Cord Dohrmann
Analyst · Rx Securities. Your line is now open. Sir, please go ahead
Thank you, Craig, and good morning, good afternoon to everybody on the call. It’s my great pleasure to give you an update on the Evotec Innovate. Evotec Innovate posted a strong first half in 2020, revenues increased by 8%, despite an overall challenging environment and lower milestone contributions. We continue to make good progress in expanding our co-owned product pipeline, and in particular, our clinical stage part of the pipeline is making good progress. In our Bayer, endometriosis collaboration, we continue to move projects forward into the clinic and keep progressing, in particular, our very exciting P2X3 antagonists program in a number of high value indications. Moving to the preclinical part of the pipeline. In the beginning of the year, we regained the rights of our beta cell therapy program for the treatment of diabetes. Since then, they have continued to invest into this very promising project and initiated partnering and financing initiatives, which are gaining good momentum. Similarly, our global health franchise is also progressing quite well. In our TB collaboration with the Bill & Melinda Gates Foundation, we continue to progress various TB initiatives. Furthermore, together with the NIH, we filed an IND application for our Chikungunya antibody project. The exact date for the start of the Phase I study which will be carried out by Duke University in North Carolina, is not entirely clear yet, and this is mainly due to COVID-19, but it is expected to happen within the next 12 months. In response to the COVID-19 crisis, the ramp up our efforts here as well, in particular, organizing a large repositioning effort of marketed drugs as well as drugs in clinical development, when advanced stages of preclinical development. Beyond the ongoing COVID-19 global health crisis, there’s another crisis looming, which we all know is coming. This is the increasing prevalence of antibiotic resistance, which is threatening healthcare as we know it. Here, we continue to invest and recently signed a licensing deal with Resolute Therapeutics, giving Evotec access to a high innovative, very promising broad spectrum antibiotics project. Furthermore, we continue to invest in expanding our multimodality platform beyond small molecules, antibodies, cell therapy and gene therapy, we now also added antisense therapeutics as a new modality. Antisense technology will give us yet another option to develop drugs based on drug targets that are not easily accessible for more conventional modalities such as small molecules antibodies. Finally, in regards to academic bridge and equity strategy, we also made considerable progress. We established a new bridge with the UCLA called Autobahn Labs, but last – and last but not least, the expanded our equity portfolio with 4 investments into very exciting therapeutic and technology development companies. Before we present the progress of our co-owned pipeline, we wanted to highlight the increasingly involved in composition of this pipeline, when it comes to treatment modalities, pursued by Evotec. The increasingly diversified composition of our pipeline is shown on Page 23. Only 5 years ago, Evotec was essentially completely focused on small molecule approaches, this has really changed dramatically. Today, small molecules still make up the majority of the pipeline, but contribute now less than 70% of the pipeline projects. Biologics continue to catch up, and in conjunction with cell therapy approaches are making up now more than 30% of the pipeline. This ratio most likely will continue to shift towards biologics and cell therapeutic approaches going forward. Evotec’s multimodality approach to drug discovery gives us the opportunity to approach each disease for the most suitable mechanisms, as it do not have to rely on small molecule or antibody targets only. But we can address all targets and mechanisms that are generally viewed as undruggable as well. Page 24 shows the progress of Evotec’s co-owned pipeline, which continues to expand through new partnerships. In addition, more and more projects are moving from discovery into preclinical development and from here into the clinic. We are particularly pleased with the progress we have made in our endometriosis collaboration with Bayer. In total, 4 molecules have been brought forward into the clinic, covering a variety of mechanisms. The most advanced project with Bayer is based on P2X3 agonist, which is beyond endometriosis has potential in a number of additional indications, including chronic cough. The chronic cough indication is currently the most advanced. In an initial Phase II study in chronic cough patients BAY1817080 has demonstrated a highly promising safety and efficacy profile. A follow-up Phase IIb study and refractory and/or as unexplained chronic cough is expected to start in 2020. Furthermore, additional Phase II studies in other high value indications are expected to start within the next 12 months. We will give a slightly more detailed update on the Phase II results on the following slide. Further additions, however, to the pipeline to [indiscernible] are expected still this year. For example, together with our partner, Exscientia, we developed an A2A inhibitor for the treatment of oncological indications, for which we expect to start a Phase I study towards the end of 2020. Finally, after period-end, Jingxin Pharma informed us that they initiate a Phase III trial of EVT 201 for the treatment of insomnia in China. This study will be carried out as a multicenter, randomized, double-blind, placebo-controlled trial with planned enrollment of 450 patients. This study will include patients 18 to 65 years of age, as well as elderly patient groups over 65 years of age. The study is expected to take about 2 years to complete. On Page 25, we would like to go into a bit more detail on the efficacy and safety profile of Bayer 1887080, exhibited in the initial Phase II study and chronic cough patients. But first a few words about refractory unexplained chronic cough. Patients with chronic cough suffer continuously, as they cough between 10 to 100 times per hour for at least 8 weeks. The continuous coughing makes regular activities like phone calls, meetings, and theater visits increasingly difficult, embarrassing and stressful. This coughing continues for months or even years. It leads to a lack of sleep from overnight [boots] [ph], and combined with daytime coughing increasingly leads to exhaustion. Chronic cough is a frequent cause of medical consultation and is associated with a large number of pulmonary and extrapulmonary disorders. Its prevalence is estimated between 11% to 13% of the population. Patients are only diagnosed with refractory chronic cough once all other possibilities or causes have been ruled out. Currently, there are only limited treatment options available to manage this condition. P2X3 antagonism is a possible new treatment, which directly interferes with desensitization of the cough reflex. In our P2X3 antagonist program, an important milestone was achieved already last year. In a Phase II study, patients with refractory chronic cough all