Financial Data and Key Metrics Changes - The meeting discussed the election of directors and the approval of an amendment to the stock option plan, which included an increase of 166,724 shares available for issuance [4][7] - The appointment of Witham Smith and Brown P.C. as the independent registered public accounting firm for the fiscal year ending December 31, 2025, was ratified [7][8] Business Line Data and Key Metrics Changes - No specific financial data or metrics related to individual business lines were provided during the meeting [10] Market Data and Key Metrics Changes - No specific market data or metrics were discussed in the meeting [10] Company Strategy and Development Direction - The company is focused on advancing its Phase I clinical trial, which includes a wide range of tumor types [10] - Future announcements regarding specific results from the clinical trial are expected in September [11] Management's Comments on Operating Environment and Future Outlook - Management indicated that the trial is an all-comers clinical trial, allowing participation from patients with various solid tumors [10] - There is an ongoing interest in the company's clinical studies, with a total of 16 patients treated in the Phase I trial [11] Other Important Information - The meeting concluded with the acknowledgment of shareholder interest and the adjournment of the Annual Meeting of Stockholders [12] Q&A Session Summary Question: How many patients are currently undergoing Transcode clinical studies? How many have dropped out and for what reasons? Are there patients with demonstrated tumor regressions so far? - The company reported that a total of 16 patients have been treated in the Phase I clinical trial, with more details expected to be announced in September [10][11]

Financial Data and Key Metrics Changes - The meeting reported the election of directors and the approval of an amendment to the stock option plan, indicating a stable governance structure and potential for future growth [7][8]. Business Line Data and Key Metrics Changes - No specific financial data or metrics related to individual business lines were provided during the meeting [9]. Market Data and Key Metrics Changes - The company is currently conducting a Phase I clinical trial with a total of 16 patients treated, indicating ongoing research and development efforts in the market [10][11]. Company Strategy and Development Direction - The company is focused on advancing its clinical trials and plans to announce specific results in September, reflecting a commitment to transparency and progress in its research initiatives [11]. Management Comments on Operating Environment and Future Outlook - Management acknowledged the diverse range of tumor types represented in the clinical trial, suggesting a broad market approach and adaptability to various patient needs [10]. Other Important Information - The meeting concluded with a commitment to provide further details on clinical trial results in the near future, highlighting the company's proactive communication strategy [11]. Q&A Session Summary Question: How many patients are currently undergoing Transcode clinical studies? - The company reported that 16 patients have been treated in the Phase I clinical trial, with more details expected to be announced in September [10][11].

Financial Data and Key Metrics Changes - The meeting reported the election of directors and the approval of an amendment to the stock option plan, indicating a stable governance structure and potential for future growth [7][8]. Business Line Data and Key Metrics Changes - No specific financial data or metrics related to individual business lines were provided during the meeting [9]. Market Data and Key Metrics Changes - The company is currently conducting a Phase I clinical trial with a total of 16 patients treated, indicating ongoing engagement in clinical research [10][11]. Company Strategy and Development Direction - The company is focused on advancing its clinical trials and plans to announce specific results in September, reflecting a commitment to transparency and progress in research [11]. Management Comments on Operating Environment and Future Outlook - Management acknowledged the diverse range of tumor types represented in the clinical trial, suggesting a broad market approach and adaptability in research [10]. - Future announcements regarding trial results are anticipated, which may impact investor sentiment and market perception [11]. Other Important Information - The meeting concluded with a focus on shareholder engagement and the importance of upcoming trial results, highlighting the company's commitment to its stakeholders [12]. Q&A Session Summary Question: How many patients are currently undergoing Transcode clinical studies? - The company reported that 16 patients have been treated in the Phase I clinical trial, with more details expected in September [10][11]. Question: How many have dropped out and for what reasons? Are there patients with demonstrated tumor regressions so far? - The company did not provide specific dropout rates or reasons but confirmed that the trial is open to a wide range of tumor types, indicating a comprehensive approach to patient selection [10].

PART I. FINANCIAL INFORMATION [ITEM 1. FINANCIAL STATEMENTS](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited financial statements for TransCode Therapeutics, Inc. for the periods ended June 30, 2025, and December 31, 2024, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the company's accounting policies, financial instruments, and significant events [BALANCE SHEETS](index=4&type=section&id=BALANCE%20SHEETS%20AS%20OF%20JUNE%2030%2C%202025%20%28UNAUDITED%29%20AND%20DECEMBER%2031%2C%202024) The balance sheets show a significant increase in total assets and a shift from a stockholders' deficit to positive equity, primarily driven by new equity issuances and the exercise of Series D warrants, while total liabilities decreased substantially due to the exercise of Series D warrant liabilities Balance Sheet Summary | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :-------------------------- | :------------------ | | **Assets** | | | | Cash | $7,374,815 | $5,811,064 | | Total current assets | $8,241,721 | $7,093,338 | | Total assets | $8,266,410 | $7,294,499 | | **Liabilities and Stockholders' Equity (Deficit)** | | | | Total current liabilities | $1,564,990 | $2,771,836 | | Warrant Liability - Series C | $553,714 | $517,871 | | Warrant Liability - Series D | $0 | $6,023,526 | | Total liabilities | $2,118,704 | $9,313,233 | | Total stockholders' equity (deficit) | $6,147,706 | $(2,018,734) | | Accumulated deficit | $(79,563,831) | $(63,201,916) | - On May 15, 2025, the Company effected a reverse stock split at a ratio of one share for every 28 shares previously held, retroactively adjusting all common stock share and per share data[17](index=17&type=chunk)[20](index=20&type=chunk) [STATEMENTS OF OPERATIONS](index=5&type=section&id=STATEMENTS%20OF%20OPERATIONS%20FOR%20THE%20THREE%20AND%20SIX%20MONTHS%20ENDED%20JUNE%2030%2C%202025%20AND%202024%20%28UNAUDITED%29) The company reported increased net losses for the six months ended June 30, 2025, primarily due to a significant non-cash change in the fair value of warrant liabilities, despite reductions in operating expenses and an increase in grant income Statements of Operations Summary | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $2,565,982 | $3,081,577 | $4,785,509 | $4,840,597 | | General and administrative | $1,655,152 | $2,032,339 | $2,606,804 | $3,562,301 | | Total operating expenses | $4,221,134 | $5,113,916 | $7,392,313 | $8,402,898 | | Operating loss | $(4,221,134) | $(5,113,916) | $(7,392,313) | $(8,402,898) | | Change in fair value of warrant liabilities | $(161,714) | $0 | $(9,396,636) | $0 | | Grant income | $153,685 | $0 | $501,529 | $27,057 | | Net loss attributable to common stockholders | $(4,276,502) | $(5,190,814) | $(16,361,915) | $(8,517,626) | | Net loss per share (basic and diluted) | $(5.13) | $(680.23) | $(32.45) | $(1,290.94) | - The significant increase in net loss for the six months ended June 30, 2025, was primarily driven by a **$9.4 million non-cash change in the fair value of warrant liabilities**[19](index=19&type=chunk) - Operating expenses decreased for both the three and six months ended June 30, 2025, compared to 2024, reflecting cost management efforts[19](index=19&type=chunk) [STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)](index=6&type=section&id=STATEMENTS%20OF%20STOCKHOLDERS%27%20EQUITY%20%28DEFICIT%29%20FOR%20THE%20THREE%20MONTHS%20AND%20SIX%20MONTHS%20ENDED%20JUNE%2030%2C%202025%20AND%202024%20%28UNAUDITED%29) The company transitioned from a stockholders' deficit to positive equity by June 30, 2025, largely due to significant issuances of common stock and the exercise of Series D warrants, which substantially increased additional paid-in capital Stockholders' Equity (Deficit) Summary | Metric | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :------------------ | :-------------------------- | | Common Stock (shares) | 36,753 | 833,683 | | Common Stock (amount) | $4 | $84 | | Additional Paid-In Capital | $61,183,178 | $85,711,453 | | Accumulated Deficit | $(63,201,916) | $(79,563,831) | | Total Stockholders' Equity (Deficit) | $(2,018,734) | $6,147,706 | - Issuances of common stock and exercise of Series D warrants contributed **$8,854,797** and **$15,384,319**, respectively, to additional paid-in capital during the six months ended June 30, 2025[22](index=22&type=chunk) - The company's accumulated deficit increased to **$79.6 million** by June 30, 2025, reflecting ongoing net losses[22](index=22&type=chunk) [STATEMENTS OF CASH FLOWS](index=7&type=section&id=STATEMENTS%20OF%20CASH%20FLOWS%20FOR%20THE%20SIX%20MONTHS%20ENDED%20JUNE%2030%2C%202025%20AND%202024%20%28UNAUDITED%29) Cash used in operating activities increased for the six months ended June 30, 2025, compared to the prior year, but was offset by significant cash provided by financing activities, leading to a net increase in cash Cash Flow Summary | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(7,291,046) | $(6,276,995) | | Net cash used in investing activities | $0 | $(8,391) | | Net cash