Good day and welcome to the Celcuity Release of Third Quarter 2019 Financial Results Conference. At this time, all participants are in a listen-only mode. Later, you have the opportunity to ask question during the question-and-answer session. [Operator Instructions] It is now my pleasure to turn the program over to Mr. Brian Sullivan. Please go ahead.

Good afternoon, everyone. Thank you for joining our call. We announced the financial results for our third quarter ended September 30, 2019 a few minutes ago. Before we begin though, I'd like to remind everyone that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties which are outlined in today's press release and in our reports and filings with the SEC. Our actual results may differ materially from those in these forward-looking statements. On this call, we will 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 three months and nine months ended September 30, 2019, which was included in today's press release. Today's press release is available on our website at www.celcuity.com under the Investors section. I'm also pleased to have with me on the call today, Vicky Hahne, our CFO. I'd like to first make some comments on our third quarter results as well as provide a general outlook. In particular, I'd like to review the status of our product development projects, our collaboration discussions and our clinical trials. Vicky will follow with more details on a few items and then we will open the line up for questions. As we've talked in the past and I think many of you understand our CELx platform gives us the unique ability to identify patients whose tumors have hyperactive oncogenic signaling pathways, despite the absence of corresponding genomic biomarkers. And this enables us to discover new cancer subtypes and to translate those discoveries into diagnostic tests. Our goal for our CELx Signaling Function tests to diagnose the signaling dysfunction driving up to 40% of the cancers in the solid tumor types are test and…

Thank you, Brian. Our third quarter net loss was $1.98 million, or $0.19 per share, compared to $1.87 million net loss or $0.18 per share for the third quarter of 2018. Net loss for the first nine months of the year was $5.55 million or $0.54 per share compared to $5.66 million or $0.56 per share for the same period in 2018. Because these quarterly net losses include a significant non-cash item stock-based compensation, we also included in our press release non-GAAP adjusted net loss for the quarter. Our non-GAAP adjusted net loss was $1.68 million or $0.16 per share for the third quarter of 2019 compared to non-GAAP adjusted net loss of $1.57 million or $0.15 per share for the third quarter of 2018. R&D expenses increased approximately $0.08 million during the first nine months of 2019 compared to the first nine months of 2018. This was primarily due to $0.37 million in clinical validation and laboratory studies, legal expenses related to patent costs and operational and business development activities. This increase was offset by a decrease of $0.19 million in non-cash stock-based compensation and $0.1 million decrease in payroll taxes, primarily resulting from utilization of research and development tax credits as authorized by the PATH Act tax provision. The approximately $0.15 million decrease in G&A from the first nine months of 2019 compared to the first nine months of 2018, primarily resulted from non-cash stock-based compensation and professional fees associated with being a public company. We ended the quarter with approximately $20.4 million of cash, cash equivalents and investments. The net cash used in operating activities for the third quarter of 2019 was $1.48 million. This was a result of the non-GAAP adjusted net loss of $1.68 million, offset by depreciation expense and working capital changes in prepaid and accounts payable of $0.2 million.

Thank you, Vicky. And, operator, we'd like now to take questions.

Thank you. [Operator Instructions] We'll go first to the side of Yi Chen with HC Wainwright.

Good afternoon. This is Edward Marks on for Yi. I appreciate you taking the questions. Just looking at the time frames that you had laid out here for the multiple collaborations, I'm just wondering if you can give a little more detail. Most of them are laid out here, but for the Roche collaboration or Genentech collaboration I'm wondering if you can provide anymore granularity on what the timing for the trial readout may be.

Well, as we indicated, I think, we said mid-2020. That's as specific as we can get. And then, with the final readout, roughly not just 12 months after that. And so, it's essentially a function of the enrollment and that we hope will be augmented by the addition of the new sites that are coming online now.

Okay. Thank you. And then, you also mentioned just in the next several quarters you anticipate having some additional collaborations. I'm just wondering if you could break these down into the different indications or if you're going to have just these conversations in the near term, and then you anticipate within the next three or four quarters to be able to announce them.

