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Edited Transcript of SYN earnings conference call or presentation 8-Nov-18 9:30pm GMT

Q3 2018 Synthetic Biologics Inc Earnings Call

ANN ARBOR Dec 18, 2018 (Thomson StreetEvents) -- Edited Transcript of Synthetic Biologics Inc earnings conference call or presentation Thursday, November 8, 2018 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Steven A. Shallcross

Synthetic Biologics, Inc. - CEO, CFO, Treasurer, Corporate Secretary & Director

* Vince Wacher

* Vincent I. Perrone

Synthetic Biologics, Inc. - Director of Corporate Communication

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Conference Call Participants

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* James Francis Molloy

Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst

* Katherine Xu

William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research, Partner & Biotechnology Analyst

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Presentation

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Operator [1]

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Good afternoon, and welcome to the Synthetic Biologics 2018 Third Quarter Investor Conference Call. (Operator Instructions) Please note, this event is being recorded. At this time, I would like to turn the conference over to Vincent Perrone, Director, Corporate Communications at Synthetic Biologics. Vincent?

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Vincent I. Perrone, Synthetic Biologics, Inc. - Director of Corporate Communication [2]

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Thank you, Keith, and good afternoon, everyone. welcome to Synthetic Biologics 2018 Third Quarter Investor Conference Call.

Today, I am joined by our acting CEO and CFO, Steven Shallcross; Dr. Michael Kaleko, Senior Vice President, Research and Development; and Dr. Vince Wacher, Product Development and Partnering.

Synthetic Biologics issued a press release this afternoon, which provided operational highlights and reported our financial results for the period ending September 30, 2018. The release can be found in the Investors section of our website. During our call today, we'll 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 this phone line, this call is being streamed live via webcast, which will be archived on our website, 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 terminologies 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 events. 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?

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Steven A. Shallcross, Synthetic Biologics, Inc. - CEO, CFO, Treasurer, Corporate Secretary & Director [3]

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Thanks, Vincent. Good afternoon, and thank you for joining us today. I will be spending most of today's call providing important and exciting updates on our planned advancement of our late-stage and emerging clinical programs. But I want to begin by discussing the recent steps we have taken to further fortify our organization's financial footing and why we chose to undertake them.

As you know, last month, we announced the closing of our underwritten public offering of over $18 million, which will be used in part to fund the advancement of our late-stage clinical assets. Beginning in the third quarter, we were also able to utilize our at-the-market or ATM facility to raise an additional $11.8 million in net proceeds. With these proceeds, we have cash on hand of approximately $32 million, which has substantially strengthened our financial position and provides us with runway to continue our operations into 2020.

I have clearly heard and truly appreciate the concerns raised by some of our long-term investors about our decision to undertake this financing and the impact it has had on them. But let me assure you, it was an essential step in ensuring that we can bring the promise of these assets to reality. Quite frankly, it was also critical in ensuring the long-term sustainability and survivability of our organization.

Our recent offering goes a long way in removing the significant financing overhang that has been gripping our stock. At the same time, it has enabled us to bring on-board well known fundamental investors, who believe in our programs and who may help reduce the volatility we've experienced with our stock during the last 2 years.

Having said that, we are still very much the belief that there remains a serious disconnect between perceived value of the company and the potential value of our product portfolio as evidenced by the fact that our stock is currently trading significantly below cash. As a matter of fact, after one takes into account the number of common and common equivalent shares outstanding following our offering, we are trading approximately $12 million below cash today. Just as importantly, the funding provides us with the resource to continue to advance our clinical assets independent of an immediate partnership, ideally unlocking value, decreasing risk and improving potential downstream commercial opportunities.

Furthermore, we now believe we have a clear path forward and the financial stability to move SYN-004 and SYN-010 back into the clinic and to advance SYN-020, an important and significant preclinical assets to an IND filing by the end of next year.

All of these activities are geared toward growing the body of clinical evidence in support of moving our assets closer to commercialization and doing so in a manner that creates long-term value and potentially a more compelling investment opportunity for interested parties.

Let me explain in a bit more detail the rationale behind our current development strategy. Over the course of many interactions with different companies and potential investors worldwide, we've received feedback that has been impartial and forthright and, importantly, has helped define the product development strategies I will highlight today.

Frankly, the primary challenge for partnering both SYN-004 and SYN-010 has been the large size and cost of the Phase III clinical programs required for approval. This has impacted perceptions of both potential risk and value.

