Innate Pharma SA (OTCPK:IPHYF) Q4 2019 Results Conference Call March 10, 2020 9:00 AM ET
Danielle Spangler – Head of Investor Relations
Mondher Mahjoubi – Chairman of the Executive Board and Chief Executive Officer
Dr. Pierre Dodion – EVP and Chief Medical Officer
Laure-Hélène Mercier – EVP and Chief Financial Officer
Yannis Morel – EVP of Product Strategy
Conference Call Participants
Samantha Semenkow – Citigroup
Swayampakula Ramakanth – H.C. Wainwright
Daina Graybosch – SVB Leerink
Good afternoon, ladies and gentlemen, and welcome to the Innate Pharma Full Year 2019 Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this call is being recorded today. [Operator Instructions].
I would now like to introduce your host for today’s conference, Ms. Danielle Spangler, Head of Investor Relations of Innate Pharma. Danielle, you may begin.
Thank you, and welcome, everyone. This morning Innate issued a press release reporting its full-year 2019 financial results and business update. The press release and today’s presentation are available on the company website. On Slide 2, I would like to remind you that we will make forward-looking statements regarding the financial outlook in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Turning to Slide 3. Participating management on today’s call include Mondher Mahjoubi, Chairman of the Executive Board and Chief Executive Officer; Dr. Pierre Dodion, EVP and Chief Medical Officer; Ms. Laure-Hélène Mercier, EVP, Chief Financial Officer; and Yannis Morel, EVP of Product Strategy is also available for Q&A.
At this time, it is my pleasure to introduce Mondher.
Thank you, Danielle, and good morning, and good afternoon everyone. 2019 was a remarkable year for Innate Pharma, and to some extent, a defining moment in our journey to our leadership in IO. As you know, we at Innate Pharma are pioneers in the field of immuno-oncology, targeting the innate immunity. We have been doing this for the last 20 years and we have leveraged a significant knowhow and expertise that we translated into a balanced pipeline of first and/or best-in-class innovative products.
If you move to Slide 4, you have a summary of our overall ambition and strategy. And as you can see, we are committed and continue to make significant progress against our strategy to pioneer in new science and to advance potential new therapy in immune-oncology. Our ambition is to successfully transition to a commercial stage biotech and build commercial capabilities and develop a rare cancer franchise. To achieve our ambition, we continue to take advantage of our strong financial position to assure the growth of our portfolio.
And actually Slide 5 evidenced this achievement in 2019. It was a tremendous year of execution for Innate Pharma. We began our transformation into a global commercial organization while delivering on our clinical development path.
Notably, in September, we announced that AstraZeneca is planning advance monalizumab in combination with cetuximab in IO-pretreated patient with head and neck cancer in a Phase III trial this year. This is truly rewarding to have an Innate Pharma discovery, moving to late stage development in high unmet need patient population.
In addition, as you know, Innate Pharma is eligible to 100 million milestone payment upon the first patient is dosed in this Phase 3 trial. 2019 was also a defining year for our lead proprietary candidate lacutamab, which entered into Phase II in multiple subsets of T-cell lymphoma, including pivotal arm in Sézary syndrome. Therefore, we have now two late stage product candidates in our portfolio as a testimony to the overall maturation of the company.
I’m also pleased that we remain very active in the early clinical development setting and to announce that the first patient was dosed yesterday in the multicenter, open-label, dose-escalation Phase I trial evaluating IPH5201 as monotherapy or in combination with durvalumab with or without oleclumab, AstraZeneca’s anti-CD73 in advanced solid tumors. This is again an important milestone for Innate and this is the first molecule from Innate-AstraZeneca expanded collaboration to progress into the clinic.
We also had multiple publications at scientific conferences and included in [estimated] journals highlighting data showing the vibrant science at Innate, in particular a major review in Nature that reposition innate immunity at the center of the overall immune response against cancer. That’s from a science viewpoint.
Now on the corporate side, we have expanded globally and now have a U.S. affiliate with established operation to support our U.S. commercial team. The team has done a terrific job of kicking off our own commercial launch strategy for Lumoxiti which will also provide a strong foundation to support our future rare oncology franchise. And recently we also established ourselves in Rockville, Maryland supporting both operational and commercial initiatives in the United States.
Lastly, we successfully raised $79.1 million in gross proceeds from our IPO on the NASDAQ and global offering. As a maturing global biotech company, this provides us access to the broadest, deepest, and most dynamic financial market as we look forward.
