Earnings Labs

Celcuity Inc. (CELC)

Q1 2018 Earnings Call· Mon, May 14, 2018

$120.88

-4.02%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-1.34%

1 Week

-0.36%

1 Month

+1.85%

vs S&P

-0.26%

Transcript

Operator

Operator

Good day everyone and welcome to today's Celcuity Release of First Quarter of 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note this call may be recorded. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Mr. Brian Sullivan, CEO.

Brian Sullivan

Analyst

Thank you and good afternoon, everyone. We announced the financial results of our first quarter ended March 31, 2018 a few minutes ago. Before we begin though, I'd like to remind listeners 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. Actual results may differ materially from those in the forward-looking statements. On this call, we'll also refer to 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 first quarter ended March 31, 2018, which was included in today's press release. Today's press release is available on our website, www.celcuity.com, under the Investors section. I also have on the call with me today Vicky Hahne, our CFO. I'd first like to make some comments on our first quarter results, Vicky will follow with more details on a few items, and then we'll open up the like for questions. As we've previously disclosed, completing development in additional signaling pathway test for breast cancer is one of our primary objectives in 2018. And I'm excited to announce that we completed development of our second CELx test for breast cancer during the first quarter of 2018. This new test evaluates independent c-Met pathway signaling activity and its involvement with HER family signaling in HER2-negative breast cancer tumor cells. Abnormal c-Met signaling, including cross-talk between c-Met and HER family receptors, has long been suspected of playing a role in a variety of cancer types. To treat c-Met involved cancer, a number of pharmaceutical companies have developed c-Met targeted therapies. Today though, clinical trials evaluating investigational anti c-Met therapies alone and in combination with other targeted…

Vicky Hahne

Analyst

Thank you, Brian. Our first quarter net loss was $2 million or $0.19 per share, compared to $1 million net loss or $0.15 per share for the first quarter of 2017. Because these quarterly net losses included significant non-cash items, 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 $1.6 million or $0.16 a share for the first quarter of 2018, compared to non-GAAP adjusted net loss of $0.9 million or $0.14 per share for Q1 2017. The approximate $0.6 million increase in our Q1 2018 R&D versus Q1 2017 R&D expense, primarily resulted from increased personnel cost. Legal expenses related to patent cost, start-up clinical trial cost. And business development activities also contributed to the increase. The $0.4 million increase in our Q1 2018 G&A versus Q1 2017 G&A expense was primarily related to increases in expenses associated with being a public company, such as professional accounting and audit fees, director and officer insurance, and employee-related expenses including approximately $0.2 million of stock-based compensation. We ended the quarter with approximately $30 million of cash, cash equivalents and investments. Brian?

Brian Sullivan

Analyst

Great. Thank you, Vicky. Operator, we'd now like to take questions.

Operator

Operator

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

Kevin Ellich

Analyst

Hey, guys, good afternoon. And thanks for taking the questions.

Brian Sullivan

Analyst

Hi, Kevin.

Kevin Ellich

Analyst

Brian, hey, congrats on the development of the second CELx test. I wonder if you could start off there. You gave us some good color in your prepared remarks, but could you talk about the potential for this test and the Multi-Pathway Test? Will you remain focused on breast cancer or should we be thinking of other solid tumor types? And the reason I ask, I just notice one of the drugs, neratinib, I think that's part of the Puma study for colorectal. Is that just a coincidence or should we be thinking kind of along those lines?

Brian Sullivan

Analyst

Well, yeah, as we've mentioned, I think previously we have three product-development-related goals for the year. One was development of the next test for breast cancer, and this is kind of following - or fulfilling that objective. The second, two were related to tests for new tissue types, which is what you're alluding to. So we're continuing to focus on those, but we've been pursuing these programs in parallel. And as you can imagine, our goal is to identify as many patients as possible, to diagnosis as many patients as possible with our test. And as we've discovered previously, we have identified other pathways that abnormally signal, and we've been conducting studies to confirm that and then to conduct animal studies as well to demonstrate the ability to reduce tumors with the c-Met - addition of c-Met to these cells. And so, the end result for us is that it significantly increases the number of collaboration opportunities for us. There are a lot of different companies that have c-Met inhibitors. I mean, ultimately, I think there are six that we've zeroed in on, six different companies c-Met inhibitors. Two of them are approved. There are, as I mentioned, six approved for two therapies. There are also a number of HER family of therapies. There are also several additional HER family of therapies that are under investigation. So the combination, those what we would hope it would do, which is create opportunities for more new drug approvals or new indications for approved drugs. And then that in turn increases the range of business opportunities, collaborations, potential partnerships we can pursue.

Kevin Ellich

Analyst

That's helpful. And then, I guess, wanting to flip over to the FACT 1 study. Again, good color there, but the thing that jumped out to me is, is there a reason why more sites are relying on internal IRB instead of central IRB?

Brian Sullivan

Analyst

No, I mean, that's one of those things that it really - each side kind of has its own rationale. And it can just be - it's not something that we've been given any color about. But it has nothing to do with the protocol. People are trying to read between the lines and wonder whether this reads on the protocol or anything about the study itself. That would be incorrect. It really is just the specific situation of each sites and whatever decision process they have to decide, whether to use a central IRB or an internal IRB.

Kevin Ellich

Analyst

Got you. Got you. And then just wondering if you had any commentary in terms of how discussions are going with other potential partners or collaborators for your technology.

Brian Sullivan

Analyst

Well, we're continuing to have those conversations, so we're happy about that. But as you know, I mean, we can't really disclose anything until we have something that's finalized and kind of definitive. But we have a good target list and we understand who to speak to. And we are engaged in ongoing discussions with folks. But as folks who've participated in the pharmaceutical industry know, the processes can be quite extended. And we're often times dealing with very large companies, and those processes just can stretch out. But - so we have a good target list. We have a good understanding who to speak to and how to engage them and we're continuing to work away.

Kevin Ellich

Analyst

And you still plan on - expect to have one more collaboration announced this year, is that right?

Brian Sullivan

Analyst

Yes.

Kevin Ellich

Analyst

Okay, great. That's it for me now. I'll hop back in queue. Thanks, guys.

Brian Sullivan

Analyst

Okay.

Operator

Operator

Thank you. [Operator Instructions] It appears there are no other questions at this time. So I'll turn the call back to Mr. Sullivan.

Brian Sullivan

Analyst

Okay. Well, I appreciate everybody's participation in the call. And look forward to - excuse me - to updating you in the future. And thanks for your involvement and interest in Celcuity. Take care. Good bye.

Operator

Operator

This does conclude today's program. Thank you for your participation. You may disconnect anytime and have a wonderful day.