AGM 2021

Jun 3, 2021

Welcome to the 2021 annual meeting of Editas Medicine stockholders. I would now like to introduce Jim Mullen, Chairman of the Board, President, and Chief Executive Officer of Editas Medicine. Good morning, and welcome to the 2021 annual meeting of stockholders of Editas Medicine. I'm Jim Mullen, Chair of the Board, President, and Chief Executive Officer of Editas Medicine. I will be presiding over this meeting. At this time, I call the meeting to order. Due to the public health impact of the ongoing COVID-19 pandemic and to support the health and well-being of our stockholders, employees, and communities, we are again holding our annual meeting in an all-virtual format, and we're pleased to have everyone join this live webcast. We have designed this meeting to provide stockholders with the same rights and opportunities to participate as they would at an in-person meeting. Before we get to the formal business of the meeting, I'd like to make some introductions. Present at the meeting today are Meeta Chatterjee and Andrew Hirsch, each a nominee for director, as well as Akshay Vaishnaw, Jessica Hopfield, and David Scadden, each a director of Editas Medicine. In addition, the following members of management are also with us today. Lisa Michaels, our Chief Medical Officer, Michelle Robertson, our Chief Financial Officer, Clare M. Carmichael, our Chief Human Resources Officer, Charlene Stern, our Chief Legal Officer, and Harry Gill, our Senior Vice President of Operations. I would also like to introduce Pam Kelleher, a representative from Ernst & Young, our independent registered public accounting firm, and Terry Hassett, who will be serving as our Inspector of Elections. After we complete the formal part of the meeting, I will give a short presentation on behalf of the company, and then we will take questions. In order to conduct an orderly meeting, I call your attention to the rules of conduct posted on the virtual meeting website, which include information about participating in the meeting, including asking questions. Please note that various remarks that we make about future expectations, plans, and prospects for the company constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is on file with the SEC. In addition, these forward-looking statements represent the company's expectations only as of today. While the company may elect to update these forward-looking statements, it specifically disclaims any obligation to do so. Any forward-looking statements should not be relied upon as representing the company's estimates or views as of any date subsequent to today. I have received an affidavit from the company's proxy solicitor, Broadridge Financial Solutions, certifying that the notice of annual meeting and proxy statement was sent to all stockholders as of the record date of April 6, 2021. This affidavit is available for inspection by any stockholder. Our first order of business at this meeting is to determine whether the shares represented at this meeting, either in person, via this virtual meeting, or by proxy, are sufficient to constitute a quorum for the purpose of transacting business. Holders of 67,580,775 shares of common stock are entitled to vote at this meeting. The Inspector of Election has informed me that there are present at this meeting, either in person or by proxy, a majority of outstanding shares of common stock entitled to vote. Therefore, I hereby declare that a quorum exists. Turning now to the items to be voted on at this meeting. As indicated in the notice of the meeting and accompanying documents that were sent to stockholders, the first matter to be voted on in this election is the election of 2 Class II directors to serve until the 2024 annual meeting of stockholders and until their successors are duly elected and qualified. These two nominees for election are Meeta Chatterjee and Andrew Hirsch. The next matter to be voted upon is the advisory vote to approve named executive officer compensation. The proxy statement for this meeting contained the text of the resolution that the stockholders are asked to approve. The final matter to be voted on is the ratification of the selection of Ernst & Young LLP as the company's registered public accounting firm for the fiscal year ending December 31st, 2021. If there are any questions on proposals, they may be submitted on the virtual meeting website. If asking a question, please also include your name and affiliation to the company. I'm going to pause for a moment to allow for the compilation of questions. Seeing no questions about proposals, we'll move on to voting the proposals. I hereby declare the polls are now open for each matter to be voted upon today. If you have not yet voted or if you previously voted by proxy and wish to change your vote, you may vote by clicking the Vote Here button on the virtual meeting website and following the instructions there. We'll pause briefly to allow stockholders to vote. Now that everyone has had an opportunity to vote, the business items on the agenda for this meeting are complete, and the polls are now closed. Terry Hassett, the Inspector of Elections, will prepare a final report that will be filed with the minutes of this meeting. Based on the preliminary results, each of the nominees for director has been elected as a Class II director. The advisory resolution approving named