Good afternoon, and welcome to the Celcuity First Quarter 2022 Financial Results and Corporate Update conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Robert Uhl with ICR Westwicke. Please go ahead.
Thank you, operator. Good afternoon, everyone, and welcome to Celcuity's first quarter 2022 financial results and business update webcast and conference call. Thank you for joining us. Earlier today, Celcuity Inc. released financial results for the first quarter ended March 31, 2022. The press release can be found on the investor section of our 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. With that, I'd like to turn the call over to Brian Sullivan, Celcuity's CEO.
Thank you, Robert, and good afternoon, everyone, and thank you for joining us today. As always, we appreciate your continued support of Celcuity. On this call, we'll update you on our first quarter financial results and key activities over the next few months. In particular, we'll review the financing transaction we announced this morning and the status of the clinical development program and pivotal phase III trial design for gedatolisib. Today, we announced that we entered into a definitive securities purchase agreement with a premier group of biopharmaceutical investors in a private placement that is expected to result in aggregate proceeds to Celcuity of $100 million. Venrock Healthcare Capital Partners is the lead investor. Commodore Capital, New Enterprise Associates, RA Capital Management, Soleus Capital, and I are also participating.
Investors will purchase shares of common stock and preferred stock at a price per share of $5.75, which is on an as converted to common stock basis. For each share of common stock and each one-tenth of a share of preferred stock purchase, investors will receive a warrant initially exercisable for preferred stock equivalent to 0.4 shares of common stock on an as converted basis. The exercise price of the warrants will be at a 40% premium to the price paid by investors for the initial shares of common stock purchased in the private placement. The preferred stock will be convertible into common stock at the holder's election, subject to certain limitations, such as beneficial ownership and the approval by the company's stockholders to increase the number of authorized shares of common stock issuable.
The warrants are initially exercisable for preferred stock and will convert into warrants to purchase common stock if the proposed increase in the company's authorized common stock is approved by stockholders. The closing of the private placement is expected to occur shortly after the first patient enrolled in our forthcoming phase III study, VIKTORIA-I, receives their first dose of treatment at a clinical site located in the United States, provided that this occurs before December 31, 2022. You'll be able to find additional details regarding the private placement in a Form 8-K that we will soon file with the SEC. We're very pleased to have attracted such a well-regarded group of investors in this very difficult equity capital market.
The erosion in the value of clinical stage biopharmaceutical companies over the past six months and the corresponding drop in financing activity create significant uncertainty for companies like Celcuity. This uncertainty, in turn, can significantly undermine a company's ability to implement its clinical development programs. In light of the uncertainty this challenging capital market creates, we concluded that strengthening our balance sheet was paramount. With the capital we expect to raise from this transaction, we believe we significantly enhance our ability to develop gedatolisib as a new therapeutic option for cancer patients and to create value for our shareholders. Gedatolisib targets PI3K/mTOR, which is considered one of the most important and complex pathways involved in cancer. Blocking PI3K/mTOR efficaciously and safely, though, has been challenging because of its structural complexity and its linkage to key cellular metabolic processes.
Gedatolisib inhibits all four Class I PI3K isoforms and mTOR I and mTOR II. This is the optimal approach biologically because it avoids the cross-activation of uninhibited subunits and resulting drug resistance that can occur with PI3K isoform or mTOR-specific inhibitors. Completely blocking the pathway also enhances the potential to induce synergistic inhibition with other targeted therapies, such as CDK4/6 inhibitors. Gedatolisib's differentiated chemical structure and intravenous formulation results in a very favorable pharmacokinetic profile. The drug is potent at low or sub-nanomolar concentrations and can maintain pathway inhibition with a tiny fraction of a drug compared to approved oral PI3K inhibitors. This results in a safety profile that compares very favorably against approved isoform-specific PI3K inhibitors. Thus, we believe gedatolisib's unique properties position it to realize the significant potential first envisioned for PI3K therapies when the pathway's critical role in cancer was discovered.
