Theriva Biologics, Inc. (TOVX) Q4 2018 Earnings Report, Transcript and Summary

Good afternoon and welcome to the Synthetic Biologics 2018 Year End Investor Conference Call. All participants will be in 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 would like to turn the call over to Vincent Perrone, Director of Corporate Communications at Synthetic Biologics. Vincent?

Thank you, Brandon, and good afternoon everyone. Welcome to Synthetic Biologics 2018 Year End Investor Conference Call. Today, I am joined by Chief Executive and Financial Officer, Steven Shallcross; Dr. Michael Kaleko, Senior Vice President, 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 period ending December 31, 2018. The press release can be found on the Investor Relations section of our website. During our call today, we will 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 lines, this call is being streamed live via webcast which will be archived on our website www.synthethicbiologics.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 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 would like to turn the call over to Steve. Steve?

Thanks, Vincent. Good afternoon, everyone, and thank you for joining our 2018 Year End Call. I'm happy to be with all of you this evening and I look forward to sharing important and exciting updates on our strategy and progress for advancing our late stage in emerging clinical programs during today's call. 2018 was no doubt a transformative and productive year for the company. We note several key advancements for our portfolio of clinical programs targeting critical unmet need in the prevention of life threatening gut microbiome infections in GI disorders. A particular note, we expanded our relationship with Cedar-Sinai Medical Center in the form of agreement to conduct a Phase 2b clinical study of SYN-010. We announced the completion of our End of Phase 2 meeting with the FDA and confirmed key elements of the Phase 3 clinical trial to support marketing approval for SYN-004 for the prevention of C. difficile infection. We began our evaluation of a potential secondary and more focused indication for SYN-004 in the prevention of acute graft versus host disease or AGVHD, an allogeneic hematopoietic cell transplant recipients and we made significant advancements for our SYN-020 intestinal alkaline phosphatase program which is currently in preclinical studies. These and other initiatives undertaken during 2018 has embedded us to realign our clinical programs to what we believe to be clear and achievable development path. And with the steps we have taken at the end of the fourth quarter to fortify our long term financial putting, we have created a strong foundation upon which to execute our strategy to advance and showcase the value of our late-stage clinical asset. With that backdrop, I'd like to share a more detailed update on our lead clinical programs. So let's begin with and update on SYN-010 first. Much has been said about the current state of the IBS-C marketplace, which is often due just crowded with products that have largely distinct therapeutic mode of action and provide temporary relief often at the cost of significant adverse side effects, namely diarrhea. With this landscape as emerged, a clear recognition of the need for novel therapeutics like SYN-010 to provide chronic long term relief for both constipation and IBS-C. Unlike currently approved and marketed therapies for IBS-C, SYN-010 is designed to treat and target the underlying cause of this disease whereas other therapies provides limited relief by targeting the symptoms. 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 the primary causable [ph] factor for IBS-C. SYN-010's unique mechanism of action is intended to target M. smithii 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 IBS-C symptoms without the negative side effects of diarrhea 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. In 2018, we are excited to announce the expansion of our relationship with our research partners Cedar-Sinai Medical Center in the form of an agreement to co-fund an investigator-sponsored Phase 2b clinical study of SYN-010. The distinguished team of the medically-associated science and technology program at Cedar-Sinai is currently conducting the study which is designed as a 12-week single-site random-diced placebo-controlled clinical trial evaluating two dose strength of SYN-010 in approximately 