Q4 2023 Nanobiotix SA Earnings Call
Operator: Good day and welcome to the Nanobiotics Business Update and Full Year 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. At this point, I will now turn the call over to Craig West, Senior Vice President of Investor Relations at Nanobiotics.
Good day and welcome to the mentor Beothuk business update and full year 2020 financial results Conference call.
At this time all participants are in a listen only mode. After the Speakers' Bakken position, there will be a question and answer session.
Be advised that today's conference is being recorded.
At this point I will now turn the call over to quake Black Senior Vice President of Investor any chance that none of the ethics. Please go ahead.
Craig West: Good afternoon, good morning, and welcome to the Nanobiotics Conference call to discuss our full year 2023 financial and operating results. Joining me on the call today are Laurent Levy, co-founder and chief executive officer, and Bart Van Rijn, chief financial officer.
Quake Black: Thank you.
Good afternoon, good morning, and welcome to the Nano Biotics conference call to discuss our full year 2023 financial and operating results.
Quake Black: Joining me on the call today are all of the co founder and Chief Executive Officer, and Bart Van <unk> Chief Financial Officer.
Craig West: 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 four 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 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.
Quake Black: As a reminder, today's call is being webcast and will be available on our website for replay.
Quake Black: 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.
Quake Black: 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.
Craig West: 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. Please review the full description of risk factors that can be found in the documents we filed with the AMF in France and the SEC in the United States, 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.
Quake Black: Accordingly, you are cautioned not to place undue reliance on forward looking statements.
Quake Black: Please review the full description of risk factors that can be found in the documents, we filed with the IMF in France, and the SEC in the United States, 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.
Craig West: 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, I'd like to turn the call over to Laurent. Please go ahead.
Quake Black: 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.
Quake Black: While we may elect to update these forward looking statements at some point in the future.
Antibiotics undertakes no obligation to update them to reflect subsequent events or future circumstances.
With that I'd like to turn the call over to morale. Please go ahead.
Laurent Levy: Thank you, Craig. And thank you, everyone, for joining us today. As Craig mentioned, we issued a press release yesterday highlighting the company's four years of work and activity and financial results for 2022. For today's call, I would like to begin with an overview of our accomplishments and upcoming milestones before turning the call over to Bart to address the financial results. Then I will provide closing remarks before opening up the call for questions.
Morale: Thank you Craig and thank you everyone for joining us today as Craig mentioned, we issued a press release yesterday, highlighting the company's full year as a broker activity and financial results for 2023.
Morale: Today's call I would like to begin was announced a few of our accomplishments and upcoming milestones before turning the call over to Bob to address the financial results. Then I will provide closing remarks before opening up the call for questions.
Laurent Levy: 2023 was an incredible year of progress for Nanobiotix and our program on MBTXR3. Last summer, we entered into a $2.5 billion license agreement with Johnson Pharmaceuticals, a Johnson & Johnson company, to expand the worldwide potential of MBTXR3, a potential first-in-class regimen answer with universal application across the.., led in 2023 our partner Yangbao assign its right to NBTXR3 in China and other Asian market to Janssen thus consolidating global development and commercialization rights with Janssen which is now responsible for the 205 million in milestone potentially available to us with this partnership, We also reported positive data from two key programs, including final and exploratory data from Study 102, our Phase I trial in head and neck cancer, as well as initial data from our Phase I-B study, supporting expansion potential in pancreatic cancer as part of an ongoing collaboration with MD Anderson. We will discuss these encouraging findings more in-depth shortly.
Morale: 2023 was an incredible year.
Bob: Very small amount of Iot and all programs NVCA phosphate last summer we enter into a $2 5 billion license agreement with Janssen from a circumstance of Johnson <unk> Johnson company to expand our worldwide potential authentic gtx fostered a potential first in class drugs or an answer with universal application across.
Sure.
Bob: Late in 2023, our partner <unk>, the <unk> pathway in China, and also the Asian market to Janssen, Thus consolidated global development and commercialization rights with Janssen, which is now responsible for the 225 million in milestone potentially available to US was this partnership.
We also reported positive data from two key programs, including final and exploratory data from study 102, our phase one trial in head and neck cancer as well as initial data from a phase one b study supporting expansion potential and thanks credits cancer as part of an ongoing collaboration with <unk>.
Bob: In Canada, we will discuss this oncology finding more in that strategy.
Laurent Levy: First, let me start with our Global Licensing for Development and Commercialization Agreement with Janssen for NBKXR. This partnership is designed to leverage the complementary strengths of both companies, accelerating and broadening the treatment potential of MDTX-PAR3. As part of the agreement, the initial clinical development focus will be on head and neck and lung cancer, with expansion potential in additional solid tumor indications. We believe this agreement underscores the therapeutic and market opportunity of MDTxR3 and, importantly, further validates our platform and scientific approach.
Bob: First let's start with our global licensing for development and commercialization agreement with Janssen for <unk> offering.
Bob: This partnership is designed to leverage the complementary strengths of both companies accelerating and broadening the treatment potential F&B jackpots free as part of the agreement. The initial clinical development focus will be on the head and neck and lung cancer with expansion potential.
Bob: All solid tumor indications, we believe the stock remains under score celebrity can market opportunity also indicate fluffy and importantly, further validate our platforming scientific approach.
Laurent Levy: We believe that this collaboration with our partners at the Interventional Oncology Group at J&J has the potential to impact the lives of many patients. We believe this because MBTXR3 can treat patients at the stage of where their disease is local and do so with radiation therapy, which is a treatment utilized by millions of patients. Better local control of disease at this stage, we believe, could have a fundamental impact on the overall outcome of patients. As a reminder of the produce new to the story, MBKXR3 is a biologically inert electron-dense nanoparticle.
Bob: We believe that this collaboration with our partner at the intentional oncology group at J&J has the potential to impact the lives of many patients.
Bob: We believe these because Andy takes off we can treat patients at the start of where this is local and do so with radiation therapy, which is a treatment utilized by millions of patients.
But inevitable control obviously at this stage, we believe could have a fundamental impact on overall complications.
Speaker Change: As a reminder.
For those new to the story <unk> is a biologically.
Speaker Change: Elektron dense nanoparticle.
Laurent Levy: It is a one-time treatment that is designed to be injected directly into a solid tumor prior to a course of radiation to amplify the anti-tumor activity of radiotherapy. NDKXR3 is made up of acinium oxide, a stable inert material with high electron density that acts as a strong energy absorber and increases the amount of energy transferred to the tumor, which in turn leads to cell damage and death This universal mode of action of NBTXR3 as a radio enhancer offers broad application potential across 60% of patients with solid tumors that receive radiation during the course of a trip.
Speaker Change: It is a onetime treatment that is designed to be injected generously into solid team all prior to of course of course.
Speaker Change: Nation to amplify the antitumor activity of <unk>.
Speaker Change: And it takes offering is made up of economic cycle, a stable Matteo with electron density that act as a strong <unk> silver and <unk> mono fanatic transfer to the T mall, which turns lead to self image on deaths.
Speaker Change: This should leave US homeowner fraction of time, DTA fluffy atherectomy and answer offer broad application potential across 60% of patients with solid Tumours accuracy project started during the course of treatment.
Laurent Levy: The potential of MDTxR3 is something that we have been actively evaluating in hundreds of patients across eight tumor types treated to date. We continue to see strong proof-of-concept data that support a well-tolerated, safety profile, and robust anti-tumor activity with radiotherapy-activated MDTxR3 treatment. Our prioritized focus has been the next-stage development of MDTXR3 in head and neck cancer, which includes an ongoing global registrational trial, the NAMURAD312 study, in elderly patients with locally advanced head and neck cancer, as well as a treatment approach using radiotherapy-activated MDTXR3 to help with local control of the injected tumor, as well as initially prime the immune system, followed by NTPD1 therapy.
Speaker Change: This book or potential F&B JAK pathway is something that we have been actively evaluating in hundreds of patients across eight tumor types treated to date, we continue to see strong proof of concept data that supports a well tolerated safety profile and robust constitute.
Speaker Change: Our activity with regular directly activated <unk> treatment.
Speaker Change: <unk> focus has been the late stage development of <unk> in head and neck cancer, which include an ongoing global Registrational trial than normal rightfully 12 study in elderly patients with locally advanced head and neck cancer as well as treatment approach using luggage.
Speaker Change: Thank you Enrique for free to help with local control of the injected tumor as well as initially primary immune system followed by anti PD. One therapies. We believe this combination has the potential to be a game changer for cancer immunotherapy and is supported by encouraging data from study 11 underwrite all phase one.
