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Theriva Biologics, Inc. (TOVX)

Q2 2018 Earnings Call· Wed, Aug 8, 2018

$0.33

-8.53%

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Transcript

Operator

Operator

Good afternoon, everyone and welcome to the Synthetic Biologics 2018 Second Quarter Investor Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note, this event is being recorded. At this time, I would like to turn the conference call over to Mr. Vincent Perrone, Director, Corporate Communication at Synthetic Biologics. Vincent, you may begin.

Vincent Perrone

Analyst

Thanks, Jamie, and good afternoon, everyone. Welcome to Synthetic Biologics 2018 second quarter investor conference call. Today, I am joined by our acting CEO and CFO, Steven Shallcross; and our Chief Medical Officer, Dr. Joseph Sliman. Synthetic Biologics issued a press release this afternoon, which provided operational highlights and reported our financial results for the period ending June 30, 2018. The release can be found on the Investors section of our website. During our call today, we will provide an operational update on our microbiome-focused clinical programs and summarize our financial results. We'll take questions after our prepared remarks. In addition to the phone line, this call is being streamed live on the internet, which will be archived on our website, www.syntheticbiologics.com for 90 days. During this call, we will be making forward-looking statements regarding Synthetic Biologics' current expectations and projections about future events. Generally, the forward-looking statements can be identified by terminology such as may, should, expects, anticipates, intends, plans, believes, estimates and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, including those set forth in Synthetic Biologics' filings with the SEC, many of which are difficult to predict. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information on this call is provided only as of the date of this call and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained on this conference call on account of new information, future events or otherwise, except as required by law. With that, I'd like to turn the call over to Steve. Steve?

Steve Shallcross

Analyst · William Blair. Please go ahead with your question

Thank you, Vincent. Good afternoon, everyone, and thanks for joining our call. Before I dive into our clinical and operational update, I want to start by stating very clearly that I and the Synthetic Biologics team are more dedicated and determined than ever to continue our work of advancing our portfolio of cutting edge microbiome-focused therapies. Our objective is incredibly clear, unlock of the value of the great invest portfolio of products for patients they aim to serve and for our dedicated shareholders. During today's call I'll share important and exciting updates on our clinical programs. First we made considerable progress with ribaxamase, which is our all enzyme designed to prevent certain IV beta-lactam antibiotics within the GI tract to protect and preserve the natural balance of the gut microbiome from antibiotic-mediated dysbiosis and CDI. I'm pleased to report we remain on track to hold our end of Phase 2 meeting with the FDA towards the end of the third quarter. In the past three months, we've made excellent progress in our partnering efforts both domestically and especially in China. Following my recent trip to China, I believe the company is well positioned to continue to pursue our core objective of completing licensing and/or co-development deal in the region. We also completed the health economic study which provided key insights on the positive benefits ribaxamase may have on the health care system. In addition to ribaxamase, we are developing an emerging and promising portfolio of microbiome-focused drugs including SYN-010 with the potential to treat significant unmet market needs. And lastly, we've taken important measures to solidify the financial stability of our company. On the clinical front, I'm pleased to report we continue to have strong momentum with ribaxamase, our first-in-class therapeutic intervention designed to prevent the onset of primary C.…

Vincent Perrone

Analyst

Thank you, Steve. Jamie, we'd like to open the phone line of questions. Would you please describe the procedure to ask questions for our listeners.

Operator

Operator

[Operator Instructions] and our first question comes from Katherine Xu from William Blair. Please go ahead with your question.

Katherine Xu

Analyst · William Blair. Please go ahead with your question

Just wondering the China deal that you're looking at potentially. Do you think that deal would be able to fund the whole Phase 3 study for ribaxamase? And why the guidance of [indiscernible] in second half of 2019?

Steve Shallcross

Analyst · William Blair. Please go ahead with your question

So the first part of your question is kind of tough to answer. I mean clearly that would be optimal for us. Okay. As I stated previously I'm not going to talk about the progress of where we are at and when something may or may not happen for that matter. The ideal situation for us to seek a traditional type of transaction that I think most everybody is familiar with, some form of upfront, some form of reimbursement for development activities and then on the backend additional milestones and royalties. But specifically I can't even comment at this point whether or not any of these potential partners are going to cover what percentage of any type of development deal. And then your second part of the question, I'm sorry was related to.

Katherine Xu

Analyst · William Blair. Please go ahead with your question

The timing of the start of the Phase 3, second half of 2019.

Steve Shallcross

Analyst · William Blair. Please go ahead with your question

Yes, right now with the end of Phase 2 meeting set for the end of the quarter coming up here, we've got some manufacturing issues that will coincide with what we learned from the FDA and then we also have on the operation side the necessity to get a CRO on board, identify the sites which actually is in process, qualify them, go through the process of putting the contracts in place and I think that's going take about a year to do. So right now, we would suggest that the second half of 2019 is accurate at this point.

Katherine Xu

Analyst · William Blair. Please go ahead with your question

Thank you.

Operator

Operator

[Operator Instructions] and ladies and gentlemen at this time showing no additional questions. I would like to turn the conference call back to Steve Shallcross for any closing remarks.

Steve Shallcross

Analyst · William Blair. Please go ahead with your question

Thank you. In closing I would like to thank each and every one of you for joining our call today. As I hope I've conveyed with my remarks today, we are truly excited and we're in an important inflection point in Synthetic Biologic's evolution. We enter this next phase with a crystal clear picture of the vast opportunities we have and what we need to do to achieve our success going forward. We have an exciting portfolio of products. We deeply appreciate the confidence and dedication you've all shown us and we look forward to continuing to update you on our progress as we continue in weeks and months ahead. Thank you and have a good evening.

Operator

Operator

Ladies and gentlemen, that does conclude today's conference call. We do thank you for attending. You may now disconnect your telephone line.