150 patients with IBS-C. Enrollment for this study began in January and is currently proceeding as expected. We anticipate top-line data read out during the second half of 2019. Importantly, this trial is designed to address specific questions about those response and ways of treatment that were not clearly answered in our exploratory Phase 2 clinical trials. As you may recall in 2017, the FDA agreed that SYN-010 dose response could be evaluated as part of a pivotal Phase 2b/3 clinical adaptive clinical trial where the Phase 2b portion might enable identification of a single SYN-010 dose strength to be used in subsequent Phase 3 studies. By partnering with Cedar-Sinai, we have in essence separated the Phase 2b component from the larger Phase 2b/3 study, allowing us to generate meaningful data at a significantly lower cost than if we were to generate this data on our own. This in turn may enable us to move forward with the revised Phase 3 clinical program for SYN-010 enabling a single-dose string, a reduced overall number of patients and potentially lead to significantly lower clinical development cost for future registration study. Of equal importance, we believe that the successful completion of this trial will allow us to reopen discussions with perspective partners who found data from our previously-completed Phase 2a study compelling, but not conclusive enough to justify the significant capital investment required to complete the clinical trials necessary for product registration. Switching gears now to SYN-004 or ribaximase. Ribaximase is our first-in-class therapeutic intervention designed to protect the gut microbiome from antibiotic mediated dysbiosis. Ribaximase is designed to be taken in conjunction with certain IV beta-lactam antibiotics. Its novel mechanism of action acts by degrading 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 use of antibiotics significantly increases the risk of developing gastrointestinal infections like CDI as well as the emergence can spread of antimicrobial resisting gene. Damage to the gut microbiome by these antibiotics is a significant risk factor for developing CDI. In the U.S. alone, more than 600,000 cases of CDI and approximately 49,000 CDI-related deaths are reported each year. Data from our previously completed Phase 2b proof of concept clinical study demonstrated that Ribaximase was successful in reducing the risk of developing beta-lactam-induced CDI to be a bit more than 71%. Last quarter, we announced a successful completion of an End of Phase 2 meeting with the FDA, during which we confirmed key element of the Phase 3 clinical program to support a marketing application for Rebaximate for the prevention of CDI. The proposed Ribaximase Phase 3 clinical program will entail a single global event-driven clinical trial with a fixed maximum number of patients for total enrollment and we'll evaluate the potential efficacy and safety of ribaximase in a broad patient population by enrolling patients with a variety of underlying infections treated with a range of IV beta-lactam antibiotics. As expected, the primary efficacy end point of the Phase 3 trial will be the reduction in the incidents of CDI compared to placebo. We also confirmed that the FDA agreed to a separate co-primary safety end point of non-inferiority mortality between the ribaximase treatment group and placebo at three months post-randomization. As we have previously shared, given this significant capital requirements associated with this Phase 3 trial, we do not intend to move this trial forward without a partner to help fund it. Its interested potential partners are so far proven reluctant to commit the funding this large Phase 3 trial. We have been keenly focused on identifying the ideal pathway for advancing SYN-004 on our own in a more specialized patient population where preservation of the gut microbiome is a key element to positive clinical outcomes. We've received highly positive feedback from key opinion leaders and potential pharma partners on this concept of a more narrow indication for ribaximase and we believe it will help us to overcome the financial and political development and risk concerns that have been shared with us by potential partners. Now I'll turn the call over to Dr. Vince Wacher, Head of Product and Corporate Development who will share the details on the clinical rational and the next steps for this new clinical indication for ribaximase. Vince?

