Operator:
Thank you for holding. Welcome to the Selecta Biosciences fourth quarter and year end 2017 conference call. Currently all participants are in a listen only mode. This call is being webcast live on the investors and media section of Selecta’s website at www.selectabio.com and it is being recorded for opening remarks. I would now like to turn the call over to John Leaman, Chief Financial Officer and Head of Corporate Strategy. Please go ahead.
John Leaman, Chief Financial Officer
Thanks to all of you for joining us this morning. Earlier this morning, we issued a press release outlining our fourth quarter and year end 2017 financial results and other corporate updates and we filed our 10K. The release of the 10K can be accessed by visiting our website, www.selectabio.com.
I am joined today by Werner Cautreels, our CEO and Skip Sands, our Chief Medical Officer. Before we get started, we would like to advise that certain remarks that are made during this call about the company's future expectations, plans and prospects constitute forward looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factor section of our most recent annual report on form 10K filed with the SEC which can be accessed at www.selectabio.com. In addition, any forward-looking statements represent our views only as of today, March 15th, 2016, and should not be relied on upon as representing our views as of any subsequent date. We may elect to update these forward-looking statements at some point in the future, it's specifically disclaims any obligation to do so even if our views change. And now let me do Werner, who will kick off our discussion.
Werner Cautreels, Chief Executive Officer
Thank you John and good morning everyone. Over the last year we continued our mission to advance our pipeline of a new class of biologic therapies that mitigates unwanted immunogenicity. Specifically in 2017, we continue to execute on a comprehensive dose ranging Phase 2 trial of SEL-212, our lead program for chronic severe gout, which we believe positions us well for a planned Phase 3 program, which we expect to get underway later this year. We licensed the clinical stage oncology assets, called LMB-100 and combined it with our proprietary immune tolerant agent, SVP-Rapamycin to form our next product candidate, SEL-403. We dosed the first patient in our Phase 1 trial last week.
We also have generated and presented further preclinical data that demonstrates the potential of SVP- Rapamycin, to transform the treatment paradigm in gene therapy by enabling repeat dosing. We received $30 million in planned payments from Spark for the license that was executed in December 2016. And finally we made key additions to our management team and board of directors as we enter the next stage of our evolution.
Now, let's focus on some of our more recent developments starting with our ongoing Phase 2 trial of SEL-212. This is a product candidate consisting of pegsiticase, an uricase enzyme that has been shown to significantly lower uric acid levels in the blood, combined with SVP-Rapamycin to mitigate the immunogenicity that normally occurs upon the dosing of an uricase enzyme. SEL-212 was designed as a monthly therapy that will enable the rapid dissolution of uric acid deposits in the joints, tissues, and organs of chronic severe gout patients. There is currently only one FDA approved therapy for severe gout patients- a uricase enzyme that has proven to be immunogenic with the majority of patients treated and unable to complete their full therapy course. We believe there remains a high unmet need for a therapy that can clear uric acid deposits and tophi in patients.
Now I will turn the call over to our CMO Skip Sands to provide an update on our SEL-212 program.
Skip Sands, Chief Medical Officer
Thank you Werner and good morning everyone. The focus of the ongoing Phase 2 trial is to evaluate different doses of both SVP- Rapamycin and pegsiticase as we seek to define the optimal dose regimens for our Phase 3 program. As of March 9th, 2018, we had enrolled 111 patients in total in the trial. I am pleased to report that we have completed the enrollment of patients in the cohorts that are receiving either 0.125 or 0.15mg/kg of SVP- Rapamycin in combination with either 0.2 or 0.4 mg/kg of pegsiticase.
As a reminder, these cohorts are receiving a dose regimen consisting of the combination therapy for the first three months of treatment and then pegsiticase only for the last two months of treatment. The results of the three combination doses will help define the dose regimen to carry forward into the Phase 3 program in which we plan to dose the monthly combination therapy for the entire six month period of the pivotal trials. We plan to report initial data from these higher dose cohorts at the upcoming Pan American League of Association Rheumatology Congress, or PANLAR 2018 on April 9th or 10th, and we'll host a conference call for investors that same morning. As has been the case in our past data announcements, you should expect to see patient serum uric acid levels, ADA and tolerability data, and gout flare rates.
