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Synthetic Biologics(TOVX) - 2025 Q1 - Quarterly Report
TOVXSynthetic Biologics(TOVX)2025-05-14 12:15

Financial Performance - The net loss for the three months ended March 31, 2025, was 4.3million,or(4.3 million, or (1.55) per common share, compared to a net loss of 5.2million,or(5.2 million, or (7.53) per common share for the same period in 2024[229]. - Cash and cash equivalents totaled 10.0millionasofMarch31,2025,adecreaseof10.0 million as of March 31, 2025, a decrease of 1.6 million from December 31, 2024[231]. - The accumulated deficit was 339.3millionasofMarch31,2025,withexpectationsofcontinuedlossesintheforeseeablefuture[230].−Cashusedinoperatingactivitieswas339.3 million as of March 31, 2025, with expectations of continued losses in the foreseeable future[230]. - Cash used in operating activities was 4.8 million during the three months ended March 31, 2025, compared to 4.9millionforthesameperiodin2024[236].−TotalresearchanddevelopmentexpensesforthethreemonthsendedMarch31,2025,were4.9 million for the same period in 2024[236]. - Total research and development expenses for the three months ended March 31, 2025, were 2.968 million, down from 3.459millionin2024[227].−Researchanddevelopmentexpensesdecreasedto3.459 million in 2024[227]. - Research and development expenses decreased to 3.0 million for the three months ended March 31, 2025, from approximately 3.5millionforthesameperiodin2024,adecreaseof143.5 million for the same period in 2024, a decrease of 14%[225]. - General and administrative expenses decreased to 1.4 million for the three months ended March 31, 2025, from 1.9millionforthesameperiodin2024,adecreaseof251.9 million for the same period in 2024, a decrease of 25%[224]. - Cash provided by financing activities during the three months ended March 31, 2025, included 1.7 million received for the research and development tax credit[238]. - As of early May 2025, cash position was 14.1million,expectedtofundoperationsintothefirstquarterof2026[232].−FutureclinicaltrialsforVCN−01,SYN−004,andSYN−020willrequiresignificantfinancing,andthecompanydoesnotcurrentlyhavecommittedsourcesoffunding[235].ClinicalTrialsandProductDevelopment−Theleadproductcandidate,VCN−01,iscurrentlyinaPhase2bclinicalstudyforpancreaticcancer,withpositivetoplineoutcomesindicatingamedianoverallsurvival(OS)of10.8monthsforpatientsreceivingVCN−01plusstandard−of−carechemotherapycomparedto8.6monthsforthosereceivingstandardcarealone[145][149].−IntheVIRAGEtrial,patientsreceivingtwodosesofVCN−01showedamedianOSof14.8monthscomparedto11.6monthsforthosereceivingstandardcare,suggestingasignificantbenefitfromtheadditionaldose[146].−ThePhase2bclinicaltrialofVCN−01incombinationwithnab−paclitaxelandgemcitabineisongoing,withadditionalstudiesevaluatingVCN−01inothercancertypes[154].−ThePhase2bclinicaltrialVIRAGEforVCN−01incombinationwithgemcitabineandnab−paclitaxelhasenrolled92evaluablepatients,achievingthetargetenrollmentbySeptember23,2024[157].−ToplinedatafortheVIRAGEPhase2bclinicaltrialisanticipatedforQ22025[157].−TheFDAgrantedFastTrackDesignationtoVCN−01incombinationwithgemcitabineandnab−paclitaxeltoimproveprogression−freesurvivalandoverallsurvivalinpatientswithmetastaticpancreaticadenocarcinomaonMay23,2024[161].−AnIndependentDataMonitoringCommitteeconfirmedthatVCN−01waswelltoleratedinthePhase2btrial,withadverseeventsconsistentwithpriortrialsandlessfrequentaftertheseconddose[164].−TheclinicaltrialforVCN−01inretinoblastomashowedpositivetoplinedata,withnodose−limitingtoxicitiesandtreatment−relatedadverseeventsprimarilyGrade1or2[165][166].−ThePhase1trialcombiningVCN−01withdurvalumabshowedwell−toleratedresults,withsustainedbloodlevelsofVCN−01andincreasedtumorinflammationmarkers[173].−TheongoingstudiessuggestthatVCN−01mayenhancethepotentialantitumoreffectsofco−administeredhuCART−mesocellsinpatientswithunresectableormetastaticpancreaticadenocarcinoma[176].−ThePhase1trialofhuCART−mesocellscombinedwithVCN−01showedoverallsurvival(OS)of10.4monthsintheconcomitantcohortand15.5monthsinthesequentialcohortatadoseof3.3×1012viralparticles(vp),withOSreaching17.3monthsatadoseof1×1013vp[178].−61.114.1 million, expected to fund operations into the first quarter of 2026[232]. - Future clinical trials for VCN-01, SYN-004, and SYN-020 will require significant financing, and the company does not currently have committed sources of funding[235]. Clinical Trials and Product Development - The lead product candidate, VCN-01, is currently in a Phase 2b clinical study for pancreatic cancer, with positive topline outcomes indicating a median overall survival (OS) of 10.8 months for patients receiving VCN-01 plus standard-of-care chemotherapy compared to 8.6 months for those receiving standard care alone[145][149]. - In the VIRAGE trial, patients receiving two doses of VCN-01 showed a median OS of 14.8 months compared to 11.6 months for those receiving standard care, suggesting a significant benefit from the additional dose[146]. - The Phase 2b clinical trial of VCN-01 in combination with nab-paclitaxel and gemcitabine is ongoing, with additional