Bergenbio ASA

OSE:BGBIO

Earnings Call Transcript 2020-Q1

[Operator]

Welcome to the BerGenBio Q1 2020 Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.I will now hand it over to the speakers. Please begin.

[Richard Godfrey, Chief Executive Officer]

Hello. Thank you. Good morning. Welcome to BerGenBio's Quarter 1 2020 Report, Highlights and Financials. My name is Richard Godfrey, and I'm the CEO of BerGenBio. This morning, I'm joined by Rune Skeie, our CFO; Hani Gabra, our Chief Medical Officer; and James Lorens, our Chief Scientific Officer. I will lead the presentation and then hand over to Rune, Hani and James to field questions.Next slide please. BerGenBio is a publicly traded company on the Oslo Stock Exchange, and I should draw your attention to the forward-looking statements and disclosures that we make here.Next slide, please. Just by way of reminder and -- of BerGenBio and a sort of overview, BerGenBio remains world leaders in understanding the biology of AXL, and its importance in the mediating aggressive diseases. AXL is a tyrosine kinase that mediates its effect by being upregulated. It drives aggressive diseases, such as immune evasion, therapy resistant and metastatic cancers. It's an important driver in fibrosis, and increasingly for understanding that it mediates severe viral infections. Selective AXL inhibitors have the potential to treat many serious diseases and unmet medical needs and we have a pipeline of opportunities that we're developing.BerGenBio has 2 selective AXL inhibitors in clinical development. Bemcentinib is our lead program. It's an oral once-a-day pill and tilvestamab is an anti-AXL antibody. We have a broad Phase II program for bemcentinib, testing it as a monotherapy and in combination with checkpoint inhibitors, targeted agents and chemo agents. We'll summarize that a little later.In addition, we're developing biomarkers and some proprietary biomarkers we've developed and developing them into a companion diagnostic. During 2020, we anticipate a number of significant clinical data points in AML, acute myeloid leukemia, in non-small cell lung cancer and also in COVID-19 infection. BerGenBio is listed on the Oslo Exchange under the ticker BGBIO. We have the privilege of working with several collaborators, including Merck, U.K. Research Institute and leading academic centers in the European Union and the United States. We're continuing developing our organization, and today, we have 40 staff located both in Bergen and our clinical development offices in Oxford in the U.K. At the end of quarter 1 2020, we reported a cash position of NOK 419 million. And in addition, we also secured a pipe funding in May of an additional NOK 500 million.Next slide, please. The last few months have been extremely busy and very successful for BerGenBio. In December, we were able to present preliminary data from our Phase II study in acute myeloid leukemia, combining bemcentinib with low-dose Ara-C, a chemo agent in relapsed and refractory AML patients. We saw complete responses in patients that developed and deepened with time and also very encouraging duration. More on that later.In January, we reported that we met the primary endpoint of overall response rate in a Phase II study of -- in non-small cell lung cancer patients, combining bemcentinib with KEYTRUDA. And that was sufficient to trigger, so that we could start the second stage, the expansion stage of that study. Again, more on that a little later.In January, we also secured additional funding of NOK 220 million. And in May, we announced that bemcentinib has been selected by a U.K. government task force to be the first experimental compound to enter a fully-funded platform trial evaluating its efficacy and safety in COVID-19 patients. And more recently, we secured additional funding through a private placement delivering NOK 500 million in net proceeds.Next slide, please. In these unprecedented times, it's appropriate that we stop for a moment and review the impact of the COVID-19 crisis as it has affected BerGenBio as well as many people worldwide. First and foremost, our highest priority is to ensure the well-being of our staff. And we took appropriate and immediate action as the crisis broke. We deployed extensive working-from-home arrangements and virtual communications, and I'm very pleased and proud to report that our teams have operated very well in these circumstances. Our laboratories at the University of Bergen were closed for a period of time, and we were required to have some furloughing or permittering of some our scientific staff in Bergen. But that is now over.Of equal importance is ensuring the well-being of our patients, and I'm very pleased to have confirmed that our patients were unaffected by the COVID crisis. All patients remained on study and received medications and follow-ups, albeit some of those follow-ups were virtual. Because of the convenient nature by which bemcentinib can be administered, a simple one-a-day pill, we were able to extend the duration of treatment that was offered to limit the patients' visits to hospital pharmacies.Continuing with our clinical trials requires that we recruit more patients into the studies. Many, but not all of the hospitals involved in our clinical trials, stopped the enrollment of new patients onto the trials. This will have an impact on time lines and data readouts and contingent on the COVID crisis, I can give some guidance as to the impact this may have on our business. Of great value to our clinical data is the corresponding translational data, this is when we take samples of blood and tissue and analyze and understand the impact and effect of our drugs. Sample collection and processing of these samples were slightly affected during the COVID crisis, but in actual fact, the impact will be minimum on the revised time lines that we will publish.The basic research continuing to understand the role and function of AXL continues both in our laboratories, but also with many collaborators worldwide. And like in Bergen, many of these laboratories were closed, and this has had a delay impact in some of our studies. However, the University of Iowa Research Labs managed by a Professor Wendy Maury remained open during the COVID crisis and was able to yield some very valuable and informative preclinical data regarding the role of AXL in mediating the COVID disease.As a business, as this crisis emerged, we took immediate action to preserve our cash and to align our project spend with what we thought would be the extended time lines. And I think that was very successful.Next slide, please. AXL drives aggressive diseases. I know that I've presented many times the role and function of AXL, and this is the foundation of our business. BerGenBio remains world leaders in understanding the role and function of AXL. And in summary, as on the top in this slide here, we know and are increasingly convinced that AXL mediates multiple survival mechanisms used by cancers, including resistance to chemo drugs, evasion to -- of the immune system and metastasis and cancer spreading around the body. More recently, we're understanding that AXL also facilitates viral entry into host cells and reduces antiviral immunity in those cells. And I'm going to talk a little bit more about that research in a moment. AXL is a very important mediator of aggressive diseases.Next slide, please. Remembering that oncology is our core business and understanding the role and function of AXL mediating aggressive cancers and how that can be limited by selective inhibition of AXL is essential for our clinical program. AXL mediates its effect by being upregulated. It's not a driver mutation, and its upregulation is a result of stress factors in and around various cells in the cancer. Stress factors, such as hypoxia that is inflammation or even chemo or radiation treatment. On the cancer cell, you get an increased expression. You get more of these AXL receptors on the surface of the cell, and it causes the tumor cell to escaping survival. We know and have reported many times that AXL is a unique type 1 interferon response checkpoint. In many ways, we might consider that a cancer cell acts like a viral infected cell. We know that AXL mediates acquired drug resistance and immune death resistance. It's also the essential mediator of metastasis. Indeed, that was the first publication that we made. But other cells of the tumor, specifically immune cells, will also have their effects suppressed by AXL. The macrophages are very important for modulating the inflammatory response and the M2 macrophages require AXL to stay in that form and stop the immune response. The dendritic cells are critical for priming the T cells and their activity is inhibited by AXL upregulation, and indeed, that activity is restored by inhibiting AXL with bemcentinib. And the warhead of the immune cell, the CD8-positive T-cell mediate its effect on the cancer cells. That effect is inhibited by AXL and restored by bemcentinib. A member of the innate immune system called the Tregs also is regulated by AXL and indeed, restored by bemcentinib. So AXL has a multifaceted mechanism of survival when given to cancer patients.Next slide, please. More recently, when conducted by Wendy Maury at the University of Iowa, and indeed, many other researchers over the last 7 years or so, have begun to understand that AXL is an important mediator of viral entry into host cells, and it dampens the viral immune response. I know I presented this slide a few weeks ago, where we explained that the enveloped virus on the left-hand side there and part A of the figure, tricks the host cell to allow it to be absorbed. It tricks the host cell by wrapping itself in a chemical called phosphatidylserine, but then allows it to be bound to be outside part of AXL, and therefore, activates the AXL signal. That, in turn, prompts the expression of more AXL on the host cell and also communicates the neighboring cells to increase the actual expression. But whilst the virus is stuck there on the outside of the cell attached to AXL, it also sends an "eat me" signal, which prompts the host cell to try and clean up its outside space by a mechanism called apoptotic mimicry, and the host cell actually eats or consumes this viral particle, taking it into the cell, and therefore, taken over the protein production mechanisms of the host cell. So this is one of the mechanisms by which the viruses can enter host cells. But equally, potentially even more important is that this actual COVID complex then interacts with another receptor on the host cell called interferon receptor. And that activates the interferon receptor, it's through a communication cascade in the cell leads to inhibition of type 1 interferon response and suppression of the immune system. This is an essential antiviral defense mechanism for all cells, which is switched off by AXL and that dampening of the antiviral mechanism is prevented by inhibiting AXL with bemcentinib. This is very compelling data produced by Wendy Maury at Iowa from the University of Iowa and also a suite of other publications in the literature. And this is the foundation by which bemcentinib was selected to enter the ACCORD trial.Next slide, please, bemcentinib. As we