Q2 2023 Nanobiotix SA Earnings Call
Good day, and thank you for standing by.
I'll come to that in antibiotics business update in the first half of 2023 financial results Conference call.
This time, all participants are in listen only mode.
After the Speakers' presentation there'll be a Q&A session.
Please be advised that today's conference is being recorded.
This point I'd like to turn the call over to Craig <unk> Senior Vice President of Investor Relations of antibiotics.
Thank you operator, good afternoon, and good morning, and welcome to the antibiotics conference call to discuss our first half 2023 financial and operating results.
Joining me on the call today are there all of the co founder and Chief Executive Officer, and Bart Van Ryan Chief Financial Officer.
As a reminder, today's call is being webcast and will be available on our web site 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 occur.
Accordingly, you are cautioned not to place undue reliance on forward looking statements.
Please review the full description of risk factors that can be found in the documents, we filed with D. A N F in France, and FCC in the United States, including the RFS and 6K filed yesterday, both of which are available in the Investor Relations section of our website along with the press release issued yesterday hi.
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 nano Biotics undertakes no.
<unk> to update them to reflect subsequent events or <unk> future circumstances with that said I'd like to turn the call over to the wrong. Please go ahead.
Thank you Craig.
I would like to welcome everyone participating via conference call and webcast today as Greg mentioned, we issued a press release yesterday I think the company's first half 2023 operating activities and finance are with US for today's call I'll begin with an overview of our accomplishments and review upcoming milestones for each of our program.
Boston taught chief Financial Officer will follow up with financial updates.
I will then give closing remarks before opening the call for question.
First half of this year I've been truly since pharmacies phone antibiotics. Following the successful completion of a global license agreement with Janssen the appointment of Doctor Okay.
And any history Victor on gene oncology as Chief Medical Officer, and the ongoing advancement of trial designed to establish the clinical foundation of FNB checks all treat in multiple solid tumor indication.
I'm very proud of what the company has accomplished in the past months collectively these achievements continue to propel a late stage development of <unk> for what extent of patients reached and ultimately position us to realize that dynamic changing potential of N P. J stout free worldwide.
We're very excited about the recent double licensing co development and commercialization agreement with Janssen Pharmaceuticals, one of the Janssen pharmaceutical company of Johnson <unk> Johnson for <unk>, XR tree or a potential first in class graduated answer.
This partnership is designed to leverage the strength of both company and accelerate and brought in the treatment potential of M. D checks all three.
Part of the agreement the initial focus of clinical development will be on the head and neck and lung cancers with expansion potential. In addition, also lead you more indication.
We believe this partnership underscores the therapeutic and market volatility, though NBA salt tree and importantly, so does it have any data platform and our scientific approach.
What we find particularly attractive about this deal is that it offers both near term and long term value for shareholders, including access to up to 60 million anything near transport up to $17 million in English.
<unk> condition and success based payments of over $1 8 billion in development as we get out to reinstate a nice thing.
Additional success based milestone payment of up to $615 million available for indications that may be developed by incentives at the sole discretion and half to $2 20.
Small indication that maybe they've loved by nano biologics in 90 minutes with Jensen.
Beyond Mexico is also include shared about the th sales royalties on product manufacturing and supply.
Recently, we received shareholder approval for Johnson, <unk> Johnson innovation to become a strategic investor off nobody with any initial tranche equal to $5 million Bob will go through the detailed mine depth. Shortly but we are pleased this deal has helped strengthen our balance sheet and extend our cash in a way into the first quarter at all.
2024, including some.
Some key clinical candidates.
Yeah.
We believe we selected the best possible strategic partner <unk>.
Amir oncology leader with global reach and we'll then experiencing pharmaceutical and medical technology.
We will continue to focus on the developmental phase <unk> three continue our manufacturing expertise and serve as the innovation engine.
<unk> will contribute its substantial development regulatory and commercial capabilities we.
We believe Janssen and regulatory and commercialization experience combined with not a biotech capabilities and knowhow in nanophysics without us to achieve our shared objectives.
We are well underway getting the collaboration starches and we look forward to the potential to bringing life changing treatment for patients around the world.
As we work to build the next chapter of antibiotics and advance clinical development and commercialization of <unk> XR tree, we're pleased to welcome industry veteran.
They tell you to our executive leadership team at this pivotal time.
<unk> brings an exceptional biopharmaceutical industry track record with proven success in developed match registration and commercialization of oncology directed east.
<unk> innovative leadership will be invaluable as we focus on maximizing the disruptive potential of her about doing that and circle media patient cancer around the world.
We look forward to working together as we prepare for registration and fastener optimization of our pipeline.
Now, let's turn to our clinical program.
As a reminder, more than 60% of all solid tumor cancer patients will receive radiation therapy during that treatment.
This presents a lot of opportunity for ABB Gx offering which is a single treatment designed to earnings outcome alone or in combination with some golf gear and importantly easily integrate into existing medical practice.
With significant clinical evidence across multiple indications to date as shown in <unk> three to be well tolerated with consistent encouraging activity in the range of studies in people.
Our ongoing clinical program evaluating <unk> three for the treatment of Davinci malls continue to progress well, including all antibiotics pump cell programs in head and neck and Andi understand Bob No program exploring expansion of opportunities in pancreatic cancer esophageal cancer, non small cell lung and head and neck.
Cancer.
Importantly, we expect multiple potential value inflection point in the next 12 to 24 months.
Oh, let's say J, Baltimore and D checks hartree I've been seeing with our ongoing people. So none of our fleet build out one of them is phase III.
Yes.
This trial evaluate regulatory deactivate Cheetah E checks coffee wheat and results at <unk> compared to about jokes there might be a long wait and we love that you've seen that in patients with locally advanced head and neck cancer that are ineligible for cisplatin chemotherapy.
