About TransCode Therapeutics Forward-Looking Statements "The Company's regaining compliance with all Nasdaq's listing standards continues recent positive news for TransCode, following our announcement of positive blood test results in connection with our Phase 0 clinical trial and FDA authorization to proceed with our upcoming Phase 1 study. We believe our organization is prepared to continue to execute on our ambitious plans to swiftly advance our clinical development programs," said Tom Fitzgerald, TransC ...

BOSTON, May 29, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced new preliminary data from its Phase 0 clinical trial with radiolabeled TTX-MC138 suggesting antitumor activity. New results from the patient dosed in this trial indicate that a microdose of radiolabeled TTX-MC138 resulted in significant inhibition of the drug candidate's molecular target, miRNA-10b, in the patient ...

BOSTON, May 29, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced new preliminary data from its Phase 0 clinical trial with radiolabeled TTX-MC138 suggesting antitumor activity. New results from the patient dosed in this trial indicate that a microdose of radiolabeled TTX-MC138 resulted in significant inhibition of the drug candidate's molecular target, miRNA-10b, in the patient ...

Clinical Development - TransCode received FDA's IND Study May Proceed notification for TTX-MC138, allowing a Phase 0 clinical trial with one patient treated [155]. - The Phase I/II clinical trial for TTX-MC138 is expected to commence in mid-2024 following FDA approval [155]. - Preliminary results from imaging studies indicated TTX-MC138's accumulation in metastatic lesions, a circulation half-life of approximately 20 hours, and drug stability in circulation [181]. - TransCode's TTX delivery platform aims to overcome delivery challenges of RNA therapeutics, enhancing targeting and accumulation in tumors [163]. - The company is developing multiple therapeutic candidates, including TTX-siPDL1 and TTX-RIGA, targeting various cancer mechanisms [156]. - The TTX platform has undergone approximately 20 years of R&D, including 12 years at Harvard Medical School and Massachusetts General Hospital [165]. - The company entered into a collaboration agreement with Debiopharm to develop targeted nucleic acid delivery modalities for cancer treatment [186]. - The company signed a five-year strategic collaboration agreement with The University of Texas M. D. Anderson Cancer Center, committing up to $10 million for Phase I and II clinical trials [209][211]. Financial Performance - The company reported net losses of approximately $3.3 million for the three months ended March 31, 2024, and $18.5 million for the year ended December 31, 2023, with an accumulated deficit of approximately $49.7 million as of March 31, 2024 [194]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future [202]. - The company received approximately $51.7 million in net proceeds from its IPO and other financing activities since its inception [193]. - The company had cash of approximately $4.9 million as of March 31, 2024, which is expected to fund operations into the third quarter of 2024 [198]. - Cash used in operating activities was $3,937 thousand for the three months ended March 31, 2024, compared to $4,514 thousand in the same period in 2023 [231]. - Grant income decreased by $52 thousand to $27 thousand for the three months ended March 31, 2024, compared to the same period in 2023 [226]. - The company incurred interest expense of $10 thousand for the three months ended March 31, 2024, down from $13 thousand in the same period in 2023 [227]. - The company anticipates significant increases in research and development expenses as it progresses with clinical trials for its product candidates [207]. - The company anticipates significant increases in general and administrative expenses as it prepares for potential commercial activities and regulatory approvals [218]. Operational Changes - The company reduced its headcount from 19 employees at December 31, 2022, to 11 employees by December 31, 2023, following a restructuring initiative [184]. - The company is subject to a mandatory panel monitor through January 26, 2025, following its compliance with Nasdaq's equity rule [189]. - The company regained compliance with Nasdaq's minimum stockholders' equity requirement of $2,500,000 after completing a January offering [189]. - The company may need to seek additional capital to support its operations and business strategy, which could include equity sales or debt financing [196]. - The company may need to raise additional funds through various means, including equity offerings and collaborations, which could dilute ownership interests [242][243]. - The company has no assurance that funding from governmental sources or collaborations will be available on acceptable terms [242]. - The company may need to consider cost reduction strategies if unable to raise additional funds, which could include limiting or terminating development programs [244]. Internal Controls and Compliance - The company has identified material weaknesses in its internal control over financial reporting, which remain unremediated, potentially affecting the accuracy of financial reporting [268]. - Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2024, due to identified material weaknesses [281]. - The company is engaged in ongoing remediation efforts to address internal control deficiencies, including hiring additional finance and accounting personnel [283]. - There were no material changes in the company's internal control over financial reporting during the three months ended March 31, 2024 [287]. - The company plans to continue establishing more robust accounting policies and procedures to improve its internal controls [282]. Market and Industry Insights - The global mRNA therapeutics market was estimated at approximately $33.8 billion in 2023, projected to grow at nearly 25% CAGR, reaching approximately $158 billion by 2030 [165]. - The company relies on third parties for preclinical studies and clinical trial services, with accrued research and development expenses estimated based on progress towards completion of related projects [252][253]. - The company recognized that fluctuations in foreign currency exchange rates could adversely affect its results of operations as it continues to develop its business [278]. Cybersecurity and Risk Management - The company is currently enhancing its cybersecurity defenses to mitigate risks from cyberattacks, including phishing and ransomware [274]. - An immediate 10% change in U.S. interest rates would not materially affect the fair market value of the company's investments due to the short-term nature of its holdings [275]. - The company has not entered into any foreign currency hedging contracts to mitigate exposure to foreign currency exchange risk [278]. - The company experienced a loss of $55 thousand from foreign currency transactions for the three months ended March 31, 2024 [277]. - As of March 31, 2024, the company had no debt outstanding, indicating no exposure to interest rate risk related to debt [276].

FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Date of Report (Date of earliest event reported): April 3, 2024 TRANSCODE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40363 81-1065054 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) TransCode Therapeutics, Inc. 6 Liberty Square, #2382 Bosto ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ___________ TO ___________ Commission File Number: 001-40363 TRANSCODE THERAPEUTICS, INC. (Exact Name of Registrant as Specified in Its Charter) ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ FORM 10-Q ____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number 001-403 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ FORM 10-Q ____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number 001-40363 TR ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Unaudited Q1 2023 financial statements detail a $4.8 million net loss, $1.6 million cash, a $0.2 million stockholders' deficit, and going concern uncertainty [Balance Sheets](index=5&type=section&id=BALANCE%20SHEETS) The balance sheet as of March 31, 2023, shows reduced cash and assets, increased liabilities, and a $236,792 stockholders' deficit, down from $3.2 million equity Balance Sheet Summary (Unaudited) | Account | March 31, 2023 (USD) | December 31, 2022 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash | $1,622,657 | $4,968,418 | | Total Current Assets | $4,346,623 | $7,379,405 | | Total Assets | $5,590,510 | $7,587,986 | | **Liabilities & Equity** | | | | Total Current Liabilities | $5,449,489 | $4,347,290 | | Total Liabilities | $5,827,302 | $4,347,290 | | Total Stockholders' Equity (Deficit) | ($236,792) | $3,240,696 | [Statements of Operations](index=6&type=section&id=STATEMENTS%20OF%20OPERATIONS) Q1 2023 net loss increased to $4.8 million ($0.33/share) from $3.5 million ($0.27/share) in Q1 2022, driven by higher R&D and G&A expenses Statements of Operations Summary (Unaudited) | Account | Three Months Ended March 31, 2023 (USD) | Three Months Ended March 31, 2022 (USD) | | :--- | :--- | :--- | | Research and development | $2,591,350 | $1,881,576 | | General and administrative | $2,309,763 | $1,595,926 | | **Operating loss** | **($4,901,113)** | **($3,477,502)** | | **Net loss** | **($4,816,934)** | **($3,470,070)** | | Net loss per share | ($0.33) | ($0.27) | [Statements of Stockholders' Equity (Deficit)](index=7&type=section&id=STATEMENTS%20OF%20STOCKHOLDERS%27%20EQUITY%20%28DEFICIT%29) Stockholders' equity shifted from $3.2 million at year-end 2022 to a $0.2 million deficit by March 31, 2023, due to a $4.8 million net loss, partially offset by $1.2 million from stock issuance - Stockholders' equity decreased from **$3,240,696** at the end of 2022 to a deficit of **($236,792)** at March 31, 2023[24](index=24&type=chunk) - This was mainly due to the net loss of **$4,816,934**, which was partially offset by **$1,180,686** from the net issuance of common stock and **$158,760** in share-based compensation[24](index=24&type=chunk) [Statements of Cash Flows](index=8&type=section&id=STATEMENTS%20OF%20CASH%20FLOWS) Q1 2023 saw $4.5 million net cash used in operations, a $3.3 million decrease in cash to $1.6 million, partially offset by $1.2 million from financing activities Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2023 (USD) | Three Months Ended March 31, 2022 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,513,551) | ($3,948,566) | | Net cash used in investing activities | ($12,896) | ($30,657) | | Net cash provided by financing activities | $1,180,686 | $5,989 | | **Net change in cash** | **($3,345,761)** | **($3,973,234)** | | Cash, end of period | $1,622,657 | $16,852,626 | [Notes to Financial Statements (Unaudited)](index=9&type=section&id=NOTES%20TO%20FINANCIAL%20STATEMENTS%20%28UNAUDITED%29) Notes detail substantial doubt about going concern due to recurring losses and insufficient cash, alongside accounting policies, collaboration commitments, stock-based compensation, and recent equity financing - The company has concluded there is substantial doubt about its ability to continue as a going concern[34](index=34&type=chunk) - Current cash is sufficient to fund operations into the second quarter of 2023, but not for a full 12 months from the financial statement issuance date[34](index=34&type=chunk)[38](index=38&type=chunk) - In February 2023, the company completed a registered direct offering (RDO) of **2,846,300** shares of common stock at **$0.527** per share, generating net proceeds of approximately **$1.2 million**[104](index=104&type=chunk) - The company has a five-year strategic collaboration agreement with The University of Texas M. D. Anderson Cancer Center, with a commitment to fund up to **$10 million** over the term[95](index=95&type=chunk) - Subsequent to the quarter end, in April 2023, the company entered into a Common Stock Purchase Agreement with White Lion Capital to sell up to **$1,081,307** in common stock[130](index=130&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the TTX oncology platform and TTX-MC138's FDA Phase 0 authorization, highlighting increased