Moleculin Q4 2019 Earnings Report
Key Takeaways
Moleculin Biotech, Inc. reported a net loss of $13.2 million for the year ended December 31, 2019. The company's cash and cash equivalents were $10.7 million as of December 31, 2019. They believe that their cash resources will be sufficient to meet operating requirements towards the end of the third quarter of 2020.
Annamycin met its primary endpoint and demonstrated a clean safety profile with no evidence of cardio-toxicity in Phase 1 portion of US Phase 1/2 clinical trial in AML.
Emory University received FDA approval for their IND status request for WP1066 in a pediatric brain tumor clinical trial.
Positive data reported from Phase 1 ‘proof-of-concept’ clinical trial with WP1220 for the treatment of cutaneous T-cell lymphoma (CTCL), which demonstrated a median reduction of 56% in skin cancer lesions.
Preclinical testing of WP1122 began as a new approach to Pancreatic cancer, by attacking cancer through inhibiting tumor metabolism.
Moleculin
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Forward Guidance
Moleculin anticipates several milestones in 2020, including the first patient treated in the Phase 1 clinical trial with WP1066, IND submission for Annamycin, pre-IND Meeting with FDA/EMA concerning a Phase 2 clinical trial with WP1220, FDA End of Phase 1 meeting for Annamycin in AML, achieving an MTD or a dose level at or above 300 mg/m2 in EU AML Phase 1/2 trial for Annamycin, and benefiting from non-dilutive financial funding for additional clinical trials
Positive Outlook
- First patient treated in the Phase 1 clinical trial with WP1066 for the treatment of pediatric brain tumors at Emory University
- IND submission for Annamycin for the treatment of tumor metastases to the lung
- Pre-IND Meeting with FDA/EMA concerning a Phase 2 clinical trial with WP1220 for the treatment of CTCL
- File IND/CTA for a Phase 2 clinical trial with WP1220 for the treatment of CTCL
- FDA End of Phase 1 meeting for Annamycin in AML
Challenges Ahead
- Achieving an MTD or a dose level at or above 300 mg/m2 in EU AML Phase 1/2 trial for Annamycin
- Benefit from non-dilutive financial funding for additional clinical trials
- The ability of Moleculin to successfully recruit sufficient patients to complete its current clinical trials
- The ability of Moleculin to be permitted by the FDA to accelerate its approval pathway for a pivotal Phase 2 trial by relying on its European trial to establish a recommended Phase 2 dose
- The ability of Moleculin to file an IND for the treatment of cancer metastases to the lung in 2020