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Actuate Therapeutics,Inc(ACTU) - 2024 Q4 - Annual Report
ACTUActuate Therapeutics,Inc(ACTU)2025-03-13 20:30

Financial Condition and Operating Losses - The company has incurred significant operating losses since its inception in January 2015, with an accumulated deficit of approximately 132.4millionasofDecember31,2024[243].−AsofDecember31,2024,thecompanyhadapproximately132.4 million as of December 31, 2024[243]. - As of December 31, 2024, the company had approximately 8.6 million in cash and cash equivalents and working capital of approximately 0.4million,raisingsubstantialdoubtaboutitsabilitytocontinueasagoingconcern[247].−Thecompanyexpectstocontinueincurringsubstantialoperatinglossesfortheforeseeablefutureasitdevelopsitssoledrugcandidate,elraglusib[243].−Thecompanyhasnotgeneratedanyrevenuefromproductsalesanddoesnotexpecttodosointhenearfuture,ifever[244].−Thedevelopmentofelraglusibandanyfutureproductcandidatesishighlycapital−intensive,andthecompanywillrequiresubstantialadditionalcapitaltofinanceitsoperations[249].−Thecompanyplanstoaddressitsfinancialconditionsbyraisingfundsfrompublicorprivateofferingsofequityordebtsecurities,butthereisnoassurancethatsuchfundingwillbeavailableonfavorableterms[248].−Thecompanyintendstoseekadditionalfinancingtoachievebusinessobjectives,butadequatefinancingmaynotbeavailableonacceptableterms[254].−Thereisnoassurancethatthecompanywillbeabletosecureadditionalfinancinginsufficientquantitiesoratall,whichmaydelayorlimitproductdevelopment[256].ClinicalDevelopmentandRegulatoryApproval−Thecompanymayfacedelaysordifficultiesinclinicaltrials,whichcouldadverselyaffectitsabilitytoobtainregulatoryapprovalsandcommercializeitsproductcandidates[237].−Thecompanyreliesonthirdpartiesforconductingnon−clinicalstudiesandclinicaltrials,andanyfailureontheirpartcouldadverselyimpactthecompany′sfinancialcondition[241].−Thecompany’sfuturecapitalrequirementswilldependonthesuccessofclinicaltrialsandtheabilitytoobtainregulatoryapprovals,whichareuncertainandtime−consumingprocesses[253].−Regulatoryapprovalsarecriticalforthecommercializationofelraglusib,andtheprocessisexpensiveandtime−consuming[258].−Thecompanymayencounterdelaysinclinicaltrialsthatcouldprecluderegulatoryapprovalandcommercializationofitsproducts[259].−Thecompanyhasnoexperienceinsuccessfullyobtainingregulatoryapproval,whichmayhinderitsabilitytomanagerelatedrisks[268].−Thesuccessofelraglusibdependsonvariousfactors,includingsuccessfulclinicaltrialsandregulatorysubmissions[266].−ThecompanyhasnotyetcompletedaPhase2clinicaltrial,whichiscriticalforobtainingregulatoryapprovalandcommercializingelraglusib[289].−Safetyconcernsinclinicaltrialscouldadverselyaffecttheprospectsforregulatoryapprovalofelraglusib,impactingthecompany′sfinancialcondition[291].−Thecompanyanticipatesdevelopingproductcandidatesforuseincombinationwithotheroncologydrugs,whichmaycomplicateclinicaltrialdesignsandregulatoryapprovalprocesses[298].ManufacturingandSupplyChainRisks−Thecompanyreliesonthird−partymanufacturersfortheproductionofelraglusib,whichposesrisksrelatedtoqualitycontrolandregulatorycompliance[305].−Thecompanydoesnotcontrolthemanufacturingprocessandisdependentonthird−partymanufacturersforcompliancewithcGMPrequirements[305].−Thecompanyreliesonthird−partymanufacturersfordrugsubstancesandproducts,withnolong−termsupplyagreementsinplace,whichmaydelayclinicaltrialsifsuppliesarenotsourcedtimely[308].−Thecurrentmanufacturerforelraglusib′sdrugsubstanceislocatedinChina,andgeopoliticalrelationshipsmayimpactcostsandregulatoryapprovals[317].−Establishingnewsupplierscouldtakeuptotwoyearsforregulatoryapproval,potentiallydelayingclinicaldevelopmentandincreasingcosts[318].−Thecompanymayfacehigherthanexpectedcostsinmanufacturingelraglusibduetoinflation,supplychainissues,orcomponentshortages[255].−Thecompanyhasnotexperiencedsignificantsupplychaindisruptionsbutacknowledgestheriskoffutureinterruptions[309].IntellectualPropertyandLegalRisks−Thecompanymayfacechallengesinobtaininglicensesfromthirdparties,whichcouldadverselyaffectitsabilitytodevelopandcommercializeproducts[375].−Thecompanymaynothavecontrolovertheprosecutionandmaintenanceoflicensedpatents,whichcouldjeopardizeitsrightstodevelopandcommercializeproducts[376].−Thecompanymayfaceclaimsregardingtheinventorshiporownershipofitspatentsandintellectualproperty,whichcouldleadtolitigationandsubstantialcosts,adverselyaffectingitsbusinessandfinancialcondition[378].−Thecompanymaylosevaluableintellectualpropertyrightsifitisunsuccessfulininterferenceproceedingsorotherdisputesregardingpatentvalidity,whichcouldimpactitsabilitytocommercializedrugcandidates[380].−Thecompanymayneedtolitigateorobtainlicensesfromthirdpartiestodevelopormarketitstechnologies,whichmaynotbeavailableoncommerciallyreasonableterms[381].−Thecompanyfacessignificantrisksregardingitsintellectualproperty,aspatentsmaybechallenged,invalidated,orcircumvented,potentiallyimpactingcompetitiveadvantage[363].−Thebiopharmaceuticalindustryischaracterizedbyextensivelitigation,whichcouldleadtocostlyandtime−consuminglegaldisputesthatmayadverselyaffectthecompany′sbusiness[365].MarketandCompetitiveRisks−Thecompanyfacessignificantcompetitioninestablishingstrategicpartnerships,whichcanbetime−consumingandcostly[325].