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Edited Transcript of SYN earnings conference call or presentation 8-Aug-19 8:30pm GMT

Q2 2019 Synthetic Biologics Inc Earnings Call

ANN ARBOR Sep 2, 2019 (Thomson StreetEvents) -- Edited Transcript of Synthetic Biologics Inc earnings conference call or presentation Thursday, August 8, 2019 at 8:30:00pm 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

Synthetic Biologics, Inc. - Head of Product and Corporate Development

* 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

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Presentation

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Operator [1]

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Good afternoon, and welcome to Synthetic Biologics' 2019 Second Quarter Investor Conference Call. (Operator Instructions) Please note, this event is being recorded. At this time, I would like to turn the call over to Vincent Perrone, Director Corporate Communication 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, Denise, and good afternoon, everyone. Welcome to Synthetic Biologics' 2019 Second Quarter Investor Conference Call. Today, I am joined by our Chief Executive and Financial Officer; Steven Shallcross; Dr. Michael Kaleko, Senior Vice President of Research and Development; and Dr. Vince Wacher, Head of Product and Corporate Development.

Synthetic Biologics issued a press release this afternoon, which provided operational highlights and reported our financial results for the quarter ending June 30, 2019. The release can be found on the Investor Relations section of our website.

During our call today, we'll provide an operational update on our GI and 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 via a 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 terminology such as may, should, expects, anticipates, intends, plans, believes and estimate 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?

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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, everyone, and thank you for joining our 2019 second quarter investor conference call. The last several months have been a period of careful plan and execution for Synthetic Biologics, as we continue to strategically position and advance our portfolio of clinical programs, targeting critical and unmet needs in the prevention of life-threatening GI and microbiome-related disorders.

Of particular note, this afternoon, we're delighted to announce the clinical trial collaboration with the Washington University School of Medicine to conduct the Phase Ib/IIa clinical trial of SYN-004, or ribaxamase, in up to 36 adult allogeneic hematopoietic cell transplant recipient.

Enrollment remains ongoing in our Phase IIb investigator-sponsored clinical trial of SYN-010, which is being conducted by Cedars-Sinai Medical Center, the study's sponsor. And we completed a very productive pre-IND meeting with the FDA for SYN-020, where we clarified the parameters for an IND-enabled toxicology studies and manufacturing requirement. Importantly, these initiatives and other activities were conducted under our continued sharp focus on prudent cash management and financial stewardship, which has enabled us to further extend our cash runway through at least the third quarter of 2020.

With that backdrop, I'd like to share a more detailed update on our product portfolio, starting with our SYN-004, or ribaxamase, program.

SYN-004 is 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 antibiotic. Its novel mechanism of action involves degrading residual antibiotic excreted into the GI track before it could disrupt the natural balance of the gut microbiome. It has been well-established that the prolonged use of antibiotics significantly increases the risk of developing gastrointestinal infections like CDI as well as the emergence and spread of antimicrobial resistant gene. We previously outlined potential approaches for a regulatory pathway through which we could advance ribaxamase in a more focused specialized patient population where preservation of the gut microbiome is an established factor in positive clinical outcomes. And importantly, where the cost of such a development pathway are far less onerous than our FDA-agreed Phase III clinical program for the prevention of CDI. With that in mind, we've identified cancer patients who undergo allogeneic hematopoietic cell transplantation, commonly called bone marrow transplantation, as a population for whom ribaxamase may provide a substantial therapeutic benefit. Earlier today, we were very excited to announce the clinical trial agreement with the Washington University School of Medicine to conduct a Phase Ib/IIa clinical trial of ribaxamase in adult allogeneic HCT recipient. Trial enrollment is expected to begin in the first quarter of 2020, contingent upon approval of the clinical study protocol by the Washington University School of Medicine's Institutional Review Board, or IRB, and the FDA. The announcement of this clinical trial agreement is an important step in the validation of our pursuit of an economically viable development strategy for ribaxamase in a more specialized patient population and will add to the already well-established clinical data set for our SYN-004 program.

Coadministered -- coadministration of SYN-004 to degrade IV beta-lactam antibiotics excreted into the GI track and prevent dysbiosis of the gut microbiome has the potential to significantly improve outcomes for patients who undergo allogeneic HCT, an area of significant unmet medical need. Allogeneic HCT recipients routinely receive long courses of IV beta-lactam antibiotics to treat neutropenic fever, which occurs in 80% to 90% of these patients. Damage to the gut microbiome caused by IV beta-lactam antibiotics is also strongly associated with a number of potentially fatal adverse outcomes in allogeneic HCT recipients, most notably acute graft-versus-host-disease, or aGVHD; VRE colonization; bacteremia; and CDI.

