Q2 2021 Innate Pharma SA Earnings Call
[music].
Operator: Thank you for standing by, and welcome to the In8 Pharma Half Year Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. If you wish to ask a question, please press Star 1 on your telephone keypad. For your information, this conference is being recorded. Now, I would like to hand the conference over to your speaker, Monder Majubi. Please go ahead.
Good day, and thank you for standing by and welcome to the ignite pharma out of fear results conference call.
This time, all participants are in a listen only mode. After the speaker presentation. There will be a question and answer session. If you wish to ask a question. Please press star one on your telephone keypad for your information. The conference is being recorded now I would like to hand, the conference over to your speaker them under a measure would be please go ahead.
Mondher Mahjoubi: Thank you. Good morning, good afternoon, and welcome everyone.
Thank you good morning, good afternoon, and welcome everyone really pleasure to be here with you. Today. This morning, we issued a press release, providing a business and they thought the first half of 'twenty one.
Mondher Mahjoubi: It is really a pleasure to be here with you today. This morning, we issued a press release providing a business update for the first half of 2021. I look forward to explaining the progress we have made during the year to date, as well as addressing future goals and milestones. The press release and today's presentation are both available on the IR section of our website. And before we start, on site two, I would like to remind you that we'll make a forward-looking statement regarding the financial outlook in addition to regulatory and product plan development. These statements are subject to risk and uncertainties that may cause actual results to differ from those forecasts.
I look forward to explaining the progress.
We've made younger yesterday, as well that got us in future goals and milestones.
And today's presentation are both available on the IR section of our website.
And before we start on slide two I would like to remind you that we'll make forward looking statements regarding our financial outlook. In addition, so I go with the audience and product development. These statements are subject to it.
That may cause actual results to differ from those forecasted.
Mondher Mahjoubi: On today's call, I'm delighted to be joined by Dr. Justin Carcuno, EEPP and Chief Medical Officer, and our TFO, Fredé Colombar, who will present an update, followed by a KNA station. On slide four, you have the classic intro slide of innate farmer. As you know, we are pioneers in the field of innate immunity, and in particular, NKS. You follow the science to develop innovative therapeutics for patients, leveraging our know-how and antibody generation platforms. We are using this expertise to develop a robust pipeline of novel medicines for cancer. Please move to slide five.
On today's call I'm delighted to be joined by Dr. Jason Cox, EVP, and Chief Medical Officer, and I want to.
Who are they called ball, who will present, an update followed by a Q&A session.
On slide four you'll have the classic into slide Nate calling them.
As you know we are pioneers in the field of Nathan entity.
And in particular, an NK cell.
Follow the science to develop innovative to ethics probation, leveraging our knowhow and antibody generation platform.
We are using this expertise to develop a robust pipeline of novel medicines for cancer.
Please move to slide five.
Mondher Mahjoubi: Our, shows how we have translated scientific leadership into a robust portfolio of both proprietary and partnered assets. It also illustrates how we are executing against our strategy, with our lead asset, Lakitamap, supported by partners and also earlier stage products. Additionally, we have a rich pipeline, including the Adiline pathway, with an anti-Cdi-S73 and an entire CD-39 in the clinic, and a pool of preclinical projects, including our NCTNCET and KSL Engager platform, which we will carefully select and bring forward to fuel our clinical pipeline. He's moved to sign six.
Our pipeline.
Shows how we have contemplated the scientific leadership into a robust portfolio of both proprietary and partnered assets.
It also illustrates how we are executing against our packaging.
Our need is to keep them up supported by partner and also earlier stage product.
Additionally, we have a rich pipeline, including the I didn't even pathway with an empty anti excuse me, Kentucky tea and an anti PD effect.
In the clinic.
Cool.
Clinical projects, including our 10-K and kits and engage her pets for which we really carefully select and bring forth and fewer our clinical pipeline.
Yeah.
Please move to slide six.
Mondher Mahjoubi: Our strategy centers around three core priorities. Furthermore, we look to drive value from our early R&D efforts through late stage partnerships, where it makes sense to do so. First, we look to create near-term value driven by our lead proprietary product candidate Lakutamab, which is in development for TCLM format. Second, fuel our pipeline and create longer-term value by leveraging our antibody engineering capabilities to develop innovative molecules with the primary focus on our multi-specific NCSEL Engager platform delivered from our property, the NKKK platform. And third, we are building a strong and sustainable foundation for our business, leveraging various partnerships across industry and academia.
Oh it was how could your centers around three core priorities, while we look to drive value come on early R&D airports.
<unk> latest stage partnerships.
It makes sense to do so.
First we look to create near term value driven by our unique proprietary product candidates that could line up which is in development for T cell lymphoma.
Second shooter in our pipeline and create longer term value by leveraging our antibody engineering capabilities to develop another.
These molecules with a primary focus on our multi specific interests and engage your platform delivered from all our propriety <unk> excellence.
Excellent.
We are building a strong and sustainable foundation for royalty revenue.
We have taken various partnerships across industry and academia.
Mondher Mahjoubi: We will look to partner, including in the late stage, when it makes sense to do so. This will further validate our science and offer capital that you can reinvest to advance our early portfolio. During the first half of this year, we have worked intelligently to execute against these three core priorities.
We will look to partner, including late stage when it makes sense to do so these moves further validate our sign ups for capital that you can reinvest to advance our early portfolio.
During the first half of this year.
We're working diligently to exit two against these three core priorities.
Mondher Mahjoubi: Number one, we have continued to advance Lekitama as we pursue a broad development strategy across T-CEL and Forma. We were excited to showcase Lekitamab data in Microsisphan from the Phase 2 telemet trial at Lugano, and we have progressed to stage 2 earlier than anticipated. In addition, we announced our stepwise approach in developing Lakutamabin PTCF, with two clinical studies for K3DL2 expression patients with relapsed perical T-cell lymphoma, including a randomized controlled trial in collaboration with our partner at the leader of lymphoma study at the disease. We have also worked hard to advance our IND efforts with our early stage program moving forward.
But one we have continued to advance likely time that as we pursue.
<unk> development package at a cost of T cell lymphoma, we were excited to showcase Medicare donut data in Microsoft's Hungary, that's from the phase II Pennymac try it I forgot and we have forecasted to stage two earlier than anticipated.
In addition, we announced our stepwise approach in developing electric imagine P. Just yet.
With two clinical studies for Q3 deal two expressing patients with T cell lymphoma.
Our optimized controlled trial in collaboration with our profit now at the Liza.
And then for Mexico, the extra C H.
We have also.
We're working hard to advance our R&D efforts with our early stage program moving forward.
And we were pleased to announce earlier this year that Sanofi made the decision to progress if you're a 61 to one our lead and guest engagement into R&D.
Mondher Mahjoubi: And we were pleased to announce earlier this year that Sanofi made the decision to progress APS 61-1, our lead and KSEL engagement, into an IND-E-11 study. This is the first candidate to emerge from our multi-specific Encayette and Kisela-Engager platform, and we are very excited by the prospect of this technology, which we believe will fuel our pipeline well into the future. We look forward to telling you more about our progress here, later in this course, and in the near future.
This is the first candidate to emerge from our own Mercury specific okay.
If they engage their platform and we are very excited by the prospect of this technology, which we believe will fuel our pipeline went into the future.
We look forward to telling you more about our progress here.
Later in this call.
And in the near future.
Lastly, we look for further updates on our I'm wondering if you might be collaborations with data from the randomized phase two of course tried in stage III unresectable non small cell lung cancer, which will be presented at ESMO. This week I would say.
I will pass the call over to Jason who will review the progress made with our portfolio starting with our lead proprietary asset Joseph.
Thank you Montana.
Mondher Mahjoubi: Lastly, we look for further updates on our Mononizumab collaboration with data from the randomized phase two cost trial in stage three, unrejectable, not-mortel, and cursor, which will be presented at ESMO. I would like now to pass the call over to Joyce, who will review the progress made with our portfolio, starting with like a time out our lead proprietary asset. Jason.
On slide seven let me start with Lacuna map, a first in class humanized monoclonal antibody.
Targets the immune receptor Q3 deal too.
As you May remember Q3 deal chose a inhibitory receptor found in approximately 65.
Septic patients across all cutaneous T cell lymphomas, and even more in certain aggressive subtype.
But with limited expression in healthy tissue.
