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Ocuphire Pharma(OCUP) - 2024 Q3 - Quarterly Report
OCUPOcuphire Pharma(OCUP)2024-11-12 14:29

Financial Performance - The company reported a net loss of 7.5millionforQ32024,comparedtoanetincomeof7.5 million for Q3 2024, compared to a net income of 5.6 million in Q3 2023, and a net loss of 22.4millionfortheninemonthsendedSeptember30,2024,comparedtoanetlossof22.4 million for the nine months ended September 30, 2024, compared to a net loss of 5.2 million for the same period in 2023[179]. - The net loss for Q3 2024 was 7.5million,comparedtoanetincomeof7.5 million, compared to a net income of 5.6 million in Q3 2023, reflecting a significant year-over-year change of 13.1million[192].−FortheninemonthsendedSeptember30,2024,licenseandcollaborationsrevenuewas13.1 million[192]. - For the nine months ended September 30, 2024, license and collaborations revenue was 6.7 million, down 10.7millionfrom10.7 million from 17.4 million in the same period of 2023[201]. - The loss from operations for the nine months ended September 30, 2024 was 24.0million,comparedtoalossof24.0 million, compared to a loss of 5.1 million in the same period of 2023, indicating a deterioration of 18.9million[201].−CashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2024was18.9 million[201]. - Cash used in operating activities for the nine months ended September 30, 2024 was 18.1 million, attributed to a net loss of 22.4million,partiallyoffsetby22.4 million, partially offset by 2.6 million in non-cash operating expenses[229]. - The company reported a net decrease in cash and cash equivalents of 13.9millionfortheninemonthsendedSeptember30,2024,comparedtoadecreaseof13.9 million for the nine months ended September 30, 2024, compared to a decrease of 284,000 in 2023[227]. - For the nine months ended September 30, 2023, the company reported a net loss of 5.2million,withcashusedinoperatingactivitiesamountingto5.2 million, with cash used in operating activities amounting to 5.7 million[230]. Revenue and Expenses - License and collaborations revenue for Q3 2024 was 3.9million,adecreaseof3.9 million, a decrease of 8.1 million from 11.9millioninQ32023,primarilyduetoaone−time11.9 million in Q3 2023, primarily due to a one-time 10.0 million milestone payment in the prior year[192]. - Total operating expenses for Q3 2024 were 11.9million,anincreaseof11.9 million, an increase of 6.3 million from 5.5millioninQ32023,drivenbyhigherresearchanddevelopmentcosts[192].−ResearchanddevelopmentexpensesforQ32024were5.5 million in Q3 2023, driven by higher research and development costs[192]. - Research and development expenses for Q3 2024 were 9.0 million, up 5.5millionfrom5.5 million from 3.5 million in Q3 2023, mainly due to increased clinical costs and drug manufacturing expenses[197]. - General and administrative expenses for Q3 2024 were 2.9million,anincreaseof2.9 million, an increase of 0.8 million from 2.1millioninQ32023,attributedtopersonnel−relatedcostsandbusinessdevelopmentexpenses[193].−TotaloperatingexpensesfortheninemonthsendedSeptember30,2024were2.1 million in Q3 2023, attributed to personnel-related costs and business development expenses[193]. - Total operating expenses for the nine months ended September 30, 2024 were 30.7 million, an increase of 8.2millionfrom8.2 million from 22.5 million in the same period of 2023[201]. - Research and development expenses for the nine months ended September 30, 2024 were 19.8million,anincreaseof19.8 million, an increase of 6.0 million from 13.8millioninthesameperiodof2023[201].−Generalandadministrativeexpensesincreasedto13.8 million in the same period of 2023[201]. - General and administrative expenses increased to 10.9 million for the nine months ended September 30, 2024, compared to 8.7millionin2023,witha8.7 million in 2023, with a 2.2 million increase attributed mainly to legal support and business development activities[204]. Cash and Financing - As of September 30, 2024, cash and cash equivalents totaled 36.6million,sufficienttofundoperationsforatleasttwelvemonthsbeyondthefilingdate[209].