Bergenbio ASA

OSE:BGBIO

Earnings Call Transcript 2020-Q3

[Richard Godfrey, Chief Executive Officer]

Good morning. My name is Richard Godfrey. I'm the CEO of BerGenBio. Welcome to our quarter 3 2020 report, highlights and financials. This morning, I'm joined by Rune Skeie, our CFO; Hani Gabra, our CMO; and James Lorens, our Chief Scientific Officer. I'll proceed through the slides one at a time. [Operator Instructions] Thank you for joining us. Next slide, please. As always, I must bring your attention to our forward-looking statements. We're a publicly traded company, and you should pay attention to these disclosures. Next slide, please. During the presentation this morning, I'd like to: give the highlights from quarter 3; review AXL biology; update you on the bemcentinib story as we're developing bemcentinib as a unique, highly selective AXL inhibitor; mention briefly an update on tilvestamab, AXL antibody; hand over to Rune to talk you through our quarter 3 finances; and then provide a summary and an outlook. Next slide, please. For way of introduction, BerGenBio remains world leaders in understanding AXL biology. And in particular, our AXL kinase mediates aggressive disease, immune evasion, therapy and drug resistance, metastatic cancers, fibrosis and viral infection. BerGenBio is developing 2 highly selective AXL inhibitors: bemcentinib is our one-a-day, orally bioavailable, highly selective inhibitor of AXL; and tilvestamab antibody.Bemcentinib is in a broad Phase II program being tested both as monotherapy in combination with chemo agents and targeted agents. Furthermore, we're developing biomarkers and a companion diagnostic to be used in future trials and hopefully for a precision medicine approach for reimbursement. We've already presented some update on our lung cancer studies and translational science at the SITC Congress last week, and we'll provide more clinical and translational updates at the ASH Congress in December and again at the [ World Lung ] Congress in January.As a reminder, we're a publicly-traded company. We're listed on the Oslo Stock Exchange with the ticker B-G-B-I-O. We have multiple collaborations with Merck, UKRI and many leading academic research centers in Europe and North America. We're growing our organization. Today, we have 47 staff. The headquarters and R&D center is still based in Bergen, Norway. But our clinical development team is growing and is based out of Oxford in the U.K. At the end of quarter 3, our cash position stood at NOK 778 million. Next slide, please. Here is a summary of quarter 3 highlights. In July, you could see that we initiated our study in glioblastoma with collaborators in Birmingham, Alabama. This is an investigator-sponsored study. In August, we announced that another investigator-sponsored study known as the BERGAMO study in second-line AML and MDS patients met its primary endpoint of overall survival. We were present at the Sachs Annual Biotech Congress in September and again initiated a further study with collaborators, this time in pleural malignant mesothelioma. This was a study in collaboration with Merck and funded by the UK lung research center.October, we initiated our COVID study in South Africa. And we also presented some data on our anti-AXL antibody. And as I just mentioned, last week, we presented an update on clinical and translational data from lung cancer study at the SITC Congress. And I think many of you would have also attended our R&D Day last week where we had a number of prominent independent key opinion leaders presenting their research on AXL. So in spite of the challenges the world faces in the current global pandemic, we've still maintained a very active operation, initiated multiple studies with collaborators and reporting out clinical data, and more data is coming. Next slide, please. Just a reminder of our R&D Day that we presented last week. We were very privileged and proud to introduce a number of our key opinion leaders, collaborators. Professor Wendy Maury from the University of Iowa is a world leader in understanding viral infections and, in particular, the SARS-CoV-2 infection and specifically how AXL mediates this viral infection and resists our body's immune system to clear this. She also demonstrated how bemcentinib has a very promising potential in that disease. Professor Cory Hogaboam from Cedars-Sinai in Los Angeles presented his research on the role of AXL in fibrosis and specifically how bemcentinib has a very promising opportunity in idiopathic pulmonary fibrosis.Dr. Matthew Krebs from The Christie Institute in Manchester presented his research and our clinical data on the combination study with pembrolizumab and bemcentinib in non-small cell lung cancer, again, confirming how by inhibiting AXL we can make checkpoint inhibitors more effective. And Professor Sonja Loges from Germany presented her research on AXL in myeloid diseases, such as AML and MDS, and also clinical data in combination with LDAC in this very frail elderly patient population. Should you be interested in seeing these presentations again or investigating their messages, they can be found on our website. Next slide, please. We generally present our broad pipeline of clinical research in 2 slides. The first slide is the summary of the clinical trials that BerGenBio is sponsoring. This is focused on our clear strategic priorities, which is evaluating bemcentinib in second-line leukemia as a monotherapy and also in combination with low-dose chemo. And our second priority is to demonstrate the utility of AXL inhibition with bemcentinib in combination with immune checkpoint inhibitors in lung cancer. And again, that study is being conducted in 3 parts. Lastly, of