Good day and welcome to the Celcuity Third Quarter 2022 Financial Results Conference Call. [Operator Instructions] I will now turn the conference over to your host, Robert Uhl with ICR Westwicke. Mr. Uhl, you may begin..

Thank you, operator. Good afternoon, everyone, and welcome to Celcuity's third quarter 2022 financial results and business update webcast and conference call. Earlier today, Celcuity Inc. released financial results for the third quarter ending September 30th, 2022. The press release can be found on the Investors section of the website.

Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer, who will be available during Q&A. Before we begin, I would 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 events or results may differ materially from those projected in the forward-looking statements.

Such forward-looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non-GAAP financial measures.

These non-GAAP measures are used by management to make strategic decisions, forecast future results and evaluate the Company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the Company's ongoing core operations and prospects for the future.

You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release. And with that, I'd like to turn the call over to Brian Sullivan, CEO of Celcuity..

Thank you, Robert. Good afternoon, everyone, and thank you for joining us today. I'm pleased to report that we made significant progress in the third quarter, advancing VIKTORIA-1, our Phase 3 clinical trial.

VIKTORIA-1 is evaluating the safety and efficacy of our lead drug product candidate, gedatolisib, an investigational pan-PI3K/mTOR inhibitor for the treatment of HR-positive/HER2-negative advanced breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor.

One of our key objectives for the third quarter was completing the selection of the clinical trial sites that will participate in this registrational study. We achieved this objective and selected approximately 200 clinical trial sites located in North America, Europe, Asia, Australia and Latin America.

Throughout the site selection process, we were very encouraged by the significant interest we received from sites and principal investigators across the world in participating in this study. Many of the world's most respected breast cancer clinical researchers are participating.

The next critical objective for our team is to activate the selected sites, so that we can begin enrolling patients. Celcuity is now working closely with our selected sites to assure completion of regulatory and operational activities at each site as planned.

Our first site was activated in the third quarter, and we are on track to achieve our site activation goals across all regions.

We also remain on track with our prior guidance of administering the first patient dosed by the end of the year, and we continue to expect data for the PIK3CA non-mutated patients to be available in the second half of 2024 and data for the PIK3CA mutated patients to be available in the first half of 2025.

As we have previously reported, during the third quarter, the U.S. FDA granted breakthrough therapy designation to gedatolisib for the treatment of HR-positive/HER2-negative advanced breast cancer. This designation allows for more intensive guidance from the FDA and a potentially accelerated review time if relevant criteria are met.

Gedatolisib previously received Fast Track designation from the FDA in January 2022. We estimate that this initial potential target patient population represents over 100,000 breast cancer patients globally on an annual basis.

Current standard of care for these patients include endocrine therapies such as fulvestrant and regimens that combine fulvestrant with an mTOR specific or PI3K alpha-specific targeted therapy. These therapies offer only modest progression-free survival periods and in the case of the approved PI3K alpha inhibitor, a very challenging safety profile.

Also during the quarter, an abstract with updates to results from our Phase 1b advanced breast cancer study was accepted for a Spotlight Poster Discussion presentation at the 2022 San Antonio Breast Cancer Symposium in December.

Preliminary data from this study was presented last year at a Spotlight Poster Discussion and included data from the cohort of second and third-line patients, who received the 3 weeks on, 1 week off dosing schedule that we're using in our Phase 3 study.

For patients in this cohort, the objective response rate was [63%], and the median progression-free survival period was 12.9 months. These results compare very favorably to historical controls from current standard of care therapies. Compelling safety data was also reported for this cohort.

Only 1 patient or 4% of the total, discontinued treatment due to an adverse event. In addition, only 7% of patients reported grade 3 or grade 4 hyperglycemia and no patients discontinued treatment due to hyperglycemia. Now I'd like to move on to the diagnostic side of our business.

CELsignia, Celcuity's third-generation diagnostic platform, identifies the underlying cellular activity dysregulated pathway signaling that may be driving a patient's tumor, so that a matching targeted therapy can be identified.

Our strategy is to combine to develop companion diagnostics that enable a pharmaceutical company to expand the number of patients eligible to receive their targeted therapy. We expect interim results from the CELsignia platform FACT-1 and FACT-2 trials in early-stage HR-positive/HER2-negative breast cancer patients in mid-'23.

