1. Completed initial public offering of common stock, raising $28.8 million in gross proceeds

    Awarded $2.3 million in funding from NIH to support clinical evaluation of TTX-MC138

    On track to submit eIND application for TTX-MC138 in Q1 2022

    TransCode Therapeutics, Inc. (NASDAQ:RNAZ), an emerging RNA oncology company, created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, today reported recent business progress and second quarter 2021 financial results.

    "2021 has so far been foundational for TransCode, highlighted by our recent initial public offering and listing on Nasdaq. With resources from the IPO and additional support from the NIH, we are driving progress across our…

    Completed initial public offering of common stock, raising $28.8 million in gross proceeds

    Awarded $2.3 million in funding from NIH to support clinical evaluation of TTX-MC138

    On track to submit eIND application for TTX-MC138 in Q1 2022

    TransCode Therapeutics, Inc. (NASDAQ:RNAZ), an emerging RNA oncology company, created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, today reported recent business progress and second quarter 2021 financial results.

    "2021 has so far been foundational for TransCode, highlighted by our recent initial public offering and listing on Nasdaq. With resources from the IPO and additional support from the NIH, we are driving progress across our organization, including key staff additions who bring valued expertise to our team and advancement of our preclinical work," said Michael Dudley, co-founder, president and CEO of TransCode Therapeutics. "Looking forward, we are positioning to move our pipeline into clinical development, as we seek to demonstrate the power and versatility of our TTX platform in solving the challenges of RNA delivery in oncology. We remain on track to submit an exploratory Investigational New Drug Application (eIND) in the first quarter of 2022 to test our lead therapeutic candidate, TTX-MC138, in a Phase 0 study in metastatic solid tumors. We believe this study has the potential to establish proof-of-mechanism for our platform, upon which we hope to build a broad and diverse pipeline of therapeutics and diagnostics with the potential to reach previously undruggable genetic targets."

    Second Quarter 2021 and Recent Highlights

    • Completed an initial public offering of 7,187,500 shares of common stock, including full exercise of the underwriters' option to purchase additional shares, resulting in aggregate gross proceeds of $28.8 million, before deducting underwriting discounts and commissions and other offering expenses.
    • Awarded a Fast-Track Small Business Innovation Research (SBIR) grant from National Institutes of Health (NIH), totaling $2.3 million expected over three years to support the clinical evaluation of TTX-MC138. The Company expects to use these funds for translational experiments to identify and optimize a method for measuring miR-10b expression in breast cancer clinical samples, as well as IND-enabling activities and measurement of delivery and target engagement of TTX-MC138.
    • Strengthened the Company's leadership team with several key appointments, including:
      • Judy Carmody, Ph.D., as SVP of Operations, Susan Duggan as VP of Clinical Operations, Dustan Bonnin as VP of Corporate Strategy and Subrata Ghosh, Ph.D., as Principal Scientist; and
      • Dejan Juric, M.D., appointed to its Scientific Advisory Board. Dr. Juric, a renowned expert in personalized cancer medicine and breast cancer specialist, is currently serving as director of the Henri and Belinda Termeer Center for Targeted Therapies and Investigational Cancer Therapeutics Program at Massachusetts General Hospital.
    • Advanced preclinical work for TTX-MC138, the Company's lead program, targeting miR-10b for treatment of metastatic solid tumors. The Company has completed development of a diagnostic assay validating a method for measuring miR-10b expression in patient blood and tissue samples. This new assay should support future TTX-MC138 clinical trials including the initial Phase 0 study.
    • Initiated IND-enabling activities to support its planned eIND filing for TTX-MC138.

    Planned Upcoming Milestones

    TransCode continues to advance its portfolio and has set the following goals:

    • TTX-MC138
      • Submission to FDA of an eIND application in the first quarter of 2022.
      • Initiation of Phase 0 clinical study evaluating TTX-MC138 for treatment of metastatic solid tumors later in 2022.
      • Concurrent completion of IND-enabling studies to support second half of 2022 filing an IND application for a Phase I clinical trial of TTX-MC138.
    • Publication of preclinical results supporting its TTX delivery platform in the second half of 2021.