Laurent Levy: We believe this combination has the potential to be a game-changer for cancer immunotherapy, and it's supported by encouraging data from study 1100 of Phase I trials in patients with advanced cancer, including those that are NTPD1-nave, as well as those for whom NTPD1 therapy has failed. We also continue to generate additional early-stage data to support the clinical potential of MDTXR3 across different solid tumor indications as part of This report includes five ongoing clinical trials in adenosolic tumors with lung or ligand metastasis, recurrent or metastatic head and neck cancer, inoperable non-small cell lung cancer, esophageal cancer, and pancreatic cancer.
Speaker Change: Trial in patients with advanced cancer, including those that are anti PD, one naive as well as boost with anti PD one therapy <unk>.
Speaker Change: We also continue to generate additional early fixed date out to support the clinical potential of <unk> across different solid tumor indication and that's part of our collaboration with MD Anderson.
Speaker Change: This effort includes five ongoing clinical trial in advanced solid tumors with lung metastases.
Speaker Change: Catastrophe retro rank Amit.
Speaker Change: Head and neck cancer, <unk>, non small cell lung cancer esophageal cancer and pancreatic cancer.
Laurent Levy: As I mentioned earlier, the license agreement with Johnson & Johnson has a total potential value of $2.5 billion, and to this, we can now add the $205 million related to the right in Asia that's being funded by Liam Dyer for J&J.
As I mentioned earlier, the license agreement with Janssen engender unhappy total potential value of $2 5 billion and to this we cannot hide too Andrew.
Speaker Change: And Greg and $5 million related to the write in Asia, That's 1 billion barrels with J&J.
Laurent Levy: The deal values include accounts and income support, and a number of development and regulatory milestones for the first indication in head and neck cancer and lung cancer, along with 12 milestones that together potentially total up to $1.8 billion. There are additional regulatory and development milestones for new indications that Gensin may develop over time for up to $650 million in aggregate. For any new indication that Nanobiotix will develop and bring to market, there will be an additional $2.20 million per new indication. Of course, this deal also includes tiered royalties that go from low-ins to low-twenties.
Speaker Change: The deal value include Exxon and intangible and a number of development and regulatory milestones for the first indication in head and neck cancer and lung cancer, along with sales milestone that together potentially to sell up to $1 8 billion.
Speaker Change: There are additional regulatory and development milestones for you indication that Janssen may develop over time.
Speaker Change: Extra $615 million in aggregate.
Speaker Change: For any new indication that nano biotechs develop and bring to market that will be an additional 220 million current indications.
Speaker Change: Of course the deal also includes tier royalties that go from low teens to low twenties in June we have secured.
Laurent Levy: In June, we secured... 140 million gross in funding, which includes several deals related to payment and equity rates. This equity deal was supported by a major shareholder and also provided J&J the opportunity to become a Nanobiotix shareholder. As Bart will review in more depth shortly, we are pleased to have significantly strengthened our balance sheet, removed the PID cash government, and expanded our cash funding rate into the third quarter of 2025.
Speaker Change: $114 million growth in funding, which includes several deal related peanuts and equity raise this equity gain was supported by a major shareholder and also provides a J&J has the opportunity to become an antibiotic shelter.
Speaker Change: As Bob will review in more depth. Shortly we are pleased to have significantly strengthened our balance sheet remove the PIV to cash government and extended our cash rental rate into the third quarter of 2005.
Laurent Levy: Looking ahead, we are strongly positioned to further advance and maximize the therapeutic potential of MDTxR3 within the solid tumor treatment landscape. Turning to our clinical progress earlier this year, we reported positive final safety and efficacy data and the successful completion of Study 102, or the Phase I Dose Escalation and Extension Study in Head and Neck Cancer, at the annual AFSCRO meeting. The robust anti-tumor efficacy and well-tolerated profile in a vulnerable elderly population with a high comorbidity burden was encouraging and included a 64% complete response rate and 82% overall response rate.
Speaker Change: Looking ahead, we are strongly positioned to further advance and maximize the therapeutic potential of <unk> and Gtx all three within the solid tumor treatment landscape.
Speaker Change: Turning to our clinical progress earlier this year, we reported positive final safety and efficacy data and the successful completion of study why don't you all phase one dose escalation and expansion study in head and neck cancer.
Speaker Change: The annual Astro meeting thereof.
Speaker Change: Others, antitumor efficacy and <unk> profile in a vulnerable elderly population with Ikea morbidity burden west and collecting and included a <unk> 64 complete response rate and 82 overall response rate.
Laurent Levy: We also saw a median progression for survival of 16.9 months and a median overall survival of 23.1 months, which is nearly double the survival reported in historical data. This data informs on next steps and supports the hypothesis underlining the design of our registrational nanowire 312 safety study.
Speaker Change: We also saw an AT&T progression free survival of 16 for nine months and the median overall survival of 23, one months, which is nearly double those survival was bolted and historical data.
Speaker Change: These data inform on next steps and she bought the hypothesis underlying design.
Paul Registrational nano a tweet 12 phase III study.
Laurent Levy: Additional signs of efficacy in exploratory analyses presented at the 23th ECMO Congress provided further confidence in our ongoing Safe Streets study, including a 42.8-month median overall survival observed in the 82% evaluable population who had a response in the NBKXR3-injected lesion, compared to 18.1 months in the all treated population. Importantly, a positive correlation associated with objective response PFS and OS extension was observed in the This high rate of response in over 80% of treated patients linked to extended survival beyond 40 months is encouraging and supports the potential of MBTXR3 to change the treatment paradigm in this patient population.
Speaker Change: Additional signs of efficacy in exploratory analyses presented at the 23 ESMO Congress, providing further confidence.
Speaker Change: Ongoing phase III study, including a 42 eight months median overall survival observed in the 82% Evaluable population would had a response in the SDK software injected lesion compared to $18 one months in the <unk> population.
Speaker Change: Importantly, a positive correlation associated with objective response, PFS and OS expansion was observed in the regulatory the activated and kicks off here injected lesion. This high rate of response in over 80% of treated patients linked to the extended survival beyond 40 months is encouraging and support.
The potential of Mdx offered to change the treatment paradigm in this patient population.
Laurent Levy: Importantly, there are several key aspects of this Phase I data that give us confidence in the design and potential outcome of our registrational NanoRay 312 study. The first is the extended survival observed in this elderly and highly comorbid population.
Speaker Change: Importantly, there are several key aspect of these phase one data that give us confidence in the design and potential outcome of hours as threshold right 312 study. The first is the extended survival observed in this elderly and highly comorbid population.
Laurent Levy: We have also applied learning from our Phase 1 study, which has the potential to optimize treatment outcomes in the Phase 3 trial. This includes injection both of the primary lesion and the possibility to inject lymph nodes in the Phase 3 trial instead of just the primary lesion as was done in the Phase 1 study. Additionally, 312 will enroll a broader population and will be stratified on comorbidity.
Speaker Change: We have also applied learning from our phase one study, which has the potential to optimize treatment outcome in the phase III trial. This includes injection both of the primary lesion and the possibility to inject in each node in the phase II trial instead of just the primary lesion.
Speaker Change: What done in phase one study.
Speaker Change: Additionally, <unk> will enroll a broader population and will be stratified on comorbidities.
Laurent Levy: Collectively, we believe this modification has the potential for enhanced outcomes over our Phase 1 findings. But let's be clear, if we reach similar outcomes in our Phase 1 trials, then the 312 should be able to be successful. We expect to report initial safety interim efficacy and safety data after 67% of planned PFS events in mid-25, which, if positive, could enable eligibility for accelerated approval as has been discussed with the US FDA. In pancreatic cancer, we were pleased to report initial data from our Phase I-B study led by our collaborators, partners, and beyond the sun, supporting the potential of radiotherapy-activated MDTXR3 after cytotoxic chemotherapy in patients with locally advanced pancreatic cancer at the ASER Special Conference on Pancreatic Cancer and Asthma.
Speaker Change: Electively, we believe this modification.
Potential for earnings outcome of our phase one findings, but let's be clear if we reach similar outcome as a phase one trial that is at 212 two vehicles to be successful.
We expect to report initial phase III interim efficacy and safety data after a 67% of Glenn PFS data in mid 'twenty, five, which if positive could enable <unk> X Ray Ritchey approval path has been discussed with the FDA.
Speaker Change: In pancreatic cancer, we were pleased to report initial data from a phase one B study led by our collaborator partner MD Anderson supporting the potential of <unk> III after sector subsea chemotherapy in patients with locally advanced.
Speaker Change: Pancreatic cancer at the <unk> Special conference on pancreatic cancer and asthma.
