Innate Pharma S.A. (IPH) Earnings Call Transcript & Summary

Good afternoon, ladies and gentlemen, and welcome to the Innate Pharma Full Year 2019 Results and Business Update Conference call. [Operator Instructions] 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-Helene 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, good afternoon, everyone. 2019 was a remarkable year for Innate Pharma. And to some extent, the 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 a very significant know-how and expertise that we translated into stated 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 new science and to advance potential new therapy in immuno-oncology. Our ambition is to successfully transition to a commercial stage biotech and build commercial capabilities and develop, hence, a rare cancer franchise. To achieve our ambition, we continue to take advantage of our strong financial position to fuel the growth of our portfolio. And actually, Slide 5, evidence 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 plan. Notably, in September we announced that AstraZeneca, signing for advanced 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 a high unmet need patient population. In addition, as you know, Innate Pharma is eligible to EUR 100 million milestone payment upon the first patient is dosed in this Phase III trial. 2019 was also a defining year for our lead proprietary candidate, lacutamab, which entered into a Phase II in multiple subsets of T-cell lymphoma, including a pivotal arm in Sezary syndrome. Therefore, we have now 2 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 multi-center, 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, as 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 ourself in Rockville, Maryland supporting both operational and commercial initiatives in the United States. Lastly, we successfully raised USD 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 newsflows from our ongoing clinical trials, we'll comment later during this presentation. This includes key data readouts for monalizumab and IPH5401 as well as the initiation of IPH5201 in the Phase I study and the completion of the Lumoxiti transition. Let me now provide you an update on our Lumoxiti commercial effort. And if you move to Slide 7, you can -- first of all, I would 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 3 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 occurred toward the end of last year thereby 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 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 transfer, 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 an Innate U.S. distribution channel will be in place by the end of the year. Now if you move to Slide 8, and as we turn to our customer-facing activity, our sales team has now been interfacing with customers for just over 3 months. And this is a great opportunity for us to build up on the launch of AZ, based on what we have learned from their 1 year experience. This means that our focus for 2020 will be first on really scaling the organization and focus where we can really capitalize on the full market opportunity of Lumoxiti versus more traditional large-scale commercial oncology model. We have hired experienced sales representatives with a unique mix of rare disease and oncology experience. Scale and focus is of paramount here in order really to be very efficient and really penetrating these markets. 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 haven't and have 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 the relapsed or 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 insights 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.

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 months of June 2019. The TELLOMAK trial is an international open-label multi-cohort Phase II study evaluating the efficacy and safety of lacutamab or IPH5201 in different subtypes of T-cell lymphoma, including Sezary Syndrome, Mycosis Fungoides and peripheral T-cell lymphoma. Since November 2019, we have been in ongoing discussions with U.S. and European regulatory authorities concerning good manufacturing practice, or GMP, deficiencies at one of the company's manufacturing subcontractor site, the site that is providing fill and finish operation and the lacutamab clinical vial support 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 9, this year, the U.S. Food and Drug Administration placed the 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 the TELLOMAK trial in Sezary Syndrome and mycosis fungoides in France and in the U.K. following the authorization by the respective national authorities of these 2 countries. This decision is based on an assessment of the unmet medical need in the patients with Sezary Syndrome and mycosis fungoides, and also the lack of currently available standard of care options for such patients. In conferences, 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 patient from all cohorts can continue treatment in the study. The TELLOMAK study remains on partial clinical hold in the U.S., Spain 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 new certified batch from the manufacturer. The clinical trial as we 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 that there has been no safety issue related to the current medication. We are working very hard to transfer the lacutamab fill and finish manufacturing to another contract manufacturing organization, or CMO, and we anticipate that the 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 the European regulatory agencies to fully reactivate the trial as soon as possible. In addition, the company is evaluating other potential options in PTCL, or peripheral T-cell lymphoma, including alternative treatment in first and second line PTCL in the maintenance setting, and we'll provide a further update in due course. Not captured on this slide, I would like, nevertheless, to quickly highlight some other key clinical milestones achieved in 2019. First of all, we presented data at the ASCO 2019 conference. Innate Pharma provided a long-term follow-up data on the 40 patients of the Phase II study, testing monalizumab in combination with cetuximab in patients with relapse 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 showed that IPH5401 and durvalumab is well tolerated. In addition, 12 patients were evaluated for efficacy, and early activity signals were all served in hepatocarcinoma and non-small cell lung cancer. Of note, both these 2 tumor types correlate accordingly with a high expression of the C5a receptor. This data supports the ongoing expansion cohorts, which we'll read out 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 IPH5401, 5201 our anti-CD39 agents and IPH5301, our anti-CD73 agent, which targets the adenosine immunosuppressive pathway as well as the company new proprietary trifunctional NK cell engagers, or NKCs. I would like now to introduce Laure-Helene Mercier, our CFO, to provide our financial overview.