know, bemcentinib is a highly selective inhibitor of AXL. Indeed, the biotechnology and the innovation of BerGenBio is linked to understanding the biology of AXL and the selective nature of our inhibitors. We manufacture it as a simple pill. We have extensive Phase I and Phase II experience in more than 350 patients, and today, we have increasing confidence that its safety profile supports the use in first-line, high-risk fragile patients. Indeed, it also combines well with other drugs and its mechanism is also synergistic with other drugs and today we have broad regulatory exposure in Europe and North America. And moreover, of course, we have medicine available for clinical trial use.Next slide, please. BerGenBio and specifically with bemcentinib has a very broad Phase II program. Some of these studies are sponsored by BerGenBio, and it's the focus of our activities. Bemcentinib is being tested in acute myeloid leukemia as a monotherapy and also in combination with low-dose Ara-C, a chemo agent. That second study surpassed the proof-of-concept stage and is now an in expansion cohort, which we anticipate should read out at the end of this year, and data will be presented at ASH, all being well. Our study in non-small cell lung cancer is in collaboration with Merck in -- and by combining bemcentinib with KEYTRUDA. As you know, this study is being conducted in 3 cohorts. Patients that are refractory to chemo agents, patients that are refractory to checkpoint inhibitors and patients that are refractory to chemo and checkpoint inhibitors. The first cohort is complete and data is readout and been presented at several conferences, and I can advise today that an updated survival data will be presented on the 25th of June at a Next-gen Immuno-oncology Conference.Cohort B, combination with KEYTRUDA in patients that are refractory to check inhibitors surpassed the first milestone, endpoint of overall response rate, and it's now into the expansion stage. Again, I confirm today that the first-stage clinical data and translational data will be presented at that same conference on the 25th of June.Cohort C in patients that have failed chemo and checkpoint inhibitors is actively recruiting now. We can hope that it will recruit at an acceptable rate and anticipate that we should be able to produce some top line data, some preliminary data towards the end of the year, either at the SITC Conference or the World Congress on Lung Cancer.The other studies where bemcentinib is being investigated are so-called investigator-sponsored studies. Here, bemcentinib is being tested as a monotherapy in combination with checkpoint inhibitors and also with chemo agents. The most recent investigator-sponsored trial to enter our pipeline is the monotherapy trial in COVID-19 patients, which we've spoken about already. I'll come to that in a moment. Our leukemia and MDS study, in collaboration with the European MDS Cooperative Group, has now completed recruitment, and we anticipate data being presented at ASH at the end of the year. You can see on this slide that there are a number of other studies that are anticipating first patient enrollment in the near future, but those studies are on hold due to COVID.Next slide, please. Bemcentinib clinical development in COVID-19 is in a clinical trial called ACCORD 2. The objective is to evaluate the efficacy and safety of bemcentinib in hospitalized COVID-19 patients. Bemcentinib was the first compound to be selected by the U.K. government's COVID-19 task force. The trial is fully funded by the U.K., and it's a multicenter, randomized Phase II study with the potential for seamless transition into a Phase III study.Next slide, please. Bemcentinib was selected because preclinical data suggested that it was potentially very useful in the treatment of COVID infection as it selectively inhibits AXL kinase, and as I explained earlier, that's important for viral entry and also dampening of the antiviral immunity. Bemcentinib is the first compound to be selected and has been fast-tracked into clinical trials. The ACCORD program is an investigator-sponsored study. The Chief Investigator is Professor Tom Wilkinson at the University of Southampton Hospital, and indeed, that is the actual sponsoring body. It is a collaboration between government and academic and industry. And as you know, it will recruit 120 patients across multiple sites in the U.K.Next slide, please. The Protocol is a Phase II adaptive randomized study to assess the efficacy and safety of multiple candidate agents for the treatment of COVID-19 hospitalized patients. This is an adaptive platform study, designed to rapidly assess multiple candidate treatments of COVID-19 patients. Candidate drugs are initially assessed as being efficacious, and if successful, will be moved from a Stage I evaluation stage to Stage II confirmatory state. The endpoint of the study is the time for clinical improvement by at least 2 points on this 9-point ordinal scale, you can see on the right-hand side here. We will be enrolling patients in -- that are either Stage III, IV or V. All patients who are hospitalized, they may require oxygen therapy or a noninvasive ventilation. These are not the most severely affected patients who require intubation or mechanical ventilation.Next slide, please. So in overview, the study will evaluate multiple agents. The first agent selected to enter the study is bemcentinib. There will be 60 patients in each agent cohort, and a control arm will be recruited as well. And the study will be randomized. Following recruitment and assessment at day 29, there will be an independent data monitoring committee that will evaluate the data and the efficacy and safety. If positive, there will then be a seamless transition into Stage II. It's potentially statistics dependent, will be approximately 126 patients in each arm. The agents are not necessarily competitive with each other, and they're not necessarily being used in the same hospitals.Next slide, please. The current status of bemcentinib in the ACCORD style is that it's still early days. As I've mentioned, it's a collaboration between government agencies, the CRO IQVIA and University Hospital Southampton, who are the sponsor, and therefore, legally responsible for the study. The ACCORD study was designed and regulatory cleared in record time. Bemcentinib is the first compound to be tested in the program. And as such, we're leading all the initiation activities in the hospitals. I understand other compounds that have been identified by the task force have not yet entered clinical trials. It's critical when we initiate a clinical trial that the appropriate quality standards are deployed and the hospital staff are trained on the protocol, they're trained an use of technical aspects that bespoke databases and they learn how to administer bemcentinib to patients. This takes a bit of time, requires training, and we're going first. Southampton University Hospital was the first to be activated. And as of Friday last week, there's a total of 4 hospitals in the U.K. activated and started screening patients to enroll them in the study. So far, no patients have been dosed with bemcentinib. Feedback from the sponsor is that there is a reduction in the number of hospital admissions for patients with COVID-19, and we can provide further updates as soon as possible. But we must not forget that COVID remains a global pandemic. In the U.K., the incidence has been managed acutely by government through very strict lockdown laws. The COVID disease remains in the population and the science supporting bemcentinib's potential as a treatment remains increasingly promising indeed. You can see here, we've plotted a map that shows where Southampton is on the south there, a number of hospitals in London, Manchester, Wales and Northern Ireland.Next slide, please. Just by way of brief summary, I just wanted to remind ourselves about our program in acute myeloid leukemia and myelodysplastic syndrome. The objective of this study again is to demonstrate safety and efficacy of bemcentinib in this elderly relapsed/refractory AML patients. We've demonstrated proof-of-concept in -- as a monotherapy, specifically in patients that we can identify using soluble AXL as a biomarker. Bemcentinib combination with low-dose Ara-C also demonstrated proof-of-concept and is now being expanded out in this trial.This trial's summary is on the next slide, please. The purpose of Cohort B5 is to confirm that we have a strong signal, ideally in a biomarker-selected patient population where we can treat with bemcentinib and LDAC, and hopefully, this will guide registration path forward.Next slide, please. Also remind of our study in non-small cell lung cancer. Again, the objective here is to improve the effectiveness of immune checkpoint inhibitors in refractory non-small cell lung cancer patients in a second-line setting. So as we've said before, we've already completed the trial, evaluated patients who are chemo refractory. We've surpassed the first endpoint in patients that are checkpoint refractory, and we have an ongoing study in patients that are chemo/checkpoint refractory.It's summarized on the next slide, please. So Cohort A, it's fully recruited, all data reported out, and we can provide an update on overall survival on the 25th of June. Cohort B surpassed the interim analysis in Stage I and is now recruiting patients in Stage II. And Cohort C is recruiting patients in Stage I at the moment.Next slide, please. Just a reminder of the data that we saw from Cohort A. 50% of the patients were AXL positive by our composite biomarker score cAXL. The overall response rate in the cAXL-positive patients was 5x greater than in the cAXL-negative patients. We saw a 442% increase in the median progression free survival in patients that were AXL positive and a 73% clinical benefit rate in those same patients. It really did seem to make a big difference. And all of this is independent of the biomarker for checkpoint inhibitors known as PD-L1. Cohort B, as mentioned previously, is in patients that are refractory to checkpoint inhibitors.Next, Slide 25, please. The definition of the checkpoint refractory patient is quite precise and specifically defined, and it's important that we pay attention to this, it's patients that must have reported a prior benefit to taking a checkpoint inhibitor and then have subsequently to have progressed on treatment. The progression is defined as patients that received at least 2 doses of an approved checkpoint inhibitor demonstrated progression according to RECIST 1.1, and that initial evidence of progression is confirmed with the second assessment no less than 4 weeks from the date of the first assessment. In other words, patients that truly saw a benefit and truly progressed. In January of this year, we reported that Cohort B met the overall response rate endpoint and progressed to Stage II, and we are actively recruiting the additional 16 patients. This clinical data and translational data will be presented at the Next-gen Immuno-oncology Congress on the 25th of June, that will be a virtual event. That's the end of the clinical and science update.I'd like to hand over to Rune to give an -- our financial report. Rune, thank you.