provided by financing activities | $8,854,797 | $6,872,339 | | Net change in cash | $1,563,751 | $586,953 | | Cash, end of period | $7,374,815 | $3,354,551 | - Net cash used in operating activities increased by approximately **$1 million** year-over-year, primarily due to the higher net loss, partially offset by non-cash adjustments like the change in fair value of warrant liabilities[25](index=25&type=chunk)[213](index=213&type=chunk) - Financing activities provided **$8.85 million** in cash in 2025, up from **$6.87 million** in 2024, mainly from equity security sales[25](index=25&type=chunk)[216](index=216&type=chunk) [NOTES TO FINANCIAL STATEMENTS](index=8&type=section&id=NOTES%20TO%20FINANCIAL%20STATEMENTS%20%28UNAUDITED%29) The notes provide detailed explanations of the company's financial position, operations, and cash flows, including its nature of business, significant accounting policies, fair value measurements, and commitments, highlighting its status as a clinical-stage biopharmaceutical company with ongoing losses and a need for additional capital [ (1) Nature of Business and Liquidity](index=12&type=section&id=%281%29%20Nature%20of%20Business%20and%20Liquidity) TransCode Therapeutics is a clinical-stage biopharmaceutical company focused on developing cancer drugs, primarily TTX-MC138. The company has not generated revenue, incurred substantial losses, and expects to require additional capital to fund operations beyond Q4 2025, raising substantial doubt about its ability to continue as a going concern - TransCode Therapeutics is a clinical-stage biopharmaceutical company developing innovative drugs for treating cancer, with TTX-MC138 as its lead therapeutic candidate[28](index=28&type=chunk) - The company has not generated revenues, achieved profitable operations, or positive cash flows from operations since inception[29](index=29&type=chunk) - Management believes existing cash of **$7.4 million** at June 30, 2025, is sufficient to fund operations into Q4 2025 but not for a full 12 months, indicating a need for additional capital and raising substantial doubt about its ability to continue as a going concern[30](index=30&type=chunk)[33](index=33&type=chunk)[36](index=36&type=chunk) [ (2) Summary of Significant Accounting Policies](index=14&type=section&id=%282%29%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the company's key accounting policies, including basis of presentation, use of estimates, loss per share calculation, cash management, fair value measurements, expensing of R&D costs, grant income recognition, share-based compensation, property and equipment depreciation, income taxes, emerging growth company status, reverse stock splits, collaboration agreements, leases, and warrant accounting, along with recent accounting pronouncements - R&D costs are expensed as incurred, including personnel, share-based compensation, materials, and third-party vendor costs[44](index=44&type=chunk) - Grant income is recognized as earned for specific R&D projects, with payments received in excess of earned income recorded as deferred grant income[48](index=48&type=chunk) - Warrants are classified as equity or liability based on specific terms and accounting guidance, with changes in fair value for liability-classified warrants recognized in the statements of operations[68](index=68&type=chunk)[69](index=69&type=chunk) - The company is an 'emerging growth company' and has elected the extended transition period for complying with new or revised accounting standards[57](index=57&type=chunk) [ (3) Fair Value Measurements](index=23&type=section&id=%283%29%20Fair%20Value%20Measurements) The company classifies fair value measurements into Level 1, 2, or 3, with warrant liabilities (Series C and D) being Level 3 due to significant unobservable inputs. The fair value of Series D warrants decreased to zero by June 30, 2025, due to exercise, while Series C warrants increased slightly - Warrant liabilities for the December 2, 2024 PIPE transaction are classified as Level 3 fair value measurements, using a Monte Carlo simulation model for valuation at December 31, 2024, and a Black-Scholes model at June 30, 2025[79](index=79&type=chunk)[80](index=80&type=chunk) Warrant Liability Fair Value | Metric | December 31, 2024 | June 30, 2025 | | :-------------------------- | :------------------ | :-------------------------- | | Warrant Liability - Series C | $517,871 | $553,714 | | Warrant Liability - Series D | $6,023,526 | $0 | | Total Warrant Liability | $6,541,397 | $553,714 | - The fair value of Series D warrants decreased to **zero** by June 30, 2025, due to their exercise, while Series C warrants increased by **$35,843**[82](index=82&type=chunk) [ (4) Prepaid Expenses and Other Current Assets](index=25&type=section&id=%284%29%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid expenses and other current assets significantly decreased from December 31, 2024, to June 30, 2025, primarily due to reductions in amounts prepaid to contract manufacturers and research organizations, as well as insurance premiums and prepaid FICA Prepaid Expenses and Other Current Assets | Category | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :-------------- | :------------------ | | Prepaid operating expenses | $34,368 | $31,563 | | Contract manufacturers and research organizations | $241,513 | $517,484 | | Insurance premiums | $56,404 | $310,735 | | Prepaid FICA | $358,499 | $422,492 | | Total | $690,784 | $1,282,274 | [ (5) Property and Equipment](index=25&type=section&id=%285%29%20Property%20and%20Equipment) Net property and equipment decreased by approximately 52% from December 31, 2024, to June 30, 2025, due to ongoing depreciation, with no new equipment purchases in the first half of 2025 Property and Equipment, Net | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :------------------ | | Laboratory and computer equipment | $362,387 | $362,387 | | Less accumulated depreciation | $(337,698) | $(310,813) | | Total property and equipment, net | $24,689 | $51,574 | - Depreciation expense for the six months ended June 30, 2025, was **$26,885**, a decrease from **$64,517** in the same period of 2024[84](index=84&type=chunk) [ (6) Accounts Payable and Accrued Expenses](index=26&type=section&id=%286%29%20Accounts%20Payable%20and%20Accrued%20Expenses) Accounts payable and accrued expenses decreased significantly by approximately 42% from December 31, 2024, to June 30, 2025, primarily driven by reductions in professional and general consulting fees and R&D-related payables Accounts Payable and Accrued Expenses | Category | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :-------------- | :------------------ | | Professional and general consulting fees | $211,689 | $1,282,428 | | R&D-related – CMOs, CROs, supplies, equipment and consulting | $1,107,158 | $1,148,917 | | Payroll and benefits | $187,322 | $131,342 | | Total | $1,564,990 | $2,708,137 | - Outstanding payables to CROs or CMOs decreased from **$997,074** at December 31, 2024, to **$542,695** at June 30, 2025[86](index=86&type=chunk) [ (7) Grant Income](index=26&type=section&id=%287%29%20Grant%20Income) Grant income increased substantially in the first half of 2025 due to a new $2 million Direct to Phase II SBIR Award received in September 2024 from the National Cancer Institute, supporting IND-enabling and clinical trial activities for TTX-MC138 - The company received a **$1,999,972** Direct to Phase II SBIR Award in September 2024 to support IND-enabling and clinical trial activities for TTX-MC138 over two years[88](index=88&type=chunk) Grant Income | Period | Grant Income | | :----------------------------- | :------------- | | Three months ended June 30, 2025 | $153,685 | | Three months ended June 30, 2024 | $0 | | Six months ended June 30, 2025 | $501,529 | | Six months ended June 30, 2024 | $27,057 | [ (8) Commitments and Contingencies](index=26&type=section&id=%288%29%20Commitments%20and%20Contingencies) The company's commitments include an operating lease for office space, license agreements for intellectual property with Massachusetts General Hospital, and a collaboration agreement with MD Anderson Cancer Center, which was amended to focus solely on clinical trial participation, relieving the company of a $10 million funding obligation [ (a) Operating Lease](index=26&type=section&id=%28a%29%20Operating%20Lease) The company terminated its sublease for laboratory and office space in Newton, Massachusetts, on January 31, 2025, and relocated to a short-term office rental space in Woburn, Massachusetts, resulting in significantly reduced rent expense - The company's sublease for **4,837 sq ft** of lab and office space in Newton, MA, terminated on January 31, 2025[90](index=90&type=chunk) - Rent expense decreased from **$38,480** for Q2 2024 to **$11,715** for Q2 2025, and from **$147,964** for H1 2024 to **$57,278** for H1 2025[91](index=91&type=chunk) [ (b) License Agreements](index=27&type=section&id=%28b%29%20License%20Agreements) The company holds exclusive licenses for intellectual property from Massachusetts General Hospital, involving annual fees, milestone payments up to $1.55 million, and royalties on net sales. No milestone events had been achieved as of June 30, 2025 - The company licensed exclusive rights to intellectual property from Massachusetts General Hospital in November 2018, amended in November 2020 to include Patent Family 1 (nanoparticle technology) and Patent Family 2 (PD-L1 targeting)[93](index=93&type=chunk)[98](index=98&type=chunk) - Milestone payments under the license agreement could total up to **$1,550,000** upon achievement of specific clinical and regulatory events, with royalties of **3.0%** for therapeutic products and **6.0%** for diagnostic products[94](index=94&type=chunk)[95](index=95&type=chunk)[96](index=96&type=chunk) - As of June 30, 2025, no milestone events had been achieved, and accrued license payments were **$14,868**[95](index=95&type=chunk)[102](index=102&type=chunk) [ (c) Collaboration Agreement](index=29&type=section&id=%28c%29%20Collaboration%20Agreement) The strategic collaboration agreement with MD Anderson Cancer Center was amended in late 2024, relieving the company of a $10 million funding obligation and focusing MD Anderson's role