Thank you for holding. Welcome to the Selecta Biosciences fourth quarter and full year 2018 financial results conference call. At this time, all participants are in the listen-only mode. This call is being webcast live on the Investor and Media section of Selecta's website at www.selectabio.com. It is being recorded. For opening remarks, I would now like to turn the call over to John Leaman, Selecta's Chief Financial Officer and Head of Corporate Strategy. Please go ahead, sir.
Thank you, Keith. Good morning, everyone. Earlier today, we issued a press release containing our fourth quarter and full year 2018 financial results and other corporate updates. We expect to file our 10-K post-market this afternoon. This release and the 10-K, when filed, can be accessed by visiting our website at www.selectabio.com. I'm joined today by Carsten Brunn, our CEO. Stephen Smolinski, our CCO, will be joining us for the Q&A portion of this call.
Before we get started, we'd like to advise that certain remarks that are made during this call, including, without limitation, statements about the company's future expectations, plans, and prospects, the anticipated timing of planned trials, related data readouts, the ability of the results to inform future trials, our collaboration with Kire, the sufficiency of the company's cash equivalents, and short-term investments, projections surrounding our cash burn rate, constitute forward-looking statements under the meaning of 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 Factors section of Selecta's most recent quarterly report on Form 10-Q, filed with the SEC, which can be accessed at selectabio.com. Our Form 10-K when it's filed.
Any forward-looking statements represent the company's views only as of today, March 15th, 2019, and should not be relied upon as representing the company's views as of any subsequent date. While Selecta may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligations to do so, even if management's views change. Now let me introduce Carsten, who will kick things off.
Thank you, John, and good morning, everyone. Selecta accomplished a lot in 2018, and I believe we successfully laid a strong foundation for a year of execution in 2019. We're off to a solid start, kicking off this year with an equity fundraise of approximately $33 million in gross proceeds in January. We're in the final stages of preparing to start a six-month head-to-head compared clinical trial that our lead program candidate for the treatment of gout, SEL-212, against KRYSTEXXA later this month. All of our past and future efforts have centered on our mission here at Selecta to advance our differentiated pipeline of biologic therapeutic candidates that mitigate unwanted immunogenicity based on immune tolerance technology, ImmTOR, which neutralizes antibody formation.
While we remain focused on our lead program in gout, we believe there's vast potential for our technology, and our intent is to maximize its full potential, starting with gene therapy. Before I go into more detail on our pipeline, let me start by reviewing the corporate restructuring we announced in January. We streamlined our organization and reduced our budgeted workforce by 36%, which, coupled with the prioritization of our pipeline programs, is projected to reduce the yearly cash burn by 19%, leaving us in a strong position to advance our development programs. Starting with our lead program, we continue to believe that based on a robust clinical package, SEL-212 has the potential to address several unmet needs in chronic refractory gout patients, including sustained serum uric acid reduction in painful flares, and once-monthly dosing.
Just as a reminder, SEL-212 is a combination of ImmTOR, our novel immune tolerance technology, and pegloticase, our proprietary pegylated uricase. In October 2018, we presented data from new cohorts of patients receiving five monthly combination doses of SEL-212 at ACR in Chicago. We subsequently reported data from all available patients, including five patients who were controlled but had not reached five months of treatment at ACR, showing that 66% maintained serum uric acid levels below six after five once-monthly treatments of SEL-212 at doses of 0.1 or 0.15 mg per kg of ImmTOR in combination with 0.2 mg per kg of pegloticase. Furthermore, this data showed a reduction in total uric burden and lowered flare rates and severity. SEL-212 continued to be generally well-tolerated.
We look forward to continuing to develop this program with the initiation of our head-to-head compared clinical trial against the current FDA-approved uricase therapy, KRYSTEXXA, this month. We anticipate announcing an interim six-month data readout in the fourth quarter of this year. We plan to announce full statistical priority data analysis in the first quarter of 2020. The results of the compared trial are expected to inform the design of the planned phase III clinical trial, which we plan to initiate in the fourth quarter of this year. We believe that the head-to-head can potentially confirm SEL-212 ability to address several unmet needs for severe gout patients. There are roughly 160,000 patients in the U.S. with chronic refractory gout, and only a small percentage are currently being treated by the current FDA-approved uricase.
