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[Captain Hindsight]

Nascent Biotech Significant Milestones Achieved since 2015

Re-engineered antibody into CHO cells: The original cell line was created as a Hybridoma. Manufacturing from the Hybridoma cell line was a prohibitively expensive very process. A recombinant form was created that secretes over 40 fold more antibodies.
Created and fully characterized and qualified Master Cell Bank (MCB):
Produced 400+ grams of GMP grade mAb: This is a key inflection point with Biotech Investors which mitigates manufacturing risk. Formulation studies show that the antibodies are stable.
Pre-IND and clinical protocol discussions with FDA: There were no preclinical issues and the FDA provided guidance for our Study Protocol which increases the probability that we will gain IND approval on the first attempt. This also mitigates IND trial delays.
Settled $1.7M debt to license holder
Retired debenture – eliminating 30% shareholder dilution.
Finished in life phase toxicology studies (monkey and rat): “This is the easiest study I have ever seen. I wish all my Toxicology Studies went this well,” Fred Reno-Toxicology trial consultant. Completing the toxicology study mitigates toxicology issues. Nascent had none.
Completed Viral Clearance study – Significantly exceeds FDA recommendations.
Completed Fill and Finish of purified bulk product.
Filed IND Application April 2017 – Finalizing FDA requested studies. Plan to refile by mid Q 1 2018 (FDA requested a new Viral Clearance Study and a Tox/Clinical lot Comparative Analysis).
Signed $16 Million licensing deal with Hisun Pharmaceuticals for Mainland China - $ 3 million received in upfront payment – Saved investors significant dilution.
Raised $1.45 Million in equity investment – no debt financing.

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