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TransCode Therapeutics, Inc. (NASDAQ: RNAZ) is a Boston-based clinical-stage biopharmaceutical company dedicated to combating metastatic disease through the discovery, development, and commercialization of novel microRNA (miRNA) therapeutics. The company's pioneering work centers around its proprietary TTX nanoparticle platform, designed to effectively deliver RNA-based therapies to target and treat various cancers.
The lead therapeutic candidate of TransCode Therapeutics, TTX-MC138, focuses on metastatic tumors that overexpress microRNA-10b, a well-known biomarker associated with metastasis. This candidate is currently undergoing rigorous clinical trials, with initial results indicating promising accumulation of the therapy in metastatic lesions.
The company also boasts a diverse pipeline of RNA therapeutic candidates, including TTX-siPDL1 and TTX-RIGA, aimed at overcoming the delivery challenges of RNA therapies and addressing novel genetic targets relevant to different cancer types. TransCode is actively engaged in expanding its research collaborations, as highlighted by its project combining the TTX platform with Debiopharm’s drug delivery technologies.
However, TransCode faces noteworthy financial and regulatory challenges. Recent communications reveal that the company is addressing compliance issues with Nasdaq listing requirements and the potential need for a reverse stock split to maintain its listing status. Despite these hurdles, TransCode remains committed to advancing its research and development efforts, securing strategic partnerships, and raising sufficient capital to drive its innovative pipeline forward.
TransCode’s vision extends beyond treating metastatic cancer; they aim to revolutionize cancer therapy by creating highly selective treatments that trigger the immune response against tumors while sparing healthy tissues. This approach is exemplified by their tumor-selective RIG-I agonists currently in development.
TransCode Therapeutics (RNAZ), the RNA Oncology Company, announced the results of its Special Meeting held on February 25, 2025, following adjournment from February 4, 2025. Shareholders achieved a quorum and approved two key proposals:
- Proposal One: Approved the issuance of Common Stock upon exercise of Series C and D Warrants, including adjustments to warrant exercise prices, an alternative cashless exercise feature for Series D Warrants, and potential future price adjustments (subject to a $2.4882 floor price)
- Proposal Two: Approved the ability to adjourn the Special Meeting if needed for further proxy solicitation regarding the Issuance Proposal
TransCode Therapeutics (NASDAQ: RNAZ) has announced the completion of initial dosing in Cohort 3 of its Phase 1 clinical trial for TTX-MC138, its lead candidate. Three patients were enrolled and dosed in Cohort 3, with the dose being approximately double that of Cohort 2. The Safety Review Committee approved the third cohort after reviewing safety and pharmacokinetic (PK) data from Cohorts 1 and 2.
Notable findings include: no significant safety or dose limiting toxicities reported across all nine trial patients; several patients from Cohorts 1 and 2 continuing treatment in 28-day cycles; and PK/PD analyses showing consistency with preclinical and Phase 0 trial results. Cohort 1 demonstrated 66% inhibition of miR-10b at 24 hours post-infusion, matching Phase 0 observations. TTX-MC138 showed increased activity with dose escalation in Cohort 2, maintaining consistency across subsequent administrations.
TransCode Therapeutics (RNAZ) announced the adjournment of its Special Meeting scheduled for February 4, 2025, due to insufficient quorum. Only 29.94% of eligible voting shares were represented, falling short of the required one-third minimum. The meeting has been rescheduled to February 25, 2025, at 9:30 a.m. Eastern time.
The adjourned meeting will address two key proposals: Proposal One concerns the issuance of Common Stock upon exercise of Series C and D Warrants, including price adjustments and exercise features, subject to a floor price of $2.4882. Proposal Two addresses the potential need for further meeting adjournments if insufficient votes are received for Proposal One.
Stockholders of record as of December 17, 2024, can vote through multiple methods including mail, internet, telephone, or during the virtual meeting. All votes must be received by 11:59 p.m. Eastern time on February 24, 2025.
TransCode Therapeutics (NASDAQ: RNAZ) has announced the dosing of the first patient in Cohort 3 of its Phase 1 clinical trial for TTX-MC138, its lead candidate. The Safety Review Committee (SRC) unanimously approved the third cohort after reviewing favorable safety and pharmacokinetic data from Cohorts 1 and 2.
