Transcode Therapeutics, Inc.

ITEM 1A. Risk Factors

Factors that could cause our actual results to differ materially from those in this Quarterly Report on Form 10-Q are any of the risks described in our Annual Report on Form 10-K for the year ended December 31, 2025, or our Annual Report, filed with the SEC, as amended and supplemented by the information in our subsequent Quarterly Reports on Form 10-Q or other subsequent filings, together with all of the other information contained in this Quarterly Report, including our unaudited consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report, and the risk factors set forth below. The risk factors disclosure in our Annual Report and subsequent Quarterly Reports on Form 10-Q is qualified by the information that is described in this Quarterly Report. Any of these factors could result in a significant or material adverse effect on our business, consolidated results of operations or consolidated financial condition. Additional risk factors not currently known to us or that we currently deem immaterial may also have a material adverse effect on our business, consolidated financial condition or consolidated results of operations. You should

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review the risk factors in our Annual Report , subsequent SEC filings and the risk factors discussed below for a discussion of iimportant 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.

We could lose our listing on the Nasdaq Capital Market if our stockholders equity or the closing bid price of our common stock do not meet Nasdaq requirements or if , if we do not meet Nasdaqs new requirement with respect to a Nasdaq-listed companys market value of listed securities, or if we do not comply with other Nasdaq requirements. The loss of our Nasdaq listing would in all likelihood make our common stock significantly less liquid and adversely affect its value, including a total loss of value. Loss of our Nasdaq listing would in all likelihood also make it much more difficult for us to raise additional capital.

Our stockholders equity in this Quarterly Report on Form 10-Q does not meet Nasdaq rCapital Market, LLC, or Nasdaq, rules for continued listing of our stock on the Nasdaq Capital Market, LLC, or Nasdaq. We expect to . As previously disclosed, on May 19, 2026, we received a deficiency notice to this effect from Nasdaq with the opportunity to present our plan to Nasdaq for regaining compliance. We believe that ifOn July 20, 2026, we obtain sharehed stockholder approval for the conversion of our preferred stock, we will e and, between July 20, 2026, and August 10, 2026, all of our outstanding shares of preferred stock converted into Common Stock. As a result, we believe that we now exceed the minimum stockholders equity requirement butand Nasdaq has confirmed this conclusion. Nevertheless, there is no guaassurantece that we will continue that such o meet Nasdaq rules for continued listing of our stock.

On July 22, 2026, the SEC approval wed a new Nasdaq rule mandating immediate delisting of companies listed on Nasdaq if the market value of their listed securities, or MVLS, falls below $5 mill be obtained.

Inion for 30 consecutive business days. Nasdaq defines MVLS as the closing bid price of a companys stock multiplied by its total listed shares outstanding. Under the evennew rule, there is no cure period

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and appealing t of a delisto a Nasdaq Hearings Panel will not halt suspension of trading on Nasdaq. While the SEC issued a stay on July 29, 2026, pausing from the this rule, there is no assurance that the new rule will not become effective, that our MVLS will remain above $5 million for 30 consecutive business days or that our stock will not be delisted. At August 10, 2026, based on our Nasdaq Capital Marketofficial closing price of $3.88 per share, our MVLS was approximately $65.7 million.

In the event of a delisting from Nasdaq, our stock would likely be traded in the over-the-counter inter-dealer quotation system, more commonly known as the OTC. OTC transactions involve risks in addition to those associated with transactions in securities traded on the securities exchanges, such as the Nasdaq Capital Market, or Exchange-listed stocks. Many OTC stocks trade less frequently and in smaller volumes than Exchange-listed stocks. Accordingly, our stock would be less liquid than it would be otherwise. Also, the prices of OTC stocks are often more volatile than Exchange-listed stocks. Additionally, many institutional investors are prohibited from investing in OTC stocks, and it might be more challenging to raise capital when needed. Further, a delisting of our stock from trading on Nasdaq could also adversely affect our reputation, relationships with business partners, and access to strategic opportunities.

As further described elsewhere in this Quarterly Report on Form 10-Q, in light of our financial position and our need to raise additional capital, delisting of our common stock from the Nasdaq Nasdaq would materially limit our ability to obtain additional equity capital.

We will need to raise substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, scale back or discontinue some of our therapeutic candidate development programs or commercialization efforts.

