Search Company
Operator: Thank you all for joining us this morning for the Biostage 2017 First 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 Biostage files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Following the company's prepared remarks, the call will be opened for a 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, Kevin. 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 first quarters financial results then turn the call over to Jim who provide an operational update. Following Jim's comments, Bill will discuss the state of our technology, As we speak to you today, we're a bit more than four months removal from having experienced and survived a financial crisis a Biostage, as we entered the first quarter of 2018 we had just completed a timely and company saving for $4 million private placement in late December. We could --we quickly re-staff key physicians and resumed normal operations using a lean and focused operating model. We consumed approximately $2.1 million of cash and operating activities during the first quarter. Of that about $700,000 represented payments that agent vendor payables that predated the private placement. We also completed two additional private placements during Q1 providing net cash proceeds of $1.1 million. At March 31st, 2018, the company had cash on hand of $2.8 million and no debt. After quarter end on May 3, 2018, we reported that two private investors had signed binding agreements to purchase a total of 1 million common shares priced at $3.60 per share for gross proceeds of $3.6 million. We expect those transactions to close in the next few weeks. We've been encouraged by our continued ability to source new equity capital through private placements to fundamental long-term investors. I'll now turn the call over to Jim.
Jim McGorry: Thanks Tom, and good morning, everyone. It's been a busy few months for us at Biostage since our last update and I'm looking forward to catching everyone up with what we've been working on. Before I turn the call over to Dr. Fodor on some comments on our technology development, I'd like to highlight a series of advances on the following three points. Markets, capital, and team. In summary, Biostage has made steady progress on all fronts in Q. While we're keeping tabs on the market for our technology as we work through our domestic and international business plans, and by all signs Biostage is at the forefront to radically improve the treatment of patients with cancer and diseases of the esophagus. Second, with backing from investors who believe in that vision, as well as by earning the competitive government grant, our company has the firm financial runway that matches our products potential. And third, as all these moving parts come together from R&D to business partner to capital supporters Biostage has assembled a team of the best people for their job in bringing our life-changing cell frame technology to market. The prognosis for kids suffering from esophageal cancer and patients diagnosed with esophageal cancer today is bleak. New studies in 2018 continue to find complications and reduce quality of life for victims of these conditions. Meanwhile, we're developing a transformational surgical alternative to these patients. There's a tremendous unmet medical need worldwide for both kids and adults. This is especially true in China and the Asia community where the incidence of esophageal cancer is 10x that of the United States. A regenerative medical medicine solution that enables the body to heal itself without eliminating or jerry-rigging other organs is being designed as a better and less expensive alternative to the current standards of care. In other words, there's a tremendous need and market opportunity that our technology is poised to fill. Of course, a market need is one thing but funding the project to solve it is another. Do we have enough capital to get us to the finish line? As I mentioned in the press release, our strength right now is in our growing connections with the right people. Our current investors are the right people at the right time. They share our vision and belief in our technology. Our Chinese investors also want to reduce the pain and suffering for patients with pediatric atresia and esophageal cancer. And we're building plans to expand our technology reach with a Chinese subsidiary. And we've just hired the expertise to make it happen. We're confident that we have long-term financial background and support from a growing team of investors ready to see this through. The right people also include our internal team. Our collaborators and partners. Our accomplishments in Q reflect the fact that we're working with these right thought leaders and best in field experts like Dr. Fodor. We published peer review results of a successful pre-clinical study this quarter not to mention the compassion e surgery that demonstrated the first successful use of a Cellspan implant in human. We know this a lot of work ahead, but at every turn we continue to receive positive and practical feedback that our technology is viable and replicatable. Put simply, our cell frame solution more than ever has demonstrated that it works and with the refresh direction we set on the company in 2018 Biostage is on its way to accomplishing what we aim for since the very start. To improve patient's lives by filling a dire unmet medical need. And with that, let me turn the call over to Dr. Fodor for comments on a technology and development. Bill?
Bill Fodor: Thank you, Jim. Good morning, everyone. The core team here at Biostage has a very strong focus on product development currently. We are finalizing three GLP reports on large animal studies to support our IND filing. These include acute and long-term safety and efficacy. We just execute an agreement with the University of Texas cell culture facility both the GLP and GMP facilities at UT for initiating our human cell comparability studies. We are streamlining several manufacturing steps at UT and we're establishing proof of concept for qualification runs. These include Zeno free manufacturing components, streamlining process steps for shipping our product and establishing cell banks and product stability. With respect to our IND, we're constructing two IND modules within the ECTD filing components. These include the summary module, as well as the CMC or manufacturing module. These will be reviewed by regulatory consultants and we'll continue to work on these two components through Q. We have also engaged with the clinical consulting group CTI for the development of a formal clinical protocol for our IND. With respect to research activities as Jim mentioned, we received funding from the NIH on an SBIR fast-track grant aimed at developing proof of concept in a pediatric model of esophageal atresia. This is in collaboration with Connecticut Children's Medical Center and the University of Connecticut Health Center. These planned animal studies will initiate before the end of Q2. We are also developing human cell studies from esophageal atresia patients and GI patients, again, through an IRB approved protocol with Connecticut Children's. These are the focus of our research activities, and I'd be happy to take any questions with respect to the technology development and product development. Thank you.
Jim McGorry: So, Jarad, we would like to open up the call for questions, sir.
Operator: [Operator Instructions] First question is with John Ajay with Ajay Capital. Please proceed with your question.
John Ajay: Yes, hi. Can you provide an update on when it looks you'll be filing your INDS on either of the two indications that you're pursuing right?
Jim McGorry: Hey, John, Jim here. And thanks for the question and so as you heard from Dr. Fodor with a little bit more detail we are really focusing on all of the specific modules. The GOP studies our partner in moving that forward. You might recall because I think here on top of things John that we said in our February update that our target is 2019. That is clearly our target. We are trying to do that as early as possible into next year. And we hope by our next conference call we'll update you in further detail. That's what we have line of sight onto right now. As you know that is the major focus of switching from a preclinical to clinical that is our timeline and we want to be absolutely confident in what we're doing. And that's why we're waiting to be able to get all of those things in place before we make those specific quarterly comments. But 2019 is the total focus, sir.
John Ajay: And are you still planning to pursue the pediatric first in exclusively? Are you now looking at potentially doing them both simultaneously?
Jim McGorry: Thanks very much. There is no question that we are pursuing two indications of pediatric atresia and also esophageal cancer into adults. I think under Dr. Fodor's leadership we have had a lot of success of using one to be able to help support the other, and we're continuing to work on those two indications. It is not just exclusively one; it is two indications, sir.
John Ajay: Okay and I noticed that was the deal, the private placement the price is above where it's trading at right now. Was it also at a premium of where it was the stock is trading at the time you negotiated it? That's an encouraging sign, the ability to make --.
Tom McNaughton: John, this is Tom. Yes, short answer to your question is yes.
Operator: There seems to be no further questions left in the queue. And I would like to turn the call back over to Jim McGorry for closing remarks.
Jim McGorry: Yes. Thanks, Kevin. And thanks to the folks being on the line. So hopefully you'll see too that we've made steady progress into Q1. In the two big areas we have long-term financial backing and we feel that it was demonstrated in to these - these most recent private placements that are a premium to the market that really demonstrates that piece. And then as you heard from Dr. Fodor we have line of sight on our development. And we're really building on all the knowledge that we have learned. So thank you very much. And we look forward to updating you further.
Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.