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Talphera(TLPH) - 2024 Q3 - Quarterly Results
TLPHTalphera(TLPH)2024-11-13 21:10

Financial Performance - Net loss from continuing operations for Q3 2024 was 3.4million,comparedtoanetlossof3.4 million, compared to a net loss of 1.4 million in Q3 2023[7]. - Net loss attributable to common shareholders for Q3 2024 was 3.4million,or3.4 million, or 0.13 per share, compared to a net loss of 1.4million,or1.4 million, or 0.08 per share, in Q3 2023[8]. - Total operating costs and expenses for Q3 2024 were 3.7million,comparedto3.7 million, compared to 3.4 million in Q3 2023[6]. - Total operating expenses for the three months ended September 2024 were 3,749,000,slightlyupfrom3,749,000, slightly up from 3,426,000, an increase of 9.4%[21]. - Non-GAAP operating expenses for the three months ended September 2024 were 3,515,000,comparedto3,515,000, compared to 3,048,000 for the same period in 2023, an increase of 15.3%[21]. - Total operating expenses for the nine months ended September 2024 were 12,256,000,slightlydownfrom12,256,000, slightly down from 12,976,000 for the same period in 2023, a decrease of 5.5%[21]. Cash and Investments - Cash and investments totaled 11.1millionasofSeptember30,2024[5].−Cash,cashequivalents,andinvestmentsincreasedto11.1 million as of September 30, 2024[5]. - Cash, cash equivalents, and investments increased to 11,117,000 from 9,381,000,representingagrowthof18.59,381,000, representing a growth of 18.5%[20]. - Total assets rose to 21,014,000, up from 20,395,000,indicatinganincreaseof3.020,395,000, indicating an increase of 3.0%[20]. - Total liabilities increased significantly to 11,373,000 from 6,290,000,reflectinganincreaseof80.56,290,000, reflecting an increase of 80.5%[20]. - Total stockholders' equity decreased to 9,641,000 from 14,105,000,adeclineof31.714,105,000, a decline of 31.7%[20]. Research and Development - Combined R&D and SG&A expenses for Q3 2024 were 3.7 million, up from 3.4millioninQ32023,primarilyduetoNEPHROstudycosts[6].−ResearchanddevelopmentexpensesforthethreemonthsendedSeptember2024were3.4 million in Q3 2023, primarily due to NEPHRO study costs[6]. - Research and development expenses for the three months ended September 2024 were 2,053,000, up 74.4% from 1,178,000forthesameperiodin2023[21].−TheNEPHROCRRTstudyaimstoenroll166patientsacrossupto14clinicalsitesintheU.S.[4].−ThefirstpatientwasenrolledintheNEPHROCRRTstudyinAugust2024[3].−Thestudy′sprimaryendpointisthemeanpost−filteractivatedclottingtimeforcircuitsinfusedwithnafamostatcomparedtoplacebooverthefirst24hours[4].−TalpheraanticipatescompletingtheNEPHROstudybytheendof2025withimprovedenrollmentrates[2].OperatingExpenses−Selling,general,andadministrativeexpensesdecreasedto1,178,000 for the same period in 2023[21]. - The NEPHRO CRRT study aims to enroll 166 patients across up to 14 clinical sites in the U.S.[4]. - The first patient was enrolled in the NEPHRO CRRT study in August 2024[3]. - The study's primary endpoint is the mean post-filter activated clotting time for circuits infused with nafamostat compared to placebo over the first 24 hours[4]. - Talphera anticipates completing the NEPHRO study by the end of 2025 with improved enrollment rates[2]. Operating Expenses - Selling, general, and administrative expenses decreased to 1,696,000 from 2,248,000,areductionof24.52,248,000, a reduction of 24.5%[21]. - Stock-based compensation expense for the three months ended September 2024 was 234,000, down from $378,000, a decrease of 38.3%[21]. Regulatory Status - The company has received Breakthrough Device Designation status from the FDA for its lead product candidate, Niyad™[11].