The high incidence and severe outcomes of aGVHD, VRE and CDI brings into sharp focus the futility and toll of waiting to treat these problems until they arrive. The message is very clear. Prevention is absolutely critical. The proposed Phase Ib/IIa study announced today comprises a single center, randomized, double-blind, placebo-controlled clinical trial in up to 36 adult allogeneic HCT recipient.

Under the terms of this agreement, Synthetic Biologics will serve as the sponsor of the study and will supply SYN-004 to Washington University. The goal of the proposed study is to evaluate the safety and tolerability of 150-milligram oral dose of SYN-004 administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever.

Previously completed clinical trials in healthy volunteers and patients with lower respiratory tract infection showed that SYN-004 remains in the GI track and is not absorbed into the systemic circulation. The present study seeks to demonstrate that this is also true in patients with impaired intestinal barrier function. Participants in the proposed study will be enrolled into 3 sequential cohorts that will be administered a different study assigned IV beta-lactam antibiotic. 8 participants in each cohort will receive SYN-004, and 4 will receive placebo. Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee, which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic. The proposed study will also evaluate the potential protective effects of SYN-004 on the gut microbiome as well as generate preliminary information of potential therapeutic benefit and patient outcomes of SYN-004 in allogeneic HCT recipients.

Dr. Erik Dubberke, Professor of Medicine and Clinical Director of Transplant Infectious Diseases at Washington University and a member of our SYN-004 Steering Committee, will serve as the principal investigator of the trial in collaboration with his Washington University Colleague, Dr. Mark Schroeder, Associate Professor of Medicine of the Division of Oncology, Bone Marrow Transplantation and Leukemia.

Washington University and their clinical team are an ideal partner for us in this proposed study, and our collaboration will create valuable opportunities, while also expanding our footprint within the cancer research committee.

Not only are Dr. Dubberke and Dr. Schroeder luminaries in their respective fields of research but both are affiliated with the Siteman Cancer Center, a nationally recognized and NCI-designated cancer center as well as the largest cancer center program in the Midwest. Furthermore, the Washington University School of Medicine and its affiliate, Barnes-Jewish Hospital, are recognized as leading experts in the field of allogeneic HCT or bone marrow transplantation, ranking among the top 5 bone marrow transplant centers nationally in terms of volume. We are thrilled to enter this collaboration with Washington University and look forward to updating you on our progress.

Switching gears now, I'd like to provide a brief update on our SYN-010 program. Unlike currently approved and marketed therapies for IBS-C, which provide temporary relief to patients by targeting the symptoms of the disease, often at a cost of significant adverse side effect, SYN-010 is designed to target and treat an underlying cause of this disease. A growing body of clinical evidence continues to support the theory that excess methane production in the GI tract caused by the organism M. smithii may be a primary causative factor of IBS-C.

SYN-010's unique mechanism of action is intended to target M. smithii inhibit and inhibit its ability to produce excessive amounts of methane without eradicating the microorganism from the GI tract. This is intended to treat the cause of the IBS-C symptoms without the negative side effects of diarrhea and nausea, which are often associated with over-the-counter and prescription therapies.

SYN-010 is designed to be a chronic treatment, is intended to normalize bowel movements over time, and importantly, reduce the abdominal pain and bloating often experienced as a result of this disease state.

Last year, we announced 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. The financial commitment to this clinical trial by Cedars-Sinai demonstrate their firm belief in the SYN-010 program.

Moreover, this partnership has enabled us to allocate a majority of our financial resources to advance our SYN-004 and SYN-020 programs. Consistent with the FDA's guidance for investigator-sponsored studies, we are providing Cedars-Sinai with SYN-010 study drug, and Cedars is responsible for the design and execution of the study protocol, patient enrollment and management of clinical data.

This study is being led and conducted by the distinguished team of Medically Associated Science and Technology, MAST, program at Cedars-Sinai and is a 12-week randomized, placebo-controlled trial, evaluating 2 doses -- evaluating 2-dose strength of SYN-010 in patients diagnosed with IBS-C.

Additionally, this trial is designed to address specific queries about dose response and length of treatment that lead to the design of -- that led to the design of the Phase IIb/III adaptive design clinical program agreed to with the FDA last year.