solely on participation in the company's Phase I/II clinical trial. Initial clinical trial expenses are being charged against a $250,000 prepaid amount - The collaboration agreement with MD Anderson Cancer Center was amended to focus solely on MD Anderson's participation in the company's Phase I/II clinical trial, removing the obligation to fund up to **$10 million**[103](index=103&type=chunk) - Initial clinical trial expenses of **$138,439** for the six months ended June 30, 2025, were charged against a **$250,000** initial payment made to MD Anderson[103](index=103&type=chunk) [ (d) Employment Agreements](index=29&type=section&id=%28d%29%20Employment%20Agreements) Executive officers have employment agreements providing severance payments upon certain terminations, with maximum aggregate severance payments of approximately $1,296,000 in the event of a Change of Control - Executive employment agreements include severance payments, with a maximum aggregate of approximately **$1,296,000** in the event of a Change of Control[104](index=104&type=chunk) [ (e) Litigation](index=29&type=section&id=%28e%29%20Litigation) The company is not currently a party to any legal proceedings that would have a material adverse effect on its business, except for disputed claims by an investment bank regarding fees - The company is not aware of any material legal claims or actions pending or threatened, except for disputed claims by an investment bank for fees[105](index=105&type=chunk) [ (f) Indemnification Agreements](index=30&type=section&id=%28f%29%20Indemnification%20Agreements) The company provides indemnification to vendors, business partners, and its directors and executive officers, with maximum potential payments often unlimited. No costs have been incurred to date, and no liabilities accrued as of June 30, 2025 - The company provides indemnification to various parties, including directors and officers, with potentially unlimited future payments, but has not incurred any costs or accrued liabilities related to these obligations[107](index=107&type=chunk) [ (g) Risks and Uncertainties](index=30&type=section&id=%28g%29%20Risks%20and%20Uncertainties) Geopolitical events (e.g., wars in Ukraine and the Middle East) and major health issues (e.g., SARS-CoV-2) introduce significant uncertainties that could delay plans, increase operating expenses, and materially adversely affect the company's financial position, results of operations, or cash flows - Geopolitical events and health issues create high uncertainty, potentially delaying company plans, increasing operating expenses, and materially adversely affecting financial performance[108](index=108&type=chunk) [ (9) Stockholders' Equity (Deficit)](index=30&type=section&id=%289%29%20Stockholders%27%20Equity%20%28Deficit%29) The company's authorized common stock is 290,000,000 shares, with 833,683 shares outstanding at June 30, 2025. Recent equity financings in January, July, and December 2024, and March 2025, involved the issuance of common stock, pre-funded warrants, and various Series C and D warrants, significantly increasing outstanding shares and capital [ (a) Overview](index=30&type=section&id=%28a%29%20Overview) The company's authorized common stock is 290,000,000 shares, with 833,683 shares outstanding at June 30, 2025. Recent equity financings in January, July, and December 2024, and March 2025, involved the issuance of common stock, pre-funded warrants, and various Series C and D warrants, significantly increasing outstanding shares and capital - As of June 30, 2025, the company had **833,683 shares** of common stock outstanding, compared to **36,753 shares** at December 31, 2024, following multiple reverse stock splits[109](index=109&type=chunk) - The January 2024 Registered Direct Offering (RDO) raised approximately **$6.1 million** net proceeds, involving common stock, PFWs, and warrants[110](index=110&type=chunk) - The March 2025 Offering raised approximately **$8.9 million** net proceeds from the sale of **366,072 shares** of common stock and accompanying warrants[114](index=114&type=chunk) [ (b) Common Stock](index=32&type=section&id=%28b%29%20Common%20Stock) Holders of common stock are entitled to one vote per share and receive dividends as declared by the Board, though no cash dividends have been paid. Upon liquidation, remaining assets are distributed to common stockholders, subject to preferred stock rights - No cash dividends were declared or paid on common stock during the six months ended June 30, 2025, or at any other time[115](index=115&type=chunk) - Common stockholders are entitled to one vote per share and receive remaining assets upon liquidation, subject to preferred stock rights[116](index=116&type=chunk)[118](index=118&type=chunk) [ (10) Warrants](index=34&type=section&id=%2810%29Warrants) The company has various outstanding warrants, including IPO Underwriter Warrants, Placement Agent Warrants from multiple offerings, Consultant Warrants, and Series A-1/A-2 Warrants. The Series C and D Warrants from the December 2024 PIPE transaction were initially classified as liabilities, but all Series D warrants were exercised in the first half of 2025 - The company has numerous outstanding warrants from various offerings and agreements, including IPO Underwriter Warrants, Placement Agent Warrants, and Series A-1/A-2 Warrants[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk)[128](index=128&type=chunk)[130](index=130&type=chunk) - The Series C and Series D Warrants from the December 2024 PIPE transaction became exercisable on February 25, 2025, with Series D warrants including a cashless exchange provision[113](index=113&type=chunk)[129](index=129&type=chunk) - All Series D warrants were exercised during the six months ended June 30, 2025, representing **425,895 shares** after reset adjustments[132](index=132&type=chunk) Outstanding Warrants | Description | Number of Shares | Exercise Price Per Share | | :-------------------------------- | :--------------- | :----------------------- | | IPO Underwriter Warrants | 1 | $3,696,000 | | February 2023 Placement Agent Warrants | 1 | $486,948 | | February 2023 Consultant Warrants | 1 | $369,600 | | June 2023 Series A-1 warrants | 55 | $348.35 | | June 2023 Series A-2 warrants | 55 | $348.35 | | June 2023 Placement Agent Warrants | 4 | $161,700.00 | | September 2023 Underwriter Warrants | 23 | $23,562.00 | | October 2023 Underwriter Overallotment Warrants | 1 | $23,562.00 | | December 2023 Placement Agent Warrants | 9 | $11,180.40 | | January 2024 Warrants | 6,745 | $1,127.28 | | January 2024 Warrants | 5,422 | $438.90 | | January 2024 Placement Agent Warrants | 386 | $1,409.10 | | July 2024 Placement Agent Warrants | 542 | $346.50 | | December 2024 Series C Warrants | 144,678 | $69.67 | | March 2025 Offering Warrants | 366,072 | $24.08 | | March 2025 Placement Agent Warrants | 18,304 | $29.96 | [ (11) Share-Based Compensation](index=38&type=section&id=%2811%29%20Share-Based%20Compensation) The company has two stock option and incentive plans (2020 and 2021 Plans) for granting equity awards. Share-based compensation expense decreased significantly in the first half of 2025 compared to 2024, with no options granted in the current period - The 2021 Plan allows for grants of equity awards to employees, directors, officers, and consultants, with **2,029 options** outstanding at June 30, 2025[134](index=134&type=chunk)[135](index=135&type=chunk)[137](index=137&type=chunk) Share-Based Compensation Expense | Period | Share-Based Compensation Expense | | :----------------------------- | :------------------------------- | | Three months ended June 30, 2025 | $131,510 | | Three months ended June 30, 2024 | $1,143,595 | | Six months ended June 30, 2025 | $289,239 | | Six months ended June 30, 2024 | $1,326,747 | - No options were granted in the six months ended June 30, 2025[139](index=139&type=chunk) [ (12) Employee Stock Purchase Plan](index=39&type=section&id=%2812%29%20Employee%20Stock%20Purchase%20Plan) The company adopted an Employee Stock Purchase Plan (ESPP) in 2021, which allows eligible employees to purchase common stock, with the number of available shares increasing annually - The ESPP, adopted in 2021, allows eligible employees to purchase common stock, with the number of available shares increasing by approximately **three shares** annually[141](index=141&type=chunk) [ (13) Net Loss per Share](index=39&type=section&id=%2813%29%20Net%20Loss%20per%20Share) The company reported net losses for both periods, resulting in basic and diluted net loss per share being the same due to the antidilutive effect of contingent securities. The net loss per share significantly decreased in 2025 compared to 2024, primarily due to a higher weighted-average common shares outstanding Net Loss per Share | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss attributable to common stockholders | $(4,276,502) | $(5,190,814) | $(16,361,915) | $(8,517,626) | | Weighted-average common shares outstanding | 833,654 | 7,631 | 504,252 | 6,598 | | Net loss per share | $(5.13) | $(680.23) | $(32.45) | $(1,290.94) | - Basic and diluted net loss per share are identical because contingent securities were excluded due to their antidilutive effect[142](index=142&type=chunk) [ (14) Income Taxes](index=41&type=section&id=%2814%29%20Income%20Taxes) The company reported no income tax benefit or expense for the six months ended June 30, 2025 and 2024, due to a full valuation allowance against its net deferred tax assets, reflecting historical net operating losses and uncertainty of realization - No income tax benefit or expense was recognized for the six months ended June 30, 2025 and 2024[145](index=145&type=chunk) - A full valuation allowance is maintained against net deferred tax assets due to historical net operating losses, indicating that realization of these assets is not more likely than not[145](index=145&type=chunk) [ (15) Segment Reporting](index=41&type=section&id=%2815%29%20Segment%20Reporting) The company operates as a single reportable business unit segment, RNA drug development, and one reportable country segment, the United States of America, as determined by its chief operating decision maker - The company operates in a single reportable segment: RNA drug