Q4 2021 Nanobiotix SA Earnings Call
[music].
Ladies and gentlemen, thank you for standing by, and welcome to Nanobiotics 2021 full-year corporate and financial.
Ladies and gentlemen, thank you for standing by and then go to an antibiotic is 2021 full year corporate and financial update.
At this time, all participants are in list and only mode. After the speaker presentation, there will be a question and answer session. To ask a question, you have to press star 1 on your telephone. I would now like to end the conference over your speaker today, Kate McNeil. Please go ahead, man.
At this time all participants are in listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question do you have to press star one on your telephone.
I'll now like turn the conference over your Speaker today Gate Mcneill. Please go ahead maam.
Kate McNeil: Thank you operator. Good afternoon and good morning and welcome to nanobiotics conference calls to discuss our 2021 full year financial and operational results.
Thank you operator, good afternoon, and good morning, and welcome to the antibiotics conference call to discuss our 2021 full year financial and operational results. Joining me on the call today are Rob <unk> co founder and Chief Executive Officer, and Bart Van <unk>, Chief Financial Officer as a reminder, today's call is being webcast.
Kate McNeil: Joining me on the call today are Laurent Levy, co-founder and chief executive officer, and Bart Van Rijn, chief financial officer. 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 filing, dates of presentation, and future research and development efforts, among other things.
And it will be available on our web site for replay.
To remind you that this call will include forward looking statements, which may include statements regarding the progress success and timing of our ongoing and planned clinical trial collaborations regulatory filing data presentation and future research and development effort among other things.
Kate McNeil: 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.
Kate McNeil: 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 AMS in France and the SEC in the United States, including the URD and 20F filed in their last version, 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.
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 IMF in France.
And the FCC in the United States, including New York and 20-F filed in their last version 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.
Kate McNeil: 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, nanobiotics undertakes no obligation to update them to reflect subsequent events or future circumstances.
In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date, while we may elect to update these forward looking statements at some point in the future and antibiotics undertakes no obligation to update them to reflect subsequent events or future circumstances.
Speaker Change: With that said, I'd like to turn the call over to Lorona. Lorona, please go ahead.
With that said I'd like to turn the call over to Laura Laura. Please go ahead.
Thank you Kate.
Laon Oron: I would like to welcome everyone participating by a conference call and webcast today. This is a busy and exciting time at Nanobike, and I'm pleased to have the opportunity to highlight some of the important progress our team has made in the past year. Provide some additional insight as to what we expect in this year, and why we continue to be excited by the potential of our lead product candidate and BTX team.
I would like to welcome everyone participating via conference call and webcast today.
Busy and exciting time at <unk> and I'm pleased to welcome volatility to highlight some of the important progress.
Our team has made.
Last year provide some additional insights on what you're expecting this year and while we continue to be excited by the potential of our lead product candidate <unk>.
Laon Oron: As we acclimed in January , our priorities for 2022 includes focusing our internal development effort on our two-lead program, including the execution of 312, our global pivotal study of NVTXR3 as a single agent, activated by radiation in locally advanced head and neck cancer patients. And two, the advancement of our follow-on checkpoint in vitro combination program seeking to expand the treatment benefit of NTPD1 therapy.
As we outlined in January our priorities for 2022 include for kidney internal developments before on our two lead program <unk>.
The execution of prequel, our global pivotal studies of <unk>, our three single agent calculated by radiation in locally advanced head and neck cancer patient.
Yeah. Thanks, maybe for Bob Cardon checkpoint inhibitor combination program seeking to expand the treatment and if you don't mind.
Do you want to.
Laon Oron: In parallel, we will continue to leverage our existing key collaboration to advance and expand, or by time, while we evaluate potential new collaborations that could contribute complementary development and commercial capabilities.
In parallel we will continue to leverage our existing key collaborations to advance and expand our pipeline, while we evaluate potential collaborations that could contribute complementary development and commercial company.
Laon Oron: As we continue to enhance our operating efficiency and carefully align our resources with the strategic priorities supported by Bob and the rest of the leadership team, we seek to both maximize and deepen our operational expertise in key functional areas to support our continued growth.
And we continue to advance our operating efficiency and carefully align our resources with the strategic priorities supported by BARDA and the rest of the leadership team.
Both maximize and deepen our operational expertise in key functional areas to support continued growth.
Laon Oron: During 2021, we took several key operational steps to position us to build the foundation of future opportunity and achieve this goal in 2020.
During 2021, we took several key operational.
Position us to build the foundation of future opportunity and achieved these goals in 2022.
Laon Oron: In May 21, we added a new strategic partner, Leigh-Anne Bio, to advance and expand the development of MDT-XR3 in Asia. We are pleased to have found a partner that is committed to revolutionize patient outcomes, share our strategic vision for MDT-XR3, and bring substantial regional expertise that should enable a meaningful contribution to a global development initiative.
In May 21, we added a new strategic partner, we entitle to advance and expand the development of MD J, Paul Creative Asia. We're pleased to have found a partner that is committed to revolutionize patient outcome share our strategic vision for mdx offering and bring substantial regional expertise that should enable a meaningful contribution.
<unk> Global development Shane.
Laon Oron: YoungBio will be a key partner for us in our head and neck registration study, enrolling 20% of the 500 patients we plan. Preparations for this are already well underway and we currently expect YoungBio to initiate patient enrollment in H312 in the second half of 2022.
The <unk> will be a key partner for.
