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Opus Genetics, Inc.(IRD) - 2024 Q3 - Quarterly Report
IRDOpus Genetics, Inc.(IRD)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]. - 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]. - For the nine months ended September 30, 2024, license and collaborations revenue was 6.7million,down6.7 million, down 10.7 million from 17.4millioninthesameperiodin2023[201].−ThelossfromoperationsfortheninemonthsendedSeptember30,2024was17.4 million in the same period in 2023[201]. - The loss from operations for the nine months ended September 30, 2024 was 24.0 million, compared to a loss of 5.1millioninthesameperiodin2023,indicatingasignificantincreaseinoperationallosses[201].−Generalandadministrativeexpensesincreasedto5.1 million in the same period in 2023, indicating a significant increase in operational losses[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]. - 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].CashandFinancing−AsofSeptember30,2024,thecompanyhadcashandcashequivalentsof13.1 million[192]. Cash and Financing - As of September 30, 2024, the company had cash and cash equivalents of 36.6 million, which is expected to fund operations for at least twelve months[209]. - The company has funded operations through equity financings totaling 67.8million,including67.8 million, including 21.15 million from the merger with Rexahn Pharmaceuticals, and received 45.0millioninlicensefeeandmilestonepaymentsrelatedtotheViatrisLicenseAgreement[178].−ThecompanyenteredintoacommonstockpurchaseagreementwithLincolnPark,allowingforthepurchaseofupto45.0 million in license fee and milestone payments related to the Viatris License Agreement[178]. - The company entered into a common stock purchase agreement with Lincoln Park, allowing for the purchase of up to 50 million of shares over a 30-month term, with 5.2millionraisedthroughSeptember30,2024[211].−Thecompanyhasreceivedatotalofapproximately5.2 million raised through September 30, 2024[211]. - The company has received a total of approximately 67.8 million from various equity offerings and 8.5millionfromconvertiblenotestofundoperations[210].−CashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2024was8.5 million from convertible notes to fund operations[210]. - 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]. Research and Development - The most advanced gene therapy candidate, OPGx-LCA5, is in an ongoing Phase 1/2 clinical trial, with early data showing visual improvement in all three adult patients[166]. - The company’s gene therapy candidate OPGx-BEST1 is planned for a first-in-man clinical trial in 2025, targeting IRDs associated with mutations in the BEST1 gene[168]. - APX3330, an oral small-molecule inhibitor for diabetic retinopathy, is in development, with a Phase 2 trial showing favorable safety and tolerability[175]. - The company expects research and development expenses to increase over the next several years as clinical development progresses, particularly for LCA5, BEST1, and PS[187]. - Research and development expenses for Q3 2024 were 9.0million,up9.0 million, up 5.5 million from 3.5millioninQ32023,mainlyduetoincreasedclinicalcostsanddrugmanufacturingexpenses[197].−Researchanddevelopmentexpensesroseto3.5 million in Q3 2023, mainly due to increased clinical costs and drug manufacturing expenses[197]. - Research and development expenses rose to 19.8 million for the nine months ended September 30, 2024, up from 13.8millionin2023,reflectinga13.8 million in 2023, reflecting a 6 million increase primarily due to higher manufacturing and toxicology costs for APX3330[205]. Regulatory and Milestones - The FDA approved Phentolamine Ophthalmic Solution 0.75% (RYZUMVI) for pharmacologically-induced mydriasis in September 2023, triggering a 10millionmilestonepaymentundertheViatrisLicenseAgreement[170].−ThecompanyanticipatesrecognizingrevenuefromreimbursementforresearchanddevelopmentservicesundertheViatrisLicenseAgreement,withatotalof10 million milestone payment under the Viatris License Agreement[170]. - The company anticipates recognizing revenue from reimbursement for research and development services under the Viatris License Agreement, with a total of 35 million in one-time non-refundable payments and a 10millionmilestonepaymentexpected[233].−ThecompanydoesnotexpecttogeneratesignificantrevenueuntilRYZUMVIsalesbecomematerialorregulatoryapprovalisobtainedforotherproductcandidates[234].OperationalExpenses−TotaloperatingexpensesforQ32024were10 million milestone payment expected[233]. - The company does not expect to generate significant revenue until RYZUMVI sales become material or regulatory approval is obtained for other product candidates[234]. Operational Expenses - Total operating expenses for Q3 2024 were 11.9 million, an increase of 6.3millioncomparedto6.3 million compared to 5.5 million in Q3 2023, driven by higher research and development costs[192]. - 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].−OtherincomeforQ32024was2.1 million in Q3 2023, attributed to personnel-related costs and business development expenses[193]. - Other income for Q3 2024 was 0.5 million, primarily from interest income related to cash and cash equivalents[200]. - Other income for the nine months ended September 30, 2024 was 1.6million,primarilyfrominterestincome,comparedto1.6 million, primarily from interest income, compared to 1.2 million in 2023[208]. Company Status and Controls - As of September 30, 2024, the company had an accumulated deficit of $103.9 million[179]. - The company is not currently involved in any legal proceedings that are likely to materially affect its business or financial results[260]. - 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].