Project Emerald
Confidential summary for informational purposes only — not an offer or solicitation. Details provided to qualified parties upon request/NDA.
Company Profile
Late-stage pharmaceutical company advancing Bivante, a DMA-free IV busulfan formulation for stem cell transplant conditioning.
Bivante removed dimethylacetamide (DMA), a Class 2 solvent used in current IV busulfan formulations, while retaining the established busulfan active ingredient.
Transaction Overview
Seeking $5.0mm Series B financing to complete registration-batch manufacturing, CMC package and NDA submission activities under 505(b)(2) pathway.
Prior financing includes $1.0m+ seed round and $1.0m+ Series A preferred.
Strategic optionality through licensing, partnership or acquisition for Bivante commercialization.
Investment Highlights
Potential safety-driven replacement thesis - Bivante is designed to eliminate the solubilizing agent DMA used in the formulation while preserving the established busulfan active ingredient, using a novel safe formulation. DMA has known side-effects of carcinogenicity, neurotoxicity and teratogenicity
Defined 505(b)2) regulatory pathway - As part of pre-IND discussions, FDA feedback has not requested new clinical trials; plan centers on completed preclinical work and CMC.
Established market with clear medical need - Busilfan is extensively used to treat treatment of leukemia, including CML, lymphomas etc., where bone marrow transplants are needed. Existing IV busulfan market estimated by management at >$300mm annually, despite known DMA limitations.
IP-protected, capital-efficient profile - Five issued U.S. busulfan patents plus foreign patents; no milestone or royalty obligations disclosed.
Disclosures
Full company name and drug name available upon NDA signature.