First, in the case of SYN-010, the constipation in IBS-C marketplace is viewed as crowded and with products that have largely the same therapeutic mode of action. However, there is also a recognized need for novel approaches like SYN-010 to treat constipation and IBS-C. It has been made clear to us that we need more definitive clinical data that clearly differentiates SYN-010 in order for potential partners to take on the financial risk of a Phase III program. As you know, we have taken steps in the form of our expanded collaboration with Cedars-Sinai to address this concern. On a very positive note, our ability to manufacture SYN-010 in a very cost-effective manner has proven very compelling in partnering discussions, potentially facilitating market access in a competitive landscape.

Second, a comprehensive body of evidence has established that the cost of CDI to patients, healthcare providers, and the community is devastating. Even with this backdrop, SYN-004 faces a challenge implicit to all preventative agents in that the incident of the actual disease, in this case, CDI, is low and the product will be administered to a broad range of patients who might never have contracted CDI at all. This mandates large trials in order to establish both efficacy and safety in broad patient populations.

Despite the potential therapeutic value of SYN-004, the perceived low incidence of CDI and the nominal availability of potentially "cheap" CDI treatments have so far proven a persistent challenge in attracting partners to fund the high cost of a SYN-004 clinical development program in this broad indication. With this feedback in mind, we have identified a pathway, which we believe will help us bridge the gap that exists between the true value of our assets and how they are currently perceived by the markets. I will now walk you through that pathway.

I'll begin with SYN-004 ribaxamase, our first-in-class therapeutic intervention designed to protect the gut microbiome from antibiotic-mediated dysbiosis.

Ribaxamase is designed to be taken in conjunction with certain IV beta-lactam antibiotics. Its novel mechanism of action is to degrade residual antibiotic excreted into the GI tract before it can disrupt the natural balance of the gut microbiome. It has been well established that the prolonged used of antibiotics significantly increases the risk of developing gastrointestinal infections like CDI as well as the emergence and spread of antimicrobial resistant genes. In advancing ribaxamase, we have focused on preventing the onset of primary C. difficile infection in patients treated with IV beta-lactam antibiotics. More than 7.5 billion doses of IV beta-lactams are administered worldwide each year, and damage to the gut microbiome by these antibiotics is well established -- is a well-established risk factor for developing CDI.

During the third quarter we held an End of Phase II meeting with the FDA to solidify the remaining elements of a Phase III clinical program for ribaxamase in this broad indication. Having a clear path forward to advance ribaxamase and being in possession of firm details on trial endpoints, patient enrollment size and costs will be highly beneficial in our ongoing partnering discussions.

Based on our previous interactions, as well as the official guidance we expect to receive in the next week or 2 from the FDA in response to our End of Phase II meeting, we believe the cost of this broad indication Phase III trial is not feasible for us to undertake at this time without a partner, given the capital constraints tied to our current market cap and share price.

We intend to continue to pursue potential pharmaceutical partnering relationships in order to advance ribaxamase in this broader indication. However, as noted above, interested parties have so far proven reluctant to commit to the large Phase III clinical program in this indication. With that said, we do not want to lose clinical momentum, and we believe there's a valuable opportunity for us to advance SYN-004 in a more specialized patient population with multiple potential disease endpoints associated with the gut microbiome damage, including higher rates of beta-lactam-induced CDI. We anticipate that targeting such a patient population would enable us to advance ribaxamase in a more cost-effective manner via smaller and more focused clinical trials. It will also provide us with an expanded set of data, which could further validate and support ribaxamase's advancement as a potential means of preventing CDI in a broader IV beta-lactam treated population.

We are excited about this potential pathway forward for ribaxamase and are currently in the process of evaluating and refining this narrow indication concept with key opinion leaders and potential pharma partners. So far, there's been great receptiveness to this idea, and a belief that pursuing a more narrow indication for ribaxamase would help overcome the financial and clinical development risk concerns that have been expressed by several interested parties.

In evaluating potential narrow indications, we have identified bone marrow transplantations, more specifically, allogeneic hematopoietic cell transplantation, or HCT recipients as a potential ideal patient population that may benefit from SYN-004 use. 80% to 90% of the allogeneic HCT patients are treated with long courses of IV beta-lactam antibiotics, with treatments typically lasting weeks, not days. The CDI rates in this population average above a staggering 31%. While this high CDI rate led us to consider HCT recipients, our discussions with KOLs and a thorough review of the literature found that there is also a striking association between reduced microbiome diversity due to IV beta-lactam antibiotics and acute graft-versus-host disease or AGVHD in this population.

