When we started the WeFunder campaign, we had just been notified that we were in line for a $2m grant to fund our research expanding the use of our drugs into chemo-induced peripheral neuropathy, a new indication that may allow us to accelerate drug approval.
For our primary indication, diabetic peripheral neuroapthy , we have finished our phase 1 trials in Australia and are about to begin our phase 2 trials in Canada, which was being funded by a Canadian consortium. We recently, in the last two weeks, have been notified that we should (based on our scores) be receiving another grant to begin trials in the United States parallel to the studies in Canada (~$3M). Obviously we are ecstatic and appreciative that we 1) received a great score and 2) can expand our studies into the United States hopefully soon. Again, these grants pay for a substantial portion of the study but do not pay for 1) drug product, 2) support of the trials including external CROs, 3) regulatory tools for submission, and 4) the regulatory filings. We are now more reliant on individuals such as those on WeFunder who have a vested interest. These are all peer reviewed grants which means that those in the community strongly believe in our work. Thank you for your support.
So, as a summary, for diabetic peripheral neuropathy, phase 1 is complete and we have a good portion of our phase 2 costs covered (maybe about half). After phase 2 is typically where you see one of the greatest inflection points (value jump). We anticipate this may be a point where we may have opportunities for some of our investors to exit some/all of their investments.
Separately, we are always looking for ways to accelerate approval. Clinical studies in smaller populations, such as hereditary peripheral neuropathies, CIPN or HIV-induced neuropathies, allows us this opportunity. Thus, we have been looking at means to accomplish this resourcefully, including through new grant submissions, partnerships particularly in foreign countries, additional investments, etc.
Finally, many of you have inquired about participating in clinical trials. I have asked that you personally reach out to me because I'd like to keep your private information private - and WeFunder is not private. If you are interested in participating, the best way to keep tabs of our activities is through our newsletter or social media accounts. We will attempt to keep you informed when we anticipate recruitment and where.
The year is not over yet and we have a few additional campaigns we will be starting. Keep tabs. Thanks.
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