Q1 2022 Nanobiotix SA Earnings Call
[music].
Speaker 1: Good day and thank you for standing by. Welcome to the Nanobiotics First Quarter Operational and Financial...
Good day, and thank you for standing by while consider none of biotechs first quarter operational and financial updates at this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question join this session you would need to press.
Speaker 1: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session.
Speaker 1: to ask a question during the session, you will need to press star 1 on your telephone.
One on your telephone.
Speaker 1: Please be advised that today's conference is being recorded, Thursday, the 19th of May, 2022. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Kate McNeil. Please go ahead.
Be advised that today's conference is being recorded Thursday, the 19th of May 2022, if you require any further assistance. Please press star zero I would not like to hand, the conference over to your speaker today Kate Mcneil. Please go ahead.
Speaker 2: Thank you, operator. Good afternoon and good morning and welcome to the Nanobiotics Conference call to discuss our first quarter 2022 financial and operational results.
Thank you operator, good afternoon, and good morning, and welcome to the antibiotics conference call to discuss our first quarter 2022 financial and operational results.
Speaker 2: Joining me on the call today are Laurent Levy, co-founder and chief executive officer, and Bart Van Rijn, chief financial officer.
Joining me on the call today are Laurent Levy co founder and Chief Executive Officer, and Barb Bedrosian, Chief Financial Officer.
As a reminder, today's call is being webcast and will be available on our website will be but I'd 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 trial collaborations regulatory filing data presentation.
Speaker 2: As a reminder, today's call is being webcast and will be available on our website for replay. I'd 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.
And future research and development effort among other things.
Speaker 2: 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.
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.
Speaker 2: Accordingly, your caution 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 file with the AMF in France and SEC in the United States.
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 file with the IMS and crafts and SBC in United States.
Speaker 2: including our most recent URD and 20F, 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.
Including our most recent U R. D. In 20-F, both of which are available on the Investor Relations section of our website along with our press release issued yesterday, highlighting our corporate and financial results for the period.
In addition, any forward looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent date.
Speaker 2: In addition, any forward-looking statements represent our views on campus today and should not be relied upon as representing our views as of any subsequent date.
Speaker 2: While we may elect to update these forward-looking statements at some point in the future, nanobiotics undertake no obligation to update them to reflect subsequent events or future circumstances. With that said, I would like to turn the call over to Laurent. Please go ahead.
While we may elect to update these forward looking statements at some point in the future antibiotics undertakes no obligation to update update them to reflect subsequent events or future circumstances, but that said I'd like to turn the call over to Iraq, Iran. Please go ahead.
Thank you Kate.
Speaker 3: I would like to welcome everyone participating via conference call and webcast today. As Kate mentioned, we issued a press release yesterday, not only highlighting the company's first quarter operating activities, but also identifying some of the key changes taking place at NanoBios.
I would like to welcome everyone participating via conference call and webcast today as Keith mentioned, we issued a press release yesterday, not only highlighting the company's first quarter operating activities, but also identifying some of the key changes taking place Sacramento biotech.
Before we open the call for Q&A I would like to take a moment both to touch on our progress and outline how we plan to move forward to optimize our operational activities to advance the development of <unk> and drive shareholder value in the near and long term.
Speaker 3: Before we open the call for Q&A, I would like to take a moment both to touch on our progress and outline how we plan to move forward to optimize our operational activities to advance development of a BGA XR3 and drive shareholder value in the near and long term.
Our strategy has been focused on three key development priorities, one securing initial U S approval of NTT ex factory.
Speaker 3: Our strategy has been focused on three key development priorities. One, securing initial U.S. approval of NVTxR3 as a treatment for locally advanced head and neck cancer.
Treatment for locally advanced head and neck cancer to developing <unk> in combination with anti PD, one therapy as a treatment for advanced cancer and foundation for immunotherapy treatment.
Speaker 3: Two, developing NBTX heart rate in combination with NTP1 therapy as a treatment for advanced cancer and foundation for immunotherapy.
Speaker 3: And three, leveraging our strategic collaborations to advance and expand the potential profile of MBTXR3 in additional cancer indication, both as a single agent and combination therapy.
Three leveraging our strategy collaborations to advance and expand the potential profile of mdx artery in additional cancer indications, both as a single agent and combination therapy.
Speaker 3: Our fundamental strategy remains unchanged. And during the first quarter of 2022, we've made significant progress toward this goal.
Our fundamental strategy remains unchanged and during the first quarter of 2022, we've made significant progress toward this goal.
Speaker 3: The most significant milestone was, of course, the randomization of the first patient in our PyRTO phase 3 trial in head and neck cancer.
The most significant milestone was of course, the randomization of the first patient in our pivotal phase III trial in head and neck cancer. This achievement reflects the extraordinary commitment dedication and hard work of the entire <unk> team and the tremendous support of investigator in patients.
Speaker 3: This achievement reflects the extraordinary commitment, dedication and hard work of the entire nanobiotics team and the tremendous support of its members.
Speaker 3: While there is a considerable work ahead, we remain driven by our belief in the potential benefit of MBT XR3 and look forward to continuing our efforts to secure approval and fulfill a critical need for patients.
While there is considerable work ahead, we remain driven by our belief in the potential benefit of <unk> and look forward to continuing our efforts to secure approval and to fill a critical need for patients.
The second truly significant events made during the first quarter related to our immuno oncology combination program.
Speaker 3: The second truly significant advancement during the first quarter relates to our immuno-oncology combination program.
Speaker 3: This program has been exciting from the start. And the data from the ongoing study 1100, evaluating NBTXR3 in combination with NTPD1 therapy, has suggested NBTXR3 may be a potent immunostimulant capable not only of enhancing response to NTPD1 treatment for those that already benefit from treatment, but also overcoming primary and secondary resistance to NTPD1 treatment for many more that do not.
This program has been exciting.
From the staff and the data from the ongoing study 11 Andrade evaluating <unk> in combination with anti PD. One therapy had suggested <unk>, maybe but then even though stimulant capable not only of announcing response to anti PD one treatment for those that already benefit from treatment, but also.
Overcoming primary and secondary resistance to anti PD, one treatment for many more that do not.
The data generated by this program combined with the potentially transformative benefit for patient of increased our sense of urgency to identify an appropriate and expedient path to market in particular, we believe that given the historically low although our response rates to anti PD one.
Speaker 3: The data generated by this program, combined with the potentially transformative benefits for patients, has increased our sense of urgency to identify an appropriate and expedient path to market. In particular, we believe that given the historically low overall response rate to NTPD1 treatment and the significant number of patients that demonstrate either primary or secondary resistance to therapy.
Treatment and a significant number of patients that demonstrate either a primary or secondary resistance to therapy butchering, a registration program targeting patient with recurrent or metastatic head and neck cancer will have developed primary or secondary resistance to anti PD, one therapy addresses the area of highest unmet need.
Speaker 3: Posturing a registration program targeting patients with recurrent or metastatic head and neck cancer who have developed primary or secondary resistance to anti-PD-1 therapy addresses the area of IS and med-medical need.
Nickel need.
Speaker 3: And last year, we initiated a dialogue with FDA regarding a potential registration program in this indication.
And late last year, we initiated a dialogue with FDA regarding a potential registration program in this indication.
Speaker 3: While we have not yet submitted a full protocol for FDA review, we have received preliminary written comments from the agency suggesting that a single controlled trial, including a pre-specified comparative analysis on overall response rate, may be suitable to support accelerated approval. With verification of clinical benefits based on overall survival results from the same trial.
While we have not yet submitted a full protocol for FDA review, we have received preliminary written comments from the agency, suggesting that a single control trial, including a pre specified comparative analyses on overall response rate may distributable to support accelerated approval with the resignation of clinical.
We'll benefit based on overall survival results from the <unk> trial.