We remain on track to report the interim efficacy fall in a re tweets, where after a 67% of the plant and independent on the asphalt plant in 'twenty four.
<unk> analyses conducted following 25% offline events is expected in the first half of 'twenty four.
First thing you wanted to the phase one dose escalation and expansion trial in patients Jabil for cisplatin chemotherapy or anti around just that you've seen that we expect to present safety and efficacy data at a medical meeting in the coming weeks.
These data from stage, one or two in a similar indication as mineral rights. We 12 will help to inform our phase III ongoing trial.
Okay.
We are also pursuing a late stage potential fall registering deactivated plus immunotherapy combination approach, which is designed to initially prime the immune system and improve the efficacy of checkpoint inhibitors, we anticipate providing a phase one data updates between now and the first half of 2024.
For potential phase three Registrational program in patients with recurrent told me, that's not a head and neck cancer.
Are resistant to previous anti PD, one PDL one therapy, we are in consultation with our newly appointed CFO and with our partner on what next steps would be for this program.
Ongoing exploration of expansion of opportunity for M. E. T X L. Three as part of our strategy collaboration with the University of Texas MD Anderson Cancer Center continues to be promising and includes five ongoing trials in have been solid Shimon.
We believe this trial can help later clinical foundation and provide proof of concept. She bought for additional indication that how derisked with demonstrated clinical therapeutic potential for M. D checks all tree.
In July the first patient was injected in the U S. NDA elite study our phase one two study evaluating <unk> in combination with an anti PD one anti PD, one immune checkpoint inhibitor in patients with advanced solid tumors, we learned at all either in metastasis.
We will present preliminary phase one dose escalation safety data at a medical conference in the coming weeks in pancreatic cancer. In addition to the plant.
Data for pancreatic trial and you understand that I have made significant progress in its phase one trial of <unk> in a great. One in non small cell lung cancer and expect to do some minor recommended phase two dose for this product in the second half of this year as you recall and you understand he is also leading a phase one trial of <unk>.
Software in combination with chemotherapy for patients with esophageal cancer, where initial data are expected in 2024.
We believe this multiple value inflection point in the coming 12 to 24 months will further support the potential of mdx all create to deliver treatment benefit and then the GTT Austin Dallas care like radiation and immunotherapy in many sort of jamaal.
With that I would like now to turn the call although to Bob's to briefly discuss our financial results for the Italian bonds.
Thank you Laura good morning, and good afternoon, everyone.
So Raul mentioned, we're pleased with our agreements with Jenson provides snowmobile IDEXX with substantial near and long term value I will start with a brief overview of the key elements of the deal.
The company already received a $30 million of prompt cashed licensing fee and is eligible to receive 30 million in-kind regulatory and development support for study than a way through 12 provided that Jensen soldiers question and $30 million in equity in two tranches of $5 million and $25 million that are subject to.
Short of conditions, and then occasion with the $25 million the future qualified financing of at least $50 million in the aggregate. We are pleased to have already received the first equity tranche of 5 million following shareholder approval and issuance of approximately 960000 shares for subscription by Johnson <unk> Johnson innovation Rep.
Presenting the stake of $2 six 5% in the company.
As part of the long term value of the company's eligible for success based payments well hope to one 8 billion and tiered double digit royalties on net sales of <unk> XR suite.
Additional success based potential development and regulatory milestone payments of up to $650 million are also available in the aggregate for five new indications that may be developed by Janssen at its sole discretion fringe.
For indications develop I know nobody Alex lend with Johnson, the company's potential to receive up to $220 million neighborhood for indication.
Yeah.
Now we transition to the financials revenue in older income increase for the six months ended June 30th 2023 at $3 3 million euros compared to $1 3 million euros for the six months.
And its June 30th 2022.
The company has mainly benefited from the research tax credits granted by the French government to encourage companies to conduct technical and scientific research and from the supply and collaboration agreement signed with Lee and bio generating an additional $1 3 billion revenue for the six months ended June 30th 2023.
R&D expenses consist primarily of preclinical clinical and manufacturing expenses related to the development of MBT extra suite. These expenses for the first six months.
In 2023 were $17 8 million euros compared to $16 6 million euros for the six months ended June 30th 2022.
Purchases subcontracting and all of our expenses increased by $1 5 million year old four to six month periods ended June 32023, as compared to the same period in 2022.
This increase reflects the company's focus on sensing its clinical trial development priorities, specifically, the global phase III Registrational trial in a way.
So we 12.
SG&A expenses consist primarily of administrative employee related expenses legal and other professional fees patent filing the maintenance fees and insurance, yes, G&A expenses for the six months ended June 30th 2023 were $10 9 million compared to $9 6 million.
You will for the prior six month periods.
Fees and other expenses increased by $1 1 million euros for the six month period ended June 30th 2023, as compared to the same periods in 2022, and mainly relates to $1 4 million euros.
Page to a financial adviser network.
Most attributable to common shareholders for the six months ended June 30th 2023 was 28.
$8 1 million euro or Amy your cents per share. This compares to a net loss attributable to common shareholders of $26 4 million euros.
Or 76 cents per share for the same periods in 2022.
As of June 30th 2023 buildings had $21 6 million euro in cash and cash equivalents compared to $41 4 million euros as of December 31, 2022 for clarity. This cash balance does not take into account the $30 million.
First upfront cash licensing fee, nor the $5 million cash related to the first equity tranche did a company. Meanwhile is received.
Based on the current operating plan of financial projections, we anticipate that the cash and cash equivalents of 21 6 million euros as of June 30th 2000, Twenty's suite in conjunction with the $30 million upfront and 5 million initial equity tranche to result in a cash run way.