If you move now to Slide 6, you have a reminder of what our pipeline looks like today. And as you can see, it’s broad and really balanced with both partners but also proprietary assets ranging from preclinical to commercial stage. As you can see, the execution over 2019 has created very exciting 2020 with robust news flows from our ongoing clinical trials, we’ll comment later during this presentation. This includes key data readouts for monalizumab IPH5401 as well as the initiation if IPH5201 in the Phase I study and the completion of the Lumoxiti transition.
Let me now provide you an update on our Lumoxiti commercial efforts. And if you move to Slide 7, you can — first of all, we’d like to highlight the fact that we have moved quickly to establish our U.S. presence and initiate the transition of Lumoxiti from AZ. As planned and as we stated in the half year call, our sales team and medical science liaison was fully staffed and deployed by the end of October 2019. That includes three medical science liaison and 10 sales representatives.
With the team now fully in place, the transition of all sales and medical affairs activity from AstraZeneca to Innate are cleared throughout the end of last year, making us the sole commercial entity promoting Lumoxiti. It is worth noting our efforts at the American Society of Hematology Annual Conference in December held in San Diego. We viewed ASH as an important opportunity to introduce Innate Pharma as the new commercial entity for Lumoxiti to the hem-onc medical community. We were quite excited to share the new, long-term data from the pivotal Phase III trial of Lumoxiti which expands on the efficacy of results and affirms the safety profile of this medicine.
And in 2020 the U.S. commercial team will continue to drive Lumoxiti sales and further transition activities from AZ in the coming months. This includes the U.S. transition of the BLA [contract], which took place early this month. In addition, all marketing and digital activities will transition this month.
Finally, patient support service will transition in the first half of 2020 and in Innate U.S. distribution channel will be in place by the end of the year.
Now, if you look at Slide 8, and as we turn to our customer facing activity, our sales team has now been interfacing with customers for just over few months. And it is a great opportunity for us to build upon the launch of AZ basis on what we have learned from their one year experience. This means that our focus for 2020 will be first on really scaling the organization, focus where we can really capitalize on the full market opportunity of Lumoxiti versus more traditional large scale commercial oncology models.
We have high experienced sales representatives with a unique mix of rare disease and oncology experience. Innate’s focus is of paramount here in order to really to be very efficient and really penetrating this market. On the other side, it’s important that we improve targeting and reach. Efforts are currently focused on activating new accounts that have not used Lumoxiti previously. In addition to large academic centers, both those who hadn’t and had used Lumoxiti must be included in our efforts. And early indicators support this approach, as we have seen uptake already in oncology practices outside of academic centers. This trend allows us to expand our breadth to reach more patients disseminated across the country, as we are not only restricting to centers of excellence. We believe that our fit for purpose U.S. commercial strategy not only provides the right platform to meet our goal in setting a new standard of care in relapsed/refractory hairy cell leukemia patients as well as support our long-term strategy to build a rare hem-onc commercial franchise. I do really look forward to providing you additional insight in 2020.
With that, I will now pass to Pierre Dodion, Chief Medical Officer to provide a brief update and review of our clinical development program. Pierre, to you.
Dr. Pierre Dodion
Thank you, Mondher. I would like to start by providing an update of our TELLOMAK study and invite you to move to Slide 9. You may remember from previous presentation that the first patient was dosed in that study in the month of June 2019. The TELLOMAK trial is international, open-label, multi-cohort Phase II study evaluating the efficacy and safety of lacutamab or IPH4102 in different subtypes of T-cell lymphoma including Sézary syndrome, mycosis fungoides and peripheral T-cell lymphoma.
Since November 2019, we have been in ongoing discussion with U.S. and European regulatory authorities concerning Good Manufacturing Practice or GMP deficiencies at one of the company’s manufacturing subcontractor site, a site that is providing fill and finish operation and the lacutamab clinical vials for the TELLOMAK study. And as many of you are aware, the TELLOMAK study has been placed on partial clinical hold globally since December 13, 2019, except in Italy, where the clinical trial has been suspended.
On January 9th this year, the U.S. Food and Drug Administration placed TELLOMAK study on partial clinical hold.
If you move to Slide 10, we have here an illustration of where we stand today. The company has reactivated TELLOMAK trial in Sézary syndrome and mycosis fungoides in France and in the UK following the authorization by the respective national authorities of these two countries. This decision is based on an assessment of the unmet medical need in patients with Sézary syndrome and mycosis fungoides and also the lack of currently available standard of care options for such patients.