Speaker 3: Given the consistently high overall response rate we have seen across our clinical trial, including study 1100, in which only one patient has experienced progressive disease following administration of our product in combination with Pembro or Nevo, we are encouraged by the opportunity this could represent to accelerate development of an inhibitive cell tree in combination with Zio. And define an attractive path to registration in an area of significant and met
Given the consistency of our response rate, we have seen across four clinical trials, including study illegal in red in which only one patient has experienced progressive disease. Following administration of our product in combination with <unk>. We are encouraged by the opportunity this could represent.
To accelerate development of MBT salary in combination with value.
And define an attractive path to registration.
A significant unmet need.
Speaker 3: Over the next several months, we will be working to develop a final protocol informed by the data generated from our ongoing study and in line with the guidance received to date. We currently expect to submit this protocol to the FDA for review early next year.
Although the next several months, we will be working to develop a final protocol informed by the data generated from our ongoing study and in line with the guidance received to date. We currently expect to submit the protocol to the FDA for review early next year.
Speaker 3: Finally, in addition to this advancement in our single-agent and combination program, our partners, MD Anderson, continue to advance their research and reported the first case study on safety and feasibility of NBTXR3 in pancreatic cancer.
Okay.
In addition to these advancements single agent and combination program or partners MD Anderson continue to advance their research and reported the first case study on safety and feasibility of <unk> in pancreatic cancer as.
Speaker 3: As we all know, pancreatic cancer continues to be a devastating and incredibly challenging disease to treat. And we are encouraged by the success of this program so far and really look forward to the completion of this dose collection study later this year.
As we all know pancreatic cancer continues to be a divesting and incredibly challenging disease to treat and we are encouraged by the success of this program. So far and really look forward to the completion of this dose escalation study later this year.
Speaker 3: As each of these accomplishments suggests, Nanobiotics has made substantial progress against its fundamental strategic goal and has a clear line of sight to multiple significant potential value drivers for the business.
As each of these accomplishments such as <unk> has made substantial progress against its fundamental strategic goal and has a clear line of sight to multiple significant potential value driver for the business.
However, as each of us know.
Speaker 3: The pressure on the biotech sector remains and prolonged volatility in the financial market appears likely.
The pressure on the biotech sector remains and prolonged volatility in the financial market appears likely while the current condition of the capital market do not change our fundamental value proposition that do require us to apply the same innovative thinking to our corporate finance and development strategy as we have applied to the creation of <unk>.
Speaker 3: While the current conditions of the capital market do not change our fundamental value proposition, they do require us to apply the same innovative thinking to our corporate finance and development strategy as we have applied to the creation of MDGXR.
<unk> sorry.
Speaker 3: In this regard, we are exploiting the inherent flexibility of our pipeline and adapting our current development plans to maintain targeted research efforts focused on the continued execution of our ongoing pivotal phase 3 study in locally advanced head and neck cancer.
In this regard we are exploiting the inherent flexibility of our pipeline and adapting our current development plans to maintain targeted research effort focused on the continued execution of our ongoing pivotal phase III study in locally advanced head and neck cancer.
Along with the continuation of our Io combination study 11 in trade and the development of a registration path from Io combination therapy.
Speaker 3: along with the continuation of our IO combination study 1100 and the development of a registration path from IO combination therapy.
I think validated the novel physical mechanism of faction of NBA country and produce a portfolio of preclinical and clinical evidence supporting the potential safety feasibility and efficacy across multiple indications and therapeutic combination.
Speaker 3: Having validated the novel physical mechanism of action of NBTXR3 and produced a portfolio of preclinical and clinical evidence supporting the potential safety, feasibility, and efficacy across multiple indication and therapeutic combinations, we are well positioned to focus our effort on building an initial franchise focused on the treatment of head and neck cancer with the confidence that this result achieved will build a solid foundation for future expansion.
We are well positioned to focus our efforts on building an initial franchise franchise focused on the treatment of head and neck cancer with the confidence that these thresholds achieved will build a solid foundation for future expansion.
In prioritizing late stage program and strategy collaboration the company plans to deprioritize direct funding in several areas, including modifying our postponing additional company sponsored clinical trials that are not required to advance our priority pathway.
Speaker 3: In prioritizing late-stage program and strategy collaboration, the company plans to deprioritize direct funding in several areas, including modifying or postponing additional company-sponsored clinical trials that are not required to advance a priority pathway.
Speaker 3: This includes delaying post-marketing study previously planned to support or see a mark in sub-tissue sarcoma, as well as modifying the protocol from study 102 to allow for a reduction in post-treatment follow-up.
This includes delaying post marketing study previously plan to support our CE Mark in soft tissue sarcoma as well as modifying the protocol from study 102 alone <unk> already shown in post treatment follow up.
Speaker 3: from 24 months to 12 months. Adjustment to Study 102 will meaningfully reduce costs associated with the study without materially impacting the value generated by this program.
From 24 months to 12 months adjustment to study 102 will meaningfully reduce costs associated with the study without materially impacting the value generated by this program.
As you will recall that one or two is fully enrolled and all the patient at competitive treatment. In fact, most of the patients will have reached to 24 months follow up at the time, where we will stop the trial based on this modification we expect to provide top line data from study 102 in mid 2023.
Speaker 3: As you will recall, Study 102 is fully enrolled, and all the patients have completed treatment. In fact, most of the patients will have reached the 24-month follow-up at the time where we'll start the trial. Based on this modification, we expect to provide top-line data from Study 102 in mid-2020.
In part to changes in our clinical program, we will be reducing ongoing and previously planned preclinical research, including development activities related to the company's subsidiary correct.
Speaker 3: In prior to changes in our clinical program, we will be reducing ongoing and previously planned preclinical research, including development activities related to the company's subsidiary, Caradax.
In addition to the cost savings afforded by the planned reduction in near term clinical and preclinical activity. These changes also allow us to make corresponding adjustment to our manufacturing activities and leverage our existing clinical supply to support our ongoing program and further reduce our near term expenses.
Speaker 3: In addition to the cost saving afforded by the planned reduction in near-term clinical and preclinical activity, these changes also allow us to make corresponding adjustment to our manufacturing activities and leverage our existing clinical supply to support our ongoing program and further reduce our near-term expenses.
Speaker 3: Finally, two years of operating in a pandemic has changed how all of us do business, and nanobiotics is no exception.
Finally, two years of operating independently as tangible all of those two business and nano Biotics is no exception, we acted quickly to adjust operational infrastructure to accommodate remote work and promote connectivity across our global footprint. At this time, we can further leverage that efficiency and innovation by <unk>.
Speaker 3: We acted quickly to adjust operational infrastructure to accommodate remote work and promote connectivity across a global footprint. At this time, we can further leverage that efficiency and innovation by reducing satellite office facilities to generate further savings, while retaining our primary offices and manufacturing facilities in Paris.
<unk> satellite office facilities to generate further savings, while retaining our primary offices and manufacturing facilities in Paris.
In addition to our planned reduction in our political footprint and in light of plan adjustment to our development program. We are there anything any expansion of our team until operational needs and circumstances warrant.
Speaker 3: In addition to a planned reduction in our physical footprint, and in light of planned adjustments to our development program, we are delaying any expansion of our team until operational needs and circumstances warrant.
Speaker 3: I would now like to turn the call over to Bart, who will address additional measures we are taking to extend our runaway and strengthen our financial flexibility. Bart?
I would now like to turn the call over to Bob will address additional measures, we are taking to extend our runway and strengthen our financial flexibility but.
Thank you Lou.
The initiatives neurologist detailed has little impact on our long term strategy to provide significant impact on our ability to execute near term priorities.
Speaker 4: The initiatives Laurent just detailed have little impact on our long-term strategy, but provide significant impact on our ability to execute near-term priorities.
Speaker 4: Collectively, these actions are expected to reduce operating costs by approximately €12-15 million through 2023, adding nearly a quarter to our operating runway.
