AGM 2019

Jun 14, 2019

Good morning, everyone, and welcome to Selecta Biosciences, Inc. Annual Meeting of Stockholders. I would now like to turn the conference over to Carsten Brunn, President and Chief Executive Officer. Please go ahead. Thank you. Good morning, ladies and gentlemen. Carsten Brunn, President and CEO of Selecta. I'd like to welcome you all to our 2019 Annual Meeting of Stockholders and thank you for your ongoing support of Selecta Biosciences. I also want to thank the members of the Board and management who are with us today. I'll act as the Chairman of this meeting and Ilona Kogan, our General Counsel, will act as Secretary. The other members of the Board who are here with us today are Tim Baravi, Omid Farooq Sat, Amir Nashad, Emeric Salin, Tim Springer and Pat Zenner. I would also like to introduce Jason Janoff and Peter Catalano of Ernst and Young, the company's independent auditor who will be available to respond to appropriate questions via the Ask a Question box found on the web portal. The meeting will now officially come to order, and I'll take this opportunity to update you on the current state of the business. Before I do so, I'd like to note that any remarks we make today may include forward looking statements that involve risks and uncertainties. Actual results could differ materially from those discussed. More information about important factors that could cause our actual results to differ materially from our expectations expressed in our forward looking statements are included in the company's SEC filings, including the company's 2018 annual report on Form 10 ks. So very briefly, if you look at our presentation, just want to kind of ground you, we are an immune tolerance platform with our core platform is Intor. And you can see here the mechanism of action, Intor is a nanoparticle that encapsulates rapamycin that induce a tolerogenic message that produces T regulated cells specific to antigens. Our lead acid is in gout. It's a combination of ImmTOR plus our proprietary uricase called Pegafricase. Chronic refractory gout is a rare disease at about 160,000 patients with a significant unmet medical need, specifically around improved efficacy. So the ability to complete a full month treatment cycle with a goal to reduce serum acids, the need for less frequent dosing, so for monthly dosing and the need to reduce gout flares. And we hope to address those unmet needs with our product SEL-two twelve. And we see a $1,000,000,000 plus market opportunity. We showed last year the results of our Phase dose finding study, which represented ACR in October, where you can see we have a response of 60 6% or 21 out of 32 patients. Also very important to note, we had significantly reduced gout flares compared to the currently approved uricase. About 32% of patients experienced gout flares. The majority of flares occurred in month 12 and no patients experienced any flares after month 2. It's important to note that 96% of the flares have been mild or moderate in severity and none of the gout flares have been We started the end of March a head to head trial versus the currently proofuricase, KRYSTEXXA. The COMPARE trial, which compares SEL-two twelve, 6 monthly infusions versus KRYSTEXXA as per label. The primary endpoint is SUA reduction, and we plan to have an interim readout towards the end of this year with final statistical superiority readout in Q1 next year. The second area we are very excited about is the application of ImmTOR in gene therapy with the potential to treat AAV mediated gene therapy. Also in this field, which I would say is one of the hottest areas right now in the medical field, a significant unmet need, specifically around dose titration. We're currently patients that don't hit the therapeutic target will not don't have the opportunity to be retreated. There is also the need for multiple vector administrations, specifically in muscular disorders, very high vector doses are required and the need or the potential to reduce multiple lower doses are a significant unmet need. And last but not least, the importance to retreat for vascular expression if a patient experience organ damage or for kids that throw obviously and that need to be treated as well. So there's significant need in the marketplace that we hope to address. And we have compelling data that we published last year in Nature Communications, where we demonstrated the ability to retreat in mice and also the ability to actually express a protein after retreatment. Our next step is to get into the clinic. We do have currently a collaboration with CureCN, which is a European consortium with Genethon and a number of academic centers in Crigler Najjar, which is a rare disease. It's a bilirubin disorder. And we're currently working on preclinical toxicology and plan to get into the clinic the second half of this year. We currently also have 2 proprietary programs in rare inborn diseases, MMA and OTC, where we're currently looking at for partners to identify a vector. And we have an existing license agreement with Spark Therapeutics that license ImmTOR for hemophilia A and we also have exclusive options for additional 4 undisclosed targets. And also I just want to remind you that the purpose that the company