Celcuity Inc.

Good afternoon, ladies and gentlemen, and welcome to the Self-Q&A First Quarter 2026 Financial Results Call Webcast. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. I would now like to turn the conference over to Jody Seavers, Corporate Communications and Investor Relations at Salcuity. Please go ahead.

Thank you, Matthew, and good afternoon, everyone. Thank you for joining us to review Salcuity's first quarter 2026 financial results and business update. Earlier today, Salcuity released financial results for the first quarter ended March 31st, 2026. The press release can be found on the investor section of Salcuity's website. Joining me on the call today are Brian Sullivan, Delcuity's Chief Executive Officer and Co-Founder, Vicki Hahn, Chief Financial Officer, as well as Igor Gorbachevsky, Chief Medical Officer, and Eldon Mayer, Chief Commercial Officer, who will also 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 involved 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 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 will turn the call over to Brian Sullivan, CEO of Cellcurity. Please go ahead, Brian.

Thank you, Jody, and good afternoon, everyone. Thank you for joining our first quarter 2026 operating and financial update conference call. We continue to make great progress as we prepare for the potential approval and commercial launch of Get It Solicit in the third quarter. Achieving these milestones would be a pivotal moment for the women with advanced breast cancer who need new therapeutic options. With the groundbreaking data we have previously reported from the WildSide cohort and the recent announcement of positive data from the Mutant cohort of our Victoria 1 study, we believe Gattasilissa is well-positioned to become a new standard of care second-line therapy for patients with HR-positive or G-negative advanced breast cancer. It's been an eventful past few months for Cellcuity. Last week, we reported positive top-line results for the PIC3CA mutant cohort of the Phase 3 Victoria 1 clinical trial, and we look forward to presenting detailed results at a late-breaking abstract oral session at the 2026 ASCO meeting on June 2nd. Given the timing of our ASCO presentation, we'll not be answering questions regarding these results during the Q&A portion of our call. Second, this morning, we announced two important updates to our clinical development plans. First, we announced the expansion of our Phase 3 Victoria 2 trial to include a second study, evaluating data solicit as first-line treatment in patients with endocrine-sensitive, either a positive or two negative, advanced breast cancer. We're now positioned to evaluate nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIC3CA status. And this offers the potential to advance the standard of care for the approximately 90,000 women each year who are newly diagnosed in the U.S., with HR-positive, HER2-negative advanced breast cancer. And secondly, we also announced this morning that we are advancing the development of a get-it-to-licit formulation for subcutaneous injection and that we have submitted our first patent application to the U.S. Patent and Trademark Office. The subcutaneous formulation is aimed at supporting potential future indications for get-it-to-licit regimens that may result in duration of treatment periods greater than several years. And finally, we remain optimistic about the outcome of the FDA's review of our NDA Assuming our NDA is approved, we intend to submit the FDA a supplemental new drug application based on the results of the PIC3CA mutant cohort in Victoria 1 and to submit Victoria 1 data for both the mutant and wild-type cohorts to other global regulatory authorities following the SMDA submission. Turning now to the top-line results for the PIC3CA mutant cohort. The primary efficacy analysis of Getazolizib combined with Fulvestrin and Tablacyclib, which we refer to as the Getazolizib triplet, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to Alpalypsib, which is a PN3K alpha inhibitor, and Fulvestrin. The secondary endpoint of Getazolizib combined with Fulvestrin, which we refer to as the Getazolizib doublet, which was not part of the primary efficacy analysis in a hierarchical order, demonstrated a statistically significant and clinically meaningful improvement in PSS compared to alpalypsis and fulvestrin. Both gadotelicid regimens were generally well-tolerated with manageable safety profiles and no new safety signals. When considered alongside previously presented data from the Victoria 1 PIK3CA wild-type cohort, the gadotelicid regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of the patient's tumor. And we believe the results from the Victoria 1 study validate our pioneering approach to targeting cancers involving the PI3K, AKT, mTOR, or PAM pathway. And researchers have sought for nearly 20 years to develop a drug that blockades this pathway comprehensively without inducing unacceptable levels of toxicity. Victoria 1 represents the first phase 3 study to demonstrate that comprehensively blocking the PAM pathway can significantly improve outcomes for patients with PIK3CA mutations compared to therapies only targeting a single component of this pathway. Now, as we've previously reported, the Victoria 1 PIK3CA WildSide cohort set several new benchmarks for clinical trials evaluating patients with HR-positive, HER2-negative advanced breast cancer. The hazard ratios for the GETA-solicit triplet and doublet were more favorable than has ever been reported by any Phase III trial for patients with