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Ocuphire Pharma(OCUP) - 2024 Q2 - Quarterly Report
OCUPOcuphire Pharma(OCUP)2024-08-13 20:06

Financial Performance - Ocuphire Pharma reported a net loss of 7.8millionand7.8 million and 14.9 million for the three and six months ended June 30, 2024, respectively, compared to a net loss of 5.0millionand5.0 million and 10.8 million for the same periods in 2023[136]. - The company has an accumulated deficit of 96.3millionasofJune30,2024[136].−Licenseandcollaborationsrevenuedecreasedto96.3 million as of June 30, 2024[136]. - License and collaborations revenue decreased to 1.1 million for the three months ended June 30, 2024, down from 3.7millioninthesameperiodof2023,primarilyduetoreducedPSresearchanddevelopmentservices[150].−LicenseandcollaborationsrevenueforthesixmonthsendedJune30,2024was3.7 million in the same period of 2023, primarily due to reduced PS research and development services[150]. - License and collaborations revenue for the six months ended June 30, 2024 was 2.8 million, down from 5.4millioninthesameperiodof2023,reflectingadecreaseinPSresearchanddevelopmentservices[157].−GeneralandadministrativeexpensesforthethreemonthsendedJune30,2024were5.4 million in the same period of 2023, reflecting a decrease in PS research and development services[157]. - General and administrative expenses for the three months ended June 30, 2024 were 3.4 million, a decrease of 1.0millioncomparedto1.0 million compared to 4.3 million in the prior year, mainly due to reduced payroll-related costs[151]. - General and administrative expenses for the six months ended June 30, 2024 were 8.0million,anincreaseof8.0 million, an increase of 1.4 million compared to 6.6millionintheprioryear[159].−Researchanddevelopmentexpensesincreasedto6.6 million in the prior year[159]. - Research and development expenses increased to 6.1 million for the three months ended June 30, 2024, compared to 4.7millioninthesameperiodof2023,drivenbyhighermanufacturingandtoxicologycostsforAPX3330[154].−ResearchanddevelopmentexpensesforthesixmonthsendedJune30,2024were4.7 million in the same period of 2023, driven by higher manufacturing and toxicology costs for APX3330[154]. - Research and development expenses for the six months ended June 30, 2024 were 10.8 million, slightly up from 10.3millioninthesameperiodof2023,primarilyduetoincreasedmanufacturingcostsforAPX3330[160].−TotaloperatingexpensesforthethreemonthsendedJune30,2024were10.3 million in the same period of 2023, primarily due to increased manufacturing costs for APX3330[160]. - Total operating expenses for the three months ended June 30, 2024 were 9.4 million, slightly higher than 9.1millioninthesameperiodof2023[150].−Otherincome,netforthethreemonthsendedJune30,2024was9.1 million in the same period of 2023[150]. - Other income, net for the three months ended June 30, 2024 was 0.6 million, compared to 0.4millioninthesameperiodof2023,mainlyfrominterestincome[155].−Otherincome,netforthesixmonthsendedJune30,2024was0.4 million in the same period of 2023, mainly from interest income[155]. - Other income, net for the six months ended June 30, 2024 was 1.2 million, up from 0.8millioninthesameperiodof2023,primarilyduetointerestincome[161].−ForthesixmonthsendedJune30,2024,thecompanyreportedanetcashusedinoperatingactivitiesof0.8 million in the same period of 2023, primarily due to interest income[161]. - For the six months ended June 30, 2024, the company reported a net cash used in operating activities of 13.0 million, attributed to a net loss of 14.9million[176].ProductDevelopment−Ocuphire′sleadproductcandidate,APX3330,isindevelopmentfordiabeticretinopathy,whichaffectsapproximately10milliondiabeticsandisprojectedtoimpactover14millionAmericansby2050[127].