Presentation
Management
Theriva Biologics, Inc. (TOVX)
Q4 2015 Earnings Call· Thu, Mar 10, 2016
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Presentation
Management
Operator
Operator
Good afternoon and welcome to Synthetic Biologics’ 2015 Year End Investor Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Ms. Kris Maly, Vice President of Corporate Communications at Synthetic Biologics. Kris?
Kris Maly
Analyst
Thank you, Diane and good afternoon, everyone. Welcome to Synthetic Biologics 2015 year-end investor conference call. Today, I’m joined by our CEO, Jeff Riley; and our CFO, Steve Shallcross. Synthetic Biologics issued a press release this afternoon which provided operational highlights and recorded 2015 year-end financial results. The release can be found in the Investors section of our website. During our call today, Jeff, will provide an update on our microbiome-focused pipeline programs and Steve will summarize our financial highlights. We’ll take questions after our prepared remarks. In addition to the phone line, this call is being streamed live over the internet today and the webcast replay will be archived on our website for 60 days. During this call, we will be making forward-looking statements regarding Synthetic Biologics current expectations and projections about future events. Generally, 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 on 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 Jeff.
Jeff Riley
Analyst · BTIG. Please go ahead
Thanks, Kris, and thanks everybody for joining the call today. 2015 was an exceptional year for Synthetic Biologics. We are very proud of the progress we’ve made and are exciting for the milestones that lie ahead. Before we dive in, I’d like to provide a brief recap of the clinical achievements Synthetic Biologics has made since the beginning of the fourth quarter of last year. As a result of clinical progress in our SYN-010 program for the treatment of irritable bowel syndrome with constipation or IBS-C. We expect to initiate Phase 3 clinical trials for SYN-010 during the second half of 2016. And we anticipate requesting an end of Phase 2 discussion meeting with the FDA during the summer of 2016. In the clinic, we reported positive top-line data from our first Phase 2 acute study, which show that SYN-010 met its primary endpoint of lowering breath methane compared to baseline. We also reported solid top-line data from our second Phase 2 extension study, has clearly demonstrated a statistically significant decrease in methane production. As statistically significant reduction in the mean IBS symptom severity score or IBS-SSS which includes abdominal pain, bloating, stool frequency and quality of life scores for all patients from Study 1 baseline to the end of the second Phase 2 study. Also an increase in the percentage of patients identified as monthly responders, an FDA-defined composite measure incorporating improvements in complete spontaneous bowel movements and abdominal pain. Also there were no serious adverse events to include diarrhea that were observed during both of these trials. We reported additional progress from our three Phase 2 trials for SYN-004, for the prevention of C. difficile infection, antibiotic-associated diarrhea and the emergence of antibiotic-resistant organisms. As a result of our clinical progress in our SYN-004 program, which I’ll outline…
Steve Shallcross
Analyst · William Blair. Please go ahead
Thanks, Jeff. During the fourth quarter of 2015, we continue to operate efficiently and remain well positioned to execute on our plan of completing our Phase 2 clinical trials for our two lead microbiome-focused candidates. Synthetic Biologics year-end 2015 financials were included in the press release, which was distributed over the newswire earlier this afternoon. The company's 10-K for the year ended December 31, 2015 will be filed with the SEC later this evening. For the year ended December 31, 2015, our general and administrative expenses were $8.1 million compared to $6 million in the same period last year. Included in these numbers were non-cash charges related to stock-based compensation of $2.1 million for the year ended December 31, 2015, compared to $ 1.6 million for the year ended December 31, 2014. Research and development expenses increased to $32.9 million for the year ended December 31, 2015. This increase of 127% was primarily the result of increased program costs associated with expanded clinical development, manufacturing and research activities within our microbiome-focused pipeline, including companies Phase 2 C. difficile and IBS-C clinical programs. Non-cash charges related stock-based compensation were $1.1 million for the year ended December 31, 2015 compared to $803,000 for the year ended December 31, 2014. Cash and cash equivalents at December 31, 2015 were $20.8 million compared to $17.5 million at December 31, 2014. We anticipate cash utilization in the first quarter of 2016 to decrease as cash prepayments made during 2015 are expected to be used to offset a large portion of the costs associated with these ongoing Phase 2b clinical trial for SYN-004 and the completion of our Phase 2 trials for SYN-010. In addition to previously disclosed positive top-line data we reported for both lead microbiome-focused programs, we expect to report top-line data in second Phase 2a clinical trial for SYN-004 in the first half of 2016. Furthermore, we expect to initiate two Phase 3 trials in the second half of the year, which we believe will further add shareholder value to our microbiome related programs. Now I’ll turn the call back over to Jeff.
