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Operator: Thank you all for joining us this morning for the Biostage Second Quarter Earnings Investor Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference is being recorded. At this time, I'd like to remind our listeners that remarks made during this call may state management's intentions, hopes, beliefs, expectations, or predictions of the future. These are forward-looking statements that involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the federal securities laws. These forward-looking statements are based on Biostage's current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are disclosed in the periodic reports that Biostage files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's Web site and on the Securities and Exchange Commission's Web site. We encourage you to review these documents carefully. Following the company's prepared remarks, the call will be opened for question-and-answer session. It is now my pleasure to turn the call over to Chief Financial Officer of Biostage, Mr. Tom McNaughton. Thank you. Please go ahead, sir.
Tom McNaughton: Thank you. Good morning, everyone. Thank you for joining our call. With me on the call today are Jim McGorry, our CEO and Dr. Bill Fodor, our Chief Scientific Officer. I'll start the call with summary of the second quarter's financial results then I'll turn the call over to Jim who'll provide an operational update. Following Jim's update, Bill will comment on our technology and development progress. As you may know, we are a much more streamlined company than we were at this time last year. And we are executing very focused operating plan this year. The financial results announcement issued earlier this morning provided a number of year-over-year operating statement comparisons which reflected the company's new operating level. My comment here will focus more specifically on giving you an indication of our current year quarterly cash burn rates. We had a very active second quarter as we came out of the first quarter with increased staffing in key position and move forward operationally beginning a new round of preclinical studies for pediatric and esophageal indications. We consumed approximately $1.2 million of cash in operating activities during the second quarter, which included a $500,000 benefit from working capital changes. We consumed $2.1 million in cash and operating activities during the first quarter of 2018 approximately $700,000 of which represented payments of agent vendor payables incurred in 2017. Backing out those two working capital effects in the first and second quarters, [1.2] [ph] adjusted cash used in operating activities were approximately $1.3 million and $1.7 million in the first and second quarter of 2018 respectively. That sequential quarter spending increase was primarily due to increased R&D spending. During the second quarter, we completed two private placements of common shares providing net cash proceeds of approximately $4.2 million and of June 30, 2018, the company had cash on-hand of $5.8 million and no debt. We have been encouraged by our continued ability to source new capital equity to private placements to fundamental long-term investors. I will now turn the call over to Jim.
Jim McGorry: Thanks Tom, and good morning. As we highlighted in our press release, Q2 was a strong quarter as we made progress and picked up momentum on all of our mid-term goals. We remain on track of our operational execution strategy and our milestone to file an IND into 2019. Under the scientific leadership of Dr. Bill Fodor, we moved to development program forward and we are well along our important proof of concept study for our pediatric program in collaboration with Dr. Chris Finck at Connecticut Children's and you will hear more from Bill following that summary. In business and sports, we got leaders in coaches comment on the moment, we are accompanying team comes together and the momentum shifts in their favor, the Biostage's team, leader and coach Q2 represented a positive momentum shift forward towards becoming a clinical stage company. This is not one ingredient that added to the momentum instead our renewed confidence is because we continue to see consistent results in our data and studies and we have gained further insight into the mechanisms and understanding of our technology. We continue to validate our progress with our scientific advisory board and additional clinical leaders. In summary, we made substantial progress in Q2 and better aligning our clinical benefit and safety profile for a successful filing. We will be further engaging with the FDA in the upcoming weeks. We are gaining new clinical insight from leading esophageal experts and thought leaders. Biostage continues to engage with leading scientist, gastroenterologist, surgeons to help us position our technology to the best possible use and outcomes. We are using these insights to improve and better position our technology for a favorable outcome with the FDA. Esophageal cancer comprises a complicated series of problems leaving clinicians and their patients frustrated by a lack of clinical breakthrough in the field. Thoracic surgeons, general surgeons, gastroenterologist are looking for a better way to treat a growing worldwide problem with esophageal