Importantly, by partnering with Cedars-Sinai, we expect to generate the data needed to address specific questions again about dose response and length of treatment to potentially continue SYN-010's advancement into Phase III clinical trials at a significantly lower cost.

Interest from prospective study participants has been robust. And at this time, enrollment remains ongoing. The team at Cedars-Sinai MAST have made direct outreach contact to almost 600 IBS-C patients and prescreened nearly 350 potential study participants. Even with this tremendous effort, the clinical team at Cedars-Sinai has determined that additional time is needed to achieve our enrollment requirement due to higher-than-anticipated screen fail rates for patients. This is, in part, due to errant laxative used by patients during the screening period that adversely impacts baseline measurements of IBS-C symptoms and breath-methane levels.

Reliable baseline parameters are critical to obtaining high-quality data from all IBS-C clinical trials. This requires rigorous screening criteria, which can be challenging for some IBS-C patients who are concerned about foregoing their current interventions for extended periods of time.

After consulting with Cedars-Sinai, we are in agreement that our objective remains to generate a comprehensive and meaningful data set that maybe permit us to choose a single SYN-010 dose strength for future Phase III clinical trial. This may further enable us to design a revised Phase III clinical program with a reduced overall number of patients and a significantly lower clinical development cost.

I'd also like to reemphasize that positive results from this trial may allow us to reengage 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 for product registration.

As a result of the unanticipated and inadvertent patient-related screening challenges and in order to ensure the generation of a meaningful data set of the highest quality, we are discussing with Cedars-Sinai the opportunity for a data readout in the first half of 2020, extending our previous guidance from the fourth quarter of 2019.

We will continue to update you on our progress of this trial in the next coming months.

Before I review our financial results for the second quarter, I'd like to share a brief update on one of our more promising early-stage asset, SYN-020.

SYN-020 is an oral form of intestinal alkaline phosphatase, or IAP. IAP is an endogenous enzyme expressed in the upper small intestine that plays an important role in reducing GI inflammation, tightening the gut barrier and promoting a healthy gut microbiome. Through these activities, oral delivery of IAP has the potential to treat both local and GI systemic disorders.

Despite its broad therapeutic potential, industry development of IAP as an oral drug has been hindered by manufacturing hurdles, which has led to currently commercially available IAP costs of up to $10,000 per gram. We believe we have overcome these hurdles and now have the ability to produce more than 3 grams per liter of IAP for roughly a few hundred dollars a gram, something that we believe is a true game changer.

We've identified and are currently pursuing a clinical indication for the treatment and prevention of radiation enteropathy, secondary to cancer therapy, as a potential novel indication with a large unmet medical need.

As part of the SYN-020 nonclinical package, we evaluated SYN-020 in conjunction with 5-fluorouracil, or 5-FU, in an exploratory mouse ectopic colon cancer model. 5-FU is a chemotherapy drug commonly used to treat different cancers, including stomach and GI-related cancers.

The purpose of our initial exploratory study was to show that oral administration of SYN-020 does not alter the effectiveness of these cancer therapeutics. As expected, SYN-020 did not diminish anticancer efficacy with either radiation or 5-FU. Interestingly, very preliminary data suggest that SYN-020 may have actually improved the outcome with 5-FU in this mouse model.

We're in the process of conducting a confirmatory study with larger cohort sizes and additional mechanistic end points, which, if repeated, may allow us to potentially broaden the clinical development strategy for this program.

During the second quarter, we took part in a very productive and informative pre-IND meeting with the FDA for SYN-020. The outcome from our discussions was encouraging and allowed us to clarify the parameters for IND-enabling toxicology studies and manufacturing requirements.

The IND-enabling toxicology studies and assay development are underway with their expected completion during the fourth quarter, likely pushing our IND filing into the first quarter of 2020.

We are very excited about this program and its potential to be a value-adding catalyst for our company. We believe the clear and viable strategies we've detailed here today will allow us to creatively and aggressively advance our development pipeline in ways that have the potential to drive significant value for our investors, which, today, to be quite frank, remains unrecognized.

With that backdrop, I'll review our financial results for the second quarter of 2019. As of June 30, our balance sheet remains strong. As a result of our restructuring activities last year, which included a resizing of our workforce and refocusing of our clinical development strategies, we've been able to considerably reduce our quarterly burn rate.