Thanks, David, and good afternoon, everyone. As Steve noted above, our successful End of Phase 2 meeting with the FDA was really a very encouraging recognition of ribaximase as a potential new intervention to prevent antibiotic-mediated CDI. We spent considerable effort elaborating a registration pathway for ribaximase in this indication, during which we've encountered an imposing development challenge which is inherent to all preventive agents. Specifically, the overall incidents of the target disease, in this case CDI, is comparatively low, which means ribaximase will be administered to a broad range of patients who might never have contracted CDI at all. This mandates large clinical trials in order to ensure appropriate safety in a broad patient population, as well as established efficacy as a means of preventing the CDI. As noted above in the fourth quarter, we described an FDA-agreed Phase 3 program that would comprise one global event-driven trial within enrollment of around 4,000 patients. Clearly, a 4,000-patient study is an expense even very costly undertaking for a company of our size and resources. So in order to maintain our clinical momentum, we've explored alternative more narrow indications for ribaximase where our target to these incidents is high and the clinical development cost should be less on us. Ensuing this alternative strategy, we can leverage our existing ribaximase clinical data and our recent regulatory insight to advance ribaximase ourselves rather than depend on a potential pharma partnership. Our decal [ph] review of potential ribaximase opportunity is identify cancer patients who wanted to go allogeneic hematopoietic cell transplantation or commonly referred to as bone marrow transplantation as a population for whom ribaximase may provide a substantial therapeutic benefit. Allogeneic HCT, hematopoietic cell transplantation is a surgical process where patients with hematologic disorder such as acute lymphocytic leukemia have their disease cells removed or destroyed and they're replaced by healthy hematopoietic stem cells from a matching donor. Allogeneic HCT recipients routinely received long causes of IV beta-lactam antibiotics to treat neutropenic fever which occurs in about 80% to 90% of the patients. Our large body of published clinical evidence is demonstrated, but damaged the gut microbiome caused by the IV beta-lactam antibiotics is strongly associated with a number of potentially fatal adverse outcomes in allogeneic HCT recipients, most notably acute graft versus host disease or AGVHD, colonization by vancomycin-resistant enterococci bacteremia via VRE and other organisms as well as CDI. Allogeneic HCT patients are particularly fragile immuno-suppressed population and prevention of AGVHD and opportunistic infections like VRE and CDI is an absolute necessity. AGVHD occurs in 40% to 60% of the allogeneic HCT recipients and it's recognized as a primary contributor to morbidity and mortality in this patient population. Significantly, first-line treatments for AGVHD fail in more than 50% of the patients and two years survival in patients with steroid refractory AGVHD which is the first line therapy steroid is only 20%. VRE bactoremia incurs in up to 16% of allogeneic HCT recipients and it's rapidly fatal. At least one study found that more than 80% of patients who developed the VRE bactoremia died within a medium of one month from acquiring the inspection. Importantly, colonization are not just the bacterium, but colonization by VRE is also associated, is absurdly more than 40% of allogeneic HCT recipient and has been associated with a nine fold increase in mortality. And CDI occurs in 10% to 31% of allogeneic HCT recipient and is associated with increased severity of AGVHD and also increased mortality. Clearly with these indications, the high incidents and severe outcomes of AGVHD, VRE and CDI emphasize that it's not possible to just wait and treat the problems when they arrived. Prevention is critical. The use of ribaximase and allogeneic HCT patients is well-supported by our existing clinical data. Our Phase 2b clinical trial demonstrated that ribaximase preserved intestinal microbiome diversity and significantly reduced the incident of CDI in patients treated with IV ceftriaxone to treat a lower respiratory tract infection, typically severe pneumonia. A particular relevance to the current strategy, rebaximate also reduced VRE colonization by about 44% in these patients and this was the most statistically significant result in the study. The mechanism by which ribaximase could reduce the incidents in severity of AGVHD and allogeneic HCT recipient is identical to what we saw in our Phase 2b, preventing microbiome damage by IV beta lactam antibiotics. The use of ribaximase to preserve the intestinal microbiome and allogeneic HCT recipients could have remarkable potential benefits to patients, providers and payers. Estimates of in-hospital cost for allogeneic HCT recipients in the U.S. range from around $180,000 to over $300,000. All cost -- inpatient and outpatient costs -- are estimated to be greater than $600,000 per patient when measured up to 12 months after the hospital admission. At least one U.S. study found that allogeneic HCT recipients who developed AGVHD had three times higher in-hospital mortality and almost twofold higher median hospital cost in the patients who did not develop AGVHD. So if ribaximase could reduce AGVHD incidents by even 20% in this population, this may provide significant improvements in patient outcomes in reduction and treatment cost. To provide some scale, there were approximately 8,500 allogeneic HCT procedures conducted in the U.S. in 2016 and an estimated 4,500 procedures in China. These are comparatively small patient numbers certainly relative to CDI. However, the substantial potential benefits for ribaximase may provide in this patient population could allow for premium pricing and significant market value. It's worth noting also that the small number of patients provides an opportunity to seek often drug designation which may facilitate clinical development of potential approval if we are able to achieve often drug designation. We're currently evaluating clinical development pathways for the use of ribaximase and allogeneic HCT recipients. Our primary indication for ribaximase as planned will be the prevention of AGVHD. Secondary endpoints related to VRE and CDI will also be evaluated and these data may support downstream development of ribaximase to prevent CDI in a broader population. Discussions with key opinion leaders in allogeneic HCT are ongoing and we're planning a pre-IND meeting with the FDA. We'd like to initiate the Phase 1/2 investigative responsive clinical study during the second half of 2019, however, this is clearly contingent upon successful identification of an investigator and subsequent review and approval by the investigators' institutional review board and the FDA. In closing, I emphasize that the advancement of ribaximase as a means of preventing AGVHD in allogeneic HCT recipients is both complementary to and enabling a longer term strategy to seek approval for ribaximase as a means of preventing CDI in a broader patient population. The AGVHD program enables us to leverage our existing clinical data and maintain our clinical momentum without having to rely on a potential development partnership. So hopefully that's compelling and with that I'll turn the call back over to Steve.