course, we've initiated our clinical trial in COVID patients, which I'll update you on in a moment. Tilvestamab, our antibody asset, continues in Phase I studies, now completed Phase Ia and in setup of Phase Ib. Next slide, please. We continue to support a broad program of investigator-sponsored studies, so that we can evaluate the potential opportunities that AXL inhibition with bemcentinib may present in multiple indications. We're evaluating bemcentinib monotherapy in a COVID study, leukemia study and in MDS, also in glioblastoma, which we initiated in last quarter. Also evaluating bemcentinib in combination with checkpoint inhibitors in mesothelioma and melanoma and in combination with chemo agents in non-small cell lung cancer and pancreatic cancer. And you can see responses of these studies listed on the right-hand side here. Next slide, please. So just a reminder of the AXL biology. As I say, unashamedly, BerGenBio, with our collaborators, remain world leaders in understanding the role and function of AXL. Next slide, please. Increasingly, we are convinced that AXL is an independent negative prognostic factor for patients in -- with many different cancers. We can see here the patients who are indicated by the red lines are those who have an high AXL expressing tumor, and they have a worse prognosis than those with the green lines. This is the same pattern for almost every cancer we can imagine. If you're unlucky enough to have an AXL-positive tumor, it's bad news. Next slide, please. So AXL is a receptor-targeting kinase. It sits across the cell membrane and is activated by a sole ligand called Gas6. When AXL is activated, it mediates aggressive diseases such as invasion, immunosuppression, survival, migration, proliferation, the terrible hallmarks of cancer. It also mediates chemo resistance and metastasis. And AXL also mediates viral entry and suppression of our natural antiviral immunity. Next slide, please. So we use this slide to try and communicate what's happening in the tumor microenvironment in the center of the slide here. We know that when the tumor microenvironment becomes hostile, whether it's inflamed, whether it's hypoxic, whether it's under attack from chemo or immune system, many of the cells will die or be stressed. That stress leads to an upregulation of AXL that mediates EMT, epithelial-mesenchymal transition, which is a survival program that cancer cells use. And in addition, they also suppress the natural immune response through interferon. On the left-hand side, you can see that, more recently, we've understood that AXL is also expressed on cell because of the innate immune system that are also present in the tumor, on the macrophages, on the dendritic cells, on the NK cells. When AXL is upregulated, it suppresses or dampens this immune response. Collectively, AXL upregulation is a survival program that's hijacked by aggressive cancers, drives drug resistance, immune evasion and metastasis. Next slide, please. The slide depicts the mechanism by which AXL facilitates viral infection and viral disease amplification. This was nicely presented by Professor Maury at our R&D Day last week. And in summary, what she showed us on the left-hand side is that when the viral particle is attached to the actual receptor on the extracellular part of the cell, it facilitates absorption by the host cell of the viral particle. And then by bringing the viral particle into the cell, it's then able to hijack the host cell and start replicating. What we've also known now is that this AXL bioparticle is able to suppress the type I interferon response, which in turn dampens our body's ability to resist and fight off viral infections. Next slide, please. Understanding that AXL is expressed on both the cancer cell and cells of the immune system that infiltrated into the tumor is an important part of our companion diagnostic strategy, we developed an immune histochemistry technique and also a proprietary algorithm for scoring IHC such that we can score patients who have actual expression on their cancer cells and also actual expression on their immune cells. The composite of that score correlates and predicts benefit from taking bemcentinib and, in many cases, the immune checkpoint inhibitor. All of our clinical data in solid tumors is presented in the context of the patient to see AXL score. Next slide, please. So our lead asset, our lead candidate drug is bemcentinib, a first-in-class selective, potent, orally available AXL inhibitor. Next slide, please. So here it is, manufactured as a straightforward capsule. It's potent, selective and quite a robust molecule and formulation. Its mode of action is synergistic with other therapies. We have a developing confidence in the safety of bemcentinib both as a monotherapy and in combination with other drugs, and it seems to combine very well. Next slide, please. So bemcentinib, in our view, is a foundation therapy for many diseases and many settings, whether it's used as a monotherapy or in combination with checkpoint inhibitors, chemo agents, target agents or even epigenetic agents such as the hypomethylating agents. We have multiple clinical trials ongoing in this space, and our mission is to train a broad as possible label once the drug is approved. Next slide, please. There's a lot of interest, of course, in the potential therapeutic benefit of inhibiting AXL with bemcentinib in patients with COVID-19 disease. We're supporting 2 studies to investigate this: the ACCORD trial in the U.K.; and trial #20, BGBC020, which BerGenBio is sponsoring. Next slide, please. Again, a reminder of the presentation by Professor Maury. So that AXL mediates viral entry through endosomes at the cell surface. In