Laurent Levy: This trial focuses on patients with large tumors that are unable to undergo surgery and rely on radiation combined with chemotherapy as a key treatment option to help control the tumor. This initial Phase 1b dose escalation data supports the feasibility and promising durable anti-tumor efficacy of radiotherapy-activated MBGXR3 in pancreatic cancer. The ASIMO data potentially help inform clinical trial development by establishing a recommended phase 2 dose and demonstrating a favorable safety profile and a preliminary median overall survival of 23 months, which is longer than the 19.2 months median survival achieved in patients who previously received a chemotherapy induction followed by radiation plus a second course of chemotherapy. In other words, to put this into perspective, the same center-controlled patient receives one additional course of chemotherapy versus the MBTXR-treated patient.
Speaker Change: This trial focuses on patients with large stream orthopods and able to undergo surgery and rely on location combined with chemotherapy as a key treatment option to have control of the tumor.
Speaker Change: This initial phase <unk> dose escalation data support that facility and promising durable antitumor efficacy of <unk> in pancreatic cancer.
Speaker Change: The ESMO data potentially helping from clinical trial development by establishing a recommended phase II dose and demonstrating a favorable safety profile and preliminary median overall survival of 23 months, which is longer than the $19. Two months median survival achieved.
Speaker Change: In patients who previously received a chemotherapy injection followed by radiation plus the second course of <unk>.
Speaker Change: Hemo therapy.
Speaker Change: In other words Defense Center control patient received one additional course of chemotherapy versus the <unk> treated patients.
Speaker Change: To put this into perspective when.
Speaker Change: When we look at the comparative data that had been previously obtained by Amgen desk, and we are seeing promising therapeutic potential versus the historical control. We plan to discuss this data with our partner Amgen discipline and Johnson <unk> Johnson to assess potential next steps for patients with pancreatic cancer.
Laurent Levy: When we look at the comparative data that have been previously obtained by MD-UNDERSTAND, we are seeing promising therapeutic potential versus this historical control. We plan to discuss this data with our partner MD-UNDERSTAND and Johnson & Johnson to assess potential next steps for patients with pancreatic cancer. In our effort to further advance the clinical development and commercialization of MDTX-R3, we were pleased to welcome industry veteran Dr. Lui-Kai Ayer to our Executive Leadership Team as Chief Medical Officer.
Speaker Change: Okay.
Speaker Change: In our effort to further advance clinical development and commercialization of <unk> XR tree, we were pleased to welcome industry veteran.
Speaker Change: Thank you to our executive leadership team as Chief Medical Officer.
Speaker Change: Okay, Okay that.
Speaker Change: Brings an exceptional biopharmaceutical industry track record with proven success in development registration and commercialization of oncology directed at each season innovative leadership has and will continue to be invaluable as we focus on maximizing the disruptive potential of arguing until for millions of patients with <unk>.
Laurent Levy: Dr. Khalid Tahir brings an exceptional biopharmaceutical industry track record with proven success in the development, registration, and commercialization of oncologic therapeutics. His seasoned, innovative leadership has and will continue to be invaluable as we focus on maximizing the disruptive potential of our radio enhancer for millions of patients with cancer around the world. In the near future, we expect immunotherapy combination data from our study, 1100 trials in head and neck cancer, where we have seen encouraging activity in both P1 treatment, naive, and refractorization. We also expect initial chemotherapy combination data in esophageal cancer from an Andy Anderson collaboration. With that, I would now like to turn the call over to Bart to briefly discuss our financial results for the period.
Speaker Change: Cancer around the world.
Speaker Change: In the year ahead, we expect immunotherapy combination data from austerity 11, the right trial in head and neck cancer, where we have seen encouraging activity in both treatment naive and a refractory patient.
Speaker Change: We also expect initial chemotherapy combination data in esophageal cancer from MD Anderson collaboration with that I would like now to turn the call over to Bob to briefly discuss our financial results for the period.
Bob: Thank you Laurie good morning, and good afternoon, everyone.
Bob: As Laura mentioned earlier <unk> has an extremely productive year and we believe that the companys position has been completely transformed into one where we have set the stage to allow us to deliver on the potential MPT XR suite, the pipeline and the products.
Bart Van Rhijn: Thank you, Laurent. Good morning and good afternoon, everyone.
Bob: More specifically, we began our collaboration with Johnson <unk> Johnson through which we are working to bring <unk> suite to the millions of patients that suffer from sold tumor malignancies that are amenable to treatment with radiotherapy.
Bart Van Rhijn: As Laurent mentioned earlier, Nanobiotix has had an extremely productive year, and we believe that the company's position has been completely transformed into one where we have set the stage to allow us to deliver on the potential of NPTX R3, the pipeline for the product. More specifically, we began our collaboration with Johnson & Johnson through which we are working to bring MBTXR3 to the millions of patients that suffer from brain tumor malignancies that are amenable to treatment with radiotherapy.
Bob: First two indications Starwood has four developments are planned to be head and neck cancers, and lung cancers, but it is far from our full potential we see possible with a therapy like <unk>.
Bob: And as you've just heard from Ron will discuss additional indications such as pancreatic cancer, Ken we believe benefit from adding our potentially first in class radio enhancer to the treatment arm than target.
Ken: To date the company has received $30 million as part of an upfront cash licensing fee of $5 million for the first equity tranche, which was received post signing $25 million as part of the second equity tranche.
Bart Van Rhijn: The first two indications targeted for development are planned to be head and neck cancers and lung cancers. But this is far from the full potential we see possible with a therapy like MBTXR3. And as you've just heard Laurent discuss, additional indications such as pancreatic cancer can, we believe, benefit from adding our potentially first-in-class radio enhancer to the treatment armamentarium.
Ken: And we are due to receive 20 million minimally 12 operational milestone.
Ken: And there's no more I mentioned the company completed an equity offering in which a total of $59 million less waste, which is inclusive of 40, if you mentioned <unk>.
Ken: Equity $425 million.
With these events we have also addressed in a significant manner the financial overhang that wasn't understandable concern of market participants as.
Ken: As of December 31, 2023, <unk> at $75 3 million in cash and cash equivalents compared to $41 4 million as of December 31, 2022, we are grateful for the continued support we receive from existing shareholders and are pleased to welcome new shareholders.
Bart Van Rhijn: To date, the company has received $30 million as part of an upfront cash licensing fee, 5 million for the first equity tranche, which was received post-signing, 25 million as part of the second equity tranche, and we are due to receive a $20 million Nanore 312 operational milestone. And, as Laurent mentioned, the company completed an equity offering in which a total of 59 million was raised, which is inclusive of the aforementioned second equity tranche of 25 million. And with these events, we have also addressed in a significant manner the financial overhang that was an understandable concern of market participants.
As previously disclosed the European investment Bank has agreed to the removal of the minimum cash and cash equivalents governance from the company's low effective October 13 2023.
Ken: As a result of the terms of this new agreements they will need to repay the pik prepayments.
Ken: Prepayments.
Ken: And the recent financing.
Ken: The company has faced the EIB approximately half a million euros, which is 1% of the net equity proceeds.
Ken: Further to the equity milestone acceleration mechanism the company agreed upon.
Bart Van Rhijn: As of December 31st, 2023, Nanobiotix had €75.3 million in cash and cash equivalents, compared to €41.4 million as of December 31st, 2022. We are grateful for the continued support we receive from existing shareholders and are pleased to welcome new shareholders in our midst. As previously disclosed, the European Investment Bank has agreed to the removal of the minimum cash and cash equivalent covenant from the company's EIB loan, effective October 13, 2023.
Ken: To turn to the specifics of our revenues and expenses our profile of $36 2 million Euro reflects an increase of $31 4 million euro versus the $4 8 million we recorded in 2022. This.
Ken: This was primarily driven by the revenue recognized following the signing of the Janssen agreement.
Ken: Our investments in <unk>, we increased our R&D expenses of approximately.
Ken: $5 8 million euros to a total of $38 4 million due to primarily.
Ken: These investments related to the pivotal phase III registration study the nunnery 12, and our immunotherapy combination study a lesser number.
Bart Van Rhijn: As a result of the terms of this new agreement, namely the repayment of the PIC prepayments and the Region Financing, the company has paid the EIB approximately half a million euros, which is 1% of the net equity proceeds. Further to the equity milestone acceleration mechanism, the company agreed. To turn to the specifics of our revenues and expenses, our top line of 36.2 million euros reflects an increase of 31.4 million euros versus the 4.8 million euros we recorded in 2020.
Ken: Our SG&A expenses increased by $4 2 million euros to 22 million euros for the year ended December 31 2023.
Ken: Year over year increase reflects growth in employee costs, and onetime business activities, including equity issuance cost license agree with execution and a termination of our services agreements.
Ken: Based on our current operating plan and financial projections, we anticipate that the cash and cash equivalents of $75 3 million Euro as of December 31, 2023 in combination with the $20 million milestone. We are due to receive results to the cash runway that extends into the third quarter of 2025.