<unk>. These actions are expected to reduce operating cost by approximately $12 million to $15 million.
In 2023.
Nearly a quarter two our operating runway.
Speaker 4: These cost reductions are in addition to the cost efficiency program initiated in the second half of 2021 that will continue to favorably impact operating expenses in 2022 and 2023, resulting in a double-digit reduction in SG&A in 2022 prior to any adjustments to our development program.
These cost reductions are in addition to the cost efficiency program initiated in the second half of 2021 that will continue to favorably impact operating expenses in 2022, and 2023 resulted in a double digit reduction in SG&A in 'twenty two.
Prior to any adjustments to our development programs.
Speaker 4: In parallel to our efforts to adjust our cost structure and capital allocation to better insulate us from current market conditions, we have also secured access to approximately €25 million in optional capital, should we need it.
In parallel to our efforts to adjust our cost structure and capital allocation to better insulated from current market conditions. We have also secured access to approximately $25 million.
And optional capital should we need it.
Speaker 4: By establishing a flexible equity financing line through KeplerCheveux, we are in a better position to control our exposure to the capital market.
By establishing a flexible equity financing lines through kept for sugar.
We are in a better position to control our exposure to the capital markets fundamentally this equity line reflects a commitment of capital.
Speaker 4: Fundamentally, this equity line reflects a commitment by Kepler Chevaux to purchase incremental equity made available by the company at prices generally in line with the market.
To purchase incremental equity made available by the company at prices generally in line with the market.
So rather than issuing a substantive amount of equity would likely deeply discounted prices. This instrument allows us to access as much or as little capital as may be required over a two year periods at a discount to market will be greater than 5%.
Speaker 4: So rather than issuing a substantive amount of equity at likely deeply discounted prices, this instrument allows us to access as much or as little capital as may be required over a two-year period at a discount to a market of no greater than 5%.
Significantly we are not committed to sell shares now or anytime in the future.
Speaker 4: Significantly, we are not committed to sell shares now or at any time in the future, nor are we obligated to.
Nor are we are obligated to do so at any price to this.
Speaker 4: Through this structure, nanobiotics has the full authority to activate or suspend access to capital through this facility at its sole discretion.
Structure that <unk> has the full authority to activate or suspend access to capital through this facility at its sole discretion.
Speaker 4: However, it does ensure that nanobiotics has guaranteed access to the capital required to fund operations and control over potential dilution despite any sustained turbulence in the broader market.
However, it doesn't ensure that nobody optics is guaranteed access to the capital required to fund operations and control over potential dilution despite interested turbulence in the broader markets.
Collectively these efforts reflect measures within our immediate control.
Speaker 4: Collectively, these efforts reflect measures within our immediate control.
Speaker 4: actions we can take. They can be calibrated at our discretion to ensure we're optimizing investment in our priority pathways and ensuring future value for our patients and shareholders.
<unk>, we can take that can be calibrated at our discretion to ensure we're optimizing investment and our priority pathways and ensuring future value for our patients and shareholders.
Speaker 4: Combined with the €70.6 million in cash, cash equivalents and investments available as of March 31, 2022, we can be confident in funding our planned operations well into at least the fourth quarter of 2023.
Combined with the $70 6 million in cash cash equivalents and investments available as of March 31, 2022, we can be confident in funding our planned operations well into at least the fourth quarter of 2023.
Speaker 4: This extended runway also affords us the flexibility to pursue additional measures that could materially impact our capital allocation and significantly reduce the need for future dilutive capital.
This extended runway also affords us the flexibility to pursue additional measures that could materially impact our capital allocation and significantly reduce the need for future dilutive capital specifically, we have initiated discussions related to the potential restructuring of our debt obligations. Our goal is to.
Speaker 4: Specifically, we have initiated discussions related to the potential restructuring of our debt obligations. Our goal is to realign the repayment schedule with our anticipated commercial timelines and defer the majority of our principal payments due in 2022 and 2023.
Realign the repayment schedule with our anticipated commercial timelines and deferred the majority of our principal payments due in 2022 and 2023.
Speaker 4: This would allow us instead to redirect the capital towards our R&D programme.
This would allow us and steps to redirect capital towards.
Our R&D programs.
Speaker 4: The efforts reflect our commitment to safeguarding the discipline development of MBTXR3 for our patients and our shareholders.
The efforts reflect our commitment to safe guard the disciplined development of MBT XR three for our patients and our shareholders as.
Speaker 4: As we continue to progress our programs, we will continue to assess the efficiency with which we are deploying our capital and seek to optimise our spend to drive near and long-term value. And now I'll turn the call back to Laurent.
As we continue to progress our programs, we will continue to assess.
Efficiency with which we are deploying our capital and seek to optimize our spend to drive near and long term value.
And now I'll turn the call back to La <unk>.
Thank you Bob.
Speaker 3: The extended runaway and enhanced flexibility bars as detail allow us to look forward with excitement, confident in the opportunities we are building to enhance outcomes for patients.
The extended runaway and flexibility Bart as detail allow us to look forward with excitement and confidence in the opportunities. We are building to enhance outcomes for patients in the coming months, we look forward to continuing to work with our partner <unk> to advance our pivotal phase III study in locally advanced head and neck.
Speaker 3: In the coming months, we look forward to continuing to work with our partner, Leon Bio, to advance our Pivotal Phase III study in locally advanced head and neck cancer, Nanorate 312, by expanding our remit to include both U.S. and Asia.
<unk> seven nano <unk> 212 by expanding our government to include both U S and Asia.
Speaker 3: We look forward to continued progress in our IOO program, not only reporting updated data from the ongoing study 1100 in the fourth quarter, but taking significant steps of establishing our second registration program in head and neck cancer by finalizing the protocol for a pivotal study for recurrent and metastatic head and neck cancer.
We look forward to continued progress in our Io program not only reporting updated data from the ongoing study 11 and trade in the fourth quarter, but taking significant step of establishing our second registration program in head and neck cancer by finalizing the protocol for a pivotal study for recurrent and metastatic head and neck cancer.
Speaker 3: As we focus our internal development effort on two registration programs in head and neck cancer, we welcome the continued contribution from our partner at MD Under...
As we focus our internal development effort on tourist installation program in head and neck cancer. We welcome the continued contribution from our partner at MD Anderson.
Speaker 3: This comprehensive collaboration is expected to provide new data in pancreatic cancer this year, esophageal cancer early next year, and continue to explore indication like non-small cell lung cancer while adding depth into our understanding for the potential for combination treatment with immune checkpoint inhibition.
This comprehensive collaboration is expected to provide new data in pancreatic cancer this year.
Youll cancer early next year and continue to explore indication like non small cell lung cancer, while adding that into our understanding for the potential for combination treatment with immune checkpoint inhibitors.
Speaker 3: This alliance will continue to be cost-efficient and operationally efficient way to characterize the broad potential benefit and future therapeutic profile for NBTXR3, complementing the rich data set already generated by the company and its partner, including data that will be presented at ASCO in June , highlighting the safety and feasibility of NBTXR3 in combination with chemotherapy in head and neck cancer and rectal cancer.
This alliance will continue to be cost efficient and operationally efficient way to characterize the broad potential benefit and future therapeutic profile for <unk> XR tree complementing the rich dataset already generated by the company and its partner, including data that will be presented at Astro in June .
The safety and feasibility of <unk> in combination with chemotherapy in head and neck cancer and rectal cancer.
As you can see momentum is building at metal biotech sector, we remain optimistic about the near and long term opportunities for our <unk> offering.
Speaker 3: As you can see, Momentum is building at nanobiotics and will remain optimistic about the near and long term opportunities for MBT-XR.
Speaker 3: I would now like to open the call for questions, operator.
I would now like to open the call for questions operator.
Thank you as a reminder, if you do wish to ask a question. Please press star one on your telephone.
