Celcuity Inc (CELC) 2019 Q4 法說會逐字稿

Good day, everyone, and welcome to today's call to discuss the Celcuity Release of Fourth Quarter and Fiscal Year 2019 Financial Results. (Operator Instructions) Please note today's call will be recorded. (Operator Instructions)

And it is now my pleasure to turn the program over to Celcuity's CEO, Brian Sullivan. Please go ahead.

Thank you and good afternoon, everyone. I know most of you are probably shell-shocked about what's going on in the market, but we must press on. We announced the financial results for our fourth quarter and year ended December 31, 2019, a few minutes ago.

Before I 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 3 months and 12 months ended December 31, 2019, which was included in today's press release. Today's press release is also available on our website, www.celcuity.com, under the Investors section.

I'm pleased also to have with me today on the call, Vicky Hahne, our CFO.

I'd like to make some comments on our fourth quarter results as well as provide a general outlook. In particular, I'll review the status of our product development projects, our collaboration discussions and our clinical trials. Vicky will follow up with more details on a few items, and then we'll open the line for questions.

Well, today, only a small proportion of cancer patients are benefiting from the advancements made over the past 20 years or so in molecular-based medicine. Recent reports estimate that roughly 80% of cancer patients lack an actionable biomarker, typically a molecular mutation, that an oncologist could use to guide selection of a targeted therapy for their cancer patients. There's thus a huge unmet need for new diagnostics with the 80% of cancer patients who today are not eligible for targeted therapies.

We founded Celcuity to address this unmet need. Our CELsignia, which we previously called CELx, platform diagnoses dysregulated oncogenic signaling, which is the underlying cellular activity driving many cancers. The patients we diagnosed with a dysregulated signaling pathway have a disease mechanism that directly corresponds to a matching targeted therapy's mechanism of action. Our strategy is to help pharmaceutical companies obtain new indications for their targeted therapies to treat the patients themselves making our test identified. Since dysregulated signaling is too complex for molecular tests to characterize, we can leverage the capability of our CELsignia platform to create a proprietary business strategy.

To execute our strategy, our R&D team is working hard to expand the applications for our CELsignia platform. New tests expand the number of patients who may positively impact and increase the number of potential pharmaceutical collaborations we can pursue. I'm excited to report that we made significant progress advancing additional CELsignia tests in the fourth quarter of 2019. As we reported in December, we presented results from preclinical studies for our new CELsignia PI3K Test at the San Antonio Breast Cancer Symposium. The studies we presented demonstrate how using our CELsignia platform can measure PI3K-involved signaling may provide a more sensitive and specific method than PI3K-mutational status to identify patients most likely to benefit from PI3K inhibitors.

Our PI3K test provides an excellent case study of the unique insights our CELsignia platform can obtain by analyzing signaling activity of living tumor cells. Today, in breast cancer, only patients with certain PI3K mutations are eligible for treatment with a PI3K inhibitor. However, recent clinical trial results found that less than 20% of PI3K-mutated late-stage breast cancer patients responded to alpelisib, a recently approved PI3K inhibitor. This suggested to us that measurement of PI3K-involved signaling activity may be more important to measure than PI3K-mutational status to identify patients eligible for PI3K inhibitors. We knew that cancer research has identified a link between PI3K signaling activity and G-protein-couple receptors, or GPCRs, in some breast cancers. However, it is not possible using molecular tests to apply this discovery to the clinic.

With our CELsignia platform, we could confirm this linkage. First, we identified tumors with dysregulated GPCR signaling. And second, we developed methods to identify whether certain pathway nodes known to play a role in promoting cancer, such as PI3K, were also involved. Ultimately, our unique ability to analyze complex signaling activity involving multiple pathways allowed us to develop a PI3K test that can identify new patients for treatment with PI3K inhibitors.

This is our third CELsignia test for breast cancer. Celcuity now has the potential to identify dysregulated signaling activity undiagnosable by molecular tests for up to 1 in 3 HER2-negative breast cancer patients. So patients diagnosed by our 3 CELsignia tests are ones current molecular tests cannot identify. Each step offers a potential opportunity for pharmaceutical companies to expand the number of patients eligible for their targeted therapies or to obtain new indications.

We're successful in working with pharmaceutical companies to gain approval for new drug indications to treat these groups. We will have an incredible impact on the outcomes for breast cancer patients. Consistent with our strategy, we're continuing our efforts to develop additional tests for breast cancer patients. The development of our fourth test for breast cancer also advanced during the quarter. We hope to complete the preclinical studies for this new test in 2020.