[Rune Skeie, Chief Financial Officer]

Thank you, Richard. My name is Rune Skeie, CFO of BerGenBio, and I will take you through the key financials for the first quarter 2020. Next slide, please.We ended Q1 2020 with an operating expenses and a loss of NOK 56.2 million compared to NOK 54.5 million in expenses in Q1 2019 and a operating loss of NOK 45.8 million in Q1 2019. 83% of operating expenses in Q1 2020 attribute to research and development expenses. So the overhead expenses was well managed.Next slide, please. We have an average cash burn of I think NOK 50 million in the quarter. Cash flow in the quarter was affected by the private placement completed in January with raising gross NOK 220 million. We ended Q1 with NOK 419 million in cash in end of the quarter. And in addition, we raised NOK 500 million in May 2020, which is not included in the NOK 419 million.Next slide, please. As part of the private placement, we have opened up the subsequent repair offering. In the private placement, we issued 13.3 million new shares at the price of NOK 37.5. In the subsequent repair offering, we will issue up to 1.5 million shares. And that will be directed to shareholder that was registered 4th of May -- was the shareholder 4th of May, registered at 6th of May and were not allocated shares in the private placement 4th of May, and is not resident in a jurisdiction that is not you stand to offer of the shares and that at the record date didn't have a shareholding above (sic) [ below ] 150,000 shares.We will issue a nontradable subscription rights at a later stage. The subsequent repair offering is subject to an extraordinary general meeting, which we will have, an approval of a prospectus and assess the share price development, if open, in 2020.Next slide, please. Just goes to show financial analyst coverage we have. We have 2 U. S. analysts that are all here, Wainwright and Jones Trading. And we have Arctic and Trinity Delta on this side of -- in there also.And that ends the finance presentation, I hand over to you now, Richard.

[Richard Godfrey, Chief Executive Officer]

Thank you, Rune. Next slide, please. So now we're approaching the summary and anticipated news flow for 2020. Next slide, please. So by way of recent highlights, say, we presented preliminary data for our combination study with LDAC in relapse/refractory AML patients at the ASH Conference in December. We met the primary endpoint of overall response rate in the Phase II trial in non-small cell lung cancer in combination with KEYTRUDA, successful private placement in January, totaling NOK 220 million, initiated with COVID-19 randomized Phase II study, an investigator-sponsored study in the U.K., fully funded study by the U.K. government, and in May of this year, we closed the second private placement of NOK 500 million.Next slide, please. Looking forward, the rest of 2020 and our expected news flow. Of course, all guidance here is somewhat conditional on managing the impact of the COVID crisis globally as that trials are in many different countries there around the world. We have some sight and some anticipation of when we will have data, and we'll be able to present. There's a high level of certainty that we'll present Cohort B1 non-small cell lung cancer bemcentinib and KEYTRUDA at the Next-gen Conference on the 25th of June, and we will communicate that -- details of that in due course. The data of the ACCORD 2 COVID trial is obviously conditional on recruitment. It's difficult to predict exactly how that will be. So we've opened up for quite a wide window there during the summer. And we hope that we will have recruited and be able to report out the performance of bemcentinib in those patients. We're planning to present more non-small cell lung cancer data at the SITC Conference in November and the World Congress on Lung Cancer in early January. And as mentioned earlier, we anticipate and hope to be able to present leukemia data, specifically the bemcentinib and LDAC data in December at the end of the year.So concluding on our news flow and outlook there, brings us to the end of the quarter 1 update and presentation. I think we should now open up if there are any questions.I think there's been a number of questions submitted through the portal. I will ask Rune to operate as a question master. And I'll either take the questions or direct them to Hani or James. So thank you, Rune, if you could take the questions, please. I guess we should start at the top with the first question that came in.