Notably, AGVHD occurs in 40% to 60% of allogeneic HCT recipients. First-line AGVHD therapies fail in more than 50% of the patients and results in very poor overall survival. The need for a novel therapy to prevent AGVHD and allogeneic HCT recipients could not be more clearer. An additional endpoint that may also be of benefit is the reduction of colonization by vancomycin-resistant enterococcus, or VRE, which confers a nine-fold increased risk of potentially fatal VRE bacteremia in these patients. AGVHD, VRE colonization and CDI, thus comprise 3 comparably high-incident and potentially fatal clinical outcomes in allogeneic HCT recipients, all of which are associated with gut microbiome damage by IV beta-lactam antibiotics and could potentially be reduced or prevented by SYN-004.

Based on this compelling scientific and clinical rationale, we are in the process of evaluating the potential regulatory framework required to pursue an additional indication for ribaxamase for the prevention of AGVHD in HCT recipients. Reductions in CDI and VRE colonization would be key secondary endpoints in this program. We believe this program would initially entail conducting a small Phase I/II study, which would evaluate ribaxamase as pharmacokinetics, safety and microbiome protection profiles in allogeneic HCT recipients and could begin -- we could begin enrollments as early as the second half of next year.

Importantly, we anticipate the total cost for the development pathway for ribaxamase in this indication, including a potential Phase III trial, to be approximately 1/3 of the cost of the current broad indication, a far more appropriate and viable investment for our company at this time. We are excited about this potential path forward for ribaxamase and expect to be in a position to share additional details about this program in the first half of 2019.

To reiterate, our pursuit of this indication would be in tandem with and ultimately support of our advancement of ribaxamase in the broader indication for the prevention of CDI. However, we believe we may be in a position where we could feasibly move this program forward in the specialty patient population on our own. Importantly, we expect both the broad and narrow indications to have similar timelines for marketing approval.

Moving on to SYN-010, our proprietary modified-release formulation of lovastatin lactone. SYN-010 is designed to reduce methane production in the GI tract. It is a stark contrast to the current standards of care to actually treat the underlying cause of the symptoms often experienced with irritable bowel syndrome with constipation.

In September, we were excited to announce the expansion of our relationship with Cedars-Sinai Medical Center in the form of an agreement to co-fund an investigator-sponsored Phase IIb clinical study to further evaluate the efficacy and safety of SYN-010. This study will be led by the prestigious Pimentel Laboratory at Cedars-Sinai. The study will be a 12-week randomized placebo-controlled trial, evaluating 2 dose strengths of SYN-010 in approximately 150 patients diagnosed with IBS-C. This trial is designed to address specific queries about dose response and length of treatment that led to the design of the Phase IIb/III adaptive design clinical program agreed with the FDA last year. Importantly, by partnering with Cedars-Sinai, we will be able to generate the meaningful data necessary to continue SYN-010's advancement at a significantly lower cost than if we were to proceed on our own. Equally as critical, we believe that positive data from this study may permit us to choose a single SYN-010 dose strength for our Phase III clinical trials. This may enable us to design a revised Phase III clinical trial program, with the reduced overall number of patients at a significantly lower clinical development cost.

We expect enrollment in the Phase IIb trial to commence before the end of this year or very early in Q1 of next year. And we anticipate having data readout from this trial to share in the second half of 2019. We believe that the successful completion of this trial will allow us to reopen discussions with prospective partners, who found the phase IIa data compelling but not conclusive enough to justify the significant capital investment required to complete the clinical trials required for registration.

While we move forward with our later-stage assets, ribaxamase and SYN-010, we are also continuing to drive new value from our microbiome-focused R&D engine. One of the most promising preclinical assets is SYN-020, an oral form of intestinal alkaline phosphatase, or IAP. IAP is an endogenous enzyme expressed in the upper small intestine that plays a role in maintaining GI homeostasis and promoting a healthy gut microbiome. IAP has several key functions, 2 of which are to detoxify the GI inflammation mediators and to diminish so-called leaky gut. Through these activities, oral delivery of IAP has the potential to treat both local and GI systemic disorders.

