Earnings Labs

Theriva Biologics, Inc. (TOVX)

Q3 2014 Earnings Call· Fri, Nov 14, 2014

$0.33

-0.12%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-6.67%

1 Week

-2.67%

1 Month

-2.00%

vs S&P

-0.80%

Transcript

Operator

Operator

Good morning and welcome to the Synthetic Biologics’ Third Quarter 2014 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. At this time, I’d like to turn the call over to Kris Maly, Vice President, Corporate Communications at Synthetics Biologics. Kris, please go ahead.

Kris Maly

Analyst

Thank you, Emily, and good morning, everyone. Welcome to Synthetic Biologics’ third quarter 2014 investor conference call. Today I’m joined by our CEO, Jeff Riley, and our CFO, Evan Ballantyne. Pre-market this morning, Synthetic Biologics issued a press release reporting its third quarter 2014 financials and summarizing recent operational highlights. That release can be found on the Investor section of our Web site. During our call today, Jeff will provide an update on our C. difficile, C-IBS and Pertussis programs and review upcoming milestones for the Phase 2 Trimesta program for the treatment of MS. Evan will then provide a brief overview of our financial statements for the three and nine months ended September 30, 2014. After the formal portion of the call, we will offer an opportunity for Q&A. In addition to the phone line, this call is being streamed live over the Internet and the webcast replay will be archived on our Web site for 30 days. During this call, we’ll 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 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 a 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 · Wells Fargo. Please go ahead

Thanks, Kris, and good morning, everyone and thanks for joining us this morning for our third quarter 2014 corporate update. Synthetic Biologics has had a very productive quarter across the board and I will go through everything here over the next 10, 15 minutes. We finalized clinical trial plans for our pathogen-specific programs, strengthened our IP initiated manufacturing programs, held a successful IBS Investor Day in New York, reported expanded data on the unique neuroprotective properties of our MS candidate and raise net proceeds of $18.9 million and registered direct offering to support our clinical development programs through key inflection points in 2015. A particular note is that roughly one half of the total capital raised was invested by new institutional investor, Great Point Partners, a strong and highly regarded biotech investment fund, an additional three existing investors participate in the remainder of the round. As capital infusions a clear vote of confidence from our new investor, as well as the investors that increase their existing positions. We appreciate the support from this group and from our ongoing shareholder base. And those of you on the call today who are new investors, let me welcome you and also take a moment to briefly review for everyone the business and scientific mission of Synthetic Biologics. We believe that Synthetic Biologics is at the forefront of assuring them a new class of pathogen-specific therapies were serious infections and diseases with a specific focus on protecting the microbiome. We are moving the needle of science beyond that probe into traditional antibiotics, whose broad use over the past 80 years has rendered many antibiotics of little value today, especially against increasingly aggressive pathogen so-called super bugs that daily defied the reference of current medicine. The stage is set where a major change in the…

Evan Ballantyne

Analyst

Thank you, Jeff, and thanks everybody for attending our call today. Synthetic Biologics third quarter 2014 financials were included in our press release, which were just distributed over the newswire earlier this morning. The company’s 10Q for the quarter ended September 30, 2014 will be filed at the SEC later today. Cash at September 30, 2014 was $3.3 million compared to $14.6 million at December 30, 2013. As Jeff mentioned earlier, we successfully completed our registered direct offering on October 16, with a select group of institutional investor from net proceeds of approximately $18.9 million. For the three and nine month ended September 30, 2014 our general and administrative expenses decreased to $1.2 million and $4.2 million. Included in these numbers were non-cash charges related to stock based compensation of $377,000 and $1.3 million for the three and nine months ended September 30, 2014. Research and development expenses increased to $3.7 million and $9.2 million for the three and nine months ended September 30, 2014. These increases of 150% and a 144% are primarily the results of increased program costs associated with expanded research, development and manufacturing activities within our pathogen specific pipeline including our C. diff, C-IBS and Pertussis programs. Non-cash charges related to stock based compensation were $232,000 and $550,000 for the three and nine month ended September 30, 2014. Jeff, I’d like to turn the call back to you.