I had a macro situation study enrolling 20% of the 500 patient we plan preparation for this are already well underway and we will currently expect young biotech initiated patient enrollment into the tree 12 independent outlook 2022.
Laon Oron: In addition, A.M.Bio has committed to participate to four additional registrational studies with MBKXR3 across indication and therapeutic combination, funding all the development and commercialization expenses in their territory.
In addition, <unk> committed capacity basis to four additional Registrational study with MD, Jake I'll creep across indications and therapeutic combination owning all the development and commercialization expenses in their territory.
Laon Oron: I'd like to give their belief in and the commitment to the broad potential of MDK culture.
Highlighting their belief in and commitment.
The potential to take battery.
Laon Oron: This commitment to the long-term vision for an ETXR tree mirrors that of our ongoing work with Indians.
This commitment to the long term vision important egfr tree neuro.
Our ongoing work with Amgen.
Laon Oron: We've been engaged in a broad collaboration with MDU in 2018.
We've been engaged in a broad collaboration with MD Anderson in 2018.
Laon Oron: Their research and development support have already generated the world's library of clinical data, particularly around the combination of potential of MDTxRT with Immune Checkpoints in England.
Research and development suite board have already generated robust library of brick clinical data, particularly around the combination potential of mdx poultry with immune checkpoint inhibitor.
Laon Oron: This resulting in multiple presentations and publications.
Noting in multiple presentation and presentation.
Laon Oron: In 2021, MD Understand initiated the fifth clinical trial with MDKX Part III under its collaboration, which now includes three Phase I studies exploring the safety
In 2021, and you're under spending initiated clinical trial.
And to kick off on that as collaborations which now include three phase one studies.
Exploiting the safety and feasibility.
Laon Oron: Authentic XR3 in pancreatic cancer, in adocadural cancer, and multiple cell cancer.
Authenticate Bell Creek in pancreatic cancer, <unk> cancer, and non small cell lung cancer.
Laon Oron: And additionally, two phase two studies exploring the potential of the efficacy of MBG XR3 in combination with immunotherapy, this in head and neck.
And Additionally, two phase III studies exploring the potential efficacy of <unk> in combination with immunotherapy this in head and neck.
Laon Oron: Having already reported the first patient case study from Andy Anderson phase one pancreatic study, anticipate the dose escalation of that study to reach its target, recommended phase two dose later this year.
Having already reported the first patient case study from MD Anderson Phase one Penn credit study.
The dose escalation study to reach target recommended phase II dose later this year.
Laon Oron: Similarly, and you understand, there's one study of MBJ software in combination with chemo is also expected to report recommended test to those in 2022.
Similarly, Amgen defense Phase one study of LBJ suffered in combination with chemo is also expected to report recommended phase two dose in 2022.
Laon Oron: In addition to expanding our external development capabilities, we also significantly strengthened our leadership team with the appointment of Gary Phillips as chairman of our supervisory board, bringing decades of experience in the pharmaceutical and healthcare industry.
In addition to expanding our external development capability. We also significantly strengthened our leadership team with the appointment of Gary Phillips as chairman of the supervisory board, bringing decades of experience in the pharmaceutical and healthcare industry.
Laon Oron: And Bart Van Ryn, our Chief Financial Officer, bringing proven capability in global financial management, business development, and pharmaceutical commercialization.
And Bob <unk>, our Chief financial officer, bringing proven capabilities and global financial management business development and pharmaceutical commercialization.
Laon Oron: More recently, we were pleased to welcome Dr. Len Farber, a board-certified medical oncologist, as our new chief scientific and medical affairs officer, adding extensive executive experience in developing and growing treatment centers and departments within the radiation oncology field.
Recently, we were pleased to welcome Carolyn Barber at both certified medical oncology as our new Chief Scientific and Medical Affairs Officer.
Adding expensive.
<unk> experience in developing and growing treatment center and departments within the radiation oncology field.
Laon Oron: Each of these individuals has already had a tremendous impact on the company, driving execution across key programs and contributing to a culture of innovation, integrity, and inclusion, while fostering transparency and accountability. Now, before I turn our attention to the results and expectations for our internal development report, I would like to ask Bob to provide a brief review on our financial results. Bob.
Each of these individuals has already had a tremendous impact on the company driving execution across key program and contributing to our culture of innovation integrity and intrusion, while clustering transparency and accountability.
Now before I turn our attention to the results and expectations for internal development, Nicole I would like to ask Bob to provide a brief review on our financial return box.
Barge: Thank you, Laurent. As Kate mentioned, yesterday after the close of the U.S. markets, Nanobiotics reported financial results for the year ended December 31st, 2021, while highlighting our financial position as well as our recent progress.
Thank you Laurel.
As Keith mentioned yesterday after the close of the U S markets <unk> reported financial results for the year ended December 31 2021.
Ill highlighted our financial position as well as our recent progress.
Barge: As described in the release, our total revenue, consisting primarily of revenue related to our prior collaboration with Pharma and Gin, totals approximately €10,000, compared to €50,000 for the year ended December 31, 2020.
As described in the release, our total revenue consisting primarily of revenue related to our prior collaboration with pharma engine.
Approximately 10000 Europe .
Compared to <unk> 50000 Euro for the year ended December 31 2020.
Barge: Our income for the period includes research tax credits which increased from 1.9 million euro in 2020 to 2.5 million euro in 2021 due to an increase in research and development expenses.
Other income for the periods includes research tax credits.