We are also pleased to report that in mid-February we began dosing patients in our current Phase 2 trial, who are expected to receive five monthly doses of SVP- Rapamycin in combination with pegciticase. These patients will receive SVP- Rapamycin doses ranging from 0.1mg/kg to 0.15 mg/kg in combination with 0.2mg/kg pegsiticase. We plan to present from these patients at an upcoming medical meeting in Q3 of 2018.
Finally, we remain on track to begin enrollment of patients in our Phase 3 program of SEL-212 later this year. Now, I will turn the call back over to Werner.
Werner Cautreels, Chief Executive Officer
Thanks Skip. As we have been executing our SEL-212 Phase 2 study, we also have been developing our next clinical program SEL-403. In mid 2017, we in-licensed LMB-100 from the National Cancer Institute. These recombinant immunotoxins targeting mesothelin may hold great promise as an agent for various solid tumors, including mesothelioma and pancreatic cancer. However, it also has proven to be highly immunogenic causing empty antibodies in old patients which uniformly negated the drugs clinical activity.
Working with Selecta, the NCI generated pre-clinical data that were recently published in PNAS, showing that by dosing SVP-rapamycin in combination with LMB-100, we can mitigate the immunogenicity and restore the immunotoxins antitumor activity. In January we announced that the FDA had accepted the IND for this combination therapy in patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy. It is important to note that this IND submission was approved on the basis of our existing preclinical and clinical data from SEL-212 program without additional combination toxicology data. We believe this is a reflection of a significant unmet need of these patients as well as the potential benefit risk profile that has been established for SVP- rapamycin in the SEL-212 program.
The design was also based on data from LMB-100 in 2 Phase 1 trials that were conducted by NCI. One in mesothelioma and one in pancreatic cancer patients. In fact, last week we began dosing the first patient in the Phase 1 trial that is being conducted under a Cooperative Research and Development Agreement (CRADA) at the NCI. Up to 18 patients will be enrolled in this dose escalation trial. Patients will receive four treatment cycles three weeks apart of the combination product, each consisting of an initial dose of SVP-Rapamycin together LMB-100 on day one of each cycle and two subsequent doses of LMB- 100 alone on day three and five of each cycle.
The starting dose of SVP-Rapamycin will be 0.15mg/kg, and the starting dose of LMB-100 will be the maximum tolerated dose from the Phase 1 studies that were conducted with LMB-100 alone by NCI. The primary objective of the trial will be to evaluate safety and tolerability, but additional objectives include the measurements of ADA and also an objective response rate assessment.
In addition to this clinical progress, we announced in the fourth quarter that we had named Stephen Smolinski to the newly created role of Chief Commercial Officer. He brings to us a tremendous amount of rheumatology and immunology experience from both large Pharma and smaller biotech companies. Stephen already has been a key contributor to our Phase 3 planning for SEL-212, and he also started preparing our commercial plans in the gout space. We also named John Leaman as our new Chief Financial Officer, Treasurer and Head of Corporate Strategy. John joins us with an impressive and well run track record in the life sciences space. Finally, in January we announced my plans for retirement at the end of 2018. I joined Selecta in 2010 and I'm extremely proud of her many achievements over these past years. My thanks go first to our investigators and patients for participating in clinical trials, but also to our employees, management and board of directors for working alongside with me to get us to this exciting stage.
In conjunction with this announcement, the board named Dr. Omid Farokhzad, one of Selecta’s co-founders as Chairman of the board, and we recently initiated a search for my successor. While I'm eager to begin the next phase of my life, and that includes spending more time with family, my goal remains to ensure that Selecta reaches its stated goals for this year. I am pleased that we already have checked one box by getting SEL-403 into the clinic. The next goal is to continue to execute on our Phase 2 program and then roll onto our Phase 3 program later in the year. In parallel with this, we will continue to ready our proprietary gene therapy candidates for M&A as we target an IND filing in 2019. With that, let me turn the call over to John Leaman to discuss ou four quarter financial results.
