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Moleculin Biotech, Inc. reports developments as a clinical-stage pharmaceutical company advancing drug candidates for hard-to-treat tumors and viruses. Its lead program is Annamycin, also known as naxtarubicin, a next-generation anthracycline designed to avoid cardiotoxicity and multidrug resistance, with development focused on relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases.
Recurring news covers Annamycin clinical and preclinical data, the MIRACLE study of Annamycin in combination with cytarabine, oncology conference presentations, intellectual-property protection for liposomal Annamycin, and corporate financial updates. Additional pipeline coverage includes WP1066, an immune/transcription modulator targeting p-STAT3 and other oncogenic transcription factors, and WP1122, an antimetabolite program for pathogenic viruses and cancer indications.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has received clearance to initiate its Phase 1b/2 clinical trial for Annamycin, targeting soft tissue sarcoma (STS) lung metastases. The trial aims to evaluate patient safety and optimal dosing, following promising animal data indicating Annamycin's superior lung accumulation and lack of cardiotoxicity compared to doxorubicin. Up to 25 subjects will be enrolled, and the study has Fast Track and Orphan Drug Designation from the FDA. A second trial in Europe is anticipated, alongside ongoing developments in oncology drug candidates.
Moleculin Biotech (MBRX) reported its Q1 financial results on May 12, 2021, highlighting significant advancements in its oncology portfolio. Key achievements include receiving Rare Pediatric Disease Designation for WP1066, Fast Track Designation for Annamycin, and successfully closing a public offering for approximately $78 million. Total R&D expenses rose to $4.1 million, with a net loss of $4.4 million. The company has the potential for up to seven clinical trials this year, indicating strong momentum for future growth and shareholder value.
Moleculin Biotech, Inc. (Nasdaq: MBRX), a clinical stage pharmaceutical firm, announced its participation in the Q2 Virtual Investor Summit on May 17, 2021, at 12:30 PM ET. CEO Walter Klemp will present, with management available for one-on-one meetings with investors. The conference aims to highlight Moleculin's innovative drug candidates that target resistant tumors and viruses. A live video webcast will be available on the company's Investor Relations page and archived for 90 days. For details, visit www.moleculin.com.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that the FDA has granted Rare Pediatric Disease Designation to its drug WP1066 for treating ependymoma, a rare tumor affecting the brain and spinal cord, mainly in children. This designation recognizes the unmet medical needs in this area and allows for potential incentives, including a priority review voucher upon approval. Moleculin already holds Orphan Drug Designation for WP1066 and aims to advance its development program, believing WP1066 has the potential for effective therapy in pediatric patients.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has partnered with IQVIA Biotech to initiate clinical trials for WP1122, a drug aimed at treating COVID-19. The decision stems from delays in obtaining FDA approval due to the unavailability of validated COVID-19 animal models in the U.S. However, the company believes it has completed necessary preclinical testing to qualify for foreign IND submission. WP1122 is designed to enhance the drug-like properties of 2-deoxy-D-glucose (2-DG), which has shown efficacy against SARS-CoV-2.
Moleculin Biotech has received FDA Fast Track Designation for its drug Annamycin, aimed at treating soft tissue sarcoma lung metastases. This milestone allows the company to pursue accelerated approval and priority review for its New Drug Application (NDA). The company plans to initiate a clinical trial in the US by mid-2021, backed by a $1.5 million grant for a related clinical trial in Poland. Annamycin is positioned to potentially replace doxorubicin, with significantly lower cardiotoxicity and up to 30-fold lung accumulation. This addresses a major unmet need in STS treatment.
Moleculin Biotech (MBRX) reported financial results for 2020, highlighting a net loss of $17.4 million and R&D expenses of $12.8 million. The company raised approximately $81 million in early 2021, providing runway through at least 2023. Key milestones include FDA IND and ODD for Annamycin, a $1.5 million grant for a clinical trial in Europe, and promising interim results for WP1066 in pediatric brain tumors. Moleculin plans up to 8 clinical trials in 2021, emphasizing a robust pipeline aimed at resistant tumors and infectious diseases.
Moleculin Biotech, Inc. (Nasdaq: MBRX), a clinical-stage pharmaceutical company focusing on oncology drug development, announced management participation in four upcoming healthcare conferences. The events include the H.C. Wainwright Global Life Sciences Conference, ROTH Conference, Oppenheimer Healthcare Conference, and Maxim Emerging Growth Virtual Conference. Presentations will be available on-demand starting March 9, 2021, with various formats including panel discussions and one-on-one meetings. Audio webcasts will be accessible for 90 days post-event on Moleculin's investor relations website.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has announced that underwriters of its public offering, dated February 3, 2021, fully exercised their option to purchase an additional 2,141,052 shares at $4.75 each. This brings the total shares sold in the offering to 16,414,736, with gross proceeds of approximately $78.0 million before expenses. The offering was made under a shelf registration statement filed with the SEC. Oppenheimer & Co. acted as the sole book-running manager for this transaction.
Moleculin Biotech announced a grant of $1.5 million from the Polish Medical Research Agency to fund a Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases. The trial, led by Prof. Piotr Rutkowski in Warsaw, aims to address the unmet need for better treatments in this area. Annamycin, a next-generation anthracycline, has shown promising results in animal models and lacks the cardiotoxicity seen in traditional treatments like doxorubicin. The study is part of a broader collaboration between US and Polish teams.