−Thecompanyisexposedtorisksfromcompetitorswhomaydevelopsuperiorproductsorobtainregulatoryapprovalsmorequickly[394].−Thecommercialsuccessofelraglusibandfutureproductcandidatesdependssignificantlyonmarketacceptanceamongphysicians,patients,andhealthcarepayors,withnoassuranceofachievingadequaterevenueifacceptanceislow[342].−Thecompanycurrentlylacksamarketingandsalesorganizationandmustinvestsignificantresourcestodevelopthesecapabilities,whichmaydelayrevenuegeneration[343].−Establishingeffectivemarketing,sales,anddistributionrelationshipswiththirdpartiesiscritical,asfailuretodosocouldhinderproductcommercializationandrevenuegeneration[345].ComplianceandRegulatoryEnvironment−CompliancewithcGMPandregulatoryrequirementsiscritical,andfailuretomeetthesecoulddelayproductapprovalsandrevenuegeneration[307].−Thecompanymayfaceincreasedcompliancecostsduetovarioushealthcarelawsandregulations,whichcouldadverselyaffectitsbusinessoperations[399].−Thecompanyissubjecttosignificantrisksrelatedtoproductliabilitylawsuits,whichcouldleadtosubstantialcostsandreduceddemandforitsproducts[410].−Thecompanyisclassifiedasanemerginggrowthcompany,allowingittotakeadvantageofreduceddisclosurerequirements,whichmayaffectinvestorattractiveness[404].DataPrivacyandSecurityRisks−Thecompanyreliesonthird−partyvendorsformanufacturingandITinfrastructure,whichincreasesvulnerabilitytodisruptionsandunauthorizedaccess[415].−Compliancewithhealthprivacyanddataprotectionlawsiscritical,asviolationscouldleadtogovernmentenforcementactionsandsignificantcosts[416].−Thecompanyissubjecttovariousstateandfederaldataprivacylaws,includingtheCaliforniaConsumerPrivacyAct,whichallowspenaltiesofupto0.4 million, raising substantial doubt about its ability to continue as a going concern[247]. - The company expects to continue incurring substantial operating losses for the foreseeable future as it develops its sole drug candidate, elraglusib[243]. - The company has not generated any revenue from product sales and does not expect to do so in the near future, if ever[244]. - The development of elraglusib and any future product candidates is highly capital-intensive, and the company will require substantial additional capital to finance its operations[249]. - The company plans to address its financial conditions by raising funds from public or private offerings of equity or debt securities, but there is no assurance that such funding will be available on favorable terms[248]. - The company intends to seek additional financing to achieve business objectives, but adequate financing may not be available on acceptable terms[254]. - There is no assurance that the company will be able to secure additional financing in sufficient quantities or at all, which may delay or limit product development[256]. Clinical Development and Regulatory Approval - The company may face delays or difficulties in clinical trials, which could adversely affect its ability to obtain regulatory approvals and commercialize its product candidates[237]. - The company relies on third parties for conducting non-clinical studies and clinical trials, and any failure on their part could adversely impact the company's financial condition[241]. - The company’s future capital requirements will depend on the success of clinical trials and the ability to obtain regulatory approvals, which are uncertain and time-consuming processes[253]. - Regulatory approvals are critical for the commercialization of elraglusib, and the process is expensive and time-consuming[258]. - The company may encounter delays in clinical trials that could preclude regulatory approval and commercialization of its products[259]. - The company has no experience in successfully obtaining regulatory approval, which may hinder its ability to manage related risks[268]. - The success of elraglusib depends on various factors, including successful clinical trials and regulatory submissions[266]. - The company has not yet completed a Phase 2 clinical trial, which is critical for obtaining regulatory approval and commercializing elraglusib[289]. - Safety concerns in clinical trials could adversely affect the prospects for regulatory approval of elraglusib, impacting the company's financial condition[291]. - The company anticipates developing product candidates for use in combination with other oncology drugs, which may complicate clinical trial designs and regulatory approval processes[298]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for the production of elraglusib, which poses risks related to quality control and regulatory compliance[305]. - The company does not control the manufacturing process and is dependent on third-party manufacturers for compliance with cGMP requirements[305]. - The company relies on third-party manufacturers for drug substances and products, with no long-term supply agreements in place, which may delay clinical trials if supplies are not sourced timely[308]. - The current manufacturer for elraglusib's drug substance is located in China, and geopolitical relationships may impact costs and regulatory approvals[317]. - Establishing new suppliers could take up to two years for regulatory approval, potentially delaying clinical development and increasing costs[318]. - The company may face higher