And finally, I'd like to welcome Dr. Polly Murphy to our Board of Directors. Polly has over 20 years of business development and commercialization experience at leading global pharmaceutical companies, including 12 years with positions of increasing responsibility at Pfizer.

We're looking forward to having the perspective for broad industry experience she’ll bring to our Board. Now I'd like to turn the call over to Vicky Hahne, our CFO, to review our financial results..

Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the third quarter of 2022, and I invite you to review the 10-Q, which will be filed later today for a more detailed discussion.

Our third quarter net loss was $10.9 million or $0.75 per share compared to a $6 million net loss or $0.41 per share for the third quarter of 2021.

For purposes of calculating net loss per share, the reported net loss of $0.75 per share included an additional $0.02 loss per share related to an approximately $0.3 million deemed dividend resulting from a warrant modification.

Because these quarterly net losses include significant non-cash items, including stock-based compensation and interest, we also included in our press release non-GAAP adjusted net loss for the quarter ending September 30th, 2022.

Our non-GAAP adjusted net loss was $9.5 million or $0.63 per share for the third quarter of 2022 compared to non-GAAP adjusted net loss of $5.1 million or $0.35 per share for the third quarter of 2021. R&D expenses were $9.6 million for the third quarter of 2022 compared to $5 million for the third quarter of 2021.

The increase of approximately $4.7 million during the third quarter of 2022 and was driven by $1.2 million related to employee expenses and the remaining $3.5 million increase primarily related to activities supporting the VIKTORIA-1 pivotal trial.

General and administrative expenses were $1 million for the third quarter of 2022 compared to $0.6 million for the same period in 2021. The increase of approximately $0.4 million was driven primarily from non-cash stock-based compensation.

Net cash used in operating activities for the third quarter of 2022 was $9.3 million compared to $4 million for the third quarter of 2021. This was a result of non-GAAP adjusted net loss of $9.5 million, offset by working capital changes of approximately $0.1 million and depreciation expense of $0.1 million.

We ended the quarter with approximately $57.5 million of cash and cash equivalents compared to cash and cash equivalents of $84.3 million on December 31st, 2021. I will now hand the call to Brian..

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

[Operator Instructions] And our first question today will come from Maury Raycroft with Jefferies..

Congrats on the progress, and thanks for taking my questions. I've got 2 questions. So prior, you have said the study would be [run at] about 175 sites worldwide from 15 countries, and today, in the update, you're mentioning that you've selected 200 sites.

Can you clarify if you'll still only run the study at about 175 of the 200 selected sites or if you need all 200 sites and maybe talk about reasons for why you would need 200?.

When we first announced the study design, I think we indicated that we would do 175-plus sites. And so at a minimum, we estimated that we wanted 175 sites, but that we, if we're able to get qualified sites and get more of them, we wanted to do that. And it generally just reflects the significant interest we had.

And we think the benefits of the Company will, in effect, enhance enrollment because you have more active sites with the broader enrollment population that they'll be available..

That makes sense.

Do you think could it actually -- does it make enrollment more robust? Or could it potentially accelerate the time lines some? What are your thoughts on that?.

We don't want to change our guidance. It's certainly having more sites increases the probability of meeting an enrollment target. I would think of it that way..

And then one other question. Just wondering if you could provide specifics on what needs to be completed in order to dose that first patient by the end of the year.

And at your first activated site, can you comment on whether some patients have been enrolled at this point?.

Sure. Well, we haven't enrolled our first patient yet. And so we just activated our first site. And a variety of activities are required once we initiate a study. And one of the first steps is selecting your sites, which is a formal process.

Once you've selected a site to participate in the trial, certain regulatory, financial, operational documentation must be approved, study must then be approved by central or institutional IRB. In some cases, approval from an Independent Ethics Committee or Scientific Committee is also required.

So all these steps have to be completed before a site can be considered active. And then once a study -- a site is active, they begin working with their patient population. Our patient population has an extended duration of treatment with their first-line treatment that's typically a CDK4/6 and inhibitor and it occurs over a period of time.

These aren't patients that are necessarily immediately available. But over time, as you activate more sites, you get into a very predictable enrollment pattern..

And we'll take our next question from Boris Peaker from Cowen..

I have 2 questions. One on the VIKTORIA trial and the other one on the CELsignia assay.

On the VIKTORIA trial, I'm just curious, have you discussed the trial design with EMA? I just want to know what -- if the study is successful, would it serve as a basis for approval in Europe as well?.