John Leaman, Chief Financial Officer
Thank you Werner. Selecta reported $100,000 in revenue for the fourth quarter of 2017, which is down from approximately $2.9 million in the comparable quarter last year. The decline is primarily the result of the termination of our collaboration with Sanofi in late 2016 and reduced revenue recognized from the company's Nicotine Vaccine Candidate Grant Award from the National Institute on Drug Abuse.
Research and development expenses for the fourth quarter of 2017 were $13.6 million, which is up from $11 million for the same quarter last year. The increase is mainly with the result of greater clinical costs related to our Phase 2 trial of SEL-212, planning for a Phase 3 program and incremental head count related expenses. General and administrative expenses for the fourth quarter of 2017 were $5.7 million which compares to $5.8 for the fourth quarter of 2016. The decrease is primarily a result of greater headcount and related salaries needed to support a clinical stage public company, offset by a reduction in payments made to the Massachusetts Institute of Technology resulting from the agreement with Spark Therapeutics.
Overall, for the fourth quarter of 2017, we reported a net loss attributable to common stockholders of $19.5million or $0.88 per share. This compares to a net loss of $14.1 million or $0.77 per share for the same period in 2016. As of December 31st, 2017, we had approximately $97 million in cash and cash equivalents, short term deposits, investments in restricted cash. This is down from approximately $105 million at September 30, 2017 as a result of our operating expenses partially offset by payments from stock purchases by Spark Therapeutics related to the license agreement we entered into with them in late 2016.
I'm pleased to report that we have now received a total of $30 million since the initiation of this agreement. We continue to expect our cash balance is sufficient to fund our operations in the mid 2019. This guidance excludes any additional payments we might receive from Spark or other potential collaborators.
That concludes our formal remarks. Would you please now open the line for questions?
Operator
We will now begin the question and answer session.
Our first question comes from Carter Gould with UBS. Please go ahead.
Carter Gould, UBS Analyst
Thanks for taking the questions. This is Jeff Hoffman for Carter. I think you've mentioned it in the prepared remarks, but for SEL-403 what will be the lowest dose you'll start with LMB-100.
Werner Cautreels, Chief Executive Officer
The lowest dose for that is the MTD, the maximum tolerated dose that NCI has defined from 2 Phase 1 trials that were conducted using LMB-100 by itself. And that was done in two patient populations, one in mesothelioma, and one in pancreatic cancer.
Carter Gould, UBS Analyst
Great, thanks. For SEL-212, what level of confidence do you have that the SVP- Rapamycin doses, ranging from 0.1 to 0.15 mg/kg with 0.2mg/kg pegsiticase to the five doses will be sufficient to help make a call on the Phase 3 design?
John Leaman, Chief Financial Officer
I think as we've described, we're going to be presenting data for the higher dose cohorts coming out in April. I think it's that data that has helped inform what we have started with the combination doses and I think we feel fairly confident that within the range that we've laid out, that we’ll have a five combination dose that we can take into Phase 3.
Carter Gould, UBS Analyst
Great. Last one. Beyond the clinical data readouts and end of Phase 2 meeting, are there any other data or pre-clinical work that might be required before the start of Phase 3?
Werner Cautreels, Chief Executive Officer
We have generated the preclinical data for the 5 combination dose, actually for the continuous dose cohorts and the processes in place for FDA approval prior to the forth combination dose, so we feel confident about that.
Operator
Our next question comes from the Difei Yang with Mizuho. Please go ahead.
Difei Yang, Mizuno Analyst
Hey, good morning guys. This is actually Alex on for a Difei. Thank you for taking the questions. I'm wondering if you could talk a little bit about some of the patients that have responded best to SEL-212 so far across the various cohorts. Are you in a position to share some specific characteristics of this patient at this point?
John Leaman, Chief Financial Officer
I think we will plan on presenting some of the data that you've just described with the April update that we're going to give that PANLAR. So if you can hold that question, we'll plan on answering it in April.