than expected costs in manufacturing elraglusib due to inflation, supply chain issues, or component shortages[255]. - The company has not experienced significant supply chain disruptions but acknowledges the risk of future interruptions[309]. Intellectual Property and Legal Risks - The company may face challenges in obtaining licenses from third parties, which could adversely affect its ability to develop and commercialize products[375]. - The company may not have control over the prosecution and maintenance of licensed patents, which could jeopardize its rights to develop and commercialize products[376]. - The company may face claims regarding the inventorship or ownership of its patents and intellectual property, which could lead to litigation and substantial costs, adversely affecting its business and financial condition[378]. - The company may lose valuable intellectual property rights if it is unsuccessful in interference proceedings or other disputes regarding patent validity, which could impact its ability to commercialize drug candidates[380]. - The company may need to litigate or obtain licenses from third parties to develop or market its technologies, which may not be available on commercially reasonable terms[381]. - The company faces significant risks regarding its intellectual property, as patents may be challenged, invalidated, or circumvented, potentially impacting competitive advantage[363]. - The biopharmaceutical industry is characterized by extensive litigation, which could lead to costly and time-consuming legal disputes that may adversely affect the company's business[365]. Market and Competitive Risks - The company faces significant competition in establishing strategic partnerships, which can be time-consuming and costly[325]. - The company is exposed to risks from competitors who may develop superior products or obtain regulatory approvals more quickly[394]. - The commercial success of elraglusib and future product candidates depends significantly on market acceptance among physicians, patients, and healthcare payors, with no assurance of achieving adequate revenue if acceptance is low[342]. - The company currently lacks a marketing and sales organization and must invest significant resources to develop these capabilities, which may delay revenue generation[343]. - Establishing effective marketing, sales, and distribution relationships with third parties is critical, as failure to do so could hinder product commercialization and revenue generation[345]. Compliance and Regulatory Environment - Compliance with cGMP and regulatory requirements is critical, and failure to meet these could delay product approvals and revenue generation[307]. - The company may face increased compliance costs due to various healthcare laws and regulations, which could adversely affect its business operations[399]. - The company is subject to significant risks related to product liability lawsuits, which could lead to substantial costs and reduced demand for its products[410]. - The company is classified as an emerging growth company, allowing it to take advantage of reduced disclosure requirements, which may affect investor attractiveness[404]. Data Privacy and Security Risks - The company relies on third-party vendors for manufacturing and IT infrastructure, which increases vulnerability to disruptions and unauthorized access[415]. - Compliance with health privacy and data protection laws is critical, as violations could lead to government enforcement actions and significant costs[416]. - The company is subject to various state and federal data privacy laws, including the California Consumer Privacy Act, which allows penalties of up to 7,500 per violation[418]. - International data protection laws, including the EU General Data Protection Regulation, impose strict requirements and potential fines of up to 4% of annual worldwide turnover[422]. - The evolving legal framework around privacy could impose significant limitations on data collection and usage practices[424]. Legislative and Pricing Pressures - Current healthcare reform legislation may increase difficulty and costs for the company to obtain coverage and commercialize elraglusib or future product candidates[427]. - The Inflation Reduction Act of 2022 allows HHS to negotiate prices for certain high-expenditure drugs under Medicare, which could significantly impact the pharmaceutical industry[431]. - The American Rescue Plan Act of 2021 eliminates the statutory cap on Medicaid drug rebates starting January 1, 2024, which was previously capped at 100% of a drug's average manufacturer price[430]. - Legislative changes have resulted in reduced Medicare payments to providers, which will remain in effect until 2032 unless further Congressional action is taken[430]. - Increased scrutiny of pharmaceutical pricing practices has led to congressional inquiries and proposed legislation aimed at enhancing transparency and reforming reimbursement methodologies[430]. - The company faces potential pressure on product pricing due to bidding procedures used by regional healthcare authorities and hospitals[432]. - The company anticipates that future legislative changes may further impact drug pricing and reimbursement practices[431].