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Praxis(PRAX) - 2024 Q4 - Annual Report
PRAXPraxis(PRAX)2025-02-28 13:06

Financial Performance - The company reported net losses of 182.8millionand182.8 million and 123.3 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of 836.7millionasofDecember31,2024[487].−Thenetlossfor2024was836.7 million as of December 31, 2024[487]. - The net loss for 2024 was 182.819 million, compared to a net loss of 123.277millionin2023,indicatingayear−over−yearincreaseinlossesofapproximately48123.277 million in 2023, indicating a year-over-year increase in losses of approximately 48%[577]. - The net loss for the quarter ending September 30, 2024, was 58,679, compared to a net loss of 51,910forthequarterendingJune30,2024,indicatingasequentialincreaseinlossesofabout13.551,910 for the quarter ending June 30, 2024, indicating a sequential increase in losses of about 13.5%[584]. - The company reported a net loss of 32,677 for the quarter ending June 30, 2024, which was an improvement compared to a net loss of 39,553forthequarterendingMarch31,2024[584].−Thebalanceofaccumulateddeficitincreasedto39,553 for the quarter ending March 31, 2024[584]. - The balance of accumulated deficit increased to (836,740) as of December 31, 2024, from (778,061)atSeptember30,2024,reflectingaworseningofapproximately7.5(778,061) at September 30, 2024, reflecting a worsening of approximately 7.5%[584]. Revenue Generation - The company has not generated any revenue from product sales since inception and does not expect to do so for several years, but recognized 8.6 million and 2.4millionofcollaborationrevenuefromapartnershipwithUCBBiopharmaSRLduringtheyearsendedDecember31,2024and2023,respectively[502].−Collaborationrevenueroseby2.4 million of collaboration revenue from a partnership with UCB Biopharma SRL during the years ended December 31, 2024 and 2023, respectively[502]. - Collaboration revenue rose by 6.1 million to 8.6millionin2024,primarilyduetoanoptionexercisefeefromUCB[519].−TheCompanyrecognized8.6 million in 2024, primarily due to an option exercise fee from UCB[519]. - The Company recognized 8.6 million in collaboration revenue for the year ended December 31, 2024, compared to 2.4millionfortheyearendedDecember31,2023[680].−UponUCBexercisingitsoptioninDecember2024,theCompanyrecognizeda2.4 million for the year ended December 31, 2023[680]. - Upon UCB exercising its option in December 2024, the Company recognized a 6.0 million option exercise fee as collaboration revenue[679]. Cash and Funding - The company has cash, cash equivalents, and marketable securities of 469.5millionasofDecember31,2024,whichareexpectedtofundoperationsinto2028[498].−Thecompanyraised469.5 million as of December 31, 2024, which are expected to fund operations into 2028[498]. - The company raised 1.1 billion in aggregate cash proceeds from various stock offerings since inception[523]. - A public offering in April 2024 generated approximately 216.0millioninnetproceedsfromthesaleofcommonstock[495].−ThecompanycompletedapublicofferinginJanuary2024,generatingapproximately216.0 million in net proceeds from the sale of common stock[495]. - The company completed a public offering in January 2024, generating approximately 161.6 million in net proceeds after expenses[527]. - The company expects its cash and marketable securities will be sufficient to fund operations for at least one year from the issuance of the financial statements[598]. Research and Development - Total research and development expenses increased by 65.6millionto65.6 million to 152.4 million in 2024, up from 86.8millionin2023[507].−Thecompanyplanstocontinueadvancingitsproductcandidatesandexpandingitsresearchanddevelopmentactivities,requiringsubstantialadditionalfunding[488].−Thecompanyanticipatesthatresearchanddevelopmentexpenseswillbemaintainedorincreaseasproductcandidatesadvancethroughdevelopment[507].−Thecompanyisfocusedondevelopingtherapiesforcentralnervoussystemdisordersthroughitstwoproprietaryplatforms,Cerebrum™andSolidus™,withmultipleclinical−stageproductcandidates[592].StockandEquity−Areversestocksplitof1−for−15wasexecutedonNovember28,2023,affectingthecompany′scommonstock[499].−Thecompany′sadditionalpaid−incapitalroseto86.8 million in 2023[507]. - The company plans to continue advancing its product candidates and expanding its research and development activities, requiring substantial additional funding[488]. - The company anticipates that research and development expenses will be maintained or increase as product candidates advance through development[507]. - The company is focused on developing therapies for central nervous system disorders through its two proprietary platforms, Cerebrum™ and Solidus™, with multiple clinical-stage product candidates[592]. Stock and Equity - A reverse stock split of 1-for-15 was executed on November 28, 2023, affecting the company's common stock[499]. - The company's additional paid-in capital rose to 1.282 billion in 2024, up from 723.577millionin2023,reflectinganincreaseofabout77723.577 million in 2023, reflecting an increase of about 77%[575]. - The weighted average common shares outstanding increased to 17,906,794 in 2024 from 6,594,316 in 2023, indicating a growth of approximately 172%[577]. - The total number of shares outstanding increased from 17,755,506 on June 30, 2024, to 19,422,358 by December 31, 2024, representing an increase of approximately 9.4%[584]. Operating Expenses - Total operating expenses rose to 208.718 million in 2024, compared to 128.820millionin2023,reflectinganincreaseofabout62128.820 million in 2023, reflecting an increase of about 62%[577]. - General and administrative expenses increased by 14.3 million to 56.3millionin2024,upfrom56.3 million in 2024, up from 42.1 million in 2023[518]. - The Cerebrum™ platform saw a 61.9millionincreaseinexpenses,mainlydrivenbya61.9 million increase in expenses, mainly driven by a 49.8 million rise in spending for the ulixacaltamide program[520]. - The company incurred stock-based compensation expenses of 41.4millionin2024,upfrom41.4 million in 2024, up from 24.9 million in 2023, reflecting a 66% increase[590]. Clinical Trials and Studies - The Phase 3 Essential3 clinical trials for ulixacaltamide are ongoing, with topline results expected in the third quarter of 2025[483]. - The company announced positive results from the Photo-Paroxysmal Response study for vormatrigine in Q1 2024 and has initiated multiple studies to gather further data[484]. - The EMBOLD study for relutrigine has shown positive topline results from the first cohort, with the second cohort currently enrolling and results expected in the first half of 2026[484]. Tax and Deferred Assets - The company has U.S. federal and state net operating loss carryforwards that may offset future taxable income, beginning to expire in 2035[516]. - The company has not recorded any U.S. federal or state income tax benefits for net losses incurred since inception[516]. - The Company assesses the likelihood of recovering deferred tax assets based on future taxable income and establishes a valuation allowance if necessary[647]. Collaboration Agreements - As of December 31, 2024, the Company had an option and license agreement with UCB Biopharma SRL, entered into in December 2022, and a collaboration and license agreement with Tenacia Biotechnology, entered into in January 2024[635]. - The Company entered into a Collaboration Agreement with UCB in December 2022, receiving a 5.0millionupfrontpaymentforresearchservices[677].−TheCollaborationAgreementallowsUCBtoin−licenseglobaldevelopmentandcommercializationrights,withpotentialmilestonepaymentstotalingupto5.0 million upfront payment for research services[677]. - The Collaboration Agreement allows UCB to in-license global development and commercialization rights, with potential milestone payments totaling up to 98.5 million and tiered royalties on net sales[677].