In addition to maximizing the number of tests we can perform in breast cancer, we're also committed to offering CELsignia tests for a range of other solid tumor types. Our breast cancer research has given us valuable insights into another cancer that uniquely afflicts women, ovarian cancer. We're pleased to announce that we will report preclinical study results for our first CELsignia test for ovarian cancer at the 2020 Annual Meeting of the American Association for Cancer Research. This meeting was originally scheduled for late April, but it has been postponed because of COVID-19-related concerns. The new date has not yet been set.

This new test is intended to identify a subgroup of ovarian cancer patients whose tumors have undiagnosed hyperactive oncogenic signaling activity. Nearly 15,000 women a year die from ovarian cancer, a disease that has less than a 50% 5-year survival rate and a limited range of targeted therapeutic options. There's thus a significant unmet need for additional therapeutic options for ovarian cancer patients. As a companion diagnostic, our CELsignia test for ovarian cancer will be intended to help pharmaceutical companies obtain new drug indications and expand treatment options for this challenging tumor type. We would expect to initiate discussions with pharmaceutical companies about collaborating on clinical trials later in 2020.

Our efforts to finalize several clinical trial collaborations with pharmaceutical companies and clinical sponsors continue to progress. We're in active discussions with a number of companies and prominent oncologists and centers. Our goal, to evaluate the efficacy of various targeted therapeutics in breast cancer patients identified by our CELsignia tests. These potential collaborations would, if finalized, enable us to study a range of drugs, either a single or combination agents. If successful, we believe these collaborations could ultimately lead to helping these therapies gain FDA approval to treat the patient populations that our test identifies.

We remain very confident that we will close several collaborations this year. But since these collaborations involve Celcuity, the clinical sponsor, and in some cases, 2 pharmaceutical companies, a significant time is required to finalize the related agreements between these 3 or 4 parties.

I'd like to now turn to an update on our clinical trials. NSABP, the group that is sponsoring our clinical trial of Genentech, has largely completed the addition of new clinical sites to the FACT 1 trial. We now have 27 active -- activated sites participating. We expect several more would get activated soon, but the activity of adding sites is largely completed. We expected that these new sites would immediately increase the enrollment rate for the trial. Today, however, these new sites have not yet impacted the enrollment rate as we -- we're at NSABP expected. As we previously discussed, early-stage cancer patients are more difficult to enroll in clinical trials than later-stage patients, and this makes it harder for NSABP to project with much accuracy the enrollment rate. So as a result, given the slower-than-expected enrollment from these new sites, we now expect interim results will be available from this trial in early to mid-'21 and final results approximately 9 months later.

The FACT 2 clinical trial is evaluating the safety and efficacy of Puma Biotechnology's pan-HER inhibitor, Nerlynx, and chemotherapy is progressing. We expect interim results from the trial in mid-2021 and final results approximately 9 to 12 months later.

And finally, in conjunction with our efforts to collaborate with pharmaceutical companies to field clinical trials, we've expanded our Scientific Advisory Board, or SAB, over the past few months. We're pleased to announce that several nationally recognized medical oncologists have joined our SAB over the past few months. Our new SAB members include Dr. Ben Park, a co-leader of the Breast Cancer Research Program and Director of Precision Oncology at Vanderbilt University Medical Center; Dr. Filip Janku, Medical Director of the Clinical and Translational Research Center at MD Anderson Cancer Center; and Dr. Bora Lim, Assistant Professor, MD Anderson Cancer Center. We're excited about the opportunities to gain their insights as well as to potentially collaborate with them on future clinical trials. The recent addition of Dr. Richard Buller, former VP of Translational Medicine at Pfizer, to our Board of Directors also provides great clinical and translational medicine experience to our company.

So overall, while we're disappointed in the slower-than-expected enrollment rate of our first trials, we remain excited, very excited about the progress we made during the quarter.

So now, I'd like to turn it over to Vicky to review our financial results.

Thank you, Brian. Fourth quarter net loss was $1.81 million or $0.18 per share compared to $1.83 million net loss or $0.18 per share for the fourth quarter of 2018. Net loss for fiscal year 2019 was $7.36 million or $0.72 per share compared to $7.48 million or $0.74 per share for the fiscal year 2018. Because these quarterly net losses include a significant noncash item, which is 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 $1.45 million or $0.14 per share for the fourth quarter of 2019 compared to non-GAAP adjusted net loss of $1.57 million or $0.15 per share for the fourth quarter of 2018.