Thank you, Jeff. 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 EUR 256 million as of December 31, 2019, from EUR 203 million at the end of '18. As Mondher mentioned, we successfully IPO-ed on the NASDAQ through a global offering and raised net proceeds of EUR 66 million, and we additionally received EUR 44.9 million in net proceeds from the final payments in relation to the October 2018 agreement with AstraZeneca at the beginning of the year. As a reminder, in the fourth quarter of 2019, AstraZeneca filed the Market Authorization Application for Lumoxiti to the European Medicines Agency that was accepted for review, and this triggered a $15 million milestone, which we paid in January 2020. Now going to the P&L, for the sake of time, I will only comment the main and most significant lines. You have a very detailed comment in the press release that you can refer to for more information. Going to the revenue from collaboration line or more globally, our revenue and other income, they amounted to EUR 85.8 million in 2019, and mainly result from revenue from collaboration and licensing agreements for EUR 69 million with the remainder being mostly research tax credit. As usual, revenue from collaboration and licensing agreement mainly relates to the spreading of payments received by Innate Pharma in the context of the AstraZeneca agreement, of which EUR 42.5 million for monalizumab and EUR 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 STELLAR [indiscernible] and the full cost of IPH5201. Note that the recognition of the IPH5201 upfront is almost completed with EUR 9 million remaining, and that we are -- that -- sorry, that they are expected to be fully recognized in 2020. With regard to monalizumab, currently EUR 62.7 million remains to be recognized with a horizon currently estimated in 2021. Now on the expenses side. Our operating expenses for 2019 amounted to EUR 104.6 million compared to EUR 87.7 million in '18. Remember that out of this EUR 17 million increase, EUR 10 million corresponds to an increase in noncash items in amortization and share-based payments. R&D expenses increased by EUR 9.3 million to EUR 78.8 million, representing 75% of our operating expenses. They primarily relate to activities for Lumoxiti, monalizumab, IPH5402 mogamulizumab and IPH5201. Subcontracting costs are mainly stable as many of our clinical trial programs were transitioning during the year, resulting in lower costs from 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 a full year. Selling, general and administrative expenses increased by EUR 7.7 million to EUR 25.8 million for the period in the context of the situation of the U.S. subsidiary and the commercialization of Lumoxiti as well as the general enforcement 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 it 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 will still act as principal and book sales in commercial expenses. Under the Lumoxiti distribution agreement, we recognized a net loss in 2019 of EUR 8.2 million in the context of the launch of the drug and recognition of the cost over a full year. As a reminder, we had a cost-sharing agreement with AstraZeneca on the R&D and commercial costs through the 2019 transition, this 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 we recognized cost for 1 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 agreements, we are pleased with our cash runway, which is about 2 years based on our current pipeline and development plans. I will now turn the call back to Mondher.

Thank you, Laure-Helen. So if you move to Slide 13, which is the potential newsflow 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 strive 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 patients with head and neck cancer. This 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 will 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 testing monalizumab, cetuximab and durvalumab in IO-naive head and neck cancer patients. 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 add an anti PD-L1, in which case, durvalumab with IPH5401 and we anticipate to have preliminary efficacy data in the first 2 extension cohorts, patients with non-small cell lung cancer, IO-pretreated NA resistant to PD-1 blockers. And the second cohort, hepatocarcinoma patients who are IO-naive, 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 read out subsequently to the first 2 expansion cohorts, 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 achievement 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.