Difei Yang, Mizuno Analyst
Aother question, just on a standalone basis. Should we expect Krystexxa and pegsiticase to behave more or less the same?
John Leaman, Chief Financial Officer
I mean they are obviously similar in terms of being an uricase enzyme, but I think it's hard for us to basically opine on our data versus theirs. But I think what we would say, and I think to Werner’s remarks, we both know that they create without the addition of something like an SVP-rapamycin, significant immunogenicity and ADA. So I think, based upon what you've seen from Krystexxa and obviously what we've described, I think you can draw your conclusions.
Operator
Our next question comes from John Newman with Canaccord. Please go ahead.
John Newman, Cannacord Genuity
Hey guys, good morning and great progress. I wonder if you could potentially comment on the number of patients and the number of patient groups that we might see at PANLAR for SVP- Rapamycin at the higher doses.
Werner Cautreels, Chief Executive Officer
In April we will report on the patients that have received 0.125 and 0.15. There will be actually three cohorts with at least 10 patients in each of those cohorts. Not all of these patients will have completed the full five month, but they will be to a large extent, completed.
John Newman, Cannacord Genuity Analyst
OK, great. In terms of five dose regimen that you're currently working on, would you expect similar numbers of patients and similar numbers of cohorts or might that be a little bit different?
Werner Cautreels, Chief Executive Officer
For guidance, we’ve planned doses that range from 0.1 to 0.15mg/kg of SVP-rapamycin. We'd approximate 10 patients in the cohorts. Just to clarify, the patients in the initial cohort that were started to dose, received 0.15mg/kg of SVP-rapamycin.
Operator
Our next question comes from Chad Messer with Needham. Please go ahead.
Chad Messer, Needham Analyst
Thank you for taking my question. I'm curious about the LMB-100, are there other indications that you are going to be looking, except the mesothelioma?
Skip Sands, Chief Medical Officer
Well, as you know, mesotheline is the part of a lot of different tumor types. Beyond mesothelioma, in pancreatic cancer over 90 percent of the tumor has mesotheline in it. So there are a lot of different tumor types to go to. I think the first two that LMB-100 was studied in was mesothelioma, which is the trial that we're doing with NCI. Second would likely be pancreatic cancer, where it's also been studied. We can also look at other tumor types such as breast, uterine, so there are many different tumor types I think we think it can be effective in.
Operator
Our next question comes from Alex Schwartz. Please go ahead.
Alex Schwartz, Stifel Analyst
Hi Team. Thank you for taking the question. First question I had was, will you have any SEL-403 or other candidate posters or presentations at AACR, and if so, which ones should we focus on?
Werner Cautreels, Chief Executive Officer
Good morning, this is Werner. That will be premature. I think we will not have enough data and we are doing it together with NCI, so we will give guidance as we go forward. We did publish the pre-clinical work and the key owners of that are actually NCI investigators, and that was published in January in PNAS.
Alex Schwartz, Stifel Analyst
And then a second question, more of a modeling question. The $2.5M cash payment you received from Spark during Q4 2017, can you disclose what that payment was related to? And do you anticipate any additional milestones from Spark this year? As much as you can talk to that. Thank you.
John Leaman, Chief Financial Officer
I think in terms of what we can expect this year, I don't think that we can guide to that because a lot of that has to do with when Spark decides to put the combination into the clinic. However, on the $30 million payments, those were preset sort of payments to the $2.5 million was part of the greater $7.5 million that we received. $2.5 million in cash and $5 million in equity investment that was made back in October 31. And that was all pre-specified. So the $30 million up front was pre-specified and these payments were made on schedule and the $30 million was what we expected up front.
Operator
This concludes our question and answer session. I would now like to turn the call back over to Werner Cautreels controls for any closing remarks.
Werner Cautreels, Chief Executive Officer
Thanks everyone for joining us this morning. We can see some of you at the Needham Healthcare Conference in a couple of weeks in New York and we look forward to speaking with you all again when we report higher cohorts data at PANLAR on April 9 and 10, and that will also have a conference call. So that concludes call.
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