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Artelo Biosciences(ARTL) - 2024 Q4 - Annual Report
ARTLArtelo Biosciences(ARTL)2025-03-03 13:00

Product Development and Pipeline - The company is developing ART27.13, a dual cannabinoid GPCR agonist for cancer-related anorexia, with a global market size exceeding 2billion[33].−ART26.12,aFABP5inhibitor,targetschemotherapy−inducedperipheralneuropathy(CIPN)andhasamarketpotentialofover2 billion[33]. - ART26.12, a FABP5 inhibitor, targets chemotherapy-induced peripheral neuropathy (CIPN) and has a market potential of over 1 billion, with additional applications in prostate cancer and breast cancer, which have market sizes of approximately 9billionand9 billion and 18 billion respectively[33]. - The company has initiated a Phase 1 clinical trial for ART26.12, with the first-in-human studies beginning in Q4 2024 after receiving FDA approval for the IND application[29]. - The Phase 1b portion of the CAReS study for ART27.13 was completed in Q1 2023, and the Phase 2a portion is expected to enroll 40 evaluable patients across 15 clinical sites in five countries[27]. - ART12.11, a synthetic CBD cocrystal, is in pre-clinical development targeting anxiety and PTSD, with a market potential exceeding 11billion[33].−Thecompanyhasacomprehensiveproductcandidatepipelinethatbalancesriskacrossvariousmechanismsofactionandstagesofdevelopment[22].−Thecompanyisfocusedondevelopingtherapeuticsthattargetlipid−signalingmodulationpathways,includingtheendocannabinoidsystem[21].−Thecompanyisfocusedondevelopingethicalpharmaceuticalproductsthatleveragelipidsignalingmodulation,particularlywithintheendocannabinoidsystem(ECS)toaddressvariousmedicalconditions[41].−ThecompanyhasapipelinethatincludesART27.13,whichhasbeendosedinover200subjectsacrossfivephase1clinicaltrials,demonstratingsafetyandtolerability[49].−Thecompanyplanstodevelopsyntheticnewchemicalentitiestargetingreceptorbindingandendocannabinoidtransportmodulation,expandingitstherapeuticapproaches[39].−Thecompanyaimstoaddressawiderangeofdiseasesthroughlipid−signalingmodulation,includingneurologicaldiseasesanddermatologicconditions[41].−Thecompanyhasatotalof27pendingapplicationsrelatedtotheART26.12program,indicatingongoingresearchanddevelopmentefforts[44].−Thecompanyiscommittedtobuildingapipelineofproductcandidatesassociatedwithlipidsignalingthroughlicensingagreementswithpharmaceuticalandbiotechnologycompanies[42].−ThecompanyenteredintoalicenseagreementwithStonyBrookUniversity,providinganexclusivelicensefordevelopingandcommercializingpatentproductsworldwide[52].FinancialPerformance−Totalcurrentassetsdecreasedfrom11 billion[33]. - The company has a comprehensive product candidate pipeline that balances risk across various mechanisms of action and stages of development[22]. - The company is focused on developing therapeutics that target lipid-signaling modulation pathways, including the endocannabinoid system[21]. - The company is focused on developing ethical pharmaceutical products that leverage lipid signaling modulation, particularly within the endocannabinoid system (ECS) to address various medical conditions[41]. - The company has a pipeline that includes ART27.13, which has been dosed in over 200 subjects across five phase 1 clinical trials, demonstrating safety and tolerability[49]. - The company plans to develop synthetic new chemical entities targeting receptor binding and endocannabinoid transport modulation, expanding its therapeutic approaches[39]. - The company aims to address a wide range of diseases through lipid-signaling modulation, including neurological diseases and dermatologic conditions[41]. - The company has a total of 27 pending applications related to the ART26.12 program, indicating ongoing research and development efforts[44]. - The company is committed to building a pipeline of product candidates associated with lipid signaling through licensing agreements with pharmaceutical and biotechnology companies[42]. - The company entered into a license agreement with Stony