That extends into the first quarter of 2024 and does not take into account any potential future financing cash inflow, resulting from milestones or future collaborations.
Additionally, subsequent to the company's licensing agreement executed with Jensen. The company has entered into discussions with the European investment bank or EIB aiming to remove the cash governance from the debt financing agreements between the company and we're pleased to inform you that these discussions have culminated in an agreement in principle on key terms.
That would result in the removal of the cash covenants in its entirety in exchange for an acceleration of payment of a portion of the applicable milestone payments calculated using an escalating single digit percentage applied to Brexit funding amounts in the event of an equity funding events and the payments will scheduled pik interest.
Execution of the definitive amendments to the agreements between <unk> and <unk> subject to finalization of necessary documentation and as expected at the beginning of the fourth quarter of 2023, which has the potential to positively influence our cash runway.
And now I'll turn the call back to the wall morale.
But as you can see we have an exciting 12 to 24 months ahead of us with multiple value, creating catalysts across indication, our new chief Medical officer to help execute across our clinical program and a new partnership with Janssen that provide both near term and long term value and robust developmental and commercial.
Operator: Good day, and thank you for standing by.
Operator: Welcome to the Nanobiotix Business Update and first half 2023 Financial Results Conference call. At this time, all participants are in less than only mode.
[noise] capability.
Collectively these achievements are all designed to help support successfully execution of our mission to bring in BT Exxon treat as many patients as we can worldwide.
Operator: After the speaker's presentation, there will be Q&A session. Please be advised that today's conference is being recorded.
Craig West: At this point, I'd like to turn the call over to Craig West, Senior Vice President and Investor Relations of Nanobiotix. Thank you, operator. Good afternoon and good morning and welcome to the Nanobiotix Conference call to discuss our first half 2023 Financial and Operating Results. Joining me on 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.
In the coming weeks, we look forward to reporting.
I know phase one data in head and neck cancer and initial phase one dose escalation data in pancreatic cancer for inkjet cartridge.
During 2024, we also expect to report data from MTI sponsored trial in esophageal cancer and finally in second half of next year. We look forward to the interim results fall nano right tweaked, where the phase III trial in head and neck cancer.
With that I would ask the operator to begin our Q&A session operator.
Craig West: 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, dates of presentations, 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 companies actual results to differ materially from our current expectations. Accordingly, you are cautioned not to place undue reliance on forward-looking statements.
Thank you well now be conducting a question and answer session.
If you'd like to ask a question today. Please press star one from your telephone keypad a.
A confirmation tone will indicate your line is in the question queue.
You May press star two if you'd like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please on the call for questions once again that starwood. Thank you.
Yeah.
Thank you. Our first question comes from Lucy Codrington with Jefferies. Please proceed with your questions.
Hi, there. Thank you for taking my questions.
Craig West: Please 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 the RFS and 6K filed yesterday, both 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, antibiotics undertake no obligation to update them to reflect subsequent events or future circumstances.
So how does the pancreatic cancer data.
In the coming weeks.
Just wondering if you could kind of outline what we should be expecting from that is it just a safety.
Well at Wuxi.
Initial efficacy measures.
Then secondly.
In terms of the payments.
Oh I see.
We wanted to win.
When can we expect that to begin hum.
From J&J I appreciate it.
Discretion.
Okay.
And then.
Finally.
E I a combination phase III.
Laurent Levy: With that said, I'd like to turn the call over to the wrong. Please go ahead. Thank you, Craig. I would like to welcome everyone participating via conference call and webcast today. As Greg mentioned, we issued a press release yesterday, highlighting the company's first half to 2023, authorizing activities and financial results. For today's call, I will begin with another view of our accomplishments and review upcoming milestone for each of our programs. But our chief financial officer will follow up with financial updates.
Just whether you can give us any insights into J&J is commitment to that.
I noticed that they have authority.
Who regulate cheap message does that include the interactions.
The phase III.
Is there still something we can expect.
Catalyst.
<unk>.
Okay.
Thank you to see so.
So, let's let's talk about maybe that's the first question about pancreatic cancer.
Laurent Levy: I will then give closing remarks before opening the call for questions. The first half of this year has been truly transformative for antibiotics, following the successful completion of a global license agreement with Jensen, the appointment of Dr. Calita here, and an industry veteran in oncology as shift medical officer, and the ongoing advancement of Krayal designed to establish the clinical foundation of MBJ-XR-3 in multiple series to more indication. I'm very proud of what the company has accomplished in the past months.
So as you may remember episodes within the large alliance, we have with M. D. Anderson back with income pass a number of clinical trials and were at the mine sites ongoing one of this trial is a phase one that include escalation and expansion of our from pancreatic cancer patients.
So what do we should expect in the in the next few weeks is about the data coming from the escalation in depressed patients coming from the expansion and this will be about the safety and feasibility of course as you mentioned, but we also start looking at the first sign of efficacy.
Laurent Levy: Collectively, this achievement continues to propel let's stage the blockment of MBTR3 forward, expand our patient's reach and ultimately position us to realize the burning, changing potential of MBTR3 worldwide. We're very excited about the recent global licensing, co-development, and commercialization agreement with Jensen Samasotika, one of the Jensen Samasotika company of Johnson & Johnson for MBTR3 or potential first-in-class graduate answer. This partnership is designed to leverage the strength of both company and accelerate and broaden the treatment potential of MBTR3.
As a reminder, and in this first part of the clinical trial, we have been tricky in locally advanced pancreatic cancer patients. So the one that have a tumor that has multiple permeable and usually what you tried to do is to stay tuned as to getting damaged some injection chemo a photo with sometime by radiation plus chemo and unfortunately.
