RNA Delivery and Therapeutics - The company has developed the TTX platform, an RNA delivery system utilizing an iron oxide nanoparticle, aimed at improving the delivery of RNA therapeutics to tumors [121]. - The lead therapeutic candidate, TTX-MC138, targets microRNA-10b and is expected to enter a Phase 0 clinical trial to demonstrate delivery to metastatic lesions in patients with advanced solid tumors [124]. - The company received orphan drug designation for TTX-siPDL1 for pancreatic cancer, which provides seven years of marketing exclusivity upon FDA approval, along with tax credits and fee exemptions estimated to save over $3 million [133]. - The company plans to conduct a microdosing Phase 0 trial with TTX-MC138, enrolling up to 12 patients to measure drug delivery using PET-MRI [132]. - The TTX platform is designed to overcome stability, efficiency, and immunogenicity issues faced by existing delivery systems, optimizing accumulation in tumor cells [123]. - The proprietary delivery mechanism aims to significantly improve outcomes for cancer patients by enhancing the effectiveness of RNA-based therapies [126]. - The company intends to optimize a diagnostic test for detecting miR-10b in blood samples, potentially leading to FDA approval for screening metastasis in various tumor types [128]. - The research published in Cancer Nanotechnology supports the efficacy of the TTX platform in delivering therapeutic candidates to metastatic lesions, indicating a promising path for clinical evaluation [129]. Financial Performance and Projections - As of September 30, 2022, the company had cash of approximately $8.8 million and expects to receive up to an additional $1.8 million under the SBIR Award [142]. - The net losses for the nine months ended September 30, 2022, were approximately $12.4 million, with an accumulated deficit of approximately $22.7 million [138]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future [146]. - The company anticipates incurring significant operating expenses as it transitions to a public company, including legal, accounting, and investor relations costs [139]. - The company has received gross proceeds of approximately $31.5 million from its IPO and borrowings under convertible promissory notes [137]. - The company may need to raise additional capital to support ongoing operations and business strategy, which cannot be assured [140]. - The company has incurred significant operating losses and does not expect to generate revenue from product sales for several years [171]. - The company expects to require additional capital for research, development, and clinical trials, as well as for operations and potential acquisitions [175]. Research and Development Expenses - Research and development expenses are expected to increase substantially as the company commences planned clinical trials for TTX-MC138 and other product candidates [150]. - Research and development expenses increased by $2,051 thousand (approximately 206% increase) for the three months ended September 30, 2022, and by $6,077 thousand (approximately 414% increase) for the nine months ended September 30, 2022, compared to the same periods in 2021 [164]. - The company anticipates significant increases in expenses related to ongoing and planned activities, particularly for clinical trials of TTX-MC138 [173]. Collaboration and Funding - A Fast-Track Small Business Innovation Research award from the National Cancer Institute is expected to provide up to $2,392,845 for a research partnership with Massachusetts General Hospital, with funding milestones achieved in previous years [134]. - The company has committed to fund up to $10 million over five years for a strategic collaboration with MD Anderson, with $500,000 payable in the first year [152]. - The company has budgeted funds for research and development to meet future payment obligations under the collaboration agreement, which do not represent additional spending [187]. - The agreement with MD Anderson is for a term of five years or until the studies are completed, whichever is later, unless terminated for a material breach [187]. Operational Challenges - The impact of the COVID-19 pandemic has affected the timeline for preclinical studies and planned clinical trials [145]. - The company relies significantly on third parties for preclinical studies and clinical trial services, with accrued research and development expenses estimated based on progress towards project completion [191]. - The company has not completed any clinical trials or obtained regulatory approvals for its product candidates [137]. Expenses and Losses - General and administrative expenses rose by $543 thousand (approximately 40% increase) for the three months ended September 30, 2022, and by $3,897 thousand (approximately 229% increase) for the nine months ended September 30, 2022, compared to the same periods in 2021 [165]. - The net loss for the three months ended September 30, 2022, was $4,290 thousand, compared to a net loss of $2,329 thousand for the same period in 2021, representing an increase of $1,961 thousand (approximately 84% increase) [163]. - Cash used in operating activities was $11,743 thousand for the nine months ended September 30, 2022, compared to $3,666 thousand for the same period in 2021, reflecting an increase of $8,077 thousand (approximately 220% increase) [181]. - The total cash decrease for the nine months ended September 30, 2022, was $12,036 thousand, compared to an increase of $21,672 thousand for the same period in 2021 [180]. Market and Risk Factors - The company is classified as an "emerging growth company" and a "smaller reporting company," with annual revenue less than $100 million during the most recently completed fiscal year [202][204]. - The company has identified material weaknesses in its internal control over financial reporting prior to its IPO, which remain unremediated [201]. - The company has taken steps to enhance cybersecurity defenses in response to increasing threats, including phishing attacks [205]. - The company’s primary exposure to market risk is foreign exchange rate sensitivity to the Euro, impacting major purchases [208]. - The company has not recognized foreign currency transaction losses for the nine months ended September 30, 2022, and an immediate 5% change in the Euro exchange rate would not materially affect results [208]. - The company has not entered into any foreign currency hedging contracts to mitigate exposure to foreign currency exchange risk [209]. - An immediate 10% change in U.S. interest rates would not materially affect the fair market value of the company's investments [206]. - The company’s cash is held in checking and savings accounts at major U.S. banks [206].