Thanks, Vince. While we move forward with our later stage assets SYN-010 and ribaximase, we're also continuing to drive new value from our 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 and plays an important role in maintaining GI homeostasis and promoting a healthy gut microbiome. IAP has several key functions, two of which are to detoxify GI inflammatory 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 around $10,000 per gram. We've overcome these hurdles and now have the ability to produce 3 grams per liter of IAP for roughly a few hundred dollars a gram. We believe this is a true game-changer. We currently are planning to pursue clinical trials for SYN-020 and have identified two noble indications with unmet medical needs, in which span a range of market sizes. Specifically, Enterocolitis associated with radiation therapy for cancer and Enterocolitis associated with checkpoint inhibitor therapy for cancer. We intend to move forward with an IND filing for one of these indications to be identified based on an ongoing preclinical research in the fourth quarter of 2019. Following the submission of an IND, we anticipate initiating a Phase 1 clinical trial for SYN-020 in the first quarter of 2020. We believe the clear and viable strategies we have detailed today will allow us to creatively and aggressively advance our development pipeline in ways that have the potential to drive significant value for our company and for our investors which to date remains unrecognized. With that backdrop, I'll review our financial results for 2018. The completion of our public offering during the fourth quarter in the proceeds raised from our ATM facility in 2018 has significantly strengthened our balance sheet with the financial putting required to continue to execute against our planned clinical activities and the value-driving milestones we've identified. We will continue to operate in an efficient manner as financial stewardship and cash management remain a top priority for us. Now I'll turn to the financial results for 2018. General administrative expenses decreased to $5.7 million for the year ended December 31, 2018 compared to $5.7 million for the same period in 2017. This decrease of 24% is due to the decrease stock-based compensation expense related to forfeitures and share price along with the reduction of sale retravel and consulting expense offset by slightly higher registration, investor relation and legal costs. The charge related to non-cash stock-based compensation expense was $1 million for the year ended December 31, 2018 compared to $2 million for the year ended December 31, 2017. Research and development expenses decreased to $11.8 million for the year ended December 31, 2018, compared to $18.8 million for the same period in 2017. This decrease of 37% is primarily the result of lower SYN-004 and SYN-010 program cost for 2018 until clinical trials were ongoing during the year. The research and development cost incurred during the quarter and for the year for that matter were primarily related to planning for future clinical trials for SYN-004 and the Phase 2b trials for SYN-010 as we sought to secure financial resources necessary for the advancement of these clinical trials. We anticipate research and development expense to increase in 2019 due to the ongoing Phase 2b investigator-sponsored clinical trial for SYN-010 and development activities associated with a potential Phase 1/2 investigate our sponsored clinical trial for the prevention of AGVHD and allogeneic HCT recipients for SYN-004. The charges related to non-cash stock-based compensation expense was $1.1 million for the year ended December 31, 2018 compared to $1.4 million for the same period in 2017. Other income was $4.2 million for the year ended December 31, 2018 compared to other income of $10.8 million for the year ended December 31, 2017. Other income for the year ended December 31, 2018 is primarily due to non-cash income of $4.1 million from the change in fair value of warrants. The decrease in the fair value of warrants is due to the decrease in our stock price from December 31, 2017. In connection with the issuance and subsequent conversion of the Series B convertible preferred stock in 2018, an issuance of the Series A convertible preferred stock in 2017, we recognized non-cash deemed dividend of $11.7 million and $6.9 million respectively for the beneficial conversion feature resulting from the intrinsic value of the Series B and Series A conversion options as of the issuance day. Cash and cash equivalent on December 31, 2018 totaled $28.9 million, an increase of $11.8 million from December 31, 2017, providing us with substantial runway to continue our operations through at least the first quarter of 2020. In closing, I would like to thank each of you for joining the call today. As I hope I have conveyed clearly in my remarks, we are well under way in our pursuit of a new direction for Synthetic Biologics designed 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 in value drivers we've established for 2019 is 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 in support you have given us. We look forward to continuing to update you on our progress on the weeks and months ahead. I'll now turn the call back over to Vincent.

