Brian Sullivan - CEO Vicky Hahne - CFO.

Kevin Ellich - Craig-Hallum Capital Group LLC Paul Nouri - Noble Equity Fund.

Good day everyone and welcome to today's Celcuity Fourth Quarter 2017 Financial Results Conference Call. At this time, all participants are any listen only mode. Later, you will have the opportunities to ask questions during the question-and-answer session. Please note this conference may be recorded.

I will be standing by should you need any assistance. It is now my pleasure to turn today's conference over to CEO of Celcuity, Brian Sullivan. Please go ahead sir..

Good afternoon everyone. Thank you. We announced the financial results for our fourth quarter and year ended December 31, 2017 a few minutes ago.

Before we began, I'd like to remind listeners that our comments today include some forward-looking statements and these statements involve a number of risks and uncertainties which are outlined in detail in our reports and filings with the SEC. Actual results may differ materially from those in the forward-looking statements.

On this call, we'll also refer to some non-GAAP financial measures. You can find a table reconciling the non-GAAP financial measures to GAAP financial measures in our earnings release for the fourth quarter and year ended December 31, 2017, which was included in today's press release.

The press release is available on our website www.celcuity.com under the Investor section. I also have with me today on our call Vicky Hahne, our CFO. I'll make some comments first on our fourth quarter results. Vicky will follow with a few more details and then we'll open up the lines for questions.

Well, major focus for us in the fourth quarter was kicking off the development of our neg [ph] CELx Signaling Function test. This required us to add seven Ph.D. level scientists and a Director of new product development to our R&D team during the last two quarters of the year.

We were very pleased with the caliber of scientists we hired and their enthusiasm for our mission. We're already making important contributions to our development projects. With these senior members in place, we've been able to make significant progress towards development of CELx tests for two new tissue types and additional ones for breast cancer.

These new tests are intended to identify new types of cancer that genomic tests can identify. Our goal with these tests is to identify multiple disease-driving signaling pathways so that we can provide as wider range of patients as possible the correct diagnosis of their cancer subtype.

Our initial development and training in such studies are encouraging and consistent with our initial concept feasibility studies. These include several mouse Xenograft studies that are designed to validate that abnormal signaling we measure is driving the cancer in the tumors we are studying and is responsive to matching targeted therapeutics.

As we've previously disclosed, our goal is to complete the development of these tests by the end of calendar year 2018. These tests will expand the range of collaboration opportunities we can pursue with pharmaceutical companies.

Through these collaborations, we hope to help pharmaceutical companies obtain new indications for targeted therapies that treat the new cancer subtypes our tests are designed to diagnose. We also continue to make significant progress towards activating the clinical trial we're fielding in collaboration with the NSABP Foundation and Genentech.

We reviewed this previously, but I'll review it as a reminder for you. This clinical trial which we refer to as FACT 1 is designed to evaluate the efficacy of two of Genentech's HER2 drugs, Herceptin and Perjeta in HER2 negative breast cancer patients selected by our CELx HER2 Signaling Function test. The trial is planning to enroll 54 patients.

Our goal is to report topline interim data from this trial by the end of 2018 and topline final data by mid-2019. We met with a number of our principal investigators at the Miami Breast Cancer Conference just last week and we're encouraged by the enthusiasm and interest.

We posted on our website this week a poster we presented at Miami Breast Cancer Conference, which provides additional detail about the FACT 1 study design and its rationale.

The collaborations with pharmaceutical companies we're seeking can vary in scope and include use of our CELx tests in a clinical trial to assess the correlation between the enrolled patients' cell signaling status and their response to the targeted therapeutic being evaluated.

In these type of collaboration, the CELx test is not used to select patients for enrollment but instead to provide critical insights after the trial is completed about the patient characteristics most correlate of drug response. We're pleased to announce our first collaboration of this type.

Celcuity was selected by the NSABP foundation and Puma Biotechnology to evaluate tissue samples from a Phase II study evaluating Puma Biotechnology's pan-HER inhibitor, Nerlynx; Genentech’s HER2 antibody, Herceptin; and Bristol-Myers Squibb’s EGFR inhibitor, Erbitux in metastatic colorectal cancer patients.

This 35-patient study is expected to be completed in late 2020. Unlike our current trial with NSABP and Genentech, Celcuity’s test is being used solely to evaluate patient samples after they have been enrolled in the trial. During the quarter, we also finalized the design of our new laboratory and office space.

We've been in our current space in 2014 and we've utilized every last square foot of this space, so the move is necessary and the timing is good. We're getting the space ready now and we're on track to move in mid-May. So, overall, we're very excited about the progress we made during the quarter.

To summarize, for 2018, our goals are to complete the development of our next three CELx Signaling Function tests to initiate another clinical collaboration with a pharmaceutical company and to obtain interim data from our FACT 1 clinical trial during the year, but so far, we're on track to meet those goals.

I'll now turn to Vicky who will review briefly our financial results..

Thank you, Brian. Our fourth quarter net loss was $1.7 million or $0.17 per share compared to $0.9 million net loss in Q4 2016 or $0.14 per share. Net loss for fiscal year 2017 was $6.3 million or $0.84 per share compared to a net loss of $3.3 million or $0.52 per share for fiscal year 2016.

[Indiscernible] quarter and year-to-date net loss include two significant non-cash items, stock-based compensation, and non-cash interest expense. We also included in our press release non-GAAP adjusted net loss for Q4 and the full year.

Our non-GAAP adjusted net loss was $1.4 million or $0.14 a share for Q4 2017 compared to non-GAAP adjusted net loss of $0.8 million or $0.13 per share for Q4 2016. Non-GAAP adjusted net loss for the fiscal year 2017 was $4.9 million or $0.66 per share compared to non-GAAP adjusted net loss of $3.1 million or $0.49 per share for fiscal year 2016.