[Rune Skeie, Chief Financial Officer]

Yes. The first question is, are you being compensated for participating in the ACCORD study?

[Richard Godfrey, Chief Executive Officer]

Thank you, Rune. I think I can take that question. No, we are not being compensated. We are not being paid to participate in the study. The study is fully funded by the U.K. government. There's no direct cost to BerGenBio. We are, of course, providing drug substance. We are providing bemcentinib, and we're providing a lot of scientific and intellectual and -- insight into the study, but we're not being paid, and we have no direct costs associated with it.

[Rune Skeie, Chief Financial Officer]

Next question is where do you think BerGenBio will be in 1 month's time?

[Richard Godfrey, Chief Executive Officer]

That's an interesting question. Well, I'm very confident that our trials will continue. We have a number of data points and news flow anticipated in the coming months. It's difficult to predict clinical trial recruitment in these times. But I remain extremely confident and very positive with respect to our science and our data. So I think our position is going to go from strength to strength.

[Rune Skeie, Chief Financial Officer]

Next question is kind of open. Have you get any positive feedback on the treatment?

[Richard Godfrey, Chief Executive Officer]

I'm not sure that I understand the question. The treatment of what? I'm sorry, I can't answer that question. I think we may have to ask the question poser to clarify the question a little bit there.

[Rune Skeie, Chief Financial Officer]

Next question is, what are the expected revenues from the ACCORD COVID-19 test in U.K.?

[Richard Godfrey, Chief Executive Officer]

I can take that question. And that's another very, very good question, and it's very difficult to anticipate that. I know there's a number of analysts that are covering us have had some attempts at that. We have -- at this point, we have not had any discussions with any agencies regarding reimbursement. We can take some insight from potentially where other therapeutics are trying to position their price points. And of course, that's just part of the equation. Other parts of equation depends on sort of regulatory clearance, distribution and of course, the number of patients. So it's a very, very difficult question to answer. I think we need to concentrate on completing our trials, reading out positive data and understanding the clinical position. With all of that information, it will become more apparent what the potential economics could be.

[Rune Skeie, Chief Financial Officer]

Next question is, can you confirm the first patient in ACCORD has received bemcentinib?

[Richard Godfrey, Chief Executive Officer]

No. At this moment, no patients in the ACCORD study have received bemcentinib.

[Rune Skeie, Chief Financial Officer]

Next question is if AXL is an important component of our complex immune system, then surely shutting it down or solely reducing its consumption have side effects. Perhaps the side effects are only important in healthy individuals. Should we see that the side effect will limit the use of BGB324 to some effect. In other words, could blocking AXL compromise the immune system in a way that makes an individual really more to other propagandas for disease?

[Richard Godfrey, Chief Executive Officer]

It sounded like a complicated question. I'm not sure that I fully got it all. Not sure if -- Jim is best qualified to field that if you heard the question clearly.

[James B. Lorens, Co]

Yes, I can. Yes, thanks, Richard. Yes, I think the question is about the role of AXL in antiviral immunity, antipathogen immunity. And as Richard's outlined, there's been a research interest in the role of AXL in promoting viral infections for several years through these mechanisms that we showed a few moments ago. In particular of interest is the fact that AXL is expressed on a number -- on important dendritic cells, which regulate the immune response. But AXL's role as it is in viral responses, as it is in cancer is actually to suppress the immune responses. So the anti-tumor immune response is suppressed by AXL and the antiviral immune response is suppressed by AXL. And in both cases, bemcentinib selectively inhibits the AXL receptor tyrosine kinase, then allowing a productive antiviral -- sorry, antiviral or -- and/or anti-immune effect in both cases.

[Richard Godfrey, Chief Executive Officer]

Thank you, Jim. Rune, is there another question? I think Rune is just having a technical problem. Please bear with us for one moment.

[Rune Skeie, Chief Financial Officer]

I'm back. The next question is, you have told about 80% chance of success with COVID trial. Like many others, I want to know how this number comes up.

[Richard Godfrey, Chief Executive Officer]

Yes. Thank you, Rune. Yes, this reference to 80% was really taken out of context in a media report. I was, of course, referring to the importance of AXL. BerGenBio regularly presents scientific results and data at medical and scientific congresses in the appropriate fashion, both ourselves and with collaborators, and we'll continue to do so. Like with all clinical data, it's important that we wait for the result, analyze it appropriately and then come up with any efficacy conclusions. So I'll say that that's where we are there.

[Rune Skeie, Chief Financial Officer]

Next question is the fibrosis indication. Is that relevant for COVID-19 and the challenge according to lung damage seen in some patients? Can data for this be used for suture applications if that's a wanted indication?

[Richard Godfrey, Chief Executive Officer]

That's a very, very good question, indeed. And I know we have spoken about it. Jim, do you want to take that first of all? And maybe Hani could add in?

[James B. Lorens, Co]

Yes. This is -- thank you for that insightful question. So as you are likely aware, so the sequelae of the COVID-19 include lung fibrosis diseases after the viral infection has cleared. And there is an anticipation in the field that there will be new -- more patients who are presenting with fibrotic diseases post COVID-19. That is something that we're particularly interested in with respect to the antifibrotic effects of bemcentinib and tilvestamab.

[Richard Godfrey, Chief Executive Officer]

Hani, did you want to add something from a clinical perspective?

[Hani Gabra, Chief Medical Officer]

Yes. I mean it's a great question, it's Hani here. So obviously, a lot is made about the death rates in COVID disease, but actually not very much has been said about the burden of illness that will -- that may follow recovery from this disease. And so there may be significant chronic disease in the populations that survive. And therefore, there is -- we're watching very carefully the potential for our approaches to modify that -- these types of problems, such as fibrosis, obviously, yes.

[Richard Godfrey, Chief Executive Officer]

Thank you. Rune, was there another question?

[Rune Skeie, Chief Financial Officer]

Yes. A recent paper, utilizing a structure-based virtual screening. So just then something then could bind SARS or F to virus, protein complex and FP16 and fetal, is this something you will investigate?

[Richard Godfrey, Chief Executive Officer]

Another very good question. And again, maybe Jim is familiar about ether and the potential for virtual screening for cells to virus.

[James B. Lorens, Co]

Yes. So I'm not going to comment specifically on the data in the paper as I haven't seen it in person as it were firsthand. But as a general theme, the main effect of bemcentinib is to block AXL kinase and AXL kinase signaling, there can be, of course, fortuitous interactions like this, particularly in sort of nonnative protein complexes that are produced by viruses, as you're suggesting where bemcentinib potentially could have some effect, but that remains to be investigated.

[Richard Godfrey, Chief Executive Officer]

Thank you. Rune?