development, with all long-lived assets located in the United States[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) [ (16) Subsequent Events](index=41&type=section&id=%2816%29%20Subsequent%20Events) The company evaluated subsequent events through August 14, 2025, and determined that no events warranted recognition or disclosure in the financial statements - No subsequent events requiring recognition or disclosure were identified through August 14, 2025[151](index=151&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=42&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on the company's financial condition and operational results, detailing its business overview, therapeutic development, recent developments including clinical trials and financing, and a comprehensive analysis of operating expenses, other income/expense, cash flows, and liquidity, emphasizing the need for additional capital and ongoing cost management [Company Overview](index=42&type=section&id=Company%20Overview) TransCode Therapeutics is a biopharmaceutical company focused on oncology, developing RNA therapeutics using its proprietary TTX delivery mechanism. Its lead candidate, TTX-MC138, targets microRNA-10b for metastatic cancers, and the company commenced a Phase I/II clinical trial in Q3 2024 - TransCode is an oncology-focused biopharmaceutical company developing RNA therapeutics using its proprietary TTX delivery mechanism[153](index=153&type=chunk)[155](index=155&type=chunk) - The lead therapeutic candidate, TTX-MC138, targets microRNA-10b, a regulator of metastatic cell viability in various cancers[153](index=153&type=chunk) - A Phase I/II clinical trial for TTX-MC138 commenced in Q3 2024, following an IND Study May Proceed notification from the FDA[153](index=153&type=chunk) [Targeted Therapeutic Delivery Background](index=42&type=section&id=Targeted%20Therapeutic%20Delivery%20Background) The company's TTX platform is designed to overcome delivery challenges of RNA therapeutics by using a modular design with iron oxide nanoparticles, optimizing targeting and accumulation in tumors while minimizing issues faced by existing lipid-based platforms - RNA-based therapeutics offer high selectivity and applicability to undruggable targets, but delivery into cells has been a major challenge[156](index=156&type=chunk) - The TTX platform uses a modular design with tunable iron oxide nanoparticles to deliver therapeutic oligonucleotides, overcoming stability, efficiency, and immunogenicity issues of other platforms[157](index=157&type=chunk)[158](index=158&type=chunk) [TTX Delivery System](index=44&type=section&id=TTX%20Delivery%20System) The TTX nanocarrier, developed over 20 years, is designed to safely and effectively deliver therapeutic oligonucleotides to tumors and metastases. Its properties, including small hydrodynamic size, charge, and magnetic iron core, enable efficient accumulation, distribution, and uptake by cancer cells, differentiating it from liver-targeting competitive approaches - The TTX nanocarrier is designed to deliver therapeutic oligonucleotides to tumors and metastases without compromising integrity, a result of approximately **20 years of R&D**[161](index=161&type=chunk)[162](index=162&type=chunk) - TTX nanocarriers minimize early kidney and liver clearance, leading to a long circulation half-life and efficient accumulation in tumors, unlike lipid-based approaches that target the liver[162](index=162&type=chunk)[163](index=163&type=chunk) - The magnetic iron core allows for MRI visibility and quantification of delivery, and its physicochemical properties facilitate rapid tumor uptake by exploiting cancer cells' high metabolic activity[164](index=164&type=chunk)[165](index=165&type=chunk) [Advancing new RNA therapies through a modular approach](index=44&type=section&id=Advancing%20new%20RNA%20therapies%20through%20a%20modular%20approach) Research published in Cancer Nanotechnology demonstrated that radiolabeled TTX-MC138 accumulates in metastatic lesions, supporting its clinical evaluation. This microdosing PET-MRI approach offers advantages in early drug development by precisely quantifying drug delivery, assessing pharmacokinetics, and informing clinical trial designs - Research published in Cancer Nanotechnology in September 2021 showed that radiolabeled TTX-MC138 accumulates in metastatic lesions, supporting its clinical evaluation[166](index=166&type=chunk) - The microdosing PET-MRI approach allows for precise quantification of TTX-MC138 delivery, measurement of pharmacokinetics and biodistribution, and informs dosing and patient inclusion criteria for clinical trials[166](index=166&type=chunk)[168](index=168&type=chunk)[171](index=171&type=chunk) [SBIR Awards](index=46&type=section&id=SBIR%20Awards) The company received a Fast-Track SBIR Award in April 2021, which concluded in March 2024, successfully achieving aims related to miR-10b expression measurement, IND filing for TTX-MC138, and imaging uptake in breast cancer patients. A second Direct to Phase II SBIR Award of nearly $2 million was received in September 2024 to support ongoing clinical trial activities - A Fast-Track SBIR Award from the National Cancer Institute, totaling approximately **$2.4 million**, funded a research partnership with Massachusetts General Hospital from April 2021 to March 2024[169](index=169&type=chunk) - The company achieved all three aims of the 2021 SBIR: optimizing miR-10b measurement, filing an IND for TTX-MC138, and using imaging to determine uptake in metastatic breast cancer patients[170](index=170&type=chunk)[171](index=171&type=chunk) - A second Direct to Phase II SBIR Award of **$1,999,972** was received in September 2024 to support IND-enabling and clinical trial activities for TTX-MC138 over two years[171](index=171&type=chunk)[173](index=173&type=chunk) [Recent Developments](index=48&type=section&id=Recent%20Developments) Recent developments include the commencement of a Phase I/II clinical trial for TTX-MC138, a successful March 2025 equity financing raising $8.9 million, regaining compliance with Nasdaq listing rules, and further restructuring efforts to manage costs, including relocating operations and reducing headcount [Phase 1 Clinical Trial](index=48&type=section&id=Phase%201%20Clinical%20Trial) The FDA approved the company's IND application for a Phase I/II clinical trial of TTX-MC138, which commenced in Q3 2024. Preliminary data from cohorts 1-4 show no significant safety or dose-limiting toxicities, with PK and PD data consistent with preclinical results - The FDA approved the IND application for a Phase I/II clinical trial of TTX-MC138 on April 15, 2024, with the trial commencing in Q3 2024 at MD Anderson and three other sites[174](index=174&type=chunk) - Preliminary data from Cohorts 1, 2, 3, and 4 indicate no significant safety or dose-limiting toxicities, and PK/PD data are consistent with preclinical and Phase 0 results[174](index=174&type=chunk) [March 2025 Equity Financing](index=48&type=section&id=March%202025%20Equity%20Financing) On March 23, 2025, the company closed a registered direct offering, issuing 366,072 shares of common stock and accompanying warrants, generating approximately $8.9 million in gross proceeds - The March 2025 Offering closed on March 25, 2025, raising approximately **$10 million** in gross proceeds (approx. **$8.9 million** net) from the sale of **366,072 shares** of common stock and warrants[175](index=175&type=chunk) - Common Warrants are exercisable from March 25, 2025, to March 25, 2030, at an exercise price of **$24.08 per share**[176](index=176&type=chunk) [Nasdaq Listing](index=48&type=section&id=Nasdaq%20Listing) As of June 2, 2025, the company was deemed in compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum closing bid price of $1.00 per share, ensuring its continued listing on the Nasdaq - On June 2, 2025, the company regained compliance with Nasdaq Listing Rule 5550(a)(2) regarding the minimum **$1.00 bid price**, ensuring continued listing[177](index=177&type=chunk) [Further Restructuring](index=50&type=section&id=Further%20Restructuring) In an effort to manage costs, the company terminated its sublease, plans to conduct R&D with Michigan State University, reduced headcount to seven employees, and relocated business activities to short-term office rental space - The company terminated its sublease, plans R&D activities with Michigan State University, reduced headcount to **seven employees**, and relocated to short-term office space to manage costs[178](index=178&type=chunk) [Financial Operations Overview](index=50&type=section&id=Financial%20Operations%20Overview) Since inception, the company has focused on R&D and capital raising, incurring significant operating losses and generating no product revenue. It expects expenses to increase with clinical trials and product development, necessitating substantial additional funding, which may involve equity/debt sales or strategic partnerships, with a risk of total loss for investors if funding is not secured - The company has incurred significant operating losses since inception, with net losses of approximately **$16.4 million** and **$8.5 million** for the six months ended June 30, 2025 and 2024, respectively[180](index=180&type=chunk) - As of June 30, 2025, the accumulated deficit was approximately **$79.6 million**[180](index=180&type=chunk) - The company expects expenses and capital requirements to increase substantially with ongoing preclinical studies, clinical trials, and pipeline development, requiring substantial additional funding[180](index=180&type=chunk)[182](index=182&type=chunk) [Components of our results of operations](index=52&type=section&id=Components%20of%20our%20results%20of%20operations) This section details the components of the company's financial results, including the absence of product revenue, the nature of operating expenses (R&D and G&A), and other income/expense items like warrant liability changes and grant income. It provides a comparative analysis of these components for the three and six months ended June 30, 2025 and 2024, highlighting key changes and their drivers [Revenue](index=52&type=section&id=Revenue) The company has not generated any revenue from product sales or other sources to