To date data from looking at that have shown promise demonstrating compelling single agent activity and offering immense potential and lymphoma historically associated with a poor prognosis for which there are few therapeutic options at an advanced stage.
Joyson Joseph Karakunnel: Thank you, Mon. On slide seven, let me start with Lakutamab, our first in-class humanized monocloval antibody that targets the immune receptor cure 3DL. As you may remember, cure 3D2 is an inhibitory found in approximately 65% of patients across all cutaneous T-cell lymphomas and even more in certain aggressives, but with limited expression and healthy tissue, data from Likidamad have shown promise, demonstrating compelling single agent activity and offering immense potential in lymphoma historically associated with a poor prognosis for which there are a few therapeutic options at an advanced stage on slide 8.
On slide eight.
I just wanted to remind you of our development strategy for Lacuna Mab in T cell lymphoma.
We are pursuing a fast to market strategy with a potentially pivotal trial underway in the niche of setting of surgery syndrome, where likuta Mab was granted us fast track designation EU Prime designation last year.
We are also looking to potentially expand past sensory syndrome, two bankruptcies from grade, where we have encouraging preliminary data from our phase III trial, which I'll cover in a minute.
Finally, we are advancing into peripheral T cell lymphomas with a couple of recently announced trials.
On slide nine.
Let me highlight the great progress we have made this year in our ongoing phase III <unk> study for surgery syndrome in my case, it's been great.
And my cookies categories. Firstly, we moved the Q3 D. L. Two expressing cohort from stage one to stage two clearing a pre determined thresholds before 50% of the cohort was involved.
Joyson Joseph Karakunnel: I just wanted to remind you of our development strategy for Lakutamab and T-Cell lymphoma. We are pursuing a fast-to-market strategy with a potentially pivotal trial underway in a niche setting of Cesary syndrome where Lakutamab was granted U.S. Fast Trek designation and EU Prime designation last year. We are also looking to potentially expand past Cesary syndrome to Microsis fungoidase, where we have encouraging preliminary data from our phase two trial, which I'll cover in. Finally, we are advancing into peripheral T-cell lymphomas with a couple of recent, on slide nine.
The Q3 deal to MF data was also presented at <unk> with the next MF data are due in 2022.
For the century syndrome cohort enrollment is on track and we expect to be able to report topline data in 2022.
On slide 10, we have a summary of the cohort two micro system glad these data in Q3 be able to express yours.
Here, we see the preliminary results of cohort two which showed an overall response rate of 35% in these late line patients with limited treatment options.
You see the median follow up is still short for eight months.
It is important to consider that there are quite a lot of confirmed responses and we now have six confirmed responses out of 17.
And you see that some patients have quite a long duration of follow up in this cohort two.
If we look at the response by compartment in the skin you see that the responses are quite high now with 11 confirmed responses out of 17.
Joyson Joseph Karakunnel: Let me highlight the great progress we have made this year in our ongoing Phase 2 Calamac study for Caesarey Syndrome and Microsisomboid. In Mykosi's fungoides, firstly, we moved the Q3DL2 expressing cohort from stage one to stage two, clearing a pre-determined threshold before 50% of the cohort was. The CIR3D2MF data was also presented at McGuG, with the next MF data For the CESRI syndrome cohort, enrollment is on track, and we expect to be able to report top-line data in 2020.
These skin results are extremely interesting because skin is very important for quality of life of the patient.
And so it is interesting to see that the majority of patients had represented a very good complete or partial response in the skin.
We are encouraged by the data and look forward to further proof points in 2022.
On slide 11 as mentioned.
We are working to advance our recently announced clinical development plan for peripheral T cell lymphoma, which will focus initially on the relapsed setting where the unmet medical need is most significant.
We are initiating our phase one b trial evaluating Luke lucrative mab as a monotherapy by mid year.
The study will enroll approximately 20 patients and will evaluate safety and characterized clinical outcome.
First data are expected in 2022.
Okay.
Separately, our partner Lisa are initiating an investigator sponsored phase two study to evaluate lacuna mab in combination with the chemotherapy jet marks.
Joyson Joseph Karakunnel: On slide 10, we have a summary of the cohort to Mycosey Stungoides data in Cure3DL2 Express. Here we see the preliminary result cohort 2, which showed an overall response rate of 35% in these late-line patients with limited treatments. You can see the median follow-up is still short, 4.8 months.
This study will be a multicenter randomized trial with approximately 16 relapsed refractory patients outside the U S.
We believe that this stepwise approach will prove efficient and identifying the optimal regimen for likuta map in the relapsed P. T C L setting.
Depending upon the data generated in these initial studies, we will consider initiating a separate trial in combination with another standard of care trip and.
Joyson Joseph Karakunnel: It is important to consider that there are quite a lot of confirmed responses, and we now have six confirmed responses out of seven. And you see that some patients have quite a long duration of follow-up in this COVID. If we look at the response by compartment in the skin, you see that the responses are quite high, now with 11 confirmed responses out of 17.
And eventually we would look to move lacuna map into earlier lines of treatment, including as potential combination and the chop regiment in the frontline P. T C L or as a consolidation therapy. Following standard first line treatment.
Okay.
Moving on to slide number 12.
We are pleased to have presented our latest innovation to our proprietary multi specific NK cell engagement platform that we call and cat.
Which Eric can deviate presented at the close of this meeting in June.
Joyson Joseph Karakunnel: These skin results are extremely interesting because skin is very important for the quality of life of the patient. And so it is interesting to see that the majority of patients had a very good complete or partial response. We are encouraged by the data and look forward to further proof points in 2020. On slide 11, as mentioned, we are working to advance our recently announced clinical development for peripheral T-cell lymphoma, which will focus initially on the relapse setting where the unmet medical need is most significant. We are initiating our Phase 1B trial evaluating Luke Lakutamab as a monotherapy by Mnich. The study will enroll approximately 20 patients and will evaluate safety and characterize clinical outcomes. First data are expected in 2020.
And for which an oral presentation has been accepted for ESMO. This week.
And kept stands for antibody based NK cell engagement therapeutics.
And these multi specific molecules are made of various building block as is illustrated here.
The reason why we are so excited about the cat is because we are announcing two breakthroughs first a technological breakthrough in second and efficacy breakthrough.
This is leading to the harnessing of NK cell effector function against cancer and also provides.
Proliferation.
So on the technological breakthrough as you can see on this slide and cat is very versatile fit for purpose technology that is creating an entirely new class of try and tetra specific molecules to induce strategic immunity against cancer.
On the efficacy breakthrough this unique NK cell engagement engages for the first time to activating NK cell receptors, namely N. K P 46, and <unk> 16, but also the combination of receptors for IL, two IL, two or beta and IL two our gamma.
With the IL, two variant and tumor antigen and a single tetra specific molecule.
Joyson Joseph Karakunnel: Separately, our partner, Lisa, is initiating an investigator-sponsored phase two study to evaluate Lakutamab in combination with chemotherapy Gemma. This study will be a multi-center randomized trial with approximately 60 relapsed refractory patients outside. We believe that this stepwise approach will prove efficient in identifying the optimal regimen for Lakutamab in the relapsed PTCL setting. Depending upon the data generated in these initial studies, we will consider initiating a separate trial in combination with another standard of care, And eventually, we would look to move Lakutamab into earlier lines, including as a potential combination in the chop regimen in front line PTCL or as a consolidation therapy following standard first line training.
Overall, it demonstrates a better antitumor efficacy then clinically approved antibodies with live within the limit of preclinical models.
Okay.
On slide 13 is a summary of the data on our recent generation of Tetra specific.
Which is made of four components in yellow and antibody fragment that recognizes the tumor antigen in green and antibody fragment that recognizes and KC 46, and then red and FC portion that will interact with <unk> 16, and then in Blue a variant of the interleukin two.
To IL two.
Got it.
On the left side of the graph. We show you the contribution of the Tetra specific and cat with the IL two variant.
The black graph on the far left is the vector.
The Green graph is the tetra specific and cat and the Red graph on the right is a tri specific end cap with the IL two very separate.
You can see the benefit from the green graph in the middle of including the Tetris perfect specific and with the Io to ovarian.
On the right you can see the benefit of Tetra specific versus the vehicle have been a Tuesday night.
