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BOSTON - TransCode Therapeutics, Inc. (NASDAQ:RNAZ), a clinical-stage biotech company with a market capitalization of $11.27 million, announced Tuesday the completion of its Phase 1a clinical trial for TTX-MC138, an investigational microRNA-10b inhibitor, reporting the achievement of its primary safety endpoint and establishing a recommended Phase 2 dose.
The trial enrolled 16 patients across four escalating dose levels, with no significant treatment-related safety events or dose-limiting toxicities observed. The median treatment duration was four months, with ranges from two to 12 months. Three patients remain on the trial. According to InvestingPro data, TransCode maintains a healthy liquidity position with a current ratio of 5.27, though analysts note the company is quickly burning through cash. Get access to 12 more exclusive InvestingPro Tips for deeper insights into RNAZ’s financial health.
According to data from the study, 44% of patients (7 out of 16) demonstrated stable disease lasting four months or longer based on RECIST criteria. The company reported positive pharmacodynamic effects across all administered dose range levels, which it stated were consistent with preclinical models and its earlier Phase 0 clinical trial. The stock has shown strong momentum recently, gaining over 10% in the past week, though InvestingPro analysis indicates significant price volatility.
"The clinical benefit we are observing in patients treated with TTX-MC138 is compelling given the pre-clinical data and length of time the drug remains in the tumor cells," said study investigator William McKean, MD, PhD from The START Center for Cancer Research, according to the press release. With the company’s next earnings report due on November 14, 2025, investors can track TransCode’s progress in advancing its clinical programs while managing its operating expenses, which resulted in an EBITDA of -$14.6 million in the last twelve months.
The company indicated it plans to advance the program to a Phase 2a clinical trial based on the treatment response, safety profile, and durability observed in the Phase 1a study.
TransCode will present preliminary data from the trial at the upcoming ESMO Congress taking place October 17-21, 2025, in Berlin, Germany.
TTX-MC138 is designed to inhibit microRNA-10b, which the company describes as critical to the emergence and progression of many metastatic cancers.
This article is based on a press release statement from TransCode Therapeutics.
In other recent news, TransCode Therapeutics announced the acquisition of Polynoma, a biotechnology company, along with a $25 million strategic investment from CK Life Sciences. This acquisition adds Polynoma’s Phase 3-ready seviprotimut-L, a vaccine for treating melanoma, to TransCode’s portfolio. The $25 million investment will primarily support the clinical development of TransCode’s lead asset, TTX-MC138, advancing it into a Phase 2 clinical trial. Additionally, TransCode shareholders recently approved all proposals at the company’s 2025 Annual Meeting of Stockholders. The approved proposals included the election of four directors, an amendment to the 2021 Stock Option and Incentive Plan, and the ratification of the independent auditor. These developments reflect significant strategic and operational progress for TransCode.
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