date and does not anticipate doing so in the foreseeable future, with future revenue dependent on successful product development and regulatory approval - The company has not generated any revenue from product sales or other sources since inception and does not expect to in the foreseeable future[179](index=179&type=chunk)[187](index=187&type=chunk) [Operating expenses](index=54&type=section&id=Operating%20expenses) Operating expenses consist of R&D and G&A costs. R&D expenses, expensed as incurred, include preclinical, clinical, manufacturing, and personnel costs, and are expected to increase significantly with advanced clinical development. G&A expenses, including staffing, insurance, and professional fees, are also anticipated to rise to support R&D and public company operations - R&D expenses are expensed as incurred and include costs for preclinical and clinical development, manufacturing, CROs/CMOs, materials, licensing fees, and personnel[188](index=188&type=chunk)[190](index=190&type=chunk) - R&D expenses are expected to increase substantially in the coming years due to additional manufacturing, clinical trials for TTX-MC138, and other development activities[191](index=191&type=chunk) - G&A expenses primarily cover staffing, insurance, professional fees (legal, patent, accounting), and corporate overhead, and are expected to increase to support R&D and public company operations[196](index=196&type=chunk)[197](index=197&type=chunk) [Other income (expense)](index=60&type=section&id=Other%20income%20%28expense%29) Other income (expense) includes changes in the fair value of warrant liabilities, grant income, currency exchange gains/losses, and interest income/expense. Interest expense has decreased significantly since convertible promissory notes converted to common stock, while grant income has become a more notable component - Interest expense has significantly decreased as convertible promissory notes converted to common stock[200](index=200&type=chunk) - Grant income is recognized as earned from government and other grants, with no assurance of future awards or full funding[202](index=202&type=chunk) [Results of operations (Comparison)](index=61&type=section&id=Results%20of%20operations) For the six months ended June 30, 2025, the company experienced a larger net loss primarily due to a significant non-cash change in warrant liability fair value, despite reductions in R&D and G&A expenses and an increase in grant income Results of Operations (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (in thousands) | | :----------------------------------- | :------------------------------- | :------------------------------- | :-------------------- | :----------------------------- | :----------------------------- | :-------------------- | | Research and development | $2,566 | $3,081 | $(515) | $4,786 | $4,841 | $(55) | | General and administrative | $1,655 | $2,032 | $(377) | $2,607 | $3,562 | $(955) | | Total operating expenses | $4,221 | $5,113 | $(892) | $7,393 | $8,403 | $(1,010) | | Operating loss | $(4,221) | $(5,113) | $892 | $(7,393) | $(8,403) | $1,010 | | Change in fair value of warrant liability | $(162) | $0 | $(162) | $(9,397) | $0 | $(9,397) | | Grant income | $154 | $0 | $154 | $502 | $27 | $475 | | Net loss | $(4,276) | $(5,190) | $914 | $(16,362) | $(8,518) | $(7,844) | - R&D expenses decreased by **$55 thousand** for the six months ended June 30, 2025, primarily due to reduced compensation and material costs, partially offset by increased clinical trial spending[205](index=205&type=chunk) - G&A expenses decreased by **$955 thousand** for the six months ended June 30, 2025, mainly due to reductions in insurance, legal fees, and corporate taxes[206](index=206&type=chunk) - A **$9.4 million** expense from the change in fair value of warrant liability was recorded for the six months ended June 30, 2025, primarily due to the exercise of Series D warrants[207](index=207&type=chunk) - Grant income increased by **$475 thousand** for the six months ended June 30, 2025, driven by the new NIH grant awarded in September 2024[208](index=208&type=chunk) [Cash flows (Comparison)](index=63&type=section&id=Cash%20flows) Net cash used in operating activities increased to $7.3 million for the six months ended June 30, 2025, primarily due to a higher net loss, while net cash provided by financing activities increased to $8.9 million from equity sales Cash Flow Summary (in thousands) | Cash Flow Activity | Six months ended June 30, 2025 (in thousands) | Six months ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(7,291) | $(6,277) | | Net cash used in investing activities | $0 | $(8) | | Net cash provided by financing activities | $8,855 | $6,872 | | Net change in cash | $1,564 | $587 | - Net cash used in operating activities increased by **$1 million**, reflecting a higher net loss partially offset by non-cash adjustments[213](index=213&type=chunk) - Net cash provided by financing activities increased by **$2 million**, primarily from the sale of equity securities[216](index=216&type=chunk) [Liquidity and capital resources](index=64&type=section&id=Liquidity%20and%20capital%20resources) The company has funded operations through equity sales and grants, with $7.4 million cash at June 30, 2025, sufficient only into Q4 2025. Substantial additional funding is required for ongoing R&D, clinical trials, and potential commercialization, raising substantial doubt about its going concern ability. Failure to secure funding may lead to scaling back programs or restructuring, potentially resulting in a total loss for investors - The company has funded operations primarily through convertible promissory notes, IPO proceeds, other equity financings, and SBIR Awards, totaling approximately **$71.3 million** net cash proceeds through June 30, 2025[217](index=217&type=chunk) - Cash balance at June 30, 2025, was approximately **$7.4 million**, estimated to fund operations only into Q4 2025[218](index=218&type=chunk)[220](index=220&type=chunk) - The company requires substantial additional capital for future R&D, clinical trials, regulatory approvals, and potential commercialization, which raises substantial doubt about its ability to continue as a going concern[220](index=220&type=chunk) - Failure to raise additional funds could force the company to delay, scale back, or terminate development programs, or seek restructuring, potentially leading to a total loss for common stockholders[223](index=223&type=chunk)[226](index=226&type=chunk) [Contractual obligations and commitments](index=68&type=section&id=Contractual%20obligations%20and%20commitments) As of June 30, 2025, the company had no future minimum lease payments under non-cancelable operating lease commitments. The collaboration agreement with MD Anderson Cancer Center was amended, relieving the company of a $10 million funding obligation, with initial clinical trial expenses charged against a prepaid amount - As of June 30, 2025, the company had no future minimum lease payments under non-cancelable operating lease commitments[227](index=227&type=chunk) - The collaboration agreement with MD Anderson Cancer Center was amended, relieving the company of a **$10 million** funding obligation, with initial clinical trial expenses of **$138,439** for H1 2025 charged against a **$250,000** prepaid amount[228](index=228&type=chunk) [Critical accounting policies and significant judgments and estimates](index=68&type=section&id=Critical%20accounting%20policies%20and%20significant%20judgments%20and%20estimates) The company's critical accounting policies involve significant estimates and judgments, particularly for accrued R&D expenses, share-based compensation, and warrant accounting. These estimates are based on historical experience and current information, but actual results may vary - Critical accounting policies involve significant estimates and judgments, especially for accrued R&D expenses, share-based compensation, and warrant accounting[229](index=229&type=chunk)[230](index=230&type=chunk) - Estimates for accrued R&D expenses rely on evaluating progress of specific tasks, milestones, and services provided by third-party vendors, with periodic adjustments[232](index=232&type=chunk)[235](index=235&type=chunk) - Share-based compensation expense is measured at grant-date fair value and recognized over the vesting period, while warrant accounting classifies instruments as equity or liability based on specific terms and fair value assessments[236](index=236&type=chunk)[239](index=239&type=chunk) [Factors that May Affect Future Results](index=72&type=section&id=Factors%20that%20May%20Affect%20Future%20Results) Future results are subject to various risks and uncertainties, as detailed in the company's Annual Report on Form 10-K and other SEC filings, which should be reviewed for a comprehensive understanding of potential adverse effects - Future results are subject to important factors and risks detailed in the company's Annual Report on Form 10-K and other regulatory filings[269](index=269&type=chunk)[244](index=244&type=chunk) [Off-balance sheet arrangements](index=72&type=section&id=Off-balance%20sheet%20arrangements) The company did not have any off-balance sheet arrangements during the periods presented and does not currently have any - The company did not have any off-balance sheet arrangements during the periods presented and does not currently have any[245](index=245&type=chunk) [Recently issued accounting pronouncements](index=72&type=section&id=Recently%20issued%20accounting%20pronouncements) A description of recently issued accounting pronouncements that may affect the company's financial position and results of operations is disclosed in Note 2 to the financial statements - Details on recently issued accounting pronouncements are provided in Note 2 to the financial statements[246](index=246&type=chunk) [Internal control over financial reporting](index=72&type=section&id=Internal%20control%20over%20financial%20reporting) The company identified material weaknesses in its internal control over financial reporting prior to its IPO, some of which remain unremediated. Remediation efforts are ongoing, including implementing new policies, hiring personnel, and enhancing software, but there is no