disease. Biostage will be attending key global meetings on the upcoming treatment of the esophagus over the next few months to further refine and favorably position our clinical development endpoints. On the capital raised front, I'm delighted with our continued success in bringing our favorable capital to extend our run rate. We continue to add value to the company everyday as we execute on our multiphase plan that includes animal studies, regulatory planning, securing additional intellectual property, gaining further clinical insights, aligning our studies to the best clinical outcomes partnering, outsourcing and quality, all under clinical trial conditions. Said in another way, the more we know about our data and technology, the more we reduce our risk and increase our value for a successful translation to the clinic. As our technology development advances, our financial value should continue to reflect that progress. Let me also thank a few of our key collaborators, Mayo Clinic, Connecticut Children's, the University of Texas Medical Center in Houston and along with our clinical advisors who are actively engaging with us and translating our technology to the clinic. What can you expect from us in the upcoming months, okay, continued execution and funding, reducing risk and more value. As we bring on new data and reach new milestones we will evaluate the best timings up list in NASDAQ and with the right momentum in opportunity for our shareholders. But for now, it's back to a heads down execution of our plans. In closing, we remain encouraged with the growing understanding of our technology and the active support of our clinical advisors in guiding our successful translation into the clinic. Let me now turn the call over to Biostage, Chief Science Officer, Dr. Bill Fodor.
Bill Fodor: Thank you, Jim. Good morning everyone. What I would like to do this morning is highlight five key development areas that we have advanced in Q2. As we disclosed back in May on our teleconference on May 4. We received an NIH SBIR Phase 1/2 fast-track grant. This is an award of $1.7 million which will fund research over 2.5 years. The grant is focused on modeling and treatment of the esophageal atresia this is a congenial defect in children where they have an incomplete developed esophagus. As far as research that is being undertaken in the Phase 1 and Phase 2 portions of this grant, we are ahead of schedule on phase. Yet, we have also initiated some Phase 2 activities, and again, this is ahead of schedule. This actually segues into our collaborations with American preclinical sciences in Minneapolis as well as Connecticut Children's hospital. At APS, we have already engaged in execution of implantation of pediatric sized esophageal implants. We have seven animals currently in life. Our second cohort which will include another five animals will start at the beginning of Q4. These studies will have set endpoints. We have revised tissue sampling implant to acquire not only histology but also mechanical tissue testing and understand the mechanical strength of this tissue over the course of the in vivo or end life portion of this study. We have also engaged with University of Texas cell biology lab, the Dr. Charles Cox and Scott Olson. And this actually addresses a question that the FDA had for us back in our preclinical, pre-IND meeting back in 2016 and that is showing that human cells are comparable to the porcine cells that we are using in our in vivo studies. This includes characterization, stability, as well as shipping and transport which will be required for -- when we establish our central manufacturing facility. In addition to the work that we are working at UT with human cells -- our cell biology lab is fully functional and up and running, it is completely staffed and fully equipped. We are doing this to support not only our animal studies at APS but also our collaboration with UT. We are also undertaking experiments that will potentially enhance our potency of the cells which could lead to additional intellectual property. And finally, I would like to update you on where we are with the FDA and our IND path forward. We retained Boston Biomedical Associates, BBA, and we are working with on responses to the FDA for our pre-IND meeting back in 2016. We have a clear path forward and as Jim mentioned, we will be engaging with the FDA in the next few weeks. We will be submitting an updated package to address concerns at the FDA had, following our pre-IND meeting and we have advanced our work to address all those questions. We will also present our 3 GLP large animal studies and the data around that all those reports are being finalized currently. In addition to that, we have first in human data as Jim mentioned with our collaboration at Mayo. Mayo Clinic in Rochester, Minnesota and we will present -- be presenting the annual report from that clinical study. If there are any questions, we will be happy to address any issues or questions that you might around our development plan. Thank you.
Jim McGorry: Operator, we can go to questions and answers please.
Operator: Thank you. At this time, we will conduct our question-and-answer session. [Operator Instructions] Thank you. [Operator Instructions] I have a question from Daniel [indiscernible]. Please go ahead with your question.