[Rune Skeie, Chief Financial Officer]

Next question. Richard told that bemcentinib has showed effects as well with other drugs? Does this mean bemcentinib outperforms drugs like remdesivir or individual inhibition of in vitro cells infecting assays or somewhat comparable assays?

[Richard Godfrey, Chief Executive Officer]

Maybe I can take that from my perspective. And maybe Jim or Hani could intervene. So the mechanism that bemcentinib deploys by inhibiting AXL. Increasingly, we are confident and assured that by inhibiting AXL, you prevent viral entry and you prevent the dampening of the type 1 interferon response. So there's a duality of mechanisms there, and increasingly, we're understanding that AXL acts a co-receptor as well, facilitating greater viral infection. Other drugs have different mechanisms of action. Some of them are quite binary, such as preventing viruses from polymerizing and reproducing. There is a growing body of science that suggests that one drug may be better complemented by adding another drug to it. So I think we just need to wait for the science to unfold and be published. I don't know, Jim, you want to add something to that?

[James B. Lorens, Co]

Yes. I can just add that bemcentinib shows nanomolar effects in these standard in vitro cell infection assays, again with the SARS-2, which are quite impressive and most importantly achievable in patients. And this is -- so the -- this -- we showed that in vitro assays through our collaborators in the United States that this is quite a potent effect, which is congruent with what we've known previously about these viral uptake mechanisms and then further that this is also congruent with the fact that we can achieve these doses of full AXL inhibition in patients as demonstrated in our AML studies.

[Richard Godfrey, Chief Executive Officer]

Thank you. Rune, was there any more questions?

[Rune Skeie, Chief Financial Officer]

Yes. Could you say some words regarding whether you or someone have already tested bemcentinib on SARS-CoV-2? Was that in vitro or in vivo? And what did you observe?

[Richard Godfrey, Chief Executive Officer]

Yes. Certainly, that's great question. The data has not been published, yes, but I know Jim has been working closely with Wendy Maury and can say something here.

[James B. Lorens, Co]

Yes. So the University of Iowa Group is working furiously to put together a scientific manuscript for peer-reviewed publication in a top flight journal, which will be published in due course. And this is -- will include a number of studies and a deeper understanding of the mechanistic effects of AXL signaling in SARS 2 infections and also the role and how bemcentinib blocks those in a number of different systems.

[Richard Godfrey, Chief Executive Officer]

Yes. Thank you. Good. Another question?

[Rune Skeie, Chief Financial Officer]

Yes. It's a few -- similar question about which studies you're expecting result from in the near future? and when is that expected?

[Richard Godfrey, Chief Executive Officer]

Okay. So we've tried to offer some guidance on news flow earlier on in the slide deck to try and keep us focused. So Slide 12 in the slide deck, which is our pipeline of sponsored studies. I indicated that our study in second-line AML patients in combination with LDAC, where we're in the expansion phase now, if COVID permitting, we will have some update on that data. And we're hoping, we're targeting being able to present some of that data at ASH at the end of the year. The second guidance I offered was on our non-small cell lung cancer study in combination with KEYTRUDA, where in Cohort A, chemo refractory, we can offer some guidance on survival data to be presented at the Next-Gen Immuno-Oncology Conference in Boston on the 25th of June. And the clinical and translational data from Cohort B1, the checkpoint refractory patients also to be presented at that same conference. The third cohort in lung cancer, checkpoint chemo refractory patients is ongoing and recruiting now. I'd say COVID permitting, we hope to have some top line preliminary data available either at SITC in November or World Congress of Lung Cancer in January. So that's the studies that we're sponsoring where we have some greater influence over our clinical operations. On the next slide, Slide 13, with the pipeline of investigator-sponsored studies, a little bit of guidance offered here. First of all, I'll draw your attention to the European MDS Cooperative Group who have now completed recruitment of their AML and MDS cohorts, and I know in recent conversations they told me they're targeting presentation of that data at ASH also at the end of the year. And as we've spoken about with the COVID study, the ACCORD study, it's difficult to predict right now. But coming to the end of quarter 2, assuming that the study recruits fairly short treatment cycle of just 15 days and then a 29-day is an evaluation period, I've suggested on Slide 33 that maybe some data from the ACCORD study will be available later in the summer. I know it's a broad window. There's many variables that are outside of our control, but that's when we think with the best knowledge we have today, there would be some clinical data available.

[Rune Skeie, Chief Financial Officer]

Next question is if bemcentinib is successful in the ACCORD study, could you give us your opinion regarding if you think there will be a need for bemcentinib against COVID-19 even if, for example, Moderna will be successful with the mRNA vaccine?

[Richard Godfrey, Chief Executive Officer]

That's a good question. Will we need a treatment such as bemcentinib, if a vaccine is available? Of course, it's difficult to give very clear information here, but maybe Hani could give a clinical perspective, recognizing that maybe his personal opinion rather than a company opinion?

[Hani Gabra, Chief Medical Officer]

Yes, sure. Thanks, Richard. So obviously, it's unclear whether or not a vaccine will really work in the end. We don't know that yet. Obviously, everyone would like a solution to this global health problem as quickly as possible. But it is certainly possible that this disease may go on for some time, and it's certainly possible that the vaccination will not be a permanent solution, a bit like influenza setting, where an annual shot of a vaccine would be required. And so it is certainly possible that the COVID-19 would become a member of the serious flu-type illnesses or worse than flu feature in seasonal conversions. And so it will be people, even if they were a vaccine, there might be people who are vaccinated, but others will still get the disease. And it would be important to have potentially life-saving therapy treatment post the vaccination for those individuals. And so although like everyone else, we truly hope that there is a vaccine and the eradication of this disease, we have to prepare for a very real probability that we may continue to see outbreaks for many years of this disease, particularly seasonally.

[Richard Godfrey, Chief Executive Officer]

Thank you, Hani.

[James B. Lorens, Co]

This is Jim. If I can just add one point, Richard. So I think it's also important to emphasize that the mechanism of how the virus activates AXL on cells and utilizes AXL on cells is via this lipid membrane. So it's the phosphatidylserine myriad in the viral envelope, which is the ligand as it were the trigger for the activation of AXL through its ligand Gas6. Now importantly, that's not going to be a function that is -- the virus is able to mutate. That is a core generic function for all envelope viruses that all share this envelope membrane, which is derived from the host cells. So I think it's important to consider also the fact that treatments, such as bemcentinib will likely find usefulness also if the virus mutates away from a current vaccine.

[Richard Godfrey, Chief Executive Officer]

Thanks, guys. Rune, was there another question?

[Rune Skeie, Chief Financial Officer]

Yes. If we have previously heard about the lung cancer patients on bemcentinib that got COVID-19 and only had mild symptoms. You have information on more patients that have been infected. If not, could that be due to possible prophylactic effects on bemcentinib?

[Richard Godfrey, Chief Executive Officer]

Thank you, Rune. So yes, we've spoken about this lung cancer patient who had very mild COVID was taking bemcentinib. And the question is, are we aware of any other patients? I do not believe there have been any reports. Is that correct, Hani?