Jeff Riley

Analyst · Wells Fargo. Please go ahead

Thanks a lot, Evan. To conclude my formal remarks today, I’m going to summarize each of our programs one more time. Each of our pathogen specific programs is on desk to enter the clinical produced top line data in the near-term. We plan to have two additional multi-billion dollar drugs in Phase 2 trials in the next six months. In addition to our Phase 2 MS drug candidate, which is also a potential multi-billion dollar opportunity. With our recent financing we have the capital to fund these programs through key clinical milestones next year. The clostridium difficile Phase 1a and 1b trials are on track to initiate this quarter. Top line Phase 1 results are expected to be released before year end. Let me remind you, there is currently no drug on the market or under development that we’re aware of designed to prevent versus treat C. diff infections. Annual addressable market is the approximately 118 million doses of SYN-004, susceptible IV beta-lactam antibiotics administered to hospital patients, suggesting a blockbuster drug opportunity. Our C-IBS program is expected to enter Phase 2 in the first half of next year following our IND submission early next year. Dr. Pimentel’s ground breaking work in IBS and his expertise in GI Motility provide great confidence in the clinical development of SYN-10 and its potential to significantly improve the lives of those suffering from C-IBS. Keep in mind we’re treating the underlying cause and not just the symptoms of that terrible disease. The mandates have developed an effective treatment for Pertussis, a whooping cough needs no further characterization and to remind you that up to 300,000 kids die from the disease each year. And the incidents as the Pertussis are increasing right here in our homeland. Preclinical testing of our synergistic antibody combination suggest a solution this quick or unmet need is close at hand. We’re hopeful that the U.S., Orphan Drug Designation at SYN-005 received from the FDA can accelerate development and further encourage funding sponsorship by one of the world healthcare organizations we mentioned earlier. Our MS program with Trimesta, we expect top line data from the Phase 2 MRI brain scans in the first quarter of the coming year. With this long awaited piece in place, we would expect to enter final negotiations with one or more groups we’re currently speaking with. We proceed with a Phase 3 program. Again to our knowledge, no other drug has demonstrated similar neuroprotective and cognitive benefits observed thus far in a Phase 2 trial. The enormous patient benefit not available for many MS drug and we expect it to drive significant value for Synthetic Biologics. At this time, I’ll turn it back over to Kris.

Kris Maly

Analyst

Thank you, Jeff. We’d like to open the lines up for questions now. Emily, would you please describe the procedure to ask questions for our listeners.

Operator

Operator

[Operator Instructions] Our first question is from Daryl Weber of Wells Fargo. Please go ahead.

Daryl Weber - Wells Fargo Advisors, LLC.

Analyst · Wells Fargo. Please go ahead

Good morning, gentlemen. So a couple of questions here; with respect to your Phase 1 and Phase 1a and Phase 1b for C. diff; how many patients are you anticipate enrolling? And the top line data you will be reporting by year end, now what would that entail? And will it be for all the patient cohort? Secondly considering your whooping cough program in your recent 8K filing slide presentation you guys stated that you’re looking for a third party funding, in fact you just mentioned briefly on your previous comments. Can you paint the picture of how that would be structured? And last with regard to the Intrexon partnership, there were a number of other disease indications you were going after, a few years ago. Can you kind of update us on how those programs are proceeding? Thank you.

