Moleculin Biotech, Inc. filings document regulatory disclosures for a Delaware clinical-stage pharmaceutical company focused on drug development and commercialization. Recent Form 8-K reports cover Regulation FD releases, investor presentations, financial results, clinical and preclinical updates for Annamycin, and intellectual-property matters involving liposomal Annamycin.
The filing record also includes capital-structure and governance disclosures tied to warrant exercise inducement arrangements, warrant-related share issuance, and stockholder voting matters. Definitive proxy materials and voting results describe special-meeting proposals, including Nasdaq-related approval for warrant shares and charter-related governance items, while exhibit filings attach press releases, presentation materials, and other public-company disclosures.
Moleculin Biotech, Inc. filed a current report to make investors aware that it is using an updated corporate presentation. The company states that this presentation is posted on its website and is included as Exhibit 99.1.
The company clarifies that the information in this presentation is being furnished under a disclosure item and is not considered "filed" under securities laws, unless a future document specifically incorporates it by reference. This distinction affects how the information is treated for legal and liability purposes.
Moleculin Biotech updated progress on its pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in second-line relapsed/refractory AML. As of February 10, 2026, 35 subjects have been treated, with another 11 in screening or identified, targeting 45 subjects for the first data unblinding.
In the first 30 treated subjects with blinded efficacy data, the company reports a preliminary composite complete remission (CRc) rate of 40%, made up of 30% complete remission (CR) and 10% CR with partial hematologic recovery (CRh). Moleculin highlights that roughly 35% of treated subjects had failed prior venetoclax regimens and that current blinded CR rates are described as 67% higher than historical cytarabine-alone HiDAC trials at about 17–18% CR.
The company continues to report an absence of cardiotoxicity for Annamycin based on safety data from 90 prior trial subjects and expects to reach 45 treated MIRACLE subjects in the first quarter of 2026, with unblinding of the first 45 subjects’ efficacy data anticipated in late second quarter 2026, followed by additional unblindings as Part A of the trial completes.
Moleculin Biotech reported that the Japan Patent Office issued a notice of allowance for Patent Application No. 2021-577862, titled “METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN.” A patent from this application is expected to be granted in Japan in the coming months.
The allowed claims cover proprietary methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilizate under controlled temperature conditions, targeting precise concentrations for intravenous use and consistent dosing and stability. This Japanese protection complements existing U.S. and European patent coverage for Annamycin.
Annamycin, also known as naxtarubicin, is Moleculin’s lead anthracycline drug candidate in Phase 3 development for relapsed or refractory acute myeloid leukemia, with Fast Track Status and multiple Orphan Drug Designations in the U.S. and Europe.
Moleculin Biotech, Inc. stockholders approved the issuance of up to 2,610,823 shares of common stock upon exercise of certain warrants issued on December 11, 2025. The warrant-related Nasdaq Proposal passed with 578,385 votes for, 68,176 against and 3,444 abstentions, with 546,307 broker non-votes.
Stockholders did not approve changing the company’s name to Moleculin Inc., because the vote did not reach the required majority of all outstanding shares, even though 1,124,921 voted for, 67,441 against and 3,950 abstained. They also approved a potential adjournment to solicit additional proxies if needed.
Moleculin Biotech, Inc. filed a current report to note that it is using a new corporate presentation for investors and other audiences. The presentation is posted on the company’s website and is included as Exhibit 99.1 to the report. The company specifies that this material is being furnished under a disclosure item for informational purposes and is not deemed filed under securities laws unless later specifically incorporated by reference.
Moleculin Biotech, Inc. filed a current report to furnish a press release about new safety information for its investigational drug Annamycin. The company states that an independent assessment confirmed no cardiotoxicity of Annamycin in 90 subjects, addressing an important safety consideration related to potential effects on the heart. The press release is included as Exhibit 99.1 and is furnished under Item 7.01, meaning it is provided for information purposes and is not treated as filed under securities law requirements.
Moleculin Biotech, Inc. filed a current report to furnish a press release dated January 12, 2026. The release states that the company is accelerating its outlook into 2026, with its first pivotal trial unblinding described as on track.
The press release also highlights global trial expansion and multiple clinical programs that are externally and investigator-initiated trial (IIT) funded. The information is furnished under a Regulation FD disclosure item and is not deemed filed under the federal securities laws unless later specifically incorporated by reference.
Moleculin Biotech, Inc. reported that it has regained compliance with Nasdaq’s continued listing standards. The company had previously been notified in May 2025 that it failed to meet Nasdaq Listing Rule 5550(b)(1), which requires at least $2.5 million in stockholders’ equity, and that it also did not meet the alternative tests for market value of listed securities or net income from continuing operations. In November 2025, Nasdaq staff issued a delisting determination, which Moleculin appealed to a hearing panel. On January 6, 2026, Nasdaq staff informed the panel that Moleculin is now in compliance with Listing Rule 5550(b)(1) and all other applicable continued listing standards, so the previously scheduled hearing has been cancelled and the company’s Nasdaq listing remains in place.
Moleculin Biotech, Inc. reports that it has issued a press release announcing positive results from a physician-sponsored Phase 1 clinical trial conducted at Emory University. The trial took place at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta and was led by pediatric oncologist Tobey MacDonald, MD, who identified STAT3 as critical to certain childhood brain tumors and directs the Pediatric Neuro-Oncology Program.
The company has attached the press release as Exhibit 99.1 to this report and incorporated it by reference, while specifying that the information is being furnished under the securities laws rather than filed.
Moleculin Biotech, Inc. reports that it has regained compliance with Nasdaq’s minimum bid price requirement for continued listing of its common stock. The company had previously been notified on June 27, 2025 that its shares failed to meet the Nasdaq Listing Rule 5550(a)(2) requirement after trading below $1.00 per share for 30 consecutive business days.
Nasdaq’s Listing Qualifications Staff informed Moleculin on December 15, 2025 that the company is back in compliance because the closing bid price of its common stock was at or above $1.00 per share for 10 consecutive business days from December 1, 2025 through December 12, 2025. Nasdaq indicated that the company is now in compliance with the bid price rule and that the matter is closed.