And since the standard of care options are available for patients with PTCL, Innate has decided not to enroll further patients in the trial until we have a new GMP-certified batch available. However, all currently enrolled patients from all cohorts can continue treatment in the study.
The TELLOMAK study remains on partial clinical hold in the U.S. and Germany based on the most recent regulatory feedback. And as I said, all currently enrolled patients can continue treatment in the study, but no new patient may enroll until we receive a new certified batch from the manufacturer. The clinical trial as I mentioned earlier has been suspended in Italy.
Importantly, the utmost priority of Innate Pharma is to ensure patient safety and it is important to note there has been no safety issue related to the primary patient. We are working very hard to transfer the lacutamab fill and finish manufacturing to another contract manufacturing organization, CMO, and we anticipate that a new clinical GMP-certified batch will be available in the second half of 2020. We continue to work closely with the U.S. FDA and with European regulatory agencies to fully to reactivate the trial as soon as possible.
In addition, the company is evaluating all the potential options in PTCL or peripheral T-Cell lymphoma, including alternative treatment in first and second line PTCL in a maintenance setting and we’ll provide further update in due course.
Now to capture on this slide, I would like to quickly highlight some other key clinical milestones achieved in 2019. First of all, we presented data at the ESMO 2019 Conference. Innate Pharma provided long-term follow up based on the 40 patients of the Phase II study testing monalizumab in combination with cetuximab in patient with relapsed and/or metastatic cancer of the head and neck. We also presented encouraging data on our proprietary drug IPH5401. This is based on the STELLAR 001 dose-escalation study. The data show that IPH5401 and durvalumab is well tolerated.
In addition, 12 patients were evaluated for efficacy and early activity signals were observed in hepatocarcinoma and non-small cell lung cancer. Of note, both these two tumor types correlate according to the high expression of the C5a receptor. This data support the ongoing expansion cohorts, which will readout in the course of the second half of 2020.
Finally, at the SITC 2019 Congress, Innate discussed its expertise in immuno-oncology drug discovery with preclinical data presentation on IP5401, 5201 or anti-CD39 agent and IPH5301 or anti-CD73 agent which targets the adenosine immunosuppressive pathway as well as the company’s new proprietary trifunctional NK cell engagers or NKCEs.
I would now like to introduce Laure-Hélène Mercier, our CFO, to provide our financial overview.
Thank you, Pierre. Good morning, everyone. And turning to Slide 11, I will start with one of our key metrics, our cash position. So our cash and cash equivalents amounted to €256 million as of December 31, 2019 from €203 million at the end of ‘18. As Mondher mentioned, we successfully IPOed on the NASDAQ through global offering and raised net proceeds of €66 million and we additionally received €44.9 million in net proceeds from the final payments in relation to the October 2018 agreements with AstraZeneca at the beginning of the year. As a reminder, in the first quarter of 2019, AstraZeneca filed Market Authorization Application for Lumoxiti to the European Medicines Agency that was accepted for review and this triggered $15 million milestone, which we paid in January 2020.
Now going to the P&L, for the sake of time and we only comment the main and most significant lines. You have very detailed comments in the press release that you can refer to for more information. Going to the revenue from collaboration line, globally our revenue and other income, they amounted to €85.8 million in 2019 and mainly results from revenue from collaboration and licensing agreements for €69 million with the remainder being mostly research tax credit. As usual, revenue from collaboration and licensing agreements mainly relate to the spreading of payments received by Innate Pharma in the context of the AstraZeneca agreements, of which €42.5 million for monalizumab and €18.8 million for IPH5201. I remind you that as usual this has no impact on cash.
We also have invoices — invoicing back to AstraZeneca for half of the cost of the IPH5401 still at high end, and the full cost of IPH5201. Note that the recognition of the IPH5201 effort is almost completed with €9 million remaining and that they are expected to be fully recognized in 2020. With regards to monalizumab, currently €62.7 million remains to be recognized with horizon currently estimated in 2021.
Now, on the expenses side. Our operating expenses for 2019 amounted to €104.6 million compared to €87.7 million in ‘18. Remember that out of this €17 million increase, €10 million accounts in non-cash items, amortization and share-based payments. R&D expenses increased by €9.3 million to €78.8 million, representing 75% of our operating expenses. They primarily relate to activity from Lumoxiti; monalizumab; IPH5402, now lacutamab; and IPH5201.