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

Absolutely. At this time, we will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Katherine Xu with William Blair. Please go ahead.

Hi, good afternoon. I'm just wondering, Steven and Vince, for SYN-010. The IBS-C drug so far approved have not been performing very well in the commercial. I know you guys have been talking to partners for some time as well. What do you think this upcoming data -- what kind of difference do you think that homing [ph] data would make later this year in terms of differentiating the profile? And also is there a real sizable market?

Thanks for the question, Katherine. Since Vince has been working on our models in assessing the market here, I'll let him answer that for us.

Hi, Katherine. I guess there are two parts to that question. One of that got to do for us coming out of the study. Well, in our conversations when we look at people that are in the GI space interested in this space, there's recognition that the things on the marketplace now or more or less do the same thing. They all pour water into the intestinal tract and they all have largely the same concern which is variability and activity on wanted side effects, particularly unpredictable and explosive diarrhea. And they are all symptom-driven. You take them once every time you get constipated and there's not really [indiscernible] of being able to get people to any kind of normalized bowel function every consistent amount of time. SYN-010 has the opportunity to do that certainly based on the mechanism of action. We should be able to give this chronically into normalized the bowel function. So the mechanism of action, the opportunity to do something on the symptom's side is recognized. The particular advantages of the product that are also recognized at the absence of diarrhea and the potential to significantly reduce bloating which I remind everybody is a symptom that IBS patients report as the most bothersome in their quality of life. So within the product itself, if the data is meaningful and compelling, then we will be able to show differentiation to the current products. Part of the challenge in terms of getting a partnership previously is that the clinical development program that we agree with the FDA was quite substantial and that's because we didn't have a good dose response coming out of our Phase 2 result. By getting good read of the data from this study, we should be able to evaluate the dose response and pick a single dose to go forward into Phase 3. That will reduce the size and the time of the Phase 3 clinical trial program and make that more compelling and more appealing to potential partners. That's where we want to get with this study, to affirm our activity, affirm our benefits, particularly the absence of diarrhea and bloating and be able to pick a dose that enables us to proceed with a smaller Phase 3 clinical trial program. And with that, we think we'll be able to have more better engagement with potential partners. Our cost of goods is very low for this product and it means that we are going into a marketplace that is technically considered competitive and poor. We will still have a very good opportunity to prices effectively to get into that marketplace certainly, to potentially take away from other products that may not be working with patients, but ultimately, to be that line of therapy where patients have tried everything else and we'll get to our product eventually. In IBS-C, and in chronic idiopathic constipation, I think we would know very well the patients have tried everything -- things they make up, things that are prescription. They stop, they start it again and we want to get -- there's an opportunity in that space for something that is different because everything that is there now is not working as well as it should be.

Katherine, I might also add that when we announced that we are going back into the clinic with this asset, we had a lot of interest generated and we've had folks proactively -- potential partners -- reaching out to us to have discussions about what this clinical design was going to look like, how long it was going to take and when we expect to have the data. So we're very excited about the renewed enthusiasm around the compound. Clearly, folks in this space understand that there's no perfect solution out there and we have a real opportunity to offer something that's truly differentiated in the marketplace.

Our next question product comes from Jim Molloy with Alliance Global Partners. Please go ahead.

Thank you for taking my question. My question is on the SYN-004 for AGVHD and they're looking at some of the -- let me be sure I get that correct; looking at the [indiscernible] trial they have ongoing, is there additional information you guys have on where that stands and your thoughts on having another partner -- or not a partner, I guess competitor -- on the space targeting the same market, speeding through the validation, perhaps of the opportunity and your thoughts of comparing and contrasting SYN-004 versus Vedoluzimab? Thank you.

Go ahead, Vince.

I think it's great to see a clinical trial going forward like that because it gives us the guidelines on what sort of endpoints the FDA is looking for in the space that also validates that the space is valuable and compelling. We are very different because the Millennium program is an antibody and it's really having a direct effect on biological targets where our, is if prevented, it doesn't do anything to the biology, but prevents the damage in the first place. So while we are in the same space, we are mechanistically quite different and could even be complementary. The way that our product would be used in AGVHD is not to plant immunosuppressive agents or things that will treat AGVHD as it emerges. Our product is an add-on to make them all that more effective because there's one less battle to fight. If we can prevent the damage to the microbiome, if we can suppress the effects of that damage on immuno-dysfunction in the GI tract, then we make all of those things more effective in terms of preventing the AGVHD. And I know that people are using immunosuppressive agents now and still getting AGVHD and still having microbiome damaged. So again, this is a space that's unaddressed in the AGVHD prevention marketplace and where we add something, not necessarily remove the immunosuppressive agents overall.

Great. Thank you for that. And then quick follow up on your comments on the R&D number going up for next year. Is there any magnitude to that number? We read about your $2 million, almost $3 million a quarter towards middle of the year. Is that sort of the range you expect to see R&D going back to? An end guidance on G&A and sort of overall -- where your [indiscernible] your cash balance to take you to?