−ThecompanyenteredintoacommonstockpurchaseagreementwithLincolnParkforanequitylinefinancingofupto36.6 million, sufficient to fund operations for at least twelve months beyond the filing date[209]. - The company entered into a common stock purchase agreement with Lincoln Park for an equity line financing of up to 50 million over 30 months, with 5.2millionraisedthroughSeptember30,2024[211].−Thecompanyhasraisedapproximately5.2 million raised through September 30, 2024[211]. - The company has raised approximately 67.8 million through various equity offerings and 8.5millionthroughconvertiblenotestofundoperations[210].−Thecompanyexpectstosatisfyitscashrequirementsthroughcashonhand,futureequityanddebtfinancings,andreimbursementpaymentsuntilitgeneratesadequaterevenuefromcommercialsales[248].ClinicalDevelopment−Thecompany’smostadvancedgenetherapycandidate,OPGx−LCA5,isinaPhase1/2clinicaltrial,withearlydatashowingvisualimprovementinallthreeadultpatients[166].−EnrollmentofthefirstpediatricpatientsintheLCA5Phase1/2trialisexpectedinQ12025,withinitialdataanticipatedinQ32025[167].−Thecompanyplanstoseekastrategicpartnerforthelate−stagediabeticretinopathyprogramAPX3330duetocapitalrequirementsanddevelopmentaltimelines[165].−ThecompanyanticipatesongoingexpensesrelatedtoclinicalworkforLCA5,BEST1,andotherproductcandidates,aswellasregulatoryapprovalsandmanufacturingcontracts[179].−Thecompanyexpectsresearchanddevelopmentexpensestoincreaseinthecomingyearsduetohighercostsassociatedwithlater−stageclinicaltrials[187].RegulatoryandCommercialization−Thecompanyreceiveda8.5 million through convertible notes to fund operations[210]. - The company expects to satisfy its cash requirements through cash on hand, future equity and debt financings, and reimbursement payments until it generates adequate revenue from commercial sales[248]. Clinical Development - The company’s most advanced gene therapy candidate, OPGx-LCA5, is in a Phase 1/2 clinical trial, with early data showing visual improvement in all three adult patients[166]. - Enrollment of the first pediatric patients in the LCA5 Phase 1/2 trial is expected in Q1 2025, with initial data anticipated in Q3 2025[167]. - The company plans to seek a strategic partner for the late-stage diabetic retinopathy program APX3330 due to capital requirements and developmental timelines[165]. - The company anticipates ongoing expenses related to clinical work for LCA5, BEST1, and other product candidates, as well as regulatory approvals and manufacturing contracts[179]. - The company expects research and development expenses to increase in the coming years due to higher costs associated with later-stage clinical trials[187]. Regulatory and Commercialization - The company received a 10 million milestone payment under the Viatris License Agreement following FDA approval of RYZUMVI for pharmacologically-induced mydriasis in September 2023[170]. - RYZUMVI was commercialized by Viatris in April 2024, following its approval[170]. - The company aims to establish a sales, marketing, and distribution infrastructure for future commercialization efforts[179]. - The company does not expect to generate significant revenue until RYZUMVI sales become material or regulatory approval is obtained for other product candidates[234]. - The company anticipates recognizing revenue from reimbursement for research and development services under the Viatris License Agreement, with a total of 35millioninone−timenon−refundablepaymentsanda35 million in one-time non-refundable payments and a 10 million milestone payment received to date[233]. Internal Controls and Legal Matters - As of September 30, 2024, the company's disclosure controls and procedures were evaluated as effective by its principal executive officer and principal financial officer[258]. - There were no changes in the company's internal control over financial reporting during the quarter ended September 30, 2024, that materially affected its internal control[259]. - The company is not currently involved in any legal proceedings that are likely to materially affect its business or financial results[260].