Key highlights include:
- No significant safety or dose-limiting toxicities reported in previous cohorts
- Cohort 3 dosage is approximately double that of Cohort 2
- Several patients from earlier cohorts continue treatment
- TTX-MC138 showed 66% inhibition of miR-10b at 24 hours post-infusion in Cohort 1
- Increased activity observed with escalated dose in Cohort 2
- PK/PD profile aligns with preclinical and Phase 0 trial results
TransCode Therapeutics (NASDAQ: RNAZ) has announced that it has regained compliance with Nasdaq's listing requirements, including minimum bid price and shareholders' equity rules. The company has also resolved a violation regarding the Shareholder Approval Rule through shareholder ratification of a July 2024 equity transaction.
The company will remain listed on the Nasdaq Capital Market but will be subject to a Discretionary Panel Monitor through December 24, 2025. If TransCode fails to maintain compliance with any listing rule during this period, it will not be granted additional time to regain compliance and may face delisting, though it will have the opportunity to request a new hearing.
Tom Fitzgerald, TransCode's Interim CEO and CFO, expressed optimism about the company's future, highlighting their focus on advancing their lead therapeutic candidate, TTX-MC138, in clinical trials.
TransCode Therapeutics (NASDAQ: RNAZ) announced the Safety Review Committee's unanimous approval to open the third cohort in its Phase 1 clinical trial of TTX-MC138, following favorable safety data from Cohort 2. The trial evaluates TTX-MC138, designed to inhibit microRNA-10b, which is important in metastatic cancer progression.
Key findings include: no significant safety or dose-limiting toxicities reported in Cohort 2; Cohort 3 will receive approximately double the dose of Cohort 2; pharmacokinetic and pharmacodynamic data from Cohort 1 align with preclinical and Phase 0 results, showing 66% inhibition of miR-10b at 24 hours post-infusion. The concentration of TTX-MC138 in human blood plasma exceeded levels achieved in nonclinical studies.
TransCode Therapeutics (RNAZ) has announced a 1-for-33 reverse stock split effective December 4, 2024, at 12:01 a.m. EST. The split aims to increase the per-share trading price to meet Nasdaq's minimum bid price requirement for continued listing. The split will reduce outstanding common shares from 17,265,658 to approximately 696,233 shares. The company's stock will continue trading under 'RNAZ' on the Nasdaq Capital Market. Proportional adjustments will be made to stock options, warrants, and shares under incentive plans. Stockholders will have fractional shares rounded up to the nearest whole number.
TransCode Therapeutics (Nasdaq: RNAZ) has announced an $8 million private placement with institutional investors. The company will issue 21,220,160 shares of common stock along with Series C and Series D warrants. The combined purchase price is $0.377 per share, with warrants exercisable at $0.475. Series C warrants have a 5-year term while Series D warrants have a 2.5-year term. The Benchmark Company is acting as exclusive placement agent, with closing expected around November 29, 2024. The proceeds will be used for general corporate purposes and working capital.
TransCode Therapeutics (RNAZ) announced a Board-approved 1-for-33 reverse stock split, which was approved by stockholders on November 22, 2024. The split aims to increase the per-share trading price to meet Nasdaq's minimum bid price requirements for continued listing. The split will reduce outstanding shares from 17,265,658 to approximately 523,202. Proportional adjustments will be made to stock options, warrants, and shares under incentive plans. No fractional shares will be issued, with fractions rounded up to the nearest whole number. The effective date is pending announcement.
TransCode Therapeutics (NASDAQ: RNAZ) has issued an open letter to shareholders regarding an upcoming Special Meeting on November 22. The company is seeking shareholder authorization for a potential reverse stock split to maintain Nasdaq listing compliance. The split would only be implemented if the stock fails to maintain a $1.00 per share closing price for any ten-day period before December 31, 2024.
Management emphasizes this measure is important for maintaining Nasdaq listing, which they consider critical for raising needed capital to continue clinical trials and operations. The company warns that delisting would likely have a material adverse effect on company and stock value.