Puma Biotechnology Inc

Good afternoon. My name is Rob, and I'll be your conference call operator today. At this time, all participants are in listen-only mode. After the speaker's formal remarks, there will be a question and answer session. If you'd like to ask a question during that time, simply press the star key, then the number 1 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 Marianne O'Hanison, Senior Director of Investor Relations for PUMA Biotechnology. You may begin your conference.

Thank you, Rob. Good afternoon and welcome to PUMA's conference call to discuss our financial results for third quarter of 2024. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of PUMA Biotechnology, Maximo Núñez, Chief Financial Officer, and Jeff Ledwick, Chief Commercial Officer. After market closed today, PUMA issued a news release detailing the earnings results for the third quarter of 2024. That news release, the slides that Jeff 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 law. 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 10-K for the year ended December 31, 2023. 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, November 7, 2024. PUMA undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this 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 non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for, our GAAP financial measures. Please refer to our third quarter 2024 news release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Ellen.

Thank you, Mary Ann, and thank you all for joining our call today. Today, PUMA reported total revenue for the third quarter of 2024 of $80.5 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 $56.1 million in the third quarter of 2024, which was an increase from both the 44.4 million reported in Q2 2024 and the 51.6 million reported in Q3 2023. Product revenue for the third quarter of 2024 was impacted by approximately 0.6 million of inventory increase at our specialty pharmacies and specialty distributors. Royalty revenue was 24.4 million in the third quarter of 2024 compared to $2.7 million in Q2 2024 and $4.5 million in Q3 2023. Royalty revenue in the latest quarter included the expected sales to China by our offshore partner Pierre Farb, as we noted in our August forecast of Q3 2024 results. We reported 2,723 bottles of Neuralink sold in the third quarter of 2024, an increase of 208 from the 2,515 bottles sold in Q2 2024. In Q3 2024, we estimate that inventory increased by about 37 bottles. In Q3 2024, new prescriptions were up 3% compared to Q2 2024, and total prescriptions were essentially flat compared to Q2 2024. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter, and then Jeff Ludwig will address our additional color on Nearlink's commercial activities. Maximo Noguez will then follow with highlights of the key components of our financial statements for the third quarter of 2024. As previously discussed, Huma has an ongoing phase two study of our investigational drug Allocertib to confirm the efficacy of Allocertib monotherapy in patients with small cell lung cancer with biomarkers where the aurora kinase pathway plays a role. The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA Lung 1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alacerdin versus paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020. If the efficacy and biomarker data are comparable from the two studies, the company believes it would represent a potential accelerated approval strategy and would engage FDA to discuss this further. As investors will remember, Alicertib was previously tested as a monotherapy in patients with small cell lung cancer, and the results of this trial were published in Lancet Oncology in 2015. In this trial, Alicertib was administered as a monotherapy to patients with small cell lung cancer. The safety results, N equals 60 from the trial, showed that 37% of the patients experienced grade 3-4 neutropenia, 7% experienced grade 3-4 drug-related febrile neutropenia, and 22% of the patients discontinued treatment due to adverse events. The efficacy results from an efficacy of valuable population of 48 patients showed that for the 36 chemotherapy-sensitive patients, the objective response rate was 19%, and the PFS was 2.6 months. And for the 12 chemotherapy-resistant or relapsed patients, the objective response rate was 25% with a PFS of 1.7 months. As investors will also remember, Alacertib was also previously tested in a randomized Phase II trial of Paclitaxel plus Alacertib versus Paclitaxel plus placebo in patients with second-line small-cell lung cancer, which was published in the Journal of Thoracic Oncology in 2020. Alacertib was dosed at a different dose than in the monotherapy trial, with Alacertib being administered at 40 milligrams BID for three weeks on days 1 to 3, 8 to 10, and 15 to 17, plus Paclitaxel 60 mg intravenously on days 1, 8, and 15, whereas the comparator arm received placebo plus Paclitaxel 80 milligrams per meter squared IV on days 1, 8, and 15 in 28-day cycles. The trial also incorporated an extensive biomarker analysis with a pre-specified analysis of CMIC expression, as well as a retrospective analysis of genetic alterations in ctDNA with clinical outcome. The safety results from the combination arm of the trial showed that 40% of the patients experienced grade 3 or higher neutropenia, with 13% experiencing grade 3 or higher drug-related febrile neutropenia. 