Bullish indicating open at $55-$60, IPO prices at $37
HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a late-stage pharmaceutical company currently trading near its 52-week low of $0.66, announced it has received the first European regulatory approval to begin recruiting for its Phase 3 trial of Annamycin for the treatment of acute myeloid leukemia (AML). The approval, granted by Ukraine’s Ministry of Health last week, marks a significant step for the company’s global "MIRACLE" trial, which includes sites in the US, Europe, and the Middle East. According to InvestingPro data, while the company maintains a healthy cash position exceeding its debt, it faces challenges with rapid cash burn.
The MIRACLE trial will evaluate Annamycin in combination with Cytarabine for patients with AML who have not responded to or have relapsed after initial therapy. The study employs an adaptive design, with an early unblinding of data from the first 45 subjects expected in the second half of 2025. The trial’s first subject is anticipated to be treated within the first quarter of 2025, aligning with the company’s projected timeline. With a current market capitalization of just $2.11 million and analyst price targets ranging from $8 to $28, this development phase is crucial for the company’s future.
Moleculin’s Chairman and CEO, Walter Klemp, commented on the progress, stating the company’s commitment to operational execution and its ongoing efforts in initiating and enrolling study sites. The MIRACLE study’s adaptive design will initially randomize subjects to receive high dose cytarabine with either placebo or two different doses of Annamycin, as recommended by the FDA. Part B of the trial will further randomize approximately 244 additional subjects to determine the optimum dose of Annamycin. InvestingPro analysis indicates the company currently shows weak financial health scores, though it maintains a current ratio of 2.08, suggesting adequate liquidity to meet near-term obligations.
Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, as well as Orphan Drug Designation from the European Medicines Agency (EMA). The drug aims to avoid multidrug resistance and eliminate the cardiotoxicity associated with currently prescribed anthracyclines.
Moleculin’s development pipeline also includes WP1066, targeting brain tumors, pancreatic and other cancers, and a portfolio of antimetabolites like WP1122 for potential treatment of pathogenic viruses and cancer indications.
This announcement is based on a press release statement and does not imply any endorsement of the claims. The MIRACLE trial is registered on clinicaltrials.gov with identifier NCT06788756, and further information can be found on the website.
In other recent news, Moleculin Biotech, Inc. has been making significant strides in its operations. The company has entered into an agreement with an investor to modify the terms of previously issued warrants, a move that will allow Moleculin to proceed with a proposed offering under specific conditions. The agreement also involves the adjustment of the exercise price of the warrants and changes to the initial exercise date.
In the realm of clinical trials, Moleculin has announced an amendment to its protocol for the Phase 3 "MIRACLE" study of Annamycin in treating acute myeloid leukemia (AML). This amendment, agreed upon with the U.S. Food and Drug Administration (FDA), will expedite the unblinding of preliminary primary efficacy data and safety/tolerability for the first 45 subjects in the trial. The company also received Institutional Review Board (IRB) approval for a pivotal Phase 3 trial of its drug candidate Annamycin.
During its quarterly earnings call, Moleculin provided an update on its financial position and the progress of Annamycin. The company ended the quarter with $9.4 million in cash, expected to last into Q1 2025, and plans to submit a rolling New Drug Application (NDA) by late 2028. The company’s leadership remains committed to advancing Annamycin through the clinical trial process, with strategic plans in place to navigate the path to potential drug approval and market entry.
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