Joyson Joseph Karakunnel: Moving on to slide number 2, We are pleased to have presented our latest innovation to our proprietary, multi-specific NK-cell Engager platform that we call NKC, which Eric Vivier presented at the Fosus meeting in June and for which an oral presentation has been accepted for asthma. NK stands for antibody-based NK-cell Engager Therapy. And these multi-specific molecules are made of various building blocks, as this illustration illustrates. The reason why we are so excited about NCAT is because we are announcing two breakthroughs, a technological breakthrough and, second, an efficacy breakthrough.
In lung mouse models.
On the top you have the vehicle in the middle Tetra specific and cat and on the bottom the CD 20 <unk> to the map.
Activity is seen with the Tetra specific model that is not seen with <unk>.
We look forward to updates on end cap this year at ESMO and other scientific Congresses, and look forward to progressing our partnership with Sanofi.
Finally on slide 14, we have our third pillar of our strategy of building sustainable business.
Wanted to highlight the latest developments for mono is a map, which we have out licensed to Astrazeneca and received $400 million in milestones to date.
With further potential milestones due.
To remind you none of them is the mab as an anti NK G to ache, which acts upon the checkpoint pathway to potentiate NK cell activation.
This is being trialed in combination with Cetuximab in head and neck cancer and also in combination with the anti PD lone immunotherapy or value map in lung cancer.
Joyson Joseph Karakunnel: This is leading to the harnessing of NK cell effector function against cancer and also provides proliferation. So this technological breakthrough, as you can see on this slide, MCAT is a very versatile, fit-for-purpose technology that is creating an entirely new class of tri and tetraspecific molecules to induce strategic immunity against cancer. On the efficacy breakthrough, this unique NK cell engager engages for the first time with activating NK cell receptors, namely NKP 46 and CD16, but also the combination of receptors for IL2, IL2R beta, and IL2R gamma, with the IL2 variant and tumor antigen in a single tetraspecific molecule.
In head and neck cancer, the phase III Interlink, one truck trial, if mentalism App plus detects about in Io pretreated head and neck cancer is underway.
In addition, we are expecting data from cohort three of the phase two trial later this year for the triplet of mono is a mab cluster value map plus cetuximab in first line head and neck cancer.
As mentioned previously the phase II data in stage III non small cell lung cancer post trial for Mona Lizabeth in combination with their value map will be presented at ESMO. This week by Astrazeneca.
In summary, we look to work further with our partners.
At Astrazeneca.
I'll now hand over to Fredrik to cover the financials for the half.
Thank you, Jason and good day everyone.
So moving to the final slide 15, I was stuck without one of our key metrics as usual how cash position.
Joyson Joseph Karakunnel: Overall, it demonstrates a better anti-tumor effect than clinically approved antibodies within the limit of preclinical models. On slide 13, is a summary of the data on our recent generation of Tetris Pacific and, which is made of four components.
Our cash and cash equivalent amount to $263.0 million Euro as of June 30, this year down from.
Under the 90 to $8.0 million at the end of Q1 'twenty 'twenty. One we are in a strong financial position with cash to fund planned operation to at least 2022.
Joyson Joseph Karakunnel: In yellow, an antibody fragment that recognizes the tumor antigen. In green, an antibody fragment that recognizes MK46, and in red, an FC portion that will interact with CD16. And then, in blue, a variant of the interleukin-2iol2 gene. On the left side of the graph, we show you the contribution of the Tetrispecific N-CAT to the IL2 variant. The black graph on the far left is the
In addition, as you can see we are efficiently managing our resources and sizing opportunity to accelerate our impact by nimbly following debtor to explore strategic and opportunistic indications.
We believe this approach ensures that we remain in position to strategically invest in our vision for Tonight.
Now going into the P&L.
Joyson Joseph Karakunnel: The green graph is the Tetris-specific NCAT, and the red graph on the right is a tri-specific N-cat with the IL2 variance separate. You can see the benefit from the green graph in the middle of including the Tetris-specific N-CAP with the IL2 very, On the right, you can see the benefit of Tetris Pacific versus the vehicle of binituzanab in lung mouse models. On the top, you have the vehicle in the middle, Tetra-specific NCAT, and on the bottom, the CD20 Obinitusuzaa. Activity is seen with the Tetra-specific model that is not seen with Obinatis.
The only comment on the main and months significant lines.
And you have very detailed equipments in the appendix of the press release is that you can refer to for more information.
I start with our revenue for Coke production.
So our revenue and other income amounted to $22.0 million Euro and domain.
From revenue was from collaboration and licensing agreements and to a lesser extent from governmental funding.
This revenue mainly result from the spreading of the upfront payments received from Astrazeneca for bananas, Schmila, which I'll remind all be cognize on the basis of the percentage of completion of the work done by the company.
Joyson Joseph Karakunnel: We look forward to updates on NCAT this year at ESMO and other scientific congresses and look forward to progressing our partnership with Fennon. Finally, on slide 14, we have our third pillar of our strategy of building sustainable business. I wanted to highlight the latest developments for Mona Lizamab, which we have outlicensed to Aschazeneca and received 400 million in milestones to date, with further potential milestones to come. To remind you, Monolizab is an anti-NKG2A antibody that acts upon the checkpoint pathway to potentiate mk cell activation.
I also remind you that he has no impact on cash.
On the operating expenses so for the first half of 2021 day amounted to $42.0 million Euro rejection of 11% from the first half of 2020.
<unk> expenses decreased by $16.0 million Euro to 'twenty one.
<unk> 8 billion, representing just over half of our approaching expenses.
This change mainly resulted from a decrease in depreciation and amortization expenses allocated to R&D. Following the end of the transition period. We just hosted in September 2020.
Also the return of commercialization rights in the U S and Europe fully amongst city isolated at the end of the equipment and trials evaluating how about.
Joyson Joseph Karakunnel: This is being trialed in combination with cytoxumab in head and neck cancer, and also in combination with the anti-PDL1 immunotherapy dervaluumab in lung cancer. In head and neck cancer, the Phase 3 Interlunk 1 trial of monolizumab plus de Tuxtap, in I.O.
Holly Mt.
Sorry.
Turning to SG&A expenses, they increased by four 8 million Europe too.
<unk> Dot 3 million euros for the period, primarily as a result of the provision for charges booked relating to the payment of $6 to USD 1 billion to be made to us wasn't it kind of April 2022.
Joyson Joseph Karakunnel: pretreated head and neck cancer is underway. In addition, we are expecting data from cohort three of the phase two trial later this year for the triplet of Monalysmab plus gervaluumab plus tetanib in first-line head and neck cancer. As mentioned previously, the phase two data in stage three non-smouthill lung cancer, the Coast Trial for monolizab in combination with dervaliumab, will be presented at ESMO this week by Astrosaner.
Amongst city transition and termination agreement this.
This is less than the company reported up to twice, but 8 million USD contingent liability at the end of 2020, which was linked to the split of certain manufacturing costs.
Such that income from distribution agreements was named following the end of the transition period relating to the commercialization of <unk>, which ended in the U S.
The company recognized 1 million USD.
That said softly Merck city for the first half of 2021.
Joyson Joseph Karakunnel: In summary, we look to work further with our partners at AstraZeneca. I will now hand over to Frederick to cover the financials for them. Thank you, Joyce Van. Good day, everyone.
With that I will turn back to him on that.
Thank you and thanks for joining us.
Please move to slide 16.
As you can see we are working diligently to execute across all of our strategic pillars and believe that we are laying the foundation to drive near and long term value for our patients and our shareholders.
Frederic Lombard: So moving to finance slide 15, I will start with one of our key metrics, as usual, our cash position. Our cash and cash equivalents amounted to 159.4 million euros as of June 30 this year, down from 181.7 million at the end of Q1. We are in a strong financial position with cash to fund planned operations to at least 2020. In addition, as you can see, we are efficiently managing our resources and sizing opportunities to accelerate our impact by namely following data to explore strategic and opportunistic indications.
Moving on to our clinical program, we expect to achieve a number of milestone over the next 18 months.
Thank you Tom Johnson, our phase two panamax tankers for electric continues to progress.
And we expect to report potentially pivotal data in <unk> syndrome.
Microsoft's longer this in 2022.
In addition, we are moving all would be helpful.
Got them into the clinic with initial data expected in the next year.
From $1 amount and we look forward to the phase two of course data at ESMO described there, which builds on the hypothalamus and then monetize them up to the anti PDL, one you're talking about.
