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TransCode Therapeutics faces Nasdaq delisting with no grace period, plans hearing

Tickers RNAZ

TransCode received a Nasdaq notice on May 6, 2025 that its stock would be delisted from the Nasdaq Capital Market unless it appeals. Earlier reverse splits left it with no compliance period, so it must request a hearing by May 13, 2025.

Key facts

Company
TransCode Therapeutics, Inc. (NASDAQ: RNAZ)
News type
Listings
Primary source
TransCode Therapeutics, Inc. 8-K (2025-05-07)
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TransCode Therapeutics, Inc. (Nasdaq: RNAZ) received a notice on May 6, 2025 from the Listing Qualifications Department of Nasdaq. The notice says the company's common stock did not maintain a closing bid price of at least $1.00 per share for 30 consecutive business days, from March 24, 2025 through May 5, 2025, as required by Nasdaq Listing Rule 5550(a)(2). TransCode disclosed the notice in a Form 8-K filed May 7, 2025 under Item 3.01. The stock is listed on the Nasdaq Capital Market under the symbol RNAZ.

No compliance period

Nasdaq said TransCode is not eligible for the compliance period specified in Rule 5810(c)(3)(A). The reason is that the company effected a reverse stock split in the prior one-year period, and reverse stock splits in the prior two-year period with a cumulative ratio of 250 shares or more to one. A reverse split combines shares into fewer shares at a higher price. The 8-K does not list the dates or ratios of those earlier splits.

Because of that finding, the common stock would be delisted from the Nasdaq Capital Market unless TransCode appeals the staff's delisting determination. The company must request a hearing before a Nasdaq Hearings Panel, and the request must be filed no later than 4:00 p.m. Eastern Time on May 13, 2025.

The hearing and what it does

The 8-K says a request for a Panel hearing stays any further delisting action by the staff until the hearing outcome. The stock would remain listed and eligible for trading at least until the hearing process ends. TransCode says it plans to request the hearing on time, and it adds that there can be no assurance it will regain compliance and remain listed on Nasdaq.

The filing says the hearing request must address the deficiency and present a plan to regain compliance. The 8-K does not describe that plan, and it does not say whether the company intends to carry out another reverse split.

The lead drug and its data

TransCode describes itself as an RNA oncology company. Its lead candidate, TTX-MC138, targets microRNA-10b, which the company calls a master regulator of metastatic cell viability in a range of cancers, including breast, pancreatic, ovarian and colon cancers and glioblastomas. The company submitted an exploratory IND application for a Phase 0 trial on November 30, 2022, and the FDA authorized that trial on December 23, 2022.

In the Phase 0 study, a microdose of radiolabeled TTX-MC138 was given to patients with advanced solid tumors. TransCode announced preliminary data on May 29, 2024, and the 10-K describes the results from "the patient dosed", a single patient. The company says a microdose reduced miR-10b in that patient's blood at 24 hours by approximately 66% compared with levels before dosing. The company is still finalizing the clinical study report, plans to publish the results in a scientific journal, and says the microdose was well tolerated with no adverse events observed. A single patient given a microdose is thin evidence.

The company submitted an IND for a Phase I/II trial, and on April 14, 2024 the FDA issued a Study May Proceed letter. That trial is an open-label, multicenter study to test safety and tolerability at escalating doses and to find a maximum tolerated dose. The company announced the first subject dosed on September 17, 2024 and the first cohort of three patients completed on October 10, 2024. On March 13, 2025, the trial's Safety Review Committee approved opening a fourth cohort. The company reports no significant safety or dose limiting toxicities in cohorts one, two and three, but that is preliminary and comes from a dose-escalation study with small cohorts.

TransCode also lists preclinical programs, including TTX-siPDL1, an siRNA-based modulator of PD-L1, and two indication-agnostic programs, TTX-RIGA and TTX-siMYC.

What the notice leaves open

The 8-K describes the Nasdaq process and the deadline but gives no share price after May 5, 2025, no figure for the company's cash, and no timeline for the hearing. Without a compliance period, the company's path to keep its listing runs through the hearing panel rather than through the time Nasdaq would otherwise allow.

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