Windtree Therapeutics Inc (OTCMKTS:WINT) is a small biotech on the OTC that recently blew up. The clear catalyst for the move appears to be the company’s announcement of its top line results for its AEROSURF phase 2b clinical trial evaluating aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants, 28 to 32 week gestational age, receiving nasal continuous positive airway pressure (nCPAP) for RDS.
According to the release, a total of 221 patients were enrolled at 48 sites in North America, Europe and Latin America. “The AEROSURF phase 2b clinical trial was a multicenter, randomized, controlled study with masked treatment assignment in premature infants receiving nCPAP for RDS, and was designed to evaluate aerosolized KL4 surfactant administered to premature infants 28 to 32 week gestational age in two dose groups (25 and 50 minutes), with up to two potential repeat doses, compared to infants receiving nCPAP alone.“ The stock lost about 70% of its value on the report.
Windtree Therapeutics Inc (OTCMKTS:WINT) trumpets itself as a Biotechnology company focused on developing novel KL4 surfactant therapies for respiratory diseases and other potential applications.
According to company materials, “Windtree Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel surfactant therapies for respiratory diseases and other potential applications. Windtree’s proprietary technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant and novel drug-delivery technologies being developed to enable noninvasive administration of aerosolized KL4 surfactant. Windtree is focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants and believes that its proprietary technology may make it possible, over time, to develop a pipeline of KL4 surfactant product candidates to address a variety of respiratory diseases for which there are few or no approved therapies.”
Find out when $WINT stock reaches critical levels. Subscribe to OracleDispatch.com Right Now by entering your Email in the box below.
Here is the key statement: “Based on the planned top-line results, data show that AEROSURF did not meet the primary endpoint of a reduction in nCPAP failure at 72 hours. The nCPAP failure rates for the 25 minute (n=71) and 50 minute (n=72) dose groups were comparable to nCPAP alone (n=71) (44 percent, 44 percent and 44 percent, respectively).”
That is likely the spur in the side of the bear move in the stock. However, the company’s management was able to strike a positive tone.
“While the results did not meet the planned top-line analysis, we are very encouraged to see that, when dose is delivered as intended, the 50 minute dose exhibited a positive treatment effect with a safety profile comparable to that of nCPAP and consistent with the results we obtained in our previously completed phase 2a open-label clinical trial in similar gestational age infants,” said Steve Simonson, Chief Medical Officer.
The chart shows a decline of about -60% grilled out of share pricing for the stock in the past week, a tanking that has taken root amid largely bearish action over the larger time frame. This is emblematic of the stock in recent times. That said, one should note that WINT has a history of dramatic rallies.
Furthermore, the company has benefitted from a jump in recent trading volume to the tune of nearly 410% above its longer-run average levels. It pays to take note of this fact with a float in play that’s very limited — of 9.6M shares. As savvy traders are well aware, a mechanically driven price squeeze can result from this type of mix of small float and ramping attention from traders.
Now commanding a market cap of $3.3M, WINT has a significant war chest ($8M) of cash on the books, which compares with about $12.5M in total current liabilities. One should also note that debt has been growing over recent quarters. WINT is pulling in trailing 12-month revenues of $2.2M. In addition, the company is seeing major top line growth, with y/y quarterly revenues growing at 192%. As more color becomes clear on the name, we will review the situation and update our take. For continuing coverage on shares of $WINT stock, as well as our other breakout picks, sign up for our free newsletter today and get our next hot stock pick!