−TheFDAapprovedPhentolamineOphthalmicSolution0.7514.9 million[176]. Product Development - Ocuphire's lead product candidate, APX3330, is in development for diabetic retinopathy, which affects approximately 10 million diabetics and is projected to impact over 14 million Americans by 2050[127]. - The FDA approved Phentolamine Ophthalmic Solution 0.75% (RYZUMVI) in September 2023, triggering a 10 million milestone payment under the Viatris License Agreement[131]. - RYZUMVI was commercialized by Viatris in April 2024, following a comprehensive clinical trial program involving over 600 subjects[131]. - The VEGA-2 Phase 3 study for presbyopia achieved its primary endpoint, and the VEGA-3 Phase 3 clinical trial has begun recruiting[134]. - Ocuphire has in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330, targeting other retinal diseases[129]. - The company anticipates recognizing revenue from the Viatris License Agreement and potential future milestone and royalty payments, but significant revenue generation is uncertain until product sales materialize[179]. - The development of APX3330 is subject to uncertainties, and the company cannot assure future profitability or positive cash flow from operating activities[183]. Funding and Capital Structure - Ocuphire has funded operations primarily through equity financings totaling 67.3million,including67.3 million, including 21.15 million from a merger with Rexahn Pharmaceuticals[136]. - The company expects to finance its cash needs through a combination of equity and debt financings, as well as collaborations and licensing arrangements[135]. - The company raised approximately 67.3millionfromvariousequityofferingsand67.3 million from various equity offerings and 8.5 million from convertible notes, including a one-time non-refundable payment of 35millionanda35 million and a 10 million milestone payment related to the Viatris License Agreement[163]. - The company entered into a Purchase Agreement with Lincoln Park Capital Fund, allowing for the purchase of up to 50millionofcommonstockovera30−monthterm[164].−Thecompanyhasashelfregistrationeffectiveforanaggregateofferingpriceofupto50 million of common stock over a 30-month term[164]. - The company has a shelf registration effective for an aggregate offering price of up to 175 million, with 26millionraisedthroughanAt−The−Marketprogramsinceinception[165].−Thecompanymayfacedilutionofstockholderownershipifadditionalcapitalisraisedthroughequityorconvertibledebtsecurities[182].−Thecompanyexpectstosatisfyshort−termandlong−termobligationsthroughcashonhand,futureequityanddebtfinancings,andreimbursementpayments[191].LegalandRegulatoryMatters−Thecompanyisnotcurrentlyapartytoanylegalproceedingsthatarelikelytomateriallyaffectitsbusinessorfinancialresults[204].−Thecompanyhasafullvaluationallowanceonnetdeferredtaxassetsduetouncertaintyoffuturetaxableincome[196].−Thecompanyhasnottriggeredanymilestoneorroyaltypaymentsasofthedateofthereport[187].Miscellaneous−AsofJune30,2024,thecompanyhadcashandcashequivalentsof26 million raised through an At-The-Market program since inception[165]. - The company may face dilution of stockholder ownership if additional capital is raised through equity or convertible debt securities[182]. - The company expects to satisfy short-term and long-term obligations through cash on hand, future equity and debt financings, and reimbursement payments[191]. Legal and Regulatory Matters - The company is not currently a party to any legal proceedings that are likely to materially affect its business or financial results[204]. - The company has a full valuation allowance on net deferred tax assets due to uncertainty of future taxable income[196]. - The company has not triggered any milestone or royalty payments as of the date of the report[187]. Miscellaneous - As of June 30, 2024, the company had cash and cash equivalents of 41.4 million, sufficient to fund operations for at least twelve months[162]. - As of June 30, 2024, the company had 5,665,838 Series A Warrants outstanding, with an initial exercise price of 4.4795pershare[172].−Thecompanyhasnosignificantcashflowsfrominvestingactivitiesduringthereportedperiods[178].−ResearchanddevelopmentexpensesrelatedtothedevelopmentofPSarefullyreimbursedbyViatris[183].−Thecompanyhaspotentialmilestonepaymentstotalingupto4.4795 per share[172]. - The company has no significant cash flows from investing activities during the reported periods[178]. - Research and development expenses related to the development of PS are fully reimbursed by Viatris[183]. - The company has potential milestone payments totaling up to 11 million and sales milestone payments of up to 20millionundertheApexianSublicenseAgreement[186].−Thecompanyhasanon−cancellableoperatingleasewithabaserentof20 million under the Apexian Sublicense Agreement[186]. - The company has a non-cancellable operating lease with a base rent of 3,000 per month expiring on December 31, 2024[185]. - The company recognizes license and collaborations revenue based on the stand-alone price of each performance obligation[194].