Brook University, providing an exclusive license for developing and commercializing patent products worldwide[52]. Financial Performance - Total current assets decreased from 10,980,000 in 2023 to 2,557,000in2024,adeclineofapproximately772,557,000 in 2024, a decline of approximately 77%[353]. - Total liabilities increased from 1,291,000 in 2023 to 1,841,000in2024,representingariseofabout42.51,841,000 in 2024, representing a rise of about 42.5%[355]. - Net loss for the year ended December 31, 2024, was 9,826,000, compared to a net loss of 9,289,000in2023,indicatinganincreaseinlossofapproximately5.89,289,000 in 2023, indicating an increase in loss of approximately 5.8%[357]. - Total operating expenses rose to 10,108,000 in 2024 from 9,930,000in2023,reflectinganincreaseofabout1.89,930,000 in 2023, reflecting an increase of about 1.8%[357]. - Cash and cash equivalents decreased from 2,815,000 at the end of 2023 to 2,338,000attheendof2024,areductionofapproximately16.92,338,000 at the end of 2024, a reduction of approximately 16.9%[362]. - Basic and diluted loss per common share improved slightly from (3.14) in 2023 to (3.05)in2024[359].−Thecompanyreportedatotalcomprehensivelossof(3.05) in 2024[359]. - The company reported a total comprehensive loss of 9,825,000 for 2024, compared to 9,238,000in2023,anincreaseofabout6.49,238,000 in 2023, an increase of about 6.4%[357]. - Stock-based compensation expenses were 818,000 in 2024, down from 1,020,000in2023,adecreaseofapproximately19.81,020,000 in 2023, a decrease of approximately 19.8%[362]. - The total stockholders' equity decreased from 11,752,000 in 2023 to 2,857,000in2024,adeclineofapproximately75.72,857,000 in 2024, a decline of approximately 75.7%[355]. - The Company incurred a net loss of 9,826,000 for the year ended December 31, 2024[368]. - The Company raised 18,262,000 from an equity offering completed in November 2021[368]. - The Company received R&D tax credits of 1,349,000 and 1,206,000fortheyearsendedDecember31,2024,and2023,respectively[375].−TheCompanyfileda1,206,000 for the years ended December 31, 2024, and 2023, respectively[375]. - The Company filed a 75,000,000 shelf registration statement effective for three years, allowing for the sale of various securities[369]. - The Company issued 425,344 shares of Common Stock under the Equity Line, generating proceeds of 679,000[368].−TheCompanyhassignificantdoubtaboutitsabilitytocontinueasagoingconcernwithinoneyearaftertheissuanceofthefinancialstatements[370].−TheCompanyhasnotgeneratedanyrevenuesinceitsinceptionandexpectstocontinueincurringlossesintotheforeseeablefutureduetoongoingresearchanddevelopmentactivities[395].RegulatoryandCompliance−Regulatorycomplianceiscritical,withextensiverequirementsfordrugapprovalprocessesintheU.S.andotherjurisdictions[66][67].−TheFDAaimstoreviewandactonastandardNDAforanewmolecularentitywithintenmonthsfromthefilingdate,typicallytaking12monthsintotal[79].−TheFDAmayissueaCompleteResponseLetteriftheNDAhasdeficiencies,requiringadditionalclinicaldataorstudiesbeforeresubmission[82].−Marketexclusivityprovisionscandelaythesubmissionandapprovalofmarketingapplicationsforproductswiththesameactiveingredient,allowingforpatenttermrestorationofuptofiveyears[90].−PediatricexclusivitycanprovideanadditionalsixmonthsofmarketingexclusivityifclinicaltrialsinchildrenareconductedinresponsetoanFDArequest[92].−TheFDAmaywithdrawproductapprovalifcompliancewithregulatoryrequirementsisnotmaintainedorifnewsafetyrisksarediscoveredpost−marketing[86].−TheFDAconductsinspectionsofmanufacturingfacilitiesandclinicalsitestoensurecompliancewithcGMPandGCPstandardsbeforeapprovinganNDA[81].−ThecentralizedprocedureintheEUallowsforasinglemarketingauthorizationvalidacrossallEUMemberStatesforcertainmedicinalproducts[95].−CompaniesmustsubmitannualprogressreportstotheFDAsummarizingclinicaltrialresultswhiletheINDisactive[77].−TheFDAmayreferanoveldrugapplicationtoanadvisorycommitteeforindependentexpertevaluationandrecommendations[80].−Changestoapprovedproducts,suchasnewindications,requirepriorFDAreviewandapproval[85].