Which increased from $1 9 million in 2020 to $2 5 million in 2021 due to an increase in research and development expenses.
Barge: Our research and development expenses for the year were €30.4 million, compared to €24.3 million for the year ended December 31, 2020.
Our research and development expenses for the year were 34 million compared to $24 3 million for the year ended December 31 2020.
Barge: This increase reflects the increased clinical trial development cost related to the company's priority pathways, including preparation and initial site activation for our pivotal phase three registration study, NanoRay 312, and our immunotherapy combination study 1100.
This increase reflects the increased clinical trial development cost related to the company's priority pathways, including preparation and initial site activation for our pivotal phase III registration study nunnery 12, an.
And our immunotherapy combination study 11 numbers.
Barge: selling general and administrative expenses were 19.4 million euro for year ended December 31st, 2021, compared to 14.6 million euro for the prior year period.
Selling general and administrative expenses were $19 4 million for the year ended December 31, 2021, compared to $14 6 million Euro put a prior year periods.
Barge: This year-over-year increase was related to a change in headcount mix in geography, recruitment expenses, and expenses resulting from the NASDAQ listing, and reflects a significant decrease in SG&A during the second half of 2021, a trend that is expected to continue year-over-year in 2022.
This year over year increase was related to a change in head count mix and geography recruitment expenses.
This resulted from the NASDAQ listing and.
And reflects a significant decrease in SG&A during the second half of 2021 trend that is expected to continue year over year in 'twenty two.
Barge: Nanobiotics net loss was 47 million euro for the year compared to a net loss of 33.6 million euro for the 2020 fiscal year which includes 5.4 million euro in auto operating income and expenses related to the termination of the pharma engine agreement in early 2021 and financial income of 5.6 million euro driven by currency translation.
<unk> net loss was 47 million for the year compared to a net loss of $33 6 million Euro put a 2020 fiscal year, which includes $5 4 million Euro and all of our operating income and expenses related to the termination of the pharma engine agreement in early 2021.
And financial income of $5 6 million driven by currency translation gains.
Barge: We ended the year with cash, cash equivalents and investments totaling 83.9 million euro compared to the 119 million euro as of December 31st, 2020.
We ended the year with cash cash equivalents and investments totaling $83 9 million.
Compared to the 119 million Euro as of December 31, 2020.
Barge: This net decrease of 35.3 million euro reflects 51.8 million euro of net cash flows used in operating, investing, and financing activities of nanobiotics, which was partially offset by the 16.5 million euro or 20 million US dollar up from payment associated with the LeonBio collaboration announced in May 2021.
This net decrease of $35 3 million.
It reflects $51 8 million euro of net cash flows used in operating investing and financing activities of <unk>, which was partially offset by the $16 5 million or.
$20 million dollar upfront payments associated with the <unk> collaboration announced in May 2021.
Barge: Finally, as we continue to optimize our capital allocation and drive ever-increasing efficiencies and flexibility in our cost structure, we anticipate that our cash equivalents and multiple securities, as of December 31, 2021, should enable us to fund operations well into the second quarter of 2020.
Finally, as we continue to optimize our capital allocation and drive ever increasing efficiencies and flexibility in our cost structure, we anticipate that our cash cash equivalents and multiple securities.
At December 31, 2021 should enable us to fund operations well into the second quarter of 2023.
Speaker Change: And now I'll turn the call back to Laurent to discuss these programs in further detail. Laurent. Thank you, Pat.
And now I will turn the call back to the wall to discuss these programs in further detail Laura Thank you Bob.
Laurong: Progress across our development program afforded us the opportunity to provide several data updates over the course of 2021, each adding meaningful support to our hypothesis that NBGFR3 offers a unique opportunity to extend and expand potential clinical benefits across spectrum of cancer or solid tumors. And this both as a single agent activated by radiation therapy, as well as in combination with other products on the market and under the law.
Progress in across our development program afforded us the opportunity to provide table data update although the course of 2021.
Each adding meaningful sportswear hypothesis that <unk> offers a unique opportunity to expand and expand potential clinical benefit across a spectrum of cancer plus 32 mall.
Both as a single agent activated by radiation therapy as well as in combination with other products on the market and under development.
Laurong: Rather than detail previously announced data space and my own achievement individually, I would like to take this time today to provide an integrated view on how we believe these results provide insight into the future opportunity for NBKXR3 and position us to achieve our development goal for 2020.
Rather detailed previously database and.
And milestone achievements individually I would like to take this time today to provide an integrated view on hope we believe as redox provide impact into the future opportunity for and began offering and position us to achieve our development goals for 2020.
Okay.
Laurong: Certainly, a key priority for us is the timely execution of nanowire 3 as well, and successful registration of the product for the treatment of locally advanced head and neck cancer in patients that are insolvent to standard healthcare, platinum-based chemotherapy.
Certainly a key priority for US is the timely execution of <unk> hundred 12, and successful registration of the product for the treatment of locally had been head and neck cancer in patients that are intolerant to standout cure mechanism based chemotherapy.
Laurong: Based on the consistently high response rate seen across multiple studies, we have long been confident in the potential for NBTXR3 to provide survival benefits in this patient group and secure fast-track designation in 2019 to potentially accelerate this opportunity.
On the constant currently high response rates seen across multiple study we have long been confident in the potential <unk> III provides survival benefit in this patient group and secure best practice nation in 2019 to potentially accelerate this opportunity.