The initial potential target population for gedatolisib is patients with HR+, HER2- advanced breast cancer whose disease progressed during treatment with a CDK4/6 therapy. We estimate this represents over 100,000 breast cancer patients globally on an annual basis. To advance the development of gedatolisib in March, we announced the trial design for VIKTORIA-I, a pivotal phase III clinical trial to evaluate the safety and efficacy of gedatolisib in combination with fulvestrant, with or without palbociclib in adults with HR+, HER2- advanced breast cancer, whose disease progressed while receiving prior CDK4/6 therapy. This open-label randomized clinical trial will enroll subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status.
Subjects who meet eligibility criteria and do not have confirmed PIK3CA mutations will be randomly assigned on a one-to-one-to-one basis to receive a regimen of either gedatolisib, palbociclib, and fulvestrant in Arm A, gedatolisib and fulvestrant in Arm B, or fulvestrant in Arm C. Subjects who meet eligibility criteria and have confirmed PIK3CA mutations will be randomly assigned on a one-to-one basis to receive a regimen of either gedatolisib, palbociclib, and fulvestrant in Arm D, or alpelisib and fulvestrant in Arm E. We are receiving the supply of palbociclib for this trial from Pfizer at no cost to Celcuity. The primary endpoints of this study are progression-free survival per RECIST 1.1 criteria as assessed by blinded independent central review. The primary PFS endpoints will be evaluated separately in subjects who lack PIK3CA mutations and in those who have PIK3CA mutations.
This multi-center international trial is expected to enroll patients at clinical sites across the U.S., Europe, and Asia. We expect to activate the VIKTORIA-I study in mid-2022, and that at the first patient receiving their first dose is expected to occur six-10 months later. There are roughly twice as many patients who lack PIK3CA mutations as those that have them. Therefore, PFS for the subjects lacking PIK3CA mutations will be available earlier than the data from those who have PIK3CA mutations. As a result, we expect that the primary analysis for PIK3CA non-mutated patients in Arms A, B, and C will be available in the second half of 2024, and we expect data for the PIK3CA mutated patients from Arms D and E to be available in the first half of 2025.
There are limited options with limited efficacy for patients whose disease progresses on a CDK4/6 inhibitor. Current standard of care treatment includes either a selective estrogen receptor degrader or SERD, such as fulvestrant, or a regimen that combines an mTOR or PI3K alpha-targeted therapy with an endocrine therapy. Finding more effective treatments for these patients is a significant unmet need. To support our development efforts, we received Fast Track designation for gedatolisib for the treatment of patients with HR+, HER2- advanced breast cancer in January. Fast Track designation is granted by the FDA for products which demonstrate the potential to address a serious unmet medical need. This designation will enhance our ability to interact frequently with the FDA to discuss our development plan. Now I'd just like to take a few moments to discuss the diagnostic sides of our business.
You know, CELsignia, our 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 develop companion diagnostics that enable a pharmaceutical company to expand the number of patients eligible to receive their targeted therapy. Our ongoing FACT trials were negatively impacted by COVID-19 related delays during early 2022. Now, with the lower COVID caseload, enrollment activities are resuming for these trials, and we expect to receive interim results from the FACT I and FACT II trials in the first half of 2023. I'd like now 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 first quarter of 2022, and I invite you to review the 10-Q, which will be filed today for a more detailed discussion. Our first quarter net loss was $7.9 million or $0.53 per share, compared to $2.8 million net loss or $0.25 per share for the first quarter of 2021. Because these quarterly net losses include significant non-cash items, including stock-based compensation and interest, we also include in our press release non-GAAP adjusted net loss for the quarter ending March 31, 2022.
Our non-GAAP adjusted net loss was $7 million or $0.47 per share for the first quarter of 2022, compared to non-GAAP adjusted net loss of $2.3 million or $0.21 per share for the first quarter of 2021. R&D expenses were $6.7 million for the first quarter of 2022, compared to $2.2 million for the first quarter of 2021. The approximately $4.5 million increase during the first quarter of 2022 compared to the first quarter of 2021 resulted primarily from the development of gedatolisib. Employee related expenses, including consulting fees, accounted for $1.6 million, including $0.2 million in non-cash stock-based compensation. The remaining increase of $2.9 million is related to costs for existing clinical trials and for activities supporting the initiation of the VIKTORIA-I pivotal trial.
