Workflow
Windtree Therapeutics(WINT) - 2024 Q3 - Quarterly Report
WINTWindtree Therapeutics(WINT)2024-11-26 21:46

Financial Performance and Losses - Net loss for the three and nine months ended September 30, 2024 was 2.7millionand2.7 million and 4.6 million, respectively, with a 7.5 million non-cash R&D expense related to the Varian asset acquisition and a 14.6 million gain on debt extinguishment[236] - The company reported a net loss of 4.55millionfortheninemonthsendedSeptember30,2024,comparedtoanetlossof4.55 million for the nine months ended September 30, 2024, compared to a net loss of 15.14 million in the same period in 2023[268] - A gain on debt extinguishment of 14.59millionwasrecordedfortheninemonthsendedSeptember30,2024[268]−Thecompanyrecognizeda14.59 million was recorded for the nine months ended September 30, 2024[268] - The company recognized a 14.5 million non-cash gain on debt extinguishment related to the Exchange and Termination Agreement with Deerfield Management Company L.P.[284] - The company recognized a 14.5millionnon−cashgainondebtextinguishmentduringthethreemonthsendedSeptember30,2024,relatedtotheExchangeandTerminationAgreementwithDeerfield[320]AccumulatedDeficitandFinancing−AccumulateddeficitasofSeptember30,2024was14.5 million non-cash gain on debt extinguishment during the three months ended September 30, 2024, related to the Exchange and Termination Agreement with Deerfield[320] Accumulated Deficit and Financing - Accumulated deficit as of September 30, 2024 was 848.8 million, with financing primarily through private placements, public offerings, and borrowings[236] - The company expects to continue to incur operating losses for at least the next several years and had an accumulated deficit of 848.8millionasofSeptember30,2024[293]−Managementhasconcludedsubstantialdoubtexistsaboutthecompany′sabilitytocontinueasagoingconcernforatleast12months,withplanstosecureadditionalcapitalthroughpublicorprivatesecuritiesofferings,convertibledebtfinancings,andstrategictransactions[296]ResearchandDevelopmentExpenses−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,increasedby848.8 million as of September 30, 2024[293] - Management has concluded substantial doubt exists about the company's ability to continue as a going concern for at least 12 months, with plans to secure additional capital through public or private securities offerings, convertible debt financings, and strategic transactions[296] Research and Development Expenses - Research and development expenses for the nine months ended September 30, 2024, increased by 8.8 million compared to the same period in 2023[268] - Research and development expenses for the nine months ended September 30, 2024 increased by 8.8millionto8.8 million to 14.1 million, primarily due to a 7.5 million non-cash charge related to the acquired IPR&D from the Varian asset purchase[270] - The istaroxime – cardiogenic shock program costs increased by 2.1 million for the nine months ended September 30, 2024 compared to the same period in 2023, driven by trial execution costs for the SEISMiC Extension study and start-up procedures for the SEISMiC C study[273] - Total direct clinical and preclinical programs expenses increased by 2.2millionfortheninemonthsendedSeptember30,2024comparedtothesameperiodin2023,primarilyduetotheistaroxime–cardiogenicshockprogram[272]ClinicalTrialsandStudies−IstaroximedemonstratedsignificantimprovementinsystolicbloodpressureandcardiacfunctionintheSEISMiCExtensionstudy,withenrollmentfortheSEISMiCCstudyexpectedtocompletebylate2025[230][241][242]−TheSEISMiCCstudyisexpectedtoenrollupto100subjectswithSCAIStageCcardiogenicshock,withanunblindedreviewofdatafromthefirst20subjectsplannedforearlyQ22025[230][242]−RostafuroxindemonstratedefficacyinCaucasianpatientsinaPhase2btrialfortreatment−naı¨vehypertension,butanadditionalPhase2trialisneededforAfricanAmericanpatientswithtreatment−resistanthypertension[246]StrategicPartnershipsandLicensing−Thecompanyispursuinglicensingarrangementsandstrategicpartnershipsforrostafuroxin,anovelproductcandidateforhypertensiontreatmentinpatientswithaspecificgeneticprofile[232]−ThecompanyhasregionallicensedpartnershipswithLee′sPharmaceutical(HK)Ltd.forthedevelopmentandcommercializationofistaroximeandothercardiovascularassetsinGreaterChina[233]−Thecompanyisactivelyexploringlicensingtransactions,researchpartnerships,orotherstrategicopportunitiestoadvanceSERCA2aactivatorcandidates[245]IntellectualPropertyandPatents−ThecompanyholdspatentsfordualmechanismandpureSERCA2aactivators,withprotectionextendinguntil2038and2039,respectively[245]−IntangibleassetsasofSeptember30,2024,included2.2 million for the nine months ended September 30, 2024 compared to the same period in 2023, primarily due to the istaroxime – cardiogenic shock program[272] Clinical Trials and Studies - Istaroxime demonstrated significant improvement in systolic blood pressure and cardiac function in the SEISMiC Extension study, with enrollment for the SEISMiC C study expected to complete by late 2025[230][241][242] - The SEISMiC C study is expected to enroll up to 100 subjects with SCAI Stage C cardiogenic shock, with an unblinded review of data from the first 20 subjects planned for early Q2 2025[230][242] - Rostafuroxin demonstrated efficacy in Caucasian patients in a Phase 2b trial for treatment-naïve hypertension, but an additional Phase 2 trial is needed for African American patients with treatment-resistant hypertension[246] Strategic Partnerships and Licensing - The company is pursuing licensing arrangements and strategic partnerships for rostafuroxin, a novel product candidate for hypertension treatment in patients with a specific genetic profile[232] - The company has regional licensed partnerships with Lee's Pharmaceutical (HK) Ltd. for the development and commercialization of istaroxime and other cardiovascular assets in Greater China[233] - The company is actively exploring licensing transactions, research partnerships, or other strategic opportunities to advance SERCA2a activator candidates[245] Intellectual Property and Patents - The company holds patents for dual mechanism and pure SERCA2a activators, with protection extending until 2038 and 2039, respectively[245] - Intangible assets as of September 30, 2024, included 22.34 million for istaroxime and 2.91millionforrostafuroxin[259]PreclinicalandOncologyResearch−ThetopicalformulationofaPKCiinhibitor(VAR−101)showeddose−dependentanti−tumoractivityinmurineandhumanbasalcellcarcinoma(BCC)celllines,supportedbypreclinicaldatafromCancerResearchUK[247]−TheoralformulationofaPKCiinhibitor(VAR−102)demonstrateddose−dependentanti−tumoractivityinamousemodelofnon−smallcelllungcancer(NSCLC)[248]−ThecompanyplanstoadvanceinvestigationalnewdrugenablingactivitiesfortheaPKCiinhibitorplatformacquiredfromVarian,withpotentialapplicationsinoncologyandraremalignantdiseases[235]StockandFinancingActivities−Thecompanyimplementeda1−for−18reversestocksplitonApril19,2024,toregaincompliancewithNasdaq′sminimumbidpricerequirement[249][252]−ThecompanyregainedcompliancewithNasdaq′sRule5550(a)(2)onMay6,2024,followingthereversestocksplit[252]−Thecompanysold1.4millionsharesofCommonStockundertheELOCPurchaseAgreementfornetproceedsof2.91 million for rostafuroxin[259] Preclinical and Oncology Research - The topical formulation of aPKCi inhibitor (VAR-101) showed dose-dependent anti-tumor activity in murine and human basal cell carcinoma (BCC) cell lines, supported by preclinical data from Cancer Research UK[247] - The oral formulation of aPKCi inhibitor (VAR-102) demonstrated dose-dependent anti-tumor activity in a mouse model of non-small cell lung cancer (NSCLC)[248] - The company plans to advance investigational new drug enabling activities for the aPKCi inhibitor platform acquired from Varian, with potential applications in oncology and rare malignant diseases[235] Stock and Financing Activities - The company implemented a 1-for-18 reverse stock split on