R&D expenses decreased approximately $0.06 million during fiscal year 2019 compared to fiscal year 2018. This was primarily due to $0.31 million decrease in compensation expense, primarily in payroll taxes resulting from utilization of research and development tax credits as authorized by Path Act, and a decrease of $0.16 million in noncash stock-based compensation. This decrease was offset by $0.41 million increase in clinical validation and laboratory studies, legal expenses related to patent costs and operational and business development activities.

The approximately $0.07 million decrease in G&A during fiscal year 2019 compared to fiscal year 2018, primarily resulted from a decrease in professional fees associated with being a public company. We ended the quarter with approximately $18.7 million of cash and cash equivalents. The net cash used in operating activities for the fourth quarter of 2019 was $1.7 million. This was a result of non-GAAP adjusted net loss of $1.45 million and $0.35 million of working capital changes in prepaid assets and payroll tax receivable, offset by depreciation expense of $0.1 million.

Thank you, Vicky. Operator, we would like now to open the lines for questions.

(Operator Instructions) We'll take first question from Yi Chen with H.C. Wainwright.

This is [Boobalan] dialing in for Yi Chen. I have few questions. So with respect to the enrollment status, I know you briefly mentioned, but maybe you can elaborate a little bit more on that. So what's the current enrollment status for the FACT 1 and FACT 2 studies? And whether there has been any disruption due to the coronavirus outbreak?

Well, I think I summarized the enrollment activity as slower than we expected. And we project based on the enrollment rate, what we expect the availability of reportable data would be. We have not heard from our sites about any impact of the COVID-19 virus. As you would expect, cancer patients' treatment pretty much has to continue without delay. So I wouldn't expect -- although I could be wrong, but I wouldn't expect the treatment for cancer patients to be disrupted. It may be the cancer patients because they're particularly vulnerable to COVID-19 are potentially more cautious and generally more concerned about the risk of COVID-19 to their health because they're being compromised, but I'm speculating. I haven't heard that directly from folks.

Okay. Understood. So maybe when could you announce the collaborations based on the CELsignia tests?

Right. So we expect to announce at least a couple of collaborations before the end of the year. And so we've engaged in discussions with a variety of different pharmaceutical companies and leading medical centers. And those discussions require us to get a lot of different documentation finalized before the collaboration itself can be finalized. And there are a lot of different groups and entities within these organizations that need to sign off on them. So it's a process. But we're far enough along and have enough of them in process that allows us to feel very confident that we'll get several that we think would be very important to us and we think very impactful for the long-term future of the company by the end of the year.

Great. Yes. One final question. The ovarian cancer you mentioned that's pretty exciting. Maybe I'm curious whether you have any additional CELsignia signaling tests to be presented during 2020?

Well, we referenced the addition of a fourth test for breast cancer. We are working towards being able to complete the characterization of that test by the end of this year. So that would be the other tests that we would expect to have data for before the end of the year.

And next we'll go to Per Ostlund with Craig-Hallum.

Brian, I'm going to follow-up to the first question on FACT 1. And I know you've delved into it. And I know that there are certainly frustrations around the ability to predict enrollment cadence and that sort of thing. But just thinking in terms of number of sites, I kind of went back to the third quarter call. And I think at that time, there were -- I believe there was 26 enrollment-ready sites and a handful more in progress. Did any sites fall off? And then I guess the part B to that is in terms of going from 26 to 27, if none fell off and there were a few in process, what are kind of the gating factors to the IRBs and the other bureaucracy that they've got to get through in order to get enrollment-ready?

Right. So I mean, typically, you've got 2 committees internally that need to review and approve these. Some of them do them in parallel, some in sequence. But it's an Institutional Review Board, which we've used with the ethical considerations for fueling the trial. And most sites also have a scientific review committee, which essentially reviews the scientific validity of the hypothesis that is being proposed for study.

Then once you get that approval, you need to go through a series of steps with each of the investigators who may be participating. If it's with a center that has a lot of oncologists that want to participate, you need to get paperwork and training done with all of them, and the center has 30. You can't activate the trial until you have all 30 oncologists trained. So in some ways, you have these very small items that can gate your ability to get the trial going. There's typically an extended process to negotiate or finalize the contract with the institution even though there's a template that can be used to hopefully facilitate, in most cases, those discussions. Lawyers do what lawyers do, and so it's never as straightforward as you would hope.

And so those are the main items. And as some of these committees only meet once a month, depending on the institution, and so the process of just getting an IRB approval can take, as I think we've discussed previously, 6 months just from the time they review the materials, indicate whether how to submit it, who will be the sponsor, they had internal documentation they have to prepare, not just a trial protocol. And so that's the type of thing that takes place. And in some cases, I alluded to this, I mean there is literally paperwork on one doc at a major center that's holding up the whole trial. And we tell them we're willing to get going with 29 docs. I mean we'll take 97% rather than 0 to get things going. But these sites kind of decide that they like everybody to be able to go all at once. That's just how they're organized for some reason. And there's not anything NSABP can do about that.

