Workflow
Traws Pharma, Inc.(TRAW) - 2024 Q3 - Quarterly Report
TRAWTraws Pharma, Inc.(TRAW)2024-11-14 22:10

Financial Performance - The Company reported net losses of 136.6millionfortheninemonthsendedSeptember30,2024,comparedto136.6 million for the nine months ended September 30, 2024, compared to 14.8 million for the same period in 2023, resulting in an accumulated deficit of 619.2millionasofSeptember30,2024[97].−RevenuesforthethreemonthsendedSeptember30,2024were619.2 million as of September 30, 2024[97]. - Revenues for the three months ended September 30, 2024 were 57,000, consistent with the same period in 2023[139]. - Total operating expenses for the nine months ended September 30, 2024 were 137.3million,significantlyhigherthan137.3 million, significantly higher than 16.0 million in the same period of 2023[146]. - The Company incurred transaction costs of approximately 8.7millionrelatedtotheplannedMergerduringtheninemonthsendedSeptember30,2024[131].−Netcashusedinoperatingactivitieswas8.7 million related to the planned Merger during the nine months ended September 30, 2024[131]. - Net cash used in operating activities was 25.8 million for the nine months ended September 30, 2024, primarily due to a net loss of 136.6millionanda136.6 million and a 7.7 million change in operating assets and liabilities[156]. - Significant non-cash charges of 118.5millionwererecorded,mainlyfromtheimmediateexpensingofin−processresearchanddevelopmentrelatedtotheacquisitionofTrawsfynydd,totaling118.5 million were recorded, mainly from the immediate expensing of in-process research and development related to the acquisition of Trawsfynydd, totaling 117.5 million[156]. - The company has not achieved profitability since inception and expects to continue incurring net losses for the foreseeable future[160]. - Projected net cash expenditures in 2024 are expected to be higher than in 2023 due to advancements in clinical trials and significant transaction-related costs associated with the Merger[160]. Cash Position and Funding - As of September 30, 2024, the Company had 5.4millionincashandcashequivalentsandraisedgrossproceedsof5.4 million in cash and cash equivalents and raised gross proceeds of 14 million through a Securities Purchase Agreement on April 1, 2024[98]. - The company believes its cash and cash equivalents will fund ongoing trials and operations into the first quarter of 2025, but raises substantial doubt about its ability to continue as a going concern beyond that period[160]. - The Company is exploring various sources of funding for development and ongoing operations, with substantial doubt regarding its ability to continue as a going concern[98][99]. - The Company plans to explore various funding sources to alleviate substantial doubt about its ability to continue as a going concern[152]. - Net cash provided by financing activities was 14.0millionfortheninemonthsendedSeptember30,2024,fromtheprivateplacementofCommonStock[159].ClinicalDevelopment−TRX100,asmallmoleculecap−dependentendonucleaseinhibitor,isbeingdevelopedforthetreatmentandprophylaxisofseasonalinfluenzaandbirdflu[100].−ThePhase1clinicalstudyofTRX100showedgoodoveralltolerability,withasingledosemaintainingplasmadruglevelsabovetheEC90formorethan20days[104].−TRX01,aninhibitorofthemainproteaseoftheSARS−CoV−2virus,demonstratedinhibitionofviralreplicationinpreclinicalstudiesandisplannedforfurtherdevelopment[105].−ThePhase1trialofTRX01included40participantsandshowednotreatment−relatedadverseevents,withplasmadruglevelsmaintainedwithinthetherapeuticwindowfor12days[106].−TheCompanyplanstoinitiateaPhase2studyforbothTRX100andTRX01inthefirsthalfof2025[104][106].−Narazaciclibisbeingevaluatedinamulti−centerPhase1/2atrialforrecurrentmetastaticlow−gradeendometrioidendometrialcancer,withapproximately30patientsexpectedtoenrollinthePhase2expansioncohort[107].−APhase1studyofnarazaciclibasamonotherapyisongoingtoassesssafetyandtolerabilityinpatientswithrelapsedand/orrefractoryadvancedcancer[108].−Thecompanyplanstoinitiatetwoinvestigator−initiatedstudiesintheUSAfornarazaciclib,targetingpatientswithrefractorybreastcancerandmultiplemyeloma[109].−Rigosertibisbeingstudiedforepidermolysisbullosa−associatedsquamouscellcarcinoma,withthecompanypursuingorphandrugdesignationfromtheFDA[111].CorporateActions−OnApril1,2024,thecompanycompletedamergerwithTrawsfynyddTherapeutics,issuing141,982sharesofCommonStockand10,359.0916sharesofSeriesC[117].−Themergerisintendedtoqualifyasatax−freereorganizationforU.S.federalincometaxpurposes[116].−Thecompanyraisedapproximately14.0 million for the nine months ended September 30, 2024, from the private placement of Common Stock[159]. Clinical Development - TRX100, a small molecule cap-dependent endonuclease inhibitor, is being developed for the treatment and prophylaxis of seasonal influenza and bird flu[100]. - The Phase 1 clinical study of TRX100 showed good overall tolerability, with a single dose maintaining plasma drug levels above the EC90 for more than 20 days[104]. - TRX01, an inhibitor of the main protease of the SARS-CoV-2 virus, demonstrated inhibition of viral replication in preclinical studies and is planned for further development[105]. - The Phase 1 trial of TRX01 included 40 participants and showed no treatment-related adverse events, with plasma drug levels maintained within the therapeutic window for 12 days[106]. - The Company plans to initiate a Phase 2 study for both TRX100 and TRX01 in the first half of 2025[104][106]. - Narazaciclib is being evaluated in a multi-center Phase 1/2a trial for recurrent metastatic low-grade endometrioid endometrial cancer, with approximately 30 patients expected to enroll in the Phase 2 expansion cohort[107]. - A Phase 1 study of narazaciclib as a monotherapy is ongoing to assess safety and tolerability in patients with relapsed and/or refractory advanced cancer[108]. - The company plans to initiate two investigator-initiated studies in the USA for narazaciclib, targeting patients with refractory breast cancer and multiple myeloma[109]. - Rigosertib is being studied for epidermolysis bullosa-associated squamous cell carcinoma, with the company pursuing orphan drug designation from the FDA[111]. Corporate Actions - On April 1, 2024, the company completed a merger with Trawsfynydd Therapeutics, issuing 141,982 shares of Common Stock and 10,359.0916 shares of Series C[117]. - The merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes[116]. - The company raised approximately 14 million through a private placement, issuing 19,879 shares of Common Stock and 1,578.2120 shares of Series C[125]. - The company has filed a registration statement with the SEC for the resale of shares related to the merger, which was declared effective on August 28, 2024[126]. - A reverse stock split of one-for-25 was approved by the Board in September 2024, retroactively adjusting all related share information[113]. - The company regained compliance with Nasdaq's minimum bid price requirement after its common stock closed at least $1.00 per share for ten consecutive business days[114]. - The Company was notified of non-compliance with Nasdaq's minimum stockholders' equity requirement and attended a hearing to present its compliance plan[153]. Operational Challenges - The Company expects to incur significant expenses and operating losses for the foreseeable future as it continues the development of its product candidates[97]. - There is currently no organization for sales, marketing, and distribution of pharmaceutical products, and the company may rely on licensing and co-promotion agreements for commercialization[161]. - Additional costs are expected to be incurred associated with operating as a public company and fulfilling obligations under the Merger Agreement and related agreements[161].