Speaker 1: Thank you. As a reminder, if you do wish to ask a question, please press star 1 on your telephone.
Speaker 1: To withdraw your question, please press the hash key. Please stand by while we compile the Q&A roster. This will take a few moments.
Withdraw your question. Please press the Husky please standby, while we compile the Q&A roster. This will take a few moments.
Thank you operator.
I apologize.
Speaker 2: No, that's okay. I think we actually received a number of questions from shareholders prior to the start of the call, and I think we'll address a couple of those before we jump to the key questions online. So, Bart and Milan, as you know, we did receive some questions prior to the call. They relate to sort of four general topics.
No that's okay I think.
We actually received a number of questions from shareholders. Prior to the start of the call I think well addressed a couple of days before we jump to the.
A quick question on line so.
So part of my life as you know we did receive some questions prior to the call they relate to sort of for general topics.
Speaker 2: And I thought we might start with one or two, specifically the first series of questions relate to our registration program at Head and Neck and largely focus on study 312.
And I thought we might start with one or two.
Specifically the first series of questions relate to a registration program and had neck and largely focused on steady between 12 and the questions include questions.
Speaker 2: And the questions include questions related to the status of patient recruitment and site activation for Study 312, expectations around the timing of the planned futility analysis and how many patients we would expect to inform that analysis, and what, if any, milestone payments from Leigh Ann Bio are triggered by the start of the Phase 3 study in head and neck.
Questions related to the status of patient recruitment and site activation for study 312 expectations around the timing of the planned futility analysis on how many patients we would expect to inform that analysis and what if any milestone payments from <unk> bio are triggered by the startup of the phase III study in head and neck.
Thank you Kate.
Speaker 3: Thank you, Kate. So as you know, this phase three registration trial is the priority of the company, and we've been tremendously working in the past years to put that into place. And as you have seen, beginning of January , we have initiated the
So as you know the phase III registration trial is the priority of the company and we've been tremendously work in the past years to put that into place and as you obtain beginning of January we have initiated.
Speaker 3: recruitment of the patient in this phase 3. So things are moving according to plan. We're still, as you know, in early stage of this trial and many sites have been opened and activated, especially across Europe . Now we anticipate in H2 to start opening sites in Asia, but also in the United States. In regard to the potential milestone of YoungBio linked to a first patient, this contract
Recruitment of the patient in this phase III. So things are moving according to plan. We're still as you know in early stage of this trial and many sites have been opened in activity, especially across Europe , no. We anticipate an edge to to start opening sites in Asia, but also in the United States.
In regard to the potential milestone of young bio link to our first patient.
This contract.
Speaker 3: has many milestones in it but not linked to the first patient recruited in the phase 3 in head and neck.
Has many milestone in it but not linked to the first patient recruited into phase III in.
In head and neck.
No.
In the next months, yes, we will continue to give you an update on where we are with this trial and how we move forward as far now things are moving as we anticipated as per the futility analyses readout and the interim readout.
Speaker 3: In the next month, years, we will continue to give you an update on where we are with this trial and how we move forward. As for now, things are moving as we anticipated. As per the futility analysis readout and the interim readout, we're still in the timelines that have been provided to the market.
Still in the timelines that have been provided to the to the market.
The operator, I think we can jump to some questions that are on the line.
As close your first question comes from the line of Lucy Codrington from Jefferies. Please ask your question.
Speaker 1: Of course, your first question comes from the line of Lucy Codrington from Jeffreys. Please ask your question.
Hi, there thanks for taking my questions just a few.
Speaker 5: Hi there, thanks for taking my questions, just a few. So starting with the planned phase 3 in combination with PD-1, just if you give us a bit more of an idea of what needs to be done between now and the first quarter of 2023, and just whether your discussions with FDA have been influenced by recent events surrounding the PI3K Chinese inhibitors and Project Optimus.
So starting with the planned phase III in combination with <unk>.
PD one.
If you can give us a bit more of an idea.
Needs to be done between now and first quarter 2023.
And just whether your discussions with FDA have been influenced by.
And then adding the <unk> kinase inhibitors and project.
Optimists.
Speaker 5: And is there any possibility that actually that phase three could have initial data before your head and neck phase three reads out?
And is there any possibility that see that phase III.
<unk> have initial data oil had a net.
Feelings out.
Speaker 5: Secondly, just with regards to the protocol amendment for 102, I may have misheard, did you say that most patients have completed 12 months or 24 months already, and you mentioned that it would reduce costs but not affect the study.
Secondly.
Just with regards to the protocol amendment to 118 and I may have missed it did you say that most patients have completed 12 months or 24 months already.
And just.
I assume that it would.
Today's call, but not effective.
<unk>.
Kind of read out, but what was the original decision to follow up to 24 months and why did you guys say 12 months.
Speaker 5: of read out but what was the original decision to follow up for 24 months and why didn't you go for 12 months originally?
<unk>.
Speaker 5: And in line with that, how important were the post, you know, with the post-marketing studies for soft tissue sarcoma, what are the implications of delaying those? And similarly, with the manufacturing reductions or changes to manufacturing, does that have any implications for your ongoing trials?
And in line with that how important where they pay with the post marketing studies for soft tissue sarcoma, what are the implications of delaying and similarly with the manufacturing reduction no changes to the manufacturing does that have any implications here ongoing trials.
Speaker 5: And then finally, just the data coming at ASCO this year, should we be doing that more as incremental updates with the more material update being the 1100 update by the end of the year? Thank you.
And then finally just the.
Data coming to ask.
Should we be viewing that more incremental updates with the more material update Andy.
1100 update by the end of the year. Thank you.
Speaker 3: OK, thank you, Lucie. So that's a lot of questions, so let's try to remind all of them. Maybe I can start with the PD-1 pathway and the I.O. trial we are planning. So as we mentioned, we are at the.
Okay. Thanks, <unk>. So that's a lot of questions. So let's try to remind all of them.
Maybe I can I can start with the PD one.
Pathway and the Io trial, we are planning so as we mentioned we are at the.
Speaker 3: early stage of developing a protocol based on the feedback we just received from FDA. So what is interesting here is when we look at the 1100 study we have which encompasses a number of head and neck patients having metastasis and being refractory to PD-1, we can start looking at what could be a potential outcome for those patients, both from a response rate perspective but also from a survival perspective.
Early stage of developing a protocol based on the feedback we've just received from from EBITDA. So what is interesting here is when we look at the 1100 study, we have which encompass a number of head and neck patients having metastases had been refractory to PD. One we can start looking at what could be a potential outcome.
For those patient both from them.
Response rate perspective, but also from a survival perspective now the next steps that are in the funnel vessels, obviously designing and refining a protocol based on their feedback but also in reaching this protocol based on the data we are seeing in this first half 11 Android trial.
Speaker 3: Now, the next steps that are in front of us is obviously designing and refining a protocol based on this feedback, but also enriching this protocol based on the data we are seeing in this first step 1100 trial.
Speaker 3: We plan to submit this to FDA beginning of next year, but in between we'll have an update on this 1100 trial that should occur H2 this year, where we'll get more patient and could likely.
We plan to submit.
Two FDA beginning of next year, but in between we will have.
An update on this 11 and drive trial that should occur to this year, where we will get more patient and good luck and we'll see what the results could be in the in this phase III. So that's where we're moving at the moment. There was also favorability to be done to see how many countries are going to be involved.
Speaker 3: and we'll see what the results could be in this phase 3.
Speaker 3: So that's where we're moving at the moment. There is also feasibility to be done to see how many countries are going to be involved. Obviously, the U.S. will be part of it, but we're also looking at Europe and other potential countries there.
Obviously U S will be part of it but we're also looking at Europe and other potential countries there.
Now in terms of the one or two amendment. So why to 24 months follow up for head and neck locally advanced patient is important especially for the one that are ineligible for cisplatin is because that's where you see if you could from a theoretical perspective as transform.
