Celcuity Inc.

Good afternoon, ladies and gentlemen, and welcome to this second quarter 20-25 Financial Results webcast and conference call. 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're requiring immediate assistance, please press star zero for the operator. I would now like to turn the conference over to a poor artillery with IC or healthcare. Please go ahead.

Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Salcuity's second quarter 2025 financial results and business update. Earlier today, Salcuity Inc. released financial results for the second quarter ended June 30th, 2025. The press release can be found on the investor section of Salcuity's website. Joining me on the call today are Brian Sullivan, Salcuity's chief executive officer and co-founder, Vicky Han, chief financial officer, as well as Igor Gorbachevsky, 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 would now like to turn the call over to Brian Sullivan, CEO of Selcuity. Please go ahead.

Thank you, Apoorva, and good afternoon, everyone. Thank you for joining our second quarter financial results conference call. The past few months have been eventful ones for Selcuity. We achieved several significant milestones. And we believe these milestones lay the foundation for us to potentially establish gadotelicib as a new standard of care therapy for patients with HR-positive, HER2-negative, advanced breast cancer. First, and most importantly, of course, was the positive top-line data we've reported from the PIK3CA wild-type cohort of our Phase III Victoria I clinical trial. In patients with HR-positive, HER2-negative, PIK3CA wild-type, advanced breast cancer, gadotelicib plus fulvestrin and pavaciclib or the get a solicit triplet, and get a solicit plus fulvestrin, or the get a solicit doublet, met the study's two primary endpoints by demonstrating statistically significant and clinically meaningful improvement in progression-free survival, or PFS, versus fulvestrin. The reported hazard ratios and improvements in median PFS are unprecedented in HR-positive HER2-negative advanced breast cancer. We believe these data validate our hypothesis that the role of the PIK3CA or PI3K, AKT, mTOR, or PAM pathway as a cancer driver is not solely a function of the presence of a pathway mutation. And the implications are profound for patients with HR-positive virtue-negative advanced breast cancer as we seek to advance Get It to Listen as a therapeutic option for patients with or without PIK3CA mutations in both the second-line and first-line settings. Second important milestone achieved was the dosing of the first patient in our Phase III Victoria II clinical trial. And this trial is evaluating Gettysalicib in combination with a CDK4-6 inhibitor and fulvestrin as first-line treatment for patients with HR-positive for a two-negative advanced breast cancer. The third milestone was the announcement of favorable preliminary top-line results from two early-phase clinical trials. One, evaluating Gettysalicib and darolutamide in men with metastatic castration-resistant prostate cancer. And the second one that evaluated get a solicit and a bio similar. In patients with her to positive pictures, get mutated metastatic breast cancer. 4th, milestone was the extension of our patent exclusivity for get a solicit into 2042 with the issuance of a new dosing regimen patent. Forget it to listen. And finally. We raised around $287 million through public offerings of convertible notes, common stock, and pre-funded warrants that provide the funding that should allow us to aggressively prepare for our long-scan solicit should we get FDA approval next year. I'd like now to turn to the Victoria 1 trial. Last month, we announced top-line results from this trial. Median progression-free survival, or PFS, for the death solicit triplet was 9.3 months. compared to only two months for fulvestrin, 7.3 months incremental improvement in median PFS. The hazard ratio was 0.24, which translates to 4.2 times higher likelihood of survival without disease progression for the gadotilisib triplet than fulvestrin. For the gadotilisib doublet, median PFS was 7.4 months, again, compared to only two months for fulvestrin, 5.4 months incremental improvement in median PFS. The hazard ratio was 0.33, which translates to three times higher likelihood of survival without disease progression for the get a felicitous doublet than fulvestrin. Now, these results established several new milestones in the history of drug development for this patient population. First, the hazard ratios reported for both the get a triplet and doublet were the most favorable ever reported by any phase three trial, first line, second line, or third line in this population. And second, the incremental improvements In median PFS for the triplet and doublet, 7.3 and 5.4 months, respectively, were the highest ever reported by any Phase III trial for this patient population, receiving at least their second line of therapy for advanced disease. And third, getafilicid is the first PAM inhibitor to achieve a positive Phase III data result in patients with PIK3CA wild-type tumors and whose disease progressed on or after treatment with a CDK4-6 inhibitor. And for comparison purposes, it's important to note that several phase three studies in this patient population have reported data recently. In these studies, the incremental improvement in median PFS ranged from 1.7 to 3.9 months, and the hazard ratios ranged from 0.55 to 0.73. Both gas elicit regimens exhibited a favorable safety profile, including lower rates of hyperglycemia and stomatitis. And the rate of discontinuation of all treatment due to a treatment-related adverse event was lower than was reported in a Phase 1b study in this patient population. In light of the favorable safety profile, more favorable hazard ratios, and longer incremental PFS with the Getifilicib regimens than the other currently available or investigational agents, we believe both the Getifilicib triplet and doublet each have the potential to establish a new standard of care for these patients. We're on track to submit a new drug application to the FDA in the fourth quarter of 2025 for data based on data from the PIC3CA WildSide cohort. And we're looking forward to presenting the full data set later this year at an upcoming medical conference. Additionally, we expect to release top line data for the Victoria 1 PIC3CA mutation cohort by the end of 2025. Moving on, I want to share just a quick overview of the market landscape we see for Get It to Listen and how we're gearing up for a potential launch should we get FDA approval. We think the market looks very promising for Get It to