studies evaluating VCN-01 in other cancer types[154]. - The Phase 2b clinical trial VIRAGE for VCN-01 in combination with gemcitabine and nab-paclitaxel has enrolled 92 evaluable patients, achieving the target enrollment by September 23, 2024[157]. - Topline data for the VIRAGE Phase 2b clinical trial is anticipated for Q2 2025[157]. - The FDA granted Fast Track Designation to VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma on May 23, 2024[161]. - An Independent Data Monitoring Committee confirmed that VCN-01 was well tolerated in the Phase 2b trial, with adverse events consistent with prior trials and less frequent after the second dose[164]. - The clinical trial for VCN-01 in retinoblastoma showed positive topline data, with no dose-limiting toxicities and treatment-related adverse events primarily Grade 1 or 2[165][166]. - The Phase 1 trial combining VCN-01 with durvalumab showed well-tolerated results, with sustained blood levels of VCN-01 and increased tumor inflammation markers[173]. - The ongoing studies suggest that VCN-01 may enhance the potential antitumor effects of co-administered huCART-meso cells in patients with unresectable or metastatic pancreatic adenocarcinoma[176]. - The Phase 1 trial of huCART-meso cells combined with VCN-01 showed overall survival (OS) of 10.4 months in the concomitant cohort and 15.5 months in the sequential cohort at a dose of 3.3×10^12 viral particles (vp), with OS reaching 17.3 months at a dose of 1×10^13 vp[178]. - 61.1% of patients (11 out of 18) were alive for more than 12 months, indicating a promising trend in disease stabilization[178]. - VCN-01 demonstrated biological activity with replication observed and increased serum hyaluronidase levels maintained for over six weeks[178]. - The safety profile of VCN-01 was consistent with expectations from monotherapy studies, with 66.6% of patients showing tumor shrinkage when receiving huCART-meso after VCN-01[179]. - A new next-generation mesothelin-specific CAR-T is being developed, which may be evaluated in combination with VCN-01 in future clinical trials[180]. - The Phase 1 clinical study of SYN-004 (ribaxamase) aims to prevent antibiotic-mediated microbiome damage and is currently in a randomized, double-blinded, placebo-controlled trial with 36 evaluable adult allogeneic HCT recipients[186][187]. - SYN-020, a recombinant version of bovine Intestinal Alkaline Phosphatase, is being developed to mitigate intestinal damage caused by radiation therapy, with production costs anticipated to be significantly lower than current market rates[192]. - The Phase 1 clinical study of SYN-020 demonstrated a favorable safety profile with no serious adverse events reported, and it was well tolerated across all dose levels[196]. - The company has received a study-may-proceed letter from the FDA for SYN-020, allowing for further clinical development[195]. - Phase 1 data from SAD and MAD studies support the development of SYN-020 for multiple clinical indications, including NAFLD and aging-related diseases[198]. Funding and Grants - The company completed a public offering on May 8, 2025, raising approximately 7.5 million through the sale of 1,990,900 shares of Common Stock and warrants[134]. - The company received €2.28 million (approximately 2.54million)fromtheSpanishgovernment′sNationalKnowledgeTransferProgramtosupporttheTHERICELproject,whichincludesa€1.3millionloananda€0.95milliongrant[139].−Thecompanyreceived2.54 million) from the Spanish government's National Knowledge Transfer Program to support the THERICEL project, which includes a €1.3 million loan and a €0.95 million grant[139]. - The company received 1.7 million from the 2023 Research and Development rebate program sponsored by the Spanish government[138]. Intellectual Property and Licensing - The company is exploring value creation options for its previous assets, SYN-004 and SYN-020, including out-licensing or partnering[133]. - The ongoing clinical trials and product developments are supported by a growing intellectual property portfolio, with efforts to maintain and build patent applications[183]. - The company has over 130 U.S. and foreign patents and over 65 patents pending, supporting its various programs[208]. - The SYN-004 program is supported by patents that will expire in at least 2031, covering compositions of matter and uses of beta-lactamases[209]. - The VCN-01 and VCN-11 programs are supported by patents that provide coverage for engineered oncolytic adenoviruses, with some patents expiring as late as 2037[211]. - The company entered into an agreement with Massachusetts General Hospital for an exclusive license related to IAP technology, which expired unexercised on July 1, 2024[197]. Manufacturing and Development - The THERICEL program is advancing a proprietary A549 suspension cell line to enhance the efficiency and reduce the cost of manufacturing VCN-01 for clinical trials[205]. - Preclinical data indicated that the ABD-containing virus VCN-11 induced 450 times more cytotoxicity in tumor cells compared to normal cells, demonstrating a low toxicity profile[203].