executive officer compensation has been approved. The appointment of Ernst & Young has been ratified. The final vote results will be included in the Form 8-K that will be filed within four business days after this meeting. As there is no further business to come before the meeting, I declare the formal part of this meeting adjourned. I will now give a presentation regarding the company, following which members of the company's management will answer appropriate questions from stockholders. Okay, hopefully everyone can see up on your screen an initial presentation, and I want to thank everybody here for joining our annual shareholders meeting today. I'd like to draw your attention to the fact that this presentation contains forward-looking statements, and we encourage you to review potential risks and uncertainties outlined in our most recent 10-Q and 10-K, which are on file with the SEC. Editas was founded in 2013 with a mission to discover and develop a novel class of genome editing therapeutics. Our goal is to create therapeutics that will enable precise and corrective molecular modification to treat the underlying cause of a broad range of diseases at the genetic level. CRISPR gene editing has opened the door of possibilities for patients seeking to cure their genetic diseases, and our long-term vision is to harness the power of this editing technology to bring medicines to patients with limited therapeutic options. Editas is the only company with multiple proprietary CRISPR editing platforms able to edit the genome in a variety of ways. It is very comprehensive in nature and breadth, gives us the broadest genomic reach. We can reach nearly any site in the human genome. The widest tissue reach, ability to use AAVs and RNPs to access tissues and address disease throughout the body, and ability to make different kinds of edits to disrupt, remove, replace, or insert DNA to precisely and durably treat illnesses. These systems are supported by the broadest intellectual property portfolio. We have over 200 issued patents and another 800 pending that cover foundational intellectual property for the Cas9 and Cas12 enzymes for editing in human therapeutics, as well as patents covering our specific products. Combining the best in gene editing technology, along with our intellectual property position, gives us the ability to develop virtually unlimited transformational medicines for serious diseases. A lot goes into unlocking the potential of gene editing. When establishing a target indication, we need to determine the correct edits that will cure the disease or import key therapeutic functions to cells. Once the editing strategy is determined, we select the best nuclease from our editing toolbox, and finally, we identify the best delivery methods that will safely and effectively deliver the desired editing machinery to the right cells. Built on top of this technology is three other platforms. We like to think of these as three platforms that give us different delivery modalities. These are not just three areas of therapeutic indication. They are three very different ways to use gene editing to solve different problems, and demonstrating proof of concept for each of these platforms will open up vast additional disease indications. All these efforts continue to strengthen our portfolio, and as you can see, our progress is steadily advancing, which I'll discuss on the next slide. These are our 2021 anticipated milestones. We're making excellent headway towards accomplishing our 2021 goals. For our in vivo gene-edited medicines, we are progressing EDIT-101 BRILLIANCE trial and plan to present clinical data by year-end. At the same time, we're further advancing our entire ocular portfolio. For our ex vivo gene-edited cell medicines, we plan to initiate dosing of the EDIT-301 RUBY trial for sickle cell disease, as well as file an IND for beta thalassemia. In cell therapy for oncology, we plan to advance our ongoing preclinical studies for iPSC-derived NK cells, as well as advance the alpha-beta T-cell medicine portfolio with Bristol Myers Squibb. Turning first to our in vivo strategy, Editas was the first company to ever dose a human with an in vivo gene-edited medicine with EDIT-101. Our approach is to continue to develop differentiated medicines that can be administered directly to patients. The eye is an excellent starting point for in vivo programs, and we plan to expand our pipeline to several other inherited retinal diseases, as well as other ocular diseases with larger patient populations. We estimate that there are over 5 million people affected by inherited retinal diseases worldwide. In the future, we plan to address a wide range of other diseases outside the eye. The curative potential for gene editing is significant given there are over 6,000 genetic disorders. The BRILLIANCE trial for Leber congenital amaurosis, or LCA 10, is a typical design for this type of rare disease. The primary endpoint is safety. Efficacy is a secondary endpoint, which will be evaluated as we move through increasing dose cohorts. We started in adult patients with light perception only and with a dose that is on the low end of the range where we expect therapeutic benefit, again, the primary goal of safety. We're escalating dose and eventually moving to children with some visual acuity. Based on safety in the first cohort, the protocol