At this time, we believe we have enough cash on hand to further extend our operations until at least the end of the third quarter of 2020. We will continue to operate in an efficient manner and continue to seek, identifying additional areas where we can further reduce our cash burn, while remaining focused on execution as it relates to the advancement of our clinical development pipeline.

Now I'll turn to the financial results for the second quarter.

General and administrative expenses decreased by 27% to $1 million for the 3 months ended June 30, 2019, from $1.4 million for the 3 months ended June 30, 2018. This decrease is primarily due to decreased stock-based compensation-related expenses and additional expenses related to forfeitures and decreased stock option grants in general, along with the reduction of investor relations and consulting costs.

The charge related to stock-based compensation expense was $59,000 for the 3 months ended June 30, 2019, compared to $264,000 for the 3 months ended June 30, 2018. Research and development expenses decreased by 27% to $2.6 million for the 3 months ended June 30, 2019, from $3.6 million for the 3 months ended June 30, 2018. This decrease is primarily the result of lower SYN-004 indirect program costs for the 3 months ended June 30, 2019, including salaries and related expense reductions resulting from the 2018 restructuring and the fact that no clinical trial activity for SYN-004 was ongoing during the quarter.

These expenses were offset by an increase in manufacturing costs for SYN-020. The research and development costs incurred during the quarter were primarily related to the investigator-sponsored Phase IIb clinical trial of SYN-010, the recently announced Phase Ib/IIa clinical trial for SYN-004 in allogeneic HCT recipients and the continued development of SYN-020.

Research and development expenses also include a charge related to stock-based compensation expense of $31,000 for the 3 months ended June 30, 2019, compared to $293,000 for the 3 months ended June 30, 2018.

Other income was $80,000 for the 3 months ended June 30, 2019, compared to other income of $789,000 for the 3 months ended June 30, 2018. Other income for the 3 months ended June 30, 2019, is primarily comprised of interest income, while the 3 months ended June 30, 2018, is comprised of noncash income of $783,000 from the change in fair value of warrants. The decrease in the fair value of warrants was due to a decrease in our stock price.

Cash and cash equivalents as of June 30, 2019, was $21.7 million, a decrease of $7.2 million from December 31, 2018, providing us with additional and substantial runway to continue our operations through the third quarter of 2020.

In closing, I'd like to thank each of you for joining in the call today. As I hope I've conveyed clearly in my remarks, we are continuing to successfully deliver on our strategy by advancing our portfolio of early- and late-stage clinical programs. Today's important announcement of our clinical trial agreement for SYN-004 with Washington University is our latest deliverable as we continue to execute against our strategy.

I'm proud of the partnerships we've cultivated with several of the most recognized and accomplished research organizations in the country. And I'm more excited than ever and encouraged by the confidence and enthusiasm they've continued to demonstrate in our clinical asset. I and the entire team at Synthetic Biologics are focused on executing on the clear and achievable milestones and value drivers we have established for our clinical vision during the remainder of 2019 and beyond.

We will continue to look for every opportunity to build long-term value for our shareholders and reward the continued confidence and support you have given us. We look forward to continuing to update you on our progress in the weeks and months ahead.

Now I'll turn the call back to Vincent.

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

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Thanks, Steve. Denise, we'd like to open the phone line to questions. Would 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) We have a question from Jim Molloy from Alliance Global Partners.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [2]

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I had a question on the SYN-004, the Washington University study in the first quarter of '20. And I apologize if I missed this on the call, I got a couple of calls and bouncing back and forth in between. When do you anticipate getting top line data from that trial?

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

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So I'll start out here, and then maybe Vince Wacher can give you a little bit more color. The only thing that we've currently announced is when we plan to start this. We haven't given any guidance yet on how long this trial is going to take. This is a very specialized patient population. And we're going to have to see how the first cohort enrolls, and the amount of time that takes. And then, obviously, that's going to depend on the subsequent cohorts, and ultimately, the timing of the complete trial.

So I think as we get started with the first cohort, and we start to get some idea of the timing around how long it's going to take to enroll, we'll be able to give clear guidance. I don't know, Vince, you want to give any other color on that?