pursues, we are relentlessly committed to overcoming immunogenicity with our pioneering ImmTOR Immune Tolerance platform to transform the lives of patients and their families. And with that, I will now turn over to Ilona Cogan, who will conduct the formal business of the meeting and set forth in the company's notice of annual meeting and proxy statement. Thank you, Carsten. We will now review a few formalities. Only select the stockholders of record at the close of business on April 17, 2019, where holders of a valid proxy are entitled to vote at today's meeting. The Inspector of Election has a complete list of the holders of record of the company's common stock on the record date for the meeting and for stockholders who have entered a valid 16 digit control number. The stockholder list is also available during this meeting on the bottom panel of your screen. I have also received an affidavit from the company's mailing agent, Broadridge Financial Solutions, certifying that the delivery of records relating to the company's annual meeting scheduled for June 14, 2019 to all stockholders of record as of the record date was made by means of a mailing, which commenced on April 29. I will file the affidavit with the records of the meeting. At this time, I'd like to introduce Joseph McClelland, a representative of Broadridge Financial Solutions, who the Board has appointed to serve as the Inspector of Election at today's meeting. Mr. McClellan has signed the customary oath of office to execute his duties with strict impartiality. I have been informed by the Inspector of Election that a majority in voting power of our outstanding common stock is present by remote communication or represented by proxy. And based on that information, I therefore declare that a quorum exists and this meeting is duly constituted for the transaction of business. We will now proceed with the formal business of this meeting. The first item of business is the election of Timothy C. Barabee and Carson Brunn to serve as directors of the company for a term of office expiring at the annual meeting of stockholders to be held in 2022. You can read a short biography of each of these director nominees in our proxy statement. Your Board unanimously recommends a vote for each of these director nominees. The second item of business is the ratification of the audit committee's appointment of Ernst and Young LLP as the independent registered public accounting firm of the company for the year ending December 31, 2019. You can read more about this proposal, including the audit fees and services and the audit committee's pre approval policies and procedures in the company's proxy statement. Your Board recommends that shareholders vote for this proposal. Mr. Janoff, would you like to make a statement? That was the final item of business for today's meeting. The polls opened today, June 14, 2019 at 9 a. M. Eastern Time for voting on all matters before the meeting. Voting is by online ballot. Select the stockholders of record at the close of business on April 17, 2019, were holders of a valid proxy who voted online or by telephone prior to this meeting do not need to vote again by ballot unless they wish to change their vote. If you wish to vote now because you want to change your previously submitted vote or you have not previously voted, you may do so now by clicking on the Vote Here button found on the web portal. The polls will remain open for another 60 seconds. Please hold during the duration of these 60 seconds to allow our stockholders to vote if they so elect. Thank you for your patience. The time is now 9:12 am on June 14, 2019, and the polls are now closed for voting. The Inspector of Election will count the votes. Mr. McClellan has provided me with the preliminary report of the Inspector of Election. I will cause the final report of the Inspector of Election to be kept with the company's records of the annual meeting. Based on the preliminary report of the Inspector of Election, Timothy C. Baravi and Carsten Braun have been elected as Directors with at least 95% of the votes cast for their election. The appointment of Ernst and Young LLP as our independent cast in favor. This concludes the preliminary voting results. The final tally of the votes will be published within 4 business days in a current report on Form 8 ks to be filed with the Securities and Exchange Commission. And with that, I will turn the meeting back over to Carsten. Thank you, Lona. And again, thank you to our shareholders and our Board of Directors for your support of Selecta Biosciences. I now declare that the official portion of the meeting is adjourned. We will now answer appropriate questions from stockholders. Only validated stockholders will be able to ask questions by typing in their question in the Ask a Question box found on the web portal. Each stockholder is limited to no more than 3 questions or comments, no more than 2 of which may be on any single topic. We do not have any questions in the queue. At this time, we will conclude our annual meeting. I want to thank you for attending and for your continued support of Selecta Biosciences. Thank you. The conference has now concluded. Thank you all for attending today's presentation. You may now disconnect your lines.