Pyxis Oncology(US:PYXS)2024-11-12 12:43Financial Performance - Pyxis Oncology reported a net loss of $41.8 million for the nine months ended September 30, 2024, compared to a net loss of $58.2 million for the same period in 2023, indicating a reduction in losses year-over-year [59]. - Net loss for the three months ended September 30, 2024, was $21.20 million, a decrease of $1.85 million compared to a net loss of $23.05 million for the same period in 2023 [65]. - Total revenues for the nine months ended September 30, 2024, were $16.1 million, compared to $0 for the same period in 2023, primarily due to a settlement agreement with Novartis [69]. - Other income increased to $7.6 million for the nine months ended September 30, 2024, compared to $6.2 million in 2023, primarily due to higher sublease income [73]. - Other income, net for the three months ended September 30, 2024, was $2.55 million, an increase of $0.25 million compared to $2.30 million for the same period in 2023 [65]. Cash and Investments - As of September 30, 2024, Pyxis Oncology had an accumulated deficit of $328.0 million and cash, cash equivalents, and short-term investments totaling $144.8 million [59]. - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $144.8 million, with net losses of $21.2 million and $41.8 million for the three and nine months ended September 30, 2024, respectively [74]. - Net cash used in operating activities was $38.4 million for the nine months ended September 30, 2024, compared to $55.5 million in the same period of 2023 [78]. - Net cash used in investing activities was $18.5 million for the nine months ended September 30, 2024, primarily due to purchases of marketable debt securities [79]. - Net cash provided by financing activities was $59.3 million for the nine months ended September 30, 2024, compared to $6.0 million in 2023 [80]. - The company expects existing cash resources to fund operations into the second half of 2026, including clinical development for PYX-201 [80]. Research and Development - The company has not generated any revenues from product sales and does not expect to do so in the foreseeable future, relying instead on research and development agreements for revenue [60]. - Pyxis Oncology's research and development expenses are expected to increase substantially due to ongoing and planned clinical activities [62]. - Research and development expenses increased by $6.7 million, from $37.98 million for the nine months ended September 30, 2023, to $44.72 million for the same period in 2024 [71]. - PYX-201 program-specific research and development costs increased by $12.6 million, primarily due to a $3.2 million increase in clinical trial expenses and a $7.6 million increase in contract manufacturing costs [71]. - Total program costs for the three months ended September 30, 2024, were $11.16 million, significantly up from $4.13 million for the same period in 2023 [66]. Clinical Trials and Product Development - The Phase 1 trial of PYX-201 has dosed 80 subjects, focusing on difficult-to-treat cancers such as head and neck squamous cell carcinoma and non-small cell lung cancer [55]. - PYX-201 received Orphan Drug Designation from the FDA for the treatment of pancreatic cancer, with a starting dose of 0.3 mg/kg in the Phase 1 trial [55]. - The acquisition of Apexigen added PYX-107 to the pipeline, which has shown a 15.2% partial response rate in melanoma patients refractory to anti-PD-(L)1 therapy [59]. - The Phase 1 trial of PYX-106 has dosed 45 subjects, with a starting dose of 0.5 mg/kg and a focus on solid tumors [58]. - The company anticipates announcing preliminary data from the Phase 1 trial of PYX-201 in November 2024 [55]. Expenses and Obligations - General and administrative expenses decreased by $4.7 million, from $10.67 million for the three months ended September 30, 2023, to $6.01 million for the same period in 2024 [68]. - General and administrative expenses decreased by $6.1 million, from $26.5 million in the nine months ended September 30, 2023, to $20.3 million in the same period of 2024 [72]. - Unallocated research and development costs decreased by $8.6 million from $28.2 million for the nine months ended September 30, 2023, to $19.6 million for the same period in 2024 [71]. - The company has contractual lease obligations totaling $27.1 million over the remaining term of its office and laboratory space lease [82].