[Hani Gabra, Chief Medical Officer]

Yes. Thanks, Richard. Yes, that is correct. And it's a great question, though. Obviously, this particular patient had a lot of comorbidities and was in a very vulnerable state that you would have not been surprised had this patient had very severe COVID. And so the fact that we have not seen clinical COVID in other patients may be indeed - well, it could be because the patient -- the doctors are all aware and been watching very carefully. But it could also be, as you say, that there may be -- we can't exclude the possibility that it's got a very potent prophylactic effect, such that patients are asymptomatic. Yes.

[Richard Godfrey, Chief Executive Officer]

Thank you, Hani. I can see that the same question asked. A few other questions that I can possibly address quite quickly. We were asked, have you received interest from other institutions that are interested and conducted COVID-19 that is with bemcentinib? Specifically, no, although it's still good early days. The next question, this person asked is, could you elaborate on the investigator-sponsored study in second-line MDS? Is it fully recruited? Are you expecting it by Q4? Given the lack of treatment in second-line MDS, could the path to market be faster than sort? Great question. Yes, that investigator-sponsored study is fully recruited. You may recall, we also have some MDS patients in our own OO3 study, which is intriguing. We will have data by quarter 4 and will be -- target is to have it presented at ASH. There is no second-line treatment for MDS placements. And could it be a route to market? I think potentially, it could. But we're waiting until we see all the data, and we understand the landscape. But I think, of course, this is why we've been supportive of this investigator-sponsored study. The next question is an excellent question, sorry, I omitted to mention that. The question says, BGD-601 is now listed as terminated due to change of plan in drug supply. Has ADCT Therapeutics said that this termination is permanent or temporary? We had noticed that they changed the status of the clinical trial to terminate it because they had some challenges with resupply of the drug product, and they had shift in priorities, and they wanted to remanufacture, to go into some different trials. So at the moment, it's -- that trial is permanently stopped. I actually don't know at this time whether or not they intend to pick up the drug and continue to develop with it. So I need to update the market as soon as I have more information on that therapeutic development. And the last question from this individual is, if the U.K. approved remdesivir as standard of care, will bemcentinib be combined with remdesivir without complications or we do need to do a safety run in? Again, if you allow me, I can answer that question quite quickly. Safety is always the priority in clinical development. So we'll always need to do a safety cohort to ensure that the drug is safe in the patient population, particularly if they're taking another agent. So yes, we would need to do a safety cohort. Rune, was there another question?

[Rune Skeie, Chief Financial Officer]

Yes. Is it possible that testing patient in hospital is too late, that bemcentinib could be more effective if taken earlier?

[Richard Godfrey, Chief Executive Officer]

Thank you, Rune, another good question. We certainly have some thoughts about that. Hani, would you like to address that question, please?

[Hani Gabra, Chief Medical Officer]

So I think what we're all very optimistic about is the outstanding scientific rationale that bemcentinib attacks the disease in an antiviral way and in a way that drives the antiviral immunity effected in the earlier part of the disease. And so we've designed the studies for the hospitalized patients deliberately based on the science, the outstanding science, to exactly identify that population of hospitalized patients that may have viral replication ongoing and benefit potentially from the bemcentinib-mediated type 1 interferon antiviral immunity response. And clearly, if this is positive, if these data are positive, one thing we would want to explore would be whether moving this even earlier would be a desirable and helpful thing to do. So yes, the question is an excellent one, and we will be paying close attention to the data that we have to see whether or not we should move in that direction subsequently.

[Richard Godfrey, Chief Executive Officer]

Thank you, Hani. Good question. Rune?

[Rune Skeie, Chief Financial Officer]

Next question, I believe is to COVID-19 trial, do you expect to be moving up to Phase III?

[Richard Godfrey, Chief Executive Officer]

I can take that. That's completely contingent on data. So we're very optimistic. This is a strong rationale, but until we have the clinical data, it's not possible to predict which way that will go. Thank you.

[Rune Skeie, Chief Financial Officer]

Are you presenting data at ASCO?

[Richard Godfrey, Chief Executive Officer]

No, we will not be presenting data at ASCO this year. We took the decision not to participate and submit an abstract. We were not sure if we would have all the necessary data in time for the submission. As it happens, the data is just about sufficiently mature, so we've elected to present our lung cancer data at the Next-Gen Immuno-Oncology Conference 3 weeks later on the 25th of June.

[Rune Skeie, Chief Financial Officer]

Next question is, do you see bemcentinib as a competitor to virus vaccine as you define it as a medicine, not a vaccine? Would you be able to offer bemcentinib in Norway to the public before approval on patients own risk?

[Richard Godfrey, Chief Executive Officer]

Okay. Thank you, it's a complicated question. Do we see bemcentinib as a competitor to a virus vaccine that is a medicine and not a vaccine? Well, they're quite different. The vaccine is designed to prevent the disease and bemcentinib could be designed to treat the disease. So potentially, they could be complementary. Clearly, if we can vaccinate people, then they won't catch the disease, they won't need a treatment. So I don't know they're competitive. But as Jim alluded to, I mean, both vaccines and treatments have limitations, so like in so many diseases, I think, there's a lot of opportunity for things to coexist. And of course, it's a difficult question to answer. The second part of the question is, would you be able to offer bemcentinib in Norway to the public before approval on patients at their own risk. Well, of course, it's not straightforward. There's very strict regulations about so-called compassionate supply. And I think we are starting to get to stage that we have sufficient confidence in the safety of bemcentinib to start thinking about that. I don't think we're there yet. But it's certainly on our radar as part of the strategic way forward. And I guess, in these times of crisis, some of these decisions can be precipitated, but I don't want to give any guidance here. It's certainly a possibility, but not by no means that we explored it.

[Rune Skeie, Chief Financial Officer]

Next question is, you mentioned that oncology patient recruitments in some centers have been delayed. Clearly, the oral administration means that bemcentinib has been impacted less than other oncology trials. But could you give an indication of any likely delay? For instance, are we looking for 12-, 6-month pushbacks on the time line?

[Richard Godfrey, Chief Executive Officer]

Yes. Thank you. I think that's a similar question to one we had previously, where we have provided guidance with as much sort of contingency on COVID as possible. Guidance here is on Slides sort of 12 and 13 with regards to data points. And you're quite right, I mean, an oral administration is far more convenient than any other sort of infusion that may be required. But of course, the recruitment rate is contingent on the hospitals and the clinics opening and having the capacity to enroll patients. We think there has been an impact, and we've offered some guidance there. Thank you.

[Rune Skeie, Chief Financial Officer]

Next one is, do you know when the first patient in the ACCORD program in England will be given bemcentinib? And will it be informed to the market when it happens?

[Richard Godfrey, Chief Executive Officer]

We don't exactly know. We know that there are 4 hospitals open and screening patients every day. And yes, we will advise the markets when the first patient has been dosed with bemcentinib.

[Rune Skeie, Chief Financial Officer]

How likely is it that bemcentinib will go further from Phase II to Phase III?

[Richard Godfrey, Chief Executive Officer]

Yes, we had that question before. Well, okay, it's very -- it's not really for us to predict. It will be directed by the data from Phase II. So we just need to wait for the data.

[Rune Skeie, Chief Financial Officer]

And if -- next question is, if and when going into a Phase III study, how will the cash burn be compared to the NOK 50 million a quarter we see now.