fact, Professor Maury proved quite nicely that AXL is a coreceptor with the ACE-2 receptor, which is so widely talked about in the context of COVID infection. Also, Professor Maury showed very nicely how actual upregulation leads to the suppression of type I interferon. And indeed, by suppression of AXL with bemcentinib, you prevent the viral entry and you amplify the release of type I interferon. So bemcentinib has a dual mechanism of action that we believe is great potential for treating patients with COVID. Next slide, please. So our clinical trials in COVID-19 patients have a simple objective, to evaluate the safety and efficacy of the drug as an add-on therapy to the standard of care in patients that are hospitalized with COVID-19. We will look to see that we can accelerate the time for clinical improvement or indeed live discharge by at least 2 points on their ordinal scale or the scale of diagnosis. There are multiple secondary endpoints and translational endpoints, including understanding the viral load, the polymerase reaction and indeed other quality of life matters such as oxygen-free days. These are all being collected as part of the clinical trial. It's anticipated that the clinical trials will recruit quickly once open in India and South Africa. And the clinical endpoints should be fairly rapid in determination. It may take a little longer to evaluate and fully resolve all of the data from the secondary endpoints. Starting with the ACCORD study, as you know, this is our clinical trial that is being sponsored by the University of Southampton and mostly being funded by grants from the U.K. government. This study started, was stopped and has now restarted again. The U.K. continues in the second wave of infection. And the latest R number or infection rate is still above 1. What we know in the U.K. is that there is a significant number of COVID tests being conducted each day. Indeed, on this particular day, the 13th of November, there was 379,000 virus tests being conducted. And we know that the number of positive test is also increasing rapidly, nearly 25,000 new positive test from that particular day. Not surprisingly, we're seeing the number of patients admitted to hospital increase substantially. And regrettably, the number of patients that are dying with COVID is also on the increase. So in spite of the fact that this study started, stopped and since restarted, we still believe we can be a great benefit to patients in the U.K. as the second wave is started to bite. The ACCORD 2 study in restart will be opening up to 25 sites across the U.K. This time, the ACCORD platform is only evaluating 3 drug candidates: bemcentinib, a drug from UCB and a third drug from AstraZeneca. It's almost identical protocol to the previous ACCORD study where 60 patients will receive bemcentinib and 60 patients will be in a control group. And we anticipate patient recruitment to commence very, very soon. I'm aware of this frustration on the -- at the time it takes to initiate these studies. And in the next few slides, I'll try and explain to you the process that's required and compel you in actual fact, BerGenBio and our collaborators are moving at a breakneck speed to initiate these studies. So here's a time line for the ACCORD study from when it first started in April. You can see that we had to proceed through several key milestones initiated -- drafting a protocol, receiving regulatory and ethics approval, activate in sites and enrolling patients. As communicated last time, the number of patients in actual fact dropped drastically during the spring and summer months, and the study was stopped. Indeed, it was stopped for 49 days. The decision was taken to reinitiate the study albeit with a smaller budget, and that facilitated a transition to -- of CRO of the company that is managing the trial with BerGenBio to the Manchester medical evaluation unit. It took a few weeks for the study to transition and for the sites to be activated. And I can now announce that we are getting very, very close to reinitiating this study and for patients to start being enrolled. Similarly, maybe I should just update you on the time line, the start-up of the COVID study that we've initiated. Study 20 has been initiated in 2 countries: in South Africa and India. Expediting a complex, multiagency process and establishing the clinical trial in these regions is no small task. There are many regulatory, ethics and clinical research organizations that need to be coordinated. And in actual facts, I'm very proud that we've been able to establish this in just 13 weeks. It's an unprecedented time frame for establishing such a complicated study in these developing nations. And you can see here, from protocol origination, the multiple layers of regulatory approval that was required from regulatory and ethics committees, both overseas and here in Norway and indeed site activation. And as you know, we initiated -- the first patient recruited a few weeks ago. In South Africa, we're recruiting at 5 sites, as shown on the next slide. Slide 26, please. Slide 27 is a summary of the start-up activities in India. This has taken a little longer. But again, you can see that from taking the decision to initiate, seeking regulatory approval in this region, securing an import license for the laboratory kit has taken a little while. But in parallel, you can see that the sites have been activated, drug has been delivered to the sites, and regulatory and ethics approval is in place. Again, we anticipate India starting up very soon now all the regulatory and import license approvals have been secured. Slide 28. You can see that this study is being initiated at 7 sites across India. Slide 29. So we're