−TheForeignCorruptPracticesAct(FCPA)prohibitsU.S.businessesfromofferingbribestoforeignofficials,impactinginternationaloperationsandrequiringcompliancewithaccountingprovisions[96].−TheU.S.federalAnti−KickbackStatuteprohibitsremunerationtoinducereferralsforservicescoveredbyU.S.healthcareprograms,withviolationspotentiallyleadingtosignificantpenalties[100].−TheAmericanRescuePlanActof2021eliminatedtheMedicaiddrugrebatecap,whichmayrequirepharmaceuticalmanufacturerstopaymoreinrebatesthanreceivedonproductsales[108].−TheInflationReductionActof2022allowsthefederalgovernmenttonegotiatemaximumfairpricesforcertainhigh−pricedMedicaredrugs,potentiallyimpactingrevenuegenerationandprofitability[110].−BiologicsareaffordedanadditionalfouryearsonthemarketbeforebeingsubjectedtopricenegotiationsundertheInflationReductionAct,comparedtosmall−moleculedrugs[113].−LegislativechangesmayimposeaggregatereductionstoMedicarepaymentsofupto2679,000[368]. - The Company has significant doubt about its ability to continue as a going concern within one year after the issuance of the financial statements[370]. - The Company has not generated any revenue since its inception and expects to continue incurring losses into the foreseeable future due to ongoing research and development activities[395]. Regulatory and Compliance - Regulatory compliance is critical, with extensive requirements for drug approval processes in the U.S. and other jurisdictions[66][67]. - The FDA aims to review and act on a standard NDA for a new molecular entity within ten months from the filing date, typically taking 12 months in total[79]. - The FDA may issue a Complete Response Letter if the NDA has deficiencies, requiring additional clinical data or studies before resubmission[82]. - Market exclusivity provisions can delay the submission and approval of marketing applications for products with the same active ingredient, allowing for patent term restoration of up to five years[90]. - Pediatric exclusivity can provide an additional six months of marketing exclusivity if clinical trials in children are conducted in response to an FDA request[92]. - The FDA may withdraw product approval if compliance with regulatory requirements is not maintained or if new safety risks are discovered post-marketing[86]. - The FDA conducts inspections of manufacturing facilities and clinical sites to ensure compliance with cGMP and GCP standards before approving an NDA[81]. - The centralized procedure in the EU allows for a single marketing authorization valid across all EU Member States for certain medicinal products[95]. - Companies must submit annual progress reports to the FDA summarizing clinical trial results while the IND is active[77]. - The FDA may refer a novel drug application to an advisory committee for independent expert evaluation and recommendations[80]. - Changes to approved products, such as new indications, require prior FDA review and approval[85]. - The Foreign Corrupt Practices Act (FCPA) prohibits U.S. businesses from offering bribes to foreign officials, impacting international operations and requiring compliance with accounting provisions[96]. - The U.S. federal Anti-Kickback Statute prohibits remuneration to induce referrals for services covered by U.S. healthcare programs, with violations potentially leading to significant penalties[100]. - The American Rescue Plan Act of 2021 eliminated the Medicaid drug rebate cap, which may require pharmaceutical manufacturers to pay more in rebates than received on product sales[108]. - The Inflation Reduction Act of 2022 allows the federal government to negotiate maximum fair prices for certain high-priced Medicare drugs, potentially impacting revenue generation and profitability[110]. - Biologics are afforded an additional four years on the market before being subjected to price negotiations under the Inflation Reduction Act, compared to small-molecule drugs[113]. - Legislative changes may impose aggregate reductions to Medicare payments of up to 