assurance these will prevent future issues - Material weaknesses in internal control over financial reporting were identified prior to the IPO, and some remain unremediated[247](index=247&type=chunk) - Remediation efforts include implementing robust accounting policies, hiring finance personnel, and deploying new accounting software[261](index=261&type=chunk) - There is no assurance that remediation measures will be sufficient or prevent future material weaknesses[264](index=264&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=72&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) The company qualifies as an 'emerging growth company' and 'smaller reporting company,' allowing it to take advantage of certain exemptions from reporting requirements, including an extended transition period for new accounting standards - The company is an 'emerging growth company' (EGC) and 'smaller reporting company,' benefiting from exemptions in reporting requirements[248](index=248&type=chunk)[252](index=252&type=chunk) - The company has elected the extended transition period for complying with new or revised accounting standards, which may affect comparability with other public companies[249](index=249&type=chunk)[251](index=251&type=chunk) [Information Technology Risks](index=74&type=section&id=Information%20Technology%20Risks) The company's data and computer systems face increasing threats from cyberattacks, including a phishing attack in July 2021. While mitigation steps are being taken, there is no assurance that these will prevent material adverse consequences - The company's systems are subject to cyber threats, including a phishing attack in July 2021[253](index=253&type=chunk) - Steps are being taken to mitigate cyberattack risks, but there is no assurance of effectiveness or prevention of material adverse effects[253](index=253&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=74&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company is exposed to market risks primarily related to interest rate fluctuations on its cash balances and foreign currency exchange rate changes, particularly for the Euro. While current impacts are not material, future operations could be more affected by these fluctuations [Interest rate risk](index=74&type=section&id=Interest%20rate%20risk) The company's primary market risk exposure is interest income sensitivity from cash balances held in U.S. bank accounts. Due to the short-term nature of its holdings and no outstanding debt, a 10% change in interest rates is not expected to materially affect its financial position - Primary market risk is interest income sensitivity from cash balances in U.S. banks[254](index=254&type=chunk) - An immediate **10%** change in interest rates is not expected to materially affect financial position due to short-term holdings and no outstanding debt[254](index=254&type=chunk)[255](index=255&type=chunk) [Foreign currency exchange risk](index=74&type=section&id=Foreign%20currency%20exchange%20risk) The company is exposed to foreign currency exchange risk, primarily to the Euro, due to certain major purchases. A loss on foreign currency transactions of $74,675 was recognized for the six months ended June 30, 2025. While a 5% change in the Euro exchange rate is not currently deemed material, future operations could be more affected - Primary exposure to market risk is foreign exchange rate sensitivity to the Euro for major purchases[256](index=256&type=chunk) Foreign Currency Exchange Gain (Loss) | Period | Foreign Currency Exchange Gain (Loss) | | :----------------------------- | :------------------------------------ | | Three months ended June 30, 2025 | $(47,487) | | Six months ended June 30, 2025 | $(74,675) | - The company has not entered into foreign currency hedging contracts[257](index=257&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=75&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and procedures were not effective as of June 30, 2025, due to identified material weaknesses in internal control over financial reporting. Remediation efforts are ongoing, including implementing new policies, hiring personnel, and enhancing software, but their effectiveness over time is not assured [Disclosure Controls and Procedures](index=75&type=section&id=Disclosure%20Controls%20and%20Procedures) As of June 30, 2025, management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were deemed not effective due to material weaknesses in internal control over financial reporting[260](index=260&type=chunk) [Continuing Remediation Efforts](index=75&type=section&id=Continuing%20Remediation%20Efforts) The company is continuing remediation efforts to address material weaknesses, including implementing robust accounting policies, hiring additional finance personnel and consultants, and deploying new accounting and operating software. These efforts are ongoing, and their sufficiency to remediate weaknesses or prevent future ones is not guaranteed - Remediation efforts include implementing robust accounting policies, hiring additional finance and accounting personnel, and implementing new accounting and operating software[261](index=261&type=chunk) - An independent consulting firm was engaged in September 2022 to assist in improving control systems and procedures[263](index=263&type=chunk) - There is no assurance that current or future measures will be sufficient to remediate identified material weaknesses or prevent new ones[264](index=264&type=chunk) [Changes in Internal Control over Financial Reporting](index=77&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) Other than the ongoing remediation measures, there were no material changes in the company's internal control over financial reporting during the six months ended June 30, 2025 - No material changes in internal control over financial reporting occurred during the six months ended June 30, 2025, other than ongoing remediation efforts[265](index=265&type=chunk) PART II. OTHER INFORMATION [ITEM 1. LEGAL PROCEEDINGS](index=47&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any legal proceedings that would materially adversely affect its business, operating results, or financial condition, except for disputed claims by an investment bank regarding fees - The company is not currently a party to any material legal proceedings, except for disputed claims by an investment bank for fees[268](index=268&type=chunk) [ITEM 1A. RISK FACTORS](index=47&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section highlights key risks that could materially affect the company's future results, including the potential for delisting from Nasdaq, substantial doubt about its ability to continue as a going concern without additional funding, adverse global economic conditions, and potential negative impacts from changes in U.S. tax law - The company faces a risk of delisting from the Nasdaq Capital Market, which would reduce liquidity, adversely affect stock value, and make capital raising more difficult[270](index=270&type=chunk) - Conditions raise substantial doubt about the company's ability to continue as a going concern, requiring additional funding beyond Q4 2025, with a risk of restructuring and total loss for investors if funds are not secured[272](index=272&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk) - Adverse global conditions, including economic uncertainty and tariffs, may negatively affect financial results[275](index=275&type=chunk) - Changes in U.S. tax law, such as the capitalization and amortization of R&D expenses under Section 174 of the IRC, may materially adversely affect the company's business, cash flow, financial condition, or results of operations[276](index=276&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=49&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) The company reported no unregistered sales of equity securities and stated that the section on use of proceeds from its initial public offering is not applicable - No unregistered sales of equity securities occurred[278](index=278&type=chunk) - The section on use of proceeds from the initial public offering is not applicable[279](index=279&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=49&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) The company reported no defaults upon senior securities - No defaults upon senior securities were reported[281](index=281&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=49&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) The company stated that mine safety disclosures are not applicable - Mine safety disclosures are not applicable to the company[282](index=282&type=chunk) [ITEM 5. OTHER INFORMATION](index=49&type=section&id=ITEM%205.%20OTHER%20INFORMATION) The company announced its 2025 annual meeting of stockholders for August 29, 2025, with a record date of July 11, 2025. Due to the change in meeting date, specific deadlines for stockholder proposals and director nominations were set for June 23, 2025 - The 2025 Annual Meeting of stockholders is scheduled for August 29, 2025, with a record date of July 11, 2025[283](index=283&type=chunk) - Stockholder proposals and director nominations for the 2025 Annual Meeting had a submission deadline of June 23, 2025, due to the change in meeting date[285](index=285&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk) [ITEM 6. EXHIBITS](index=51&type=section&id=ITEM%206.%20EXHIBITS) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including various amendments to the Certificate of Incorporation and Bylaws, certifications from executive officers, and Inline XBRL documents - Exhibits include amendments to the Certificate of Incorporation and Bylaws, certifications from the principal executive and financial officers, and Inline XBRL documents[289](index=289&type=chunk) [SIGNATURE](index=53&type=section&id=SIGNATURE) The report was duly signed on August 14, 2025, by Thomas A. Fitzgerald, Interim Chief Executive Officer and Chief Financial Officer, who serves as the Principal Executive Officer and Principal Financial and Accounting Officer - The report was signed on August 14, 2025, by Thomas A. Fitzgerald, Interim Chief Executive Officer and Chief Financial Officer[296](index=296&type=chunk)