Laurong: In 2021, we have the opportunity to report the first survival data from ongoing study 102, validating this hypothesis.
In 2021, we had the opportunity to report the first survival data from ongoing steady 100 team validating this hypothesis.
Laurong: As we presented at ASTRO21, iris, elderly patients with locally advanced disease that were ineligible for cisplatin and intolerance to cecumet, achieved a median survival of 18.1 months and median progression-free survival of 10.6 months in the available population as of September 21, 2021.
As we presented at Ash for 'twenty, one iris elderly patients with locally advanced disease.
<unk>.
And in sort of on the 16 that achieved a median survival of $18 one months and median progression free survival of $10 six months easy Evaluable population as of September 21.
Laurong: Response rate remained consistent with previously reported results from both those escalation and those expansion phase, showing a response rate of 85.4% and complete response of 63.4% in the target region.
Response rate remained consistent with previously reported results from both those escalation and of attention paid showing a response rate of 85, 4% and complete response of $63 four in the target lesion.
Laurong: Even with consistency, we were not surprised, but certainly pleased, by an internal review of data from February data update this year.
Given this competency.
We were not surprised but certainly pleased by an internal review of data from February kit update this year.
Laurong: Continued improvement with an ongoing median overall survival of 17.9 months in the all treated population, which includes 66 patients. And 23 months in the 44 evaluable.
Generally improvement with an ongoing median overall survival of about $17 nine months in the <unk> treated population which includes patients.
And 23 months in the 44 Evaluable patients.
Laurong: We are not only pleased by the treatment effects observed in patients enrolled in this study, but we are highly encouraged by the implications for the 312 study of pivotal.
We are not only pleased by the treatment epic observing patients enrolled in this study, but we are encouraged by the implications for the <unk> study.
Great.
Laurong: As you will recall, patient meeting, the criteria for study one or two, are historically foot-to-trick.
As you will recall patient meeting the criteria for study one or two historically.
Laurong: They are generally older with a higher level of comorbidity than patients to digital force 3312 and have two or three times the prevalence of comorbidity compared to the overall localism population.
We are generally older with a higher level of comorbidity that patient to digital across 33, 12 and have two or three times equivalent of comorbidity compare to the overall liquidity of the nation.
Laurong: While there are no direct comparator literatures, suggests that locally advanced patients with a better prognosis than all patients have a medium of survival of approximately 12 months.
While down no direct comparative literature suggests that locally advanced patients with a better prognosis than all patients have a median overall survival.
12 months.
Laurong: Providing us with what we believe is a conservative estimate
Providing us with what we believe is a conservative estimate benchmark.
Laurong: On an operational front, study 102 has no completed enrollment with the last patient expected to complete their last treatment within next year.
On an operational front, certainly one or two as no completed enrollment with the last patient is expected to complete their last treatment within the next month.
Laurong: This allows us now to leverage 102 sites with historically high enrollment for study 312. As part of our site selection process, we have selected 8 sites of the 102 sites for participation of the study 312, representing possible activities, 10% of our expected European
This allow us now to leverage one of our two sites.
Pretty iron enrollment post 30 <unk>.
Part of our site selection process, we have selected a site.
Of the one or two sites for occupation of SGD 212, representing approximately 10% of our expected European sites as we look more broadly at European type plan, we are sensitive to the pricing geopolitical concern and instability in Ukraine and Russia.
Laurong: As we look more broadly at your open-side plans, we are sensitive to the pressing geopolitical concern and instability in Ukraine and Russia.
Laurong: while we do not have any one-of-two sites in the region targeted for the treat well.
While we do not have any one or two sites in the region targeted quad 312.
Laurong: We have previously planned to activate a small number of centers in this region as part of the 312 study.
We had previously planned to activate a small number of penetrating discretion as part of the <unk> study.
Laurong: These sites were not scheduled for activation until the second half of 2022, and we are actively working with our CIO to identify alternate sites and countries. And as of today, we do not expect any impact on our overall timing or execution of the Study 312.
This time, we're not scheduled for activation into the second half of 2022, and we are actively working with our CMO to identify alternate site and country and as of today, we do not expect any impact on our overall timing of execution of the study 212 at this time.
Laurong: Looking ahead, we plan to continue adding sites across Europe through the year and expect to activate our first US site in mid-2020.
Looking ahead, we plan to continue adding sites across Europe .
And expect to activate our first U S site in mid 2022.
Laurong: In parallel, our partner, EMBIO, who is expected to contribute approximately to 100 patients of the 500 patient plan, have been actively preparing to initiate study 312 in China and currently anticipate beginning patient enrollment in the second half of 2020.
<unk> was expected to contribute approximately to 100 patients of the 500 patient plan have been actively preparing to any shifts between 12 and China and currently anticipate beginning patient enrolment in the second half of 2022.
Laurong: Overall, execution since the start of the study has been in line with expectation, and we are pleased with the ramp up.
Overall execution since the start of the study at <unk> in line with expectation and we are pleased with the ramp up we are seeing.
Laurong: We look forward to gaining additional insights on patient enrollment rates. And as more sites and countries come online, and look forward to getting you updated on this progress.
We look forward to gaining additional insights on patient enrollment rate and at multi anchor concrete come online and look forward to keeping you updated on this call right.
Laurong: Now, turning our attention to our IEO combination program, I will again note that we were pleased to provide two updates related to our ongoing study.
Now turning our attention to our I O combination program.