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, 2022 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 __ ...

RNA Delivery Platform and Therapeutics - The company has developed an RNA delivery platform, the TTX platform, utilizing an iron oxide nanoparticle approved for clinical use, aimed at improving the delivery of RNA therapeutics to tumors [125]. - The lead therapeutic candidate, TTX-MC138, targets microRNA-10b and aims to submit an exploratory IND application for a Phase 0 clinical trial in patients with Stage IV breast cancer [128]. - The TTX platform is designed to overcome stability, efficiency, and immunogenicity issues faced by existing delivery systems, optimizing accumulation in tumor cells [127]. - The TTX platform allows for a modular approach, enabling the adaptation of therapeutic loads for various RNA-based therapies, including RNAi and CRISPR technologies [127]. - The company is exploring LIN28B as a potential target for pancreatic cancer and plans to negotiate licensing if evaluation results meet criteria [131]. - The TTX-MC138 study results suggest effective delivery to metastatic lesions, supporting further clinical evaluation and potential FDA authorization for additional studies [133]. - The company plans to conduct a microdosing Phase 0 trial with TTX-MC138, enrolling 10 patients to measure delivery to metastatic lesions using PET-MRI [137]. - The SBIR Phase II milestone includes the development of a qRT-PCR test for measuring miR-10b expression, which is critical for patient inclusion in the Phase 0 study [142]. - The company plans to continue preclinical studies and initiate clinical trials for TTX-MC138 and other product candidates [145]. - The company aims to expand its proprietary TTX platform to identify additional product candidates and acquire new intellectual property [151]. Financial Performance and Funding - As of March 31, 2022, the company had received gross proceeds of $31.0 million primarily from its IPO and convertible promissory notes, with no products approved for sale or revenue generated from product sales [143]. - The company incurred net losses of $3.5 million and $6.8 million for the three months ended March 31, 2022, and the year ended December 31, 2021, respectively, with an accumulated deficit of $13.8 million as of March 31, 2022 [144]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future [153]. - The company expects to receive an additional $2 million under the SBIR Award, although there is no guarantee of receipt, and believes current cash of $16.9 million will fund operations into Q1 2023 [150]. - The company may need substantial additional funding to support ongoing operations and pursue its business strategy, relying on equity sales, debt financing, or collaborations [148]. - The company expects to require additional capital for research, development, and commercialization efforts, raising substantial doubt about its ability to continue as a going concern [183]. - The company has incurred significant operating losses and does not expect to generate revenue from product sales for several years [178]. Expenses and Operational Costs - Research and development expenses are anticipated to increase significantly as the company commences planned clinical trials for TTX-MC138 and other product candidates [158]. - General and administrative expenses are expected to rise as the company increases headcount and prepares for potential commercial activities, including partnerships for product development [165]. - Research and development expenses increased by $1,618 thousand for the three months ended March 31, 2022, compared to the same period in 2021, primarily due to purchases of materials and personnel costs [172]. - General and administrative expenses rose by $1,410 thousand for the three months ended March 31, 2022, compared to the same period in 2021, mainly due to increased costs for liability insurance and personnel [173]. - The company anticipates substantial increases in expenses related to ongoing and planned activities, particularly for clinical trials of TTX-MC138 [180]. Operational Challenges and Impact - The COVID-19 pandemic has impacted the timeline for preclinical studies and clinical trials, contributing to operational disruptions [152]. - The company has engaged a European CMO for the manufacturing of TTX-MC138 and a CRO for IND-enabling studies, indicating progress in product development [159]. Internal Controls and Compliance - The company has identified material weaknesses in its internal control over financial reporting prior to its IPO, which remain unremediated [214]. - The company is classified as an "emerging growth company" and will remain so until it exceeds $1.07 billion in annual revenue or meets other specified criteria [215]. Cash