Subcontracting costs are mainly stable as many of our clinical trial programs were transitioning during the year, resulting in lower costs for monalizumab, lacutamab and IPH5401 offset by some R&D costs in relation to Lumoxiti for regulatory purposes. Increase in R&D costs are mainly related to the increase in the amortization of monalizumab following the payment to Novo Nordisk and the amortization of IPH5201 and Lumoxiti over full-year.
Selling, general and administrative expenses increased by €7.7 million to €25.8 million for the period in the context of the situation of the U.S. and Italy and the commercialization of Lumoxiti, as well as the general reinforcement of our support function in light of Innate’s corporate evolution.
Now going to the line item, net income from distribution agreements, we have this line under the operating expenses and sums the net global inflow and outflow received from or paid to AstraZeneca for the commercialization of Lumoxiti. As a reminder, in the current context of the transition of the responsibilities with regard to Lumoxiti from AstraZeneca to Innate, the former is still considered as principal in drug sale and commercial expenses. Under the Lumoxiti distribution agreement, we recognized a net loss in 2019 of €8.2 million in the context of the launch of the drug and the recognition of the cost over the full-year.
As a reminder, we had cost sharing agreement with AstraZeneca on the R&D and commercial cost through the 2019 transition. The part of the cost that we incurred in 2019 will be reimbursed in 2020. When we look into 2020, we expect to continue to see an increase in our investment in R&D and SG&A, albeit at a lower pace. The U.S. subsidiary will be fully in place and will recognize cost for one year with a cost structure that we already said would be in the mid-teens. The net loss from the distribution agreement should significantly decrease as the transition will end during 2020.
With the proceeds from our recent IPO and not taking into account any other proceeds from our agreement, we are pleased with our cash runway which is about two years based on our current pipeline and development plans.
I will now turn the call back to Mondher.
Thank you, Laure-Hélène. So, if you move to Slide 13, which is the potentially useful slide, I would like to start by again reiterating that we — at Innate we are committed in continuing to execute on our long-term strategy. We thrive to build value for all shareholders and stakeholders. And as I mentioned, 2020 will be an exciting year. I started by mentioning the first patient that was dosed yesterday in the dose escalation Phase I trial evaluating 5201 as monotherapy or in combination with durvalumab with or without oleclumab in advanced solid tumors. That’s a key milestone. And as you know IPH5201 is an anti-CD39 antibody that targets the immunosuppressive adenosine pathway and we are very excited to be working with AstraZeneca as they are a leader in exploring targeted therapy in the adenosine pathway.
We will file an IND for our own anti-CD73 antibody IPH5301 in the near term. And in the first half of 2020 as Pierre mentioned, we along with AstraZeneca will present monalizumab data in combination with cetuximab in IO-pretreated patient with head and neck cancer. These 40 patient extension study, in addition to the IO-pretreated patient in cohort 1 will provide an analysis of about 60 patients in total with head and neck cancer who were pretreated and relapsed after IO-prior treatment.
As you know, we expect the start of the Phase III trial this year, which we’ll be evaluating monalizumab in combination with cetuximab in the same population of IO-pretreated head and neck cancer. Moreover, in the second half of 2020, there will be preliminary efficacy data from the triplet combination study that we initiated, that’s in monalizumab, cetuximab and durvalumab in IO-naïve head and neck cancer patient. This is very exciting as it’s a potential chemo-free regimen that could be tested in the frontline setting.
Also the second half of this year we will have data from IPH5401, our C5aR targeted approach to cancer. As you know the STELLAR study is a Phase Ib combination study that adds an anti-PD-L1 and which gets durvalumab with IPH5401 and we anticipate to have preliminary efficacy data in the first two extension cohort, patient with non-small cell lung cancer, IO-pretreated and resistant to PD-1 blockers and the second cohort hepatocarcinoma patients who are IO-naïve but previously treated with other targeted therapy.
We did also initiate a third extension cohort in hepatocarcinoma patient who had previously treated and progressed on PD-1, PD-L1 blockers. The data will readout subsequently through the first two extension cohort, i.e., most likely in 2021.
Now if you move to Slide 14, in closing, I’m very proud of the strong performance we had in 2019. Our achievements from successful NASDAQ IPO to advancing our robust pipeline and building out our U.S. commercial infrastructure marked a significant step in raising the company’s global profile, and executing on our corporate, clinical and commercial strategy.