Listen. We estimate there are 34,000 patients moving to second-line treatment after progressing on a CDK4-6 inhibitor, and roughly 60% of them are PIK3CA wild-site. That's a very large opportunity. And there's also a significant need for more efficacious therapies than those currently available. Currently, approved therapies only offer two to four months of median TFS. We've got a solicit unique mechanism of action, corresponding clinical benefit. It's all positioned to address critical needs in the second-line space. And this unmet need has been verified in our market research, which shows that oncologists are hungry for options that are more effective and have a safety profile they can manage. And as we've discussed on prior calls, Efficacy and safety are the two primary criteria oncologists use to select therapies for their patients. This is also consistent with the criteria used by treatment guidelines, such as NCCN, to determine recommendation categories for drug treatments. Additionally, as an IV-administered therapy, we believe Gettys Illicit will be very well received in the community practice setting, where over 80% of patients are treated. Gettys Illicit will fall under the medical benefit category, which means typically smoother reimbursement process compared to oral drugs that fall under the pharmacy benefit category. For oral drugs, payers tend to manage claims more heavily, resulting in a more cumbersome prescribing and reimbursement process for practices. And unlike oral drugs, IV-administered therapies also allow physicians to recover costs associated with the purchase and administration of therapy and to better ensure patient compliance with the treatment regimen. And finally, The breast cancer community is active, engaged, and well-supported by advocacy groups, which will help create awareness for new treatments in general, and we think for Gettysburg specifically. As a result, we believe Cellcuity has the opportunity to build strong presence amongst medical oncologists to address this large, underserved patient population. And based on our projections, we believe the addressable market potential for a standard of care second-line therapy to treat this patient population is roughly $5 billion. I'd like now to turn to our phase 3 Victoria 2 trial. Last month, we announced that we dosed the first patient in Victoria 2 that's evaluating, get a solicit, plus a CDK4-6 inhibitor that the investigator may choose, and fulvestrin as first-line treatment for patients who have endocrine therapy-resistant, HR-positive, HER2-negative advanced breast cancer. The standard of care first-line treatment for most Endocrine therapy-resistant patients includes any one of three approved CDK4-6 inhibitors combined with filvestrin. And results from a recent trial suggest the median progression-free survival period for patients receiving one of these three regimens is only about seven to eight months, and highlighting the significant need for more efficacious frontline therapy for these patients. We believe the positive top-line data from the PIK3CY type cohort of our Victoria 1 study augurs well for the getathelicib triplet in this patient population. I'd like now to turn to our Phase 1B2 clinical trial that's evaluating getathelicib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. In late June, we announced encouraging Phase 1B preliminary efficacy and safety data from this study, which enrolled 38 prostate cancer patients who were randomly assigned to either receive 80 milligrams of darolutamide twice daily combined with either 120 milligrams of getafilicib in arm one or 180 milligrams of getafilicib in arm two. And getafilicib was administered once weekly for three weeks and then one week off in both arms. The preliminary analyses for the combined arms show the six-month radiographic PFS rate was 66%, which compares favorably to published data for androgen receptor inhibitors in this setting. Additionally, the data highlighted the favorable safety profile of this novel combination. There were no treatment-related discontinuations, and less than 3% of patients experienced grade 3 stomatitis. These data indicate that the optimal getafilicid dose for this patient population may not yet have been reached, and we believe it's important to explore additional dose options for getafilicid. And as such, we amended the clinical trial protocol. to enable exploration of additional doses in the Phase 1b portion of this clinical trial to determine the recommended Phase 2 dose. In addition to announcing the encouraging preliminary data from our prostate cancer trial, we also announced encouraging data from an investigator-sponsored Phase 2 clinical trial. In this trial, 44 patients with HER2-positive PIK3CA-mutated breast cancer were treated with getafilicid plus standard doses of a trastuzumab biosimilar. No prophylaxis for stomatitis was administered. The median number of prior anti-HER2 therapies enrolled patients received in the metastatic setting was four or more. Eighty-six percent of patients had received at least three prior anti-HER2 therapies, so these patients were heavily pretreated. The overall response rate was 43 percent, and no patients discontinued detethylizib due to a treatment-related adverse event. Achieving 43 percent overall response rate in patients receiving a fourth or fifth line of anti-HER2 treatment for their disease is very encouraging and compares favorably to published data for other available therapies in this group of patients. It also suggests to get it solicited in combination with HER2 targeted therapy may be an effective and well-tolerated therapeutic option for patients with HER2-positive metastatic breast cancer. Now, I'd like to turn to a few corporate updates. The U.S. Patent and Trademark Office issued Salcuity a new patent covering the clinical dosing regimen for Get It to Listen in HR-positive, HER2-negative breast cancer patients. The patent extends Get It to Listen's patent exclusivity in the U.S. into 2042. And with this added patent exclusivity, we expect to have a long runway to optimize development of Get It to Listen. And last but not least, we also completed concurrent offerings of convertible notes, common stock, and pre-funded warrants with net proceeds of $286.5 million at the end of July and beginning of August. With our current resources and other financing arrangements, we believe we are well positioned to advance multiple blockbuster indications in breast and prostate cancer and to aggressively prepare for and launch Gettysburg commercially should we receive FDA approval. I'd like now to hand the call over to Vicki Hahn, our CFO, to review our finances.