Note that we were pleased to provide two updates related to our ongoing studies.
At Agnico and Astral.
Laurong: This presentation was complemented by new clinical data, journal publication, and further review of the clinical data and clinical findings by a few of our key opinion leaders in June .
This presentation were complemented by new preclinical data journalist application and further review of the data and preclinical filing by a few of our key opinion leader in June .
Laurong: The data, like all 3102 data, are available on the website, and I would encourage those of you that haven't not yet had the opportunity to review to do so.
Peter <unk> 31, or two data are available on our website.
<unk> those of you that haven't not yet had the opportunity to lead you to do so.
Laurong: As this data update made clear, evidence continues to support our hypothesis that the physical mechanism of action of NDGFR tree triggers a subsequent priming of the immune system that, when paired with immune checkpoint individuals, allows for better than expected response to MTPD-1 tree
As this data update mid tier evidenced continues she boardwalk.
The physical mechanics of action of Mdx lottery triggered subsequent priming of the immune system.
When paired with immune checkpoint inhibitors below for a better than expected response to anti PD one treatment.
Laurong: among not only naive patients, but also appears to rescue prior treatment failure.
Among not only 90 patient, but also appears to rescue prior treatment data.
Laurong: A daily data from study 1100 presented as astro remain consistent with prior data tests, demonstrating that this is control of 81% in the available population, including 73% in stations with prior primary of secondary resistant to anti-pd1.
But take data from study 11, and Greg presented at Astro remain consistent with prior data demonstrating this is control of 81% in the evaluable population, including 73% in patients with primary or secondary resistance to anti PD one.
Laurong: in a 16-evaluable patient, three complete response, and five partial response.
In the 16 evaluated patient three complete responses.
And five partial responses were reported.
Laurong: But sadly, only one corrosive disease was reported in the inevitable population.
But that leaves only one cooperative disease was reported in de lever those population.
Laurong: Some delayed tumor response and or abscopal effects were also reported, suggesting that MBTXR3 may potentially prime an immune response.
Tom delay two more with Paul and our Abscopal effects were also reported suggesting that <unk> may potentially prime and.
An immune response.
Laurong: To date, this activity is paired with a tolerability profile similar to what is traditionally seen with radiotherapy or NTPD1 therapy.
To date this activity is paired with a total liability profile similar to what we've traditionally seen with regulators.
PD one therapy.
Laurong: 30-1100 is a basket trial, including pre-coordination patients in the dosage condition.
Steady 11, Android is a basket trial, including three cohorts of patients in the dose escalation phase.
Laurong: The third one are local regional recurrents or recurrents in the fact that he can and may cancel patients.
The first one.
Norwegian or a reconnect our recurrent metastatic head and neck cancer patient.
The second one.
Laurong: A learning metastasis from any primary cancer that is eligible for NGP1 therapy.
<unk> metastases from any primary cancer.
Eligible for anti PD one therapy.
Laurong: And the third one are liver metathesis from any primary cancer eligible for NTPD1 therapy.
And the third one our liver metastases from any primary cancer eligible for anti PD one therapy.
Laurong: Considering the competing data, we have seen from the study demonstrating the potential to both increase the response rate and NTP1 treatment as well as rescue prior treatment failure, we have updated our planned expansion phase of this study to explore this potential more fully in head and neck cancer.
Considering the competing data we are seeing from the study demonstrating the potential to both increase the response rate in MTBE, one treatment as well as with Q prior treatment, Peter we have updated our plant expansion.
This study to explore this potential more fully in head and neck cancer patients.
Laurong: Therefore, the extension phase will divide patients into three new cohorts. Cohort one will include only head and neck cancer patients naive to NTPD1 treatment.
Therefore, the extension phase, we will devise patient into three new cohorts cohort one.
Will it include only head and neck cancer patients nave to anti PD one treatment.
Laurong: CoA2 will include only RNA cancer patient resistant to prior NTPD1.
For Q1.
It will include only eliminate cancer patient who has extensive prior anti PD, one treatment and cohort three will come by in a patient with lung liver or soft tissue metastasis from any advanced cancer eligible for anti PD one treatment.
Laurong: And CORE3 will combine patients with lung, liver, or soft tissue metastasis from any advanced cancer eligible for NCPD1 treatment.
Laurong: Enrollment in each of these courses is expected this year and will begin after reaching the recommended phase 2 dose for each patient.
Enrollment in each of these calls are expected this year and will begin after reaching the recommended phase II dose for each patient group.
Laurong: In addition, to informing the expansion phase of study 1100, the data generated to date has also added to our sense of urgency in defining a registration path for radiation-activated and DTXR3 in combination with in-check point inhibitors. And we have initiative discussions with the FDA to guide us in this process.
In addition to informing the extension phase of study 11, a great data generic shape to date has also added to our sense of urgency and defining a registration path for our addiction activated <unk> in combination with immune checkpoint inhibitor and we have initiated discussion.
With the FDA to guide us in this process.
Laurong: Preliminary feedback has been very encouraging, and we will be working with the aim of finalizing a protocol and proposed regulatory plan for review by the end of this video.
Preliminary feedback has been very encouraging and we will be working with the aim of finalizing a protocol and proposed regulatory paths for review by the end of this year.
Laurong: While our clinical program exploring the combination potential of a product candidate with full NTP1 treatment represents the priority pathway in our combinations,
While our clinical program exploring the combination potential of our product candidate with <unk> anti PD. One treatment were presented with priority pathway combined action strategy, we have presented clinical and preclinical data that support the potential synergy of <unk> Valkyrie, which chemotherapy luxury.