Yes. And we discussed that in the second quarter, but we saw it specifically to get scientific advice from EMA. They have a formal process. We received their feedback at end of May. And based on that feedback, we made the decision to add Arm F, which is an arm 2 study, gedatolisib plus fulvestrant.

And essentially, their input or recommendation was for us to essentially have the study for PIK3CA mutated patients, mirror the study for PIK3CA wild-type patients..

And on the CELsignia, can you set expectation of what the FACT-1 and FACT-2 studies need to show in order to get the assay approved?.

Sure. The objective of that study is to demonstrate or to show that the pathological complete response rate with our study treatment in the patient population that CELsignia is identifying will be superior to historical controls.

And so the target population, who are HER2-positive/HR -- HER2-negative/HR positive historically have a PCR rate of around 11%. Standard of care treatment for these early-stage patients in the neoadjuvant setting is chemotherapy. And so our assumption is that or the hypothesis is that we can demonstrate superiority through that historical control..

But is there any kind of a specific metric that the FDA wants to see that you may be discussed with the agency? Or is it just....

Pathologic complete response is the endpoint..

And we'll go next to Gil Blum with Needham & Company..

This is [Chan] for Gil.

We just want to ask when are you planning to start commercial preparations? And if the cost of the commercial preparations are included in the cash guidance?.

The commercial preparations go through an evolution, obviously, at this stage, we're assessing more holistically the approach that we want to take. There are a variety of different options, a variety of different approaches that could be taken. So we begin that evaluation.

I think the more intensive expenditures would begin 12 months to 18 months prior to expected approval. So we're a ways off from that. And in the back period of time, as we get closer to that, we would expect to see some of those expenses ramp and some of those expenses are included in the cash flow..

[Operator Instructions] And we'll take our next question from Alex Nowak with Craig-Hallum..

This is Connor on for Alex. I guess, first, a couple on CELsignia and then 1 or 2 on VIKTORIA. First on CELsignia, I mean FACT-1 and FACT-2 interim still reading out mid-2023, that all sounds good.

Can you just kind of speak to enrollment trends into those trials, as COVID has kind of abated here? And then second part of that question, just -- I mean, what about FACT trials 3, 4 and 5? I mean, where do they stand? And what's the potential time lines there?.

Sure. Those -- so regarding FACT-1 and FACT-2, the enrollment has gotten back on track now that COVID seems to have abated or at least healthcare systems have adjusted to it. And that's why our guidance remains the same for that interim analysis. As far as the other FACT studies, those are in a metastatic setting.

Those were set up just as COVID was coming to fore. And so those basically got significantly affected by that, as you would imagine. And so those would be expected to have potentially interim data in later '23, early '24..

Yes. And then second on VIKTORIA, with the first site activated, is there anything you can offer us on maybe the cadence of site activation so far into Q4? And then maybe, I guess, at what point do you feel comfortable with the sites in U.S. and Asia to the point, where you can kind of move to Europe and Latin America and the other geographies..

Sure. Well, all those -- all the activities across the world are occurring simultaneously, and different countries have different requirements. So the process varies by country. The time lines will vary by country as well just because of differences in some of those requirements.

And so we're proceeding a pace across all those -- the countries for all the sites we've selected. We expect that process to take multiple months to complete. It's something that doesn't happen immediately.

I outlined the process that's required where financial operational documentation has to be prepared and approved, each site needs to either get a central IRB to approve the study or an institutional IRB, in some cases, particularly hospitals and larger institutions, Independent Ethic Committees -- Ethics Committees will need to approve or Scientific Committee.

So all those factors come into fore. And we have identified a time line for each of our sites. We have a projection that incorporates those site activation projections into our enrollment projections. And so we're on track with what we've initially projected for our site activation and the enrollment that will follow..

Maybe if I could just squeeze one more in. I mean, with the first patient expected to be dosed by year-end and the private placement kind of being based off of that, the first patient needs to be dosed by December 31st. Maybe just speak to -- speak to your confidence level there that you can indeed get a patient dosed by December 31st..

No, we're very confident. We're activating sites, and that's kind of the plan. That's really -- feel very good about that..

[Operator Instructions] And there are no further questions at this time. I'd like to turn the call back to Brian Sullivan for any additional or closing remarks..

Thank you, everyone, for attending our call. We appreciate your interest and look forward to catching up with you over the next few months. Goodbye..

And this concludes today's conference call. Thank you for attending..