Company Overview - TransCode Therapeutics, Inc. is a clinical-stage oncology company focused on developing RNA-targeted therapeutics for cancer treatment [1][4] - The company aims to combat metastatic disease through the intelligent design and effective delivery of RNA therapeutics using its proprietary TTX nanoparticle platform [4] Key Appointment - Dr. Phillip D. Zamore has been appointed to the Scientific Advisory Board of TransCode Therapeutics [1] - Dr. Zamore is recognized for his pioneering work in RNA interference (RNAi) and co-founded Alnylam Pharmaceuticals, which developed the first FDA-approved RNAi drug [1][6] Research Contributions - Dr. Zamore's research has advanced the understanding of non-coding RNA and its implications in health and disease, particularly in the processing of microRNAs [2] - His contributions have earned him recognition from prestigious institutions, including the National Academy of Sciences and the National Academy of Medicine [2] Strategic Vision - The company emphasizes the importance of Dr. Zamore's expertise in RNA biology to enhance its pipeline of RNA-targeted cancer therapies [3] - Dr. Zamore expressed enthusiasm for contributing to the development of effective RNA-based treatments for cancer patients [3] Product Focus - TransCode's lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker associated with metastasis [4] - The company has a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges to access novel genetic targets for various cancers [4]

[PART I. FINANCIAL INFORMATION](index=8&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=8&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited consolidated financial statements for TransCode Therapeutics, Inc. for the quarter ended March 31, 2025, reflecting a significant net loss and reliance on equity financing [Balance Sheets](index=8&type=section&id=BALANCE%20SHEETS) As of March 31, 2025, the company's total assets increased to approximately $13.2 million from $7.3 million at year-end 2024, primarily due to a rise in cash from financing activities, leading to a positive stockholders' equity of $10.3 million from a $2.0 million deficit Balance Sheet Summary (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $11,569,154 | $5,811,064 | | Total current assets | $13,044,388 | $7,093,338 | | **Total assets** | **$13,194,375** | **$7,294,499** | | **Liabilities & Equity** | | | | Total current liabilities | $2,509,677 | $2,771,836 | | Total liabilities | $2,901,677 | $9,313,233 | | Total stockholders' equity (deficit) | $10,292,698 | $(2,018,734) | | **Total liabilities and stockholders' equity (deficit)** | **$13,194,375** | **$7,294,499** | [Statements of Operations](index=9&type=section&id=STATEMENTS%20OF%20OPERATIONS) For the three months ended March 31, 2025, the company reported a net loss of $12.1 million, a significant increase from the $3.3 million net loss in the same period of 2024, primarily driven by a $9.2 million non-cash charge related to the change in fair value of warrant liability Statement of Operations Summary (Unaudited, in thousands) | Line Item | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Research and development | $2,219.5 | $1,759.0 | | General and administrative | $951.7 | $1,530.0 | | **Total operating expenses** | **$3,171.2** | **$3,289.0** | | Operating loss | $(3,171.2) | $(3,289.0) | | Change in fair value of warrant liability | $(9,234.9) | $0 | | Grant income | $347.8 | $27.1 | | **Net loss** | **$(12,085.4)** | **$(3,326.8)** | | **Net loss per share** | **$(2.51)** | **$(21.35)** | [Statements of Stockholders' Equity (Deficit)](index=10&type=section&id=STATEMENTS%20OF%20STOCKHOLDERS%27%20EQUITY%20%28DEFICIT%29) During the first quarter of 2025, stockholders' equity increased from a deficit of $2.0 million to a positive $10.3 million, primarily due to $8.9 million in net proceeds from common stock issuance and a $15.4 million non-cash contribution from warrant exercises, offsetting the $12.1 million net loss - The company transitioned from a stockholders' deficit of **($2,018,734)** at the end of 2024 to a positive equity of **$10,292,698** by March 31, 2025[22](index=22&type=chunk) - Key activities impacting equity in Q1 2025 included a net loss of **($12,085,413)**, offset by **$8,854,797** from common stock issuances and a **$15,384,319** non-cash impact from the exercise of Series D warrants[22](index=22&type=chunk) [Statements of Cash Flows](index=11&type=section&id=STATEMENTS%20OF%20CASH%20FLOWS) For the first quarter of 2025, net cash used in operating activities was $3.1 million, with $8.9 million generated from financing activities, resulting in a net increase in cash of $5.8 million and a period-end balance of $11.6 million Cash Flow Summary (Unaudited, in thousands) | Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,097) | $(3,937) | | Net cash used in investing activities | $0 | $(4) | | Net cash provided by financing activities | $8,855 | $6,087 | | **Net change in cash** | **$5,758** | **$2,146** | | **Cash, end of period** | **$11,569** | **$4,914** | [Notes to Financial Statements](index=12&type=section&id=NOTES%20TO%20FINANCIAL%20STATEMENTS) The notes provide critical context to the financial statements, detailing the company's business, liquidity challenges, significant accounting policies, recent equity financings, and subsequent events including a planned reverse stock split and Nasdaq delisting notice - The company has concluded there is substantial doubt about its ability to continue as a going concern, as existing cash is not sufficient to fund operations for a full 12 months from the financial statement issuance date[33](index=33&type=chunk) - In March 2025, the company raised approximately **$8.9 million** in net proceeds through a best efforts public offering of common stock and warrants[116](index=116&type=chunk) - Subsequent to the quarter end, the company received a delisting notice from Nasdaq for failing to meet the minimum bid price requirement and approved a **1-for-28** reverse stock split expected to be effective May 15, 2025[156](index=156&type=chunk)[157](index=157&type=chunk) - During Q1 2025, all Series D warrants were exercised, resulting in the issuance of **11,925,041 shares** after reset adjustments and a non-cash charge of **$9.2 million** to the change in fair value of warrant liability[80](index=80&type=chunk)[134](index=134&type=chunk)[212](index=212&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=45&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's business strategy, focusing on its RNA therapeutic delivery platform and lead candidate TTX-MC138, detailing recent developments, financial results, and liquidity challenges, concluding there is substantial doubt about its ability to continue as a going concern [Company and Technology Overview](index=45&type=section&id=Company%20and%20Technology%20Overview) TransCode is a biopharmaceutical company focused on defeating cancer through RNA therapeutics, with its proprietary TTX delivery platform and lead candidate TTX-MC138, currently in a Phase I/II clinical trial - The company's lead therapeutic candidate, **TTX-MC138**, targets **miRNA-10b**, a key regulator of metastasis in various cancers[159](index=159&type=chunk) - The proprietary **TTX delivery platform** is designed to improve stability, efficiency, and tumor targeting of RNA therapeutics compared to existing lipid-based systems[164](index=164&type=chunk) - A **Phase I/II clinical trial** for TTX-MC138 commenced in the third quarter of 2024 after receiving an IND 'Study May Proceed' notification from the FDA[159](index=159&type=chunk) [Recent Developments and Financial Overview](index=51&type=section&id=Recent%20Developments%20and%20Financial%20Overview) Key recent events include advancing the Phase I/II clinical trial for TTX-MC138, securing approximately $10 million in equity financing, and receiving a Nasdaq delisting notice, with the company facing an accumulated deficit of $75.3 million - The Phase 1a clinical trial is progressing, with the Safety Review Committee (SRC) approving dose escalation up to the fourth cohort and noting no drug-related serious adverse effects or dose-limiting toxicities in the first three cohorts[179](index=179&type=chunk) - In March 2025, the company closed a registered direct offering, raising gross proceeds of approximately **$10 million**[180](index=180&type=chunk) - On May 7, 2025, the company received a delisting notice from Nasdaq for not meeting the **$1.00** minimum bid price requirement and intends to appeal the determination[182](index=182&type=chunk) [Results of Operations](index=62&type=section&id=Results%20of%20Operations) Comparing Q1 2025 to 2024, R&D expenses increased by $0.5 million due to clinical trial costs, G&A expenses decreased by $0.6 million, and the net loss surged to $12.1 million from $3.3 million, primarily due to a $9.2 million non-cash loss from warrant liability Comparison of Results of Operations (in thousands) | | Three Months Ended March 31, | Change | | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **($)** | | Research and development | $2,220 | $1,759 | $461 | | General and administrative | $952 | $1,530 | $(578) | | **Operating loss** | **$(3,172)** | **$(3,289)** | **$117** | | Change in fair value of warrant liability | $(9,235) | $— | $(9,235) | | **Net loss** | **$(12,085)** | **$(3,327)** | **$(8,759)** | - The increase in R&D expenses was primarily due to start-up costs for the clinical trial[210](index=210&type=chunk) - The significant increase in net loss was mainly due to a **$9.2 million** non-cash loss on the change in fair value of warrant liability, resulting from the exercise of Series D warrants[212](index=212&type=chunk) [Liquidity and Capital Resources](index=64&type=section&id=Liquidity%20and%20Capital%20Resources) The company, historically funded by equity and grants, held $11.6 million in cash as of March 31, 2025, but estimates this is sufficient only into Q4 2025, raising substantial doubt about its going concern ability and necessitating additional capital - As of March 31, 2025, the company had approximately **$11.6 million** in cash[189](index=189&type=chunk)[224](index=224&type=chunk) - Existing cash is projected to fund operating expenses and capital requirements