RNAZ 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• TransCode is an immuno-oncology and targeted cancer therapy company with a focus on treating advanced malignancy. Our lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. In 2023, we conducte…

• Contingent Value Rights Agreement. Concurrent with the closing of the Acquisition, we entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of our Common Stock as of October 20, 2025, (the “Record Date”) includi…

• The CVRs entitle the holders thereof (each a “Holder”), in the aggregate, to 50% of the Net Proceeds (as defined in the CVR Agreement) from any Upfront Payment (as defined in the CVR Agreement) or Milestone Payment (as defined in the CVR Agreement) we receive in a given calendar quarter during the T…

• Under the CVR Agreement, the Rights Agent has, and Holders of at least 30% of the CVRs then-outstanding have, certain rights to audit and enforcement on behalf of all Holders. The CVRs may not be sold, assigned, pledged, encumbered or in any other manner transferred or disposed of, in whole or in pa…

• Unleash Licensing Agreement. In March 2026, we entered into the Unleash Licensing Agreement with Unleash pursuant to which the we acquired a pre-clinical candidate program involving genetically-engineered adenoviruses to harness the immune system to fight cancer, as well as an exclusive, perpetual, …

相对上期删除的文字 · 来源:10-Q · 2025-11-14

• TransCode is an immuno-oncology and targeted cancer therapy company with a focus on treating advanced malignancy. Our lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis.

• In addition to TTX-MC138, we have a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells. TTX-siPDL1 is an siRNA-based modulator of programmed death-ligand 1, or PD-L1. TTX-RIGA is an RNA-based agonist of the retinoic a…

• melanoma cell lines. Seviprotimut-L works by stimulating both humoral and cellular immune responses. It is Phase 3 ready and has been administered to approximately 1,000 patients in prior clinical trials.

• In 2023, we conducted a Phase 0 clinical trial intended to demonstrate quantitative delivery of radiolabeled TTX-MC138 to metastatic lesions in subjects with advanced solid tumors. We treated one patient in the Phase 0 trial. In April 2024, we received an IND Study May Proceed notification from the …

• All our therapeutic candidates are designed with the goal of significantly improving outcomes for cancer patients.

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• As of March 31, 2026, and December 31, 2025, we had no debt outstanding and therefore were not subject to interest rate risk related to debt.

• Our primary exposure to market risk is foreign exchange rate sensitivity to the Euro, the currency for certain of our major purchases. Foreign currency transaction gains or losses, if any, are recorded as a component of other income (expense) in our consolidated statements of operations. For the thr…

• As we continue to develop our business, our consolidated results of operations and consolidated cash flows will likely be more affected by fluctuations in foreign currency exchange rates, including the Euro and other currencies, which could adversely affect our consolidated results of operations. To…

相对上期删除的文字 · 来源:10-Q · 2025-11-14

• At September 30, 2025, and December 31, 2024, we had no debt outstanding other than liabilities related to the right-of-use asset from our sublease in Newton, Massachusetts. We currently, therefore, are not subject to interest rate risk related to debt.

• Our primary exposure to market risk is foreign exchange rate sensitivity to the Euro, the currency for certain of our major purchases. For the three and nine months ended September 30, 2025, we recognized a loss on foreign currency transactions of $32 thousand and $120 thousand, respectively, record…

• statements of operations. We do not believe that an immediate 5% change in the Euro exchange rate would have a material effect on our results of operations.

• As we continue to develop our business, our results of operations and cash flows will likely be more affected by fluctuations in foreign currency exchange rates, including the Euro and other currencies, which could adversely affect our results of operations. To date, we have not entered into any for…

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• Management’s Report on Internal Control Over Financial Reporting

• Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Exchange Act Rule 13a–15(f) or 15d-15(f). Our internal control system was designed to provide reasonable assurance to our management and our Board regarding th…

• To remediate the material weakness in our internal control over financial reporting and address the material weakness in our accounting processes, we previously implemented steps to address internal control deficiencies such as implementing more robust accounting policies and procedures, implementin…

• While we believe that these efforts will improve our internal control over financial reporting, implementation of these and other measures will be ongoing and will require validation and testing of the design and operating effectiveness of our internal controls over a sustained period of financial r…

• Other than the remediation measures taken to date as described above, there were no material changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended March 31, 2026, which have materially…

相对上期删除的文字 · 来源:10-Q · 2025-11-14

• Our management, with the participation of our principal executive officer and principal financial and accounting officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2025. Based upon such evaluation, our principal executive officer and principal financia…

• To remediate the previous material weaknesses in our internal control over financial reporting and address other deficiencies in our accounting processes, we previously began and continue to implement steps to address these matters, including the following:

• ●implementing more robust accounting policies and procedures;

• ●hiring of or engaging additional finance and accounting personnel including consultants and other third-party resources with requisite experience and technical accounting expertise;

• ●documenting and formally assessing our accounting and financial reporting policies and procedures; and

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• On April 24, 2026, Wheeler Bio, Inc. (“Wheeler”) filed a complaint in the Supreme Court of the State of New York, County of New York, captioned Wheeler Bio, Inc. v. Polynoma LLC, et al., No. 652458/2026 against Polynoma and us (the “Wheeler Action”). The Wheeler Action asserts two causes of action: …

相对上期删除的文字 · 来源:10-Q · 2025-11-14

• From time to time, we may become subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any legal proceedings, and we are not aware of any pending or threatened legal proceedings against us that we believe could have a material adverse effect on …

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• 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 …

• 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 we do not comply with other Nasdaq requirements. The loss of our Nasdaq listing would in all likelihood make our common stock signific…

• 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 regain…

• In the event of a delisting from the Nasdaq Capital Market, 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 …

• 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 Capital Market would materially limit our ability to obtain additional equity capital.

相对上期删除的文字 · 来源:10-Q · 2025-11-14

• We could lose our listing on the Nasdaq Capital Market which would in all likelihood make our common stock significantly less liquid, adversely affect its value, and make raising additional capital far more difficult.

• From time to time, the Nasdaq Stock Market (“Nasdaq”) has notified us that we were not in compliance with certain listing requirements. As of the date of this Quarterly Report on Form 10-Q, we are in compliance with Nasdaq listing requirements. In the event of a delisting from the Nasdaq Capital Mar…

• 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 Capital Market would materially limit our ability to obtain additional equity capital. We may need to seek …

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

• 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 quarte…