Due diligence and valuation of a preclinical kinase inhibitor

Challenge

We were commissioned to conduct a comprehensive technical risk assessment and due diligence of a novel preclinical, small molecule, kinase inhibitor.

Solution

We assembled a team of three ex-industry experts to assess:

  • mechanism of action
  • in vivo efficacy
  • pharmacokinetics
  • dosing and schedule
  • toxicology
  • competitive positioning
  • clinical strategy
  • IP
  • CMC/formulation
  • management

There was a strong rationale for the target, and it was noted that the work conducted to date was of high quality. Our analysis of the competitive landscape identified a big pharma program which was a direct threat and several years ahead for a particular indication. The toxicity of the molecule was a significant concern with side effects that rivaled cytotoxic chemotherapy. However, we believed the narrow therapeutic window to be manageable given the strength of the in vivo efficacy data. Our initial concerns around dosing were mitigated with additional data provided by the company to demonstrate a more practical dosing schedule. The patent claims were robust and valid and the CMC/formulation was adequate for the stage of development of the molecule.

We recommended that the management team be significantly strengthened and that the company pursue a different development strategy to differentiate the molecule against competition, address significant unmet medical needs and maximize the potential for the molecule to be positioned as best-in-class.

We were then asked to develop a valuation model to help inform investment negotiations. We developed a risk adjusted NPV valuation model for the asset, using Monte Carlo simulations to accommodate the significant uncertainties facing a preclinical oncology program. In our report, we documented the rationale behind our assumptions, all of which were based on real-world data and personal professional experience. In addition to providing this theoretical NPV model, we advised the client on real-world valuations for similar assets which were the subject of a Series A financing.

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