Speaker 3: So, why the 24-month follow-up for head and neck locally adjuvant patients is important, especially for the ones that are ineligible to CIS platins, because that's where you see if you could, from a theoretical perspective, have transformed...
Speaker 3: the treatment into some curative pathway. After two years of follow-up, if you have no results for the patient,
The treatment into some curative pathway. After three years of follow up if you have no relevance for the patients then you'll have a good chance to go to the five years that could be considered at some point as a cure. That's why we have defined 24 months in this trial initially now when the Covid.
Speaker 3: then you have a good chance to go to the five years that could be considered at some point as a cure. That's why we have defined 24 months in this trial initially.
Speaker 3: Now, when the COVID hit, there has been a gap in recruitment in this trial, as you know, and the very last patients have been recruited way later, the final numbers of patients.
There have been a gap in our recruitment in this trial as you know and the very last patient has been recruited way later.
Final numbers of patients it means that when we will stop.
Speaker 3: It means that when we will stop the follow-up of the patient at 12 months...
Follow up of the patients at 12 months, there will be only a few patients that will have the only 12 months follow up versus the vast majority of other patients having 24 months or more follow up. So that's why we felt rather than continuing spending money on this trial to make an amendment to <unk>. After 12 months follow up for the loss.
Speaker 3: There will be only a few patients that will have only 12 months follow-up versus the vast majority of other patients having 24 months or more follow-up. So that's why we thought, rather than continuing spending money on this trial, to make an amendment to cut it after 12 months follow-up for the last patient in order to save money and do not degrade what results could come from this trial.
Patients in.
In order to save money and do not degrade what redox could come from this trial.
Now for the manufacturing.
Speaker 3: Now for the manufacturing, what we have in place now is everything that is needed to cover every ongoing clinical trial, including a potential registration phase 3 in the IO setting. And obviously, as needed, we can re-engage and continue to produce new batches on demand with our facility.
What we have in place now is everything that is needed to cover every ongoing clinical trials, including a potential registration phase III in the <unk> setting and obviously <unk>.
Got it.
We can.
Reengage and continue to project, new batches on demand with our with our facility.
Speaker 5: Now there was a question about STS. Lucy, I'm not sure. I got it completely. Would you be able to restate it? Yeah, sure. It's just in terms of the implications of postponing those post-marketing studies. Given the, I guess, the priorities is head and neck, is that immaterial, not conducting those now, can you just conduct them later?
No doubt there was a question about <unk> I'm not sure I got it completely would you be able to restated.
Yes, sure just in terms of the implications of dissipating those post marketing studies.
Given the I guess the priorities is head and neck is not immaterial not conducting days now can you just conduct of nature.
Speaker 3: Yes, that's the reason why we have postponed the study is that we don't see any material impact on our way forward.
Yes.
A reason why we have postponed. This study is that we don't see any material impact on our way forward.
Nowadays I think that there was a question about <unk>.
Speaker 3: Now, I think there was a question about ASCO. I did mention just a minute ago that the 1100 trial will be updated later this year. No, not at ASCO, but H2 as planned. At ASCO, what we are waiting are the results of two trials that have been done by our former Asian partner, PharmaEngine, which means the expansion called in the rectum cancer where patients have received
I Didnt mentioned, just a minute ago that 1100 trial will be updated later this year not as core but <unk> plan at <unk>, what we are waiting.
The record of two trials that have been done by our former Asian partner Pharma engine, which mean the expansion cohort in the rectum cancer, where patients have received radiation chemo plus nanoparticles and the other one would be in head and neck cancer for patients that have received radiation chemo and metal. So those are <unk>.
Speaker 3: radiation chemo plus nanoparticles and the other one would be in head and neck cancer for patients that have received radiation chemo and nano. So those are different setting of patients that have been treated previously and for us what is important here is to look at the possibility of combining all product with radiation and chemotherapy.
Setting of patients that had been treated previously and for US what is important here is to look at the possibility of combining all product with radiation and chemotherapy because as we know this is a standoff care in many other indications and will help us to establish our treat not only as a single agent like we do in soft tissue sarcoma.
Speaker 3: Because, as we know, this is a standard of care and many other indications and will help us to establish arteries not only as a single agent, like we do in soft tissue sarcoma or head and neck cancer free trial, but also in combination with chemo and in combination with I.O. That's the way we move forward to try to establish franchising head and neck first, then to expand it into other indications.
Our head and neck cancer Phase III trial, but also in combination with chemo and in combination with Io. That's the way we move forward to try to establish franchise in head and neck first then to expand it into other indications.
Speaker 6: So I hope to see I did cover your questions. Yep, very helpful. Thank you. Thank you.
So I hope to see a deep cover your questions. Yes very helpful. Thank you. Thank you.
Thank you. Your next question comes from the line of Michael <unk> from Evercore. Please ask your question.
Speaker 1: your next question comes from the line of Michael Diffel from Evercore. Please ask your question.
Hi, guys. Thanks, so much for taking my question I guess, the biggest issue for I guess investors in.
Speaker 7: I guess the biggest issue for, I guess, investors and the question of where we're standing is whether or not you guys
Questions, we're receiving is whether or not you guys will have.
Runway to do the interim analysis for the phase III Nano Ray study and I just want to clarify certain things.
Speaker 7: want to clarify certain things. Will, after all of these measures have have taken place...
After all of these measures have taken place.
In order to save the incremental $12 million to $15 million of Opex.
Speaker 7: So all of these measures plus the equity line of credit, will that get you into 4Q23 runway? Or will tapping the equity line of credit provide an additional runway beyond that such that the interim analysis could possibly take place?
Well all of these measures plus the.
Equity line of credit will that get you into.
<unk>.
For Q 'twenty three.
Runway or will be tapping the equity line of credit.
Credit provided an additional runway beyond that such that the interim analysis could possibly take place or.
Speaker 7: Will the equity line, the debt restructuring, and all the current efforts to save money, is that it? Will that be?
The equity line the debt restructuring and all the current efforts to save money.
Is that.
Is that it will that be.
Will that only gets you to the fourth quarter of 'twenty three thank you.
Thank you Michael we appreciate the question and happy to respond.
Speaker 4: Thank you, Michael. We appreciate the question. I'm happy to respond. As our press release implements on our call indicate, we're highly disciplined to preserve the long-term value. We've taken steps that are in our control to extend our runway. And that includes both the...
Our press release incremental medical indicate we're highly disciplined to preserve long term value.
We've taken steps are in our control to extend our runway.
That includes both the.
Speaker 4: actions that we've taken, as well as the equity line that will get us to Q4 of 23, that provides us the necessary flexibility to continue to drive value.
Actions that we've taken as well as the equity line that will get us to Q4 of 23 that provides us the necessary flexibility to continue to drive.
<unk>.
Speaker 4: and use other opportunities in order to bridge the gap. And these additional measures could materially impact our capital allocation. As we've indicated in the press release, the restructuring of the debt is one of them. We believe that there still is a smaller gap to get us to interim analysis, but it's now a very bridgeable gap.
And.
Huge opportunities in order to bridge the gap.
And these additional measures could materially impact our capital allocation as we've indicated in the press release the restructuring of the debt is one of them.
We believe that there are still is.
The small gap to get us to <unk>.
From analysis, but it's now a very applicable.
I hope that answers.
Speaker 7: I hope that answers your question.
And I guess as a follow up to that very visual gap could that be satisfied by the possible debt restructuring.
Speaker 4: Not in its entirety, but it's a good step in...
Not not in its entirety, but is a good step into it.
Speaker 7: uh... also just as a as a add-on to uh... you mentioned manufacturing changes that will be taking place and and and just recognizing that
Also just as an add on to you.
You mentioned manufacturing changes that that'll be taking place in just recognizing that.
A lot of these.