Bart Van Rhijn: This was primarily driven by the revenue recognized following the signing of the agenda. Our investment in MBTX R3 increased our R&D expenses by approximately... 5.8 million euros to a total of 38.4 million due mainly to the investments related to the Pivotal Phase III Registration Study, the NaNoWave 312, and our Immunotherapy Combination Study 1100. Our SG&A expenses increased by €4.2 million to €22 million for the year ended December 31st, 2023. The year-over-year increase reflects growth in employee costs and one-time business activities, including equity issuance costs, license agreement execution, and the termination of a services agreement.
Ken: Now I will turn the call back to la.
Ken: <unk>.
La: Thank you Bob.
Speaker Change: As you have heard today, we made incredible progress this year advancing clinical development of <unk> software fostering strong strategic partnership to further maximize the potential of mdx lottery and extending our runway through key milestones.
Speaker Change: The totality of clinical data continue to support the potential of mdx offering to offer a meaningful therapeutic benefit to potentially millions of patients in oncology.
Speaker Change: We are pleased with the progress we have made in our initial focus in head and neck cancer as well as the expansion potential across all of our indications like pancreatic cancer.
Bart Van Rhijn: Based on the current operating plan and financial projections, we anticipated a cash-in-to-cash equivalence of €75.3 million as of December 31, 2023, in combination with the $20 million milestone we are due to receive, resulting in a cash runway that extends into the third quarter of 2025.
Speaker Change: Looking ahead, we expect multiple clinical readouts in 2004, including immunotherapy combination data from study 11, Android and new data from the collaboration with Amgen does side with the recent strengthening of our balance sheet. We believe we are strongly poised to execute across our near term milestone and work toward our mission of bringing.
Oh technology derived products like <unk> to more patients worldwide with that and I'll ask the operator to begin our Q&A session operator.
Laurent Levy: As you have heard today, we made incredible progress this year, advancing clinical development of NVTXR3, fostering strong strategic partnerships to further maximize the potential of NVTXR3 and expanding our runaway protein micellar platform. The totality of clinical data continues to support the potential of NVTXR3 to offer a meaningful therapeutic benefit to potentially millions of patients in oncology. We are pleased with the progress we have made in our initial focus on head and neck cancer, as well as the potential across other indications like pancreatic cancer.
Speaker Change: Thank you and ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the number one on your telephone keypad.
Speaker Change: You will hear from Morgan Your question Youre questions Yogi falls into <unk>.
Speaker Change: Should you wish to declines on the filing process. Please press the star followed by the number two if you're using a speaker phone. Please keep your handset before pressing any piece.
Speaker Change: Please for your first question.
Speaker Change: Your first question comes from the line of Jonathan Chang from Leerink Partners. Your line is open.
Laurent Levy: Looking ahead, we expect multiple clinical readouts in 2024, including immunotherapy combination data from study 1100 and new data from the collaboration with MD Anderson. With the recent strengthening of our balance sheet, we believe we are strongly poised to execute across our near-term milestone and work toward our mission of bringing nanotechnology-derived products, like MDTxR3, to more patients worldwide. Operator?
Speaker Change: This is Dylan on for Jonathan Thanks for taking my question first of all can you provide any context for what we should be expecting to see regarding patient numbers duration of follow up on potential readouts upcoming ASKO update for studying 1100.
Speaker Change: Yeah.
Speaker Change: Okay.
Hi, This is Craig the head of IR here at antibiotics, it's our understanding that some of our attendees have had trouble connecting to the webcast I just wanted to make sure that people know that we are aware of the problem. We will post the slides and the replay as soon as possible, we're very sorry for the inconvenience.
Speaker Change: And I'm, sorry could you repeat your question.
Speaker Change: Yes, no problem this until and Jason on for Jonathan.
Speaker Change: Wanted to ask if you could provide any context for what we should be expecting to see regarding patient numbers duration of follow up or potential readouts in the upcoming ESCO.
Operator: Thank you. And, ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your cell phone keypad. You will hear a three-tone prompt acknowledging your request, and your questions will be answered in the order they are received. Should you wish to decline the polling process, please press the star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any keys.
Speaker Change: Update on study at 100.
Speaker Change: Hi, Thanks.
Speaker Change: I had a question.
Speaker Change: Maybe for the audience that maybe recap what is the steady and what is the intention here. So that our steady 11 indirect which is a study that is made to define and observe safety and efficacy and defend population were treated with radiation therapy, NBC ex Gulfstream and checkpoint inhibitor.
Speaker Change: And in head and neck cancer, So maybe before to go into some of the detail on what we should expect to see <unk> as the title abstracts have been really.
Operator: One moment, please for your first question. Your first question comes from the line of Jonathan Chang from Learink Partners. Your line is open. This is Dylan Dr. Jonathan. Thanks for taking our question. First of all, can you provide a context for what we should be expecting to see regarding
Speaker Change: Lately.
Speaker Change: Here, we're talking about patients that had received a certain number of line of treatment pre medicated.
Speaker Change: We have had radio chemo or chemo or surgery, followed by radiotherapy and then after this first line of treatment experience arena.
Speaker Change: And when experience industry labs have been eligible to go call PD one treatment. So if you want a comparator of such a baseline in population and you should look at trials Checkmate 141 notable faulty.
Craig West: Hi, this is Craig, the head of IR here at Nanobiotix. It's our understanding that some of our attendees have had trouble connecting to the webcast. I just want to make sure that people know that we are aware of the problem. We will post the slides and the replay as soon as possible. We're very sorry for the inconvenience. And I'm sorry, could you repeat your question?
Speaker Change: So in all trials, we have in the current extension phase that is ongoing liquid foods, including plan called for that next patient the first call being patient, but are naive to PD, one and the silicon cost being patients that are refractory to PD one.
So the equipment have been going very well, we expect to have a good number of patients to show both.
Laurent Levy: Hi Jonathan, thanks for the question. So maybe for the audience, let's maybe recap what this study is about and what the intention here is. So that's our study 1100, which is a study that is made to define and observe safety and efficacy in different populations treated with radiation therapy and DTXR3 and checkpoint inhibitors in head and neck cancer. So maybe before we go into some of the detail on what we should expect to see at ASCO as the title abstracts have been released.
Speaker Change: So our refractory and naive to PD, one patient for <unk> and what we should expect in terms of data is of course safety.
Speaker Change: And.
Importantly, the efficacy and in terms of efficacy we should look at response rate.
Speaker Change: The receipt.
Speaker Change: So the old target lesion response, and overall survival and PFS.
Speaker Change: We think that's achieving.
Number of patient recruitment in this trial will start to really allow us to quantify the potential effect of NPG XR treat and dispose to amplify the response for naive patients and potentially to reverse the resistance in refractory patients to PD one.
Laurent Levy: Here, we're talking about patients that have received a certain number of lines of treatment premedicated, which have had radiotherapy, chemo, or chemo or surgery, followed by radiotherapy. And then, after this first line of treatment, they experience a relapse. And when experiencing this relapse, I've been eligible to go for PD-1 treatment. So if you want a comparator of such a baseline in the population, you should look at trials like Checkmate 141 or Keynote 040.
Speaker Change: Great.
Speaker Change: For your question.
Speaker Change: Yeah I appreciate that thank you.
Speaker Change: Youre welcome.
Speaker Change: Your next question comes from the line of Lucy Codrington from Jefferies. Your line is open.
Lucy Codrington: Hi, there thanks for taking my questions.
Lucy Codrington: Just a couple of one from me say in terms of B and lung cancer trials start and Johnson is planning and then just I guess more regular more generally about your relationship with the Addison how how regularly are you meeting to make these decisions.
Laurent Levy: So in our trial, we have split the teams into two different cohorts for adenomic patients, the first cohort being patients that are naive to PD-1, and the second cohort being patients that are refractory to PD-1. So the recruitment has been going very well. We expect to have a good number of patients to show both for refractory and naive to PD-1 patients for ASCO. And what we should expect in terms of data is, of course, safety.
So you asked about the lung cancer stop but also you mentioned about pancreatic cancer, we can wait you need.
Lucy Codrington: Our registrational strategy the IV combination.
Laurent Levy: And importantly, the efficacy. And in terms of efficacy, we should look at response rate, ASPR assist, also the all-target lesion response, and overall survival and TFS. So we think that choosing a good number of patients to recruit in this trial will start to really allow us to quantify the potential effect of MBTXR3. It is both to amplify the response from ACE patients and potentially to reverse the resistance in refra
Lucy Codrington: When will we get more detail on the next indications beyond head and neck.
Lucy Codrington: And then secondly, and it still relates to the Jensen.
Lucy Codrington: Relationships, what's the visibility on the in time funding for nano raised 312.
Lucy Codrington: And kind of the cadence of that and why.
Laurent Levy: Great, thanks so much for answering all your questions.
Is that included in your cash runway and if it isn't why isn't it.