also focusing our efforts on evaluating bemcentinib in leukemia, acute myeloid leukemia and myelodysplastic syndrome. Again, we have 2 studies that are being conducted in this space, trying to refine precisely the patient population that will benefit most from bemcentinib and identifying our regulatory pathway. Study #3, BGBC003, is BerGenBio-sponsored study in elderly relapsed and refractory AML patients, both as monotherapy and in combination with chemotherapy. Study #9, the BERGAMO investigator-sponsored study, is in elderly relapsed AML patients and MDS patients, similarly, at this time, just a monotherapy. Slide 30. So what is AML and high-risk MDS? When it's a cancer of the blood and bone marrow, they generally affect elderly, older, frail patients. And it results in an excess production of immature blast cells or blood cells that leads to multiple complications. Typically, these patients have severe pain, shortness of breath. Often they have frequent infection and easily bruised. There are things in developments in the treatment landscape for these patients. First-line treatment for AML has really evolved such the patients would take a drug called venetoclax plus a hypermethylating agent. And there, they can expect to see a benefit, 37% response rate and a survival rate of about 14 to 17 months. Similarly, they could take venetoclax plus low-dose AC, and here, they may see 27% response rate in just 11 months duration of response. However, there's a vacuum in second line. The second-line treatments have not really developed. The response rate is less than 15% and the survival rate is really less than 6 months. Slide 31. So myelodysplastic syndrome and acute myeloid leukemia is a continuum. Approximately 30% or 40% of patients with high-risk MDS transition or transform into AML. So this is still a minority disease, although it's estimated there will be nearly 20,000 cases diagnosed in the U.S. Slide 32, please. The study that BerGenBio is sponsoring, study #3, is conducted in Phase I and Phase II parts. The Phase I part is complete and is to evaluate bemcentinib as a monotherapy in this patient population. We've expanded that into Phase II cohorts, monotherapy in AML and MDS, and also in combination with hypermethylating agents, B3 and low-dose AC, Cohorts B2 and B5. We saw very encouraging results in Cohort B2. We're now expanding Cohort B5. We'll be updating the markets with clinical and translational data from B5 at the ASH Congress in December. Next slide, Slide 33, please. The BERGAMO study is an investigator-sponsored study conducted in Germany, France and Holland. It was an open-label, multicenter study, recruiting high-risk MDS and AML patients that have failed on hypermethylating agents. This study patient population has a very poor prognosis, just the survival projection of just 5.6 months. This study met its overall objective of -- its primary objective overall response rate at assessment of 17 -- week 17. And a number of secondary endpoints were also observed. Again, this later will be presented in full at the ASH Congress on the 6th of December. Next slide, Slide 34, please. Bemcentinib is also being evaluated in second-line lung cancer. Lung cancer treatment outcomes has significantly improved in recent years. First-line treatment for lung cancer is now clearly directed by biomarkers. Indeed, Matthew Krebs presented this nicely in our R&D Day last week. The biomarkers that are used are mutations or molecular drivers or indeed a patient's PD-L1 status, which indicates their suitability for checkpoint inhibitor treatment.Treatment includes target agents, chemo agents, plus or minus the checkpoint inhibitors. And in the first slide, patients may expect to have a response rate of about 50% and maybe an overall survival of 1 to 2 years, depending on the study. However, there remains a vacuum in second line. Second-line treatment outcomes remain quite dismal and haven't really improved in many years. The standard of care chemo regimens that are used really have a response rate of less than 20% and a median overall survival of less than 12 months. It still remains a very serious disease. Next slide, Slide 35, which is one of the reasons why we are evaluating the combination of bemcentinib and pembrolizumab in the second-line non-small cell lung cancer patients. Our ambition is to provide a chemo-free, well-tolerated and effective treatment option for patients in the second-line setting such that chemo is relegated to third- or fourth-line treatment. This study, study #8, is being conducted in 3 cohorts: patients that are chemo refractory, patients that are checkpoint refractory and patients that are checkpoint chemo refractory, so-called Cohorts A, B and C. We have presented many times the results from Cohort A and also the results from Cohort B1. I'll just give a brief summary of that data. Next slide, please, Slide 36. Cohort A, patients that were checkpoint refractory. Ultimately, patient benefit is best described as improvement in survival rate. We can see on the left here, when we define the patients according to their cAXL status, the patients that are cAXL positive in red have a fourfold improvement in progression-free survival as opposed to those in the blue, those that do not have an AXL-driven disease. And on the right, we have a summary of the overall survival. Again, we can see substantial benefit in the cAXL-positive patients having a median overall survival of 17 months, whereas the AXL-negative patients just 12 months and historic controls would also be about 12 months or 10 months. So we can see a significant benefit for these patients who have failed chemo taking checkpoint inhibitors and bemcentinib. Next