Flow and Investments - Cash used in operating activities was $3,949 thousand for the three months ended March 31, 2022, compared to $522 thousand in the same period of 2021 [190]. - The net cash used in investing activities was $31 thousand for the three months ended March 31, 2022, a decrease from $75 thousand in the same period of 2021 [192]. - As of March 31, 2022, all shares of restricted stock have vested, resulting in no further compensation expense related to restricted stock [203]. Market and Risk Factors - The fair value of derivative liabilities was $0 for the three months ended March 31, 2022, compared to $3,936 thousand in the same period of 2021, as these liabilities were extinguished at the IPO [175]. - The company had no debt outstanding as of March 31, 2022, and therefore is not subject to interest rate risk related to outstanding debt [223]. - There were no foreign currency transaction gains or losses recognized for the three months ended March 31, 2022, and 2021 [224]. - An immediate 10% change in U.S. interest rates would not materially affect the fair market value of the company's investments [222]. - The company has not entered into any foreign currency hedging contracts to mitigate exposure to foreign currency exchange risk [225]. - The company intends to enhance its cybersecurity defenses in response to increasing threats from cyber-attacks [221]. - The company’s financial position and results of operations may be affected by fluctuations in foreign currency exchange rates as it continues to develop its business [225].

TransCode Therapeutics, Inc. (NASDAQ:RNAZ) Q4 2021 Earnings Conference Call April 7, 2022 4:30 PM ET Company Participants Alan Freidman - Vice President, Investor Relations Michael Dudley - Co-Founder, Chief Executive Officer, and Director Thomas Fitzgerald - Vice President and Chief Financial Officer Zdravka Medarova - Chief Technology Officer Conference Call Participants Operator Hello, thank you for standing by and welcome to the TransCode Therapeutics Conference Call. At this time, all participants are ...

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, 2021 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) ...

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's analysis of financial condition and operations, market risk disclosures, and an assessment of internal controls and procedures [Financial Statements](index=7&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) The unaudited financial statements for the period ended September 30, 2021, reflect improved financial position post-IPO, with increased cash and equity, despite widened operating losses due to R&D and G&A expenses - The company completed its IPO on July 13, 2021, raising approximately **$25.4 million** in net proceeds from issuing 7,187,500 common shares[37](index=37&type=chunk) - The IPO led to the conversion of all outstanding convertible promissory notes and accrued interest into 1,068,135 common shares, eliminating this debt[37](index=37&type=chunk)[97](index=97&type=chunk) [Selected Balance Sheet Data (Unaudited)](index=7&type=section&id=BALANCE%20SHEETS) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,499,856 | $828,016 | | Total assets | $25,359,852 | $1,055,368 | | Total liabilities | $2,204,732 | $4,463,600 | | Total stockholders' equity (deficit) | $23,155,120 | $(3,408,232) | [Statements of Operations Highlights (Unaudited)](index=8&type=section&id=STATEMENTS%20OF%20OPERATIONS) | Metric | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Research and development expense | $1,468,457 | $132,636 | | General and administrative expense | $1,696,444 | $214,967 | | **Operating loss** | **$(3,164,901)** | **$(347,603)** | | **Net loss** | **$(4,044,140)** | **$(1,542,362)** | | Net loss per share | $(0.58) | $(0.33) | [Statements of Stockholders' Equity (Deficit)](index=9&type=section&id=STATEMENTS%20OF%20STOCKHOLDERS'%20EQUITY%20(DEFICIT)) [Statements of Cash Flows](index=10&type=section&id=STATEMENTS%20OF%20CASH%20FLOWS) [Notes to Financial Statements (Unaudited)](index=11&type=section&id=NOTES%20TO%20FINANCIAL%20STATEMENTS%20(UNAUDITED)) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's RNA therapeutics strategy, focusing on lead candidate TTX-MC138 and plans for a Phase 0 trial, while noting increased operating expenses and sufficient cash post-IPO to fund operations through December 2022 - The lead therapeutic candidate, TTX-MC138, targets microRNA-10b (miR-10b), a key driver of metastasis in various solid tumors[139](index=139&type=chunk) - The company is shifting TTX-MC138's First-in-Human clinical strategy to a microdosing Phase 0 trial, targeting eIND submission in the first half of 2022 for precise drug delivery data[144](index=144&type=chunk)[145](index=145&type=chunk) - As