Celcuity Inc.

Ladies and gentlemen, welcome to the Q&A second quarter 2026 financial results conference call and webcast. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require any assistance, please press star zero for the operator. I would now like to turn the conference over to Jody Severs, Corporate Communications and Investor Relations at CQD. Please go ahead.

Thank you, Lili, and good afternoon to everyone. Thank you for joining us today to review Salcuity's second quarter of 2026 financial results and business update. Earlier today, Salcuity released financial results for the quarter ended June 30th, 2026. 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 Hahne , as well as Igor Gorbatchevsky , and Eldon Mayer , who will be available during Q&A. As 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 for the SEC. Actual events and 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 financial 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 the GAAP measures in today's press release. And with that, I would like to turn the call over to Brian Sullivan, CEO of CellCuity. Please go ahead, Brian.

Thank you, Jodi, and good afternoon, everyone. Thank you for joining our second quarter 2026 operating and financial update conference call. CellCuity continues to make monumental progress advancing clinical development of gettalizib for patients with HR-positive HER2-negative advanced breast cancer. With the FDA approval of RepterPIC, positive results from the PIC3CA mutant cohort of our pivotal Victoria 1 study, and a preferred Category 1 recommendation in the NCCN guidelines, we're well positioned to address a significant unmet need for the tens of thousands of patients affected each year by HR-positive HER2-negative advanced breast cancer. We remain on track to begin shipping RepterPIC late in the third quarter of 2026, and we look forward to making this important therapy available to patients with advanced breast cancer. Based on the positive data from the PIK3CA mutant cohort of the Phase 3 Victoria 1 study, we plan to submit a supplemental NDA or SNDA in the third quarter of 2026. Additionally, our Victoria 2 study was expanded to enable evaluation of treatment IE patients who have endocrine sensitive breast cancer Positioning get us a list of regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status. In sum, we've had an eventful past few months. I'd first like to review in a bit more depth the status of our clinical development programs and then provide an update on the commercial launch of RevTripIt. On July 14th, a few days before our procurement date, We received notice from the FDA that RevtorPIC in combination with Fulvestrin with or without polycycline was approved for the treatment of patients with the HR-positive HER2-negative locally advanced or metastatic breast cancer without a PIC3CN mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. A little over two weeks later, NCCN updated their guidelines for HR-positive HER2-negative breast cancer treatment. recommending both the RetroPIC triplet and doublet regimens as preferred Category 1 regimens for second-line or subsequent treatment for tumors without a PIC3CA mutation. We're very encouraged by the panel's rapid review and recommendation. In June, we presented positive efficacy and safety results from the PIC3CA mutant cohort of the Victoria 1 Phase 3 trial at the ASCO annual meeting. The primary efficacy analysis of the gadathelizib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS, progression-free survival, compared to alpalypsin, a PF3K alpha inhibitor, and fulvestrin. Median PFS was 11.1 months with the gadathelizib triplet versus 5.6 months with alpalypsin plus fulvestrin with a hazard ratio of 0.5. The secondary endpoint comparing the gadathelizib doublet versus alpalypsin plus fulvestrin which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to epilepsy and fulvestrin. Median PFS was 11.3 months with the get-up solicit doublet versus 5.6 months with epilepsy plus fulvestrin with a hazard ratio of 0.51. The safety data for the get-up solicit triplet and doublet were consistent with previously reported data from the wild-type cohort of Victoria 1. Now, we've since updated the analyses of the treatment discontinuation rate due to an adverse event for Geta-Felicitib and Alpalypsib in the PIK3CA-Newton cohort using the same methodology that determined the discontinuation rate due to an adverse event for the PIK3CA-Wildtype cohort presented in the Ref2Pik label. For patients who received the Geta-Felicitib triplet and Geta-Felicitib doublet, 5.2% and 3.8% of patients discontinued Geta-Felicitib due to an adverse event, respectively. for patients who received epilepsy, 19% discontinued treatment with epilepsy due to an adverse event. Now, we believe the lower get a solicit treatment discontinuation rate for the mutant cohort than was reported in the wild type cohort reflects the fact that the discontinuation rate was higher early in the overall Victoria 1 study and then fell as physicians gained experience. Since a much higher proportion of wild type patients were enrolled during this period than the mutant patients, the impact of this initial higher discontinuation rate early in the study all disproportionately on the wild-type cohort. And thus, we believe the treatment discontinuation rate for getafilicid reported for the mutant cohort, roughly 4% to 5%, best represents what we expect to see in a real-world setting. We also updated analyses of the mean number of getafilicid treatment cycles patients received in the wild-type and mutant cohorts in Victoria 1 as of August 2, 2026. This analysis had a median follow-up period of approximately 21 months for the wild-type cohort and 17 months for the mutant cohort. For patients treated with the gadathelicid triplet in the wild-type cohort, the mean number of treatment cycles for gadathelicid was 9.0, and 16 of these patients, representing 12% of those dosed, are still receiving gadathelicid. For those treated with the gadathelicid triplet in the mutant cohort, the mean number of treatment cycles for gadathelicid was 10.0. 