They can be sure as you've heard from Jason We will present the data from cohort three of the phase III in head and neck cancer study.
Just on the combination of monetarism up which took some I've been doing probably not in Io naive patients with advanced head and neck cancer.
We are further advancing the Edmonton pathway agents in the clinic.
Where we are starting a new phase one trial for <unk> hundred one.
Enticing because they can see and we look forward to data from the impact should be 39 acres 50 to a one <unk> and 'twenty to 'twenty two.
Frederic Lombard: We believe this approach ensures that we remain in a position to strategically invest in our vision for ENA. Now, going into the P&L, we only comment on the main and most significant lines, and you have very detailed comments in the appendix of the press release that you can refer to for more information. I will start with our revenue for collaboration. So our revenue and other income amounted to 15.7 million euros, and the main resulted mainly from revenues from collaboration and licensing agreements and to a lesser extent from governmental funding.
In parallel we continue to the breadth of our technology platform and we are very encouraged by the preclinical lines from our next generation it and kitchen engagements. We believe this represents a natural evolution of our platform. It is placement of the potential for all the thinking.
And the fact that they could become the next generation off the shelf cancer immunotherapy with more to come as Jason said.
Is that the day as an oral presentation at ESMO.
We look forward to further updates on the pockets of our <unk> platform.
In the second half of this year.
Most of the conclusion slide number 17.
So as you can tell we have an exciting journey ahead.
We continue to build our business to create value for patients and stakeholders and then somebody would have positioned you made pharma for the future would be surfaced RPG and made meaningful progress throughout the year just to recap in summary.
Frederic Lombard: This revenue mainly results from the spreading of the upfront and uptime payments received from Afrazeneca for Monadishma, which are recognized on the basis of the percentage of completion of the work performed by the company. I also remind you that it has no impact on cash. For operating expenses,
We moved forward with our MF trial and presented data at ESMO guidance next year, when we'll have data on MF and potentially pivotal data in <unk> syndrome, and we will start with people who sell products.
Second our R&D engine was further validated at Sanofi chose to progress a pea of 61 to one into R&D, enabling studies will continue to leverage this antibody capability to develop innovative molecules with a primary focus on our next generation and kit and consent engaging molecules has also demonstrated that.
Frederic Lombard: So for the first half of 2021, they amounted to 41.1 million euros, a reduction of 11% from the first half of 2020. R&D expenses decreased by 9.7 million to 21.8 million, representing just over half of our operating expenses.
S mortgage here and finally as you heard from Jason we continue to be the sustainable business by balancing our portfolio with partners.
Provide substantial revenue stream to support our continued investment in early on.
Collectively we are driving value across all of our business that there's some I think I had mentioned our goal to deliver innovative medicines to patients we look forward to keeping Europe Lincoln.
On our program.
With that I conclude the prepared remarks, and I will now open the call to questions operator.
Frederic Lombard: This change mainly results from a decrease in depreciation and amortization expenses allocated to R&D following the end of the transition period with AstraZeneca in September 2020. Also, the return of commercialization rights in the US and Europe for Lemox City, as well as the end of recruitment in trials evaluating Abdo Halimab in oncology. Turning to SG&E expenses, they increased by 4.8 million to 19.3 million euros for the period, primarily as a result of the provision for charges booked relating to the payment of 6.2 USD million to be made to AstraZeneca in April 2022 under the Lumox City transition and termination agreement.
Thank you if you wish to ask a question. Please press star one and wait for your name to be announced if you wish to cancel your request. Please press the husky.
In Star one if you wish to ask a question.
And our first question from the line of Dana Great Bush.
Go ahead.
Hi, Thank you for the question two for me one just thinking ahead for them on their list.
Spend it on Saturday.
If you could remind us.
How much overlap in efficacy and read through.
That supercell concept study do you believe there is when you combine lunar listen aperture of Allomap versus attack the man.
Does either of these.
Combinations or mechanism by the activity the CD eight cells or NK cell.
And then in addition.
Keeping alive.
Could we see neocart.
I noticed in Europe.
Also implied that maybe.
You don't have.
Frederic Lombard: This is less than the company reported up to 12.8 million USD contingent liability at the end of 2020, which was linked to the split of certain manufacturers. As such, net income from distribution agreements was nil following the end of the transition period relating to the commercialization of Lomoc City in the U.S.
Specific visit you just wondering if the possibility of a car.
Thank you Dana.
I repeat the question because the line was not so great. So it makes it worth it.
Got it right in every one of them are also kind of get them. So you you you ask a question on the new Yorkers data when they do you think there will be a public and your first question was about the potential read across or read through.
The constant data to the Entel, Inc. Ah trial and the combination of one of them is in Marlborough cyclic steam up I'm, a correct repeating in car T. Okay. Okay perfect.
Frederic Lombard: The company recognized one million ULD net cells of Lomoc City for the first half of 2020. With that, I will turn back to Monda. Thank you, Fredelik. Thanks to Jerry.
With the with the <unk>.
Second question very quickly.
Say that Oh, and you know the no because.
It was done by Uh Huh.
Sponsored and run by Us.
I really don't hurt inflammation than what is publicly available on the AG side, which means that the data are expected in the second half of 'twenty 'twenty. One. So you will hear more from income aging in the near future.
With regard to your first question I think this is this is an excellent opportunity also for us too.
Mondher Mahjoubi: So please move to slide 16. As you can see, we are working diligently to execute across all our strategic pillars and believe that we are laying the foundation to drive near and long-term value for our patients and our shareholders. Looking at our clinical program, we expect to achieve a number of milestones over the next As you've heard from Jason, our Facebook, Calomax Study for Lakota Map, continues to progress, and we expect to report potentially pivotal data in cesare syndrome and in microsophongoidase in 2020.
I remind you our I was talking to you from the basic research in the slide that Johnson showed to illustrate his remarks I'm wondering as you map and you have to making it more friction that where the blocker now went out as the first one is oh.
Way to enhance the agency CMO of antibodies that are like Citrix you could.
Have a synergistic effect when combined with the.
No no listen I've been to watch what's led to the Europe had to make poker arm in.
The phase III trial that we'll stop it there.
Last year in the second.
Yeah.
Diesel for inflammation and piece of data that was published already instead in 2019 was basically the preclinical package that supported the clinical program of the competition I'm wondering is about Ben.
Mondher Mahjoubi: In addition, we are moving our PTG program into the clinic, with initial data expected in the next year. For monolizumab, we look forward to the phase two course data at Esmo Discride, which builds on the hypothesis adding monolizumab to the anti-PDL1 drivolumab. Later this year, as you've heard from Jersey, we will present the data from cohort three of the phase two Hedinac cancer study testing the combination of monolizumab with seducinum and duolumab in Ayu, a naive patient with advanced head and neck cancer.
Anti PD, one or PDL, one showing the clear synergy coming from the fact that you know encouraged ways not only expressed on NK cells, but also on a subset of CDA positive T cells.
First of all I think the two trials the two setting and in the two type of combination are supported by strong scientific rationale no as you as you are no better than that.
These are two different tumor types in two different setting and it's really.
Pre mature to a festival to speculate on the data before because data presented then of course I would be very cautious not to have a cross trial comparison or read across but I'll hand over to Joyce into who.
Ken maybe complete defensive.
Yeah.
Hmm.
Mondher Mahjoubi: We are further advancing the advertising pathway, agents in the clinic, where we are starting a new phase one trial for APH 5301, the anti-CD 73, and we look forward to data from the anti-CD-39 APH-50202. In parallel, we continue to develop our NK technology platform, and we are very encouraged by the preclinical results from our next generation of KCLengagers. We believe that this represents a natural evolution of our platform, illustrates the potential role of encase and the fact that they could become the next generation of shelf cancer immunitarity. With more to come, as Jason said, this Saturday is no reflection of ESMobil, Eric. We look forward to further updates on the progress of our Enkate platform, the second couple.
I think Monday are summed it up very nicely I think the strength of the preclinical data that supported these trials both with Cetuximab.
As well as with Durbin devalue Mab have two different mechanisms of actions that we look for that.
The combination potentials, we've already kind of seen some of that with head and neck.
And we'll have to wait for the data to see what.
What happens with the.
With coast.
I think second I think Monday I printed it out very nicely, which is these are two different indications two very different settings.
Adjuvant the other metastatic.
And it.
