Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was reported at $46 million, with product revenue net at $43.1 million, a decline from $54.4 million in Q4 2024 but an increase from $40.3 million in Q1 2024 [6][21] - Royalty revenue was $2.9 million in Q1 2025, down from $4.7 million in Q4 2024 and $3.5 million in Q1 2024 [7][36] - Net income based on GAAP for Q1 2025 was $3 million or $0.06 per share, compared to $19.3 million or $0.39 per share in Q4 2024 [34][35] Business Line Data and Key Metrics Changes - NERLYNX sales saw a decrease in bottle sales to 2,338 in Q1 2025, down from 2,964 in Q4 2024, with a 6% increase in new prescriptions compared to the previous quarter [8][22] - Demand for NERLYNX declined by 6% quarter over quarter but increased by 2% year over year [25] - The distribution model showed 67% of business through the specialty pharmacy channel and 33% through the specialty distributor channel [20] Market Data and Key Metrics Changes - Enrollment for NERLYNX increased by 6% quarter over quarter but declined by 8% year over year [24] - Total prescriptions decreased by 9% quarter over quarter and 3% year over year [24] - Stronger growth was noted in the specialty distributor channel, driven by increased sales in the GPO segment and 340B purchasing [20] Company Strategy and Development Direction - The company is focused on expanding NERLYNX utilization, particularly among patients at increased risk of recurrence, and has revised marketing strategies accordingly [18][26] - Puma is evaluating several drugs for potential in-licensing or acquisition to diversify its portfolio [17] - The company aims to maintain positive net income and is committed to financial discipline and expense management [43] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of seasonal inventory changes and higher gross to net expenses on revenue [21][36] - The company anticipates net NERLYNX product revenue for fiscal year 2025 to be in the range of $192 million to $198 million [38] - Management expressed optimism regarding the ongoing clinical trials and the potential for new data to be presented in the future [12][16] Other Important Information - The company reported cash burn of approximately $7.8 million in Q1 2025, compared to $4.3 million in Q4 2024 [41] - As of March 31, 2025, the company had approximately $93 million in cash, cash equivalents, and marketable securities [42] - The company is in the process of amending the protocol for the ELYSCA lung study to increase the dose of alisertib [16] Q&A Session Summary Question: Inquiry about Alosertib IP and Manufacturing - Management confirmed that the IP for Alosertib is licensed from Takeda, and manufacturing is primarily done in the U.S. [48][50] Question: Questions on ELYSCA lung cancer trial and NERLYNX Phase one data - Management stated that the protocol amendment for the lung cancer trial is underway, and they expect interim data later this year [58][60] - They noted better activity in certain tumor types with the combination of neratinib and ADCs, but more data is needed for specific expectations [61] Question: Impact of Medicare Part D redesign - Management indicated that co-pays for patients have declined, making NERLYNX more affordable and increasing the percentage of business going through Medicare [64]

Core Insights - Predictive Oncology Inc. has made significant advancements in biomarker discovery and drug repurposing through the integration of active machine learning and a biobank of live-cell tumor specimens [1][2] - The company’s innovative approach has successfully identified three compounds for further exploration in tumor indications that have not been previously examined [3][4] Drug Discovery and Development - The efficient screening process identified Afuresertib, Alisertib, and Entinostat as promising candidates for ovarian and colon tumors, with Alisertib and Entinostat outperforming standard care drugs [4][6] - Afuresertib is an Akt inhibitor previously studied in various cancers, while Alisertib is a selective Aurora A inhibitor showing strong responses in ovarian and colon tumors [5][6] - Entinostat, an HDAC1/3 inhibitor, demonstrated strong responses in colon tumor models and is currently in clinical trials for combination therapy [7] Methodology and Future Directions - The company’s AI platform, PEDAL, predicts with 92% accuracy whether a tumor sample will respond to specific drug compounds, enhancing drug/tumor type selection for testing [10] - The next logical step involves applying this methodology to other publicly available abandoned drugs, potentially creating partnership opportunities with pharmaceutical companies [9]