slide, please. We presented this slide to illustrate how effective our companion diagnostic has the potential to be, where we can identify patients who have actual positive staining in the macrophages or immune cells and also actual staining on some of their tumor cells. By being able to take a pretreatment biopsy sample and evaluate the patient's actual status means that we can identify patients that most likely will benefit from taking bemcentinib and the checkpoint inhibitor. Next slide, please, Slide 38. Matthew Krebs presented this data last week. This is the first cohort of patients that are refractory to checkpoint inhibitors. They previously received a checkpoint inhibitor in the first line. They saw benefit. They subsequently relapsed, and we've rechallenged these patients with a checkpoint inhibitor plus bemcentinib. What we can see in this cohort of patients is the patients that are cAXL positive clearly have a significant benefit as opposed to those that are cAXL negative. Indeed, we can see a number of patients that have stable disease or indeed a partial response, meaning their tumor have not grown or have shrunk by up to 30%. And again, next slide, please, 39. We can see that, that manifests itself in significant benefit for the AXL-positive patients in terms of progression-free survival. The overall survival data for this cohort is not yet mature, and the cohort continues to recruit. Next slide, please, Slide 40. Last week at the SITC Congress, Professor Spicer presented some translational data related to this cohort of patients. The most significant of which was having done a whole tumor gene expression analysis of patients that benefited from bemcentinib and KEYTRUDA. We saw that the patient population falls into 2 groups: those with benefit, and those that do not. The patients that benefit saw an increase in AXL expression, an increase in the genes associated EMT and also the presence of tumor-associated macrophages and regulatory dendritic cells of a particular species that are immunosuppressive, and that's a new finding and of significant importance. Next slide, Slide 41. Again, it allowed us to postulate that AXL mediate immunosuppression by promoting the exhaustion of the T cells. Remember, the T cells are the warhead of the immune system. They're the cells that engage with and destroy the cancer. And actually, if present on the regulatory dendritic cells or on the tumor-associated macrophages, it leads to an exhaustion and a dysfunction of these T cells. This is an interesting discovery that we made and confirms the world that bemcentinib inhibition reverses the state of immune suppression in the tumor microenvironment and promotes the rationale for checkpoint inhibitor reengagement, further underpinning our rationale for testing these patients with bemcentinib and KEYTRUDA in the second-line setting. Next slide, please, 42. Just briefly, Matthew Krebs last week introduced a study in mesothelioma. This is an investigator-sponsored study that he's leading. Mesothelioma study is called MiST. It's the first of its kind where patients are being stratified according to their molecular markers and being tested with different drugs or drug combination to see if they're effective. There are just 4 agents being tested. Bemcentinib plus pembrolizumab is one set of combination in the third cohort, and this study again is being conducted in collaboration with Merck. Next slide, Slide 43. So mesothelioma is associated with asbestos exposure, and actual expression is very high in these patients. Whilst it's still a minority disease, it's on the increase, and it's estimated and anticipated that it will continue to grow as asbestos is still being used in various parts of the world. First-line treatment for these patients using chemo is quite poor with just a 12-month overall survival expectation. And the second-line setting is quite dismal. Indeed, although this is an inflammatory disease, checkpoint inhibitors seemingly do not work. And it is hoped that by inhibiting AXL, we're facilitating the immune system, once amplified with a checkpoint inhibitor, to be effective in treating these patients. Next slide, Slide 44, please. So Cohort 3 of this study, MiST3, is to evaluate bemcentinib and pembrolizumab in these patients. These patients all have pleural mesothelioma. They failed 1 or 2 previous lines of treatment, and they must provide a fresh biopsy sample, which is used for molecular screening and degenomic analysis. The endpoints for this study are relatively near term, disease control week of 12 weeks and at 24 weeks and potentially overall survival and overall response rate. This study will recruit up to 26 patients and is open and recruiting now. Next slide, please, Slide 45. A brief update on tilvestamab, our anti-AXL monoclonal antibody drug. So different to bemcentinib, tilvestamab works on the extracellular domain of the actual receptor. It's an IgG1 antibody, fully humanized with high affinity and displaces Gas6, the ligand for AXL activation. We've developed this with a contract manufacturer with a robust process and formulation. The Phase I study is now complete, and there were no safety signals of any concern. There was dose proportional pharmacokinetics and also a PK/PD or a response in correlating to increased dosing was also observed. Next slide, please, 47. Tilvestamab was evaluated in multiple dose levels, up to 3 milligrams per kilo of body weight. I would say there was no significant findings. We're now in setup phase to evaluate tilvestamab in a Phase Ib/IIa study, which will be disclosed in the fullness of time. Next slide, please, Slide 48. I'd now like to hand over to Rune Skeie, our CFO, for financial report.