The $1.9 million increase in our 2017 R&D versus 2016 R&D expense was primarily related to increased personnel costs including approximately $400,000 of stock-based compensation costs, legal expenses related to patent costs, startup clinical trial cost, business development activities also contributed to the increase.

The $0.7 million increase in 2017 G&A versus 2016 G&A was primarily related to increases associated with being a public company such as professional accounting and audit fees, directors and officers' insurance, and employee-related expenses including approximately $300,000 of stock-based comp.

We ended the quarter with approximately $31.4 million of cash, cash equivalents, and investments. And that concludes the review. I'll turn it back over to Brian..

Operator -- thank you, Vicky. Operator, we'd now like to take questions..

[Operator Instructions] And we'll take our first question from Kevin Ellich with Craig-Hallum. Please go ahead your line is open..

Good afternoon. Thanks for taking the questions. Hey Brian and Vicky..

Hi Kevin..

Starting off with the Puma study, can you give us a little bit of color as to how that came about? And also I don't think you said it in your prepared remarks, what are the costs associated with that study? And who's bearing those? Are there any monies or upfront payments or anything that you guys are collecting?.

Sure. Study came about because we got to know NSABP and they got to know us and the capability of our technology, we started to discuss other studies they had in process. And the study with Puma was getting ready to go, but the Medical Director at NSABP was very interested in using our test to evaluate the signaling status of patients for this trial.

The trial had already been designed, it had been designed several years before, it had been delayed in getting fielded, so we weren't able to be incorporated upfront, but we both agreed that it made sense to use our test to analyze the status of the patients' signaling pathways.

I don't know the financial arrangements between Puma and NSABP, but we are not funding any parts of the trial and we're not receiving any payments for the trial, but we will receive access to all the data.

And at this stage of our development given the nature of this study, we think that's very valuable to us as an opportunity to collaborate in a new tissue area with a new pharmaceutical company and it made a lot of sense in our opinion to proceed on that basis..

That's fantastic. And then can you give us an update as to how enrollment on the FACT 1 study is going? Are we track, ahead of schedule, or kind of right in line with--.

We're on track. As I've mentioned previously, our goal is to get topline interim data by the end of the year. NSABP restricts us from reporting any real detail data from this file except in a very topline basis.

So, we're not able to really provide much insight other than the timing of when we expect to have some of that data and then reporting it on a topline basis prior to a major meeting. But no, we're on track for that, the dates that I've indicated previously..

Sure. That's great. And then in the press release you guys talked about the development work that you've been doing in additional activity, then you called out cell signaling function for breast as well as two additional tumor types.

Could you give us a little bit more color or detail as to what we should be thinking about on those additional tumor types?.

So, I think we discussed some of the major solid tumors that are of interest to us and it will be -- and I think we've discussed and I'm not going to name these in any particular order, but really just for our own competitive reasons, we aren’t going to disclose exactly which ones we're working on until our data is ready.

But they would be from the list of major cell tumor types, so it include colon cancer, or lung cancer, or ovarian cancer, kidney cancer, bladder cancer. So, it would be in that grouping of solid tumors..

Got it. No, that's helpful. And then I guess one for -- or a couple for you Vicky, so you guys are going to move into the new office space mid-May.

How should we think about any incremental cost or is the -- will the lease expense go up at least?.

Yes, it's going to go up in proportion to the additional space that we're taking. It's pretty nominal expense for overall [Indiscernible]..

And it's baked into the numbers that we've discussed with you previously. This has been in our plan since the end of last year..

Got you.

So, really no additional capital expenditures or incremental cash burn base basically?.

Just in line with what we've talked about..

Okay, got you, got you. And then one last thing Brian. Also you've talked about hopes to initiate an additional clinical collaboration with the pharmaceutical company by year end.

Just wondering how those discussions are going?.

Well, they're going well. We're having them and we think we're on track to being able to announce something before year end. I mean, obviously, we know sooner rather than later, but we're initiating or rather have been engaged in those types of conversations. And we have reason to be optimistic that something will be announced before year end..

Sounds good. Thanks for taking the questions. And great to see the additional study here, that's helpful. Thanks..

You're welcome..

Thank you. And we'll take our next question from Yi Chen from H.C. Wainwright. Please go ahead your line is open..

Hello. This is Mitchell on for Yi Chen. We have a couple questions.

So, when do you expect CELx to start generating revenue? And what could potentially be the price of the test?.

So, the first revenue we generate we believe will be from collaboration payments that are part of a larger partnership agreement that we would hope to negotiate in conjunction with obtaining a new drug indication for a drug company. Our overall strategy is to just to partner with drug companies, help them get a new indication.

At the time that we would start to collaborate to make that happen, we expect that agreement would include some milestone payments that that would be recorded as revenue.

The first test revenue that we generate -- from actually performing a test and reading out results to an attending physician would come after the associated drug that we're partnering with has received approval and the pharmaceutical company is launching that. We would expect potential agreement to yield revenue sometime in 2019.

So, as a test price, once we launch that, it will range in price between $4,000 and $7,000 depending on the number of pathways that we're evaluating..

Okay, great. Thank you. That that was very helpful..

Thank you. [Operator Instructions] Our next question comes from Paul Nouri with Noble Equity Fund. Please go ahead your line is open..

Hey, my questions were answered. Thank you..

Thank you. [Operator Instructions] It appears if no further questions at this time..

Well, thank you everyone for attending our call. We appreciate your support and your interest in our company and look forward to speaking with you again in a few months. Good bye..

This does conclude today's conference. You may disconnect your line anytime and have a wonderful day..