16% of the patients discontinued study treatment because of an adverse event, and 38% of the patients had a dose reduction because of an adverse event. The primary endpoint of that trial was progression-free survival, or PFS. For the ITT population, the hazard ratio for PFS was 0.77, with a p-value of 0.113. When using the corrected definition for the stratification of relapse type, the hazard ratio for PFS was 0.71, with a p-value of 0.038. For the patients with chemotherapy-resistant or refractory disease, the hazard ratio was 0.66, with a p-value of 0.037. With respect to the biomarkers that were studied in that trial, for the patients in the trial who were found to be IHC-positive for CMIC expression, the hazard ratio in the trial was 0.29, with a median PFS for the paclitaxel plus alacertibarm of 4.64 months, and a median PFS for the paclitaxel plus placebo arm of 2.27 months. Also for patients with alterations in cell cycle genes, including CDK6, RBL1, RBL2, and RB1, the PFS for the paclitaxel plus allocertib arm was 3.68 months, while the placebo plus paclitaxel arm was 1.8 months, and the hazard ratio for PFS was 0.395, with a p-value of 0.003. The overall survival for that subgroup of patients was 7.2 months for the Alicertib arm and 4.47 months for the placebo arm with a hazard ratio of 0.427 and a p-value of 0.00085. When PUMA licensed Alicertib, we stated that one of our focuses was to try to reduce the adverse event profile of the drug and more specifically the grade 3.4 neutropenia by giving prophylactic GCSF with the administration of Alicertib and this is being instituted in the ALISCO Lung 1 trial. Currently, there are 20 patients enrolled in the ALISCO Lung 1 trial, with several in screening and prescreening. For the first 18 patients who were available for safety, there has been one patient, or 5.6%, with grade 3.4 neutropenia, and one patient, 5.6%, with febrile neutropenia. No patient has discontinued L-assertive due to adverse events, and one patient, or 5.6%, has required a dose hold. Based on the preliminary improved neutropenia and tolerability that is being seen in the trial, and assuming this continues to be seen, the company is considering the potential to increase the dose of allosterative monotherapy in the trial. Also, assuming this improved neutropenia and tolerability continues to be seen when allosterative is combined with paclitaxel, The company believes that it may result in better efficacy of the combination of Paclitaxel with Alacertib, and that the company may be able to increase the dose of Alacertib that is able to be given with Paclitaxel. Of the 18 patients dosed with Alacertib, 16 have had a post-baseline tumor assessment. Of these, seven had chemotherapy-sensitive disease, which is defined as a relapse more than 90 days but less than 180 days after primary treatment, And nine had chemotherapy-resistant or refractory disease, defined as relapsed less than 90 days after primary treatment. In the chemotherapy-sensitive patients, one patient, or 14%, has shown stable disease, and the median PFS has been 1.2 months. In the patients with chemotherapy-resistant or refractory disease, there have been two patients, or 22%, with a partial response, and one patient, or 11%, with stable disease, and the median PFS has been 1.4 months. As previously mentioned, we are conducting an extensive analysis of the biomarkers that are known to be involved with the aurora kinase pathway activation to see if it correlates with clinical outcome. The two refractory or resistant patients with partial responses did have biomarkers that correlate with the aurora kinase pathway activation, including RB1 mutations and MYC gain. We caution that this is very early data, and we do not have tissue on all the patients enrolled, so the number of patients with biomarker data is too small to be able to draw definitive conclusions on the associations between biomarkers and allocertib activity. The company believes that the preliminary data from the ELISCA-1 trial is providing a preliminary indication of potentially better activity in patients with chemotherapy-resistant or refractory disease, which is similar to what was seen in the trials published in the Lancet Oncology and the randomized trial that was published in the Journal of Thoracic Oncology. The company plans to continue enrollment in the ELISCA-1 trial and anticipates additional data will be presented at medical conferences in 2025. The company also plans to meet with its steering committee for the trial in order to determine the next steps for the drug and the treatment of small cell lung cancer patients. The company will keep investors updated on this as it progresses. Investors will also remember that the company plans to test Alicertib in the ALISCA Breast 1 trial, a Phase 2 trial of Alicertib in combination with endocrine treatment in patients with chemotherapy-naive HER2-negative hormone receptor-positive metastatic breast cancer. Currently, there are three sites that have been activated for the trial, and we anticipate the initiation of the trial in the fourth quarter of 2024. The company will keep investors updated on this as it progresses. As mentioned on prior earnings calls and in response to investor questions, PUMA continues to evaluate several drugs to potentially in-license that will allow the company to diversify itself and leverage PUMA'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 Jeff Ludwig, PUMA's Chief Commercial Officer, for a review of our commercial performance during the course.