Financial Performance - The net loss for Q4 2023 was 14.1million,comparedtoanetlossof10.5 million in Q4 2022[10][15]. - Revenue for Q4 2023 was 0,unchangedfromQ42022,whiletotalrevenuefortheyearwasalso0, consistent with the previous year[21]. - Gross profit for Q4 2023 was 0,maintainingthesamelevelasQ42022,withagrossprofitof112,000 for the year[21]. - The net loss for Q4 2023 was 14,132,000,comparedtoanetlossof10,451,000 in Q4 2022, with a total net loss of 54,369,000fortheyearversus68,701,000 in 2022[21]. - Loss per ordinary share for Q4 2023 was 0.02,consistentwithQ42022,whiletheannuallosspersharewas0.09 compared to 0.13 in 2022[21]. Research and Development - R&D expenses for the fourth quarter of 2023 were 4.1 million, down from 6.8 million in Q4 2022, primarily due to reduced clinical trial costs[10][11]. - Full-year R&D expenses for 2023 totaled 17.2 million, significantly down from 49.3 million in 2022, reflecting the completion of the Phase 3 ENHANCE program[10][15]. - The company plans to submit an IND for a fixed-dose combination formulation of ensifentrine and glycopyrrolate in the second half of 2024[10][12]. Selling, General and Administrative Expenses - SG&A expenses for Q4 2023 were 15.0 million, up from 8.3 million in Q4 2022, driven by increased personnel and commercialization preparation costs[10][15]. - Full-year SG&A expenses for 2023 were 50.4 million, an increase from 26.6millionin2022,largelyduetocostsassociatedwithbuildingcommercialinfrastructure[10][15].−Selling,generalandadministrativeexpensesincreasedto14,972,000 in Q4 2023 from 8,323,000inQ42022,withtotalexpensesfortheyearrisingto50,353,000 from 26,579,000[21].CashandAssets−CashandcashequivalentsatDecember31,2023,were271.8 million, an increase from 227.8millionattheendof2022[10].−Cashandcashequivalentsincreasedto271,772,000 in Q4 2023 from 227,827,000inQ42022[21].−Totalassetsroseto308,124,000 in Q4 2023, up from 259,468,000inQ42022[21].−Shareholders′equityincreasedto249,283,000 in Q4 2023 from 230,466,000inQ42022[21].DebtFinancingandFuturePlans−Thecompanycompleteda400 million debt financing facility in December 2023 to support commercialization and pipeline expansion[5][10]. - The FDA has assigned a PDUFA target action date of June 26, 2024, for the NDA of ensifentrine, which is aimed at treating COPD[10]. - The company expects to launch ensifentrine in the US market in the second half of 2024, pending FDA approval[10][7]. - The weighted average shares outstanding for Q4 2023 was 642,139,211, compared to 604,204,929 in Q4 2022[21].