study endpoints regarding safety and efficacy were met. After only 1 week of treatment, BAY1887080 reduced chronic cough counts by 33%, which is essentially in line with all other competitor compounds, like from Merck and Shionogi. Concomitantly, BAY817080 also reduced cough severity in a dose-dependent session, which is also very encouraging. Furthermore, at this point, it may turn out to become an important aspect of the overall profile of BAY1817080. Only low rates of mild taste-related adverse events were observed. Although, all clinical results presented here are not directly comparable to competitor compounds, which is due to the different development phases, potential geographic differences, and difference in treatment durations. In conclusion, we believe that BAY1887080 clearly has potential to add significant therapeutic benefit for patients suffering from refractory chronic cough and even the potential to become the best-in-class P2X3 antagonist in the field. Preparations for Phase-IIb study in patients with refractory chronic cough are currently ongoing and are further studies in additional indications for which we hope to be able to update you later in the year. With the next slide, Page 26, we would like to shift gears and give an update on our cell therapy program in diabetes. At the end of last year, Sanofi announced that they intend to discontinue their efforts in diabetes research. In the wake of this strategy, strategic decision, Evotec regained all rights to diabetes beta cell therapy project early in 2020. Since then, we continued the development of this program with an initiative we call QRbeta Therapeutics. The program has made significant progress, especially when it comes to the identification of a possible device, which is needed for transplantation of iPSC-derived beta cells. Furthermore, we complemented the program by gaining access to GMP-compliant immuno-invisible cell lines, through a partnership with panCELLa. These cell lines come with and without a potential killswitch and thus enabled the development of a second generation beta cell product which will not need a device. Based on all the progress we have made in the first half of 2020, we feel that Evotec’s QRbeta initiative provides an exciting partnering opportunity for potential pharma companies and/or strategic investors for the next 12 months. With this, I would like to move to Page 27, and update you on exciting developments in our ID portfolio. The ongoing COVID-19 pandemic is a stark reminder that infectious diseases will always have to be reckoned with. Evotec is committed to the field of infectious diseases and continues to be very active in global health, antimicrobials and antivirals. In regards to COVID itself, Evotec is involved in a number of important activities. Evotec is leading the pre-clinical repurposing effort of a large number of pharma companies trying to identify possible therapeutics based on drugs that are already on the market, in clinic development or advanced pre-clinical development. Evotec is part of the NIH-led initiative ACTIV. Evotec recently signed an agreement with the U.S. Department of Defense for process development and manufacturing of monoclonal antibodies against COVID-19. Finally, we are involved in efforts to establish a fast response platform that allows early identification of viruses that has the potential to lead to future pandemics to recognize them early and have tools available to rapidly develop treatments. In this context, I would like to briefly mention Kara Carter, who has been leading all of these efforts at Evotec. Kara is a world-renowned expert in antiviral and we are all very proud that she has been appointed as President of the International Society of Antiviral Research. Beyond COVID-19, there is another global health crisis, which we can always see coming and need to prepare for. The global health crisis is the increasing development of antimicrobial resistance towards the currently existing arsenal of antibiotics. Evotec continues to be active in the field. And we are proud to have added yet another exciting program to our current pipeline from Resolute Therapeutics, which we would like to introduce on Page 28. Resolute’s program is based on a clinically proven target and has the potential to be developed into a novel broad spectrum antibiotic, covering major Gram-positive and Gram-negative pathogens. The program is currently at lead stage and the best analog display, really outstanding attributes. This cover essentially most, if not, all major pathogens, with antibiotic resistance. There’s no cross resistance to known antibiotics that has been observed. They have little potential to drive the selection of resistant strains. And the lead compound efficacious in multiple modes of infection and they have an overall promising in-vivo profile, including safety. We are very excited that we have been able to add this program to our AMR portfolio and we are advancing it with highest priority. In this respect, we also want to acknowledge the very strong support of CARB-X. CARB-X will support this program with up to US$8.4 million, covering most of the development cost into the clinic. So much for the update on Evotec Innovate pipeline. On Page 29, we want to give a very brief update on the further expansion of our platform technologies. As part of the Evotec Innovate strategy, we continuously invest into proprietary platform technologies, whose access is coupled to licensing fees or product royalties. We recently announced a further expansion of our multi-modality approach to drug discovery, which is essential to offer the best possible approach to each and every disease-related mechanism. So, beyond small molecules, which Evotec covers, in essentially all flavors, that is to say in traditional small molecules by function of natural products, we also cover antibodies, cell and gene therapy. And now, we also cover antisense therapeutics through a strategic alliance with Secarna. Antisense therapies are able to target mechanisms that are either difficult or impossible to approach by other treatment modalities. They usually specifically target mRNA expression through a variety of mechanisms. These include RNA’s age-mediated destruction of messenger RNA, direct steric blockade of messenger RNA translation into disease causing proteins and axon content modulation to slicing side binding. Several antisense oligonucleotides have already been approved in the United States and Europe. Secarna’s locked nucleic acid stabilized antisense technology belongs to the market-leading technologies, which also underpins key products in the antisense field, such as Spinraza and Nusinersen, for the treatment of SMA. Spinraza, for example, belongs to the most expensive drugs in market today in more than 40 countries. Through our strategic alliance, we can use Secarna’s antisense technology for in-house Evotec Innovate project or offer it directly through Evotec Innovate partners. We are very excited about the addition of Secarna’s antisense technology to our multimodality platform as it does fill an important gap. So much for the update on Evotec Innovate. With this, I would like to hand back to Werner.