Puma Biotechnology Inc

Good afternoon. My name is LaTonya, and I will be your conference call operator today. At this time, all participants are in a listen-only mode. After the speaker's foremost remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press the star key, then the number one on your telephone keypad. If you would like to withdraw your questions, please press star 2. If you should require operator assistance during the conference, please press star 0. As a reminder, this call is being recorded. I would now like to turn the conference over to your host today, Marianne Ohanison, senior director of IR for Puma Biotechnology. You may begin your conference.

Thank you, LaTonya. Good afternoon, and welcome to Puma's conference call to discuss our earnings results for the second quarter of 2025. Joining me on the call today are Ellen Arbach, chief executive officer, president, and chairman of the board of Puma Biotechnology, Maximo Noguez, chief financial officer, Heather Blaber, senior vice president of marketing, and Roger Storms, senior vice president of sales. After the close today, Puma issued a news release detailing earnings results for second quarter 2025. That news release, the slides that Roger will refer to, and a webcast of this call are accessible via the home page and investor sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days. Today's conference call will include statements about Puma's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, August 7, 2025. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these GAAP metrics may be useful to investors as a supplement to, but not a substitute for our GAAP financial measures. Please refer to our second quarter 2025 earnings release for reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Thank you, Mary Ann, and thank you all for joining our call today. Today, Puma reported total revenue for the second quarter of 2025 of 52.3 million. Total revenue includes product revenue net, which consists entirely of Neuralink sales, as well as royalties from our sub-licensees. Product revenue net was 49.2 million in the second quarter of 2025, an increase from 43.1 million reported in Q1 2025, and an increase from 44.4 million reported in Q2 2024. Product revenue for the second quarter of 2025 was impacted by approximately 1.3 million of inventory decrease at our specialty pharmacies and specialty distributors. Royalty revenue was 3.2 million in the second quarter of 2025, compared to 2.9 million in Q1 2025, and 2.7 million in Q2 2024. We reported 2,608 bottles of Neuralink sold in the second quarter of 2025, an increase of 270 from the 2,338 bottles sold in Q1 2025. In Q2 2025, we estimate that inventory decreased by 72 bottles. In Q2 2025, new prescriptions were down approximately 3% compared to Q1 2025, and total prescriptions were up approximately 3% compared to Q1 2025. Roger will provide further details in his comments and slides. I will now provide a clinical review of the quarter. Then Heather Blaber and Roger Storms will add additional color on Neuralink's commercial activities. Maximo Noguez will follow with highlights of the key components of our financial statements for the second quarter of 2025. As investors are aware, Puma currently has two ongoing phase two trials of our investigational drug Allocertib. One is the Allisca breast trial, which is a phase two trial of Allocertib, in combination with endocrine treatment in patients with HER2 negative, hormone receptor positive metastatic breast cancer. The second is the Allisca Lung One trial, which is a phase two study looking at the efficacy of Allocertib monotherapy in patients with small cell lung cancer. As a reminder, the Allisca breast one investigates Allocertib in combination with endocrine treatment, which consists of either anastrozole, exomestane, letrozole, flouvestrin, or tamoxifen in patients with HER2 negative, hormone receptor positive metastatic breast cancer. Patients must be chemotherapy naive, must have previously received treatment with a CDK46 inhibitor, and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Patients are being dosed with Allocertib either at 30 milligrams, 40 milligrams, or 50 milligrams twice daily, BID, on days one to three, eight to 10, and 15 to 17 on a 28-day cycle, in combination with endocrine therapy of the investigator's choice. Patients must have not been previously treated with the endocrine therapy in the metastatic setting that is being given in combination with Allocertib in the trial. Primary efficacy endpoints include objective response rate, duration of response, disease control rate, and progressions for e-survival. As a secondary objective, the company will be evaluating each of these efficacy biomarkers within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy, as has been seen in preclinical and clinical studies in other cancers, including breast and small cell lung cancer. The company will then look to focus the future clinical development of Allocertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer within these biomarkers. The trial was initiated in late November 2024. There are currently 33 sites in the US and 18 sites in Europe that have been activated. For the trial, and the trial is enrolling ahead of expectations. There are currently 62 patients enrolled in the trial and 10 additional patients in screening. We are looking to have interim data from this trial later in 2025. With respect to the ALISCA Lung 1 study, as investors are aware, Puma has an ongoing phase two trial of our investigational drug Allocertib to investigate the efficacy of Allocertib monotherapy in patients with small cell lung cancer and specifically look at the efficacy of the drug in patients with biomarkers where the aurora kinase pathway plays a role. The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA 1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of Paclitaxel plus Allocertib versus Paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020. In that randomized trial, a progression free survival and overall survival benefit were seen in patients with biomarkers that correlate with the aurora kinase pathway. If the efficacy and biomarker data are comparable from the two studies, the company would look to engage with the FDA to discuss the regulatory path further. As discussed on the recent earnings call, the company believes that the data obtained to date from the ALISCA Lung 1 study is providing a preliminary indication of potentially better activity in patients with biomarkers where the aurora kinase pathway plays a role. The most recent analysis of the pharmacokinetic data from the ALISCA Lung 1 study suggests that we are seeing a lower PK of Allocertib in the ALISCA 1 trial compared with the previous phase two study of Allocertib monotherapy in small cell lung cancer patients that was published in Lancet Oncology. The company has amended the protocol for the trial to increase the dose of Allocertib from 50 milligram BID to 60 milligram BID, which the company believes will increase the PK of the drug to levels closer to that what was seen in the prior phase two trial. The company is currently enrolling patients at the 60 milligram BID dose. There are currently 52 patients enrolled in the trial with an additional three patients in screening. The company looks to have additional interim data from the trial later in 2025. As mentioned on prior earnings calls and in response to investor questions, PUMBA continues to evaluate several drugs potentially in license or acquire that allow the company to diversify itself and leverage PUMBA's existing R&D regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Heather Blaber for an update on our marketing initiatives and Roger Storms will follow with a review of our commercial performance during the quarter.