This is Samantha on for Yigal. I wonder if you could provide a bit more information on the trajectory of the Lumoxiti launch, thus far. And particularly in 2019 in terms of growth that you've seen since it's been over -- about 1.5 years now since approval? And also how many patients have you treated thus far?

Thank you. The -- I think it was Samantha, but I'm not sure. You said Yigal had a question from Citi. And it's about Lumoxiti launch so far. So first of all, as Laure-Helene mentioned, AstraZeneca has acted up to now as the principle, and they did not disclose any details about the commercial performance, and we do not provide guidance on sales. We are leveraging data from AstraZeneca. We estimate, as you know, about 1/3 of the roughly 1,000 patients in the U.S. with hairy cell leukemia could be eligible to be treated with Lumoxiti. And whilst we fully transition all interfacing activity, we will build our own data set, and of course, we'll provide more granularity on the commercial performance. What we can tell you is that the feedback that our sales representatives 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 paradigm of this disease. What is interesting actually and what we are 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 the patient relapse for the third or fourth time or fifth time, the decision to treat is not immediate. And of course, the pool of patient is builded up, but the decision to treat is basically the conviction that physicians have 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 are making sure that we not only help identify the patients who are eligible but provide data that reinforce the conviction to treat with Lumoxiti.

That's very helpful color. I appreciate all the detail. Switching 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 is this related more to the changes that you're seeing in the PTCL treatment landscape? Or -- and when you noted other potential options in PTCL, is that related to -- in reference to [indiscernible] or to additional drugs in your pipeline?

Again, thank you, Sam, for another very important question. So IPH4102 now is called lacutamab, 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 as lacutamab. And I'll hand over to Pierre Dodion to give you more color on the PTCL program. But remember, the TELLOMAK trial actually has 2 -- 3 components. The Sezary is what could be potentially pivotal. The other 2 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 the -- 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 were to happen, it would be very difficult to really identify what's the contribution of what. And that's why, given that there are other levels of decision, it was recommended to pause there. And we actually take it as an opportunity to rethink the overall PTCL program, and I'm going to ask Pierre to maybe give you more color on where we are in this process.

Yes. Thank you, Mondher. In addition to what you have fully explained, there are perhaps a few other points that I would like to mention. The field of PTCL is indeed somewhat more crowded in terms of competitive activities than Sezary 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 is a fact that the competitive landscape is somewhat more significant. If you look, by the way, at the design of the TELLOMAK study. You will notice that in cohorts #4 and 5, which are testing lacutamab in PTCL, patients are receiving lacutamab in combination with a chemotherapy regimen called GemOx. So GemOx by itself is in fact, if you will, a competitor. Then the second critical point that I would like to mention is that, again, well before the GMP questions, we had initiated scientific and medical discussions about expanding the PTCL program, working with a corporative group that could express a quite strong 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 efforts 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 of our efforts. Actually, it's the opposite, it's going to expand our efforts in PTCL. And finally, although 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.

The next question over the phone today comes from Swayampakula Ramakanth from H.C. Wainwright.

Mondher, I'm glad to see that you have initiated your study on 5201. And certainly, this seems to be like a broad program. The first question on that program, is this -- who's running this program? Is it AstraZeneca that is going to be running most of the program? Or is it from Innate and how would we think about -- when we start thinking a bit though, what -- who is going to run that part of the study?

Thank you, RK. 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?