Laurent Levy: As part of the agreement, the initial focus of clinical development will be on the head and neck and lung cancers, with expansion potential in additional solitude more indication. We believe this partnership underscores the therapeutic and market opportunities of MBTR3 and importantly, further validate our platform and our scientific approach. What we find particularly attractive about this deal is that it offers both near-term and long-term value for shelter, including access to up to 60 million in the near-term support, up to 30 million in equity, subject certain conditions, and success-based payment of over 1.8 billion in development regulatory and set milestone.
Because of the type of the disease and those patients. They have a very short life expectancy and nuts are many of them will respond to treatment.
I think what it will be very important to look at here outside sentient suitability is also what what is the first thing we can see intermodal disease control rates each of them all survival, but what's what's called an emerging from this trial.
And of course as I mentioned the expansion of Baltic ongoing so we'll be happy to continue to communicate on this trial.
So I think that that's called out there.
That's question one.
Medicinal question, if I remember.
Well Lucy was about the contribution incline.
From J&J being down 312 trial, which is ongoing global phase III.
And locally advanced head and neck cancer patients at up to five to six <unk>.
So here by contract.
Laurent Levy: Additional success-based milestone payment of up to 650 million are available for indication that may be developed by Jensen and sole discretion and help to 220 millions for indication that may be developed by nano-biotics in alignment with Jensen. Beyond milestones, this also includes here-the-beldigit sales royalties and product manufacturing and supply. Recently, we received shoulder approval for Johnson & Johnson innovation to become a strategic investor of nano-biotics, with an initial tranche equal to $5 million.
Mentioned, there's a searching again in time for this specific program. So we've been initiating this contract in July it became effective in August and since then we've been working a lot with the 10 southern Jensen team to start putting everything into a into motion and that includes the tweets web and the potential health and wellbeing.
<unk> in helping us across do you find the countries. So we are finalizing the plan as we speak and so we have no specific to deliver to the market somehow but be reassured that we have predictive asking that that aspect of the program.
Laurent Levy: Bath will go through the details more indefinitely. But we are pleased this deal has helped strengthen our balance sheets and expand our cash on a way into the first quarter of 2024, including through some key clinical catalysts. We believe we selected the best possible strategic partner in Jensen. Premiere oncology leader with global rich and proven experience in pharmaceutical and medical technology. But at nano-biotics, we will continue to focus on the development of NBGXR3, continue on manufacturing expertise and serve as the innovation engine.
And I think the final question was about the Io program, where it is moving in a workshop, we expect some some a bit here.
Just probably a crowd around the table to remind that our products are not only could have local effects in combination with radiation therapy, but we have been showing what's so true multiple animal.
Animal model and also in the first half of their clinical trial would be showing that this product crime and immune response and the overall goal of combining recreation nano and Immunotherapies is to try to see if we can get much more patient we admit that studied stage disease to respond to checkpoint inhibitor.
Laurent Levy: Jensen will contribute its substantial development support, regulatory and commercial capability. We believe Jensen regulatory and commercialization experience combined with nano-biotics, capabilities and know-how in nano-physics without us to achieve or share objectives. We are well underway getting the collaboration started and we look forward to the potential to bring in the life-changing treatment of patients around the world.
No.
In a better way so what do we expect in this program first of all all extension phase.
Is progressing really well and we expect you to give substantial update within the next nine months and that will inform us more about the certainty of the magnitude of the effect we already observed in the escalation box. So we will be happy to provide that.
Laurent Levy: As we work to build the next chapter of nano-biotics and expand clinical development and commercialization of NBGXR3, we are pleased to welcome industry veteran Dr. Luica Italia to our executive leadership team at this people's whole time. Luiz brings an exceptional bio-pharmaceutical industry track record with proven success in development, registration, and commercialization of oncology directories. Its season's innovative leadership will be invaluable as we focus on maximizing the disruptive potential of our regime and therefore millions of patients, cancer around the world. We look forward to working together as we prepare for registration and further optimization of our pipeline.
As soon as possible to one of the medical conference season, and a half.
The phase III is concerned when we talk about a potential phase III in a refractory head and neck cancer patients and which is something we've been discussing with FDA of course and it since we've been signing a collaboration with J&J No. We're reviewing what's best for their product to move forward.
So as a standalone company, the head and neck refractory patient population or what and he is a good choice not actually have a much bigger partner there may be something much more powerful and interesting to do within the I O field. So it doesn't mean that we won't go for this population had a niche but at the moment, we are discussing with us Glenn.
Laurent Levy: Now let's turn to our clinical programs. As a reminder, more than 60% of all solitude-more-cancer patients will receive radiation to redidure in their treatment. This presents a lot of opportunities for MBTXR treatment, which is a single treatment designed to enhance outcome alone or in combination with the endowed care and importantly easily integrate into existing medical practice. The significant clinical evidence across multiple indications to date has shown MBTXR treatment to be well-tolerated with consistent and encouraging activity in the range of solitude-more.
And I will come back to you with some that's supposed to build on this.
Yes.
Thank you and I hope he does intend to place them.
Okay.
Our next question comes from the line of Sam Roundhouse with H C. Wainwright. Please proceed with your questions.
Thank you good morning, Ryan.
On the data.
Expecting some final data.
From city why not do it in the coming weeks you said.
Just trying to see what kind of how can.
Laurent Levy: Our ongoing clinical program, evaluating MBTXR treatment for the treatment of solitude-mores continue to progress well, including our Nanobiotix sponsor programs in head and neck and our engine-understand partner program, exploring expansion opportunities in pancreatic cancer, esophageal cancer, non-small cell lung, and head and neck cancer. Importantly, we expect multiple potential family inflection points in the next 12-24 months. Our last stage effort for MBTXR treatment is advancing, with our ongoing people's Nanobiotix 12 global randomized phase 3.
