Due Diligence Challenge:
An investor was considering re-investing into a development-stage microbiome company that had experienced certain issues that delayed timelines and changed the risk profile. In particular, they were concerned about the feasibility of completing the remaining clinical trials within predicted timeframes and also the capacity of the organization to scale up GMP manufacturing sufficiently for a possible commercial launch.
Solution:
Alacrita assessed the clinical issues via a combination of dataroom review, secondary research and by interviewing the target company's clinical team. We concluded that the company had taken all reasonable steps to ensure timeliness of trial recruitment and that, although risks remained, there was a reasonable chance that the trials would complete on time.
On the CMC issues, Alacrita sent a manufacturing expert with deep experience in biomanufacturing to conduct a field visit. He reviewed critical documentation, inspected the plant and the designs for scaled-up production and held meetings with the target company's manufacturing team. Alacrita's report highlighted a number of critical areas where short and medium term actions were necessary to ensure that the future capacity could come on stream at the projected time and with sufficient capacity to serve the market.
Due diligence for investors:
Alacrita routinely works with investors to perform independent evaluations of life science, pharmaceutical and biotech companies, assets and opportunities. Our many years of industry experience and our scientific expertise uniquely position us to handle complex assessments and provide dependable due diligence and valuations. For more information on this expertise please contact us.