It would be hard to kind of read across the trials or read across.
Cross trial comparisons.
Not only because we we try not to do that but also just because of the different indications.
Settings, as well as commitments of action.
Thank you Jason.
Does it answer your question Dan.
Yes. It does thank you very much.
Yeah.
We're taking our next question from the line of Ethan No home of Citigroup.
Okay.
Thanks, Amanda and Tim I, just had a few questions. So first I know, obviously, you can't disclose the data yet on the or.
Yes, that's for cost ahead of the late breaking presentation.
Mondher Mahjoubi: Please, most of the conclusions slide, try number 17. So, as you can tell, we have an exciting journey ahead at Inmate. We continue to build our business to create value for patients and stakeholders. And, in summary, we have positioned in eight farmers for the future with this approach strategy and made meaningful progress throughout the year. Just to recap, in summary.
That said to the extent that you can comment generally what percent improvement or are in PFS would you view as clinically meaningful benefit for amount of losing that cluster valley Mab combo over the valley map monotherapy.
Yes.
Thank you there you go.
Again.
We look forward to seeing the port.
They presented at ESMO.
As you know as an oral late breaking abstract these won't be tainted by a backlog or any kind of a quick and visa.
A report or.
But they also are present PFS data pool.
Mondher Mahjoubi: Lekitama, we moved forward with our MF trial and presented information data at Lugan. Next year, we will have data on MF and potentially pivotal data on Suzary Syndrome, and we will start the particular trial. Second, our R&D engine was further validated as Sanofi chose to progress APH 6101 into R&D enabling studies. We will continue to leverage this antibody capability to develop innovative molecules with a primary focus on our next generation, NKET, NKEL Engager molecules, which we have also demonstrated at FOSI and ESMO this year.
Both arms are worried about this when I was an oven you brought it up.
And it came out versus just dumping okay.
I think.
The design of the trial as is well known it has been already a.
Publicly disclose it it's oh.
When a controlling stake.
One of the nice things to trial.
They are.
But I have not.
To my knowledge a publicly disclosed the.
Details of the statistical hypothesis.
But I believe what is interesting to have in mind is that.
These are patients who.
Finish the cumulative nation therapy and are randomized within six weeks, if they do not progress and they are being treated.
With the with the different mono mono literally amount for up to 12.
We had a small the response rate is certainly a very important endpoint then.
The primary endpoint for this trial, but the quality of the response and in particular, the disease free survival or progression free survival is certainly something to look at is what I thought I believe.
Mondher Mahjoubi: And finally, as you heard from Jason, we continue to build a sustainable business by balancing our portfolio with partner assets that provide a substantial revenue stream to support our continued investment in early hours. Collectively, we are driving value across our business and, ultimately, advancing our goals to deliver innovative medicines to patients. We look forward to keeping you updated on our program. With that, I conclude the prepared remarks, and I will now open the call for questions.
So I think it's certainly.
And important to us and we look forward to.
Those data, but I think the U.
The PFS is something of course, we can keep in mind.
Yeah.
Okay got it. Thank you and then a second question I had on the Kitimat.
Talk a bit about how you're planning to identify hazards syndrome, and Microsoft's been greatest patients given that in the major pharma markets U S. Europe and Japan. There are only 270 patients and about 3000 micro sprung bernie's patients. According to the Seer database.
Yeah.
Yeah, just to make sure I get your question.
Is it.
It would be the commercial opportunity.
And in China on about how we are designing and implementing and executing our clinical trial.
Now more about the commercial opportunity yeah, we will.
Operator: Thank you. If you wish to ask a question, please press Star 1 and wait for your name to be announced. If you wish to cancel your request, please press the hash key. Once again, Star 1, if you wish to ask a question. We're taking our first question from the line Dina Graybos. Please go ahead.
Yeah. Thank you.
This is of course, a great question and it gives me the opportunity to go.
Go back to our strategy I think.
Is there any syndrome indication came off as.
As a as a.
Prototype indication if I can say to validate the mechanism of action since the majority of these patients are expressed in Q2 and we have seen in the phase one basically from the parent level debt. When you target. This these tumor antigen in Q2.
Daina Graybosch: Hi, thank you for the question. Two for me.
Daina Graybosch: One, just thinking ahead to the Mona Lisman data to be presented on Saturday, I wonder if you could remind us how much overlap in efficacy and read-through from concept to proof of concept study there is when you combine Mona Lismab after Valamette versus sotucamab? Does either of these serenic combinations or mechanisms bias B activity to CD8 cells or NK cells? And then, in addition, keeping alive my prudence, could we see Neo-Cost data this half? I notice it's not on your miles from slides, but maybe you don't have specific visibility. Just wondering if it's the possibility of
You get a significant tumor shrinkage and even an improvement with Pfizer I think this is any tend to make sense.
He's the I have to say that the first step and I should say would be the Uh huh.
Fast to market strategy in order to.
Really get loser.
Fast track designation and prime designation in exchange with the FDA and EMA in order to exit eight to clinical development.
The.
Intense of course used to extend beyond that.
The micros each country. This is.
It's half of the PTC and as you know.
Alright, and nucleus longer does that account for about three and a half two macs 4000, new patients and the U S and in Europe, and Japan, and there are about 4000, none may cause he's bumping against Pete.
T cell lymphoma. So already noted we're talking about up to 8000.
Mondher Mahjoubi: Thank you, Dana. I'm going to repeat the question because the line was not too long, so to make sure that I got it right and everyone else can hear it. So you asked questions about the neocos data, when this data will be public, and your first question was about the potential read-across or read-through from the cross-data to the entailing trial and the combination of nether-link monolizumar buz
Patients with cutaneous T cell lymphoma half of them would express the case, you're going to and again the macro just won't grow this segment.
Not at the end of the story.
Much more attractive and much more competing.
The business case, but of course, the the I think the.
Most important is my understanding also of the Lugano meeting that we have been able to show that like within that.
Works.
I was trying to convey syndrome and walks in T cell lymphoma, which expressed that keeps you there too which of course.
Hum.
Mondher Mahjoubi: I may repeat and correct. Okay, perfect. So I'll start with the second question very quickly to say that, as you know, the Neocas data is run by AstraZeneca, it's sponsored and run by AstraZica, and we have really no further information other than what is publicly available on the AD site, which is that the data is expected in the second half of 2021. So you will hear more problems from AD in the near future.
So really define if I may say, the scientific rationale to expand now to parents and T cell lymphoma, where the business case that of course with more than 18000, new cases every year because they felt they tend lymphoma has a much more attractive commercial prospects, but again the stepwise approach is to you.
Validate the mechanism of action.
This is not this is Eddie syndrome syndrome drug, but he blocks I would try to state syndrome, which we are exploring and very data and as we speak in Panamax and then Golden pass on T cell lymphoma, and then when you look at the totality of the business case.
It's no longer a need.
Each indication, it's a significant market opportunity.
Mondher Mahjoubi: With regard to your first question, I think this is an excellent opportunity also for us to remind you of our strategy from the basic research and the slide that Joison showed to illustrate his remarks on monolizumab. You have two mechanisms of action that have been developed. But, you know, what I was the first one on is a way to enhance the ADTCO of antibodies that, like Cyptychumab, could have a synergistic effect when combined with monolizumab.
Got it thanks, and just on <unk>.
One final question. This one might be good for Eric Johnson I'm, just curious about the <unk> platform in the course of combining mek before six or $22.0, an IL two or so is the thought that this tetra specific asset would be better suited to solid tumors or to hematologic malignancies or both categories.
Incineration.
Yeah, that's a that's another excellent question.
Of course, we debated internally and then I'll hand over to Joyce.
Mondher Mahjoubi: And that's what led to the Heidenek program and the PACE 3 trial that was started last year. And the second piece of information and piece of data that was published already in Cells in 2019, was basically the pre-clinical package that supported the clinical program of the combination of Monolizab and anti-PD1 or PD1, showing the clear synergy coming from the fact that, as you know, NKG2A is not only expressed on NK cells but also on a subset of CD8 positive T-SEL.
To sum up the thought behind it.
The selection of the tumor antigen.
These are multi specific.
Antibody Georgeson Yep Yep.
Thank you all for the question. So so yes, I mean, so I'm going to kind of go back and talk a little bit about the uncapped platform and the amazing thing about the <unk> platform is very versatile. So as you were stating that the NK P 46, CD 16 attachments to the NK cells with the IL two variant.