Can we get some of that.
To the K.
K 12.
Oh.
Yeah.
Okay.
Thanks Hakan.
And.
So yes, you mentioned and we did mentioned in the PR again in the coming few weeks or are we going to have an update on the one or two data, which will be about the final readout on this trial I think.
And this reduction is really important because that's the last one we have on the primary endpoint all all these trials that show that including Thomas on the potential success of the tree 12, our ongoing phase III trial.
Laurent Levy: This trial evaluates radiotherapy-activated MBTXR treatment with and results at CHIPSYMAP compared to radiotherapy alone with and results at CHIPSYMAP, in patients with locally-advented head and neck cancer that are in an individual force, it's like in chemotherapy. We remain on track to report the interim efficacy for Nanobiotix 12 after 67% of planned events in the second half of 2024. The futility analysis conducted following 25% of planned events is expected in the first half of 2024.
What we should look at it Cassidy here are of course, <unk> always almost haven't seen such a population, which is frail elderly and that can't receive many treatments, but on the top of that is the final readout of the secrecy that would include the rate of response to complete response duration of response, which is critical.
And and also the TSA Cynthia O S. When the data off My chart you May remember that we had been given to the market. Some inflammation ongoing basis with this trial, but the data were not that mature and now we have the full set of data with a long term sort of local patients. So we'll get that out there.
Laurent Levy: For study 102, the phase 1 dose is a calculation and expansion trial in patients in eligible for cis-platine chemotherapy or intolerance at CHIPSYMAP, which expect to present safety and efficacy data at a medical meeting in the coming weeks. This data from study 102 in a similar indication as Nanobiotix 12 will help to inform on our phase 3 ongoing trial. We are also pressuring the lead stage potential for radiotherapy-activated plus immunotherapy combination approach, which is designed to initially prime the immune system and improve the efficacy of checkpoint inhibitors.
Super.
So just to put that into perspective versus the ongoing a phase III trial, you may remember that in the phase one we haven't very frail population with very high co Morbidities and in this population we have injected the primary tomorrow and irregular agent the primary at your mall.
And they've been looking at the impact of these solid patient when I talk about the primary tomorrow, just that's the number off the station to also happen each node.
In Beijing, and photo sleeps, notably just I've given a radiation interrupted there was no no M. D checks all three so that's a difference which is fundamental could be very important with the ongoing phase III, where we inject not want me to primary metal so potentially some of the lymph node, but I'm sure it won't be.
Laurent Levy: We anticipate providing phase 1 data at the age between now and the first half of 2024. For potential phase 3, registrational programming patients with recurrent or metastatic head and neck cancer that are resistant to previous NTPD1, PDR1, therapy, we are in consultation with our newly appointed CMO and with our partner on what next step should be for this program. Ongoing Exploration of Expansion Opportunity for MBTXR3, as part of our strategic collaboration with the University of Texas MD Anderson Cancer Center, continues to be promising and includes five ongoing trials in advanced solitude mode.
So, but what it does tell us is.
When you look at the page I've found when do you want to have we may expect additional efficacy in the tree travels, but let's see and let's wait when do they talk coming in how does for review them on what it means for patients and what is the impact we could expect for the tree 12.
Thank you for that one one more okay.
Laurent Levy: We believe this trial can help lay the clinical foundation and provide performative support for additional indications that are de-risk with demonstrated clinical therapeutic potential for MBTXR3. In July, the first patient was injected in the US NDLA study, a first-one-two study evaluating radiotherapy activated in combination with an anti-PDL-1, anti-PDL-1 in a checkpoint inhibitor, in patient with absensitivity more with lung or liver metastasis. We will present preliminary phase-1, dose escalation 50 data at a medical conference in the coming weeks in pancreatic cancer.
On the non small cell lung cancer data that M D. Anderson.
Hmm mm.
It's going to release them.
Is yours.
And I'm going to wait for that data before they decide on their study in terms of design and whatnot.
These two independent events.
Okay. Thanks for the question and then I think that's an important precision so thanks for asking.
These are two independent pathways right.
At Amgen by saying, we are switching here, a very specific population and non small cell lung cancer, we're talking about patients that already receive radiation political treatment of the disease and had to look for relapse. So here, we try to inject the product plus relapse and tried to make her a rehab revaluation I was a smaller bolt on Friday.
Laurent Levy: In addition to the plan upcoming data of pancreatic trial, Angie Anderson has met significant progress in its phase-1 trial of MBTXR3 in operable, non-small cell line cancer and expected determine a recommended phase-2 dose for this product in the second half of this year. As you recall, Angie Anderson is also leading a phase-1 trial of MBTXR3 in combination with chemotherapy for patient with the zophageal cancer, where initial data are expected in 2024. We believe this multiple value inflection point in the coming 12th, 24 months will further support potential of MBTXR3 to deliver treatment benefits and enhance the utility of tendaofcare like radiation and immunotherapy in many soluchimo.
Sure you know pre regulated area. So the good thing is that we did not hear about these trials in bad times. So it means that so far the safety is good and that's a very good surrogate to see that we can inject in line even in very specific them help condition of the decree irradiated tissue. So that's the agenda and the best way and we expect to come through.
Dr. Peter <unk>, very soon and you'll be able to communicate that the first data after that as far as the J&J learn cancer program is concerned here, we will talk more about nice patient.
Bart Rhijn: With that, I would like not to turn the call over to BOT to briefly discuss of financial results for the period, but thank you, Laurent.