I'm glad you asked that question. When you think about our burning going forward, first and foremost, we guided that. We raised sufficient capital to fund these programs that we've described you today and allow us to operate without having to go back to the market, at least through the first quarter of 2020 and I believe possibly a little bit beyond that. We've already taken our fixed burned down significantly. As we announced in December, we resized the organization to accommodate our human resource needs in order to conduct the clinical activities that we laid out for you. If you recall, perhaps not even two or three quarters ago, our monthly fixed borrowing was sort of in that $800,000 to $900,000 a month range. Currently we've got our fix burned down to around $700,000 a month and we continue to work to get that down further. So we have a very, very focused effort to continue to reduce our overhead costs. Cost associated with our clinical programs -- these are numbers that we've talked about publicly particularly around the last financing -- we're probably going to commit somewhere around $700,000 this year to SYN-010; maybe about $200,000 or $300,000 for manufacturing in the rest for clinical work. Our SYN-020 program will commit about $7.5 million that pay for our manufacturing and some clinical activities and then we also stated we commit somewhere in the neighborhood of $5 million to our SYN-004 program for bone marrow transplant. So that's what you can expect and you can run the numbers. The timing of when the expenses will happen will obviously be correlated to when we start these activities. You saw a little bit of burn here in the fourth quarter and you'll see a little bit of a bump in the first quarter because we've had the front load. Some of our manufacturing costs for SYN-020, but that's exactly what you can spend. We're very confident that we put ourselves in a really solid financial position here without having to go back to the markets until we have clinical data.

Great. Thank you for that. My final question is just on the ideas program with Dr. Pimentel's lab. Do you still have confidence -- and I know you said in the press release -- second half of '19, when you do you have an idea of that third quarter, fourth quarter for that data?

We're very excited and happy about our progress to date. Right now, our guidance is the second half. What I'd like to do is probably get a few months or so under our belt and then we'll be able to probably tighten the time frame of when we'll have top-line data. I'm not going to put ourselves in the position where we start giving updates on enrollment. I think that's just unfair to Cedar's organization and to us and everybody starts sort of gaining the system. When we have a little bit more data, we'll tighten up the guidance and when we expect to have the top-line.

Great. Thank you for taking the questions.

This concludes our question-and-answer session. I would now like to turn the conference back over to Steve Shallcross for any closing remarks.

Thanks again and before we end the call, I just want to make a couple brief comments. First, we're incredibly excited and probably more excited than ever with our continued progress in our path forward. First and foremost, we're back in the clinic and we haven't been able to say that for a while and that created some great enthusiasm within our organization as well as with our existing and new investors that have become engaged with us and are now behind us as we pursue these clinical activities to finally develop some solid clinical results. We have incredible products that again we believe have the potential to significantly impact the quality of life for patients all over the world and we've talked to folks not only in North America, but in Europe and you've heard me talk before in China. Our products are needed. This has been reaffirmed in multiple discussions that we had for our team and key opinion leaders, clinicians, researchers and public health officials, again, all around the world. The strategy we've laid out, it's simple. It's designed to give us multiple ways to advance our products through the development cycle by number one, focusing on targeted indications that again addressed significant unmet needs allow us to rapidly advance our programs through the clinic at reasonable cost. I don't think we've paid enough attention to that in the past and I think we've got a solid strategy on how to do this and do this in a respectable way. This will allow us to capitalize on our investment, again with the goal of having products that have a viable commercial path forward. I've referred to this in the past as sort of our multiple shots on goal strategy. And then finally -- and we tried to talk about this on our call today -- we have the financial resources to execute on our plan. The cash on hand will fund our plan through again at least the first quarter of 2020 and we're continuing to work diligently to extend that runway beyond that time frame. This will allow us again to deliver several value-creating milestones, the most significant being the SYN-010 Phase 2b data for the 150 patient trial that would describe where the results would be available on the second half. And again, this date is going to be key to advancing our partnering discussion selecting a dose for the Phase 3 program for SYN-010 and more importantly, once we've identified that, we'll be able to lower the overall cost of that Phase 3 program. In closing, you have our commitment and the commitment of our team that we will do everything possible to get the job done. We remain focused on execution and delivering the return on investment that all of your shareholders expect from us. Thank you again for your support and we look forward to keeping you updated on our progress as we continue to move these products through the clinic.

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