2% per fiscal year through 2032, affecting financial performance[106]. - Compliance with international privacy laws regarding health information access and disclosure is critical, as violations could significantly impact business operations[98]. - Increased scrutiny over drug pricing and transparency measures may lead to greater compliance burdens and potential liabilities for the company[109]. - Future healthcare reforms and regulatory changes could materially affect the company's ability to commercialize product candidates and achieve profitability[103]. Operational and Employment Information - As of December 31, 2024, the company had six employees, with no labor union representation, and relies on contractors and consultants for day-to-day operations[116]. - Total general and administrative expenses for the year ended December 31, 2024, were 4,115, a decrease of 2.8% from 4,234in2023[397].−TotalresearchanddevelopmentexpensesfortheyearendedDecember31,2024,were4,234 in 2023[397]. - Total research and development expenses for the year ended December 31, 2024, were 5,993, an increase of 5.2% from 5,696in2023[397].−TheCompanyincurredanaggregatenetoperatinglossof5,696 in 2023[397]. - The Company incurred an aggregate net operating loss of 27,433, with net operating loss carryforwards beginning to expire in varying amounts starting in 2034[420]. - The Company has capitalized costs associated with acquiring an exclusive worldwide license for the compound ART27.13 as an intangible asset valued at 2,039asofDecember31,2024,and2023[422].−AsofDecember31,2024,theCompanyhad3,281,032sharesofCommonStockissuedandoutstanding,anincreasefrom3,188,959sharesin2023[403].−TheCompanygranted254,500stockoptionsduringtheyearendedDecember31,2024,withanaverageexercisepriceof2,039 as of December 31, 2024, and 2023[422]. - As of December 31, 2024, the Company had 3,281,032 shares of Common Stock issued and outstanding, an increase from 3,188,959 shares in 2023[403]. - The Company granted 254,500 stock options during the year ended December 31, 2024, with an average exercise price of 1.48[417]. - The intrinsic value of the warrants outstanding as of December 31, 2024, is 0,withalloutstandingwarrantsbeingexercisable[404].−TheCompanyrecognizedstock−basedcompensationexpenseof0, with all outstanding warrants being exercisable[404]. - The Company recognized stock-based compensation expense of 818 for the year ended December 31, 2024, down from 1,020in2023[418].−TheCompanyhasnotrecordedanydeferredincometaxassetsasofDecember31,2024,duetouncertaintiesingeneratingfuturetaxableincome[420].−TheCompanycapitalizedatotalof1,020 in 2023[418]. - The Company has not recorded any deferred income tax assets as of December 31, 2024, due to uncertainties in generating future taxable income[420]. - The Company capitalized a total of 1,500 and the fair value of 4,087 shares of Common Stock valued at 539[423].−OperatingleasecostfortheyearendedDecember31,2024,was539[423]. - Operating lease cost for the year ended December 31, 2024, was 32, down from 40in2023,representingadecreaseof2040 in 2023, representing a decrease of 20%[426]. - Cash paid for operating leases was 30 in 2024, compared to 40in2023,indicatinga2540 in 2023, indicating a 25% reduction[426]. - Right-of-use assets obtained in exchange for new operating lease liability amounted to 111 in 2024, while there were none in 2023[426]. - The weighted-average remaining lease term for operating leases increased to 2.58 years in 2024 from 0.67 years in 2023[426]. - The weighted-average discount rate for operating leases rose to 7.50% in 2024 from 3.00% in 2023[426]. - Future minimum lease payments under operating lease liability total 115,with115, with 42 due in 2025 and $43 in 2026[426]. - The Company has ongoing financial commitments related to research and development contracts, with additional payments dependent on program milestones[427]. - An additional 484,155 shares of common stock were reserved for issuance under the 2018 Plan as of February 28, 2025[429].