And the thing.
But the tumor antigen is what I call is removable you could kind of.
Mondher Mahjoubi: So, first of all, I think the two trials and the two settings, and the two types of combinations are supported by strong scientific rationale. Now, as you know better than me, these are two different types and two different settings, and it's really premature to, first of all, speculate on the data before because the data are presented, and of course, I would be very cautious not to have cross-trial comparison or radio cross. But I'll hand over to Joyce, who can maybe complete this answer.
Put different tumor antigens in there this allows for that flexibility and as Mandara said, there's heavy debates going on internally to determine sort of what is the best approach. We are looking at both solid tumors as well as hematologic tumors. So at the the versatility of the platform allows.
For us to.
Kind of really have those debates internally to see which would be the best opportunity either in solids or hematologic malignancies.
Thank you very much it did that okay.
Yeah.
Thank you.
Wish to ask a question. Please press star one and wait for your name to be announced if you wish to cancel your request. Please press the husky once again star one if you wish to ask a question.
Joyson Joseph Karakunnel: Yeah, no, so I think Mandir summed it up very nicely. I think the strength of the preclinical data that supported these trials, both with Satyxama, as well as with Dervam, and Devalumab has two different mechanisms of action that we look for, you know, the combination potentials. We've already kind of seen some of that with head and neck, and, you know, we'll have to wait for the data to see what happens with the second. I think Mander pointed it out very nicely, which is that these are two different indications, two very different settings, one adjuvant, the other metastatic.
We're taking our next question from the line of Greg Savanna, Jay at Goldman Sachs. Please go ahead.
Hey, good afternoon. Good morning, Thanks for taking my questions.
I've got a couple the first is actually on a 53 O. One certainly we'll be interested to see what the elect when that data is for the astrazeneca compound but could.
Could you remind us.
How to think about differ.
Differences are.
That you are aware of that.
Tween thereafter.
Their asset in your assets. So that's my first question around 50, 301 and then.
Second of all as it relates to the coast data anything at least from a scientific or biological rationale that would help us think about.
Joyson Joseph Karakunnel: And it would be hard to kind of read across the trials or read across trial comparisons, not only because we try not to do that, but also just because the difference is an indication, settings, as well as mechanisms of action.
How to think about known.
Lithium mab and the efficacy and safety that.
That we might see relative to a C. D 73 targeted assets such as the Elektron up so that's the second question.
Daina Graybosch: Thank you. Does that answer your question then? Yes.
Daina Graybosch: Yes, it does. Thank you very much. Thank you.
And then maybe just.
A question on the P&L.
Operator: We're taking our next question from the line of Egel, Noomovitz, at Citigroup. Thank you.
How should we think about trending over the next.
Several quarters and.
It just given the many moving parts and and in that context, as we think about your current cash balance where you say you have cash at least until 2022, I mean were right around the corner. So.
Yigal Nochomovitz: Thanks, Mandarine. I just had a few questions. First, obviously, you can't disclose the data yet on the ORR and TFS proposed ahead of the late-breaking presentation, but that said, to the extent that you can comment generally, what percent improvement in ORLR and TFS would you view as a clinically meaningful benefit for monolusimab plus tervalimab combo over Devalimab monotherapy?
How is the company thinking about financing.
Financing options.
Kind of options are available and what the strategy. Thanks.
Thank you Greg.
They are very important and good questions and as usual I'll start with the first one I then hand over to Joyce for the post and the and the <unk>.
Mondher Mahjoubi: Thank you, Egil. Again, we look forward to seeing the full data presented at ESMO, as you know, as an oral later, breaking abstract. This was detailed by PASKh RZNica and their curtain razor. They will report ORR, but they also present PSA data for both arms, Jovolumab plus Monolith and Volumop plus Elipimab versus System Health Care. I think the design of the trial is well known because it has already been publicly disclosed.
Mechanistic approach, who you're thinking about in particular with.
With regard to the potential combination within Empire.
And then I'll get into these opportunities.
Our new CFO.
To address your question about the financing moving forward.
But if you only took your tier one so as you said I mean, we agree.
Really.
Look forward to.
The data are you mind you.
Other than those data to them not to where we are not aware of other public randomized data in this field every one I remember the <unk> things one the data presented about two years ago.
Mondher Mahjoubi: It's in a well-controlled phase, randomized phase to trial. They have not, to my knowledge, publicly disclosed the hypothesis. But I believe what is interesting to have, to have publicly disclosed the details of the statistical hypothesis. Keep in mind that these are patients who finish their chemotherapy and are randomized within six weeks if they do not progress, and they are being treated with Derva, Derva Mona, or Derva Leklymavam for up to 12 months.
And if you are showing some trends of activity.
But I think since then so clearly the results so far of the concerns with regards to electric Admob are all for major interest what happens for the other companies that are playing in D C and number two I.
A reminder, that we published that data and the gains we have even presented these data at ACR back in 2019, if my memory.
Each cohort comparing our entitled you can see with the BMS and the as he wants.
Mondher Mahjoubi: The response rate is certainly a very important endpoint and is the primary endpoint for this trial. But the quality of the response, in particular, the disease-free survival or the progression-free survival, is certainly something to look at as well. So I believe the responsibility is certainly important to assess and we look forward to seeing this data, but I think the PFA is something called
And clearly when it comes to the antibiotic activity.
Our our antibody is much better.
Superior and doing the job of blocking.
You said that you see of course, we we.
I have to translate those preclinical.
Strength into a clinical benefit for patients and that's why we will.
To some extent a.
Waiting to see some very data emerge.
Yigal Nochomovitz: Okay, got it. Thank you. And then, a second question I had on Lleutamab. Can you talk a bit about how you're planning to identify Cesri syndrome and Lycosus fungoyus patients, given that in the major farmer markets, U.S. 05, and Japan, there are only 200 Cesri patients and about 3,000 Lycosphungortis patients, according to the Sear database?
To try to learn from others.
We have we have been working.
Over the last couple of months.
Transform in India.
But with time at the end of last year, and two clinical trial, which.
He is about to start soon that would be our first clinical trial.
Testing and that sort of thing API shifting to one we have we have a plan on.
What combination approach, we should do and of course, we look forward to seeing the data from the cost side to further trying to.
Yigal Nochomovitz: Yeah, just to make sure I understand your question, is it vis-à-vis the commercial opportunity or talking in general about how we are designing and implementing or executing
And also maximize the opportunity around pricing.
That's my maybe my answer for your first question no. Jason the question around coast, how do we think to the extent of course.
Yigal Nochomovitz: Now more about the commercial opportunity and how you will find it. Thank you. No, I, this is, of course, a great question and gives me the opportunity to go back to our strategy.
I don't want to speculate on the data.
Mechanism of action and the potential can be companion.
Companion ability with an enticing 73.
The two arms are effective.
Yeah.
Yeah, So I think I'll go back and kind of.
Also state that the mechanisms of action here clearly.
Mondher Mahjoubi: I think the Cesarid syndrome indication came as a prototype indication, if I can say, to validate the mechanism of action since the majority of these patients are, you know, expressing K3DL2. And we have seen in phase one, basically from the first dose level, that when you target this tumor anti-gen, K3DL2, you get a significant tumor shrinkage and even improvement in quality of life. I think the Sisy syndrome itself is the, how to say, the first step, and I would, I should say, the fast-to-market strategy in order to really get those fast track designation and prime designation and exchange with the FDA and with the MA in order to accelerate clinical development. The intent, of course, is to expand beyond that. And Microsisphomboides is half of the PTCL. As you know, you are right.
R. R. As we know are different to the ones that anti 73 ones and MTN K G to a one we're looking to see I mean, we have preclinical data that has supported a D. C C.
Synergy and then finally with with with one of them was a man that's a sort of done redundant pathway mechanism of action in combination.
I think.
When we look at this we see two once again two different tumor types I mean, two different I mean same setting.
But two different mechanism of actions that do have different potentials.
When it comes to the clinical data I think we'll have to wait to see what the coast data shows, but I would just say these are two very distinct mechanism of actions operating in two different ways one hum.
Sort of sorry, both of them, leaving immune suppression and sorry, I just missed the Cetuximab question, but this was <unk> 73, so with $75.0, it's basically the reading of the tumor Ah Ah Ah be amount of adenosine that's present, so really decreasing immune suppression. So.
