On August 23, 2021 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, reported recent business progress and second quarter 2021 financial results (Press release, TransCode Therapeutics, AUG 23, 2021, View Source [SID1234586819]).

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"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.