has been updated to broaden the inclusion criteria of sentinel patients, where we will no longer be restricted to light perception-only patients. Success in this trial is principally demonstrating that we can safely deliver this medicine. In addition, we're looking for indirect evidence of editing and finally, clinical benefits of efficacy. Moving on to the ex vivo platform, where our initial focus is hemoglobinopathies, our differentiated strategy in hemoglobinopathies is to use human genetics to develop a potential best-in-class medicine for sickle cell disease and beta thalassemia. With EDIT-301, our lead program for sickle cell disease, we are able to induce fetal hemoglobin by editing a site within the beta-globin locus. We are able to edit the site through our proprietary Cas12 enzyme and have demonstrated superior preclinical data using this approach. We let human genetics point us toward what we think is the best-in-class medicine for sickle cell disease and beta thalassemia, and this slide summarizes why. Sickle cell disease is caused by a mutation in the beta globin genes that causes blood cells to form a sickle shape. What's fascinating is that there are patients harboring the sickle cell mutation that show no signs of the disease, and the reason is that they had a compensating mutation at a different site in the beta-globin locus that allows them to continue to express fetal hemoglobin throughout their lives, even though the sickle mutation compromises their adult hemoglobin. We are able to restore fetal hemoglobin in patients by editing a site in the HBG1-2 promoter within the beta-globin locus to mimic these mutations. We believe this will be a safer and more effective approach than editing the BCL11A enhancer because we are editing a region where human fetal hemoglobin mutations naturally occur. This slide depicts the process which EDIT-301 has administered into the patient. As with most allogeneic hematopoietic transplantations, patient conditioning is a critical component. Our approach, EDIT-301, streamlines the autologous process compared to how hematopoietic stem cell transplants were conducted in the past. Finally, I want to review our cellular therapy platform. Our initial focus is oncology, where we are developing multiplex gene-edited iPSC-derived NK cells for the treatment of solid tumors. We believe gene-edited NK cells or Natural killer cell medicines will be the next wave of transformational therapies for cancer patients. Combining the advantage of NK cell therapies with renewable source of iPSC master cell lines and a proprietary gene-editing technology, we believe we can create best-in-class off-the-shelf treatments for solid tumor cancers. Again, we believe gene-edited Natural killer cells will be a key part of the future of immuno-oncology. Our approach utilizes the innate immune system's own mechanism, shown here. We then leverage our proprietary editing technology to further enhance various cell functions such as specificity, persistence, homing, resistance, and effector function. Partnerships have been and will continue to be an important component of building our leadership position. Being a leader in genomic medicine requires immense expertise and resources. As we continue to advance our programs, partnerships will be critical for development and commercialization. We will pursue opportunities that extend our leadership and accelerate, enable, and expand our pipeline. We believe we've been successful to date, exemplified by our collaboration with Bristol Myers Squibb, a global leader in oncology. As I mentioned at the beginning, our business is supported by a very strong intellectual property position. Intellectual property has and will continue to be a significant area of investment for Editas because it is important to the long-term genome editing field and the novel medicines that we're developing. Given our current intellectual property portfolio, Editas is positioned to have a critical seat at the table when CRISPR-based medicines start entering the market. Companies using Cas9 or Cas12a nucleases in the creation of their products most likely need a license from Editas. To close, it's an extraordinary time to be involved in gene editing medicine. Editas was built as one of the CRISPR gene editing pioneers, and we continue to make important progress to bring transformational differentiate therapy to patients. The company has the necessary components to succeed in that objective, including experienced team, development and manufacturing capabilities, intellectual property. Do you estimate a return to profitability? When do we estimate return to profitability? Well, we are an early-stage biotech company, and as such, there never has been profitability. I think this is really a function of continuing to bring these products forward in the pipeline. The history of biotech, and I've been a long part of that history, is companies that typically take anywhere from 10-15 years to develop their first products, and turn from a research company to a profitable commercial company. That looks like the same pathway that we're on. There are no further questions at this time. Jim, I turn the call back over to you. Thank you again for your questions and continued dedication to the company. The annual stockholder meeting for Editas Medicine has now come to an end. I thank you for your time.