    Second Quarter Financial Highlights

    • Cash and Cash Equivalents: As of June 30, 2021, cash and cash equivalents totaled approximately $80 thousand, excluding approximately $25.4 million in net proceeds from the Company's July IPO.
    • R&D Expenses: Research and development expenses were approximately $212 thousand in the second quarter of 2021, compared to approximately $75 thousand in the second quarter of 2020. The increase was primarily due to purchases of materials, license fees, lab facility expenses, costs related to development of intellectual property, and share-based compensation expenses.
    • G&A Expenses: General and administrative expenses were approximately $144 thousand in the second quarter of 2021, compared to approximately $177 thousand in the second quarter of 2020. The increase was primarily due to increased legal, accounting, insurance, and investor relations costs associated with the Company's IPO and to share-based compensation expenses.
    • Operating Income (Loss): Operating loss was approximately $356 thousand in the second quarter of 2021, compared to approximately $92 thousand in the second quarter of 2020. Net income was approximately $2.8 million, or $0.60 per basic share and $0.51 per diluted share, for the second quarter of 2021, compared to a net loss of approximately $127 thousand, or $0.03 per basic and diluted share, for the second quarter of 2020. The results in the second quarter of 2021 primarily reflect a change in fair value of derivative liabilities related to convertible promissory notes. The convertible promissory notes automatically converted into common stock upon completion of the IPO. In the foreseeable future, the Company expects that operating losses will increase substantially and does not expect net profits.

    Financial Guidance

    TransCode expects that its cash and cash equivalents as of June 30, 2021, together with net proceeds from its initial public offering and the SBIR award, are sufficient to fund planned operations through year-end 2022.

    About TransCode Therapeutics

    TransCode is an emerging RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics. The Company has created a platform of drug candidates designed to target a variety of tumor types with the objective of significantly improving patient outcomes. The Company's lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which causes approximately 90% of all cancer deaths representing over nine million deaths per year worldwide. The Company believes that TTX-MC138 has the potential to produce regression without recurrence in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others. The Company's other drug candidates, TTX-siPDL1 and TTX-siLIN28b, focus on the treatment of tumors by targeting PD-L1 and Lin28b, respectively. The Company is also developing diagnostic products related to its planned therapeutics business.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the timing and outcome of expected regulatory filings, including the filing of an eIND for the planned first-in-human study of TTX-MC138, and statements concerning the timing and outcome of this study, including whether this study will demonstrate proof-of-concept, and statements concerning TransCode's development programs and TTX technology platform generally. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk associated with drug discovery and development; the risk that the results of our planned clinical trials will not be consistent with our pre-clinical studies or expectations; risks associated with the timing and outcome of TransCode s planned regulatory submissions; risks associated with TransCode's planned clinical trials for its product candidates; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risks associated with TransCode's financial condition and its need to obtain additional funding to support its business activities, including TransCode's ability to continue as a going concern; risks associated with TransCode's dependence on third parties; and risks associated with the COVID-19 coronavirus. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause TransCode's actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled "Risk Factors" in TransCode's Quarterly Report on Form 10-Q for the period ended June 30, 2021, as well as discussions of potential risks, uncertainties and other important factors in TransCode's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release; TransCode undertakes no duty to update this information unless required by law.

    Balance Sheet Data

     

    (unaudited)

     

     

     

     

     

     

     

     

     

     

     

     

    June 30,

    2021

     

     

    December 31,

    2020

     

    Cash and cash equivalents

     

    $

    79,567

     

     

    $

    828,016

     

    Prepaid expenses and other current assets

     

     

    460,652

     

     

     

    3,199

     

    Deferred offering costs

     

     

    890,452

     

     

     

    224,153

     

    Total assets

     

     

    1,522,265

     

     

     

    1,055,368

     

    Accounts payable and accrued expenses

     

     

    1,216,501

     

     

     

    369,177

     

    Deferred grant income

     

     

    251,810

     

     

     

    --

     

    Convertible promissory notes, net of debt issuance costs and debt discount

     

     

    2,125,813

     

     

     

    2,086,675

     

    Accrued interest – convertible promissory notes

     

     

    247,285

     

     

     

    191,687

     

    Derivative liabilities

     

     

    2,618,000

     

     

     

    1,751,000

     

    Total stockholders' equity (deficit)

     

     

    (5,036,081)

     

     

     

    (3,408,232)

     

    Statement of Operations Data

     

    (unaudited)

     

     

     

     

     

     

     

     

     

     

     

     

    Three Months Ended June 30,

     

     

     

    2021

     

     

    2020

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

     

    $

    211,752

     

     

    $

    75,000

     

    General and administrative

     

     

    143,776

     

     

     

    16,605

     

    Total operating expenses

     

     

    355,528

     

     