We look forward to another exciting year ahead, where we’ll continue to deliver on our broad and balanced portfolio and remain dedicated to building value for our stakeholders.
Operator, please start the Q&A session now. Thank you.
[Operator Instructions]. The first question we have on the line today comes from Yigal Nochomovitz from Citi. Please go ahead.
Hi, this is Samantha on for Yigal. Thanks very much for taking our questions. I wonder if you could provide a bit more information on the trajectory of the Lumoxiti launch thus far in — particularly in 2019 in terms of growth that we’ve seen, as it’s been only — it’s about a year and a half and half years approval? How many patients have you treated thus far?
Thank you. I think it was Samantha, but I’m not sure, you said Yigal, but I’m having question from Citi. And it’s about Lumoxiti launch so far. So first of all, as Laure-Hélène mentioned, AstraZeneca has acted up to now as the principal and they did not disclose any details about the commercial performance and we do not provide guidance on sales. We’re leveraging data from AstraZeneca. We estimate as you know about one-third of the roughly 1,000 patient in the U.S. with hairy cell leukemia, could be eligible to be treated with Lumoxiti. And as we quite transition all interfacing activity, we will build our own dataset, and of course we will provide more granularity on the commercial performance.
What we can tell you is that the feedback that our sales representative and medical science team on the field are getting as we start interacting with HCP healthcare providers in the U.S. both in center of excellence and community hospital is extremely positive, in particular people appreciate the long-term efficacy data, the durability of the response and the manageable safety profile.
So first feedback is positive. And again, we are building our own database about the overall patient flow and the overall treatment by them of diseases. What is interesting actually and what we’re learning about is that the pace is completely different from what we usually see in other leukemia or other solid tumors given that this is an indolent disease. And even when patient relapsed for the third or fourth time or fifth time, the decision to treat is not immediate. And of course the pool of patient is bended up by the decision to treat, it’s basically on the conviction that physician has about the need to treat and the available therapy. And the more we reach out to these key accounts and we have selected roughly 300 accounts, mix of center of excellence and community based hospitals where we’re making sure that we not only help identify the patient who are eligible but provide data that reinforce the conviction to treat with Lumoxiti.
Thank you. That’s very helpful color. I appreciate all the detail. Looking then I guess to IPH4102, I’m trying to understand one of your comments in the press release a little bit more clearly on the pause for a lack of better word in PTCL, was this decision triggered based on the manufacturing delay or it’s just related more to the changes that you’re seeing in the PTCL treatment landscape? And when you noted other potential options in PTCL, is that related to — in reference to 4102 or with the additional drugs in your pipeline? Thank you.
Again, thank you Sam for another very important question. So IPH4102 now is called lacutumab. Actually, many, including myself were complaining that we didn’t have a name. Now that we have a name, I’m trying to really stick to it, it’s lacutumab. And I will hand over to Pierre Dodion to give you more color on the PTCL program. But remember, the TELLOMAK trial actually has three components. The Sézary is what could be potentially pivotal. The other two cohorts in CTCL and PTCL are exploratory and the PTCL 1 is in combination with chemotherapy. And as you know in a situation where we have some uncertainty, the health authority based on the feedback we received including from agency here in France consider that this is an area where there are in second line at least other therapeutic options available. And given that this is a combination study, if side effects or something was happening, it’s very difficult to really identify what the contribution was. And that’s why given that other therapeutic option, it was recommended to pause there. And we actually take it as an opportunity to rethink the overall PTCL program and I’m going ask Pierre to maybe give you more color on where we are in this process.
Dr. Pierre Dodion
Thanks Mondher. In addition to what you explained, there are probably a few other points I would like to mention. The field of PTCL is indeed somewhat more crowded in terms of competitive activities than Sézary and CTCL. That was already the case before the report on these GMP deficiencies. It didn’t really change because of that, of course, but it’s the fact that the competitive landscape is somewhat more significant. If look by the way at the design of the TELLOMAK study, you will notice that in course number four and five which are testing lacutamab in PTCL patients who are exceeding lacutamab in combination with chemotherapy regimen called GEMO. So GEMO assay sets, in fact, if you will, a competitor.