Speaker 7: manufacturing plans are done well in advance and making changes are often very costly. Has that been taken into consideration and will there be any penalties that may arise?
Our manufacturing plans are done well in advance and then making changes are often very costly.
That been taken into consideration and then will there be any penalties.
That may.
Sure.
Unexpected shortfall in funding.
Thank you Mike.
As the manufacturing if concern nano biotechs itself is an owned facility is manufacturing the API. So the vast majority of it is controlled by us So if any penalty on us not externally. So that's why we.
Speaker 3: As the manufacturing is concerned, nanobiotics itself, in its own facility, is manufacturing the API. So the vast majority of it is controlled by us. So if any penalty hits on us, not externally. So that's why we can control easily the spending in the manufacturing without incurring penalties or other issues linked to that. So we are in full control of that. Nevertheless, we still have external partners.
Control easily to spending in the manufacturing without incurring penalties.
Other issues linked to that so we are in full control of that Nevertheless, we still have external partners to help us to work on the final steps of manufacturing, but they are not representing the vast majority.
Speaker 3: to help us to work on final steps of manufacturing, but they are not representing the vast majority.
Speaker 8: of the cost of the product manufacturing.
The cost of the product manufacturing.
Okay.
Thank you very much.
Youre welcome.
Thank you. Your next question comes from the line of Kevin.
Please ask your question.
Yes.
Speaker 9: Hello, thank you for the presentation. I have just two questions following the cost reduction started in 2021. Just would like to know if you have further steps to improve more the cash runways such as delaying other site studies.
Hello. Thank.
Thank you for the presentation.
Just two questions really did the cost reduction started in 'twenty or 'twenty one.
Let's move to a further step to improve.
To improve the cash one with just the region, although site studies.
Speaker 9: in collaboration with MD Anderson, for example, which are in preclinical phases. And the other question concerns the number of patients. I would like to know how many are already enrolled for a nanoarray. And how many do you expect for the next?
Question with Amgen doses for example.
Which are in preclinical phases.
And.
<unk> <unk> concerns the number of patients I would like to know how many.
And world.
And how many do you expect for the next and last question do you expect some milestones from late into this year.
Speaker 9: And the last question, do you expect also some milestone from Lion Build this year? Thank you.
<unk>.
Okay. So.
So we got to the 312 I think I have covered.
Speaker 3: So in regards to the 312, I think that I have covered this part in the first question, and I can't go far beyond that. For the MD Anderson collaboration, so just in the structure of this collaboration with MD Anderson, there is a very small amount of money that is involved in it, as MD Anderson is taking the vast majority of costs on them.
In the first first question and I can't can go far beyond that.
For the MD Anderson collaboration so does the infrastructure of this collaboration with Amgen understand there is a very small amount of money that would involve any have any understanding is picking the vast majority on costs.
Dan.
The preclinical work we are doing with them is coming to an end at least for this space. So there is no need to reengage on that matter in the short term for the only cost that is linked to engender Sun is relating to the ongoing clinical trial, which has which are already covered in the contract we signed with them. So we will continue to work there.
Speaker 3: The preclinical work we are doing with them is coming to an end, at least for this phase, so there is no need to re-engage on that matter in the short term. So the only cost that is linked to MD Anderson is really linked to the ongoing clinical trial, which are already covered in the contract we signed with them. So we'll continue to work there as the engaged cost is very low for nanobiotics.
Has the <unk> cost is very low for fundamental biologics now sorry, what was the last question about <unk>.
Speaker 8: No, sorry, what was the last question about, please? Leanne Bayo. Leanne Bayo. What was the last question?
<unk> and what have you.
My question was about <unk> <unk>.
Speaker 9: My question was about Lion View, if you have some milestone expected in the upcoming years?
Most unexpected.
In the upcoming years.
Yes.
Speaker 8: Yes, there are milestones expected in this contract, not to the first patient injected in Asia countries, but many more milestones coming out from different step of development and also commercial step in this collaboration. Okay, thank you.
Yes, my unexpected in this contract are not to the first patient in <unk> in Asia countries, but many more milestones coming out from different type of development and also commercial step in this collaboration.
Okay. Thank you.
Youre welcome.
Thank you. Your next question comes from the line of John <unk>.
Speaker 1: Thank you. Your next question comes from the line of RK Surajam Pakula from HCE Wainwright. Please ask your question.
From H C. Wainwright. Please ask your question.
Speaker 10: Thank you. Good morning or good afternoon, Lauren. Most of my questions have been asked, but I just want to touch base on a couple of things. On the study 102, where you're amending the protocol to decrease the follow-up period to 12 months from 24 months.
Thank you and good morning, or good afternoon Lauren.
Okay.
Most of my questions have been asked but just wanted to.
I'll touch base on a couple of things on the study went out too.
Yeah.
Amending the protocol to decrease in follow up period.
12 months 24 months.
Speaker 10: On that trial, I just want to understand, you know, how the follow-up would go on. So once the follow-up is done, and let's say the data is positive and it looks mighty interesting.
On that trial.
Just wanted to understand how the follow up would go on so once.
Once the follow up is done in let's say the data is positive.
It looks might be interesting.
Does that mean your interest in that particular patient population, which is thats, just flatten ineligible head and neck.
Speaker 10: does that mean your interest in that particular patient population, which is the stratum ineligible head and neck cancer population?
Cancer population.
Yes.
Speaker 10: in terms of developing the next phase of studies.
In terms of developing the next phase of studies.
Who would you not be doing them.
Speaker 10: would you not be doing them, you know, would you not be interested right away or you need to shore up funds before you get back to them? I'm just trying to understand, you know, how you could expand on that patient population. Okay.
You know what.
Do not be interested right away or you would need to show the funds before you get back to them.
I'm just trying to understand how you could expand on that patient population.
Okay.
Okay.
Speaker 8: So the 102 trial has been the premises to define what the 312 trial will be, which is now ongoing. And as you know, the 312 trial will take part of the population, will be the one that has been treated in the 102.
So the one or two trials has been the premises to define what the treat 12 trial will be which is now ongoing and as you know to treat waste trial will take part of the population will be the one that had been created in the 102.
Speaker 8: If we have stopped this trial, or at least changed the final follow-up for the very few patients remaining in terms of follow-up, then it's because we extracted, we think, everything we could from this trial. And what we extracted in the past helped us to design the 312, which is now moving forward. As I did mention previously...
If we have stopped.
This trial is change the the final follow up for the very few patients remaining in terms of follow up then it's because we extracted we think everything we could from this from this trial and what we expected in the past help us to design to treat well, which has no moving forward.
You'd mentioned previously that the patient that will have 12 months versus 24 months follow up will be a very small number of patients because of the timing for equipment of different patient now that the population in the 312.
Speaker 3: The patient that will have 12 months versus 24 months follow-up will be a very small number of patients because of the timing for equipment of different patients.
Speaker 8: Now the population in the 312 will get this population plus a broader population in order to enlarge the market we can target with our product in locally advanced head and neck patients that are eligible for cysplatin.
We'll get this population plus a broader population in order to enlarge the market, we can target with our product and locally advanced head and neck patients that are eligible for cisplatin.
Thank you for that and then.
Speaker 10: Thank you for that. And then, you know, the various studies that MD Anderson is doing in different indications, I'm just trying to see if within the next year or year and a half that you have the current runway for, would there be any data updates from any of those studies? The reason I'm asking is would that be a subject for soft money in terms of relationships with the outside collaborators?
The various studies that MD Anderson is doing in different indications.
I'm just trying to see if we can.
In the next year or year and a half.
Back to you.
And therefore would there be any data updates from any of those studies.
The reason I'm asking is that.
That would be a subject for us.
Soft money by in terms of relationships with.
I would say its collaborators.
Thank you.
Good question, we lagged a collaboration with MD Anderson, because not only MD Anderson, but also.