Despite its broad therapeutic potential, the development of IAP as an oral drug has been hindered by manufacturing hurdles, which has led to currently commercially available IAP cost of $10,000 per gram. We have overcome these hurdles and now have the ability to produce 3 grams per liter of IAP for roughly a few hundred dollars, a true game-changer for us. We are currently planning to pursue clinical trials for SYN-020 and have identified 3 novel indications with unmet medical needs, which span a range of market sizes.

These 3 indications are the following: enterocolitis associated with radiation therapy for cancer, enterocolitis associated with checkpoint inhibitor therapy for cancer, and microscopic colitis. We intend to move forward with an IND filing for one of these indications to be identified based on further preclinical research in the fourth quarter of 2019. We have every confidence we will be able to do so with a small and appropriate capital commitment.

I believe our strategies creatively and aggressively advance both our late-stage and early-stage clinical assets in the ways that have the potential to drive significant value for our company and our investors, change the way our assets are perceived and valued and, frankly, to definitively untether ourselves from some of the missteps of our past. With that backdrop, I will review our financial results for the third quarter.

As I mentioned earlier, the completion of our public offering and the proceeds raised from our ATM facility beginning in the third quarter significantly strengthens our balance sheet and provides the financial resources for us to continue to execute against our planned clinical activities and value-driving milestones.

As I previously stated, we will continue to operate in an efficient manner as financial stewardship and cash management remains a top priority for us.

Now the details for the quarter. General and administrative expenses decreased 12% to $1.5 million for the 3 months ended September 30, 2018, compared to $1.7 million for the same period in 2017. This decrease is primarily the result of lower salary expense, stock-based compensation and related benefit costs incurred during the 3 months ended September 30, 2018, as compared to the 3 months ended September 30, 2017, and due to the resignation of the prior CEO, along with the reduction of travel and consulting expenses, offset by higher registration, Investor Relations and legal costs.

The charge related to stock-based compensation expense was $186,000 for the 3 months ended September 30, 2018, compared to $583,000 for the 3 months ended September 30, 2017. Research and Development expenses decreased by 32% to $2.8 million for the 3 months ended September 30 2018 compared to $4.1 million for the same period in 2017. This decrease is primarily the result of lower SYN-004 and SYN-010 program costs for the 3 months ended September 30, 2018, since no clinical trials were ongoing during the quarter.

The research and development cost incurred during the quarter were primarily related to planning for future Phase III SYN-004 and Phase IIb/III SYN-010 clinical programs as we sought to secure the financial resources necessary for the advancement of these clinical trials. The charge related to stock-based compensation was $289,000 for the 3 months ended September 30, 2018, compared to $317,000 for the 3 months ended September 30, 2017. Other income was $631,000 for the 3 months ended September 30, 2018, compared to other expense of $5.1 million for the 3 months ended September 30, 2017. Other income for the 3 months ended September 30, 2018 is primarily comprised of noncash income of $626,000 from the changed fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price from the prior quarter.

Cash and cash equivalents as of September 30, 2018, totaled $9.5 million. However, this figure does not include the $18.6 million in gross proceeds raised from our public offering or the $5.8 million in net proceeds raised from the utilization of our ATM facility, beginning in October. As of the date of this call, our cash position is approximately $32 million, providing us with a substantial runway to continue our operations into 2020.

In closing, I'd like to thank each of you for joining the call today. As I hope I have conveyed clearly in the remarks, we are embarking on an exciting new direction for Synthetic Biologics, which should allow us to unlock and showcase the value of our clinical assets in a practical and financially responsible manner. I and the entire team at Synthetic Biologics are focused on executing on the clear and achievable milestones and value drivers we have established as a part of this pathway. We will continue to look for every opportunity to build long-term value for our shareholders and reward the continued confidence and support you've given us.

We look forward to continuing to update you on our progress in the weeks and months ahead. And now, I'll turn the call back over to Vincent.

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Vincent I. Perrone, Synthetic Biologics, Inc. - Director of Corporate Communication [4]

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Thank you, Steve. Keith, we'd like to open up the phone line to questions. Can you please describe the procedure to ask questions for our listeners?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And the first question comes from Katherine Xu with William Blair.

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Katherine Xu, William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research, Partner & Biotechnology Analyst [2]

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Steve, I'm just wondering, with regards to the sort of new direction to take Syn-004, the allogeneic transplant market. Can you just talk a little bit more about the size of the market and how many patients are actually taking the IV beta-lactam antibiotics? And also, from a pricing perspective, this could be a premium pricing market versus the broader indication that could be much lower in pricing. So just curious about the source there? And also for the China partnership, can you give some update on that?

