Moleculin Biotec Stock Price, News & Analysis

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.

Moleculin Biotech, Inc. announced a public offering of 14,273,684 shares of common stock priced at $4.75 per share, expected to close on February 5, 2021. The offering could raise approximately $67.8 million before expenses. The funds will support clinical trials, preclinical programs, and general corporate purposes. The underwriters have an option to purchase an additional 2,141,052 shares. Oppenheimer & Co. Inc. is the sole book-running manager, with Roth Capital Partners and Maxim Group serving as co-managers.

Moleculin Biotech, Inc. (Nasdaq: MBRX) announced its intention to conduct an underwritten public offering of common stock or pre-funded warrants. The offering will be managed by Oppenheimer & Co. Inc., which will also have a 30-day option to purchase an additional 15% of the shares. Proceeds will be allocated to clinical trials, preclinical programs, and general corporate purposes. The offering is subject to market conditions and completion timelines are uncertain, as detailed in their effective Form S-3 registration statement.