     

    91,605

     

    Loss from operations

     

     

    (355,528)

     

     

     

    (91,605)

     

    Other income (expenses), net

     

     

    3,126,432

     

     

     

    (35,593)

     

    Income (loss) before income taxes

     

     

    2,770,904

     

     

     

    (127,198)

     

    Net income (loss)

     

    $

    2,770,904

     

     

    $

    (127,198)

     

    Basic earnings (loss) per share

     

    $

    0.60

     

     

    $

    (0.03)

     

    Diluted earnings (loss) per share

     

    $

    0.51

     

     

    $

    (0.03)

     

     

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  2. -- TTX-MC138 targets MicroRNA10b for treatment of metastatic disease; TransCode on track to submit exploratory investigational new drug (eIND) application in Q1 2022 --

    TransCode Therapeutics, Inc. (NASDAQ:RNAZ), a platform company solving the challenge of RNA delivery in oncology, today announced that it has been awarded a Fast-Track Small Business Innovation Research (SBIR) grant from the NIH to support the clinical evaluation of TTX-MC138, TransCode's lead therapeutic candidate for the treatment of metastatic solid tumors. The award totals $2.3 million expected over three years.

    "We are honored that the NIH recognizes and supports our mission to overcome the obstacles of RNA delivery in oncology," said Michael Dudley, President and Chief…

    -- TTX-MC138 targets MicroRNA10b for treatment of metastatic disease; TransCode on track to submit exploratory investigational new drug (eIND) application in Q1 2022 --

    TransCode Therapeutics, Inc. (NASDAQ:RNAZ), a platform company solving the challenge of RNA delivery in oncology, today announced that it has been awarded a Fast-Track Small Business Innovation Research (SBIR) grant from the NIH to support the clinical evaluation of TTX-MC138, TransCode's lead therapeutic candidate for the treatment of metastatic solid tumors. The award totals $2.3 million expected over three years.

    "We are honored that the NIH recognizes and supports our mission to overcome the obstacles of RNA delivery in oncology," said Michael Dudley, President and Chief Executive Officer of TransCode. "We believe our TTX delivery platform offers tremendous potential across a range of indications. Specifically, this SBIR grant will help fund our planned first-in-human study of our lead candidate, TTX-MC138, in patients with metastatic breast cancer. We look forward to submitting an eIND application in the first quarter of next year. This trial is designed to evaluate and demonstrate proof-of-concept for the mechanism of action for our novel delivery platform, potentially enabling TransCode to pursue a diverse pipeline of TTX-based therapeutics."

    TransCode's proprietary TTX platform leverages an iron oxide nanoparticle as a novel, image-guided system to safely and efficiently deliver oligonucleotides to their intended RNA target. TTX-MC138 targets MicoRNA-10b, believed to drive metastatic disease. The therapeutic has been validated preclinically in multiple indications and has been shown to induce durable regressions of metastatic disease in murine models of disseminated breast cancer.

    About TransCode Therapeutics

    TransCode is an emerging RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics. The Company has created a platform of drug candidates designed to target a variety of tumor types with the objective of significantly improving patient outcomes. The Company's lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which causes approximately 90% of all cancer deaths representing over nine million deaths per year worldwide. The Company believes that TTX-MC138 has the potential to produce regression without recurrence in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others. The Company's other drug candidates, TTX-siPDL1 and TTX-siLIN28b, focus on the treatment of tumors by targeting PD-L1 and Lin28b, respectively.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the SBIR grant, including the expected timing and receipt of the funds thereunder, and statements concerning the planned first-in-human study of TTX-MC138, including the timing of the planned eIND for this study and the outcome of this study, including whether this study will demonstrate proof-of-concept, and statements concerning TransCode's development programs and TTX technology platform generally. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risk associated with drug discovery and development; the risk that the results of our planned clinical trials will not be consistent with our pre-clinical studies or expectations; risks associated with the timing and outcome of TransCode s planned regulatory submissions; risks associated with TransCode's planned clinical trials for its product candidates; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risks associated with TransCode's financial condition and its need to obtain additional funding to support its business activities, including TransCode's ability to continue as a going concern; risks associated with TransCode's dependence on third parties; and risks associated with the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause TransCode's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in TransCode's Final Prospectus for its initial public offering filed with the Securities and Exchange Commission on July 9. 2021, as well as discussions of potential risks, uncertainties and other important factors in TransCode's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

    The names of other companies and products mentioned herein may be trademarks of their respective owners.

