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Merger | Merged



About CVie Therapeutics

CVie Therapeutics is a stand-alone drug development company specialized in cardiovascular diseases.

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Windtree Therapeutics Reports First Quarter 2019 Financial Results and Provides Key Business Updates

May 20, 2019

0 Message : *Required fields WARRINGTON, Pa., May 20, 2019 /PRNewswire/ -- Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today reported financial results for the first quarter ended March 31, 2019 and provided key business updates. Key Business and Financial Updates In December 2018, Windtree completed the acquisition of CVie Investments Limited (CVie), together with its wholly-owned subsidiary, CVie Therapeutics Limited, a privately-held company focused on developing drugs to treat cardiovascular diseases, in an all-stock transaction. The combined Company is a diversified acute care company with multiple late-stage product candidates targeting acute cardiovascular and pulmonary diseases and multiple pre-clinical assets and programs. Led by Windtree management, the Company is headquartered in Warrington, PA with pre-clinical operations in Taipei, Taiwan and Milan, Italy. During the first quarter of 2019, the Company completed the operational integration of CVie into Windtree and is now focused on development activities potentially to transition its lead programs – istaroxime for acute heart failure and AEROSURF® for respiratory distress syndrome (RDS) in premature infants – towards phase 3. The Company recently announced the results of a new post-hoc, pooled analysis of previously released phase 2 data suggesting that AEROSURF® may reduce the overall incidence and severity of bronchopulmonary dysplasia (BPD) in premature infants with RDS, regardless of whether or not the infant was ultimately intubated. The new data were recently presented at the Pediatric Academic Societies (PAS) Meeting, the leading event for academic pediatrics and child health research. As of March 31, 2019, the Company had cash and cash equivalents of $2.1 million and $13.5 million of available-for-sale marketable securities. The Company currently believes that it has sufficient cash, cash equivalents and available-for-sale marketable securities to fund its development activities, business operations and debt service through October 2019. "Through the first quarter of 2019, we worked to transition Windtree into a diversified, global late-stage development company," commented Craig Fraser, President and Chief Executive Officer. "By completing the CVie acquisition, we have successfully met our goal to create a company with numerous, short- to mid-term value-creating opportunities. I am pleased with the post-acquisition integration and the strong progress made to advance the istaroxime and AEROSURF® programs, fueled by the recent investment. We have new data and events planned over the next few months and we look forward to keeping our stakeholders updated on our plans and milestone achievements." Select Financial Results for the First Quarter ended March 31, 2019 For the quarter ended March 31, 2019, the Company reported an operating loss of $6.7 million, compared to $4.8 million for the first quarter of 2018. The increase was due to an increase in general and administrative expenses. Research and development expenses were $3.3 million for the first quarter of 2019 compared to $3.1 million for the first quarter of 2018. General and administrative expenses for the first quarter of 2019 were $3.4 million, compared to $1.9 million for the first quarter of 2018. The increase was due to a $1.1 million increase in non-cash, stock compensation expense as a result of employee stock option grants in the fourth quarter of 2018 and the first quarter of 2019. There were no employee stock option grants in the first quarter of 2018. For the quarter ended March 31, 2019, the Company reported a net loss of $6.5 million ($0.20 per share) compared to a net loss of $4.5 million ($1.40 per share) for the first quarter of 2018. As of March 31, 2019, the Company had cash and cash equivalents of $2.1 million and available-for-sale marketable securities of $13.5 million. In addition, as of March 31, 2019, the Company had current liabilities of $17.0 million (including $7.5 million in debt). The Company anticipates that its currently existing cash, cash equivalents and marketable securities resources are sufficient to fund its development activities, business operations and debt service through October 2019. Readers are referred to, and encouraged to read in its entirety, the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 which is expected to be filed with the Securities and Exchange Commission on or before May 20, 2019 and includes a discussion of the Company's business plans and operations, financial condition and results of operations. About Windtree Therapeutics Windtree Therapeutics, Inc. is a clinical-stage, biopharmaceutical and medical device company focused on the development of novel therapeutics intended to address significant unmet medical needs in important acute care markets. Windtree has four lead development programs and multiple pre-clinical programs spanning respiratory and cardiovascular disease states, including istaroxime, a novel, dual-acting agent being developed to improve cardiac function in patients with acute heart failure while avoiding the unwanted side effects of existing treatments; AEROSURF®, an innovative combination drug/device product candidate that is designed to deliver the Company's proprietary synthetic, peptide-containing surfactant non-invasively to premature infants with respiratory distress syndrome (RDS); and rostafuroxin, a novel precision drug product being developed to target hypertensive patients with certain genetic profiles in the important group of patients with resistant hypertension. Windtree also has multiple pre-clinical products including potential heart failure therapies delivered orally that are based on SERCA2a mechanism of action. For more information, please visit the Company's website at . 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, including projections of future cash balances and anticipated cash outflows, to differ materially from the statements made. Examples of such risks and uncertainties include: the risk that, as a development company with limited resources and no operating revenues, the Company's ability to continue as a going concern in the near term is highly dependent upon successful and timely advancement of its clinical development programs for istaroxime and AEROSURF®; risks that Windtree will be unable to secure significant additional capital as and when needed, or to access debt or equity financings, which could result in substantial equity dilution; risks related to Windtree's  development programs, which may involve time-consuming and expensive pre-clinical studies and clinical trials and which may be subject to potentially significant delays or regulatory holds, or fail; risks related to technology transfers to contract manufacturers and manufacturing development, and problems or delays encountered by Windtree, contract manufacturers or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the FDA or other regulatory authorities may not agree with Windtree on matters raised during regulatory reviews, 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 (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals; risks related to Windtree's efforts to maintain and protect the patents and licenses related to its 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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