Jeff Riley
Analyst · BTIG. Please go ahead
Thanks, Steve. As we continue to move our lead microbiome-focused candidates through Phase 2 development and begin to plan for Phase 3 trials and commercial entry. We should be well positioned with the financial resources necessary to maintain the momentum we experienced in 2015. Let me recap our progress from the beginning of the fourth quarter once more. For our IBS-C program, first we anticipate beginning Phase 3 clinical trials in the second half of this year. Two, we intend to submit a request for an end of Phase 2 meeting with the FDA during the summer of 2016 this year. Three, we completed the first Phase 2 clinical trial and announced top-line data demonstrating symptom met its primary endpoint. Four, we completed the second Phase 2 clinical trial, extension study and announced outstanding top-line results including data demonstrating that SYN-010 sustained a statistically significant reduction of breath methane and more importantly data demonstrating a statistically significant reduction in the mean IBS-SSS scores for all patients from Study 1. And there were no serious adverse events including diarrhea, during both of these studies. Turning your attention back to C. difficile and antibiotic-associated diarrhea prevention program. We also – we anticipate initiating a Phase 3 trial or trials in the second part of this year. Our Phase 2b proof-of-concept study is going very well and has enrolled 98 patients to-date. We announced top-line results from the first Phase 2a study, demonstrating SYN-004 successfully degraded residual IV ceftriaxone and we will announce top-line data from the second Phase 2a clinical trial, during the first half of this year. Overall 2015 was a year filled with clinical, positive clinical milestones and we are optimistic about the potential Synthetic Biologics to address large markets and meet unmet medical needs while generating significant returns for our shareholders. Looking forward to 2016, we believe this will be the year Synthetic Biologics completes the pivot from an early stage clinical development company to a late stage Phase 3 commercially focused company. At this time, I will turn it back over to Kris.
Operator
Operator
Thank you, Jeff. Diane, we’d like to open the phone line back to questions now. Would you please describe the procedure to ask questions for our listeners?
Operator
Operator
Certainly. We will now begin the question-and-answer session. [Operator Instructions] Our first question will come from Tim Chiang of BTIG. Please go ahead.
Tim Chiang
Analyst · BTIG. Please go ahead
Jeff Riley
Analyst · BTIG. Please go ahead
Tim Chiang
Analyst · BTIG. Please go ahead
Jeff Riley
Analyst · BTIG. Please go ahead
Tim Chiang
Analyst · BTIG. Please go ahead
Jeff Riley
Analyst · BTIG. Please go ahead
Operator
Operator
Out next question will come from Katherine Xu of William Blair. Please go ahead.
Katherine Xu
Analyst · William Blair. Please go ahead
Jeff Riley
Analyst · William Blair. Please go ahead
Katherine Xu
Analyst · William Blair. Please go ahead
Jeff Riley
Analyst · William Blair. Please go ahead
Joe Sliman
Analyst · William Blair. Please go ahead
Katherine Xu
Analyst · William Blair. Please go ahead
Joe Sliman
Analyst · William Blair. Please go ahead
Jeff Riley
Analyst · William Blair. Please go ahead
Steve Shallcross
Analyst · William Blair. Please go ahead
Jeff Riley
Analyst · William Blair. Please go ahead
Katherine Xu
Analyst · William Blair. Please go ahead
Steve Shallcross
Analyst · William Blair. Please go ahead
Katherine Xu
Analyst · William Blair. Please go ahead
Steve Shallcross
Analyst · William Blair. Please go ahead
Katherine Xu
Analyst · William Blair. Please go ahead
Jeff Riley
Analyst · William Blair. Please go ahead
Katherine Xu
Analyst · William Blair. Please go ahead
Jeff Riley
Analyst · William Blair. Please go ahead
Operator
Operator
Okay. Our next question comes from Adnan Butt of RBC Capital Markets. Please go ahead.
Adnan Butt
Analyst · RBC Capital Markets. Please go ahead
Joe Sliman
Analyst · RBC Capital Markets. Please go ahead
Adnan Butt
Analyst · RBC Capital Markets. Please go ahead
Joe Sliman
Analyst · RBC Capital Markets. Please go ahead
Jeff Riley
Analyst · RBC Capital Markets. Please go ahead
Adnan Butt
Analyst · RBC Capital Markets. Please go ahead
Jeff Riley
Analyst · RBC Capital Markets. Please go ahead
Steve Shallcross
Analyst · RBC Capital Markets. Please go ahead
Jeff Riley
Analyst · RBC Capital Markets. Please go ahead
Adnan Butt
Analyst · RBC Capital Markets. Please go ahead
Jeff Riley
Analyst · RBC Capital Markets. Please go ahead
Adnan Butt
Analyst · RBC Capital Markets. Please go ahead
Operator
Operator
Our next question comes from Ed White of FBR and Company. Please go ahead.
Ed White
Analyst · FBR and Company. Please go ahead
Jeff Riley
Analyst · FBR and Company. Please go ahead
Ed White
Analyst · FBR and Company. Please go ahead
Jeff Riley
Analyst · FBR and Company. Please go ahead
Steve Shallcross
Analyst · FBR and Company. Please go ahead
Ed White
Analyst · FBR and Company. Please go ahead
Steve Shallcross
Analyst · FBR and Company. Please go ahead
Ed White
Analyst · FBR and Company. Please go ahead
Jeff Riley
Analyst · FBR and Company. Please go ahead
Ed White
Analyst · FBR and Company. Please go ahead
Operator
Operator
This concludes our question-and-answer session. I’d now like to turn the conference back to Jeff Riley for any closing remarks.
Jeff Riley
Analyst · BTIG. Please go ahead
Thanks, Diane. Again, everybody, thank you for joining us today. With more intensive placed on the microbiome research continues to shed light on all importance of microbiome place in human health. We feel a great sense of purpose and pride and continue to develop our two lead multibillion dollar programs. SYN-010, again to treat IBS-C and SYN-004 to treat CDI, CDAD, AAD in antibiotic resistance. As both programs continue to march toward Phase 3 clinical trials later this year. Synthetic Biologics move closer to our goal of offering novel microbiome-focused projects. We’re proud of the progress we’ve made in 2015 becoming a clinical development stage company and we’re very excited to move into a late stage clinical development company within a next two to three years to hopefully become commercial based company. Thanks again everybody for joining our call. Have a great evening.
Operator
Operator
The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect your lines.