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Forte Biosciences(FBRX) - 2024 Q4 - Annual Report
FBRXForte Biosciences(FBRX)2025-03-28 20:01

Financial Position - As of December 31, 2024, the company had approximately 58.4millionincash,cashequivalents,andshortterminvestments[343].Cash,cashequivalents,andshortterminvestmentstotaledapproximately58.4 million in cash, cash equivalents, and short-term investments[343]. - Cash, cash equivalents, and short-term investments totaled approximately 58.4 million as of December 31, 2024, expected to fund operations for at least 12 months[380]. - Net cash used in operating activities for 2024 was 30.7million,comparedto30.7 million, compared to 28.7 million in 2023, indicating an increase in cash outflow[387]. - Net cash provided by financing activities in 2024 was 51.9million,primarilyfromaprivateplacementofcommonstockandprefundedwarrants[390].Thecompanyhasnotgeneratedanyrevenuefromproductsalesandhasincurredoperatinglossessinceinception,withanaccumulateddeficitof51.9 million, primarily from a private placement of common stock and pre-funded warrants[390]. - The company has not generated any revenue from product sales and has incurred operating losses since inception, with an accumulated deficit of 154.0 million as of December 31, 2024[375]. Private Placement - The gross proceeds from the 2024 Private Placement were 53.0million,withissuancecostsof53.0 million, with issuance costs of 3.4 million[344]. - The gross proceeds from the 2023 Private Placement were 25.0million,withissuancecostsof25.0 million, with issuance costs of 272 thousand[345]. - The gross proceeds from the 2024 Private Placement were 53.0million,withissuancecostsof53.0 million, with issuance costs of 3.4 million[377]. Research and Development - The company anticipates research and development expenses to continue to increase as it develops its lead product candidate, FB102[353]. - The company anticipates an increase in research and development expenses as it continues to develop its lead product candidate, FB102, currently in Phase 1 clinical development[371]. - Research and development expenses decreased to 21.2millionin2024from21.2 million in 2024 from 21.9 million in 2023, primarily due to a 7.0milliondecreaseinmanufacturingexpenses[370].OperatingExpensesTotaloperatingexpensesfortheyearendedDecember31,2024,were7.0 million decrease in manufacturing expenses[370]. Operating Expenses - Total operating expenses for the year ended December 31, 2024, were 36.6 million, an increase of 4.1millionfrom4.1 million from 32.5 million in 2023[369]. - General and administrative expenses increased to 15.4millionin2024from15.4 million in 2024 from 10.6 million in 2023, reflecting a rise of 4.8millionmainlyduetohigherprofessionalandlegalexpenses[372].ClinicalTrialsandProductDevelopmentFB102demonstratedsignificantreductionsinNKcellpharmacodynamicmarkers,withreductionsofapproximately704.8 million mainly due to higher professional and legal expenses[372]. Clinical Trials and Product Development - FB102 demonstrated significant reductions in NK cell pharmacodynamic markers, with reductions of approximately 70% in Phase 1 trials[338]. - The company is currently enrolling patients in a trial for celiac disease, with top-line results expected in the second quarter of 2025[338]. Market Overview - The global vitiligo treatment market was estimated at 1.2 billion in 2018 and is projected to reach 1.9billionby2026[340].Theglobalalopeciatreatmentmarketwasvaluedat1.9 billion by 2026[340]. - The global alopecia treatment market was valued at 2.7 billion in 2018 and is projected to reach 3.9billionby2026,withaCAGRof4.63.9 billion by 2026, with a CAGR of 4.6% from 2019 to 2026[341]. - Celiac disease affects approximately 2.5 million people in the U.S., with 0.3% to 0.5% of patients being non-responsive to a gluten-free diet[339]. Net Loss - The net loss for the year ended December 31, 2024, was 35.5 million, compared to a net loss of 31.5millionin2023,representinganincreaseof31.5 million in 2023, representing an increase of 4.0 million[375].