BOSTON - TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a micro-cap biotech company with a market capitalization of $3.3 million and trading near its 52-week low, has received approval from its Safety Review Committee (SRC) to proceed to the third cohort in its Phase 1 clinical trial, following a review of safety data from the second cohort. The trial is evaluating TTX-MC138, a treatment designed to target microRNA-10b, which is implicated in the progression of various metastatic cancers.
The SRC, comprising clinicians and experts overseeing patient safety, has found no significant safety concerns or dose-limiting toxicities in the second cohort, allowing the trial to move forward. The dosage for the third cohort will be approximately double that of the second. Current patients from the first two cohorts continue with the treatment, and new patients are now being evaluated for potential inclusion in the third cohort. According to InvestingPro data, the company maintains a healthy current ratio of 1.58 and holds more cash than debt on its balance sheet, though it's quickly burning through its cash reserves.
Preliminary data from the first cohort shows that TTX-MC138's pharmacokinetic (PK) and pharmacodynamic (PD) profiles are consistent with earlier preclinical and Phase 0 trial results. Notably, a 66% inhibition of miR-10b was observed 24 hours post-infusion in patients with high baseline expression of this microRNA.
TransCode's Senior Vice President of Operations, Sue Duggan, highlighted the role of the SRC in ensuring the trial's safety and informed that patient enrollment is ongoing based on the cumulative safety data.
TTX-MC138 is considered a first-in-class therapeutic candidate with the potential to address metastatic disease by targeting miR-10b. The Phase 1 trial aims to establish the safety and tolerability of escalating doses of TTX-MC138 in patients with various metastatic solid tumors and may also provide early signs of the drug's clinical activity.
The company is focused on developing RNA therapeutics for metastatic cancer, with TTX-MC138 being its lead candidate. It aims to overcome the challenges of RNA delivery to target novel genetic markers for cancer treatment.
This news is based on a press release statement from TransCode Therapeutics, Inc. Further details about the trial can be found on the clinical trials website with identifier NCT06260774. InvestingPro analysis suggests the stock is currently undervalued, with 14 additional ProTips available to subscribers covering crucial metrics like profitability outlook and financial health scores. Discover more detailed insights and investment opportunities by exploring InvestingPro's comprehensive analysis tools.
In other recent news, TransCode Therapeutics, a clinical-stage oncology company, has secured $8 million in a private placement agreement set to close in November 2024. The proceeds will be used for general corporate purposes and working capital. Simultaneously, TransCode's lead therapeutic candidate, TTX-MC138, has advanced to the next stage of its Phase 1 cancer trial, backed by a $2 million grant from the National Institutes of Health.
In a bid to address potential delisting from Nasdaq due to non-compliance with minimum bid price and equity requirements, TransCode's Board of Directors has approved a 1-for-33 reverse stock split. The company has also announced plans for a public stock offering, with ThinkEquity acting as the sole placement agent.
H.C. Wainwright, an analyst firm, has maintained a Buy rating on the company's shares, indicating confidence in the ongoing development of TTX-MC138. These are among the recent developments that highlight TransCode's commitment to advancing its drug development program while navigating regulatory challenges.
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