[Rune Skeie, Chief Financial Officer]

Thank you, Richard. I will give a brief update on our key financial in the quarter. Next slide, please. We are reporting an operating loss on NOK 68 million in the quarter compared to NOK 47 million in Q3 2019. The increased loss is due to start-up of new clinical studies and organization development in preparation for late-stage trials. Employee expenses is comparable to second quarter 2020. Operating expenses is -- and overhead costs is well managed. 84% of the operating expenses in the quarter was spent on research and development activities. Next slide, please. Cash burn on operating activities in the quarter was NOK 68 million. Quarterly average cash burn is on NOK 53 million for the last year. And 2020 have been a busy and successful year for fundraising, and we have raised in total NOK 740 million, included NOK 20 million in the -- from the repair offering in July. We ended the quarter with a cash position of NOK 778 million. Next slide, please. Happy to show the analyst coverage. We have good support from the current Wainwright, Jones Trading, Arctic and DNB. And we can report that Carnegie just have initiated just a few weeks ago. So they cover the BerGenBio for the moment. And this morning, we have a sponsored research from Edison Group. So those reports will soon be available from our website. And then I will hand it back to you, Richard, to summarize the presentation.

[Richard Godfrey, Chief Executive Officer]

Thank you, Rune. Slide 52, highlights and outlook. Slide 53, so I think we can see that quarter 3 was a very busy and operationally very successful quarter for BerGenBio. We made solid progress on our primary objectives in lung cancer and leukemia, presenting clinical and translational data at the SITC Congress last week and also some data on tilvestamab was presented as well.We continue to investigate bemcentinib's potential as a treatment for infectious diseases, specifically COVID-19. We anticipate that those trials will recruit quickly. And as I mentioned earlier, the clinical readout will be quite rapid. We see promising data emerge from our broad program of investigator-led studies. BERGAMO study in AML and MDS will be presented at the ASH Congress in December. And we initiated the glioblastoma study and pleural mesothelioma studies with first patients dosed during the quarter. Slide 54, please. So just a reminder, at the ASH Congress, that's the American Society of Hematology, will be a virtual congress, be open from the 5th to the 8th of December. We have 2 presentations. A presentation on our Study 3 in AML and MDS will be presented by Professors Sonja Loges on Sunday, the 6th of December. And in particular, she will be updating on the combination study with LDAC in the second-line relapse patients. And on the same day, Professor Platzbecker will be presenting the BERGAMO study, which is the monotherapy study in AML and high-risk MDS patients. So I draw your attention to those data points in a few weeks' time. Slide 55, please. So BerGenBio's outlook as we approach the end of the year is that we remain well funded. And our quarter 3 cash position was NOK 778 million. We continue with our promising pipeline of 2 first-in-class drug candidates against AXL in multiple Phase II clinical trials. And our pioneering biology and a substantial amount of favorable clinical and translational data is very encouraging, both safety and efficacy. Upcoming data will be presented at the ASH Congress and at World Lung in January. We're very excited by the strong science supporting potential of bemcentinib in treating COVID-19 patients. We have 2 randomized Phase II studies, recruiting potential 240 patients, opening very soon in the U.K., currently open and recruiting in South Africa and very soon in India. With that, I thank you for your attention and prepare for any questions that may be asked from those who have tuned in. I'll be joined by, firstly, Jim Lorens; and, of course, Hani Gabra, to field any questions. I will act as question master.