Speaker 8: We like the collaboration with MD Anderson because not only it's MD Anderson, but also because of the cost-efficient collaboration we have with them. And they're running a number of clinical trials, and we expect later this year to have the first control readout on the pancreatic cancer trial, which is a devastating disease, as we know. Here we intend to define what would be the RP2D dose, and then to move into the expansion part.
Because of the cost efficient collaboration we have with them and they are running a number of clinical trials and we expect later this year to have the first potential readout.
The pancreatic cancer trial, which is a diverse taking disease as we know here, we intend to define what will be the ERP to the door and then to move into the expansion cohort and I think thats, a very interesting trial, because we start with patients that are truly inoperable.
Speaker 3: And I think that's a very interesting trial because we start with patients that are truly unauthorable, that have usually a very short life expectancy and a high risk of having a metastatic setting following the locally advanced tumor. So here if we could control those patients, that will allow us to move into the expansion phase that will go to borderline respectable patients.
Usually a very short life expectancy, and a high risk of having metastatic setting following the locally advanced GMO. So here, if we could control of those patients.
Allow us to move into the expansion phase that will go to borderline resectable patient, where there is a huge need for them to get.
Speaker 8: where there is a huge need for them to get to surgery. Because if you get that, then you limit the chances for the patient to get, at a later stage, some metastasis. And at least improving survival, currently, for this patient. So we are eager to look at what the data will be on that, and if we can move to the expansion part of this trial. Obviously, this will happen, it should this year, so very soon.
To surgery, because you should get that then the limit the champion patient to get at a later stage some metastasis and at least improving survival currently for those patients. So we are eager to look at what the data will be on that and if we can move to the expansion part of this trial. Obviously this will happen exclude ECS.
So very soon now a second trial that should give us the data and then the <unk> will be the one with bezel federal cancer again, Thats, a setting where you have radiation chemo plus nano and hear that the goal is to get to a good response for the patients. So you can either avoid surgery or to get to a surgery.
Speaker 8: Now, the second trial that should give us the data in MD Anderson will be the one with esophageal cancer. Again, that's a setting where you have radiation, chemo, plus nano. And here the goal is to get to a good response for the patient, so you can either avoid surgery or to get to a surgery that will not be detrimental to keep the function of the organ. And we're waiting this result for next year from MD Anderson.
That will not be detrimental to to keep the function of the organ and we are waiting.
Records for next year from MD Anderson, along the way and we will inform you about other trials that are running and when we should expect some clinical data coming from it.
Speaker 3: Along the way, we will also inform you about other trials that are running and when we should expect some clinical data coming from it.
And I think thank you Laura.
Speaker 3: To go back to the other part of your question about how this will be seen from a partnership perspective, I think the more we show that our product can be combined with chemo, can be combined with I.O., and can be used in so many settings in oncology, the broader is the option for us to go to find a partner out there.
Sorry to go back to the other part of your question about how this will be seen.
I'm a partnership perspective, I think the more we show that our product can be combined with chemo can be combined with value and can be used in so many settings in oncology the broader the option for us to go to find a partner out there.
Mhm.
Yeah.
Thanks, Thanks, a lot thanks for taking the lessons.
Your next question comes from the line of Deutsche Bank Goldman.
Speaker 1: Your next question comes from the line of Frederic Gomez from Charmianne, Seguin.
Securities. Please ask your question.
Hey, guys. Thanks for taking my questions.
Speaker 11: Yes, thanks, Laurent, for taking my questions. A few on 3.12, now that the study is ongoing. On the design itself, can you tell us, maybe, can you share with us more colors on the statistical power of the study? Is it 85%, 90%? And I would like, maybe, to get a better understanding around this statistical power between the OS.
<unk>.
Not that the study is ongoing.
On the design. It says can you can you tell us maybe can you share with us more colors on the statistical power of the study is at 85%, 90% and then we'd like maybe to get a better understanding.
<unk> grew up between the U S and also the PFS should we.
Speaker 11: and also the PFS should we understand maybe that the PFS is over powered if you have a decent power for the U.S.
Maybe.
PFS is a a poor world.
Four.
And just also maybe to check what's out your assumption in terms of gain on PFS.
Speaker 11: And just also maybe to check what are the assumptions in terms of gain on PFS versus the chemo arm, the COMPA arm, when you look at the, at the distribution, the gain is C2 plus 30 is close to seven months.
Sure.
Chemo.
When you look at the good news for us.
The game users.
She is close to seven months.
Speaker 11: You mentioned in the past that you were looking for a gain of three months.
You mentioned in the past that.
Q4 again of three months.
Speaker 11: So should we still use this number of 3 to 4 months gain in PFS between the two arms?
So should we.
So just number of suites formally gaining PFS between the two arms.
Speaker 11: And my last question is on the amendment on the study of 102.
And my last question is on <unk>.
The amendment on the studio for.
One or two.
Can you maybe comes from that.
Speaker 11: Can you maybe confirm that this study will be supported when you will file with the US FDA? And I got your explanation on the rationale for the amendment, but are you sure that this amendment will have absolutely no impact when you will file for approval with the FDA? Thanks.
He will be supported when you will file.
And I guess your explanation on the rationale for the amendments but are you sure that seven months will have absolutely no impact when you will file.
Thanks.
Thank you.
So it didn't have any question around the trade 12 does that general statement hotter.
Speaker 8: So did I have any questions around the 312? Just a general statement on how the trial has been designed, you're right. That's a trial that's been designed with PFS as a primary endpoint.
How the trial has been designed youre right that the trial has been designed with PFS as a primary endpoint, but nevertheless, being able to demonstrate an OS benefit. So it makes that the PFS power is the PFS is overpowered versus.
Speaker 8: but nevertheless being able to demonstrate an OS benefit. So, it makes that the PFS power, the PFS is overpowered versus the OS. And the interim readout is planned to be done on the PFS.
In the interim readout planned to be done on the PFS.
Speaker 8: For the sake of time, I will send you the details that are publicly available on the design of the trial and the different powers of the different endpoints we're looking at. And I think you'll find all your answer there.
For the sake of time I'll send you. The details that are publicly available on the design of the trial and the different pillars of the different.
Endpoints, we're looking at and I think Youll find all your answer there.
Speaker 8: Now, on the question of the 102, the population being included in the 312, I don't think we can directly use what is the overall outcome of the 102 to the 312.
Now on the on the question of the one or two.
The population being included in the 2012 I don't think we can directly you.
What is the overall outcome of the 100 to the tree 12.
Speaker 8: That would be supportive in terms of understanding what the potential impact of the product for a frail population.
That will be supportive in terms of understanding what the potential impact of the product for a frail population.
Speaker 8: And what we have at 24 months is something which could be good enough in terms of super cheap data.
And what we have at 24 months is something which could be good enough in terms of supporting data following patient longer will not bring that much value versus what what we have today now in regards to the pure registration strategy and what data will be submitted to the FDA at the time of registration.
Speaker 8: Following patients longer will not bring that much value versus what we have today. Now, in regards to the pure registration strategy and what data will be submitted to the FDA at the time of registration, we did not communicate that yet to the market. And that will obviously include the 312, but also the 102 as supportive data and every other trial as addition.
<unk>.
We did not communicate that yet.
Yet to the market and that will obviously include the <unk>, but also the one or two AD supportive data in every other trial.
Addition.
Speaker 3: I think there was another question about the potential control arm radiation.
I think there was another question about the potential control.
Radiation plus.
Speaker 8: plus septuximab, just to re-precise the design of the clinical trial we are running. So this is a two-arm trial with 500 patients, randomized one to one. So in each arm, the patient will receive either radiation alone or radiation plus septuximab. And in one of the two arms, we will have the nanoparticle of our product.
Plus the <unk> mab.
Just to be precise the design of the clinical trial. We are running. So this is a two arm trial with 500 patient randomized one to one.
So in each arm the patient will receive either radiation alone or radiation plus.