As we develop SEL-212, we're aiming for consistent SUA control, defined as SUA below six for six months, low flare rates, and monthly dosing, which has potential to address currently identified unmet needs in this patient population. Represents over a billion-dollar market opportunity. Turning to our other priorities for maximizing the potential of our proprietary technology platform, ImmTOR. We're encouraged by its ability to induce tolerance and differentiation from systemic immunosuppressive regimens that are not approved and yet to complete a well-controlled clinical trial. We believe our technology can potentially allow for the full benefit of biologics, including the redosing of AAV gene therapy programs.
In September 2018, we announced a collaboration with the European consortium CureCN for the use of our ImmTOR technology in combination with AAV gene therapy in Crigler-Najjar syndrome, a rare genetic disorder characterized by an inability to properly convert and clear bilirubin from the body. This collaboration builds upon preclinical work that was published together with Genethon in Nature Communications in October 2018, suggesting the potential for redosing gene therapy products with our technology. We look forward to dosing the first patient with this combination product candidate in the second half of this year. We continue to be active in exploring potential additional collaborations with which to utilize our ImmTOR platform, both in gene therapy and other biologics with immunogenicity issues. We believe 2019 will be a significant year of clinical results for ImmTOR platform.
With initial interim data from the head-to-head compare trial expected in the fourth quarter of this year, with full statistical superiority data expected in Q1 of 2020. We plan to potentially dose ImmTOR with AAV gene therapy in the second half of 2019 through our collaboration with CureCN, which will be the first opportunity to potentially translate the preclinical data for redosing published in Nature in October 2018 to the clinic. We look forward to providing you with updates in the coming year. With that, let me turn the call over to John to discuss our fourth quarter and full year 2018 financial results.
Thank you, Carsten. For the fourth quarter of 2018, the company recognized $900,000 in revenue, which compares to less than $100,000 for the fourth quarter of 2017. The increase in grant revenue was the sole result of the conclusion of our grant with NIDA. Research and development expenses for the fourth quarter of 2018 were $10.3 million, which compares to $13.6 million for the fourth quarter of 2017.
The decrease was driven by reduced expenditures for our preclinical product candidates, combined with the winding down of our phase II clinical trial of SEL-212 in the second half of 2018. General and administrative expenses for the fourth quarter of 2018 were $5.1 million, which compares with $5.7 million for the fourth quarter of 2017. The reduction in cost was primarily the result of reducing consulting fees. For the fourth quarter of 2018, Selecta reported a net loss of $14.7 million, or $0.65 per share, compared to a net loss of $19.5 million or $0.88 per share for the same period in 2017.
Selecta has $37.7 million in cash equivalents, and restricted cash as of December 31st, 2018, which compares to cash equivalents, and short-term investments of $50.5 million at September 30th, 2018. The company currently has an expected cash runway into Q1 2020, which includes proceeds net of underwriting discounts and commissions of $31.3 million from the company's recent follow-on offering in January of 2019. That concludes our formal remarks. Now we'll open the line for questions. Operator?
Yes. Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. If you are using speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble the roster. This morning's first question comes from Chad Messer with Needham and Company.
Great. Good morning, and thanks for taking my questions. Can we just start with the interim SEL-212 readout? Can you kind of set our expectations? What triggers that readout? Is it a certain number of patients? How much data is coming with the interim?
Thanks, Chad. It's a great question. As we guided, we plan to do the readout in the later half of Q4, and we'll look at the patients who have completed the six months, basically. Obviously, we're assuming rapid recruitment because it is a trial with two active arms. To my understanding, it's one of the first actually head-to-head comparisons. We expect interest from both the investigators and from patients who participate in this. That drives the interim readout.
Okay. Great. Thanks. Is it possible to share sort of what you've powered for? If it's not, can you at least discuss what you guys would view a meaningful beat over KRYSTEXXA to look like?
Yeah. We have not guided and don't plan to guide on that in detail, but I think if you look at the data we presented at ACR, where we had 66%, and the EULAR data, where we're in the 80s, we expect efficacy is somewhere in the middle of this. Then you can look at the label and the published data for KRYSTEXXA and to anticipate the spread we expect for this trial.
