Current Report · Items 3.01 · 8-K
Moleculin Biotech, Inc.
MBRXNASDAQEQUITYCurrent
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing. On September 15, 2026, Moleculin Biotech, Inc. (the “Company”) received a letter (the “Staff Determination Letter”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the Staff has determined that the closing bid p…
Filed Sep 18, 2026Accepted Sep 18, 2026, 5:00 PM EDTCIK 1659617Accession 0001437749-26-030757
Company context
We are a late-stage pharmaceutical development company currently evaluating Annamycin, also known as L-Annamycin and by its generic name “naxtarubicin”, which we believe is a “next-generation” anthracycline and, with it, are conducting a pivotal Phase 2/3 trial in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). We call this the “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation). A blinded preliminary data readout has been released for the MIRACLE trial, we released an interim unblinding of data in June 2026, and we expect an additional unblinding at the end of 2026, thereby concluding Part A of the two-part trial. We believe such early visibility for a pivotal registration-enabling trial is unique in that stakeholders will receive preliminary safety and efficacy data long before the conclusion of the trial.
Current securities
Registered securities in this filing
MOLECULIN BIOTECH, INC. · 8-K · Filed 2026-09-18
As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.
Common Stock
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Filing context
Context: d20268K
Dimensions: Not supplied
Accession 000143774926030757 · 1 registered-security cover member
Read the exact SEC filing ↗Disclosure sections
Items 3.01Select an item to read the extracted section. The as-filed document remains the primary evidence.
Item 3.01Item 3.01 - Notice of Delisting
Item 3.01
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On September 15, 2026, Moleculin Biotech, Inc. (the “Company”) received a letter (the “Staff Determination Letter”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the Staff has determined that the closing bid price of the Company’s common stock, par value $0.001 per share (the “Common Stock”), has been below $1.00 per share for the previous 30 consecutive business days (from July 31, 2026 through September 11, 2026) and, as a result, the Company is not in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
Ordinarily, a company that fails to meet the Minimum Bid Price Requirement would be afforded a 180-calendar day compliance period pursuant to Nasdaq Listing Rule 5810(c)(3)(A) to regain compliance. However, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), the Staff has determined that the Company is not eligible for any compliance period specified in Nasdaq Listing Rule 5810(c)(3)(A), because the Company has effected a reverse stock split in the prior one-year period. As previously disclosed, the Company effected a 1-for-25 reverse stock split of the Common Stock on December 1, 2025.
The Company intends to make a timely request for a hearing before the Nasdaq Hearings Panel (the “Panel”), in accordance with the procedures set forth in the Nasdaq Listing Rule 5800 Series. A timely request for a hearing will stay any suspension or delisting action pending the Panel’s decision, and the Company’s Common Stock will continue to trade on The Nasdaq Capital Market during the pendency of the hearing process. There can be no assurance that the Company’s request for continued listing will be granted or that the Company will be able to regain and maintain compliance with the Minimum Bid Price Requirement or all other applicable requirements for continued listing on The Nasdaq Capital Market.
Forward-Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the Company’s intent to request a hearing before the Panel, the Company’s ability to regain and maintain compliance with the Minimum Bid Price Requirement and other applicable Nasdaq continued listing requirements, and the outcome of any Panel hearing. Forward-looking statements are subject to a number of risks and uncertainties, including that the Panel may deny the Company’s request for continued listing or condition continued listing on requirements that the Company may not be able to satisfy, that the Company may not regain compliance with the Minimum Bid Price Requirement, and other risks and uncertainties set forth from time to time in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.