General and administrative expenses were $0.8 million for the first quarter of 2022 compared to $0.6 million for the same period in 2021. The approximately $0.2 million increase in G&A during the first quarter of 2022 compared to the first quarter of 2021 arose primarily from employee-related expenses, including $0.1 million in non-cash stock-based compensation. Net cash used in operating activities for the first quarter of 2022 was $5.9 million, compared to $2.5 million for the first quarter of 2021. This was the result of non-GAAP adjusted net loss of $7 million, offset by working capital changes of approximately $1 million and depreciation expense of $0.1 million.
We ended the quarter with approximately $78.3 million of cash and cash equivalents compared to cash and cash equivalents of $84.3 million on December 31, 2021. Today, as Brian mentioned earlier, we entered into a securities purchase agreement with investors via a PIPE for gross proceeds of $100 million. The funding will occur in conjunction with the date that a patient enrolled in VIKTORIA-I receives their first dose of treatment. Including the additional proceeds from the PIPE, we expect our cash will support our activities through the back half of 2025. I will now hand the call back to Brian.
Thank you, Vicky. We believe gedatolisib has great potential to provide more effective treatment for women with breast cancer as well as other cancers in the future. We've built an incredibly talented team of drug developers with deep experience in guiding drug candidates through pivotal phase III clinical trials. We're hopeful this will represent the first of many opportunities for us to impact the lives of cancer patients. Operator, I'd like now to open the call for questions.
We will now begin the question and answer session. To ask a question, you may press Star, then one on your telephone keypad. If you're using a speaker phone, please pick up your handset before pressing the keys. To withdraw your question, please press Star then two. The first question comes from Maury Raycroft of Jefferies. Please go ahead.
Hi. Congrats on the update, and thanks for taking my questions.
Welcome.
To start off, just wondering if you could talk more about progress you've made with preparation to get the phase III started in the middle of 2022. You've mentioned potential for 175 sites in 15 countries. Can you talk more about the plan for site rollout on a country-by-country basis?
Sure. Thanks for the question, Maury. Our preparation is on track. We are laying the groundwork to be able to initiate the study in the next few months and then to begin enrollment activities once the sites are activated. You know, we'll focus initially on countries in the U.S. and in Asia, which can have shorter regulatory timelines and then move out to the rest of Europe. You know, as is the case with any of these studies, you know, the sites roll out over a fairly extended period of time.
We've incorporated, you know, that site rollout timeline in our enrollment projections and, you know, our determination of when we expect to get, you know, primary analysis in the second half of 2024.
Got it. Maybe just a quick follow-up on that one. Getting that first patient dose, is that gonna be in the U.S., or do you think it could be at an Asia site?
It most likely the U.S.
Okay. With the new financing, just wondering if you can clarify if you'll invest in developing gedatolisib outside of the phase III. I think on the last call, you mentioned a potential life cycle development update in the first half of 2022. I'm just wondering if you could talk more about that.
Sure. The financing, you know, was we think a great event for us because it certainly beefs up our balance sheet, provides flexibility. It allows us to have some margin for error, which I think in this environment everybody's looking for. It also allows us to, you know, think about the next steps in other indications. You know, it's possible, you know, to initiate, you know, phase I-B studies, you know, at a relatively small scale that can, you know, be, you know, hypothesis confirming or not, but essentially allow you to generate data in different indications. This funding, you know, will allow us to begin that type of work as well.
Got it. Okay. That could start this year potentially, or is that something we wait to learn more about next year?
Just, we haven't provided details on that.
Okay.
As far as the life cycle development plan, you know, just with this financing and with, you know, the focus on the phase III, you know, we'll probably provide, you know, life cycle update, you know, closer to sometime in the third quarter.
Got it. Okay. Okay, congrats again, and thanks for taking my questions.
Oh, you're welcome. Thanks.
The next question comes from Gil Blum of Needham & Company. Please go ahead.
Hi, everyone. I'd like to add my congratulations on the successful financing. First of all, just to make sure I heard this correctly. Timeline for the pivotal data is now second half 2024 and full data in the first half of 2025. Did I get that right?