60 months and in one of the two we will have.
Emmanuel particle or cloud products. So here there is a stratification in the trial was the use on out of Cetuximab and the choice of putting cetuximab in the trial was linked to the fact that the gypsy navigate still standard of care.
Speaker 3: So here, there is a stratification in the trial with the use or not of cetuximab. And the choice of putting cetuximab in the trial was linked to the fact that cetuximab is still standard of care in some of the population we want to treat. Nevertheless, when you look at literature, it is true that in the general population, cetuximab on the top of radiation brings benefits.
And some of the population and we want to treat Nevertheless, when you look at the literature. It is true that in the general population Cetuximab on the top of radiation bring benefit to patients versus radiation alone, but if you look at the frail elderly patients.
Speaker 8: to patient versus radiation alone, but if you look at the frail elderly patient, it does not. If you look at the Bonner paper, it will tell you that for elderly patients, cetuximab is even detrimental versus radiation alone.
If you look at the Bono paper.
I will tell you that for elderly patients <unk> 11 detrimental versus radiation radiation alone and in the past that one of our PPI has published during one of the head and neck constrained some real world evidence data showing that the PFS for elderly patients being treated either with radiation.
Speaker 8: And in the past, one of our PI has published during one of the Head and Neck conference some real-world evidence data showing that the PFS for elderly patients being treated either with radiation or radiation plus the Tuximab is quite similar. I think there's less than a month difference between the two.
Our radiation plus Rituximab is quite similar I think there is less than a month.
Difference between the two.
Speaker 12: So that's why we think when we look at what could be the comparator, what the comparator could look like, in literature it's really important that we really look at what population we are talking about. But Frédéric, I will be happy to extend this discussion and to go in deeper detail as you need.
So that's why we think when we look at what could be the comp ratio what the comparator could look like in literature. It's very important that we really look at what population.
We're talking about but I'll be happy to extended discussion and to go into deeper detail as unique.
Okay.
No further questions from the audio I would now like to turn the conference.
Mcneill Joseph Mitchell question.
Yes, thank you operator.
Speaker 2: Yes, thank you, Operator. Bart and Lauren, as you know, we did receive several additional questions in going through the Q&A and prepared remarks. So far, I believe we've actually covered a majority of the questions related to potential financing strategies and our I-O development program. However, we do have three remaining questions, which I'd like to present for you to address.
But on the line as you know we did receive several additional questions and go into the Q&A and prepared remarks, so far I believe we've actually cover.
A majority of the questions related to potential financing strategy and our.
<unk> development program. However, we do have three remaining questions, which I would like to present for you to address those.
Speaker 2: before we close out the call. The first series of questions relate to anticipated data from our MD Anderson studies and specifically include questions about when we expect to see results from any of these studies and a request to clarify the status of the re-irradiation IO combination study. And head next.
Before we close out the call. The first series of questions relate to anticipated data from our MD Anderson studies and specifically include questions about when we expect to see results. Many of these studies and a request to clarify the status of the re irradiation Io combination study in head and neck.
Second to that there is.
Speaker 2: Second to that, there is questions related to the availability of the products in soft tissue sarcoma in the European market, and if there are any patients that currently have access to that product.
Questions related to the availability of the product.
In park tissue sarcoma in the European market and if there are any patients that currently have access to that product.
Speaker 6: And the final question relates to the status update on Curidime and specifically the ongoing development with Sanofi. Thank you, Kate.
And the final question.
Related to the status update on teradyne and specifically.
Ongoing developments with Tennessee.
Thank you Kate.
So let's start maybe with the.
Access to patients for.
Speaker 8: access to patient for Soft tissue sarcoma patient to the to the product. So as we we've seen at a neck is our priority and the company will start looking at soft tissue sarcoma commercialization after And a neck have been registered in in Europe Now as you know, our product is a medical device in Europe and a drug in u.s
So tissue sarcoma patient to the to the product so as we've seen at NEC <unk>.
Priority and the company.
We'll start looking at soft tissue sarcoma commercialization after.
And Nick have been reduced.
In Europe now as you know our product is a medical device in Europe , and a drug in the U S.
Speaker 3: And unlike drugs, the medical device does not offer a predefined pathway to give access to the patient, the product, until it is reimbursed in a country. So that's why we're eager to move forward as fast as we can our head and neck trial, not only to bring this product to head and neck patients but also to stop tissue sarcoma.
Unlike drug the medical device does not offer a predefined pathway to give access to the patient the product until it is reimbursed.
In a country. So that's why we are eager to move forward as fast as we can all head and neck trial, not only to bring this product to head and neck patient, but also to soft tissue sarcoma patient.
Speaker 8: Now, on the second question about MD-UNDERSTAND, I think for the deadline to next data point, we've covered this point in the previous question, but there's still a remaining question about the I.O. trial that are running there and how do we handle that versus other trials.
Now on the second question about MD Anderson I think for the deadline to next data point, we've covered this point in the previous question, but Theres still a remaining question about that.
The Io trials that are running there and how do we handle that versus other trial.
Speaker 8: So I think, especially with the latest feedback coming from FDA about a potential pathway forward, along with the amendment.
I think especially with the latest feedback coming from FDA about a potential pathway forward.
With the amendment.
Speaker 8: of our protocol in order to redefine the expansion code.
The protocol in order to redefine the expansion cohort.
Speaker 8: We are reviewing with MD Anderson the different trial in IO in order to optimize the resources that are developed there And to prevent any potential redundancy with the different population we are treating So not only we are discussing new trials with them and we'll see that later but we're also refining our current strategy about what are the IO trial running and
We are reviewing with MGM and the different trialing in Iowa in order to optimize the resources that are developed there and to prevent any potential within 90 with the different population. We're treating so not only we are discussing a new trial with them and we will see that later, but we're also refining our current strategy.
About what how the Io trial running.
Speaker 8: internally, the one we are sponsoring, or the one that MD Anderson sponsors, but we'll obviously give an update, as we do regularly, on the overall portfolio of trial we are running.
Internally the one we are sponsoring or the one that MD Anderson sponsored but we'll obviously give an update as we do regularly on the overall portfolio of cloud we are throughout running.
Speaker 8: I think that the last question concerns Curadigm, as we did mention in the call and in the press release. For now, internal work at Curadigm is on hold until we have a different financial perspective. But externally, our partners continue to work with the technology and making progress. So that's where we are today with the Curadigm program.
I think that the last question comes and concern paradigm.
As we mentioned in the call and in the press release from our internal work at Carillon is on hold until we have different financial perspective, but externally our partners continue to work with the technology and making progress. So that's where we are today with the <unk> program.
Speaker 1: This concludes today's question and answer session. I would now like to hand back to the speaker for any closing remarks.
Thank you. This concludes today's question and answer session I would now like to hand back to the speaker for any closing remarks.
Speaker 8: So I just would like to thank you. Thank you everyone for participating in the call today. We really appreciate your time and look forward to seeing you and many of you in the coming weeks as we attend the UBS, the HCW and the Jeffries conferences.
So I just would like to thank you. Thank you everyone for participating on the call today, we really appreciate your time and look forward to seeing you. Many of you in the coming weeks as we attend UBS the <unk> and the Jefferies confronted and also we will have our general Assembly in June where we hope to see you.
Speaker 8: And also, we'll have our general assembly in June , where we hope to see you there. If you don't have, if you did not have time to ask your question, please feel free to reach us and to send us any questions that haven't been answered during that call. I just would like to thank you again and wish you a great day.
There if you don't have if you do not have time to ask your questions. Please feel free to reach us and to send US any question that hasn't been in surgery that call I'd just like to thank you again and wish you a great day.
Yes.
Thank you everyone.
This concludes today's conference call. Thank you for your participation you may now disconnect.
Speaker 1: This concludes today's conference call. Thank you for participating, you may now disconnect.
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