[Richard Godfrey, Chief Executive Officer]

Okay. The first question was asking, why is it taking so long to initiate the trials in India on ACCORD? And I hope that the presentation made a little earlier address some of those questions. In actual fact, it's quite unprecedented to initiate these clinical trials in such a short period of time, which has complicated regulatory environments. And I can assure you that these studies will start dosing patients in the U.K. and India very, very soon, and we will be announcing that to the market. A further question was asked about the estimated price per pill when bemcentinib is approved. Of course, it's very difficult to give such estimations. We have an idea of the manufacturing cost, but that doesn't necessarily reflect what a reimbursement price would be. And that would be subject to multiple discussions and negotiations with reimbursement agencies across the globe as we get closer to that time point. We are including the appropriate data point to support reimbursement and value propositions during the next phase of clinical development. Okay. Next question is a good question. It says how many patients are viewing -- will you include in your COVID-19 trials? And what's your take on the vaccine news coming out in the last week? Maybe I could hand over to -- I can confirm that the 2 COVID trials will recruit the total of 240 patients, 120 each study, randomized, 1:1 bemcentinib with the control arm. Maybe I'll ask Hani to comment on his view on the vaccine news that's been announced in the last week or 2 and also where that may have an impact and present an opportunity for bemcentinib.

[Hani Gabra, Chief Medical Officer]

Thanks, Richard. Hope you can hear me. Yes, of course, well, it's great and welcome news that vaccines are on their way and are likely potentially to be effective. And we hope very much that this can be rolled out. But obviously, as I'm sure everyone is aware, there is a big gap between the rollout and actually vaccinating the entire population such that herd immunity is achieved initially and then completeness. There are, of course, question marks around the long-term vaccine efficacy. We know that immunity can drop. And we know that the virus is mutating. And so, therefore, there are longer-term uncertainties as well as shorter-term issues both for the completeness of safety and also uptake of the virus that, I think, I'm sure and I think most commentators would agree that there would be a role not just for vaccination but also for treatments such as another major viral diseases. So we remain bullish and optimistic that there would be a role for bemcentinib, which should be ongoing as we move forward.

