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Moleculin Biotech CEO Discusses Preliminary MIRACLE Trial Results for Annamycin in Virtual Investor Segment

Moleculin Biotech announces positive preliminary results for Annamycin in a pivotal AML trial, led by CEO Walter Klemp.

Quiver AI Summary

Moleculin Biotech, Inc. announced that its Chairman and CEO, Walter Klemp, participated in a Virtual Investor segment discussing preliminary unblinded efficacy results from the first 45 patients in Part A of the pivotal Phase 2/3 MIRACLE trial for Annamycin, a treatment for relapsed or refractory acute myeloid leukemia (R/R AML). Klemp highlighted the importance of the observed trends across the treatment arms and outlined the commercial potential of Annamycin, supported by recent market research. The company is developing Annamycin, designed to prevent multidrug resistance and cardiotoxicity, along with other therapeutic candidates targeting challenging tumors and viruses. The trial follows a successful Phase 1B/2 study, and while there are positive signs, further financing and regulatory approvals are needed to continue development. The segment is available for on-demand viewing.

Potential Positives

  • Announcement of positive preliminary unblinded efficacy results from the first 45 patients in the pivotal Phase 2/3 MIRACLE trial for Annamycin, providing potential market interest and investor confidence.
  • Discussion of early efficacy trends across treatment arms indicates promising therapeutic potential for Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML).
  • Company's recent market research suggests a significant addressable market for Annamycin if approved, highlighting commercial opportunities.
  • Moleculin's development of Annamycin aims to avoid common cardiotoxicity associated with current anthracycline therapies, addressing a critical need in cancer treatment.

Potential Negatives

  • The efficacy results mentioned are based on a small sample size (n=45) and have not achieved statistical significance, raising concerns about the robustness of the findings.
  • The company has no current commitments for significant additional financing required to conduct ongoing clinical trials, which could jeopardize the continuation of its development programs.
  • Forward-looking statements indicate uncertainty and risk regarding the company's expectations for the potential efficacy and safety of its treatments, which could lead to investor skepticism.

FAQ

What was discussed in the Virtual Investor segment featuring Wally Klemp?

Wally Klemp discussed preliminary efficacy results from the Phase 2/3 MIRACLE trial of Annamycin for R/R AML patients.

What is Annamycin and its intended use?

Annamycin is a drug designed to treat relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases.

What are the key findings from the MIRACLE trial presented by Moleculin?

Preliminary unblinded efficacy results showed positive trends in early patient responses across Annamycin treatment arms.

How does Annamycin compare to traditional anthracyclines?

Annamycin aims to avoid multidrug resistance and lacks the cardiotoxicity common with current anthracyclines used in treatment.

Where can I watch the Virtual Investor segment on Annamycin?

The segment is available for on-demand viewing through the link provided in the company's announcement.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.


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Full Release

HOUSTON, July 06, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin, participated in a Virtual Investor “What This Means” segment .

For the segment, Chairman and CEO Wally Klemp discusses the positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML). During the conversation, Mr. Klemp provides his perspective on the significance of the early efficacy trends observed across both Annamycin treatment arms, summarizes the key data, and discusses the commercial opportunity, including insights from the Company's recent market research assessing the potential addressable market for Annamycin if approved.

The segment is now available for on-demand viewing here .

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company has begun the MIRACLE ( M olecul i n R /R AML A nnAraC Cl inical E valuation) Trial (MB-108), a pivotal, adaptive design, multi-center, randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X , LinkedIn and Facebook .

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential efficacy and safety of Annamycin and AnnAraC in R/R AML and the expectation that interim efficacy trends observed in a limited patient population will be confirmed in the full study population (the interim results presented are based on a small sample size (n=45), have not achieved statistical significance, and may not be predictive of results from the completed trial). Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com


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