HR-positive, HER2-negative advanced breast cancer. The 7.3 months incremental improvement in median PFS for the get a triplet over fulvestrin is higher than has ever been reported by any Phase III trial for patients with HR-positive, HERC-negative, advanced breast cancer, receiving at least their second line of endocrine therapy. And the 17.5 months of median duration of response for the get a thylacine triplet and 31% incremental increase in the objective response rate relative to the control for the get a triplet are the highest reported for an endocrine therapy-based regimen in the second-line setting. Now, both regimens were found to have a manageable safety profile that was well tolerated by patients, as evidenced by the 2% and 3% adverse event-related discontinuation rates for the triplet and doublet, respectively. We've also previously reported safety and tolerability-related analyses. In particular, for patients who experienced stomachitis, we reported that measures to mitigate it were generally effective, the median time to improvement from first onset to a lower grade of stomatitis for patients with grade 2 or grade 3 stomatitis who receive the get a solicit triplet was 12 and 14 days, respectively. Now, to characterize the overall tolerability of the get a solicit regimens, we reported results from patient-reported outcomes to capture a patient's perception of their overall well-being. A particular note was the stability of the patient's assessment of their well-being relative to their well-being prior to starting treatment with get a solicit Over the first eight cycles of treatment with getosilicib, patients reported no degradation in their sense of well-being, which we believe provides meaningful evidence that patients treated with getosilicib tolerate it well. Now let's talk about our Victoria 2 study. Results from the PIC3CA wild-type and mutation cohort of our Victoria 1 study demonstrated the benefit of getosilicib combination treatment in the second-line setting of HR-positive, protein-negative advanced breast cancer. And these results confirm the role the PAM pathway plays in patients with or without PIK3C mutations and the importance of multi-target inhibition of this pathway. Additionally, results from our Phase Ib clinical trial provided strong evidence that the PAM pathway is also an important disease driver in treatment-naive patients with advanced breast cancer. In the early phase study that we performed, we evaluated betafilicid plus toliciclib and leprazole, as first-line treatment in patients with endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer. Median progression-free survival, or PFS, is 48.6 months. It compares favorably to historical data of approximately 25 months for ribocyclob plus letrozole. And the objective response rate was 79%, which, again, compares favorably to historical data of 53% for ribocyclob plus letrozole. In light of the positive results for the PIC3CA wild-type and mutant cohorts of VICTORIA-1 and the promising preliminary data for a get-a-source of triplet in this first-line treatment, we have high confidence that we can successfully develop a get-a-source of triplet for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIC3CA status. Successful development in the first-line setting would offer the potential to advance the standard of care for the approximately 90,000 women each year who were diagnosed with late-stage HR-positive, HER2-negative advanced breast cancer in the United States. So to achieve this goal, we amended several important elements of the Victoria 2 study design. First, Victoria 2 will now evaluate the safety and efficacy of patients with endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer, in addition to those with endocrine-resistant disease. which was the original study. Endocrine-sensitive patients represent approximately two-thirds, or 60,000, of the 90,000 women in the U.S. newly diagnosed with advanced breast cancer each year. Current standard of care therapies for these patients provide median PFS of approximately 25 months. The patients will be assigned manually, according to their endocrine sensitivity status, to either study one, if they're endocrine-resistant, or study two, if they're endocrine-sensitive. and subsequently be randomized to a treatment arm. Each study will have independent statistical analysis plans that will include separate primary endpoints. Second, the primary efficacy analyses for both Study 1 and Study 2 of Victoria 2 will evaluate the entire Intention Tree population enrolled in their respective study. Primary endpoints for patient cohorts based on their PIC3CA status are no longer included. And this revision of the primary analyses allowed us to reduce the sample size for Study 1. the endocrine-resistant study, from 638 patients to 440 patients without affecting the power of the analysis. And third, the control arms for study one and study two will evaluate ribociclib combined with either fulvestrin for study one or lecozole for study two. Study one will enroll patients with treatment-naive endocrine-resistant advanced breast cancer. And these are women whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. It's a more aggressive disease. The trial will evaluate the efficacy and safety of Gettyslicib combined with Pabo and Fulvestrin in arm A and compare that to Rivasiclib combined with Fulvestrin in arm B. We expect to have top-line data by the end of 2028 for this study. Study 2 is expected to enroll approximately 740 subjects with treatment-naive endocrine-sensitive advanced breast cancer. And