Operator: Your next question comes from the line of Lucy Codrington from Jefferies. Your line is open.
Lucy Codrington: I was under the impression that would be it would be near term funding.
Operator: Hi there, thank you for taking my questions. So just a couple of ones from me.
Lucy Codrington: And then finally in terms of the mid 2025 readout.
Laurent Levy: So in terms of the lung cancer trial start that Janssen is planning, and then just, more generally, about your relationship with Janssen, how regularly are you meeting to make these decisions, both about the lung cancer start but also you mentioned about pancreatic cancer, with a registrational strategy for IO combination? When will we get more detail on these next indications beyond head and neck? And then secondly, still related to the Janssen relationship, what's the visibility on the in-kind funding for NanoRay 312 and the cadence of that, and why is that included in your cash runway? And if it isn't, why isn't it?
Lucy Codrington: Not every 312.
What's your comfort in that.
Lucy Codrington: Timeline I do appreciate you is.
Speaker Change: And then Jonathan but I guess.
Speaker Change: She'll come to with your current cash run way.
Speaker Change: Get you to that data.
Speaker Change: And I guess related to that.
Speaker Change: Date, please on the recruitment of 93, one thank you.
Yes.
Speaker Change: Thank you Latif and that's a bunch of question, maybe let's start with the.
Speaker Change: We go to them.
Speaker Change: Relationship with J&J and within the priority and how we've been shaping this collaboration since we signed that.
Laurent Levy: I was under the impression it would be near-term funding. And then finally, in terms of the mid-2025 readout for NanoRay 3.1.2, what's your confidence in that timeline? I do appreciate it is event-driven, but I guess what's your comfort with your current cash runway and will it get you to that data? And, related to that, an update please on the recruitment of Nano A312. Thank you.
Speaker Change: Number.
Latif: So altogether before to bring in some some some details about the question we've been asking we've been working a lot with J&J to shape. This collaboration first of all establishing the guidance then establishing joined team.
And working team that I can tell you mid almost on daily basis to get to work.
Latif: Also as CMO priorities that we're moving forward in the trees well.
Laurent Levy: Thank you, Luthi. That's a bunch of questions. Maybe let's start with the... We go to Durham, Maine; relationship with J&J and within the priority and how we've been shaping this collaboration since we signed last summer. So, all together, before I bring in some details about the question you've been asking, we've been working a lot with J&J in order to shape this collaboration. First of all, establishing governance, then establishing a joint team and working team, which, I can tell you, meets almost on a daily basis to work.
And the lung cancer program done by J&J, So things that are really two priority for abbvie.
Latif: The initial developments in this program.
Latif: Something that you don't see but we've been working a lot of full manufacturing and also exploring potential other.
Latif: Indication with our medical team internal nano and the J&J team. So that's a lot of underground work to shed this collaboration.
Latif: And there's a lot of discussion ongoing to refine the best way to go to market with our tree and I can assure you that in due time, we'll give you more information when things have been finalized and agreed with our partner.
Laurent Levy: We also have confirmed our priorities that we are moving forward with the 312 and the lung cancer program done by J&J. So, those are really the two priorities for the initial development of this program. Something that you don't see, but we've been working a lot in manufacturing and also exploring potential other indications with the medical team internal at Nano and the J&J team. So, there's a lot of underground work in order to shape this collaboration, and there's a lot of discussion ongoing to refine the pathway to go to market with Artery.
Latif: At the time, we can't say much more on this but being sure that we are working with the J&J team on daily basis to shape. These days.
Latif: <unk> maintained to try to bring in <unk> XR tree.
Latif: Fast as we can to the market.
Latif: Nowadays.
Latif: A question about when the lung cancer program I'll try out.
Latif: While we can talk about.
Latif: But the I'm sure that they have been working a lot on that and with help from time to time and as soon as we can tell you we would inform you about this.
Laurent Levy: And I can assure you that, in due time, we'll give you more information when things are finalized and agreed with our partner. But at the time, we can't say much more on this, but be sure that we're working with the J&J team on a daily basis to shape this development and to try to bring MBTX Artery as fast as we can to the market. Now, there was a question about when the lung cancer program or trial should start.
Latif: Specific and important program.
Latif: Now.
Latif: Above the in kind contribution.
Latif: That's been done.
Latif: It's something that was in the contracts as you may notice its not in the current linearly.
Latif: Destination, but that's something that is also ongoing discussion with J&J on how to help work you have and how can we shift that maybe.
Laurent Levy: Well, we can talk on behalf of our partner but be sure that they have been working a lot on that and with our help from time to time. And as soon as we can tell you, we will inform you about this very specific and important program. Now about the in-kind contribution that's in, that's something that was in the contract, as you may notice. It's not in the current runaway definition, but that's something that is also an ongoing discussion with P&J on how to help, where to help, and how we can shape that. Maybe I would like Bart to comment a little on that.
Latif: Maybe I will let Boston to come into any thought on that yes happy to thank you for the question the Lucy show.
For the audience. This is the current contribution that was agreed upon in the license agreement.
Boston: And that is.
Boston: And kind of supports that will directly be funded by J&J from their own P&L. So it will not flow through our P&L and therefore, it doesn't influence our cash runway. However, it helps too.
Boston: Accelerates the ongoing 312 study.
Bart Van Rhijn: Yeah, happy to. Thank you for the question, Lucy.
Boston: So now for the.
Boston: The interim analyses of between 12, so has the previous guidance, we'd given we continue to expect to have the right number of event.
Bart Van Rhijn: So, for the audience, this is the in-kind contribution that was agreed upon in the license agreement. And that is in-kind support that will directly be funded by J&J from their own P&L. So it will not flow through our P&L, and therefore it doesn't influence our cash runway. However, it helps to accelerate the ongoing free trial study.
Boston: By mid 'twenty five to be able to do this is laid out and as you may have noticed.
Boston: All financial statements that we have the.
Boston: Money up to into Q3, 2025, so maybe ill leave box too.
Laurent Levy: So now for the interim analysis of the 312, like the previous guidance we've given, we continue to expect to have the right number of agents by 2025 to be able to do this readout. And as you may have noticed in our financial statement, we have money up to or into Q3 2025. So maybe I will leave Bart to refine or give some context about the financing moving forward.
We fine I'll give some context about the financing moving forward.
Speaker Change: Happy to Oh, yes, the cash runway into Q3 of 25.
Further to the.
Speaker Change: Guidance that has been provided previously with regards to the interim.
Bart Van Rhijn: Yes, happy to, Laurent. Yes, the cash flow annuity into Q3 of 2025, further to the guidance that has been provided previously with regard to the interim, that continues to be our expectation. And as you may expect, in the license agreement that we concluded with J&J, there is a significant number of milestones, which are typically payable at key inflection points. And without being able to share anything more, one could expect that at significant moments in time, that would trigger payments in order to sustainably finance the company going forward. That's all that I can share at this point in time, but I hope that that provides clarity.
Speaker Change: <unk> continues to be our expectation and as you may expect in the license agreement that was concluded with J&J.
Speaker Change: There is a significant number of milestones milestones are typically payable at a key inflection points and without being able to share anything more but one could expect that at significant moments in time.
Speaker Change: That would trigger payments in order.
Speaker Change: To sustainably finance the company going forward.
Speaker Change: That's all that I can share at this point in time, but I hope that that provides clarity.
Speaker Change: So we see I hope this and so on your question would love to.
Speaker Change: Okay.
Speaker Change: It was very helpful.
Speaker Change: Yes. Please go ahead.
Speaker Change: Alright, very helpful. Just to clarify on that last mile, saying things or the other.
Laurent Levy: So you see, I hope this answers your question. We'd love to hear more.
Speaker Change: Other than the 20 million you've already included days.
Laurent Levy: Sorry, very helpful. Just to clarify on that last milestone thing, so other than the 20 million you've already included, those potential significant number of milestones, some of those could come before the mid-25 readout to extend that beyond, comfortably beyond the day. As you know, we're not at the...
Speaker Change: So a significant number of miles, saying some of those could come before the mid 25 readout T extend that they own.
Speaker Change: Comfortably be on data.
Speaker Change: As you know, we're not at Liberty to disclose the sequence of the Manageability.
Speaker Change: And so the question that all into it but.
Speaker Change: But I think from a.
Laurent Levy: As you know, we're not at liberty to disclose the sequence of the milestones, either the events or the quantum that are linked to them. But I think from a...
Speaker Change: A logical perspective, we should assume that some of those milestones may come win.
Speaker Change: Some of the de risking and all validating event with Altair and as we did mentioned in the past there is a good proportion of this nice pool in that case by the initial program that <unk> had to make in lending program.
Laurent Levy: From a logical perspective, we should assume that some of those milestones may come when some of the risking events or validating events occur. And as we have mentioned in the past, there is a good proportion of those milestones, at least for the initial program, that are linked to Head & Neck and Learning Program. Although not being able to tell you more, I think we could anticipate a number of Meistern overtime hours linked to this program.
