Story of AntiOp, Inc. (f/k/a Alcomed, Inc.) Daniel Wermeling, Pharm.D. President and CEO Professor of Pharmacy University of Kentucky College of Pharmacy

Starting History My background Opioid overdose is health crisis Opioid antidote expansion in public policy discussion Antidote (naloxone) is approved only as injection Naloxone IP expired IP for nasal spray is prior part Filings with FDA, NIH and State to address public health need and seek grants and research approvals

Is Commercialization of Naloxone Nasal Spray Possible? Can It Pass Tests? Company Formation Intellectual Property Unmet Medical Need Business Plan Market Assessment Capital Needs Political Position Product Design – Formula – Device – Product FDA Regulatory Strategy – CMC – Pharm/Tox – Clinical Cost of Goods Commercial Production Competition Market Exclusivity Pricing Partner/License Exit

Development Plan Work it forwards and backwards – Meaning starting from scratch and going forward to launch – Consider the actual usage in healthcare and how medical personnel (MD, RN, RPh) and patients will use And the steps necessary to support the vision going backwards – Consider how it fits into traditional healthcare delivery (i.e., drug distribution/administration) and healthcare finance – For each market segment

Seek Input From the Governing Federal Agency Before Grant Filing FDA in this case File pre-IND dossier Explain product and development plans ASK THEM QUESTIONS – Like structured interview – Do you agree there is an unmet need for…..? – Do you agree with seeking approval under…? – Do you agree with product design………? – Do you agree with preclinical plan…….? – Do you agree with clinical study design…..? FDA must respond in writing The GOLDEN LETTER: Endgame is CLARITY

Then Write The Grant One risk factor is removed/diminished for reviewers – credible FDA plan The path is the path Virtual versus Brick & Mortar Co. Can you do good science? Are you in regulatory compliance? It is unlikely you can do it all – do not be over- confident Get good contractors and consultants

AntiOp History 2 Awarded STTR Fast-track $ 1.45 M – SOW – to clinical proof State matching funds – 2 awards ($ 150 and $ 500 K) – Fills in gaps for what feds can not pay for Phase 2 b - $ 3 M/ 3 years FDA User Fee Waiver ($ 2 M) through SBA FDA regulatory path clear Seeking final capital and marketing partner

Concluding Remarks Comprehensive assessment early Resolve weaknesses Seek early government assessment Regulatory strategy is driver Focus on critical path elements adding value Be virtual where possible Leverage state and other sources of funding Know exit point – do only what you do best