And then the second critical component I would like to mention is that, again, well before the GMP questions, we had initiated a scientific and medical discussions about expanding the PTCL program working with a cooperative group that could express quite an interest for lacutamab in PTCL. We are talking about multiple lines of treatment including first line and have identified a potential opportunity to merge the TELLOMAK-PTCL forward into that potential other study. It’s too early to really provide you all the details. But again, we are pursuing this revision of the strategy. It will not reduce in any manner our efforts, actually the opposite is going to expand our efforts in PTCL.
And finally, all those discussions should be fully completed and the potential trials could be activated by the time we receive the fully certified GMP batch in the second half of the year.
Thank you very much. The next question on the phone today comes from Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.
I’m glad to see that you have initiated your study on 5201 and suddenly this seems to be like a broad program. So, first question on that program. Is this — who is running this program? Is it AstraZeneca is going to be running most of the program or is it from Innate? And how would we — would we think about — just talking about days dosed, who is going to run that part of the study?
Thank you RK. Good morning. I would like again to hand over to Pierre to answer this question about who is in charge. But give a little bit maybe more color on the overall IPH5201 strategy moving forward. Pierre?
Dr. Pierre Dodion
Yes. Thank you, Mondher. And thanks RK for your question. Technically, the study — the current study, the one that has been executed yesterday is sponsored by AstraZeneca. But generally speaking, I would like to insist on the fact that in our partnership with AZ it’s really a two partnership with the two partners having very significant voice upon the table in terms of clinical development.
Furthermore, there are so many options that either could be pursued with IPH5201 as Mondher mentioned, we are initially pursuing a combination with durvalumab and oleclumab. But there are other combination programs that could be set up. Quite obviously, we would like first to have the critical dose and safety data from the ongoing study, but there could really be multiple extensions down the road. And we are working again together with AZ to see how to share the workload that will be announced in due time.
And then on the same program, how — both of you, Mondher and Pierre, how do you see 5201 versus Surface’s CD39 antibody? Their study got started a few months ahead of your in November and I’m just trying to — is there something that — some color that you can give by comparing, contrasting your molecule versus theirs?
Maybe I’ll ask Yannis to give you and the audience a brief recap on the preclinical data that we already published actually at AACR about our anti-CD39, how does it compare with the competition. And let me also say before I hand over to Yannis, is that at this point in time, I think our preclinical data are good. We and AstraZeneca believe that we have a best-in-class — but what really matters now is how we develop these drugs and how can you differentiate in development anti-CD39 versus Surface or [indiscernible]. Yannis, do you want to briefly say a few words about the preclinical package of IPH5201 and how does it compare with the competition please?
Yes. Actually, I think that you were mentioning the [indiscernible] antibody that is currently in Phase I, because it’s tough phase as a CD39 but — well — and it’s still in the technical stage. Obviously the — as you’re aware, competition is an important feature in that way. And based on certain information and certain sequence of antibody, we are obviously benchmarking our antibodies — our all antibodies but this information is not studied so far. So we have any competition based on [indiscernible] molecule, and also with regard to the clinical development that is, as Pierre just mentioned is being developed with — in collaboration with AZ.
Thank you. Last question from me. I’m not sure whether you’ve mentioned this earlier. Regarding Lumoxiti approval in EU. Can you give us a little bit of color around how the conversations are going within EU — with the EU regulators?
I think the opportunity to add to that not only we filed in Europe but also with Swissmedic. But Pierre do you want to provide some color on the process so far with the EMA, when to expect the first set of question and when we are expecting the formal approval?
Dr. Pierre Dodion
Yes, certainly, so we filed actually ahead of time. The process is extremely well standardized, you probably know the critical turning points, either the 80 question or 120 questions. And all of this lead to a final decision by the CHMP, followed later on by the EMA. These are at the end of 2020, or in the very beginning of 2021. That really depends on as you probably know on the speed at which the questions and answers are being closed during the so called stop-clock procedures. So we are basically following the procedure that has been absolutely no particular issue in contrast. As I said, the process has been approved by EMA at the end of last year and we are waiting for the first set of questions.
[Operator Instructions]. The next question comes from Daina Graybosch from SVB Leerink. Please go ahead.
The first one on monalizumab, the cohort 2 data, a couple part question. Do you have any guidance on when you might specifically see that data? And if coronavirus delays the conference, how you might get that data there? And the second part of that question is, is that — given this is the registration indication, is there something specific in this data you’re looking for to help finalize the design of that registration setting? Can you help us understand what that might be?