Laurong: We have presented clinical and all clinical data that support the potential synergy of NDTxRT with chemotherapy, electry, TG, and CTLF.
T J and cyclical.
Laurong: Early last year, we presented initial data from the dose escalation phase of our chemo combination study in Redstone, Canada.
Early last year, we presented initial data from the dose escalation phase about chemo combination study in rectal cancer and look forward to updating swivels, along with the phase one chemo combination study in head and neck cancer to be presented next quarter Biopharma partner in Asia.
Laurong: and look forward to a depth of results along with the phase one chemo combination study in head and neck cancer to be presented next quarter by our former personnel.
Laurong: Further, both are previously reported and ongoing practical work suggests that as the oncology treatment lengths get continued to evolve and innovation leads to promising new product candidates, MBTXR3 may be uniquely suited to revolutionize the pilars of cancer as a foundational component of future treatment, potentially having efficacy without increasing safety or tolerability concerns.
Further both our previously reported and ongoing preclinical work suggest that at the oncology treatment landscape continue to evolve and innovation leads to promising new product candidates and we kicked off pre made are uniquely suited to address the PDR of cancer with <unk>.
Additional component of future treatment potentially heading of efficacy without increasing safety or tolerability concerns.
Laurong: We remain committed to fulfilling this promise through discipline execution and look forward to continuing to advance our development program through 2022 and beyond.
We remain committed to fulfilling chronic true disciplined execution and look forward to continuing to advance our development program through 2022 and beyond.
Laurong: We hope to make a significant impact on unmet needs with our Solitimum Agnostic, IOCombination Agnostic Plastic.
We hope to make a significant impact on unmet needs with our solid tumor agnostic Io combination agnostic platform.
Laurong: Before I open the call for questions, I would like to thank our patients, investigators, and collaborators.
Before I open the call for questions I would like to turn off patients investigators and collaborators.
Laurong: Your support and contribution to our mission are invaluable, and our success will not be possible without you. We will not be happy to open the call.
Support and contribution to our mission are invaluable in our system will not be possible reduction.
We would now be happy to open the call for questions.
Director.
Okay.
Laurong: Ladies and gentlemen, we now begin the question and answer session. If you wish to ask a question, you can press star one on your smartphone or you can type your question on the ask a question box.
Ladies and gentlemen, we'll now begin the question and answer session.
Wish to ask a question you can press star one on your telephone Hawkins type your question on the ask a question box.
Laurong: All right, team, while we're waiting for questions to queue up on the call, we have received a few inbound questions from investors prior to the start of the call, so I think we'll get started there.
Alright team, while we're waiting for questions to queue up on the call. We have received a few inbound questions from investors prior to the start of the call. So I think we will get started that.
Laurong: There have been a number of questions on similar topics, so I've advocated the questions with the hopes that you can address them. So we did receive a number of questions about regarding the status of 312, which we addressed during the call, and how we plan to communicate around the progress in that study going forward, and specific questions regarding the status of that study on clinicaltrials.com.
There have been a number of questions on similar topics on advocating for the question.
With the hubs the Eaton interests and so we did receive a number of questions regarding <unk>.
The status of 312 between Investor will call and how we plan to communicate around the progress on that study going forward.
The key questions regarding the status of that study and clinical trial starts up.
Laurong: Okay, so as we just mentioned some minutes ago, the 312 study is progressing well according to plan. Sites have been initiated already last year in Europe and the first patient has been injected beginning of January . So now we're progressing according to plan with the goal to open outside Europe the U.S. site for mid-22 and the Asian part with our partner, the NBio, for H2B care.
Thank you Kate.
As we just mentioned a.
Some minutes ago.
Treat well steady progressing well according to plan.
<unk> already locked here in Europe and in the first patients have been injected beginning of January .
I know we are progressing according to plan.
With the goal to open outside Europe U S tight for May 22, and the Asian art with our partner <unk> extra this year.
Laurong: In regards to clinicaltrials.gov, the update has been made last week and will come to life as soon as they are validated.
We got two clinical trials Gov EBITDAR at the net last week and it will come to life when I've got validated.
Speaker Change: Okay, great one more question from our investors before we go to questions on the line. The next regards status updates related to our non priority pathways, including where we stand with the liver study, the prostate study, and both the chemo combination studies conducted in Asia.
Okay, Great. One more question from my end, let's just before we go to questions on the line.
Look our status updates related to our non priority pathways, including.
Where we stand with the liver study the prostate study.
The chemo combination study conducted in April .
Speaker Change: Just as a reminder, the priority of the company is to move forward this phase 3 trial in head and neck cancer.
Just out of time.
As a reminder.
The priority of the company is ready to move forward.
Phase III trial in head and neck cancer.
Speaker Change: and the priority two is to open this new path for registration within the IO combination field. So we believe that those two paths will be ensuring the success of the content.
The priority two is to open these new paths for registration within the I O combination sale. So we believe that those two actions will be.
Ensuring the success of the company now has you know a product has wide applicability in cocoa our menus are chemo. So the other trial, we've been running for us are opening new doors, while potential future lever of growth.
Speaker Change: Now, as you know, our product has a wide applicability and could go for many other tumor. So the other trial we've been running for us are opening new dough for potential future liver out of growth.