Pre treated with no pretreatment, sorry, and as we mentioned in our PR, we're looking at stage III lung cancer patients. So the chemo treatments and patients are different so.
Bart Rhijn: Good morning and good afternoon everyone. As Laurent mentions, we are pleased that our agreements with Jensen provides antibiotics with substantial near and long-term value. I will start with a brief overview of the key elements of the deal. The company already received the 30 million in front of cash licensing fee and is eligible to receive 30 million in-kind regulatory and development support for study, then away 312, provided that Jensen's sole discretion and 30 million in equity in two tranches of 5 million and 25 million that are subject to certain conditions and in the case of the 25 million, a future qualified financing of at least 50 million in the aggregate.
The maximum we could get inspired by the safety off like we see it and as you understand that the program itself will be starchy, then we'll be launching separately.
Thank you. Thank you along for taking all my questions.
Youre welcome.
Yeah.
Thank you that's what might be you May press star one to ask a question.
Our next question is from the line of climbing stairs with Stifel. Please proceed with your question.
Okay.
Yes, Hi, I had a question.
Can you hear me.
Yes.
Oh, Yeah alright.
Bart Rhijn: We are pleased to have already received the first equity tranche of 5 million following a share of approval and issuance of approximately 960,000 shares for subscription by Jensen and Johnson Innovation, representing a stake of 2.65% in the company. As part of the long-term value, the company is eligible for success-based payments of up to 1.8 billion and tier double digit royalties on net sales of MBTXR3. Additional success-based potential development of regulatory milestone payments of up to 615 million are also available in the aggregate for 5 new indications that may be developed by Jensen at its sole discretion. For indications developed by Nanobriolix, in alignment with Jensen, the company is potential to receive up to 220 million in aggregate for indication.
Another question regarding hence pie in soft tissue sarcoma was it just catch is changing because they plan to launch it.
Since the launch of <unk>.
The first trial that came out.
In head and neck and the second question was regarding Leon be Oh, and sorry commitment to five Registrational trials have they mentioned any terrorists young L. A head and neck program.
Okay.
Thanks Carol.
Let's start maybe with the soft tissue sarcoma.
As you May know around the table, we already have had a closer to a phase III randomized trial IDE trial and subsequent sarcoma patients that's led us to to get an approval out of the European market. So obviously that have been part of the extensive due diligence that J&J had been doing on the product and part of the discussion we have.
Bart Rhijn: Now with transition to the financials, revenue and over income increased for six months and it's June 30th, 2023 at 3.3 million euros, compared to 1.3 million euros for six months and it's June 30th, 2022. The company has mainly benefited from the research tax credit, granted by the French government to encourage companies to conduct technical and scientific research and from the supply and collaboration agreement signed with Leambio, generating an additional 1.3 million revenue for the six months and it's June 30th, 2023.
And as soon as we were going to start like operations and discussion around the commercial aspects of the product and how are we going to do it in which sort of stopping with countries. Like this will come back obviously are on.
On the table, that's on ours, and we have no specifics specific sorry.
To give an army decided this aspect.
Columbus, we'll keep you posted on what's going to happen I saw these products in that in this underserved population.
So the second question about the Unbilled AR, you're right to mention that in the contracts we've been signing with them. There is a commitment from them to be actually starts to Beijing to fight Registrational trial and in the context and they do participate to the ongoing phase III in head and neck cancer, where they have a commitment.
Bart Rhijn: R&D expenses consist primarily of preclinical and manufacturing expenses related to the development of MBTXR3. These expenses for the first six months in 2023 were 17.8 million euros compared to 16.6 million euros for the six months and it's June 30th, 2022. Participants, subcontracting and older expenses increased by 1.5 million euros for the six month period and it's June 30th, 2023 as compared to the same period in 2022. This increase reflects the company's focus on phasing its clinical trial development priorities, specifically the global phase 3, registration trial and array 312.
To recruit 20% of the patients out of the five I'm glad we have and the recruitment of Dallas is progressing well and I'll call. Other indication are especially because of the arrival of J&J in the game and now we have true tools. Our partner was not a bad thing to developing this product. So we have time to discussing beyond what is on the.
Table and see what would be the next steps, but we have ongoing discussions specifically with young by also to think about different options and different types of activity.
Activities, we could benefit from <unk>.
Bart Rhijn: SGA expenses consist primarily of administrative and pre-erelated expenses, legal and older professional fees, patent filing and maintenance fees and insurance. The SGA expenses for the six months ended in June 30th, 2023, were 10.9 million euros compared to 9.6 million euros for the prior six month period. Purchases, fees and older expenses increased by 1.1 million euros for the six month period and the June 30th, 2023 as compared to the same period in 2022 and mainly relates to 1.4 million euros paid to a financial advisor.
Specific population that exists in Asia, but I would not mention which cancer, but yeah I mean, that's.
It would be a specific problem in all of this.
Part of the globe.
We're trying to attack it.
Okay.
Alright.
Thank you very much.
Youre welcome.
Yes.
Thank you there are no further questions I'll now turn the call over to Dr. Levi for his closing remarks.
So Ryan Thanks, Thank you very much for participating how to actually see there are multiple than usual we are happy about that.
And we'll be very happy to communicate very soon with you about the next set of data that are coming so pancreatic cancer and head and neck saves one final data and I think we will.
Bart Rhijn: Net loss attributable to common shareholders for the six months ended June 30th, 2023, was 28.1 million euros or 80 euro cents per share. This compares to the net loss attributable to common shareholders of 26.4 million euros or 76 cents per share for the same period in 2022.
Take this occasion to looking about how is the future is coming and also what would be the potential outcome of the phase III based on the oldest so again happy to have you on board. Thank you for your help and let's talk soon.
