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TRANSCODE THERAPEUTICS TransCode Therapeutics Reports Business Progress and Third Quarter 2021 Financial Results November 15 , 2021 eIND application submission for TTX - MC138 anticipated in H1 2022 BOSTON -- ( BUSINESS WIRE ) -- Nov . 15 , 2021-- TransCode Therapeutics , Inc. ( Nasdaq : RNAZ ) , an RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics , today reported recent business progress and third quarter 2021 financial results . " TransCode has made further progress across our corporate infrastructure and bourgeoning portfolio , advancing our mission to design RNA therapeutics that can effectively treat cancer . Reflecting the results of an important microdosing study recently reported in Cancer Nanotechnology , TransCode believes it has an opportunity in its planned First - in - Human ( FIH ) Phase 0 clinical trial of its lead therapeutic candidate , TTM - MC138 , to obtain results that will better inform designs of planned follow - on trials than the original FIH trial design . The reported study was conducted by Dr. Zdravka Medarova , a scientific co - founder of TransCode Therapeutics who was appointed Chief Technology Officer effective October 1 , " said Michael Dudley , co - founder , president and CEO of TransCode Therapeutics . Dr. Medarova noted , " We believe a microdosing study offers the potential to more definitively establish proof - of - mechanism for our delivery platform , upon which we hope to build a broad and diverse pipeline of therapeutics and diagnostics with the potential to reach previously undruggable genetic targets . ” Dudley added , " We are striving to file our exploratory Investigational New Drug Application ( eIND ) required for the FIH trial by the end of the first quarter 2022 , although because of COVID - 19 - related backlogs at contract research organizations , the filing may be later in the first half . Regardless , we believe the proposed microdosing study should , if successful , demonstrate the power and versatility of our TTX platform in solving the challenges of RNA delivery in oncology . In addition , we have continued IND - enabling work for TTX - MC138 and remain on track to file an IND for a Phase I clinical trial for treatment of metastatic disease by year end 2022. " Third Quarter 2021 and Recent Highlights • Expanded the Company's executive team with the appointment of TransCode's scientific co - founder , Zdravka Medarova , Ph.D. , as Chief Technology Officer effective October 1. Dr. Medarova is a leader in the field of non - coding RNA delivery to cancer and has authored multiple high - impact publications on the topic of RNA delivery , nanotechnology , and the biology of cancer metastasis . • Continued elND - enabling activities for TTX - MC138 , the Company's lead program , targeting micoRNA - 10b ( miR - 10b ) for treatment of metastatic solid tumors . Due to continued COVID - 19 - related backlogs at contract research organizations , the planned eIND filing may be in the second quarter 2022. Concurrently , IND - enabling efforts remain on track to support an IND expected to be filed in 2H 2022 for a planned Phase 1 study of TTX - MC138 . • Announced publication of preclinical results supporting TTX - MC138 in Cancer Nanotechnology , based on research conducted at the Athinoula A. Martinos Center for Biomedical Imaging in the Department of Radiology at Massachusetts General Hospital and Harvard Medical School . The key results of the study demonstrated that a radiolabeled derivative of TTX - MC138 , when injected intravenously , accumulated in metastatic lesions , confirming its intended pharmacokinetic profile . • Based on joint research conducted at Michigan State University and the Athinoula A. Martinos Center for Biomedical Imaging in the Department of Radiology and Massachusetts General Hospital and Harvard Medical School , additional preclinical data were published in Oncotarget highlighting the potential for microRNA - based therapies in glioblastoma multiforme ( GBM ) . The publication included in vivo animal studies confirming the inhibitory effect of TTX - MC138 on the growth of stem cell - derived orthotopic GBM xenografts , suggesting miR - 10b may represent a useful target in GBM therapy . • Conversion of the Company's convertible promissory notes into common stock upon completion of the initial public offering ( IPO ) in July . Key Planned Upcoming Milestones TransCode's goals to continue to advance its portfolio include : • TTX - MC138 • Submission to FDA of an eIND application by second quarter 2022 . • Initiation of a FIH Phase 0 clinical study evaluating TTX - MC138 for treatment of metastatic solid tumors later in 2022 . • Concurrent completion of IND - enabling studies to support a second half 2022 filing of an IND application for a Phase I clinical trial of TTX - MC138 . • Publication in the first half of 2022 of preclinical results supporting the TTX delivery platform in pancreatic cancer and glioblastoma multiforme .