Well, we don't really want to preview the deals until they happen, just because we don't think that is practical. But I can say that we've had ongoing discussions with five or six different pharmaceutical companies. We're pursuing a lot of potential different indications or different drugs and we're -- as a result of those conversations and the stage, confident that we will have collaborations to announce. But as I indicated in my remarks, these are multiparty agreements and those just take a longer time to get done. They are -- in some cases, it's just a lot of drill time getting feedback on agreements or having follow-up meetings, et cetera. It's just reality in the pharmaceutical world, because of the nature of the collaborations themselves. But regardless, I mean, we're -- have a number of these discussions, far enough along for us to have great confidence that we will have a number of them to announce in 2020 and we think that some of those will be in the next few quarters.

Understood. Thank you. And that’s all for me. So I appreciate taking the questions.

You're welcome. Thank you.

[Operator Instructions] We'll go next to the line of Per Ostlund from Craig-Hallum Capital.

Good afternoon. Thanks for taking the question, Brian and Vicky.

Hi, Per.

Wanted to ask, I guess, since we're talking about future collaborations and specifically the pan-HER, c-Met test. If I'm right the multi-pathway test is essentially iterative in the sense that you'll continue to add test for additional subtypes to the Multi-Pathway test. I assume that there's nothing that holds you back from striking collaborations, as you add tests along the way. In other words, you can have a c-Met, pan-HER collaboration and then when you add something else to it with your third and fourth tests coming down the road, you can strike fresh --

Exactly.

-- collaborations. Okay. That makes sense. And that's what I expected, but figured I would clarify because clearly you do have a lot that you're working on there. You brought up Eric's hiring in your prepared remarks, Brian, and I know it's only been a couple of months, but I'd kind of love your early take, I guess, on what he's bringing to the table for you from a business development standpoint. Are you having more conversations with pharma partners? Or is it a matter of those conversations just being a little bit deeper, because you've got another high-level executive at the table alongside? And then, maybe just bigger picture how does his background stand out?

Sure. Well, Eric is a listing in on this call. So I'll have to bring him back down to earth after the call. But no, we did an extensive national search and found a lot of very good candidates who were very interested in working with us. The companion diagnostic industry over the past 10 years has really exploded. There are a lot of companies that offer molecular tests that are important for drug companies to get approvals to select their patients. And so there's a good pool of people out there who've spent their careers collaborating with pharmaceutical companies to coordinate clinical trials, FDA approvals and in the process developed relationships with senior executives across a range of disciplines in the pharmaceutical area whether its translational medicine, medical affairs, biomarker group or even the discovery group and preclinical Phase I groups. And so I had the chance in the national search to evaluate a lot of candidates and so I had I think a pretty good take on the talent available and the experience available to us. And Eric stood out. I really was fortunate to have the opportunity to select amongst a number of very, very capable people. And what was most intriguing about Eric was that he's been at the forefront of a lot of the most advanced companion diagnostic technologies. He was involved in helping launch the first HER2 tests and involved in advancing the development of next generation of HER2 tests focusing on HER2 amplification using FISH or ISH. His most recent experience in Natera, was very impressive to me and I think he'd be very helpful to us because he was directly involved in launching a new technology and new tests that could directly impact how pharmaceutical companies evaluate their drugs incorporate those tests…

Perfect. Very good to hear. Last question. And I realize this might be just a little bit early to telegraph, but is there anything early as you look to turning the calendar into 2020 from an operating plan standpoint that would deviate from your expense/investment levels of 2019?

No. No, I mean I think 2019 -- we're always very budget conscious and so we're frugal. And to the extent that we spend more money in 2020 it'll be because we're doing some good things that are advancing the ball. But I -- we're not changing our overall direction or guidance vis-à-vis our spending.

Excellent. Okay. Thanks, Brian.

You're welcome. Thank you.

Thank you. [Operator Instructions] And it does not appear we have any further questions at this time sir.

Okay. Well, thank everyone for joining the call. Look forward to speaking with you in the future. I'll talk to you later. Goodbye.

We'd like to thank everybody for their participation in today's conference. Please feel free to disconnect your line anytime and have a wonderful day.