Unidentified Analyst: Hello. Thank you. And I would like to ask a question about further potential in grants and similar non-dilutive financings. You already mentioned $1.2 million from the fast-track and is there anything else with potential there on the horizon within the next couple of years?
Tom McNaughton: Yes. We've considered writing additional grants to the SBIR program at NIH. These could -- these will focus around increasing the potency of our cells and potentially other ways to deliver the cells. And we're actually exploring non-surgical methods of delivery. So those -- that's the plan currently. We have not engaged in the construction of those grants as of yet.
Unidentified Analyst: Okay. And if it's like -- just a very rough estimation what kind of money could come in through these kinds of grants?
Tom McNaughton: Again, the SBIR program at the NIH has a Phase 1 program, a follow-on Phase 2 program for Phase 1/2 fast-track. Our current grant is a Phase 1/2 fast-track again it was $1.7 million over 2.5 years. Potentially some of these ideas around increasing the potency and/or other methods of delivery, we'll probably follow the track of doing a Phase 1 first which is about $75,000 that would then -- once the progress report is submitted then engaging with a Phase 2 portion of that program depending on the results from those studies.
Jim McGorry: We appreciate your comment. We thank Dr. Fodor and Dr. Sundaram here have a very good knowledge of the SBIR program bringing in that non-dilutive capital has really helped us here at Biostage. We will continue to be able to pursue other ways around this. The NIH and the small business grants are to be able to translate technology and bring that to patients. And I think that we're very aligned into their goals and the work that we're doing here and the early success and the things that Bill talked about of being ahead of schedule. We feel good about that. So thanks for your question.
Unidentified Analyst: Thank you.
Operator: Thank you. [Operator Instructions] We have an additional question from Daniel [indiscernible] Please go ahead.
Unidentified Analyst: Thank you. And looking at the involvement or the increased involvement of Chinese shareholders and plans for that country. Like from the presentation it looks like in the area of like region of application of the technology, my question is, what is necessary for that? How does the process look there? Do they for example respect FDA decisions and it can be translated or will it be a completely new process just to get an overview on that?
Jim McGorry: Let me start. Thank you, Daniel. I'm pleased to bear with all and to tell you that sitting right here at the meeting is the Chairman of the Board of Biostage Dr. Jason Cheng, who flew in from China to join us right now and also the President of our company Hong Yu, who has really driven this private placement opportunity for our company. Our long-term investors that we have tied into thanks to Hong and Jason really see the potential for our technology. They also really care to be able to do the right thing of getting it developed properly. And that's what we're doing and going through Dr. Fodor and the FDA. There's tremendous work being done behind the scenes with the CFDA and other KOLs in China to better understand our pathway from a medical device, two of regenerative medicine product, two other incentives in China, how is this done? What's the best way to do it? How do coordinate it? All of this work is currently being done right now. We had a good Board meeting yesterday, where we coordinated these areas. And so like I said, again, I don't want to get over promise and under deliver. We are staying focused in doing our development. We see a global strategy that includes China that includes Japan that includes Korea that includes Europe. But, we need to be able to move our technology into the clinic and then coordinate with all of those respective agencies incentives, opportunities, financial structures to work through it. So, like I said, one day at time, head down on execution and we believe that hopefully those good things will happen. Thanks.
Unidentified Analyst: Thank you.
Operator: Thank you. [Operator Instructions] Ladies and gentlemen, there appears to be no additional request for questions, I will turn the floor back over to management for closing remarks. Thank you.
Jim McGorry: Yes. Thanks operator for your good help right here. So, look in closing, we really appreciate it. We thank you for getting on the call. I hope you see that there is really concrete stuff that we are doing as Dr. Fodor takes you through that. You see that there is a financial runway. And we look forward to continued momentum financial runway and growing value. Thank you very much.
Operator: Thank you. This concludes today's conference. All parties may disconnect. Have a great day.