Sure. Okay. That makes sense. I guess speaking of what people can do, and I know we've talked about this in past calls and so I'd hazard that the answer is no different, but from the standpoint of activating the enrollment, so let's say that the IRBs are all in place and the sites enrollment-ready, from a promotional standpoint, your hand, Celcuity's hands are pretty well tied besides just being able to have documentation about your test basically on hand for the clinicians. What about the clinicians? And what about your pharma collaborators? Where can they step in?

Well, the collaborators, the pharma collaborators typically don't get involved because they're really not supposed to be involved in these things to maintain the proper -- well, this is an institutional -- this is an NSABP trial. So there are certain kind of guardrails that are put up. That's why we're kind of hands -- somewhat kept at arm's length by NSABP with some of the stuff.

But what we try to do, we have materials. We have a patient brochure, which attempts to help the patient understand the potential benefit to them, the potential benefit to all women with breast cancer if the trial is successful. There's limited amount of promotion that you can do because there are no guarantees for these patients. And you can't unduly pressure them. They're vulnerable -- people in a vulnerable state. It's a lot of complexity, so you can't make declarative statements.

So it's a lot of -- as I think I'd mentioned, what you can communicate to these patients is very watered down. And you're really limited in promoting it. You can educate but you can't sell, if you can appreciate that distinction.

You're dependent really as well on how effectively the nurses who do the -- in many cases, manage the patients and kind of get them up to speed, how engaged a particular oncologist is in bringing patients in the loop about clinical trials. So there are a lot of variables that we do not control. And actually, most of the variables we don't control, in fact.

So we're doing what we can. We've gone out and we'll continue to go out where we are able to connect with the docs and the nurses at these sites to meet with them, give them a presentation if we can. In fact, try to get to be top of mind to the extent you can. But along the complaint, again, I'm just rehashing what I think many people have heard either from me or from others.

The bigger challenges in medical research is the challenges of getting patients to participate in clinical trials. And it's particularly challenging when you have a new technology or drug that doesn't have a proven outcome in a -- to point to. If you were evaluating a drug that has already been evaluated and has favorable clinical results, it's a lot easier to enroll patients because you can point to that data. When you don't have that data, you're really speaking to a concept and you point to other data, but it's certainly not as direct as the data from a clinical trial.

So again, I'm just giving people a sense of the dynamic. And we were aware of that dynamic going into this trial, so it's nothing that surprises us. It's just -- I think the surprise has been, call it, the slow general uptick inability to get patients on board. I think because of the clinical trial as well, the criteria of patients is fairly -- well, it's very strict which limits the range of patients that can participate. Patients have to kind of fit a certain set of criteria. They don't necessarily represent the range of women who ultimately would be eligible for the test or for the drugs, if we want to make it to that stage. So the trials, again, you're dealing with a narrower group of patients. Early stage, you don't have the sense of urgency. And you're executing through a number of folks who you have -- in our case, we have really no day-to-day contact with. So we can't affect the visibility very easily, although we do what we can wherever possible.

Okay. That makes sense. Real quickly on Puma, I know that, that -- again, that's -- as of the last call, there had been the delay getting access to Nerlynx. But I think that, that had been remedied at that point. So is this just also kind of enrollment...

There's a similar dynamic. We're talking to them about possibly adding some sites to that trial. West Clinic is a very significant clinic that covers a good chunk of Tennessee, and -- but we think there are some sites that we've had discussions with that would like to participate. So we might be able to essentially affect that enrollment rate by adding sites. But again, that's -- that doesn't happen overnight either. So in that case, because we're working directly with the principal investigator, we can communicate a little bit more directly, and -- but again, the similar type of -- I don't want to say restrictions, but just challenges because, again limited patients necessarily qualifying and the ones that may have other considerations that prevent them from not participating, et cetera.

Last one, real quick. Anything as you look into 2020 from an expense standpoint that deviates from the very steady cadence you've been on the last handful of quarters?

Not that we expect. No. We think -- as you know and we talked about, we want to be good stewards of the capital. And we have very focused R&D projects. And we kind of think do a pretty good job of budgeting those and have a pretty good -- a very handle on all the other expenses. So we feel very comfortable with our cash burn rate staying about where it is.

(Operator Instructions) And we have no further questions in queue at this time.

Okay. Well, I appreciate everybody's participation on the call. We look forward to speaking with you again in a few more months. Take care.

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