Puma Biotechnology Inc

Good afternoon. My name is Sherry, and I will be your conference call operator today. At this time, all participants are in a listen-only mode. After the speaker's formal 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 two. If you should require operator assistance during the conference, please press star zero. As a reminder, this call is being recorded. I would now like to turn the conference over to Marianne Ohannesson, Senior Director of Investor Relations for PUMA Biotechnology. Thank you. You may begin your conference.

Thank you, Sherry. Good afternoon and welcome to PUMA's conference call to discuss our earnings results for the first quarter of 2025. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President, and Chairman of the Board of PUMA Biotechnology, Maximo Noguez, Chief Financial Officer, Jeff Ludwig, Chief Commercial Officer, Heather Blaber, Vice President of Marketing, and Jeff Storms, Vice President of Sales. After the close today, PUMA issued a news release detailing earnings results for first quarter 2025. That news release, the slides that Jeff will refer to, and a webcast of this call are accessible via the homepage 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. 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 reviewed in December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as the date of this live conference call, May 8, 2025. COMA 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 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 first quarter 2025 earnings release for a 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, Primo reported total revenue for the first quarter of 2025 of $46.0 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 $43.1 million in the first quarter of 2025, a decline from the $54.4 million reported in Q4 2024, and an increase from the $40.3 million reported in Q1 of 2024. Product revenue for the first quarter of 2025 was impacted by approximately $4.7 million of inventory decrease at our specialty pharmacies and specialty distributors. Royalty revenue was $2.9 million in the first quarter of 2025, compared to $4.7 million in Q4 2024 and $3.5 million in Q1 2024. We reported 2,338 bottles of Nearlinks sold in the first quarter of 2025, a decrease of 626 from the 2,964 bottles sold in Q4 2024. In Q1 2025, we estimate that inventory decreased by 251 bottles. In Q1 2025, new prescriptions, or NRX, were up approximately 6% compared to Q4 2024. And total prescriptions were down approximately 9% compared to Q4 2024. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter Then Jeff Ludwig, as well as Heather Blaber and Roger Storms, will add additional color on Nearlink's commercial activities. Maximo Noguez will follow with highlights of the key components of our financial statements for the first quarter of 2025. At the recent American Association for Cancer Research, or AACR, annual meeting, interim data from an ongoing Phase I trial, which is NCT05372, that is sponsored by the National Cancer Institute, evaluating the combination of duratinib and fam-trestuzumab-durextacan, or in HER2, in patients with metastatic solid tumors was presented. The Phase I data includes patients with metastatic solid tumors harboring HER2 overexpression, IHC3+, ERB2 amplifications, or activating HER2 mutations. In the poster presentation, 20 patients received study treatments, Dose level 1 had 7 patients. Dose level 2 had 4 patients. Dose level 3 had 9 patients. The most common treatment emergent adverse events of any grade included nausea, N equals 15 or 75%, diarrhea, N equals 15 or 75%, fatigue, N equals 13 or 65%, and hypokalemia, N equals 11 or 55%. Grade 3 treatment emergent adverse events That occurred in more than two patients included anemia, N equals 6 or 30%, diarrhea, N equals 4 or 20%, and hypokalemia, N equals 3 or 15%. The only grade 4 treatment-related adverse event was neutropenia. That occurred in one patient, which was 5%. One DLT, which was acute kidney injury, was observed at dose level 1. No DLTs were observed at dose level two, and one DLT was observed, which was fatigue, leading to early discontinuation at dose level three. Three patients developed grade one pneumonitis, or interstitial lung disease, ILD, two patients at dose level one, and one at dose level three. The proportion of reported treatment emergent adverse events was lower at higher doses. Of the 15 response-available patients by RESIST, four patients had a partial response, including patients with gastroesophageal, which was N equal 2, and it was 1 HER2 positive IHC3 plus and 1 HER2 mutated. Pancreatic, which was one patient who was an IHC3 plus, and ovarian, which was one patient who was also a 3 plus, and the ovarian was a confirmed response. Most notably, three of five patients with advanced pancreatic cancer were observed to have tumor regression. one PR for 13 cycles, which is ongoing, and two with stable disease, consisting of one patient with a 29.4% tumor regression for nine cycles, and one patient with a 13.3% regression for eight cycles. Dose level three, which consisted of trastuzumab, durextacan at 5.4 mg per kg, and neratinib at 120 mg in week one, 160 in week two, and 240 in week three and onward, was selected as the recommended phase two dose. Part two of the study, which consists of a pharmacodynamic evaluation of trastuzumab durextacan with neratinib in 12 patients, open to enrollment in March of 2025. Patients with advanced solid tumor and HER2 amplification or overexpression or a HER2 mutation will be enrolled. We look forward to updated data from this trial to be presented, likely in 2026. In addition, PUMA currently has two ongoing phase two studies of our investigational drug alicerib The ALISCA Breast 1 trial, which is a Phase 2 trial of L-acertib in combination with endocrine treatment in patients with HER2 negative, hormone receptor positive, metastatic breast cancer, and ALISCA Lung 1, which is a Phase 2 study looking at the efficacy of L-acertib monotherapy in patients with small cell lung cancer. As a reminder, the ALISCA Breast 1 trial investigates L-acertib in combination with endocrine treatment, which consists of either anastrozole, exomestane, letrozole fulvestrant or tamoxifen in patients with HER2-negative hormone receptor-positive metastatic breast cancer. Patients must be chemotherapy naive, have been previously treated with CDK4-6 inhibitors, 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 aliceridib given at either 30 mg, 40 mg, or 50 mg twice daily, BID, on days one to three, eight to 10, and 15 to 17 on a 28-day cycle in combination with the endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that is being given in combination with L-acertib in the trial. Primary efficacy endpoints will include objective response rate, duration of response, disease control rate, and progression fee survival. As a secondary objective, the company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy as has been seen in the preclinical and clinical studies in other cancers, including breast cancer and small cell lung cancer. The company will then look to focus the future clinical development of Alicertib in combination with endocrine for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers. The trial was initiated in late November 2024. There are currently 26 sites in the U.S. and 12 sites in Europe that have been activated for the trial, and the trial is enrolling ahead of expectations. There are currently 28 patients enrolled in the trial, one expected to be enrolled this week, and six additional patients in screening. We are looking to have interim data from this trial later in 2025. With respect to the ELISCA lung study, As discussed on the last conference call, the company believes that the data obtained to date from the ALISCA Lung 1 trial 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 trial suggests that we are seeing a lower PK of aliceridib in the ALISCA Lung trial compared to the previous Phase II study of aliceridib monotherapy in small cell lung cancer patients that was published in the Lancet Oncology. The company is in the process of amending the protocol to increase the dose of Alacertib from 50 mgs to 60 mgs, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior phase two trial. The company looks to have additional interim data from this trial later in 2025. As mentioned on prior earnings calls and in response to investor questions, PUMA continues to evaluate several drugs potentially in-license or acquire, that would 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 view of our commercial performance during the quarter.