April 19, 2024, to regain compliance with Nasdaq's minimum bid price requirement[249][252] - The company regained compliance with Nasdaq's Rule 5550(a)(2) on May 6, 2024, following the reverse stock split[252] - The company sold 1.4 million shares of Common Stock under the ELOC Purchase Agreement for net proceeds of 3.1 million during the three months ended September 30, 2024[294] - The company completed two private placement transactions in July 2024 for aggregate gross proceeds of approximately 13.9million,withnetproceedsof13.9 million, with net proceeds of 2.3 million[294] - The company entered into the ELOC Purchase Agreement in June 2024, allowing it to sell up to 35millionofnewlyissuedsharesofcommonstockovera36−monthperiod[306]−ForthethreemonthsendedSeptember30,2024,thecompanysold1.4millionsharesofcommonstockundertheELOCPurchaseAgreementforgrossproceedsof35 million of newly issued shares of common stock over a 36-month period[306] - For the three months ended September 30, 2024, the company sold 1.4 million shares of common stock under the ELOC Purchase Agreement for gross proceeds of 4.4 million[307] - The company's April 2023 public offering resulted in gross proceeds of approximately 12.4million,withnetproceedsof12.4 million, with net proceeds of 10.8 million after deducting underwriting discounts and commissions[311][312] - During the nine months ended September 30, 2024, the company sold 143,120 shares of common stock under the 2023 ATM Program, resulting in aggregate gross and net proceeds of approximately 1.4million[317]CashFlowandLiabilities−NetcashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2024was1.4 million[317] Cash Flow and Liabilities - Net cash used in operating activities for the nine months ended September 30, 2024 was 11.7 million, primarily driven by a net loss of 4.6millionanda4.6 million and a 14.6 million gain on debt extinguishment[299] - Net cash provided by financing activities for the nine months ended September 30, 2024 was 9.6million,including9.6 million, including 4.4 million from the ELOC Purchase Agreement and 3.9millionfromprivateplacements[302]−AsofSeptember30,2024,thecompanyhadcashandcashequivalentsof3.9 million from private placements[302] - As of September 30, 2024, the company had cash and cash equivalents of 2.3 million and current liabilities of 14.4million,includingan14.4 million, including an 8.6 million warrant liability[295] - The company financed 0.5millionofinsurancepremiumsinAugust2024ata7.940.5 million of insurance premiums in August 2024 at a 7.94% fixed annual interest rate, with monthly payments of approximately 56,000 due through May 2025[318] Goodwill and Intangible Assets - Goodwill impairment losses totaled 3.1millionfortheninemonthsendedSeptember30,2023,withgoodwillwrittendowntozeroasofJune30,2023[258]−IntangibleassetsasofSeptember30,2024,included3.1 million for the nine months ended September 30, 2023, with goodwill written down to zero as of June 30, 2023[258] - Intangible assets as of September 30, 2024, included 22.34 million for istaroxime and 2.91millionforrostafuroxin[259]GeneralandAdministrativeExpenses−Clinical,medical,andregulatoryoperationsexpensesdecreasedby2.91 million for rostafuroxin[259] General and Administrative Expenses - Clinical, medical, and regulatory operations expenses decreased by 0.8 million for the nine months ended September 30, 2024 compared to the same period in 2023, due to a 0.7milliondecreaseinpersonnelcostsanda0.7 million decrease in personnel costs and a 0.1 million decrease in non-cash stock-based compensation[280] - General and administrative expenses decreased by $0.8 million for the nine months ended September 30, 2024 compared to the same period in 2023, driven by reductions in personnel costs, severance costs, non-cash stock-based compensation, and insurance costs[283] Off-Balance Sheet Arrangements - The company did not have any material off-balance sheet arrangements as of September 30, 2024 or 2023[322]