these are women whose cancer relapsed to progress 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease who've had no prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gadotelicib combined with polycyclib and letrozole and compare itself to ribociclib combined with letrozole. The clinical trial primary endpoints for the Victoria 2 clinical trial are progression-free survival for Rhesus 1.1 criteria, as assessed by blinded independent central review. And we expect top-line data for the study 2 in the under-consensual patients to be available by 2030. And prior to finalizing this amended Phase 3 trial design, we conducted a type B meeting with the FDA to obtain their feedback and to gain alignment on these planned amendments. Now knowing that our life cycle plan would eventually include indications that may offer several years of progression-free survival benefit, we initiated a program to develop a subcutaneous formulation of Geta-Felicitin that would enable a patient to receive Geta-Felicitin as an injection, as an alternative to an infusion. And this program is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of getosilicib. And this work has resulted in a submission to the United States Patent and Trademark Office of our first patent application for an injectable formulation of getosilicib. Now let's turn to our Phase 1b2 trial that's evaluating getosilicib in combination with barolutamide and then with metastatic castration-resistant prostate cancer. We presented data for the Phase 1b portion of the study at a poster presentation at ESMO last year. And in this portion of the trial, 38 patients were randomly assigned to receive standard doses of veraludamide twice daily and either 120 milligrams of getotelicib in arm 1 or 180 milligrams of getotelicib in arm 2. The combination of getotelicib and veraludamide was generally well-tolerated in the trial and mostly low-grade treatment-related adverse events. No dose-limiting toxicities were observed in either arm No patients discontinued study treatment due to an adverse event. For all patients treated, the six-month radiographic PFS rate was 67%, and the median radiographic PFS was 9.1 months. And these results compare favorably to historical results of a 40% six-month radiographic PFS rate for patients with metastatic testation-resistant prostate cancer or treated with an androgen receptor inhibitor as second-line treatment. Now, enrollment of Patients in the dose escalation portion of the trial is ongoing. We expect to provide a data update at an upcoming medical conference. Now, as we near what we hope is an FDA approval for Get It Felicit in 2026, our efforts to prepare for the potential launch of Get It Felicit continue to ramp up per our strategic launch plan. And we began laying the groundwork for a potential Get It Felicit launch over 24 months ago. Last call, we mentioned that we had largely completed building the commercial organization, except for the sales force. I'm excited to report now that we have since hired and onboarded all of our oncology sales specialists. They're a very experienced crew. On average, these individuals have 24 years of experience selling pharmaceuticals and 16 years of experience in oncology. They're an incredibly talented group of individuals who have a strong track record of successfully launching novel oncology therapeutics. And key efforts today include continuing our extensive outreach across the country to payers, strategic accounts, which include health systems, integrated delivery networks, and community oncology practices. We're also very encouraged by the results of research. We continue to feel to gauge the willingness of community and academic oncologists to prescribe Geta-Felicib should it get approved. And these results make us optimistic about the possibility of establishing Geta-Felicib as the new standard of care in the second-line setting for HR-positive, HER2-negative advanced breast cancer in the wild-type patient population. Now, with positive results from our study with patients whose tumors have PIK3C mutations, we expect the Gettys-Lissab combination regimens to be uniquely positioned to provide second-line therapy for patients regardless of their PIK3C mutation status. Based on the analysis of published epidemiological data, we estimate there are 37,000 patients in the U.S. receiving second-line treatment for HR-positive HER2-negative advanced breast cancer. And using internal duration of treatment estimates and pricing assumptions consistent with currently available novel therapies, therapeutics for breast cancer, we estimate the total addressable market for Get It to Listen in the second-line setting is more than $5 billion annually. Given the significant penetration our research is suggesting we can achieve, we believe it's reasonable to estimate that a second-line indication for Get It to Listen can potentially generate peak revenue of up to $2.5 billion annually. And so the progress we've made today is encouraging, and we look forward to providing you with updates over the next few quarters. Get It Solicit is well-positioned to address critical needs in the second-line space with its unique mechanism of action and potential first-in-class and best-in-class safety and efficacy profile. And this gives us an exciting opportunity to event potential blockbuster indications in breast cancer and prostate cancer while also aggressively preparing for and potentially launching Get It Solicit commercially should we receive FDA approval. And now I'd like to hand the call over to Vicki to review our finances.