“Crossing the barrier for more efficient reproduction and increased Take-Home Baby Rate”
Scientific and business workplan


Years to sales:
As a drug, this product will have to undergo a full FDA approval including all clinical phases (6-7 years to Market).
The IUI enhancement indication, as it an ex-vivo procedure, might be approved for Fast track or as a solution or medical device rather than a drug, and as such might reach the market by 4-5 years.

Business model and revenue generation:
We plan to bring the molecules to a successful Toxicity and ADME assessment. At this stage we could either license out specific NCEs to interested companies based on License fees, Milestone payments and Royalties, or create a formulation of a synergistic nature by different potent factors that might be mixed to enhance their individual activity. A formulation for the proposed Gel/Ointment/Suppository will be generated and tested on animal models. We are planning to achieve either IND position or get the formulation to the end of a successful safety trial (Phase I) and/or efficacy trial (Phase 2a) and then either find a partner or license out most of the successful molecules/formulations.
This part should be either done with a big pharmaceutical/biotech company as a strategic partner or by an out licensing agreement. This could also be possible in-house following a public offering and fund raising in larger volumes. This stage might be a good exit point for original investors as success in previous stages will increase the value of the company significantly.


Research plan:
FertiProt is in the process of identifying candidate proteins, peptides and chemicals, which projected deployment is planned at a Proof of Concept (POC) site and running in-vitro and in-vivo models within months. Using a minimal team, the product will show POC within 18 - 24 months.
To date, there were no significant development costs; however, we’d like to move faster with a selected team of 2-3 employees within the upcoming year.
In order to get minimal POC (within six months), we would like to run a pilot test on two candidates (and their controls), in order to show the effect the proteins have on sperm function in-vitro. For that purpose we are looking for a quick investment of ~$400K, and are willing to allocate equities for that investment, as well as the right for first options/refusal on the full scale investment should basic POC be reached.
In parallel, FertiProt is in the process of raising ~$800K, and is willing to allocate company equity towards this purpose. During 2012-2013, the capital will be spent mostly on Research and Development and ensuring milestone progress achievements according to the plan. This in return will enable FertiProt to reach POC and achieve a significant IP portfolio, introducing the technology to the Pharma and fertility market. An additional capital fundraising round (in the order of $3-5M) is anticipated during the beginning or second half of 2014 in order to begin substantial preclinical and FIH development process.