34 of these patients, representing 22% of those doses, are still receiving Geta-Felicit. For patients treated with the Geta-Felicit doublet in the wild-type cohort, the mean number of treatment cycles for Geta-Felicit is 9.7, and 15 of these patients, representing 12% of those doses, are still receiving Geta-Felicit. And for patients treated with the Geta-Felicit doublet in the PIC3CA mutant cohort, The mean number of treatment cycles for patients receiving Geta-Felicit was 11.3. And 10 of these patients, representing 19% of those doses, are still receiving Geta-Felicit. Analyses of mean treatment cycles for Reftropik in the Victoria 1 trial are particularly relevant for assessing the commercial potential of Reftropik since they incorporate the effect that patients who remain on Reftropik for extended periods of time have on the likely usage expected in the real world. The median duration of treatment metric truncates this effect and thus underestimates drug usage for a patient population. We expect to provide further updates to results from both the wild-type and mutant cohorts of Victoria 1 at medical conferences later in the year. Now, with the FDA approval of our NDA in hand and positive data from the mutant cohort, we expect to submit the data from the mutant cohort to the FDA as an SNDA in the third quarter of 26. And we expect to submit Victoria 1 Phase 3 data for both the wild-type and mutant cohorts the global regulatory authorities following the SMDA submission. Now the get it to list regimens have 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. Additionally, these results augur well for the Phase III VICTORIA-2 trial we have underway to advance in the first-line setting for patients with advanced breast cancer. In May, we announced that we were expanding the Victoria 2 file to include a second study, study 2, evaluating the efficacy and safety of getafilicib in combination with pylosiclip and letrozole in patients with treatment-naive endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer. And these are women whose cancer relapse will progress 12 months or more after completion of adjuvant endocrine therapy. or those with de novo metastatic disease without prior endocrine therapy exposure. Endocrine-sensitive patients represent approximately two-thirds of the women in the U.S. newly diagnosed with advanced breast cancer each year. The current standard of care therapies for these patients provide median progression-free survival of approximately 25 months. Study 1 of the Victoria True Trial, which was already ongoing, is evaluating getotelicib in combination with tablacyclib and fulvestrin. and patients with treatment-naive endocrine-resistant HR-positive HER2-negative advanced breast cancer. And these are patients whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. Now, results from the Phase 1B clinical trial that we ran several years ago provided strong evidence that the PAM pathway is an important disease driver in treatment-naive patients with advanced breast cancer. In this early Phase 1 study, re-evaluated getotelicid plus polycyclob and letrozole as first-line treatment in 41 patients with endocrine-sensitive HR-positive HER2-negative advanced breast cancer. Median PFS was 48.6 months, which compares favorably to historical data of approximately 25 months for ribocyclob plus letrozole. Ribocyclob plus letrozole is the therapy that we're using as the control in our VICTORIA-II trial for endocrine-sensitive patients. The objective response rate was 79%, which, again, compares favorably to historical data of 53% in the first-line setting for rhodocyclib 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 get-its-licit triplet as first-line treatment, we're optimistic about the results of both our first-line studies. Successful development in this 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 U.S., irrespective of their endocrine sensitivity or PIK3CA status. Our advancement of subcutaneous Geta-Felicit formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of Geta-Felicit. Subcutaneous formulation is aimed to support potential future indications for Geta-Felicit regimens that may result and duration of treatment periods greater than several years. And now let's turn to our Phase 1b-2 trial. That's evaluating getathelizib in combination with darolutamide and then with metastatic castration-resistant prostate cancer. In the dose-finding portion of the Phase 1b study, evaluation of a 240-milligram dose of getathelizib was completed. No adverse events led to treatment discontinuation of getathelizib, and dose-limiting toxicity criteria for dose reduction were not met. and this allowed us to begin evaluation of a 300-milligram dose, which is ongoing. Once the dose-finding portion of the study is completed, we expect to select two potential recommended Phase II dose levels and control arm options for the randomized Phase II portion of the study. We expect to provide updated clinical data and additional visibility into our development strategy for prostate cancer during the fourth quarter of 2026. Now I'd like to discuss our launch plans and the commercial opportunity for Reptipix. We began laying the groundwork for a potential get-up solicit launch over 24 months ago. During this period, we've engaged over 1,000 key opinion leaders and community breast cancer experts, over 250 key accounts, major oncology organizations, including GPOs, state societies, and special interest groups, as well as patient advocacy groups. Our unbranded marketing campaign at PAMPathway.com has already driven awareness of the PAMPathway, with metrics tracking well ahead of industry benchmarks. CME and third-party peer-to-peer programs and regional events have further increased levels of awareness about the unmet need in the second-line setting. Now, the build-out of the commercialization infrastructure needed to support the successful launch of Rev2Pick is now complete, and commercial launch activities for Rev2Pick commenced immediately after approval. Our 88 oncology sales specialists, who have an average of 24 years of industry experience, are calling on physicians and supporting installation of RetroPIC order sets within the electronic health record systems of their accounts and in servicing infusion centers and pharmacies. Our strategic accounts, payer reimbursement, medical science liaison, and KOL-focused teams are following through on the groundwork they laid prior to RetroPIC approval. Payer and strategic account pathway dossiers have been submitted, and formal efforts to get included on formularies and pathways are in process. All of these efforts are designed to offer patients and providers with rapid access and seamless support. Shipments of Reptripic are expected to begin late in the third quarter of 2026. Now, wholesale acquisition costs, or WAC, of Reptripic, which has been reported to the drug pricing compendium, will be $10,000 per vial or $30,000 per cycle of treatment once Reptripic is commercially available. To enable treating physicians to obtain, get a solicit on behalf of their eligible patients prior to commercial availability of Reptripic, So Acuity opened an expanded access program last week, and shipments to these physicians have begun. Based on analysis of published epidemiological data, we estimate there are 37,000 patients in the U.S. receiving second-line treatment for ASR-positive for T-negative advanced breast cancer. Assuming an average of roughly 10 cycles of treatment for Reptripic per patient at the WAC price, we estimate the total addressable market for Reptripic in the wild-type N-mutant setting combined is potentially over $6 billion annually. And that concludes my remarks. I'd now like to hand the call over to Vicky to review our finances.