Decreasing adenosine is one the other one is decreasing.
Mondher Mahjoubi: I mean, Microsis Fongodias accounts for about 3 and a half to max 4,000 new patients every end, the U.S. in Europe and in Japan. And there are about 4,000 non-micosis conglodyase ketanifety cell lymphoma. So all in all, we're talking about up to 8,000 patients with ketanistic cell lymphoma. a half of them would express the key three delta and again the the my position from Gaurida's segment is not the end of the story it's certainly much more attractive and much more compelling business case but of course the the the I think the the most important milestone of the Lugano meeting was that we have been able to show that Lekutana works outside there is from them and and works in T-cell and formal, which expressed the case to the year too, which of course solidify, if I may say, the scientific rationale to expand now to peripheral Tyself, where the business case stands, with more than 18,000 new cases every year, the RACAL T cell lymphoma has a much more attractive commercial prospect.
Two different pathways, one MTN kg to AAV everyone.
With PD, one so I think with that we'd have to wait for the clinical data to see what's happening.
I know that was a little roundabout messed up answer so I'm happy to repeat it.
Yeah.
I think it might had I had some talks about but I was like Oh gosh. This is attached to that.
So clearly I'm excited about both of these and I'm like sitting here going Okay. If you know, but yeah. So.
In short the <unk> 73, a dentist.
You really stopping adenosine synthesis, and so because of that relieving the immune suppression. The other is to pathways one acting on T cells. The other one on NK cells, and so I think the clinical data will speak for them at least which pathway, but you'd be better I think that last answer is the one.
I would kind of COVID-19 versus my first [laughter].
Okay. Thank you Jason.
Thank you. Thank you.
Today would you one I'll take the question on.
And the financing of the company moving forward.
Thank you.
Yeah, as I said before the cash position.
It is quite a run.
Robust at the moment with another 59 immediate way.
Mondher Mahjoubi: But again, the stepwise approach is to validate the mechanism of action, check that this is not a Cesare syndrome drug, but it works outside Czada syndrome, which we are exploring and validating as we speak in Pellomat, and then go to CARFLT salamoma. And then when you look at the totality of the business case, it's no longer, you know, a niche indication. It's a significant market opportunity. Got it, thanks. And I just had one final question.
I was lucky money trial financial needs and we provide them a bit when needed.
Can also communicate that at this stage.
In terms of flying for sure. If you look at the cash building for this.
I guess just last year, we see a big decrease is not following these investments outside we keep our plan as a.
Uh-huh plan, let's say.
Last year was I think some special cash burn related to Limbach city, especially in payments at the same time.
So today do you think you will see a slight increase in the second half due to the delivery of sub studies that we are having in the pipeline.
Mondher Mahjoubi: This one might be good for Eric or Joyce. I'm just curious about the NKET platform and the choice of combining NKP46, CD16, and IL2R. So is the thought that this Tetra-specific asset would be better suited to solid tumors or to hematologic malignancies, or both categories under consideration?
And then just in terms of how youre thinking about potential options to extend the cash runway.
Uh huh.
First of all week.
Well that you won't see it.
Yeah go ahead.
Okay.
The so the did the different options are we.
Yigal Nochomovitz: Yeah, that's another excellent question that, of course, we debate internally, and I'll hand over to Joyce to sum up the thought behind the selection of the tumor antigenets for these multi-specific Thank you, but Jarsen.
We look at the market for sure we look at financing options or so with some banks as well.
But more than ever we look I'll pause I think the way, we operate them and see what they can get out of those partnerships.
Joyson Joseph Karakunnel: Yeah, yeah. Thank you, Al, for the question. So, yeah, I mean, I'm going to kind of go back and talk a little bit about the NKET platform. And, you know, the amazing thing about the NKPP platform is that it's very versatile. So as you were stating that the NKP 46, CD16, attachments to the NK cells with the IL2 variant are the same, but the tumor antigen is what I call removable. You could kind of, you know, put it on. different tumor antigens are found in there.
Yeah, So Greg knock sorry chartering.
Solid cash position and we've been actually.
I have a pretty good track record on making sure that our.
Cash cover all the multiple patterning.
Catalyst and milestones that we Havent had the part that's not because we constantly monitor what kind of needs and will provide an update when needed.
Thank you.
Okay. Thank you.
Operator, do we have a more question on the line, yes, we have one question for hostile Heath on HCV.
Please go ahead.
Hey, good morning.
Hey, good afternoon, one that I've been in grading to the intimate.
Thanks for taking my question.
So I just wonder one question on the mountain isn't that for the data is going to be reported for the Io naive patients later this year, so could you remind us.
Joyson Joseph Karakunnel: This allows for that flexibility. And as Mondaer said, there's heavy debates going on internally to determine sort of what is the best approach. We are looking at both solid tumors as well as hematologic tumors. So the versatility of the platform allows for us to kind of really have those debates internally to see which would be the best opportunity, either in solids or hematural. To logic military. Thank you very much.
What kind of data set that we could expect and.
How many patients we can routines of the data. Thank you.
Yeah.
Yes.
Jason.
We do like to rent so I can take it.
Okay.
Joyson Joseph Karakunnel: Thank you. If you wish to ask a question, please press Star 1 and wait for your name to be announced. If you wish to cancel your request, please press the hash key. Once again, Star 1, if you wish to ask a question. We are taking our next question from the line of Greg Suvan Nege at Goldman Sachs. Please go ahead.
Yeah go ahead Monday right, yes, okay. Thanks for the question so first of all.
To remind everyone. This is a single arm study.
That test the triplet combination.
And again as I said in my answer to the first question. We have those two mechanism affection. We know that one of them is enough could be synergistic with antibody that have will act.
Operator: Hey, good afternoon, good morning. Thanks for taking my questions. I've got a couple; the first is actually on 5301. Certainly, we'll be interested to see what the electmab data is for the Aschazeneca compound. But could you remind us how to think about differences that you are aware of between their assets and your assets? So that's my first question about 5301. Second of all, as it relates to the Coast data, anything, at least from a scientific or biological rationale, that would help us think about how to think about Monolizumab and the efficacy and safety that we might see relative to a CD73 targeted asset such as lechlamab.
A DTC and that's the combination with chemo, we notice wondering somebody's synergistically been anti PDL one.
And of course data.
Built based on their rational I think the triplet is simply the combination of both she picks them up and do it and do it well enough to see whether we can have that.
An increase in response and in quantity of Christmas intensive therapy. So this study was designed to really first of all to assess the safety of the triplet because I imagine. This is the first I believe ever triplets are you ought to be the block adult triplet.
Non cytotoxic.
Oh, chemo free regimen to be developing in head and neck cancer.
The safety was was it was good.
Transportation, So we expanded the trial to 40 patients, but yet still.
A single arm trial in adolescence.
Operator: So that's the second question. And then maybe just a question on that. On the P&L, how should we think about trending over the next several quarters? It's just given the many moving parts. And in that context, as we think about your current cash balance, where you say you have cash at least until 2022, I mean, we're right around the corner. So how is the company thinking about financing options, what kind of options are available, and what's the strategy? Thanks.
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Patients with squamous cell carcinoma of the head to Nik, who might have been pre treated with the.
Chemotherapy or radiation therapy, but who are naive of any <unk> treatment.
The data will be presented.
At the end of the yen.
So Tony do you have the data with FDA to really determine whats the platform as you know the competitive landscape is evolving and its important to take into consideration the specific unmet need than where we can position. This triplet and again I insist on the fact that today, the standoff guidance temporal plus or minus chemo dependent.
The level of Cps and the SEC.
We are presenting at the end of the air will be looked at also from that perspective, she passed more than one person. It's a C. P S.
Greg Suvan Nege: Thank you, Greg. Very, very important and good questions as usual. I'll start with the first one.
No BD and when they get to we will be.
Did I get to show these data as I said towards the end of the year.
Thank you for that and congratulations on the progress.
Mondher Mahjoubi: Then I'll hand over to Jocene for the coast and the mechanistic approach you're thinking about, in particular with regard to the potential combination within Anticid 73. And then I'll give the opportunity to our new CFO, Frederick, to address your question about the financing moving forward. Very briefly, on the 50th 401.
Thank you very much thank you.
I think we're putting so much there are no further question on the phone.
Okay.
