Transcode Therapeutics, Inc.

Current report

Our stockholders’ equity in this Quarterly Report on Form 10-Q does not meet Nasdaq rules for continued listing of our stock on the Nasdaq Capital Market, LLC, or Nasdaq. We expect to receive a deficiency notice to this effect from Nasdaq with the opportunity to present our plan to Nasdaq for regaining compliance. We believe that if we obtain shareholder approval for the conversion of our preferred stock, we will exceed the minimum stockholders’ equity requirement but there is no guarantee that such approval will be obtained.

Previous report

We will need to raise additional capital to continue operations in the future.

Previous report

As of September 30, 2025, we had cash of approximately $2.8 million. In connection with the October 8, 2025, Investment, we received $20 million in equity. We believe that the combined amount of these funds will enable us to fund our operating expenses and capital requirements into the fourth quarter 2026. We will need to raise additional capital to continue as a going concern. The failure to obtain sufficient additional funds on commercially acceptable terms or at all when needed to fund our operations and satisfy our obligations to creditors may have a material adverse effect

Previous report

on our business, results of operations and financial condition and jeopardize our ability to continue operations. If we do not obtain capital when needed, we may be forced to amend, delay, limit, reduce or terminate the scope of our development programs and/or limit or cease our operations.

Previous report

Adverse global conditions, including economic uncertainty and tariffs, may negatively affect our financial results.

Previous report

Global conditions, dislocations in the financial markets, or inflation could adversely impact our business. In addition, the global macroeconomic environment has been and may continue to be negatively affected by, among other things, instability in global economic markets, increased U.S. trade tariffs and trade disputes with other countries, instability in global credit markets, supply chain weaknesses, instability in the geopolitical environment, political tensions, and foreign governmental debt concerns. Such challenges have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets, which may adversely affect our business. For example, certain governments (including the United States government) have imposed or may impose tariffs on a wide range of products, raw materials, and intermediate goods. Additional tariffs, or retaliatory measures by other countries in response, may be implemented at any time. We cannot predict future changes in trade policy or the terms of any renegotiated trade agreements, nor can we determine the impact they may have on our business. Any such changes could have a material adverse effect on our business, financial condition, and results of operations.

Previous report

The rules dealing with U.S. federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. For example, the One Big Beautiful Bill Act ("H.R.1") was signed into law on July 4, 2025, and made significant changes to U.S. federal tax law. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock. For example, under Section 174 of the Internal Revenue Code of 1986, as amended, (the “IRC”) in taxable years beginning after December 31, 2021, expenses that are incurred for research and development performed outside the U.S. will be capitalized and amortized, which may have an adverse effect on our cash flow. H.R.1 provides that for taxable years beginning after December 31, 2024, expenses that are incurred for research and development performed in the U.S. may, at the taxpayer’s election, be immediately deducted or capitalized and amortized. In addition, H.R.1 provides that for taxable years beginning after December 31, 2021, and before January 1, 2025, certain eligible taxpayers generally may elect to retroactively deduct expenses for research and development performed in the U.S. in such taxable years by filing amended tax returns for such taxable years, and all other taxpayers that are not eligible to make such an election and that amortized expenses for research and development performed in the U.S. in such taxable years generally may elect to accelerate and deduct the remaining unamortized amounts of such research and development expenses (i) in the first taxable year beginning after December 31, 2024, or (ii) ratably over the two-taxable years period beginning with the first taxable year beginning after December 31, 2024. In recent years, many changes have been made to applicable tax laws and changes are likely to continue to occur in the future. For example, under Section 174 of the Code, in taxable years beginning after December 31, 2021, expenses that are incurred for research and development in the U.S. will be capitalized and amortized, which may have an adverse effect on our cash flow. Future changes in tax laws could have a material adverse effect on our business, cash flow, financial condition or results of operations.

Previous report

It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be enacted, promulgated or issued under existing or new tax laws, which could result in an increase in our or our stockholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof. We urge investors to consult with their legal and tax advisers regarding the implications of actual and potential changes in tax laws on investment in our common stock.

Previous report

The ability of FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel, accept payments of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result of these and other factors. In particular, it has been reported that FDA’s planned expansion of its oncology division is delayed. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Previous report

Disruptions at FDA and other agencies may also slow the time necessary for new therapeutic candidates to be reviewed and/or approved by those agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times, and certain regulatory agencies, such as FDA and the SEC, have had to furlough critical employees and stop critical activities. Should FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel or for other reasons, and FDA does not determine that a remote interactive evaluation will be adequate, the agency has stated that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the application until an inspection can be completed. Regulatory authorities outside the U.S. may adopt similar restrictions or other policy measures in response to a pandemic or for other reasons and may experience delays in their regulatory activities.

Previous report

While the full impact of a U.S. federal government shutdown cannot be determined, a shutdown could affect us in several ways, including, but not limited to, the following:

Previous report

●A shutdown could reduce or delay services from federal agencies that are critical to our business, such as the Internal Revenue Service (IRS) and the SEC. Delays in income verification, social security number verification, and regulatory reviews, approvals, or inspections could disrupt our operations or time-sensitive transactions.

Previous report

●Critical government functions could be affected causing delays that impact the broader market. For instance, the Bureau of Labor Statistics and other agencies might pause the release of key economic indicators, which could increase market volatility.

Previous report

The length and severity of any potential shutdown are uncertain, making it difficult to predict the full impact on our business.

Previous report

Uncertainty regarding the potential for new initiatives, laws, regulations, policies and guidance affecting our product candidates or other aspects of our business, could materially and adversely affect our business.

Previous report

There is substantial uncertainty as to whether and how the current administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval. This uncertainty could present new challenges as we navigate development and approval of our therapeutic candidates or any future product candidates. Some of these efforts have to date manifested in the form of personnel cuts and measures that could impact the FDA’s ability to hire and retain key personnel. This could result in delays or limitations on our ability to obtain guidance from the FDA on our therapeutic candidates or any future product candidates we develop or on our ability to obtain requisite regulatory approvals in the future. There is uncertainty as to whether we will be materially and negatively impacted by governmental orders, regulations, policies or guidance, or disruptions to the normal operations of government agencies making it difficult to predict the full impact on our business.

Current report — wording carried from elsewhere

review the risk factors in our Annual Report and the risk factors discussed below for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.