The development of pharmaceutical drugs and biological products is capital intensive. At June 30, 2026, we had cash totaling approximately $8.4 million. We believe that these funds together with funds we expect to receive in connection with the Second Convertible Note under the SEPA will be sufficient to support our operating expenses and capital expenditure requirements through approximately year end 2026. As a result, we will need to raise additional capital to continue as a going concern. Unless we receive additional funding, we may not be able to complete clinical trials we begin. Further, we may only be able to complete the trial in a small subset of patients and in only one tumor type. Even if completed, we will require additional funds to advance further. If we are capital constrained, we may not be able to meet our obligations. If we are unable to meet our obligations, or we experience a disruption in our cash flows, it could limit or halt our ability to continue to develop our therapeutic candidates or even to continue operations, either of which occurrence would have a material adverse effect on us.

We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we continue the research and development of, advance the preclinical and clinical activities of, and seek marketing approval for, our current or future therapeutic candidates. In addition, if we obtain marketing approval for any of our current or future therapeutic candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution to the extent that such sales, marketing, product manufacturing and distribution do not become the responsibility of collaborators. We may also need to raise additional funds sooner if we choose to pursue additional indications and/or geographies for our current or future therapeutic candidates or otherwise expand more rapidly than we presently anticipate. Furthermore, we expect to continue to incur significant costs associated with operating as a public company. If we are unable to raise capital when needed, we would be forced to delay, scale back or discontinue the development and commercialization of one or more of our therapeutic candidates, delay our pursuit of potential licenses or acquisitions, or significantly reduce our operations.

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Identifying potential current or future therapeutic candidates, manufacturing, and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve drug sales. In addition, our current or future therapeutic candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of drugs that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to continue to rely on additional funding to achieve our business objectives. In addition to having obtained funding from sales of equity and equity-related securities, we have also received funding under grants awarded by U.S. federal government agencies and may seek additional grants in the future. Recently, an application we submitted to the National Capital Market would materially limit our ancer Institute was removed from consideration based on a foreign risk assessment. There can be no assurance that any future applications we submit to any U.S. federal government agencies will result in any awards, which could increase our need to obtain funding from other sources.

Because we are relying on the exemptions from corporate governance requirements as a result of being a controlled company within the meaning of the Nasdaq listing standards, you do not have the same protections afforded to stockholders of companies that are subject to such requirements.

Because entities affiliated with CKLS control a majority of our common stock, we are a controlled company within the meaning of the Nasdaq listing standards. Under these rules, a company of which more than 50% of the voting power is held by an individual, a group or another company is a controlled company and may elect not to comply with certain Nasdaq corporate governance requirements, including (1) the requirement that a majority of the Board consist of independent directors, (2) the requirement that we have a nominating and corporate governance committee that is composed entirely of independent directors with a written charter addressing the committees purpose and responsibility to obtain additional equities, and (3) the requirement that the Board have a compensation committee composed entirely of independent directors with a written charter addressing the committees purpose and responsibilities. However, our Board is currently comprised of a majority of independent directors and we currently have a Nominating and Corporate Governance Committee the members of which are all independent directors. If we were to fully avail ourselves of the controlled company rules, you do not have the same protections afforded to stockholders of companies that are subject to all of the Nasdaq corporate governance requirements.

 
CKLS controls us and its interests may capital. onflict with ours or yours in the future.

CKLS, through its wholly-owned subsidiary DEFJ, beneficially owns approximately 83.5% of the voting power of our common stock as of August 10, 2026. For so long as CKLS continues to have voting power over a significant percentage of our common stock, even if such amount is less than 50%, it will still be able to significantly influence the composition of our Board and the approval of actions requiring stockholder approval. Although the holders of our common stock will be entitled to vote on all matters on which stockholders of a corporation are generally entitled to vote under the Delaware General Corporation Law (the DGCL), including the election of our Board, CKLSs voting power may effectively allow it to control the outcome of matters submitted to our stockholders for approval. Accordingly, CKLS will have significant influence with respect to our Board, management, business plans and policies, including the appointment and removal of our officers. In particular, for so long as CKLS continues to beneficially own a significant percentage of our common stock, it will be able to cause or prevent a change of control of our company or a change in the composition of our Board and could preclude any unsolicited acquisition of our company. CKLSs ownership could deprive you of an opportunity to receive a premium for your shares of common stock as part of a sale of our company and ultimately might affect the market price of our common stock.