Speaker Change:
Speaker Change: Not being able to tell you more and I think we could anticipate a number of my spend all that time link to this program.
Speaker Change: Okay. Thank you.
Speaker Change: Okay.
Speaker Change: And your next question comes from the line.
Speaker Change: I am Bakula Rama <unk> from H C. Wainwright your line is open.
Operator: And your next question comes from the line of Swayampakula Ramakanth from HC Wainwright. Your line is open.
Bakula Rama: Thank you.
Bakula Rama: Okay from hits Midnight.
Bakula Rama: Good morning, good afternoon.
Operator: Thank you. This is R.K. from Hits Company. Good afternoon, Laurent and Bart.
Bakula Rama: Lauren.
Bakula Rama: Sure.
Bakula Rama: A couple.
Laurent Levy: A couple of questions, but they're related within the NanoRAID 312 program. So, the first question is, since you will be taking a couple of looks into the data, one for futility analysis and another for the interim safety and efficacy look on the preplanned 67% of PFS units, would there, and because you also stated that depending on how strong the data is, you could file for an accelerated approval. My question basically is, would this impact the alpha in terms of statistical calculation when you're doing multiple looks before you see the interim data, especially for significance? to file for accelerator approval.
Lauren: Couple of questions, but they're related.
Lauren: They tend to nano Red 312 program so.
Speaker Change: First question is.
Speaker Change: Since you will be taking a couple of looks into the data one for futility analysis and the antidote for.
Speaker Change: In the interim.
Speaker Change: Do you have an efficacy look.
Speaker Change: I got on the plate.
Speaker Change: 6% to 7%.
Speaker Change: PFS events.
Speaker Change: And because you also stated that they do.
Speaker Change: Depending on how strong the data is you could file for an accelerated approval.
Speaker Change: My question basically is would this impact the <unk>.
Speaker Change: In terms of statistical calculation, when you're doing multiple looks before.
Speaker Change: You did before.
Speaker Change: Before you see the interim data, especially.
Speaker Change: For significance.
Speaker Change: To file for accelerated approval.
Laurent Levy: Thanks, Ake. Yes, if we look at the design of this trial, there are a number of events. First, the facility, then the interim readout, and the final readout of the data, with the primary endpoint being TSS and T-Secondary OS. And as mentioned, there is a certain number of events that will trigger those results. And after the design of the protocol, those multiple loops will have an influence on the alpha. And also, when we were designing this trial, we powered this trial to be good for OS, and therefore it has been overpowered for the PSS.
Speaker Change: Thanks RK.
Speaker Change: Yes, if you look at the design of this trial are guys on multiple.
Speaker Change: Number seven.
Speaker Change: CVT dengue interim laid out in the final.
Speaker Change: Readout of the data on the primary endpoint being PFS and secondary O S.
Speaker Change: As mentioned there was a second number of event that would trigger the second screen and at their design of the protocol Booth multiple Luke.
Speaker Change: <unk> had an influence on the ARPA and also when we have been designing this trial, we have been poor in this trial to be good for oil and therefore have been overpowered for the PSA, but all in all this obviously have been taken into account in the number of patients we need to recruit.
Laurent Levy: But all this obviously has been taken into account in the number of patients we need to recruit in order to get to the positive statistical benefits that we intend in this trial. Okay, if you want a bit more detail, discussion, I think we can go over the clinicaltrials.gov protocol and have a more precise discussion on this. We'll be happy to. Or we can have a call with our CMO for that regard.
Speaker Change: In order to get to the statistical benefit that we intent in this trial.
Speaker Change: If you want a bit more detailed discussion I think we can.
Speaker Change: All right.
Speaker Change: Clinical trials.
Speaker Change: Tropical and had a multiple point of discussion on this we'll be happy to we can have a call with our CMO for that $3.
Laurent Levy: Certainly, certainly, we can take that offline. I just wanted to, you know, at a high level, I just wanted to check on that. And then the second question is on... Obviously, beyond what we are talking today, you have multiple studies ongoing with MD Anderson, and I think I've asked this question multiple times, but so what is the appetite for Janssen in terms of picking up these other indications, whether it's esophagus, you know, the other solid tumors like pancreatic, what do you think is their appetite, you know, going beyond what they're doing now?
Speaker Change: Suddenly suddenly we can take that offline I just wanted to I know at a high level I just wanted to check on that.
Speaker Change: And then the second.
Speaker Change: Question is on.
Speaker Change: Obviously beyond what we are talking today, you'll have multiple studies ongoing.
Speaker Change: M D Anderson and I think I've asked this question multiple times, but [laughter].
Speaker Change: So what is the appetite for your arms.
Speaker Change: In terms of picking up.
Speaker Change: No indications.
Speaker Change: But it's it's a vegas.
Speaker Change: You know yeah, the other solid tumors.
Speaker Change: Pancreatic.
Speaker Change: What what do you think is there appetite going beyond what they're doing now.
Laurent Levy: Okay, so first maybe let's remind ourselves of the context of MDA collaboration and how it does it with the Gen-J licensing out. So in the Gen-J licensing out, that's a full licensing out worldwide now that they have taken back the rights from NBio for development and commercialization of MDTXR3. So we have a relationship between Nanobiotix and Gen-J on that matter.
Speaker Change: Okay.
Speaker Change: Okay. So maybe Netflix we mine the context of MVA collaboration and how he does it with the J&J.
Speaker Change: Licensing out in.
Speaker Change: In the J&J licensing out that's a food licensing as well.
Speaker Change: <unk> now that they have to come back the rights on me and ideal for development and commercialization of <unk> XR trade. So we have a relationship between antibiotics and J&J in that matter.
Laurent Levy: We still have a collaboration with MD Anderson, which is compatible with this alliance with Gen-J. And so it's two different collaborations, one with MD Anderson and one with Gen-J. Nevertheless, we're all developing the same product with the same intention to try to maximize the impact for the patient. Let me say that if I look at how this is split in terms of the period of activity, for sure, when you think about a big company like J&J, their intention is to run some pivotal and randomized trials in order to get to market and start and prepare commercialization and so on within standard of care or outside.
Speaker Change: We still have a collaboration with MD Anderson, which is compatible with these items.
Speaker Change: And so it's two different collaborations one one with MD Anderson in one language J&J. Nevertheless, we holding up being the same product was the same intention to try to maximize the impact for the patient.
Speaker Change: Let's say that if I look at harvest is completed in term of retail activity.
Speaker Change: For sure when you think about a big company like J&J joint in Chinese to run some pivotal and.
Speaker Change: Randomized trial in order to get to market and stuff and preparing commercialization and so on within standoff care I'll cite for AMD understand the spirit of the collaboration is more about how can we push the boundaries.
Laurent Levy: For MDUnderstand, the spirit of the collaboration is more about how we can push the boundaries of medicine using MDTXR3, not only in the existing standard of care with radiation as a role, but potentially beyond that. So, I see the MDA collaboration more as a pushing the boundaries of medicine collaboration and also trying to find some signals in terms of efficacy that could help us to design future development. So, there's no three-part relationship in these two collaborations, but there are medical and scientific exchanges in order to make sure that what we do one way or the other is compatible.
Speaker Change: Medicine, using MDT stock fee not only in the existing standard of care with regulation as a world, but potentially beyond that so ITD MDA collaboration more as a pushing the boundaries collaboration and also trying to find some signal in terms of the efficacy that could have.
Speaker Change: With us to design future development, So theres no treat party relationship in these two collaborations but there is medical and scientific exchanges in order to make sure that what we do one way or the other is compatible now and as I mentioned just previously in the call are part of the discussion.
Laurent Levy: Now, as I mentioned just previously in the call, part of the discussion with the interventional oncology group is about, okay, how and what could happen, where we could go after learning and head and neck. So, there's a lot of discussion around that, and definitely, what we do at MDUnderstand is part of the information we use to inform that discussion. Unfortunately, I can't tell you more right now, even though there is a lot of discussion around all those matters.
Speaker Change: The interventional oncology group is about okay hold on.
Speaker Change: Could happen the way that we could go after lung and head and neck. So there's a lot of discussion around that and definitely what we do at <unk> is part of the information we use to inform that discussion.
Speaker Change: Unfortunately, I can't can do more like now even if there is a lot of.
Speaker Change: Discussion along all of those matters.
Laurent Levy: Thank you. Thank you, Laurent, for taking my question. I'll talk to you soon.
Speaker Change: Thank you. Thank you Lorraine for taking my question and talk to you soon.
Speaker Change: Thank you okay.
Operator: Your next question comes from the line of Clemence Sears from Stiefel. Your line is open.