Henry is do we have a question on the.
The wolfcamp.
No more questions. Thank you.
Yeah.
Great. Thanks.
No more question we like.
Again, we thank everyone for dialing in this morning. This afternoon I'm very excited with the again the progress we are making are with our package here as I said, we have good data with likely tomorrow or R&D.
Mondher Mahjoubi: So, as you said, I mean, we... do really look forward to seeing the Olecula data. I remind you, other than those data, actually, I'm not aware, we are not aware of any other public randomized data in this field. Everyone remembers the BMS and the AG phase one B data presented about two years ago at ASCO and ACR, showing some trends of activity. But I think since then, so clearly the results of the cost trials that I got with Oleglid Mab are of major interest for and for the other companies that are playing in this field.
It is progressing nicely with the new data from from Ara aren't get platform and we also look forward to the continued progress.
Including the upcoming winter season, my presentation at the ESMO data.
Friday.
I look forward.
To talking to you.
Thank you very much.
That concludes the conference for today. Thank you for participating you may all disconnect.
Thank you Brian.
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Mondher Mahjoubi: Number two, I remind you that we published data, and again, we even presented data at ACR back in 2019, if my memory is correct, comparing our entire CD-70c with the BMS and the AZ1. And clearly, when it comes to enzymatic activity, our antibody is much better. It's superior to doing the job of blocking the entire V-CD-73.
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Mondher Mahjoubi: Of course, we have to translate these pre-clinical strengths into clinical benefit for patients, and that's why we were, to some extent, waiting to see some data emerge in order to try to learn from others. And we have been working over the last couple of months on transforming the I&D that we filed at the end of last year into a clinical trial, which is about to start soon. That would be our first clinical trial, testing and assessing APHC31.
Okay.
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Mondher Mahjoubi: We have a plan on what combination approach we should do, and, of course, we look forward to seeing the data from the course trial to further fine-tune and also maximize the opportunity around our entire campus. That's my answer for your first question. Now, Jason, the question around Coast, how do we think, to the extent, of course, I don't want to speculate on the data, but the mechanism of action and the potential combineability with an entire C-73 if the two arms are affected?
Joyson Joseph Karakunnel: Yeah, so I think I'll go back and kind of also state that the mechanisms of action here clearly are, as we know, different. So one's in anti-S73, and one's in NKG2A. One, we're looking to see, I mean, we have preclinical data that has supported ADCC, so synergy, and then finally, with Monolitha, with Monolizumab, it's sort of a non-redundant pathway mechanism of action and combination. So I think, you know, when we look at this, we see two, once again, two different tumor types. I mean, two different, I mean, same setting, but two different mechanisms of actions that do have different potentials.
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Joyson Joseph Karakunnel: I think when it comes to the clinical data, I think we'll have to wait to see what the Coast data shows. But I would just say these are two very distinct mechanisms of action operating in two different ways. is one, um, uh, sort of, sorry, both of them relieving immune suppression, and sorry, I just messed up the cytosumab question, but this was CD-73. So with CD-73, it's basically the leaving of the tumor, the amount of adenosine that's present, so really decreasing immune suppression.
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Joyson Joseph Karakunnel: So, you know, decreasing adenosine is one; the other one is decreasing in two different pathways, one anti-NKG2A and the other one with PD1. So I think with that, we'd have to wait for the clinical data to see what happens. I know that was a little roundabout messed up answer, so I'm happy to repeat it. I think in my head I had cetuxabab, and I was like, oh, gosh, this is a petuxabab.
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Joyson Joseph Karakunnel: So clearly, I'm excited about both of these, and I'm, like, sitting here going, okay, you know. But, yeah, in short, the CD73 is adenosine. You're really stopping adenocy synthesis, and so because of that, relieving immune suppression. The other is two pathways, one acting on T cells, and the other one on NK cells.
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Joyson Joseph Karakunnel: And so I think the clinical data will speak for at least which pathway is better. I think that last answer is the one I would kind of go with versus my first. Okay, thank you, Jason. Thank you, thank you. Frederick, would you want to take the question on what's the plan and the financing of the company moving forward? Yeah, thank you, Mandar.
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Frederic Lombard: Yeah, as I said before, the cash position is quite robust at the moment with $159 million. We constantly monitor our financial needs, and we provide an update when needed. We cannot communicate at this stage, but in terms of the plan, for sure, if you look at the cash burning for this, for its first average, just last year, we see a big decrease that is not following these investments on our side. We keep our plan as a half plan, let's say.
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Frederic Lombard: Last year we had some special cash burn related to Lumox City and special payments at the same time. So today you will see a slight increase in the second half due to the delivery of some studies that we are having in the pipeline.
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Frederic Lombard: And then just in terms of how you're thinking about potential options to extend the cash runway.
Frederic Lombard: At the moment, first of all, we Myr? Yeah, go ahead. Okay. So
Frederic Lombard: Yeah, please, go ahead. So the different options are we look at the market for sure. We look at financing options with some banks as well. But more than ever, we look at progressing the way we operate and see what we can get out of it. Yeah, so Greg, long story short, we have a solid cash position. And we've actually, we have a pretty good track record of making sure that our cash covers the multiple catalysts and myelstones that we have ahead of us because we constantly monitor our financial needs, and we'll provide an update when necessary. Thank you. Thank you. Operator, do we have more questions on the line? Yes, we have one question.
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Operator: Yes, we have one.
Unknown Attendee: Hey, good afternoon Monday. I agree.
Yeah.
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Unknown Attendee: Malolizumab for the data going to be reported for IO naive patients later this year. So could you remind us what kind of data set we could expect and how many patients we could look into the data? Thank you.
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Joyson Joseph Karakunnel: Jason, would you like to answer, or should I take it? Okay, go ahead. Go ahead.
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Mondher Mahjoubi: Yeah, okay, thanks for answering the question. So first of all, to remind everyone, this is a single-arm study that tests the triplet combination. And again, we, as I said in my answer to the first question, we have those two mechanisms of action. We know that monolizum could be synergistic with antibodies that have or act within ADCC, and that's the combination with Tidicc. We know that monosomab is synergistic within our type DL1, and the cost data were built based on that rationale.
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Mondher Mahjoubi: I think the triplet is simply the combination of both Cyticsimab and Duralibon amounts to see whether we can have an increase in response and quality of response in terms of durability. So the study was designed really, first of all, to assess the safety of the trip because this, I remind you, this is the first, I believe, ever triplet to be perfect. or triplet of non-cyotoxic, uh, uh, or chemo-free regimens to be developed for head and neck cancer.
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Mondher Mahjoubi: The safety was good in the first 20 patients, so we expanded the trial to 40 patients, but yet it's still a single-arm trial in advanced or metastatic patients with squamous cell carcinoma of the head and neck, who might have been pre-treated with chemotherapy or radiation therapy but who are naive of any pedicle treatment.
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Mondher Mahjoubi: The data will be presented at the end of the year, and we are looking at the totality of the data with AG to really determine what the path is. As you know, the competitive landscape is evolving, and it's important to take into consideration and see the specific admit needs and where we can position this triplet. And again, I insist on the fact that today the standard of care is temporal, plus or minus chemo, dependent on the level of CPS, and the results that we present at the end of the year will also be looked at from that perspective, CPS more than 1 versus CPS low PDR1 negative. And we will be delighted to share this data, as I said, with you.
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Unknown Attendee: Thank you for the end and congratulations on the program.
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Mondher Mahjoubi: Thank you very much. Thank you.
Okay.
Operator: Thank you. Thank you.
Okay.
Henry Wheeler: Okay, Henry, do we have questions on the web?
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Henry Wheeler: No more questions, Wanda. Thank you.
Okay.
Mondher Mahjoubi: Okay, so if there are no more questions, I would like, again, to thank everyone for dialing in this morning and this afternoon. I'm very excited about the progress we are making with our strategy. As I said, we have inconesion data with Lakitamab, our R&D is progressing nicely with the new data from our ANKET platform, and we also all look forward to the continued progress, including the upcoming Monorzema presentation at ESMO this Friday.
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Mondher Mahjoubi: With that said, I look forward to talking to you in the near future. Thank you very much. That's concluded the conference for today. Thank you for participating in Hum Hell Disconnect.
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Operator: That's concluded the conference for today. Thank you for participating in Humail Disconnect. Thank you, bye-bye.
Okay.
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