TransCode Therapeutics, Inc.

For the year ended December 31, 2021, TransCode reported R&D expense of $2.8 million, up from $284,000 in 2020, and G&A expense of $3.4 million versus $440,000 a year earlier. Net loss was $6.8 million, or $0.81 per share, compared with $2.3 million, or $0.51 per share in 2020. Cash at December 31, 2021 was $20.8 million, which management said should carry the company into the first quarter of 2023. The company said it expects to file the eIND around the July timeframe and, depending on FDA approval, begin the Phase 0 study later this year with about 10 patients at the Termeer Center at MGH.

Michael Dudley framed the quarter as a period of substantial progress toward entering the clinic and repeatedly stressed the novelty of TransCode’s RNA oncology approach. He said the company’s key differentiator is its proprietary delivery system, which he believes can solve the long-standing problem of getting RNA therapeutics inside tumor cells, and highlighted preclinical data showing up to 98% uptake versus about 2% for current delivery systems. His tone was upbeat and promotional, but anchored to the upcoming Phase 0 study as the critical proof point for the platform.

Tom Fitzgerald focused on the 2021 financial statements and the company’s capital runway. He reported R&D of $2.8 million, G&A of $3.4 million, net loss of $6.8 million, and cash of $20.8 million at year-end, and said that cash should fund operations into the first quarter of 2023. He also noted about 13 million common shares outstanding, options for about 1,000,007 shares, warrants for 312,500 shares, and approximately 15 million fully diluted shares, while saying the company currently has 14 employees and expects headcount to increase slightly.

The only analyst question centered on the timing and mechanics of the Phase 0 study. Management said the eIND filing is targeted for around July, the study is expected to enroll about 10 patients, and it will be a short single-dose study using PET-MRI to assess delivery into metastatic lesions. Dudley said results may be shareable not long after completion, though a final report would take additional time after the fact.