Well, we have two primary analyses. You know, we'll have you know the primary analysis for the PIK3CA wild type patients who lack mutations in the you know second half of 2024. Separate primary endpoint data for patients with PIK3CA mutations in the first part of 2025.
Okay. Thanks for the clarification. I know this is maybe a little. Just from the cash run rate perspective, it seems you have a run rate all the way through this readout. Does that leave you with sufficient cash for strategic optionality after the first readout?
Well, you know, we plan to have cash, you know, in excess of what's needed to achieve our first primary readout. Obviously, you know, one of the purposes of the cash is just to make sure we have sufficient cash to handle bumps in the road. Not that we're anticipating them, but just, you know, again, we wanna have a robust balance sheet. Once we have the primary analysis, you know, if it's favorable as we hope, you know, we would likely have a variety of options that we could consider.
Okay. That makes sense. Maybe a last one. I know this is relatively unlikely. Does this financing limit in any way strategic options for monetization of future revenues in gedatolisib? Are there like any or anything like that?
No, this is a financing that'll end up, you know, with the issuance of what will ultimately be common shares, and there's no restrictions and, you know, or other strings associated with it. It doesn't, you know, create any restrictions on our ability to make decisions in the future.
Okay. Just wanted to make sure. I knew that was unlikely. Thank you for taking our question.
You're welcome.
As a reminder, if you have a question, please press star one. The next question comes from Alex Nowak of Craig-Hallum Capital Group. Please go ahead.
Great. Good afternoon, everyone. This is Connor on for Alex. I guess first, a couple weeks back, the FDA had a discussion or a meeting on PI3K trials kinda happening around the country. It seemed pretty obvious that the meeting was kinda only applicable to hematological drugs and, you know, the outcome of the meeting was really requiring a trial design like yours. I guess is there any sort of read-through to data from that meeting?
No. Thanks for the question. That meeting was very explicitly focused on a particular class of PI3K drugs, delta inhibitors that are designed and intended for hematological indications. The focus of the meeting was around the regulatory pathway, accelerated approval, that those drugs had used to, you know, initially get approved for marketing. One of the obligations associated with an accelerated approval is doing a follow-on randomized study to confirm the findings. I don't think any of those drugs had done confirmatory studies. I think the agency was highlighting a concern that these drug companies haven't followed through with their commitments that are embedded in the accelerated approval process.
You know, those drugs also have a different safety profile than our drug and those, you know, variety of other factors. Really, our drug nor alpelisib, which is a PI3K alpha inhibitor that's approved for breast cancer, you know, those, you know, our drugs weren't part of that conversation. The reason is that we're pursuing a normal regulatory path for approval for you know, this indication, and we're doing a randomized study. None of those drugs, you know, met those conditions. They did accelerated approvals with single arm studies.
Sure. Okay. All right. That makes sense. I guess on the CELsignia side, can we expect any updates here, you know, this year on upcoming collaborations and things like that? Or does the focus really remain on data for now?
I mean, we have the trials ongoing, and, you know, we're continuing to pursue those. We also have studies that we'll be pursuing, you know, that combine CELsignia and Geda. That'll, you know, be, we think, something that could be very interesting. And then obviously, you know, our, you know, the budget that we're spending and the opportunity, you know, at hand with gedatolisib we think is in the near term, you know, the most significant opportunity we have.
Yeah. No, that makes perfect sense. Then I guess one for Vicky, just a real quick one. Following the placement announced this morning, just wanna make sure my math is correct. What is the new fully diluted share count?
We'll have those details in the 8-K that will follow, with that, we'll be filing later today or tomorrow.
Okay. All right. That's all.
Yeah.
Thank you for the update.
You're welcome.
Seeing that there are no further questions, I would like to turn the conference back over to Brian Sullivan for closing remarks.
Great. Well, thank you again for participating in our call today. We'll be at the Craig-Hallum and Jefferies investor conferences in June and hope have a chance to run into some of you there. If you have any additional questions, please feel free to contact us. Hope everyone has a good evening. Goodbye.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.