Challenge:
A VC firm was interested in a US-based drug repurposing company and asked Alacrita to perform a high level technical due diligence exercise to help the firm make an informed decision about whether to proceed to full formal due diligence.
Solution:
The target company was capitalizing on the FDA’s 505(b)(2) regulatory pathway to progress several clinical candidates in different CNS indications to the market within five years. After review of the key development programs covering preclinical and clinical data, clinical development plan, regulatory review, exit strategy, market opportunity and management team, Alacrita discussed its preliminary findings with the target company. Using the additional information gained from this discussion, Alacrita highlighted the key risks with each program and the company as a whole, labelling them by severity and impact for the VC firm.
Alacrita concluded that the number of programs the company was running, all at critical phases was ambitious and would require significant attention to ensure they were adequately resourced and given the optimal chance of success. We also recommended an in-depth evaluation of the company’s CMC planning and activities, and clinical development capabilities. A deeper dive into the company’s plans to address specific requests from the FDA was also suggested, as well as potential review of the opportunity for indication expansion for one of the clinical candidates.
Our CNS Expertise
We regularly consult with clients developing CNS therapeutics, as well as advise investors and BD teams on individual assets, pipelines and companies in this field. For more details on our expertise, please visit the below page or reach out.
Explore Our Due Diligence Services
Alacrita's due diligence consultants have been a trusted source of pharma and biotech DD for over 15 years, underpinned by our ability to ensure each due diligence exercise is supported by individuals with the precise industry expertise required to be thorough, complete and accurate.