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BOSTON - TransCode Therapeutics, Inc. (NASDAQ: RNAZ) has announced the initiation of a Phase 1 clinical trial for its leading drug candidate, TTX-MC138, marking a notable advancement in the pursuit of new treatments for metastatic cancer. The first two patients were recently dosed, with several others screened for participation in this multicenter, open-label study focused on dose escalation and expansion.
The trial aims to assess the safety and tolerability of TTX-MC138, an antisense oligonucleotide linked to TransCode’s proprietary TTX delivery system. This system is designed to inhibit microRNA-10b, a molecule known to drive metastasis in various cancers. The drug has previously shown promise in a Phase 0 clinical trial, demonstrating delivery to metastatic lesions.
Sue Duggan, Senior Vice President of Operations at TransCode, expressed optimism about the clinical development program, highlighting the potential impact on patient outcomes across multiple cancer types, including breast, pancreatic, ovarian, colon, and lung cancers.
The Phase 1 trial consists of an initial dose-escalation phase to evaluate the safety and tolerability of escalating dose levels of TTX-MC138, followed by a dose-expansion phase to further assess safety, tolerability, and anti-tumor activity in selected tumor types based on preliminary results.
TransCode Therapeutics is a clinical-stage oncology company dedicated to developing RNA therapeutics for metastatic disease. Its lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b.
Investors and interested parties can find more details about the trial under NCT Identifier NCT06260774 at www.clinicaltrials.gov. The company cautions that forward-looking statements involve risks and uncertainties, including the possibility that clinical trial results may differ from pre-clinical studies or expectations. The success of the trial could significantly influence the company's future prospects and position in the market for metastatic cancer treatments.
This news is based on a press release statement from TransCode Therapeutics.
In other recent news, TransCode Therapeutics has been making significant strides in the development of its therapeutic candidate, TTX-MC138. A study in collaboration with Michigan State University indicated that TTX-MC138 may reduce the ability of tumor cells to self-renew, a key factor in metastatic breast cancer. Additionally, the company received a $2 million grant from the National Institutes of Health to support the progression of TTX-MC138 in a Phase 1/2 study.
Analyst firm H.C. Wainwright has maintained a Buy rating on the company's shares, reflecting confidence in the ongoing development of TTX-MC138. However, TransCode Therapeutics is also facing potential delisting from Nasdaq due to non-compliance with minimum bid price and equity requirements, but the company has appealed this decision.
In a bid to raise funds for product development, the company announced plans for a public stock offering, with ThinkEquity acting as the sole placement agent. The company's Phase 0 trial of TTX-MC138 has shown potential anti-tumor activity, leading to FDA authorization for a Phase 1/2 clinical trial. These are the recent developments at TransCode Therapeutics.
InvestingPro Insights
As TransCode Therapeutics (NASDAQ: RNAZ) embarks on a Phase 1 clinical trial for TTX-MC138, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, TransCode Therapeutics currently holds a market capitalization of $4.5 million, reflecting the market's valuation of the company. Despite the potential of TTX-MC138, the company's stock has experienced significant price volatility, with a 3-month price total return of -77.07%, underscoring the high-risk nature of investing in clinical-stage biotech companies.
InvestingPro Tips reveal that TransCode Therapeutics has more cash than debt on its balance sheet, which could provide some financial flexibility as it advances through clinical trials. However, the company is quickly burning through cash, which is a critical factor for investors to consider when evaluating the company's long-term viability. Additionally, analysts do not anticipate the company will be profitable this year, and the stock has not been profitable over the last twelve months. This information, coupled with the fact that the company does not pay a dividend, may influence investment decisions.
For investors seeking a deeper dive into the company's prospects, InvestingPro offers additional insights. There are currently 12 more InvestingPro Tips available for TransCode Therapeutics, which can be accessed for those looking for a more comprehensive analysis of the company's financials and market performance. These tips and data points can provide valuable context as the company navigates the critical stages of its clinical development program.
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