Speaker Change: Just as a reminder, the head and neck trial with chemotherapy and radiation data will be presented in Q2 this year. And concerning the
Just as a reminder, the head and neck trial with chemotherapy and.
And radiation.
Data will be presented in Q2, this year and concerning the.
Speaker Change: Trial on the rectum cancer, again with radiation TMO plus narrow, will also be reported in the future.
Trial on the rectal cancer again with radiation chemo plus nano will also be reported in Q2.
Speaker Change: So we are very happy with the data generated in Libre, in Prostate, and other trials. So after we develop and move forward in the two-price pathway, we will start exploring other opportunities for MBJ.
We're very happy with the data generated in labor and across APAC and the other trial so.
We have developed and move forward into two pricing pathway, we will start exploring or the opportunity for MB kicked off trade.
Speaker Change: Operator, I think we can turn to the question that we have on the line right now.
Operator, I think we can turn to the question.
We have on the <unk>.
Line right now.
Speaker Change: If we have one question from the phone, it's from Jonathan Miller from Evercore IC, please go ahead, your line is open.
We have one question from the phone is from Jonathan Miller from Evercore ISI. Please go ahead. Your line is open.
Hi, guys. Thanks, so much for taking the question.
Jina Mille: I guess a lot of what I was really curious about from the release has been addressed in your prepared remarks. Thank you, but I'll focus, I guess, instead on financial.
I guess a lot of what I was really curious about from the releases has been addressed in your prepared remarks. Thank you Ben.
<unk> focus I guess instead on financials.
Jina Mille: You say you've got a runway well into 2Q of next year that gives you about 12 months of cash. But obviously, registrational data, which I think is the big catalyst, isn't expected until possibly as late as 24. So I was wondering what you were thinking about your cash position and how you were thinking about the prospect of some sort of financing and what your priorities were from a financing perspective.
You say, you've got a runway well into <unk> of next year that gives you about 12 months of cash.
But obviously registrational data, which I think is the big catalyst isn't expected until possibly his latest 24. So I was wondering what you were thinking about your cash the cash position.
And how you were thinking about the prospect of that.
Some sort of financing and what your priorities were.
On the financing perspective.
Thank you Jordan disbursement Ryan.
Speaker Change: Thank you, Jordan. This is Bart van Rijn. As any other biotech, we're always evaluating all our options to ensure sufficient capital on hand and disciplined capital allocation. We're sensitive to capital dilution, even more so given the current state of the markets.
The older biotech, which is the only way to all of our options to ensure sufficient capital on hand, and disciplined capital allocation.
We're sensitive to a couple of delusion, even more so given the current state of the markets.
Speaker Change: We look forward to keeping you apprised of the progress and are feeling good about what is ahead of us. We've initiated...
We look forward to keeping you apprised of the progress and are feeling good about what is ahead of us we've initiated.
Speaker Change: Of course, optimizations program that are bearing fruit already and we're very excited about the two strategic partners that were collaborating with both and the Anderson and the in bio, which allow us for a very efficient pathway from a development perspective.
Cost optimization program that are bearing fruit already.
We're very excited about the two strategic partners that we're collaborating with both the Emerson and Liam bile, which allow us for a very efficient pathway from a development perspective.
Thank you.
Speaker Change: Great. That makes sense. Then, I guess, one follow-up then, since we're talking about those collaborations, I think we're all excited to see a little bit more out of those MD Anderson trials, you know, both in terms of the different combos and the different indications that they're exploring there.
Great that makes sense and then I guess one follow up then.
Since you were talking about this collaborations I think we're all excited to see a little bit more out of those MD Anderson trials.
But in terms of the different combos and the different indications that they are exploring there.
Speaker Change: In terms of the data that you have said we should expect to see in the next year, it seems like there's a bunch of different data sets coming. What do you think is the most important catalyst for you guys in those upcoming data releases? What should we be paying most attention to in terms of the ability to really generate interest in the nanostory?
In terms of the data that you have said, we will we should expect to see in the next year. It seems like there's a bunch of different datasets coming.
What do you think is the most important catalyst for you guys in those upcoming data releases.
Should we be paying most attention to.
In terms of the ability to really.
Generate interest in the nano story.
Speaker Change: So I think we have a rich year in the front of us.
So I think we have rich year in front of us.
Speaker Change: We could say that in Q2 we will report two new set of data, one in the expansion phase of the rectum cancer, the other one in the head and neck chemotherapy setting. That's the first part. We also wait for the second part of the year, the RP2D of the pancreatic cancer trial that is done at MD Anderson.
In Q2, we booked two new backup data one in the extension phase of the rectal cancer.
The one in head and neck chemotherapy.
That's the first half we also wait for.
The bump up there.
<unk> of the pancreatic cancer trials, I think done and we understand.
Speaker Change: The overall program there, including esophageal cancer, non-small cell cancer, and two phase two in head and neck in combination with diarrhea was also moving in the right direction.
The overall program, there, including agile schedule cancer or non small cell lung cancer and two phase II in head and neck in combination with value was also moving in the right direction.
Speaker Change: Where we really want to focus the attention is in the definition of what's going to be of that
Where we want to focus the attention is in the definition of what's going to be faster to market with the Io combination.
Speaker Change: to market with the IO Combination. Recent discussion with FDA let us think that we will have enough to start defining what should be this path. And we intend to communicate that to market by the end of this year to make sure we have another people who try running in parallel to the T-12.
Discussion.