Speaker Change: Your next question comes from the line of Clemens fears from Stifel. Your line is open.
Operator: Hi. Thanks for taking my question. I'm stepping a bit away from the presentation, but I had a couple of questions regarding your Curadig and OQITI platform, which you kind of unveiled this year. Can you give us more details on your activities there, maybe at what stage of development you are? Is there any chance to see a candidate in the clinic this year? And regarding Curadig in particular, you had a collaboration with Sanofi back in 2021 for gene therapy. Could you maybe tell us if it's still ongoing where you are now? And finally, on this, are there any ongoing discussions with GNG about this platform? Thanks.
Clemens Fears: Hi, Thanks for taking my question.
Clemens Fears: I'm, just having a bit away from this presentation, but I had a couple of questions regarding your tragic and accretive platform, which kind of unveiled this year.
Clemens Fears: Can you give us more colors on your activities and maybe at what stage of benchmark is there any chance to chicken do batch and cleaning T shirts, and regarding China, particularly that you had a collaboration which kind of sheep vacuum 2021 fritchman, Turkey could.
Clemens Fears: Could you maybe tell us is.
Clemens Fears: It's John go hang where you are now and finally strong jeeps are there any discussions ongoing and we've changed a lot.
Clemens Fears: This platform.
Clemens Fears: Thanks.
Laurent Levy: Thank you, Kenos. So, as you mentioned, the two other ethnology platforms we have at Nanobiotix. Maybe before I dig in and just briefly explain what it is, I just want to remind you of the philosophy behind developing those three platforms. So for Nanobiotix, the motive, since we created this company, has been to try to find products or platforms that could help millions of patients, and also, on top of that, to have products or platforms that will be new, meaning we want to be the first ones to develop what we are developing at Nanobiotix.
Speaker Change: Thank you Tito.
Speaker Change: So as you mentioned the two other technology platform, we have us at Meadowbank ethics.
Speaker Change: Maybe any thoughts with digging into just briefly explain what it is just want to kind of gain which will be the bookings.
Speaker Change: Treat platform so far on antibiotics.
Tito: Most of them since we've created this company has been to try to find product platform product that could help millions of patients.
Tito: Also on the top of that to have product or platform back.
Tito: Will be new meaning we want to be the first one to develop what we have been looking at number of biotechs and the latest point is that we want that to be broadly protected by intellectual property. So far we've been able to do that and for the <unk> platform that potentially would generate multiple.
Laurent Levy: And the latest point is that we want that to be broadly protected by intellectual property. So far, we've been able to do that, and for the three different platforms that potentially will generate multiple first-in-class products, widely protected with IP. So we've been using this, and I've been able to develop this because we use nanophysics as a fundamental prerequisite to our different products. Why?
Tito: First in class product.
Tito: Widely protected with IV. So we've been using this and have been able to develop that because we use nano Phoenix as a.
Tito: Fundamental prerequisite toward defense product why because we think when you get busy again you have much less variability in June by biology, and therefore, you can start imagining product that could have been a lot of patients. So that's why we've been using metal physics, instead of biology of chemistry.
Laurent Levy: Because we think when you use physics, then you have much less viability induced by biology, and therefore you can start imagining products that could help a lot of patients. So that's why we've been using nanophysics instead of biology or chemistry so far. So now within this context, we've been developing the first platform, which is the radio announcer platform that you know, and two other platforms, one which is linked to CNS disorder, and that's the name we've mentioned at OQET, and this platform is about looking at the brain more as an electric circuit rather than looking at the brain as a biological organ.
Tito: So now we can just context within the European defense platform, which is a regimen into that form.
Tito: No.
Tito: And to our platform, one which is linked to <unk>.
Tito: CNS disorder, and that's the name was mentioned advocating and this platform is about looking at the brain more AD and military separate rather than looking at the brand as a biological all again and when you start looking at degenerative disease in the brain or in that there is a whole system you candidly, we can see that.
Laurent Levy: And when you start looking at degenerative disease in the brain or in the peripheral system, you can see that most of the deficiencies that come are expressed through a misconnection between neurons or conduction that is too fast or too slow or asynchronous. So we've been developing a number of nanoparticles that have the ability to change the way electricity is conducted, and this at the neuron level. So you can imagine that if we can have this particle in contact, like on the surface, inside or outside the neuron, we will really change the way electric conduction is done within a neuron or between neurons.
Tito: Most of the efficiencies that come oil price true amidst connection between your own all of that would come with conviction that is too fast or too slow or as important. So we've been developing a number of nanoparticles that have the ability to change the way electricity is conducted and is at the new AUM level. So you can.
Tito: Imagine that if we can add this particle and contact like on the surface inside of <unk>.
Tito: Outside the Euro we will.
Tito: Really change the way electric conviction is done within the new one or between Euro. So is this just the fundamental of this technology.
Laurent Levy: So this is just the fundamental of this technology platform that potentially will lead to multiple products, and that's the less advanced platform and also not the current focus for nanobios. So you did mention Curadigm, which is here again, a different approach where we've been looking at... Why can so many products not be delivered the right way? Or why are we limited in terms of efficacy or safety? And I can take, for example, the drug delivery systems that have been used to deliver doxorubicin, irinotecan, and some others, but also the RNA-based, LNP that faced a number of problems when delivering IV or oncolytic virus using some other technology or approach.
Tito: Platform that potentially would be to multiple products and that's the less advance platform and also met the QM focused for fund antibiotics. So you did mention <unk>, which is here again defense approach, where we've been looking at.
Tito: Why so many products cannot be the right way or how why are we limited in terms of the efficacy safety and I can take for example, like the drug delivery standard have been used to deliver books already be seen in our pecan on some others, but also the RNA beds.
Tito: LNP that faced a number of problems when deliver IV oncology virus on some other technology approaches.
Laurent Levy: What makes a link between all the technology I've been mentioning is when you inject that IV, the liver will act as a strength filter and will capture the vast majority of this product and will not allow those products to go outside the body. Therefore, you're limited by the way you can deliver it.
Tito: What makes a link between older technology I've been mentioning is when you inject that IV deliver would act as a strength feature and we will capture the vast majority of this product and will not allow juice product to go outside in the body. Therefore, youre limited by the way you can deliver and that's why.
Laurent Levy: And that's why people are delivering oncology viruses most of the time directly where they want them to be, just like the LNP with RNA product. So looking at this, we thought, can we rethink the way products are delivered and can we... change this? Can we do it differently?
Tito: People are out there you got anyone quality virus most of the time directly where they want it to be just like the LNP with RNA <unk> product. So looking at this with felt that and we think the way products are delivered and can we.
Tito: Change can we do it differently, that's what led us to develop what we call. The nano primer, which is a nanoparticle that you inject IV and the political will go in the liver as many of their quality of life, but it has been designed in a very specific way. So this vertical will be sort of digested.
Laurent Levy: That's what led us to develop what we call the nanoprimer, which is a nanoparticle that you inject IV, and this particle will go into the liver, like many other particles. But it has been designed in a very specific way, so this particle will be sort of digested by the liver for a certain amount of time. And while the liver is busy digesting this particle, when you inject other types of products, they will go more freely through the liver, and therefore, you change completely the bio-distribution of this product.
Tito: They deliver for a certain amount of time and while deliver is busy digesting the cycle when you inject or the type of product that will go more freely to de lever and therefore, we changed completely the bio distribution of.
Laurent Levy: And more than changing things, you can allow yourself to do things with this nanoprimer that you will not be allowed to do without. If I take RNA, the delivery particle as an example, it's very hard when you inject IV to go and target other things like brain or lung or other type of organ.
Tito: This product and more of them changing things.
Tito: You can do things with this metal primary, but you would not be able to do without if I take RNA.
Tito: Delivery particle as an example, very hard when you inject IV to go and target.
Tito: Although like brain or auto type of Oregon, and we've done a primer and we've been looking at different animal model, we are able to do that.
Laurent Levy: And with our nanoprimer, and we've been looking at different animal models, we are able to do that. So, there's a lot to do with this platform, as you can imagine, given the potential and the different approaches we could use, both in terms of product impact and also in terms of therapeutic area. But a big part of the ongoing programming is certainly about defining the business model, defining how we're going to move forward with different aspects of this product, and we expect to give an update on that before the end of this year.
Tito: There's a lot to do with this platform as you can imagine given the potential in the different approaches that could you. Both in term of product impact, but also in terms of therapeutic area that a big part of the ongoing programming entities about defining the business model.
Tito: And how are we going to move forward and defensive aspect of this product and we expect to give an update on that.
Tito: Before the end of this year.
Laurent Levy: So, we are talking about the stage of development, so it's in the clinical stage of development, but we already have established a good number of proof-of-concepts on different types of products. Now, it's all about how we're going to bring that to people, to patients, and how we're going to bring that to market, and Yvonne Beaudet. The potential of this platform on so many fronts, I think this will allow us to have different types of business models, ranging from licensing out to in-house development for different products.