operating expenses and critical liquidity, with $1.6 million cash only sufficient into Q2 2023, raising going concern doubt - The company's lead therapeutic candidate, TTX-MC138, received authorization from the FDA in December 2022 to conduct a Phase 0 clinical trial[133](index=133&type=chunk) - The company received IRB approval in April 2023 to commence the trial[133](index=133&type=chunk) - Management states that cash of approximately **$1.6 million** at March 31, 2023, plus subsequent receipts, will be sufficient to fund operations into but not through the second quarter of 2023, raising substantial doubt about the company's ability to continue as a going concern[164](index=164&type=chunk)[191](index=191&type=chunk) Comparison of Operating Expenses (Q1 2023 vs Q1 2022) | Expense Category | Q1 2023 (in thousands USD) | Q1 2022 (in thousands USD) | Change (in thousands USD) | | :--- | :--- | :--- | :--- | | Research and development | $2,591 | $1,882 | $709 | | General and administrative | $2,310 | $1,596 | $714 | | **Total operating expenses** | **$4,901** | **$3,478** | **$1,423** | - The increase in R&D expenses was primarily due to increased consulting, purchased services, and personnel costs[184](index=184&type=chunk) - The increase in G&A expenses was mainly from higher personnel costs, legal and accounting services, and other public company costs[185](index=185&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) Primary market risks are interest rate sensitivity on cash and Euro-denominated foreign currency exchange, neither of which is expected to materially affect financial results due to current scale - The company's primary market risk exposures are interest rate sensitivity on cash holdings and foreign currency exchange risk, mainly from the Euro[223](index=223&type=chunk)[225](index=225&type=chunk) - Management states that an immediate **10%** change in interest rates or a **5%** change in the Euro exchange rate would not materially affect the company's financial results[223](index=223&type=chunk)[225](index=225&type=chunk) [Controls and Procedures](index=41&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Disclosure controls and procedures were ineffective as of March 31, 2023, due to material weaknesses, with ongoing remediation efforts including hiring finance personnel and engaging consultants - Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2023, due to an existing material weakness[229](index=229&type=chunk) - Ongoing remediation efforts include hiring more finance and accounting personnel, documenting policies and procedures, and assessing significant accounting transactions with the help of an independent consulting firm engaged in September 2022[230](index=230&type=chunk)[231](index=231&type=chunk)[233](index=233&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=43&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material legal proceedings, nor is it aware of any pending or threatened litigation with a material adverse effect - As of the reporting date, the company is not a party to any material legal proceedings[235](index=235&type=chunk) [Risk Factors](index=43&type=section&id=ITEM%201A.%20RISK%20FACTORS) As a smaller reporting company, TransCode is not required to update its risk factors in this quarterly report on Form 10-Q - The company is not required to disclose information under this item as it qualifies as a smaller reporting company[236](index=236&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) In Q1 2023, the company issued unregistered warrants to a consultant for up to 250,000 common shares at $0.50 per share, exempt under Section 4(a)(2) - In Q1 2023, the company issued warrants to a consultant to purchase up to **250,000** shares of common stock at **$0.50** per share[237](index=237&type=chunk) - The issuance was exempt from registration requirements[237](index=237&type=chunk) [Defaults Upon Senior Securities](index=43&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) No defaults upon senior securities were reported during the period - None[240](index=240&type=chunk) [Mine Safety Disclosures](index=43&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company's business - Not applicable[241](index=241&type=chunk) [Other Information](index=43&type=section&id=ITEM%205.%20OTHER%20INFORMATION) No other information required to be disclosed under this item was reported - None[242](index=242&type=chunk) [Exhibits](index=43&type=section&id=ITEM%206.%20EXHIBITS) This section lists exhibits filed with Form 10-Q, including various agreements like the Placement Agent Warrant, Securities Purchase Agreement, Common Stock Purchase Agreement, and officer certifications - Exhibits filed with the report include the Form of Placement Agent Warrant, a Securities Purchase Agreement, the Common Stock Purchase Agreement with White Lion Capital LLC, and officer certifications[243](index=243&type=chunk)[244](index=244&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ___________ TO ___________ | Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered | | --- | --- | --- | | Common S ...