Latest thing that we will have enough to start defining what should be the path and we intended to communicate that to market by the end of this year to make sure. We have another pivotal trial running in parallel to the street level.
Speaker Change: Is there any possibility that that I-O combination pass would be more rapid than 3-12? Is there any possibility that the I-O combo could be approved before the head and neck study is done? If there's nothing, we can end the stage. Okay, fair.
Is there any possibility that that Io combination path would be more rapid than $3 12 is there any possibility that the io combo could be approved before the head and neck study is done.
There is nothing we can set the stage.
Okay fair enough.
Thank you so much.
Okay.
Thank you for your question I hand back the conference of the Sneaker collection.
Gosh.
Speaker Change: Yes, we have received a question online from Panabasit from Postman Park. His first question, I think, was discovered in our Q&A, so we'll move to question two, which is asking if you could please provide the breakdown of your R&D expense program for 2022.
Yes, we have received a question online component backlog comparison park.
First question I think was discovered in our Q&A that we'll move to question two which is asking if you could please provide the breakdown of your R&D expense program for 2022.
Speaker Change: Yes, thank you. Thank you, Kate. Thank you for the question.
Yes. Thank you.
Thank you for the question.
Speaker Change: For 2022, the majority of our expenses will relate to the Phase 3 NanoWave 312 study, which will...
Or 2022, the majority of our expenses will relate to the.
Okay.
<unk> three <unk> hundred.
<unk> hundred 12 study.
Which will.
B, reaching a peak, we expect the enrollment to reach its peak.
Speaker Change: be reaching a peak as we expect the enrollment to reach its peak in 2023. The other part of the expenses will primarily relate to the 1100 study, which is our I-O combination, in line with the two priority pathways that we have explained.
In 2023.
The older.
<unk> quarterly expenses will primarily relate to the.
The 1100 study, which is our I O combination.
In line with the two priority pathways that we have explained.
Speaker Change: Very good. Thank you for that clarification Bart. We do have another question that was submitted online during the call asking what we can expect from the discussion about immunotherapy with the FDA.
Very good thank you for that clarification we.
We do have another question that was submitted online during the call asking what we can expect in the discussion about immunotherapy with the SBA.
You want to add some color to that.
Speaker Change: We could, I think we've discussed this topic a little bit already. What we were saying, what we were expecting with this meeting is really to clarify a question about the population, about the use of the D1, about the type of endpoint we should use to move forward into market and we've been very satisfied with the answer we got. And now we are in the active phase of designing this program with our internal team and external TI.
We could I think with this.
Perfect. However, there'll be there already.
We can say and what we were expecting was it meeting its route to clarify a question about the population about the use of PD one about the type of endpoints, we should use to work to move forward into market and we've been very satisfied with the answer we got us and now we are in the active phase of designing this program with our internal team and excellent.
Speaker Change: So, we're really keen to continue that and to have that portfolio present to you, what is our plan to move forward.
So we're really keen to continue that into the.
<unk> presents you what is our plan to move forward.
Speaker Change: Thank you for that, Laurent. Our final question actually is a combination of a couple of questions that were submitted in advance and they relate to our ongoing work with curidine and if you could provide a status there as well as work related to the CNS.
Thank you for that.
Our final question actually it's a combination of a couple of questions that were submitted in advance and they relate to.
Our online work with paradigm and if you could go buy the status there.
And as well as worker and you can see.
Yes.
Sure.
Okay.
Speaker Change: So just to put that into context of perspective, our priority, meaning the investment and the attention of the vast majority of the company is focused on the development of NVTxRT. Nevertheless, there is a small team working for the future and preparing what will be our next platform. And we have two platforms in that regard under development at a critical stage. The first one is curatime and the other one is linked to CNS, the developer.
So just to put that into context all perspective.
Our priority, meaning the investments and the attention the vast majority of the company is focused on development and the Kid Entrees. Nevertheless, there is a small team working for the future and preparing for what will be on our platform and we have two platforms that we call under development at a preclinical.
Pitch. The first line is core and yoga one is lead to unit.
The disorder.
Speaker Change: So in the previous first platform, Curadigm, there is an ongoing collaboration with Sanofi that has been expanded to continue preclinical work and that should provide some data in the future.
So in the previous call.
Platform paradigm.
An ongoing collaboration with incentive fee being expanded.
To continue breaking equal work and.
That should provide some data in the future.
Speaker Change: According to the previous development we've made, and I think you can look at the patents we have published, and you will see the content of those two platforms. If you go to the one concerning the CNS, this is moving at the right pace from a pretty simple perspective and establishing proof of concept. And we'll report things as soon as we think it's agreeable after having moving our priority program in NBTI.
According to the private development, we've made and I think you can look at the back end, we established and you will see the content August two platform. It go to the one concerning the CNS visit.
Is it moving at the right pace from a preclinical perspective, and establishing proof of concept and we will report.
As soon as.
We think it's a gravel after having moving.
Alrighty program in any country.
Okay.
Speaker Change: All right, well, it looks like that concludes the Q&A session for today's call. We'd like to thank everyone for joining us in today's discussion, and look forward to keeping you updated on future calls of the year for Brexit. Thank you.
Alright.
That concludes the Q&A session for today's call, we'd like to thank everyone for joining us in today's discussion and look forward to keeping you updated on future calls as the year progresses. Thank you.
Okay.
Speaker Change: That's all for today, thank you for participating, you may hope.
It does conclude the conference for today. Thank you for participating you may all disconnect.
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