Workflow
Onconova Therapeutics(ONTX) - 2024 Q1 - Quarterly Report
ONTXOnconova Therapeutics(ONTX)2024-05-15 21:27

Financial Performance - The Company reported net losses of 5.0millionforthethreemonthsendedMarch31,2024,comparedto5.0 million for the three months ended March 31, 2024, compared to 5.8 million for the same period in 2023, with an accumulated deficit of 487.6millionasofMarch31,2024[88].−RevenueforthethreemonthsendedMarch31,2024,was487.6 million as of March 31, 2024[88]. - Revenue for the three months ended March 31, 2024, was 56,000, consistent with the same period in 2023[123]. - The Company’s net loss for the three months ended March 31, 2024, was 4,983,000,adecreaseof4,983,000, a decrease of 792,000 compared to the net loss of 5,775,000forthesameperiodin2023[123].−Operatingactivitiesused5,775,000 for the same period in 2023[123]. - Operating activities used 4.4 million of net cash during the three months ended March 31, 2024, slightly lower than the 4.5millionusedinthesameperiodof2023[137].−Cashflowsfromoperatingactivitiesresultedinanetdecreaseof4.5 million used in the same period of 2023[137]. - Cash flows from operating activities resulted in a net decrease of 4.4 million in cash and cash equivalents for the three months ended March 31, 2024[137]. - The company had an accumulated deficit of 487.6millionandcashandcashequivalentsof487.6 million and cash and cash equivalents of 16.4 million as of March 31, 2024[131]. - The company expects net cash expenditures in 2024 to be higher than in 2023 due to advancements in clinical trials and significant transaction-related costs associated with the merger[140]. Corporate Developments - The Company acquired Trawsfynydd Therapeutics, Inc. on April 1, 2024, as part of a merger agreement, which is intended to qualify as a tax-free reorganization[94]. - Upon the merger's consummation, the Company issued 3,549,538 shares of common stock and 10,359.0916 shares of Series C Preferred Stock to Trawsfynydd's stockholders[95]. - The Company plans to hold a stockholders' meeting to approve the conversion of Series C Preferred Stock into Common Stock and potentially amend its certificate of incorporation[95]. - The Board of Directors appointed new executives, including Werner Cautreels as CEO, Iain Dukes as Executive Chairman, and Nikolay Savchuk as COO, effective as of the merger closing[98]. - The Company incurred approximately 1millionincashcompensationtoTungstenPartnersLLCforservicesrenderedinconnectionwiththeMerger[115].ResearchandDevelopment−TheCompanyplanstoadvancethedevelopmentoffourclinicalprograms,includingViroxavir(TRX100)forinfluenza,Travatrelvir(TRX01)forCOVID−19,narazaciclibforsolidtumors,andRigosertibforepidermolysisbullosa−associatedsquamouscellcarcinoma[91].−ViroxavirhascompletedaPhase1studydemonstratingpositivesafetyandtolerabilitydata,withplansforaPhase1doseextensioninthesecondhalfof2024[91].−TravatrelvirisexpectedtobemorepotentthanPfizer′sMproinhibitoranddoesnotrequireco−administrationwithaCYPinhibitor,potentiallyallowingforwideruse[91].−TheCompanyenteredintoacontingentvaluerightsagreement,entitlingholdersto43.71 million in cash compensation to Tungsten Partners LLC for services rendered in connection with the Merger[115]. Research and Development - The Company plans to advance the development of four clinical programs, including Viroxavir (TRX100) for influenza, Travatrelvir (TRX01) for COVID-19, narazaciclib for solid tumors, and Rigosertib for epidermolysis bullosa-associated squamous cell carcinoma[91]. - Viroxavir has completed a Phase 1 study demonstrating positive safety and tolerability data, with plans for a Phase 1 dose extension in the second half of 2024[91]. - Travatrelvir is expected to be more potent than Pfizer's Mpro inhibitor and does not require co-administration with a CYP inhibitor, potentially allowing for wider use[91]. - The Company entered into a contingent value rights agreement, entitling holders to 43.7% of net proceeds from the sale of its two leading cancer drug candidates, Narazaciclib and Rigosertib, during the CVR Term[104]. Expenses and Financial Management - General and administrative expenses increased by 1.2 million, or 59%, to 3.4millionforthethreemonthsendedMarch31,2024,primarilyduetohigherlegalandprofessionalfeesrelatedtotheTrawsfynyddacquisition[125].−Researchanddevelopmentexpensesdecreasedby3.4 million for the three months ended March 31, 2024, primarily due to higher legal and professional fees related to the Trawsfynydd acquisition[125]. - Research and development expenses decreased by 2.2 million, or 53%, to 1.9millionforthethreemonthsendedMarch31,2024,mainlyduetoareductioninmanufacturingcosts[127].−TheCompanyincurredtransactioncostsofapproximately1.9 million for the three months ended March 31, 2024, mainly due to a reduction in manufacturing costs[127]. - The Company incurred transaction costs of approximately 1.7 million during the three months ended March 31, 2024, included as general and administrative expenses[114]. - The Company issued and sold an aggregate of 496,935 shares of Common Stock and 1,578.2120 shares of Series C Preferred Stock for approximately 14millionaspartofaSecuritiesPurchaseAgreement[106].−TheCompanyisexploringvariousfundingsourcesfordevelopmentandregulatoryapprovalofitsresearchcompounds,indicatingpotentialchallengesinobtainingsufficientfinancing[90].−Thecompanyplanstoexplorevariousdilutiveandnon−dilutivesourcesoffundingtoalleviatesubstantialdoubtaboutitsabilitytocontinueasagoingconcern[132].GoingConcern−Substantialdoubtexistsregardingthecompany′sabilitytocontinueasagoingconcernwithinoneyearafterthedatethesefinancialstatementsareissued[132].−Thecompanydoesnotcurrentlyhaveacommercialinfrastructureforsalesandmarketingofpharmaceuticalproductsandmayrelyonlicensingagreementsforcommercialization[143].−TheCompanyterminated11ofits17employeesonApril8,2024,withestimatedseverancecostsofapproximately14 million as part of a Securities Purchase Agreement[106]. - The Company is exploring various funding sources for development and regulatory approval of its research compounds, indicating potential challenges in obtaining sufficient financing[90]. - The company plans to explore various dilutive and non-dilutive sources of funding to alleviate substantial doubt about its ability to continue as a going concern[132]. Going Concern - Substantial doubt exists regarding the company's ability to continue as a going concern within one year after the date these financial statements are issued[132]. - The company does not currently have a commercial infrastructure for sales and marketing of pharmaceutical products and may rely on licensing agreements for commercialization[143]. - The Company terminated 11 of its 17 employees on April 8, 2024, with estimated severance costs of approximately 1 million to be expensed in the second quarter of 2024[118]. Stock Market Activity - The company’s Common Stock began trading on the Nasdaq Stock Market under the ticker symbol "TRAW" effective April 3, 2024, following a name change to Traws Pharma, Inc.[113].