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Steven A. Shallcross, Synthetic Biologics, Inc. - CEO, CFO, Treasurer, Corporate Secretary & Director [3]

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Okay. So you raised a very good point on pricing power in this more narrow indication. As a matter of fact, we think we also have the opportunity to possibly apply for orphan status. So along with that, obviously, would come significant pricing power. Let me let Vince Wacher talk a little about the market, and then I could follow up with what we're seeing in our China discussions.

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Vince Wacher, [4]

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Thanks, Steve. The overall number of allogeneic transplants in the U.S. is significantly lower than CDI cases, as you can imagine. It's about, I think, 10,000 per year so far in the U.S., allogeneic HCT procedures and although, as Steve indicated before, there'll be very few people that did not get the IV beta-lactams. It's a standard therapy to treat people for febrile neutropenia or once in the allogeneic HCT population. So 80% to 90% of those people would be eligible to receive our drug in the U.S. The numbers would be similar in Europe and somewhat lower in China. But as pointed out, the potential pricing power a significant, and that's because of the outcomes because the GVHD is so prevalent, because the primary therapy for GVHD, which is steroids, fails more than 50% of the time. Prevention is everything, and that indication is no to excuse to not try and prevent GVHD. So the smaller numbers would balance out with the higher pricing power. And then moving forward into the broader indication, leveraging the data from that study, we could then, post-market, on the HCT side, have off-label use Phase II studies, expanded Phase IV studies in the broader CDI population and look to leverage the higher price from the bone marrow transplant to get an increase in either the diagnoses-related group payments for the CDI or maybe a new technology add-on payment for the ribaxamase in the CDI populations. So there are opportunities to elicit the appropriate payment for the product in the bigger indication at the higher price. But, again, that's all right now hypothetical, we've got to get through our clinical trials first.

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Steven A. Shallcross, Synthetic Biologics, Inc. - CEO, CFO, Treasurer, Corporate Secretary & Director [5]

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So then, Katherine, to answer to your question about China. Our discussions continue. We have a number of parties that remain engaged and interested. We continue to have various degrees of diligence, and we are having discussion with folks about how to possibly proceed into the clinic. I'll be honest, though, and I could tell you that we've also experienced that since the Chinese market, particularly the biotech market there since it's taken a hit. And some of the value in these companies that are public have seen the value eroded that it is -- put some of them on their heels. We don't think, over time, this is going to be an issue as we continue to try to move the ball forward. But it is an issue. And again, as I said before, I'm not going to talk any further about where we stand in terms of status. And when we have something more definitive to talk about, obviously, we'll make the disclosure at that time.

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Operator [6]

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(Operator Instructions) And the next question comes from Jim Malloy with AGP.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [7]

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I had a quick question on the HCT indication. Obviously, a thin edge of the wedge to sort of get some data rather than have to pay for the much larger study. How much would data from that study inform any potential FDA approvals for the larger study, should you get a partnership and get that up and running? Is that something that can be used adjunctively with the larger study to sort of show, hey, we can get this through the FDA. Look at the small study, it's going to work and it should apply to the larger study.

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Steven A. Shallcross, Synthetic Biologics, Inc. - CEO, CFO, Treasurer, Corporate Secretary & Director [8]

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Vince, why don't you go ahead?

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Vince Wacher, [9]

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So I think inform is the right word. I think it informs on a number of levels we can use safety data. We would definitely anticipate using pharmacokinetic data from that study. One of the things about the bone marrow transplant population is that they have somewhat permeable intestines. And so if we demonstrate that our drug is not absorbed in that population and it doesn't alter pharmacokinetics of the intravenous antibiotics, then that data will be extremely beneficial since that sort of question comes up with the FDA, can we be sure that the drug is not absorbed in a sick population? If we see an effect on the VRE, if we see an effect on the CDI in our studies, that is all submissible to the FDA as part of our overall data package to show hints of efficacy and also safety. So I think it contributes to that, but it wouldn't necessarily be considered a subgroup that we could discount the larger study based on that. It may advise our dosing, but we couldn't say, ok we've done 200 patients here, we have to do 200 less than the big indications.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [10]

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Got it. And then could you talk a little bit about the timing of the HCT study? I know that a lot of work has been done. But second half next year seems like -- is that allowing too much time? Obviously, you put it there for a reason. But can you talk a little bit about why it's going to be second half next year?

