Nature of Business and Liquidity |
6 Months Ended |
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Jun. 30, 2026 | |
| Nature of Business and Liquidity | |
| Nature of Business and Liquidity | (1) Nature of Business and Liquidity TransCode Therapeutics, Inc. (the “Company” or “TransCode”) was incorporated on January 11, 2016, under the laws of the State of Delaware. TransCode is a clinical-stage biopharmaceutical company focused primarily on the research and development (“R&D”) of innovative drugs for treating cancer. The Company operates in one segment. Its lead therapeutic candidate, TTX-MC138, comprises an oligonucleotide conjugated to an iron oxide nanoparticle designed to be administered by infusion to inhibit the ability of metastatic tumor cells to survive. The goal of the therapy, if approved, is to achieve durable disease regression, progression-free survival and long-term patient survival. In the second quarter 2026, the Company initiated a Phase 2a clinical trial with TTX-MC138 in patients with colorectal cancer (CRC) who are at high risk of recurrence despite having already received curative intent therapy with surgery and/or chemotherapy. Initial patient enrollment in the Phase 2a trial is expected in the third quarter 2026. In addition to TTX-MC138, the Company has several other cancer therapy drug candidates in its pipeline, including Seviprotimut-L as described below and a pre-clinical candidate program involving genetically-engineered adenoviruses to harness the immune system to fight cancer licensed from Unleash Immuno Oncolytics, Inc. (“Unleash”). The Company completed its initial public offering (“IPO”) on July 13, 2021. The Company plans to expand development of its lead therapeutic candidate and other candidates and to explore strategic partnerships. On October 8, 2025, the Company entered into a Membership Interest Purchase Agreement (the “Purchase Agreement”) with DEFJ, LLC, a Delaware limited liability company, (“DEFJ”) pursuant to which the Company acquired 100% of the issued and outstanding membership interests of ABCJ, LLC, a Delaware limited liability company, (“ABCJ”) (such transaction, the “Acquisition”). Prior to the Acquisition, ABCJ was a wholly-owned subsidiary of DEFJ and an indirect wholly-owned subsidiary of CK Life Sciences Int’l., (Holdings) Inc. (“CKLS”), a listed entity on the Main Board of the Hong Kong Stock Exchange. In the Acquisition, the Company issued approximately 1,153 shares of its Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share, (the “Series A Preferred Stock”). ABCJ owns 100% of the issued and outstanding membership interests of Polynoma, LLC, a Delaware limited liability company, (“Polynoma”) previously headquartered in San Diego, California. Polynoma is an immuno-oncology focused biopharmaceutical company developing Seviprotimut-L, an investigational polyvalent antigen vaccine intended to reduce the risk of recurrence of melanoma in patients in stage IIB and IIC who have limited options. Seviprotimut-L has been safely administered to more than 1,000 patients in clinical trials. Concurrent with the Acquisition, the Company entered into an Investment Agreement (the “Investment Agreement”) with DEFJ. Pursuant to the Investment Agreement, DEFJ purchased in a private placement an aggregate of approximately 224 shares of the Company’s Series B Non-Voting Convertible Preferred Stock, par value $0.0001 per share, (the “Series B Preferred Stock” and, together with the Series A Preferred Stock, the “Preferred Stock”) for a price per share of $111,740, or an aggregate purchase price of approximately $25 million. The aggregate purchase price consisted of a $20 million cash subscription paid on October 8, 2025, and a promissory note (the “Promissory Note”) in the aggregate principal amount of approximately $5 million (together, the “October 2025 Investment”). The Promissory Note accrued interest at a rate of 4% per annum, calculated as simple interest on a 365-day year. DEFJ paid the principal and accrued interest on the Promissory Note on December 30, 2025. The Company intends to continue developing TTX-MC138 and on developing Seviprotimut-L as available funding allows, with the primary near-term focus on advancing TTX-MC138 in a Phase 2a clinical trial for patients with CRC. The Company is evaluating the potential to augment Seviprotimut-L's anti-cancer effects by combining it with TTX-MC138 to address micrometastases in stage IIB and IIC melanoma patients. The Company has not generated revenues and has not yet achieved profitable operations, nor has it ever generated positive consolidated cash flows from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. The Company is subject to those risks associated with any early-stage biopharmaceutical company that requires substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approvals, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants. Further, the Company’s future operations are dependent on its success in raising additional capital. (1) Nature of Business and Liquidity (continued) To further support its planned operations, the Company will require additional capital; however, the Company cannot be certain that additional funding will be available on acceptable terms, or at all. Through the date of these consolidated financial statements, the Company’s primary source of capital was from the sale of equity securities in its IPO and subsequent financings, sales of convertible promissory notes, and funds received under SBIR Awards. For the foreseeable future, the Company plans to fund its operations by continuing to raise additional capital, primarily through sales of equity or debt, and from funds that may be awarded under government and other grants. To the extent the Company raises additional funds by issuing equity securities, its stockholders may experience significant dilution. Any debt financing, if available, may include potentially dilutive features and include restrictive covenants that impact the Company’s ability to conduct business. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may have to (i) significantly scale back its planned operations or (ii) relinquish or otherwise dispose of rights to technologies on unfavorable terms. Going Concern These consolidated financial statements have been prepared assuming that the Company will continue as a going concern which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course of business. Due to the Company’s recurring and expected continuing losses from operations, the Company has concluded there is substantial doubt concerning its ability to continue as a going concern for one year after the issuance of these consolidated financial statements without additional capital becoming available. These consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. To date, the Company has incurred substantial consolidated losses and negative consolidated cash flows from operations. It expects to continue to incur operating losses for the foreseeable future as it pursues development of its lead therapeutic candidate and other programs. Operating losses are expected to continue until such time, if ever, that the Company can generate significant revenue from product candidates currently in development. The Company is unable to predict the extent of any future losses or when the Company will become profitable, if ever. For the six months ended June 30, 2026, consolidated net cash used in operating activities was approximately $10.4 million and the Company’s consolidated net loss was approximately $24.5 million. As of that date, the Company had a consolidated accumulated deficit of approximately $122.4 million and approximately $8.4 million in cash. Management believes that cash at June 30, 2026, along with proceeds from the July 2026 sale of a convertible note, are sufficient to fund the Company’s operations and capital requirements to approximately year-end 2026. |