Tito: So we ought to think about the stage of development. So preclinical stage development, but we already have established a good number of proof of concept on different type of product.
Tito: Thought about how are we going to bring that to people to patients and how are we going to bring that to market.
Tito: And even though.
Tito: Potential of this platform on so many phones I think this will allow us for different type of business model ranging from licensing out to in house development, well defined products, but as I said, we'll tell you more before the year end on this.
Laurent Levy: But, as I said, we'll tell you more before the year-end on this matter. Now, you mentioned a collaboration with Tanofi that we've been establishing to try to test this platform with different types of therapies they have internally. So, the collaboration went well; we've been establishing some good data. Now, the next step, or next potential step, will be to explore further, but this, obviously, within the bigger context of establishing the right business model for the company.
Tito: This matter now you mentioned a collaboration with Sanofi that we have been establishing to try to test this platform with different type of therapies they have integrity.
Tito: The collaboration length of well, we have been establishing some some good data now the next steps on the potential step will be to explore further.
Tito: This obviously within the bigger context.
Tito: Establishing the right business model for the for the company with this platform.
Speaker Change: Okay. Thank you very much and.
Laurent Levy: Thank you very much. Did you discuss it with G&G, or are they only focused on R3? No, for now, we haven't been discussing other technology platforms with G&G. We're really focusing on the development of MBTX R3, as is the vast majority of our team. Okay, make sure. Thank you very much.
Speaker Change: So did you discuss it with J&J on all that when we focused on inventory.
Speaker Change: No we don't.
Speaker Change: We haven't we haven't been discussing with J&J or above all of our technology platform and really focusing on the development of <unk> as is the vast majority of our team.
Speaker Change: Okay makes sense. Thank you very much.
Operator: Your next question comes from the line of Colin Bristow from UBS. Your line is open.
Speaker Change: Your next question comes from the line of Colin Bristow from UBS. Your line is open.
Operator: Hi, this is Elliott Bosco on behalf of Colin Bristow. A few questions from me.
Speaker Change: Hi, This is Ellie BASCO on for Colin Bristow a few questions for me you recently shared the recommended phase II dose and inoperable lung cancer I know that study was led by M. D. Anderson, but is there anything you can say on our next steps and then on the initial phase one beat.
Laurent Levy: You recently shared the recommended phase 2 dose in inoperable lung cancer. I know that study was led by MD Anderson, but is there anything you can say about next steps? And then on the initial phase 1b2 esophageal cancer readout that you're expecting? Are you able to share what might be expected in the readout and what you see as the threshold for success?
Speaker Change: To esophageal cancer readout that youre expecting or.
Speaker Change: Are you able to share what might be expected in the readout and what you see is the threshold for success. Thank you.
Laurent Levy: Thank you. Thank you. Thank you for the question.
Speaker Change: Thank you. Thank you for the question. So as you know we have a number of clinical trial ongoing I've done by them at MD Anderson.
Laurent Levy: Thank you. Thank you for the question.
Laurent Levy: So, as you know, we have a number of clinical trials ongoing done by and at MD Anderson. We've been, in the recent past, delivering two good news stories coming from this trial, the one on pancreatic cancer that we've been summarizing during the first part of the call with potential good data coming in. And this trial is now getting close to completion, and we may expect to get additional data on this pancreatic cancer trial.
Speaker Change: We've been in the recent past delivering two good news coming from this trial, but one of them things like cancer that we've been summarizing during the first part of the call with potential good data coming in and this trial is getting clear.
Speaker Change: Close to completion, and we May expect to get additional data on these pancreatic cancer trial.
Laurent Levy: Rightly, you've mentioned that we reached the RP2D in a lung cancer trial in one of the lung cancer trials at MDA. Just to reiterate the context of this lung cancer trial. As you know, radiation therapy is widely used in lung cancer for different stages of the disease. Here at MDA, it was a very particular trial where we wanted to help patients that already received radiation and relapse, did not respond well enough to radiation and had a local relapse within the field of previously radiated tissue.
Speaker Change: Right and you've mentioned that with which are the <unk> in lung cancer trial, and one of the lung cancer trial that NDA.
Speaker Change: Just to be precise the context of this.
Speaker Change: Cancer trial.
Speaker Change: As you know radiation therapy is widely used.
Speaker Change: In the lung cancer.
Speaker Change: Different specialty business here at <unk>. It was a very positive <unk> trial, where we wanted to help patients.
Speaker Change: <unk> already received liquidation.
Speaker Change: And relax did not respond well enough to radiation and had their local relapsed within the field of previously Red dead tissue.
Laurent Levy: The goal here being the following; you can't reapply a full dose of therapeutic radiation to a pre-radiated tissue without risking damaging the tissue of the patient. So the idea of this trial was, first, is it feasible to re-radiate the lung area safely? And two, does it provide a benefit if we put R3 on top of radiation with a lower dose of radiation than the total dose it would give for a therapeutic effect? So, we have established RP2D, have expanded it into the extension phase, and recruitment is moving well.
Speaker Change: The goal here being the following you can't reapply in a pre let Yankee tissue full those off directly to each location without risking damaging to match the tissue of the patient. So the idea of this trial with first is it feasible to rewrite the timberland area.
Speaker Change: And two does it provide benefit if we put all three on the top of radiation with a lower dose of radiation that the total daus, who wouldn't be followed directly effects.
Speaker Change: We have established the op each of them have expanded into the expansion phase and the recruitment is moving well and again here lacking bank credit.
Laurent Levy: And again, here, like in Pancreatic, we should be able, hopefully soon, to give an update on this trial, including more patients than what would be presented both in Pancreatic and Lung. But as you know, MDA is the sponsor of the trial, so at the end of the day, we're still depending on when and how they want to communicate the data, even though there is a joint steering committee and this collaboration works really well.
Speaker Change: We should be able fully are assumed to be an.
Speaker Change: An update on this trial, including more patients than what would be prevented.
Speaker Change: Both on pancreatic.
Speaker Change: As you know our NDA.
Speaker Change: MDA is the sponsor of the trial. So at the end of the day, we're still depending on when and how they want to communicate the data even though there is a jumpstart in committee and this collaboration in the west really well.
Laurent Levy: So, now for esophageal cancer, that's a different type of approach. We're talking about patients having esophageal cancer that cannot be removed surgically. And here, having good local control is also very important for the potential improvement in the survival of the patient, quality of life, and in some cases, if we can't get to surgery, that could remove the primary tumor. So, the trial is recruiting, and we're discussing potential reshaping of that with MD Anderson.
Speaker Change: So now for the Zohydro cancer that's different.
Speaker Change: <unk> approach.
Speaker Change: We're talking about patients, having esophageal cancer that cannot be removed surgically and having a good local control is also very important for the potential improvement of survival of the patients quality of life and in some case, if we can get to a surgery that could remove the primary chemo.
Speaker Change: So the training recruiting and we are discussing about potential reshaping of that we're gonna be understand and.
Laurent Levy: And we don't have the exact timing for now on when this should happen and when we should be able to give the data. But as I said, when I look at esophageal, pancreatic, and lung cancer, this is moving, and we should expect some updates in the coming...
Speaker Change: We don't have the exact timing for now on when.
Speaker Change: For background and when it should be able to to keep debate.
Speaker Change: But as I said, when I look at Brazil, faithful pancreatic lung cancer.
Speaker Change: And we should expect some update.
Speaker Change: Coming in the coming.
Laurent Levy: Thank you, and there are no further questions at this time. I would like to turn it back to Laurent Levy for closing remarks.
Speaker Change: Quarters.
Speaker Change: Thank you and there are no further questions at this time I would like to turn it back to Ron Levy for closing remarks.
Laurent Levy: Thank you. So, I would like to thank everyone for participating in this call and be sure that we will keep you updated as soon as we are moving forward with some of the developments we've been explaining today. And I would like to personally thank you for all the support you've been giving us during the past year and a half in helping us to help millions of patients with our different technology platforms. And I hope to talk to you soon, and I wish you a great day.
Laurent Levy: Thank you so I would like to thank everyone for participating to this call and being sure that we will keep you updated has seen have we are moving forward in some of the development, we have been explaining them today and I would like to personally. Thank you for all the support will be addressing.
Speaker Change: During the past year, and vacate and helping us to help millions of patients with all different technology platform.
Speaker Change: I hope to talk to you soon and I wish you a great day.
Operator: Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Speaker Change: Thank you presenters, ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.
Operator: Swayampakula Ramakanth, Craig West, Colin Bristow, Laurent Levy, Clément Bassat, Bart Rhijn, Yihan Li, Nanobiotix
Speaker Change: [music].