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Vince Wacher, Synthetic Biologics, Inc. - Head of Product and Corporate Development [4]

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No. I think that's a good description. The study, we reiterate needs -- we need to go back and have another discussion with the FDA to ensure that they are comfortable with that. It is pending the approval. So we can't be too particular about it with the overall details, but as Steve indicated, there's 3 cohorts. There's an opportunity for data readouts between each of those based around safety and pharmacokinetics. And we look forward to initiating that in the first part of next year.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [5]

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Great. And then on the 010 for IBS-C, obviously, I guess there's disappointment that there was an issue with the recruitment. Have they cleared it up and gotten squared away on the recruitment? And when do you just -- how much do you think this pushes back data on this, I guess, you're saying into the first quarter of '20? Do you think there's room for that to move in the mid-'20? Or do you think they sort of got the issue well in hand at this point?

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Steven A. Shallcross, Synthetic Biologics, Inc. - CEO, CFO, Treasurer, Corporate Secretary & Director [6]

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Do you want to take that Vince, again?

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Vince Wacher, Synthetic Biologics, Inc. - Head of Product and Corporate Development [7]

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Yes. So I think the recruitment challenge has been predominantly around screen failures. And it is a challenge in IBS-C studies because you need to run people in for 2 weeks to make sure that you get the appropriate baseline symptoms. The population is very well diagnosed IBS-C population with a long history of the disease, which means they have a long history of managing their disease. So I think the challenge has been to encourage people to change some of these long-term behaviors as they enter the study. The -- I think the issue is being well recognized now by the Cedars-Sinai team. They are doing a lot of education and a lot of interacting with the patients to make sure that they can get pass this. And I think moving forward, the screen fail rate will go down significantly, but we don't have a handle on that yet because this is a comparatively recent development as far as understanding what's been going on with the enrollment.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [8]

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Understood. Yes, Cedars-Sinai is certainly top in their field and should get it under control.

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Operator [9]

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And at this time, I would like to turn the conference call 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 [10]

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Thank you. I'd just like to make a few final comments before we conclude the call. I guess, first and foremost, we really have a great company here with 3 outstanding assets that really address 3 distinct therapeutic areas. GI and with that area, obviously, SYN-010, where we have an opportunity to make a huge difference in IBS-C and CIC. Second, cancer treatment complications as we categorize it. With SYN-004, we have the opportunity to address acute graft-versus-host-disease and VRE. And with SYN-020, a product that could really, I think, provide a decent solution for cancer patients that are being treated with radiation. And then finally, infectious disease, where, again, we have the ability to move SYN-004 forward in the prevention of C. difficile infection and antimicrobial resistance. Each of our assets have the potential to really, really help large numbers of patients and achieve sizable market share. And because we have multiple products and in, we have many opportunities to succeed. It's sort of the multiple shots-on-goal opportunities that I've talked about in the past.

Second, we're really a new company with a new focus. Following our restructuring last year, we've really been able to sit down and come up with what I think is a very clear clinical and regulatory strategy.

And with this strategy, we've really developed a real keen understanding of the market potential for all of our products. And once we've really had that understanding under our belt, we've put together a clinical strategy that, I think, finally, and maybe for the first time, we are really targeting the right indications for each of these products. You couple that with the fact that we've got a great manufacturing team. So we've been able to leverage that expertise, and we've been able to produce these products at a very, very low cost to goods sold, which ultimately will have an impact on how we price these products once they're approved.

And finally, we've been able to leverage our relationships with thought-leading KOLs, institutions and investigators, which has been very important for us to get the clinicians and the scientific community behind what we are trying to do.

We've also done, I think, a very good job of making effective use of our financial resources. We've continued to deploy capital in order to generate what I think are the best value-creating events and milestones for each of these products. And coupled with that, I think, we've done a real good job with tapping into our outside resources that, in many cases, are much more efficient at what they do than hiring a whole team here, while we still maintain a core group of internal talent, which are focused on designing, evaluating and overseeing our operations.

Finally, we're committed to delivering results. I'm not happy with the share price, but I can assure you that we're working to remedy of that. Clearly, I understand that, ultimately, data and deals matter. And we're focused keenly on that. I think I believe I've made it clear in my remarks that we're committed to well thought out clinical programs with the goal of generating robust and compelling data. And the programs are in process, and the data will follow in the quarters to come as we've described our activities to you. Once we have the data, we'll have more options. We'll be in a position to reengage with potential partners interested in possibly licensing 1 or more of these assets, and/or we'll have the opportunity to decide whether or not we want to take these assets forward on our own, and we'll be in a position to evaluate ways to do that.

So again, you have our commitment that we're on top of this, we're working very hard on execution. And again, I thank you for your support, and we look forward to continuing to update you on our progress. Have a good afternoon.

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Operator [11]

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