We are building our pipeline through an internal process that identifies novel combinations of FDA-approved drugs that we can repurpose and combine to target biochemical pathways relevant to supportive care indications.

From a development standpoint, repurposing drugs is highly practical since much of the clinical and commercial risks can be mitigated before initiation of clinical trials. In addition, by leveraging both the 312.2(b)(1) and 505(b)(2) regulatory pathways, the clinical trials are highly expedited, with lower risks and substantially lower costs.

In making the determination to develop a combination product through Phase II, we use a series of highly focused screens that maximize the clinical and commercial likelihood of success.

We screen the indication for:

• Significant unmet medical need with more than 50,000 patient prevalence
• Potential for timely (less than four years) regulatory approval
• Multiple pharmaceutical partner interest in the category and in combination products
• Significant third-party reimbursement potential for combination products

We screen each component and combination product for:

• Key pathways associated with the indication
• Synergistic modes of action
• Compatibility with concurrent cancer therapies
• Ease of reformulation and access to third party manufacturing
• Potential for strong proprietary position via patent, orphan drug and other regulatory exclusions

These screens enable a highly cost-effective infrastructure with capital used for multiple, high impact clinical programs generating powerful and compelling proof-of-concept clinical data.