only into the **fourth quarter of 2025**[189](index=189&type=chunk)[226](index=226&type=chunk) - These conditions raise substantial doubt about the company's ability to continue as a going concern, and failure to raise additional capital may force it to delay, reduce, or terminate programs and potentially seek restructuring[226](index=226&type=chunk)[231](index=231&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=76&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 in non-interest-bearing accounts and foreign currency exchange risk from Euro-denominated vendor payments, without hedging instruments - The company's primary market risk exposure is foreign exchange rate sensitivity to the Euro for certain vendor purchases, which resulted in a loss of **$27,188** in Q1 2025[263](index=263&type=chunk) - Interest rate risk is considered minimal as cash is held in short-term bank deposits and the company has no significant debt[261](index=261&type=chunk)[262](index=262&type=chunk) [Controls and Procedures](index=77&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2025, due to identified material weaknesses in internal control over financial reporting, with ongoing remediation efforts - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were not effective due to existing material weaknesses[267](index=267&type=chunk) - The company is continuing remediation efforts, which include implementing robust accounting policies, engaging additional finance personnel and consultants, implementing new software, and formally documenting and assessing procedures[268](index=268&type=chunk)[269](index=269&type=chunk) [PART II. OTHER INFORMATION](index=79&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=79&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, with the exception of a disputed claim from an investment bank asserting entitlement to fees, which the company rigorously disputes - The company is not involved in any material legal proceedings, with the exception of a disputed claim for fees by an investment bank[275](index=275&type=chunk) [Risk Factors](index=79&type=section&id=Item%201A.%20Risk%20Factors) This section highlights critical risks facing the company, including potential Nasdaq delisting due to minimum bid price non-compliance and substantial doubt about its ability to continue as a going concern, which could lead to restructuring and total loss for security holders - The company is at risk of being delisted from the Nasdaq Capital Market for failing to meet the minimum **$1.00** bid price requirement. A delisting would severely impact stock liquidity and the ability to raise capital[277](index=277&type=chunk)[279](index=279&type=chunk)[280](index=280&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern. Failure to secure additional funding may lead to a restructuring of liabilities, where holders of common stock would likely suffer a total loss of their investment[282](index=282&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=81&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the reporting period - None[284](index=284&type=chunk) [Defaults upon Senior Securities](index=83&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[287](index=287&type=chunk) [Mine Safety Disclosures](index=83&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable[288](index=288&type=chunk) [Other Information](index=83&type=section&id=Item%205.%20Other%20Information) The company did not report any other information for the period - None[289](index=289&type=chunk) [Exhibits](index=83&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, financing agreements, and officer certifications - The report includes exhibits such as corporate governance documents, financing agreements, and officer certifications required by the SEC[290](index=290&type=chunk)[291](index=291&type=chunk)

Core Viewpoint - TransCode Therapeutics is advancing its Phase 1a clinical trial for TTX-MC138, a novel RNA therapeutic aimed at treating metastatic cancers, with positive safety and pharmacokinetic data supporting further development [1][3][5]. Group 1: Clinical Trial Progress - The third patient in Cohort 4 has received the initial dose of TTX-MC138, with all cohorts having at least three patients dosed [1]. - A total of 15 patients have been treated across four dose levels (0.8 mg/kg to 4.8 mg/kg), with no significant safety or dose-limiting toxicities reported [2][8]. - Ten patients remain on study, receiving doses every 28 days, with two patients showing stable disease after seven doses over approximately seven months [2][8]. Group 2: Safety and Efficacy Data - Preliminary pharmacokinetic (PK) and pharmacodynamic (PD) analyses indicate a predictable dose-response relationship, with evidence of miR-10b target engagement at 24 hours post-infusion [2][4][8]. - The observed tolerability profile supports the advancement of the trial into the Phase 1b dose expansion stage to further evaluate safety and potential anti-tumor activity [3]. Group 3: About TTX-MC138 - TTX-MC138 is designed to inhibit microRNA-10b, which is implicated in the progression of many metastatic cancers, and has shown promising delivery and activity in preclinical studies [4][7]. - The drug candidate has demonstrated a broad therapeutic window, suggesting potential for effective treatment of metastatic tumors [4]. Group 4: Trial Design - The Phase 1 clinical trial is a multicenter, open-label study aimed at evaluating the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers [5]. - The trial consists of an initial dose-escalation stage followed by a dose-expansion stage to further assess safety, tolerability, and anti-tumor activity [5].

Core Points - TransCode Therapeutics has announced a 1-for-28 reverse stock split effective at 12:01 a.m. Eastern Standard Time on May 15, 2025, to increase the per share trading price and meet Nasdaq listing requirements [1][2] - The reverse stock split will reduce the number of outstanding shares from approximately 23,341,336 to about 833,620 shares, with no fractional shares issued [2] - The company's CUSIP number will change to 89357L 501 as of the effective time of the reverse stock split [4] Company Overview - TransCode Therapeutics is a clinical-stage oncology company focused on treating metastatic disease through RNA therapeutics, utilizing its proprietary TTX nanoparticle platform [5] - The lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker associated with metastasis [5] - The company is also developing a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges to access novel genetic targets for cancer treatment [5]

Core Viewpoint - TransCode Therapeutics has announced a 1-for-28 reverse stock split to comply with Nasdaq's minimum bid price requirements, aiming to increase the trading price of its common stock [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will convert twenty-eight current shares into one new share, reducing the total outstanding shares from approximately 23,341,336 to about 833,620 [2]. - No fractional shares will be issued; instead, stockholders will receive rounding up of fractional shares to the nearest whole number [2]. - Proportional adjustments will be made to the exercise prices of outstanding stock options and warrants, as well as to the shares issued under stock incentive plans [2]. Group 2: Implementation and Process - Vstock Transfer LLC will serve as the exchange agent for the reverse stock split, and stockholders of record will not need to take action to receive their post-split shares [3]. - Stockholders holding shares through banks or brokers will have their positions automatically adjusted, but they may need to check with their respective institutions for specific procedures [3]. - The effective date of the reverse stock split will be announced by the company at least two business days prior to implementation [4]. Group 3: Company Overview - TransCode Therapeutics is a clinical-stage oncology company focused on treating metastatic disease through RNA therapeutics [5]. - The company's lead candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker of metastasis [5]. - TransCode is also developing a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges to access novel genetic targets for cancer treatment [5].

Financial Data and Key Metrics Changes - The proposal for a reverse stock split has been approved by a majority of votes, indicating a strategic move to potentially enhance the stock price and attract more investors [6] - The adjournment proposal was also approved, allowing for further solicitation of proxies if necessary [6] Business Line Data and Key Metrics Changes - No specific financial data or performance metrics for individual business lines were provided during the meeting [7] Market Data and Key Metrics Changes - There was no detailed market data or key metrics discussed in the meeting [7] Company Strategy and Development Direction - The company is focused on clinical trials and is committed to reporting data as it becomes available, emphasizing transparency in their research process [8] - The management is preparing to draw down NIH grant funding in the foreseeable future, indicating ongoing reliance on external funding sources [9] Management Comments on Operating Environment and Future Outlook - Management has not experienced adverse effects from NIH grant funding cuts to date, but they are cautious about future implications [9] - The company is optimistic about the nature of their grant and the timing, although uncertainties remain [9] Other Important Information - The meeting concluded with a commitment to report clinical trial data as expeditiously as possible, highlighting the importance of quality control and safety review processes [8] Q&A Session Summary Question: How often are clinical trial assessments done during the current clinical study? - Management stated that they report data as soon as it is available, emphasizing the need for quality control and committee checks before publishing results [8] Question: Has your NIH grant funding been affected by the recent funding cuts? - Management confirmed that there have been no adverse effects from NIH grant funding so far, but they are preparing to draw down funds soon, with future implications still uncertain [9]