA on the design of this Phase 3 would be hard to understand how much cash we will need to execute it, and what would be the endpoint and time line for that. So that's why we'll come back to the market in due time when we have more information about the next step forward. Now as far as the financing in general is concerned, maybe I will leave Bart to answer that question.

Bart Van Rhijn

Management

Thank you, Laurent. Happy to follow on. Hi, Mike, hi, John. We received a similar question via the website. So I will address these questions together. But maybe to provide a holistic perspective. We've been able to extend our runway by taking actions within our control, such as ensuring highly efficient operations in line with our company priorities as well as deferred maturity dates of our debt obligations with the EIB. And we continue to be opportunistic in BD efforts and financings when opportunities arise, and we look forward to the future with both conviction and confidence. Thank you.

Mike DiFiore

Analyst

Great. Very helpful. Thanks so much.

Operator

Operator

[Operator Instructions] And now we’re going to take our next question. And the next question comes from the line of Clément Bassat from BNP Paribas. Your line is open. Please ask you question. Clément Bassat: Good morning. Clément Bassat from Portzamparc. Thank you for taking my questions. This is about the next step in the IO programs. The first one will focus only on the head and neck cancer patient resistant to Anti-PD-1. So could you please provide some colors about the categorization of the core, mostly about the control arm since these patients are resistant on Anti-PD-1. Are you going to happy then to start treatment again with Anti-PD-1s, which do not work for them, just to be included in the control arm. So how will you deal it with the FDA?

Laurent Levy

Management

Thank you for the question. That's a very important question and an interesting one. You're 100% right, saying that if these patients are failing PD-1, that's hard to continue treatment on PD-1 for them because we don't expect for them to get any benefit out of it. So we need to think about, in general, control arm that would be a bit different that could be the choice of physician of any treatment that could help the patient. So that's part of sorry, just mic problem -- so that's part of the thinking we have in designing this Phase 3 and also the discussion we have had with FDA. Now to be more precise, there's many options for a control arm, and that's something which is under discussion, and we'll get the final feedback from FDA when we will submit that to them. Clément Bassat: All right. Okay. Thank you very much.

Operator

Operator

Thank you. [Operator Instructions] There are no further questions. And I would like to hand the call over to Kate Mcneil for closing remarks.

Kate Mcneil

Management

Thank you. I'm going to take the lead on that. And I would like to thanks everyone for participating to do that call. Again, very happy about this new data we have generated and presented at SITC. There are also many other data that will be presented from a clinical perspective. And on that note, I'm going to wish you all a very good day and hope to talk with you very soon. Thank you very much.