EmergingGrowth.com NewsWire – EmergingGrowth.com, a leading independent small cap media portal with an extensive history of providing unparalleled content for the Emerging Growth markets and companies, reports on Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE)
- Extended Study Interim Results Well Tolerated in 3 Shots
- Confirmation of Warrant Exercise Reduces Dilution Risks
- Expectation of Clinical Study Report Expected Today
- 12 year Exclusivity under FDA Rules
- Licensing and Buyout Expectations Growing
Ampio Pharmaceuticals (NASDAQ: AMPE) announced yesterday highlights from their conference call that seemed to spark a change in investor sentiment. According to shortsqueeze.com the outstanding short position has been reduced by 31% in the latest reporting period. This puts the current reported short position at 7.7 million shares and doesn’t even include the large naked short position as reported by the Company. The opioid epidemic is in the headlines again, this time in Federal court. Some of the high-profile defendants include pharmaceutical giants Johnson & Johnson (NYSE: JNJ), Purdue Pharma and Teva Pharmaceuticals (NASDAQ: TEVA), large distributors McKesson (NYSE: MCK) and Cardinal Health (NYSE: CAH) and pharmacy chains like CVS (NYSE: CVS), Rite Aid (NYSE: RAD) and Walgreens. Opioids are the primary drug of choice for Osteoarthritis of the Knee (OAK) patients. Approval of Ampion could have a major effect on the opioid epidemic.
AMPE announce that it would complete the Open Label Extension (OLE) study before filing the BLA in Q3. According to CEO Macaluso “We are pleased to report the continued safety and tolerability of the product following three injections of Ampion with no drug-related TEAEs or serious TEAEs reported in the OLE study.” The label is seeking up to 5 injections and the OLE is over the halfway point and is safe and well tolerated.
The need for additional financing was a recurring theme that died on the release of the company’s cash position. Right now the company has $10.4 million of cash and they have enough money given their $830K estimated burn rate which includes the filing of the BLA into January of 2019 without having to raise any additional money. Furthermore they also have 5 million warrants left to be exercised that could bring in additional funding should the company not be purchased or unable to get a licensing deal. AMPE seems focused on securing a licensing deal or an outright purchase of the company. A licensing agreement alleviates the need for any future financing.
In the conference call the last appraisal was in the 10 digits which means over a $1.0 billion valuation and with no dilution in sight this year and a possible licensing deal there seems to be much more upside risk in the stock. The news from the OLE study was very positive and indicated they are making quick progress with the study and the filing of the BLA. Drug approval could come as soon as 2019 assuming that company isn’t purchase by one of their suitors before then. Every study update reduces the risk of approval. According to industry metrics there is an 86% chance of approval of a BLA in the current stage of development. Assuming a $1 billion valuation metric on submission the company should be worth $860 million in Sept or $8.60/share. Over the next 6 months there will be additional catalysts and a strong possibility of a licensing deal which could explode the valuation.
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