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Steven A. Shallcross, Synthetic Biologics, Inc. - CEO, CFO, Treasurer, Corporate Secretary & Director [11]

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Go ahead, Vince.

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Vince Wacher, [12]

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So this population, as you can imagine, is quite sensitive. They're quite ill. These are people that are going to be treated with chemotherapy to wipe out their immune systems before they get the bone marrow transplant and before they get the antibiotics. So we have to move with a great degree of caution in this population, and that's reflected in the different institutions. And some of our early conversations have highlighted that there are a number of levels of approval within any given institution, as many as 5 in some of them. So we have to move with some degree of caution with this. We also have to have our first discussions with the FDA about this indication. We've not approached the FDA yet, and devising a protocol, organizing a pre-IND meeting, those are key near-term elements that have their own timelines. As you know, the FDA has a certain set of timing to set these meetings up. But beyond that, I think, really, the length of time will be driven more by the institutions and their need to be sure that they're taking the appropriate care with their patients.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [13]

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My last question, then. On the 020, Dr. Pimentel's study -- Pimentel's Lab study, that's a pretty quick turnaround. From starting it to getting the data by the second half next year. Obviously, Dr. Pimentel's Lab does quite a [bit of this]. If you could talk a little bit about the sort of excitement level on this compound, and getting this trial up and running?

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Steven A. Shallcross, Synthetic Biologics, Inc. - CEO, CFO, Treasurer, Corporate Secretary & Director [14]

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You mean Syn-010. Yes, go ahead, Vince.

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Vince Wacher, [15]

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So this is SYN-010, our lovastatin program. You're quite right. There is a great deal of excitement, and lot of this has to do with the fact that Cedars-Sinai has such a comprehensive GI presence, but also has really specialized in functional gastrointestinal disorders like IBS. And so Mark and the Cedars-Sinai team, he's the person that will actually be executing the study. Ruchi Mathur is the head of the MAST Program; and Ali Rezaie, who's also well known probably for the breath gas analysis. This is a team that sees a lot of patients. They have advised them that the patients are well educated about gas, about methane, and they have been prompting, they've been saying, once we get studies, would you be available, are you interested? And so people know that SYN-010 is in the works. And now they have something concrete to hold onto. So they've projected that they can enroll the kinds of patients in the kind of timeframe that we've anticipated, and we look forward to seeing that -- those results happen ideally in the timeframe that we've discussed.

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Operator [16]

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I would now like to turn the conference back over to Steve Shallcross for any closing remarks.

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Steven A. Shallcross, Synthetic Biologics, Inc. - CEO, CFO, Treasurer, Corporate Secretary & Director [17]

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Great. Thanks, Keith. Well, before we end today's call, I just want to make a couple of final comments here. First and foremost, thank you again for your support and believing in the assets that we currently have under development. These assets are great. And more importantly, as we move them back into the clinic, something that often gets left on the sideline, when you think about biotechs, is that we have, what I'll refer to as multiple shots on goal that significantly reduce the risk as we move back to the clinic to develop these programs that we've outlined for you today. The other point I hope we made clear for you is that we're taking a very strategic and thoughtful approach toward unlocking the value of the assets that we own. And we believe that not only have we taken this approach that makes the most sense for a company our size. We've taken steps to make sure we can maximize our ROI with the appropriate degree of clinical development risk that one would expect with the investment that we're trying to make.

Finally, I just want to highlight once again the serious disconnect that we believe that exists between the perceived value of the company and the potential value that we can unlock through our product portfolio. We, again, are trading significantly below cash, and we are going to do everything we can to continue to reach out to new and existing investors so that we can fix this. We've laid out a number of short-term and long-term milestones so that we can identify the key inflection and value-creating points over the next 12 to 18 months that each of our investors should be able to benefit from. But more importantly, we have the cash to support these programs into 2020. And finally, you have the commitment from me and our team that we will do whatever it takes, and we will remain focused on execution and, ultimately, delivering results.

Thanks again, and we look forward to keeping you updated on our progress as we move our lead programs back into the clinic, and move our SYN-020 program further down the path toward an IND. Thanks again, and have a great weekend.

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Operator [18]

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The conference has now concluded. Thank you for attending today's presentation, you may now disconnect your lines.