Workflow
Pyxis Oncology(PYXS) - 2024 Q3 - Quarterly Report
PYXSPyxis Oncology(PYXS)2024-11-12 12:43

Financial Performance - Pyxis Oncology reported a net loss of 41.8millionfortheninemonthsendedSeptember30,2024,comparedtoanetlossof41.8 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 21.20million,adecreaseof21.20 million, a decrease of 1.85 million compared to a net loss of 23.05millionforthesameperiodin2023[65].−TotalrevenuesfortheninemonthsendedSeptember30,2024,were23.05 million for the same period in 2023 [65]. - Total revenues for the nine months ended September 30, 2024, were 16.1 million, compared to 0forthesameperiodin2023,primarilyduetoasettlementagreementwithNovartis[69].−Otherincomeincreasedto0 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 6.2millionin2023,primarilyduetohighersubleaseincome[73].−Otherincome,netforthethreemonthsendedSeptember30,2024,was6.2 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 0.25millioncomparedto0.25 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 328.0millionandcash,cashequivalents,andshort−terminvestmentstotaling328.0 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 144.8million,withnetlossesof144.8 million, with net losses of 21.2 million and 41.8millionforthethreeandninemonthsendedSeptember30,2024,respectively[74].−Netcashusedinoperatingactivitieswas41.8 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 55.5millioninthesameperiodof2023[78].−Netcashusedininvestingactivitieswas55.5 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 59.3millionfortheninemonthsendedSeptember30,2024,comparedto59.3 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 6.7million,from6.7 million, from 37.98 million for the nine months ended September 30, 2023, to 44.72millionforthesameperiodin2024[71].−PYX−201program−specificresearchanddevelopmentcostsincreasedby44.72 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 3.2millionincreaseinclinicaltrialexpensesanda3.2 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 11.16million,significantlyupfrom11.16 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 4.7million,from4.7 million, from 10.67 million for the three months ended September 30, 2023, to 6.01millionforthesameperiodin2024[68].−Generalandadministrativeexpensesdecreasedby6.01 million for the same period in 2024 [68]. - General and administrative expenses decreased by 6.1 million, from 26.5millionintheninemonthsendedSeptember30,2023,to26.5 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 8.6millionfrom8.6 million from 28.2 million for the nine months ended September 30, 2023, to 19.6millionforthesameperiodin2024[71].−Thecompanyhascontractualleaseobligationstotaling19.6 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].