[Richard Godfrey, Chief Executive Officer]

That's a good question. So the ACCORD study is fully funded. So BerGenBio will not be required to fund that trial. Although moving from Phase II to Phase III, may have some cash impacts. We'd certainly want to be scaling our organization, our operations to secure that the asset and the organization is ready for very late-stage development, potential commercialization. So there could well be some impacts -- cash impacts for the company in that transition, but not directly linked to execution of the Phase III study, more to do with supporting the asset for late-stage development and regulatory clearance, and of course, supply chain preparations as well.

[Rune Skeie, Chief Financial Officer]

And the next question is on the repair offering.

[Richard Godfrey, Chief Executive Officer]

Sorry, what was the question, Rune?

[Rune Skeie, Chief Financial Officer]

If there will be a repair offering?

[Richard Godfrey, Chief Executive Officer]

Well, I can reiterate what Rune mentioned in the presentation that the repair offering remains a possibility. It will be a decision taken by the Board. It's contingent on share price performance post the admission and will be limited to the appropriate shareholders. So I think we just need to wait for the board decision and the announcement there.

[Rune Skeie, Chief Financial Officer]

The next question is, are there any more anecdotal signals of anti-COVID effects from the cancer trials?

[Richard Godfrey, Chief Executive Officer]

Hani, are you aware of any anecdotal signals in that patient population?

[Hani Gabra, Chief Medical Officer]

Well, I mean, I don't want to be tried, but anecdotally, we have had no cases of COVID clinically in any of the patients who are currently on treatment, which is, I suppose, remarkable. It may be just that the patients have been very carefully watched and screened and are in themselves aware, and therefore, are sheltering and shielding. But as someone has astutely commented previously that this may represent some sort of prophylactic effect. We're not sure at this point. We'll see the results in the clinical trials.

[Richard Godfrey, Chief Executive Officer]

Yes. Thank you. Rune, was there another question?

[Rune Skeie, Chief Financial Officer]

Yes. The next one is, why hasn't dosing started in the ACCORD trial? And how long has bemcentinib screened with ACCORD patients?

[Richard Godfrey, Chief Executive Officer]

Yes, thank you. So it's still early days. It's not until we have a regulatory clearance that we can actually initiate clinical trial sites. And that's a military operation. That takes quite a lot of organizing and coordination. So the first site that was activated was the South Hampton site, and it's been open for 10 days or so, I think, now. But they've not -- they screened quite a few patients. I don't actually know how many. They screened a number of patients, but none of them have been appropriate to come on a clinical trial. It was only at the end of last week, and that's in fact, Thursday and Friday that the other 3 sites were initiated and activated. So the full fleet of sites that are active in recruiting is only just starting to come live and active now. And I know that there are more site initiation meetings and training sessions ongoing this week as well. So we should expect to see more sites opened and recruiting sort of in real-time now. Let's say -- we are the first in the say -- it is a large activity opening a clinical trial on a site to ensure that everything is done appropriately and documented, and people are trained and confident to administer our experimental agent to these patients. Was there another question?

[Rune Skeie, Chief Financial Officer]

Yes. It's following up from one of the other questions. AXL is a component of our immune system, so surely blocking it expression must have side effects in healthy individuals?

[Richard Godfrey, Chief Executive Officer]

Good question...

[James B. Lorens, Co]

I can start and then Hani can add. So the important thing to remember about AXL is that in the normal healthy individuals the AXL expression is very low. AXL is described as an all-hands on deck sort of response in the immune system, but it's also redundant with other receptors, which is evidenced by the fact that the AXL knockout mouse has no phenotype and is completely healthy. And we also conducted, as you may recall, our initial studies with bemcentinib in healthy volunteers.

[Richard Godfrey, Chief Executive Officer]

Thank you. Did you have anything to add, Hani?

[Hani Gabra, Chief Medical Officer]

Not really, but just to say that the drug is clearly very safe. And we see the AXL activation, for instance, in cancer, as a result of aggressive cancer type being promoted. So in a sense, it picks off and drives aggressiveness, but actually, it's very quiescent in a normal state. So on both sides of the equation, it seems to be very specific for the abnormal state and seems to have little impact and little toxicity in the normal state.

[Richard Godfrey, Chief Executive Officer]

Thank you. Rune, we have one more question?

[Rune Skeie, Chief Financial Officer]

Yes. Given the way bemcentinib works, should it also work more broadly against other coronavirus?

[Richard Godfrey, Chief Executive Officer]

Given the way bemcentinib works, would it also work against other viruses? Jim, do you want to take that?

[James B. Lorens, Co]

Well, the short answer would be yes, although I hasten to add that that's not demonstrated. But when we went into this, the most -- of all the data, there was quite a bit of data that these mechanisms are important or at work for all different forms of envelope viruses, that is viruses that have a membrane, which exposes phosphatidylserine, which is then exploited by the viruses to bind phosphatidylserine receptors on cells to enhance their uptake and also through AXL to antagonize the antiviral immunity. So the answer would be yes. And in fact, that was one of the reasons why we considered the COVID -- looking at SARS-CoV-2 is these basic principles that have been worked on for some 10, 15 years.

[Richard Godfrey, Chief Executive Officer]

Okay. Rune, was there one more question?

[Rune Skeie, Chief Financial Officer]

Yes. Is there any update on partnerships outside the COVID-19 indication?

[Richard Godfrey, Chief Executive Officer]

Well, of course, we can't comment on that other than to remind ourselves that BerGenBio is world leaders in AXL biology. Bemcentinib is clearly the most advanced AXL inhibitor in a very broad clinical program. So we're certainly on the radar of many potential partners and are in frequent dialogue with many potential partners.

[Rune Skeie, Chief Financial Officer]

There are a lot of similar questions, but one here, many health workers have succumbed to COVID-19. Could they take bemcentinib as a precaution in the absence of a vaccine?

[Richard Godfrey, Chief Executive Officer]

That's a good question. Many health workers have succumbed to COVID-19, could they take bemcentinib as a precaution in the absence of a vaccine? So like a prophylactic, well, again, I think it's an excellent question and similar -- we've had similar thoughts to ourselves potentially, but it will be a complicated and very large study and difficult to control. So the answer is, not in the first instance, but maybe potentially in the future, there's certainly a role for bemcentinib to be as a prophylactic, it will not be a clinical trial we will initiate in the near term.

[Rune Skeie, Chief Financial Officer]

Next one is how many patients are today on bemcentinib?

[Richard Godfrey, Chief Executive Officer]

Well, that's a good question. I actually don't think I know the precise answer to that. Hani, if you got a gut feel for how many patients remain on study right now?

[Hani Gabra, Chief Medical Officer]

Yes. So obviously, when the COVID situation broke out, one of our first thoughts was how many patients around the world are on bemcentinib and let's watch those patients carefully, not just for their benefit to cancer treatment, but potentially also the absence of COVID-19. I think we worked out that there were something like 55 patients currently on bemcentinib. And we've reached out to all investigators during this period, obviously, to discuss these issues. So 55 broadly, yes.

