Windtree Receives $0.7 Million SBIR Grant in Continuing Support of the AEROSURF® Phase 2b Clinical Trial Completion

WARRINGTON, Pa., May 22, 2018 /PRNewswire/ -- Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that the Company has received $0.7 million under a previously-awarded 2016 Phase II Small Business Innovation Research Grant (SBIR) valued at up to $2.6 million from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to support the AEROSURF^® phase 2b clinical trial in premature infants 26 to 32 weeks gestational age (GA) receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS). Under the terms of the grant, the Company had previously been awarded $1.9 million and has now been awarded the final $0.7 million to support activities through the completion of the AEROSURF phase 2b clinical trial one-year patient follow-up.

"We appreciate the NIH's continued recognition of the importance of our RDS research and support of our AEROSURF development program," commented Craig Fraser, Windtree's President and Chief Executive Officer. "We believe that the NIH's decision to continue its support of this program is the result of encouraging results throughout the AEROSURF phase 2 program. Our key objectives for 2018 include completing the one-year patient follow-up for the phase 2b clinical trial, initiating an AEROSURF bridge study to transition to our next generation aerosol delivery system (NextGen ADS) in the clinic, and advancing the AEROSURF program to phase 3. This award from the NIH contributes towards achieving these objectives."

In June 2017, the Company announced that it had completed enrollment in the AEROSURF phase 2b clinical trial, a multicenter, randomized, controlled study with masked treatment assignment in 221 premature infants that was designed to evaluate aerosolized KL4 surfactant administered to premature infants 26 to 32 weeks gestational age receiving nCPAP, in two dose groups (25 and 50 minutes) with up to two potential repeat doses, compared to infants receiving nCPAP alone. Based on the planned top-line results, AEROSURF did not meet the primary endpoint of a reduction in nCPAP failure at 72 hours due in large part to an unexpected rate of treatment interruptions, predominantly in the 50-minute dose group.  The Company believes these interruptions were primarily related to specific lots of disposable cartridge filters with a higher tendency to clog – the design of which has been modified in the Next Gen ADS to mitigate such interruptions.  After excluding in a pre-specified analysis those patients whose dose was interrupted, nCPAP failure rates were 44% in the control group (n=71) compared to 32% (n=44) in the AEROSURF 50-minute dose group, which is a 12% absolute reduction or a 27% relative reduction in nCPAP failure compared to control.  These data suggest a meaningful treatment effect in line with the desired targeted outcome. The overall data suggest that the safety and tolerability profile of AEROSURF was generally comparable to the control group.  As expected, some peridosing events occurred (e.g., changes in oxygen requirements and blood pressure in the time around dosing) more commonly in the AEROSURF groups; however, these were transient in nature and occurred less frequently than seen in intratracheal administration of surfactant.

Reported common complications of prematurity were those expected among premature infants with RDS and comparable to the control group.

Research supported by this SBIR grant is being conducted by Robert Segal, MD, Principal Investigator at Windtree under award number R44HL107000.  The content of this press release is solely the responsibility of the Company and does not necessarily represent the official views of the NIH.

About Windtree Therapeutics 
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.

For more information, please visit the Company's website at www.windtreetx.com.

Forward-Looking Statements  
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.  Examples of such risks and uncertainties include without limitation those risks related to Windtree's aerosolized KL4 surfactant development programs, including AEROSURF, which may involve time-consuming and expensive clinical trials and which may be subject to potentially significant delays or regulatory holds, or fail; risks related to the development of aerosol delivery systems (ADS) and related components; risks relating to manufacturing activities by contract manufacturers or suppliers of drug products, drug substances, ADS and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including those of the U.S. Food and Drug Administration or other regulatory authorities, that may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of Windtree's products; and other risks and uncertainties described in Windtree's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.

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SOURCE Windtree Therapeutics, Inc.