Yes, thank you, Mondher. Thank you, RK for your question. Technically, the study, the current study, the 1 that has been activated 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 2 partnership with the 2 partners having a very significant voice under the table in terms of clinical development. Furthermore, there are so many options that 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 expansions 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 antibodies? Their study got started a few months ahead of yours 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 best-in-class. But what really matters now is how we develop these drugs and how can you differentiate any development anti-CD39 versus Surface or Tizona. 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. RK, I think that you were mentioning that Tizona antibody that is currently in Phase I because Surface has a CD39, but to our knowledge, it's still at the preclinical stage. Obviously, as you are aware, competition is an important feature of the adenosine pathway. And based on public information and public statements of antibody, we are obviously benchmarking our own antibodies, but this information is not public so far. So we have a differentiation based on the intrinsic properties of our molecule and also, with regard to the clinical development that is -- as Pierre just mentioned, is being developed with -- in collaboration with AZ.

Okay. And last question for me. I'm not sure whether you mentioned this earlier. Regarding Lumoxiti approval in EU, can you give us a little bit of color around how the conversations are going within the -- with the EU regulators?

I take the opportunity to add to that, that not only we filed it 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 questions? And when we are expecting the formal approval?

Yes, certainly. So we filed actually ahead of time. The process is extremely well standardized. You probably know the critical turning point, like the Day 80 questions or Day 120 questions. And all this should lead to a final decision by the CHMP, followed later on by the EMA, either at the end of 2020 or in the very beginning of 2021. That all depends on -- as you probably know, on the speed at which the questions and answers are being processed during the so-called stopclock procedures. So we are basically following the procedure. There 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.

The first 1 on monalizumab, the cohort 2 data. A couple of part questions. Do you have any guidance on when we might specifically see that data? And if coronavirus delays the conference, how you might get that data to us? The second part of that question is that, given this is a registration indication, is there something in specific in this data you're looking for to help finalize the design of that registration study? Can you help us understand what that might be?

All right. Daina, 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, we are taking the situation very seriously, and we are monitoring the 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 principle is that we communicate the data at scientific conferences. 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 canceled, 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.

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 is 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 #2 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 broader sample size. Instead of relying on approximately 20 patients, we would be relying on about 60. That provides better estimates of response rates and long-term outcomes that are useful to calibrate the expected effects and sample size. But this will be, again, very margin vis-à-vis what has been fully endorsed by AstraZeneca and ourselves.

That's helpful. And then a question on Lumoxiti, you mentioned that the sales force is a unique mix of oncology and rare disease experienced sales force. And I wonder if you could talk about the rare disease element of this and how you're going out and using the expertise to better find these patients?

Yes. Again, thanks, Daina. This is a very important question. And I already said it to some of your colleagues in the past. We, in personally actually, are learning about this rare disease model. It's really differentiated from the classic kind of mix you use in large solid tumors or eventually more frequent heme diseases. 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 that include, of course, HCPs, but also patient and patient advocacy and making sure that they have access to the data. I mean, the challenge we've had in cell leukemia is that nothing 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 our appetite for novel therapy is not the same. So reaching out to a physician, reaching out to health care 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, and that would be a very powerful tool, of course, to ensure that we have the word out through those tools, but at the same time, implementing the one-to-one, peer-to-peer interaction between physicians who have been involved or have been using the drug so far, and community hospital's practitioners who do not have experience with the drug to educate them and teach more on the way we manage this disease. The spread is certainly interesting. But again, it's important, if you focus on those hospitals, both community hospital and academic centers, center of excellence, that drive most of the patient and who set, of course, the guidelines and provide advice for patients who may not get to these sites, 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 pace is not the same as in solid tumors or classic heme malignancy. The patients don't come often to the office. So there is no need for increased 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 updated data coming from the pivotal trial about the benefit of Lumoxiti. And I -- actually, as I said, the -- early -- it's early, too early to conclude, of course, but the early feedback, our MSL team and our sales representatives are getting from the physician about the new data that we presented at ASH last year, the durability and the quality of the complete remission that you obtained with Lumoxiti is extremely positive. And people are -- actually are very, 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, do you want to?

Yes, if there's any additional questions, we'll take them now. Also, you can contact myself at [email protected] for -- 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.

Bye-bye.

Thank you very much. That does conclude the conference for today. Thank you for participating. You may all disconnect.

Thank you.