Ladies and gentlemen that concludes today's presentation.
Can you once again for your participation you may now disconnect.
Bart Rhijn: As of June 30th, 2023, net bill decks had 21.6 million euros in cash and cash equivalents compared to 41.4 million euros as of December 31st, 2022. For clarity, this cash balance does not take into account the 30 million dollars upfront cash licensing fee nor the five million cash related to the first equity charge that a company meanwhile has received. Based on the current operating plan of financial projections, we anticipate that the cash and cash equivalents of 21.6 million euros as of June 30th, 2023 in conjunction with the 30 million upfront and five million initial equity charge to result in a cash-run way that extends into the first quarter of 2024 and does not take into account any potential future financing of cash inflow resulting from milestones or future Editionally, a subsequent to the company's licensing agreement executed with Jensen, the company has entered into discussions with the European Investment Bank, or EIB, aiming to remove the cash covenants from the debt financing agreements between the company and EIB.
Laurent Levy: And now, turn the call back to Laurent. Thank you, Bart.
Laurent Levy: As you can see, we have an exciting 12-24 months ahead of us with multiple value creating catalysts across indication. A new chief medical officer to help execute across a clinical program and a new partnership with Jensen that provides both near-term and long-term value and robust developmental and commercial capabilities. Collectively, the achievements are all designed to help support successfully execution of automation to bring NVGXR3 to as many patients as we can worldwide.
Laurent Levy: In the coming weeks, we look forward to reporting final phase 1 data in head and neck cancer and initial phase 1 dose escalation data in pancreatic cancer for NVGXR3. During 2024, we'll also expect to report data from NDS once or trial in as a federal cancer. And finally, in the second half of next year, we look forward to the interim result for our manual right tweet 12 phase pre-trial in head and neck cancer.
Operator: With that, we now have the operator to begin our Q&A session. Operator? Thank you. Well, now we can talk to the question and answer session. If you'd like to ask a question today, please press star 1 from your telephone keypad, and the confirmation tone indicate your lines in the question Q. You may press star 2 if you'd like to remove your question from the Q. From distance using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, we'll be poll for questions. Once again, that's star 1. Thank you. Thank you for that.
Lucy Coddington: Our first question comes from Lucy Coddington with Jeffries. Please receive your questions. Hi there. Thank you for taking my questions. So ahead of the pancreatic cancer data in the coming weeks, just wondering if you could kind of outline what we should be expecting from that. Is it just a safety update, or will it also include initial efficacy measures? Then secondly, in terms of the payment and kind support for 312, when can we expect that to begin?
Lucy Coddington: from J&J. I appreciate it. It is at their discretion, but any special guidance on that. And then finally, in terms of the I.O, combination, phase three and beyond, just whether you can give us any insight into J&J's commitment to that. I noticed that they have authority over all regulatory matters. Does that include the interactions regarding the phase three? And is there still something we can expect as a near-term catalyst? Thank you. Thank you, Lucy.
Laurent Levy: So let's tackle maybe the first question about pantherally cancer. So as you may remember, this is within the large alliance we have with Andy Anderson, that will encompass a number of clinical trials and where the moments five are ongoing. One of these trials is phase one that includes a collection and expansion of pantherally cancer patients. So what we should expect in the next few weeks is about the data coming from the collection and the first patients coming from the expansion.
Laurent Levy: And this will be about safety and feasibility, of course, as you mentioned, but we will also start looking at the first kind of efficacy. Just as a reminder, in this first part of the clinical trial, we have been treating locally at times pantherally cancer patients. So the one that has a tumor that is not operable, and usually what you try to do with this patient is to get them some induction chemo followed sometime by radiation plus chemo.
Laurent Levy: And unfortunately because of the type of disease, then those patients, they have a very short life expectancy and not many of them will respond to the treatment. So I think what will be very important to look at here outside safety and feasibility is also what is the first thing we can see in terms of this is control rate, in as I mentioned, the expansion part is ongoing, so we'll be happy to continue to communicate on this trial. So I think that's for the question one.
Laurent Levy: The second question, if I remember, well you see what's about the contribution in crime from J&J in the 312 trial, which is ongoing global phase 3 on locally advanced heavenly cancer patients that are too far through cystillation. So here by contract, as you've mentioned, there's a 13 million in crime for this specific program. So we've been initiating this contract in July, it became effective in August, and since then we've been working a lot with the turns on and turns on the team to start putting everything into motion, and that includes the 312 and the potential health that will bring in helping us across different countries.
Laurent Levy: So we are finalizing the plan, as we speak, so we have no specific to deliver to the market for now, but be sure that we are free to achieve in that aspect of the program, and I think the final question was about the IO program, where it is moving and where shall we expect some a bit here. Just for the crowd around the table to remind that our products not only could have a local effect in combination with radiation therapy, but we've been showing also through multiple animal model and also in the first part of the clinical trial, we've been showing that this product primary mirror response.
Laurent Levy: And the overall goal of combining radiation, nano and immunotherapies is to try to see if we can get much more patient. We've made a static stage to these to respond to technology to a better way. So what do we expect in this program? First of all, our extension phase is progressing really well. And we expect to give substantial updates within the next nine months. And I will inform us more about the certainties of the magnitude of the effect we already observed in the escalation box.
Laurent Levy: So we'll be happy to provide that as soon as possible through one of the medical conferences. And as far as the phase three is concerned, when we talk about our potential phase three in refractory head and neck patients, which is something we've been discussing with FDA, of course, since we've been signing this collaboration with J&J. Okay, now we're reviewing what's best for the product to move forward. So as a standalone company, the head and neck refractory patient population was and is a good choice.
