TransCode Therapeutics Reports Third Quarter 2023 Results; Provides Business Update - Seite 2

TransCode’s goals to continue to advance its portfolio include:

• TTX-MC138
  • Enroll additional patients in First-in-Human Phase 0 clinical trial intended to demonstrate quantifiable evidence of delivery of radiolabeled TTX-MC138 to metastatic lesions in advanced solid tumors; measure pharmacokinetics and biodistribution in vital organs and other tissues; potentially inform therapeutic dose levels for future trials based on Phase 0 microdose results; and potentially validate delivery for the TTX pipeline more broadly, which could open-up additional relevant RNA targets that have been previously undruggable due to challenges with RNA delivery.
  • Submission to FDA of an Investigational New Drug (IND) application for a Phase I clinical trial with TTX-MC138.
• Publication of preclinical in vivo studies supporting therapeutic candidates, TTX-RIGA and TTX-siPDL1, as well as TTX-MC138 in pancreatic adenocarcinoma.
• Continuation of discussions with potential strategic partners regarding partnerships in multiple therapeutic areas including CRISPR and intracellular delivery of proteins using TransCode’s TTX delivery platform.
• Filing for orphan drug designation for TTX-MC138 in additional tumor indications.

Third Quarter 2023 Financial Highlights

• Cash was approximately $7.5 million at September 30, 2023, compared to approximately $5.0 million at December 31, 2022.
• Research and development expense was approximately $3.3 million in the third quarter of 2023, compared to approximately $3.0 million in the third quarter of 2022.
• General and administrative expense was approximately $2.0 million in the third quarter of 2023, compared to approximately $1.9 million in the third quarter of 2022.
• Operating loss for the three months ended September 30, 2023, was approximately $5.3 million, compared to an operating loss of approximately $4.3 million in the prior year period.

Financial Guidance

TransCode expects that its cash of approximately $7.5 million as of September 30, 2023, is sufficient to fund planned operations into January 2024 but not for a full 12 months from the date of its financial statements.

About TransCode Therapeutics

TransCode is an RNA oncology company created on the belief that cancer can be more effectively treated using RNA therapeutics. Using its iron oxide nanoparticle delivery platform, the company has created a portfolio of drug candidates designed to target a variety of tumor types with the objective of significantly improving patient outcomes. The company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which is believed to cause approximately 90% of all cancer deaths totaling over nine million per year worldwide. Another of the company’s drug candidates, TTX-siPDL1, focuses on treating tumors by targeting a protein called Programmed death-ligand 1 (PD-L1). TransCode also has three cancer-agnostic programs: TTX-RIGA, an RNA–based agonist of the retinoic acid-inducible gene I designed to drive an immune response in the tumor microenvironment; TTX-CRISPR, a CRISPR/Cas9–based therapy platform for the repair or elimination of cancer-causing genes inside tumor cells; and TTX-mRNA, an mRNA-based platform for the development of cancer vaccines designed to activate cytotoxic immune responses against tumor cells.