All right, great. Thank you.
Thanks, Chad.
Thank you. The next question comes from Derek Archila with Stifel.
Thanks. This is actually Ben on the line for Derek. I guess in light of the recent Spark deal, can we still expect to hear if they opt in by the end of, I think this year? That's it. Thanks.
Derek. Thank you for that. We have not had a chance to connect with Spark after the Roche acquisition. We obviously plan to do this, there's no reason why this guidance would change. Spark/Roche has the opportunity to opt in until the end of this year. That remains unchanged to our knowledge at this point.
Great. Thanks.
Thanks, Derek.
Thank you. The next question comes from John Newman with Canaccord.
Guys, good morning. Thanks for taking my question. First question I had was just regarding the clinical design of the head-to-head study. Just wondering if you could talk to us a bit about the number of sites that we'll be enrolling and the geography of all of those sites will be in the United States. Thanks.
Good question, John. As we guided earlier, we are planning to use our phase III sites for this, and we're looking at 40- 50 sites throughout the United States for this trial. We also guided 50- 70 patients per arm. 40- 50 sites to answer your question.
Great, thanks. Can you talk about what the overall length of follow-up is for this study? After you report the statistical results in early 2020, how long will you be able to follow these patients in the head-to-head study?
Yeah. John, we actually are determining this right now as we speak.
Okay, great. Excellent. Thanks, guys.
Thank you. The next question comes from Difei Yang with Mizuho.
Hey, good morning, guys. This is Alex on for Difei. Thank you for taking the questions. Any additional color you can provide around what the gene therapy trial in Crigler-Najjar would look like? Any insights on how you're selecting the first few patients, and are you going to be looking at liver function, for example? Any additional color around design would be helpful. Thank you.
Yeah, I think, Alex, this is John. Broadly, I think the way we're looking at it is we would use basically our ImmTOR platform post getting agreement from the regulatory agencies with their AAV gene therapy vector for Crigler-Najjar. As you know, it's an enzyme that basically works on the metabolism of iron. I think immediately what you'd have is you'd have antibody data to know whether the ImmTOR actually didn't allow the patient to produce antibodies against the AAV vector. I think once you knew that, then depending on what the enzymatic levels were in that patient after they received their gene therapy, you'd have the ability to potentially redose that patient.
I think at a minimum, the data we'll be looking at is basically, did they produce antibodies against that AAV vector, which would allow then the potential for the redosing. Secondarily, as you've mentioned, we'd be looking at the enzymatic levels that the gene therapy was actually producing in that patient's liver to see whether that would give them enough of the metabolite to allow them to not have a liver transplant.
Great. Thank you very much.
Thank you. The next question comes from Yun Zhong with Janney.
Hi. Sorry. Good morning. Thanks for taking the question. First, a follow-up question on the patient enrollment in the head-to-head study. I wanted to ask if you have any expectation in terms of the pace of patient enrollment, given that there are other studies ongoing for the similar patient population.
Yes. As I mentioned, we believe, we anticipate fast recruitment of this, because you do have two active arms in this study. That's also the feedback we received from the sites, that there's interest to recruit rapidly here because patients will get an active drug on both arms.
Okay. On the CureCN study, gene therapy study, have you provided guidance on when initial data will be available?
We have not. We have only guided that we are conducting the preclinical studies in the first half of this year and initiate the second half of this year, the actual clinical trial. We have not guided on when we will get results.
Okay. The last question. Before you start the phase III study, do you plan or is it a requirement for you to meet with the FDA or no?
Yeah. At this time, we'll probably plan on another interaction with the FDA just to confirm the design of those phase III programs as we move that forward.
That will be after the interim data from the head-to-head study?
We'll determine that in a bit. There's a lot of different time points when we can submit different data points down to them and seek their guidance. Again, as we move forward on that, we'll make sure we keep people informed as to the next steps.
Okay. Thank you.
Thank you. As there are no more questions at the present time, I would like to turn the floor to management for any closing comments.
Thank you very much for your attention. Thank you.
Okay. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may disconnect your lines.