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  3. TransCode Therapeutics, Inc. (NASDAQ:RNAZ) ("TransCode" or the "Company"), an emerging RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, today announced the closing of its initial public offering of 7,187,500 shares of its common stock at a public offering price of $4.00 per share. Gross proceeds from the offering totaled $28,750,000, before deducting underwriting discounts and offering expenses. The shares sold in the offering include the exercise in full by the underwriters of their over-allotment option to purchase up to 937,500 shares of common stock, in addition to the 6,250,000 shares of the Company's common stock which the underwriters initially…

    TransCode Therapeutics, Inc. (NASDAQ:RNAZ) ("TransCode" or the "Company"), an emerging RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, today announced the closing of its initial public offering of 7,187,500 shares of its common stock at a public offering price of $4.00 per share. Gross proceeds from the offering totaled $28,750,000, before deducting underwriting discounts and offering expenses. The shares sold in the offering include the exercise in full by the underwriters of their over-allotment option to purchase up to 937,500 shares of common stock, in addition to the 6,250,000 shares of the Company's common stock which the underwriters initially agreed to purchase. The shares sold in the offering began trading on July 9, 2021 on the Nasdaq Capital Market under the symbol "RNAZ".

    The Company intends to use the proceeds for testing required to file an Investigational New Drug application ("IND") for the Phase 0 trial of its lead candidate, TTX-MC138, and for further development of TTX-MC138. Proceeds will also be used for strategic expansion of TransCode's drug candidate portfolio and for working capital and general corporate purposes.

    ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering.

    A registration statement on Form S-1 (File No. 333-253599) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on July 8, 2021. This offering is being made only by means of a prospectus. This registration statement can be obtained by visiting the SEC's website at www.sec.gov. Copies of the final prospectus may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at prospectus@think-equity.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About TransCode

    TransCode is an emerging RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics. The Company has created a platform of drug candidates designed to target a variety of tumor types with the objective of significantly improving patient outcomes. The Company's lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which causes approximately 90% of all cancer deaths representing over nine million deaths per year worldwide. The Company believes that TTX-MC138 has the potential to produce regression without recurrence in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others. The Company's other drug candidates, TTX-siPDL1 and TTX-siLIN28b, focus on the treatment of tumors by targeting PD-L1 and Lin28b, respectively. Learn more at https://www.transcodetherapeutics.com.

    Forward Looking Statements

    This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

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  4. TransCode Therapeutics, Inc. (NASDAQ:RNAZ), ("TransCode" or the "Company") an emerging RNA oncology company, created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, today announced the pricing of its initial public offering of 6,250,000 shares of its common stock at a public offering price of $4.00 per share, for gross proceeds of $25,000,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 937,500 shares of common stock to cover over-allotments at the initial public offering price, less the underwriting discount. All of the shares of common stock are being…

    TransCode Therapeutics, Inc. (NASDAQ:RNAZ), ("TransCode" or the "Company") an emerging RNA oncology company, created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, today announced the pricing of its initial public offering of 6,250,000 shares of its common stock at a public offering price of $4.00 per share, for gross proceeds of $25,000,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 937,500 shares of common stock to cover over-allotments at the initial public offering price, less the underwriting discount. All of the shares of common stock are being offered by the Company.

    The Company intends to use the proceeds for testing required to file an IND for the Phase 0 trial of TTX-MC138, for further development of TTX-MC138, strategic expansion of their drug candidate portfolio, and the balance for working capital and general corporate purposes.

    The shares are expected to begin trading on the Nasdaq Capital Market on July 9, 2021 under the symbol "RNAZ." The offering is expected to close on July 13, 2021, subject to satisfaction of customary closing conditions.

    ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

    A registration statement on Form S-1 (File No. 333-253599) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on July 8, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at prospectus@think-equity.com. The final prospectus will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About TransCode

    TransCode is an emerging RNA oncology company, created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics. The Company has created a platform of drug candidates designed to target a variety of tumor types with the objective of significantly improving patient outcomes. The Company's lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which causes approximately 90% of all cancer deaths representing over nine million deaths per year worldwide. The Company believes that TTX-MC138 has the potential to produce regression without recurrence in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others. The Company's other drug candidates, TTX-siPDL1 and TTX-siLIN28b, focus on the treatment of tumors by targeting PD-L1 and Lin28b, respectively. Learn more at https://www.transcodetherapeutics.com.

    Forward-Looking Statements

    This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

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