[Richard Godfrey, Chief Executive Officer]

Thank you, Hani. And there was just one more question received through the portal, which is asking about how many patients have been enrolled in the COVID study in South Africa. I'm sure the audience will understand that we really can't give patient enrollment details on an ongoing clinical trial. I need to say that, with regret, we see the incidence of COVID increase in South Africa. And the number of patients admitted to hospital with COVID disease has also increased in South Africa, and we are seeing substantial interest and eagerness for the trial in that region. So we have high expectations that the studies will recruit quickly, in particular, once opened in India and the U.K. And then there's one last question that's just been received, so that I can read it. Bemcentinib have an interesting dual [indiscernible] the primary mechanism [indiscernible]. Do you see opportunity of bemcentinib combining with treatments that target the spike protein [indiscernible] synergies. So maybe a question for you, Jim. The question asked is do we see opportunities for bemcentinib to combine with other drugs that engage with the spike protein?

[James B. Lorens, Co]

Yes. Thank you. No, interesting question. And I think that we're still looking into a number of potential synergies of bemcentinib with other treatments. Bemcentinib distinguishes itself from other antiviral approaches in that it both affects the actual uptake of the virus into the cells, as Richard explained, but perhaps even as important or potentially more importantly, will potentiate the antiviral immunity. And this is a -- particularly, this is a unique aspect of targeting AXL in infectious diseases in general, but very important for coronavirus as Professor Maury articulated in her excellent R&D Day presentation. So yes, so there will be potential for positive interactions between bemcentinib and other antiviral treatments, also those addressing the protein interaction between the spike and ACE-2 as this listener indicates. That's true.

[Richard Godfrey, Chief Executive Officer]

Thank you, Jim. And the follow-on question was linked to the possibilities of AXL antibody to treat COVID-19 patients. I'd say whilst we have no firm plans there, maybe you'd like to carry on and talk about that as a potential opportunity.

[James B. Lorens, Co]

Sure. So as the listener is alluding to, we were introduced to -- reminded of the challenges of the post-COVID long polar syndrome, as it's called, in which many patients will develop severe lung disease following the initial infection with the COVID virus. And the -- and there's a -- this is also linked to lung fibrosis. And indeed, we see the -- knowing the role of AXL in various types of fibrosis, including lung fibrosis, which was, again, presented by Professor Hogaboam at the R&D Day, and I refer you to that excellent talk, is indeed an opportunity for AXL inhibitors, including tilvestamab to improve or prevent lung fibrosis in a post-infectious setting.

[Richard Godfrey, Chief Executive Officer]

Yes. Thank you. Okay. One last question in a similar vein was asking about when we'll be able to provide top line data from the COVID studies.And of course, it's a very difficult question to answer as these studies are either about to initiate or ongoing. And it's quite a dynamic status with regards to the disease and public health measures that are affected in the various countries and regions, which -- where the trials are being conducted. As we saw in the U.K. in the summer, there was a very rapid fall off in the incidence of the disease and the admissions to hospital, which restricted the ACCORD study.So what I can assure is that we've invested heavily to initiate in regions where the disease is still at a high incidence rate, at multiple hospitals and sites where we are quite alone in providing treatment options outside of the dexamethasone that they are providing to patients. We believe that the clinical data will be available reasonably quickly, although some of the translational aspects may take longer to be analyzed and read out. So just as soon as we have collected the data and validate it, we'll be in a position to provide top line data. And indeed, we're as eager as anyone to report that and also move forward into a later stage study, hopefully, that we'll be able to facilitate some sort of approval such that a wider pace of population will be able to receive the drug. So that seems to bring us to the end of this quarter 3 update and report. There are no further questions that have been presented from the audience. So with that, I thank you for tuning in and listening. Thank you, Rune, Hani and Jim for your support, and I'll close the webinar. Thank you very much indeed.