Alright. Good morning Diana and thank you for this very good question. Again, as it is a medical one, I’m going to hand over to Pierre in a moment. But let me say that in terms of continuity of our business so far and of course we are monitoring this and we have taken this situation very seriously and we are monitoring this situation almost by the day, there is no impact whatsoever. We did not receive any feedback from Congress’ organizers about the cancellation of some of these meetings, the principals that we communicated with that scientific conference. And I think when the situation will evolve, we will have to discuss this with AstraZeneca and decide if by chance the meeting, we were planning to present the data is cancelled we have to discuss internally with AstraZeneca and decide when to present this data and in which form, okay? Now with regard to the second part of your question I’m going to hand over to Pierre.
Dr. Pierre Dodion
Thank you, Mondher. So, in a nutshell, the design of the Phase III study with monalizumab in head and neck cancer has been fully vetted by the various governance committees. As you can imagine as well, for a trial that it’s supposed to start at some point during 2020. It means that the trial has been submitted to regulatory agencies and I can’t give you all the details here, but the process is moving very, very smoothly. In other words, the data from cohort number two are not going to change anything fundamental in the design of the Phase III trial. Having said that, it is always useful to have a global sample size instead of relying on approximately 20, they should be relying on about 60, that provides a better estimate of rest on phase and the long-term outcome that are useful to calibrate the expected effect and sample size. But this will be again very large and vis-à-vis what has been fully endorsed by AstraZeneca and ourselves.
And then last question on Lumoxiti, you mentioned that the salesforce has a unique mix of oncology and rare disease experienced salesforce. And I wonder if you could talk about the rare disease element of this and how you’re going out and you’re getting expertise to better find new patients?
Yes, again, thanks, Daina. This is a very important question and I already said to some of your colleagues in the past, we personally actually are learning about this rare disease model. It’s really differentiated from the classic kind of mix use in large solid tumors or eventually more frequent heme disease. I think it’s all about — and it’s more about data here than the classic marketing mix, establishing really the right relationship and interaction with the different stakeholders and by different stakeholders I include of course HCPs, but also patients and patient advocacy and making sure that they have access to the data. I mean the challenge with hairy cell leukemia is that nothing has happened for the last 25 years. And when you have no competition it’s good and bad actually to some extent. The level of knowledge, interest and even appetite for novel therapy is not the same. So, reaching out to a physician and reaching out to healthcare providers in general, reaching out to patient advocacy and making sure that they get access to the data, and we use different tools and means. And as I mentioned actually, we are in the process of transitioning all marketing and digital activities from AZ to Innate Pharma. That would be a very powerful tool of course to ensure that we have the word out, original tool. But at the same time, implementing the one-to-one peer-to-peer interaction between the physician who has been involved or who have been using the drug so far and community hospitals, practitioners who do not have experience with the drug to educate and teach more on the way we manage this disease.
The spread is certainly interesting, but again, it’s important that we focus on whose hospital is both community hospital and academic centers, center of excellence that drive most of the patients and who set of course the guidelines and provide advice for patient who may not get to the site but who may be treated by their physician in the site on the local town where they are. And the work that our team is doing — and that’s why I say this is — these people are really used to this type of paradigm. They are not in the numbers, it’s not about share of voice and it’s about not about visiting the physician or the hospital every month. First of all, you don’t have to do that because the base is not the same as in solid tumors or classic heme maliganancy. The patient don’t come often to the office. So, there is no need for increasing share of voice, but there is need for more education, spread of the data to again educate the community and raise the profile of Lumoxiti and share the data coming from the pivotal trial about the benefits of Lumoxiti. And actually, as I said the — too early to conclude, of course, but the early feedback, our MSL team and our sales representative are getting from the physician about the new data that’s we presented at ASH last year, the durability and the quality of the complete remission that you obtain with Lumoxiti is extremely positive and people actually are very happy also with the overall safety profile of the drug. And again, early days but positive feedback so far.
Thank you very much. There are no further questions over the phone at this stage. Please continue.
Danielle you want to…?
If there’s any additional questions, we’ll take them now. Also, you can contact myself at firstname.lastname@example.org or if you would like to set up a call with management, or ask any additional questions. At that, I think that we will finish the call and we all wish you well.
Thank you very much. Thank you all for connecting and wish you well. Bye, bye.
Dr. Pierre Dodion
Thank you very much. That does conclude the conference for today. Thank you for participating. You may all disconnect.