Current Report · Items 7.01, 8.01, 9.01 · 8-K
Moleculin Biotech, Inc.
MBRXNASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 7.01 Regulation FD Disclosure On September 23, 2026, Moleculin Biotech, Inc. (the “Company”), issued a press release which announced that the Mexican Patent Office has granted Patent No. 436849, further strengthening the Company's global intellectual property portfolio protecting its proprietary lung-targeted liposomal Annamycin technology.…
Filed Sep 23, 2026Accepted Sep 23, 2026, 8:25 AM EDTCIK 1659617Accession 0001437749-26-031005
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 2026-09-23
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 000143774926031005 · 1 registered-security cover member
Read the exact SEC filing ↗Disclosure sections
Items 7.01, 8.01, 9.01Select an item to read the extracted section. The as-filed document remains the primary evidence.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure
On September 23, 2026, Moleculin Biotech, Inc. (the “Company”), issued a press release which announced that the Mexican Patent Office has granted Patent No. 436849, further strengthening the Company's global intellectual property portfolio protecting its proprietary lung-targeted liposomal Annamycin technology.
A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated by reference herein.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (“Exchange Act”), nor shall it be incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (“Securities Act”), unless specifically identified therein as being incorporated by reference.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events
As previously reported, in July 2025 the Company entered into an At Market Offering Agreement (the "Agreement") with Roth Capital Partners, LLC (the "Roth"). Pursuant to the terms of the Agreement, the Company may offer and sell, from time to time, Company common stock through Roth, acting as agent, through an "at the market offering" as defined in Rule 415(a)(4) (the "ATM Offering") promulgated under the Securities Act. To date in September 2026, the Company issued 888,400 shares of common stock through the ATM Offering for aggregate gross proceeds of $0.48 million. After the completion of the foregoing issuances, the Company will have 20,385,780
shares of common stock outstanding.
On August 3, 2026, the Company issued Series I Warrants to purchase up to 37,130,001 shares of common stock in a public offering. The Series I Warrants were initially exercisable into one share of common stock at an exercise price of $0.75 per share and expire on the five-year anniversary of the closing date. The Series I Warrants contain anti-dilution provisions that reduce the exercise price (subject to a floor price) in the event the Company issues common stock or common stock equivalents at a price below the then-current exercise price, other than in connection with certain exempt issuances. Subsequent to the issuance of the shares of common stock in the ATM Offering described above, the exercise price of the Series I Warrants was reduced to $0.51 per share.