[Richard Godfrey, Chief Executive Officer]

Okay. And I think I seem to remember, you also told me that there was one lung cancer patient that's been on drug, was it for 4 years?

[Hani Gabra, Chief Medical Officer]

Indeed, there are patients that have been on this for a very long time, are extremely well with no side effects whatsoever.

[Richard Godfrey, Chief Executive Officer]

So that was really pleasing to hear that. That's great. Rune, is there another question?

[Rune Skeie, Chief Financial Officer]

The 324 suppresses AXL, have you evaluated the time lag between dosing and reemergences of AXL? Could be BGB324 be given as a preventative agent?

[Richard Godfrey, Chief Executive Officer]

That's a complicated question. I see that now. BGB324 suppresses AXL. Have you evaluated the time lag between dosing and reemergence of AXL. Could 324 be given as a preventative agent? I don't know, Jim, do you want to take that? I'm not sure if you have any data on that.

[James B. Lorens, Co]

Yes. I think that may be a pharmacodynamic kinetic question. So it suppresses AXL activity. And then the -- we -- and we have a loading dose regime, so that we rapidly reach an efficacious dose of AXL, which then will have a continuous inhibition of AXL kinase activity. And the pharmacology, as we've described in previous presentations lends itself to the once-a-day dosing with a continuous inhibition of AXL kinase inhibitor. And as we have pointed out, theoretically, the BGB324 could be -- bemcentinib could be given as a preventive agent. Yes, but that remains to be demonstrated.

[Richard Godfrey, Chief Executive Officer]

Thank you. Rune, are there any more questions?

[Rune Skeie, Chief Financial Officer]

Yes, do you have to wait for all the patients to be selected for the COG study before starting the treatment? Or can we start off since the foundation has been selected?

[Richard Godfrey, Chief Executive Officer]

I think I can answer that. No. I think it's very important that we complete the recruitment and evaluate all the patients. In order for good science to prevail, we have to have a statistically controlled study. So in the absence of something quite miraculous, I think we'd wait for all places to be recruited and evaluated and then make a judgment to move forward. Thank you, Hani -- thank you, Rune.

[Rune Skeie, Chief Financial Officer]

I think the question was, if you can start treatment as soon as we have any patients to be selected before we can start treatment.

[Richard Godfrey, Chief Executive Officer]

Sorry, I'm not sure I understand. Can you say that again, please?

[Rune Skeie, Chief Financial Officer]

The question was, if we have to wait for all the patients to be selected before we can start treatment.

[Richard Godfrey, Chief Executive Officer]

Sorry, I don't understand. Do we have to wait -- sorry, maybe you can show me the question if someone's written it. Do you have to wait for all patients to be selected for the COVID study before starting treatment? Oh, no, I see. No, no, no, not at all. No. So patients come in to the hospital on a daily basis and are evaluated, and if suitable, then they will be enrolled in the study. So it's a rolling recruitment. That's the question. Thank you.

[Rune Skeie, Chief Financial Officer]

It's similar question that we had, but a follow-up one. Will the company inform the market when the first patient in ACCORD will get bemcentinib? If a successful trail, when will bemcentinib be able to be mass produced, the drug.

[Richard Godfrey, Chief Executive Officer]

I see. So will we inform the market? Yes, we will. If successful, we would be able to mass produce the drug. But of course, potentially there's a gigantic market hit for bemcentinib to treat COVID patients, particularly in the absence of a vaccine. And of course, it is a very convenient one-a-day pill that potentially just administered for 15 days. So the potential is tremendous. Could we mass produce it? Well, clearly, we couldn't just mass produce it now. We've had a number of discussions with our supply chain partners as to how we could address this opportunity. And I think the only valid and robust and sane comment to make here is that there's a global need for a medicine to treat the COVID patients in the backdrop of sort of clinical success. We would be confident that a collaboration facilitated by governments and big industry on a global basis would be able to provide the medicine. So clearly, there will be lag times. But there's nothing more pressing the world at the moment. So if we're successful in our clinical trials, then I think we can a find a way of producing the medicine that we have there. A pivotal role to play in that.

[Rune Skeie, Chief Financial Officer]

It's a new question about the ACCORD study. It's about Stage III and how many patients we will need for Phase III? And if -- what sufficient effectively for the next stage will be? So what's the efficacy for Phase II we need to enter Phase III?

[Richard Godfrey, Chief Executive Officer]

I see. Hani, I think the question was, what's the efficacy threshold to go from Stage I to Stage II and how big will the Phase III study be?

[Hani Gabra, Chief Medical Officer]

Thanks, Richard. So we expect that patients just receiving standard of care, about 70% of the people admitted to be discharged essentially by day 29, a month -- by a month from admission. And the clinical trial is powered in the first part and indeed in the second part of the Phase II to show an improvement of about 15%, so going from 70% to 85% of patients discharged by day 29. That's the statistical basis of the clinical trial. So meeting those primary endpoints would obviously allow us to move from the Stage I to the Stage II, where a larger number of patients we needed to confirm and to increase the power and the confidence that indeed a real result. Beyond that, a Phase III trial would be essentially confirmatory. But obviously, Phase III trials would be larger. And the purpose of the Stage III, the second part of the trial is really to give that confidence that giving a Phase III trial subsequently will be very confirmatory, and we would hope to see the result that we expect at that point.

[Richard Godfrey, Chief Executive Officer]

Thank you. Rune, any more questions?

[Rune Skeie, Chief Financial Officer]

Yes, has there been any interest from other pharmaceutical companies after BerGenBio was included in the ACCORD trial?

[Richard Godfrey, Chief Executive Officer]

Has there been any interest from other pharmaceutical -- sorry, Rune? Has there been any interest? I can't see the question, sorry. Maybe you could read the question again, Rune, I couldn't see it.

[Rune Skeie, Chief Financial Officer]

Has there been any interest from other pharmaceutical companies after BerGenBio was included in the ACCORD trial?

[Richard Godfrey, Chief Executive Officer]

I see. Okay. I'm not quite sure. The question is referring to, have we received any inbound inquiries from pharma companies to some sort of commercial discussion? Of course, I can't comment on that. Similarly, I am unaware of what are the dealings of the COVID therapeutic task force or whether they're looking at other compounds, I'm unaware of that. So I can't really comment on such questions. Thank you.

[Rune Skeie, Chief Financial Officer]

Next question is, if you think about the clinical trials and studies that have been executed, what is the average percentage of successfully testing will be a positive outcome?

[Richard Godfrey, Chief Executive Officer]

If you think about all the clinical trials and studies that have been executed, what is the average percentage of successful testing with a positive outcome? Again, a difficult question to answer. Brad, I probably need a more specific question to answer. So we could maybe ask that like individual to contact us for a specific discussion there. I can't really answer that.

[Rune Skeie, Chief Financial Officer]

I think that was all.

[Richard Godfrey, Chief Executive Officer]

Is that all the questions? Very good. Okay. So in that case, I think I need to thank, everybody, for their attention. And thank you all for the questions. Thank you, Rune, Jim and Hani, and I look forward to updating the markets with news and data in the coming weeks and months. With that, I'll close the quarter 1 report and presentation and Q&A. Thank you, everybody, and stay safe. Bye-bye.