Jeff Riley

Analyst · Wells Fargo. Please go ahead

Thanks for the questions, Daryl. To answer your first question the Phase 1a and 1b will be between 12 and 20 patients. We’re looking for safety in these, and obviously we’re doing a dose response as well. These are in normal patients and these are very, very quick studies. Really look and see what's happening in both genetically as well as PK/PD profiles of these patients. And as we said, we should have data from that by the end of this year. We’ll then be jumping directly into a Phase 2a study early next year and that will be, at the moment we’re looking at ileostomy patients to do that. Again this particular program similar to the IBS program, these studies are very quick, between one week and four weeks depending upon what we’re looking at from the dose response in efficacy perspective. So, we’re pretty excited about it. Standby for some data that will be coming out here shortly in press releases, and we’re hopeful that our current version of this drug will behave and we have no reason to think otherwise just like the drug a predecessor compound that went through successful Phase 2 trials in Europe. Your second question was on Pertussis. As we are looking at third party funding for this particular source, this isn’t -- Pertussis isn’t Intrexon related program. We’ve worked on this program together in combination with the University of Texas. We may fund it ourselves downstream, but right now we think that there is a significant amount of interest from non-governmental organizations and other groups that have an interest in moving this type of product into the developing world, mostly for infant use. The current product would be used as a prophylactic, but we do have evidence that it works as a therapeutic, basically the new born infant in the developing world. The mom and baby usually only see a doctor once and that’s usually at birth. So the idea would be to inoculate the baby with a Pertussis right at birth. We hope that we can show a vaccine like a defect on that child for six months or greater in which case that the infant then can receive a natural vaccine after that point in time. That’s the current thought process as well as developing that for a -- as a therapeutic as well.

Daryl Weber - Wells Fargo Advisors, LLC.

Analyst · Wells Fargo. Please go ahead

But with regard to the structure of that relationship, would that be a grant from -- The WHO or The World Health Organization or a Gates Foundation, or would there be some sort of economics involved?

Jeff Riley

Analyst · Wells Fargo. Please go ahead

It’s usually a grant, but it really depends on which organization. Gates Foundation tends to take a piece of the action, so they may want the international world as their piece of the equation or as we would keep the developed world U.S., Europe, Japan et cetera. It really depends on who you talk to Daryl specifically as to what the deal terms look like which obviously a fair number of grants available as well for that through the NIH and other, and The WHO which we are pursuing and those would just be your classic grant to move a product forward as rapidly as possible. Does that answer your question on Pertussis?

Daryl Weber - Wells Fargo Advisors, LLC.

Analyst · Wells Fargo. Please go ahead

Yes.

Jeff Riley

Analyst · Wells Fargo. Please go ahead

Okay. But the last question you had was with respect with Intrexon. We have two ongoing programs with Intrexon, and one that were -- is in its nascent stages. The Pertussis is the lead program we have, and that is now almost entirely in the clinical side of the equation. So that’s almost entirely within our bucket as Synthetic Biologics, though Intrexon’s clinical development team is adding input into that process as well. The second product which I didn’t talk about today is for a nasty, gram-negative bug called Acinetobacter baumannii. This is a discovery stage product, so that we’re still probably a good two years away from the clinic, and we are making pretty good progress. So we are seeking again a sniper like approach using the Intrexon heat technology to find monoclonal antibodies that target this particular gram-negative bacteria and Acinetobacter in particular is pretty gastro [ph] resistant. I think it’s like 46%, 47% resistant to all existing antibiotics. So there is a high demand for that particular program among the United States Military for a variety of reasons, mostly due to blast wounds. Soldier would get a wound [indiscernible] sand where these bugs would get into the wound. Soldier then gets a nasty infection and as we founded earlier we felt most of the antibiotics don’t work on that. There is a high interest from U.S. military again on that specific program. I didn’t highlight it today, because again it’s an early, early stage program. As soon as we get some antibodies, it look like we have some good in vitro, in vivo results. We’ll definitely bring that program to the forefront, and it’ll show folks what we’re doing there; very similar to the Pertussis program.

Daryl Weber - Wells Fargo Advisors, LLC.

Analyst · Wells Fargo. Please go ahead

Thank you.

Jeff Riley

Analyst · Wells Fargo. Please go ahead

You are welcome.

Operator

Operator

Thank you. I’d now like to turn the conference back over to Kris Maly for any closing remarks.

Kris Maly

Analyst

Thanks, Emily, and thanks everyone for joining us this morning. As we head towards the end the close of 2014, we certainly wish everyone a happy holiday season and we look forward to updating you again next quarter. Thank you so much.

Operator

Operator

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.