of September 30, 2021, the company held **$22.5 million** in cash and equivalents, deemed sufficient to fund operations through December 2022[159](index=159&type=chunk)[198](index=198&type=chunk) [Comparison of Operating Expenses (in thousands)](index=187&type=chunk) | Expense Category | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | Change | | :--- | :--- | :--- | :--- | | Research and development | $1,468 | $133 | +$1,335 | | General and administrative | $1,696 | $215 | +$1,481 | | **Total operating expenses** | **$3,165** | **$348** | **+$2,817** | - Increased R&D expenses resulted from material purchases, compensation, license fees, and lab costs, while G&A expenses rose due to D&O insurance, compensation, and public company costs[188](index=188&type=chunk)[189](index=189&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company's market risk exposure is limited, with minimal interest rate risk due to cash holdings and no debt post-IPO, and immaterial foreign currency risk primarily from Euro-denominated purchases - Primary market risk is interest income sensitivity on cash balances, but a 10% interest rate change would not materially affect results due to short-term instruments[233](index=233&type=chunk) - The company is not subject to interest rate risk from debt, as all convertible promissory notes converted to common stock upon IPO[234](index=234&type=chunk) - Foreign exchange rate sensitivity exists, primarily with the Euro for certain purchases, but a 5% change would not materially affect results[235](index=235&type=chunk) [Controls and Procedures](index=43&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were ineffective as of September 30, 2021, due to an unremediated material weakness in internal control over financial reporting, with steps taken to mitigate cybersecurity risks - Disclosure controls and procedures were deemed ineffective as of September 30, 2021, due to an unremediated material weakness in internal control over financial reporting[240](index=240&type=chunk) - Following a July 2021 phishing attack, enhanced cybersecurity measures were implemented, including email screening, employee training, two-factor authentication, and revised payment verification[241](index=241&type=chunk) [PART II. OTHER INFORMATION](index=44&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section details the company's legal proceedings, comprehensive risk factors, and a list of exhibits filed with the quarterly report [Legal Proceedings](index=44&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently involved in any legal proceedings deemed to have a material adverse effect on its financial condition or operations - Management believes no pending claims or actions would materially adversely affect the company's results of operations or financial condition[242](index=242&type=chunk) [Risk Factors](index=44&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant risks including a history of losses, substantial funding needs for early-stage programs, high clinical development risks for TTX-MC138, reliance on third parties, intense competition, intellectual property challenges, and operational risks as a new public company with internal control weaknesses - The company has a history of significant losses, expects continued losses, and requires substantial additional funding to advance product candidates[244](index=244&type=chunk)[250](index=250&type=chunk) - Business success is highly dependent on the early-stage lead candidate, TTX-MC138, which faces significant preclinical and clinical development risks and potential failure[270](index=270&type=chunk) - Reliance on third parties for manufacturing, preclinical studies, and clinical trials poses risks, as their failure to perform could significantly delay or prevent product development and commercialization[370](index=370&type=chunk)[378](index=378&type=chunk) - Identified material weaknesses in internal control over financial reporting could hinder accurate or timely financial condition and results reporting[457](index=457&type=chunk) - Executive officers, directors, and principal stockholders hold significant influence, beneficially owning approximately **32.6%** of outstanding common stock as of November 12, 2021, potentially limiting other shareholders' influence[446](index=446&type=chunk) [Exhibits](index=98&type=section&id=ITEM%206.%20EXHIBITS) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, officer certifications, and XBRL-formatted financial statements - The report includes key corporate governance documents and officer certifications required under the Securities Exchange Act of 1934[514](index=514&type=chunk)

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, 2021 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 ...