Laurent Levy: Not that we have a much bigger partner, they may be something much more powerful and interesting to do within the IO field. So it doesn't mean that we won't go for this population in head and neck, but at the moment we're discussing with the plan and we will come back to it with some as possible on this. Thank you. I hope you don't have to answer your question.
Unknown Attendee: Our next question, from some light of the swine pool around with us with H.E. Wade, right? Please just use your questions.
Laurent Levy: Thank you. Good morning, Warren. On the data, we're expecting some final data from study one or two in the coming weeks, you said. Just trying to see what sort of a bridge can we get from that to the next three to all. Thank you. So as you mentioned, and we did mention in the PR again, in coming few weeks, where we're going to have an update on the one or two data, which will be about the final readout of this trial.
Laurent Levy: I think this readout is really important because that's the last one we have on the primary point of this trial that should include in promise on the potential success of the 312 ongoing phase 3 trial. I think what we should look at carefully here, of course, 60 is always a must have in such a population, which is frail elderly and that can't receive many treatment, but on the top of that is the final readout of the efficacy that will include the rate of response, the complete response, the duration of response, which is critical.
Laurent Levy: And also the PFS and the OS when the data are measured. You may remember that we have been given to the market some information ongoing basis with this trial, but the data were not that mature. And now we have the full set of data with a long term follow-up for patients, so we'll get that there is. So, just to put that into perspective versus the ongoing phase three trial, you may remember that in the phase one we have a very frail population with very high comorbidities and in this population we have injected the primary tumor and irradiated the primary tumor and have been looking at the impact of this for the patient.
Laurent Levy: When I talk about the primary tumor is that the number of the patient also have lymph node in the patient and for those lymph nodes we just have given irradiation to those no MDGX artery so that's a difference which is fundamental or could be very important with the ongoing phase three where we inject not only the primary but also potentially some of the lymph nodes that are surrounding. So, what you just tell us is when you look at the data from the 102 we may expect additional efficacy in the three 12 also but let's wait when the data coming and have a full review on what it means for patients and what is the impact we could expect for the three 12.
Laurent Levy: Thank you for that one more moment. On the non-small cell lung cancer data that Andy Anderson is going to release is your partner Jan and going to wait for that data before they decide on their study in terms of design and whatnot or these two independent events. Thanks for the question and I think that's an important precision so thanks for asking those are two independent pathways right. At MDM, the screen we are treating here a very specific population in the most time cancer we're talking about patients that already receive radiation for the local treatment of the disease and have a local relapse so here we try to inject the product plus relapse and try to make a relapse re-radiation with a small dose of radiation in a pre-radiated area.
Laurent Levy: So, the good thing is that we did not hear about this trial in back term so it means that so far the safety is good and that's a very good surrogate to see that we can inject in learning is on its very specific and out condition of the pre-iradiated tissue. So, that's Jan and Anderson pathway and we expect to conclude the RPGs very soon and to be able to communicate the first data after that.
Laurent Levy: As far as the Jan and Jay learn cancer program is concerned, here we will talk more about naive patients, pre-treatment. We know pre-treatment, sorry. And as we mentioned in our PR, we're looking at their three learning cancer patients, so the team of treatments and the patients are different. So, at maximum, we could get inspired by the safety of what we see at MD understand that the program itself will be started and will be launched separately. Thank you. Thank you, Lauren, for taking on the questions. You're welcome. Thank you. That's our mind when you read for a star one to ask a question.
Unknown Attendee: Our next question is in the line of Clement Theres with Cecil. Please use your question. Yes, hello. I had a question. Can you hear me? Yes, it is. Oh, yeah, all right.
Unknown Attendee: I had a question regarding Hentify in soft tissues or coma. Was it discussed with Genji to they plan to launch it after the launch of the first product in in head and neck?
Laurent Levy: And the second question was regarding Leanne Bio and their commitment to five registration trial? Have they mentioned any interest beyond the LA and neck program? Thank you. Thanks, Timon.
Laurent Levy: So, let's talk maybe with soft tissues or coma. As you may know, around the table, we already have had a positive phase three randomized trial and trials in soft tissues or coma patients that led us to get an approval on the European market. So obviously, there has been part of the extensive due diligence that Genji have been doing on the product. And part of the discussion we have and as soon as we don't start like operations and discussion around the commercial aspect of the product and how we're going to do it in which order starting with country, then this will come back obviously on the table.
Laurent Levy: For now, we have no specifics. Specific what's going to happen for this product in this underserved population. For the second question about the end value, you're right to mention that in the contract we've been signing with them, there is a commitment from them to be at least participating to five registered from all the trial in the context. And they do participate to the ongoing phase three in head and neck cancer, where they have the commitment to recruit 20% of the patient out of the 500 we have.
Laurent Levy: And the recruitment there is progressing well. Now for other indications, especially because the arrival of Genji in the game, and now we have two tools or partners with nanobiotics developing this product. So we are currently discussing beyond what is on the table and see what will be the next steps. But we have ongoing discussions, specifically with the end value also to think about different options and different two-activity activities we could benefit from in specific population that exist in Asia. I would not mention which cancer, but there are many that will be a specific problem of this part of the globe that we're trying to affect. All right. Thank you very much. You're welcome. Thank you.
Operator: There are no further questions.
Laurent Levy: I'll now turn that all of us after we leave the first closing remarks. So, Juan, thank you very much for participating to at least go. I see there are multiple and unusual. We are happy about that. We'll be very happy to communicate very soon with you about the next state of data that are coming. So pancreatic cancer and head and neck phase one final data. And I think we'll take this occasion to look about how the future is coming and also what will be the potential outcome of the phase three based on all this. So again, happy to have you all involved. Thank you for your help and let's talk soon.
Operator: Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation.
Operator: You may now...