Windtree Therapeutics Reports Third Quarter 2017 Financial Results

General and administrative expenses were $1.7 million for the third quarter of 2017, compared to $1.6 million for the third quarter of 2016.

Interest expense for the third quarter of 2017 and 2016 was $0.6 million and primarily represents interest expense on $25 million of long-term debt.

The Company reported a net loss of $5.4 million for the third quarter of 2017, compared to a net loss of $8.4 million for the comparable period in 2016.

In addition, in the third quarter of 2017, the Company reported a $1.9 million non-cash deemed dividend on preferred stock, resulting in a net loss attributable to common shareholders of $7.4 million ($0.69 per basic share) on 10.6 million weighted-average common shares outstanding, compared to a net loss attributable to common shareholders of $8.4 million ($1.00 per basic share) on 8.4 million weighted average common shares outstanding for the comparable period in 2016.

As of September 30, 2017, the Company had cash and cash equivalents of $1.8 million. In addition, as of September 30, 2017, the Company reported current liabilities of $29.5 million (including $12.5 million of long-term debt, current portion and $2.6 million loan payable to Lee's Pharm) and long-term debt of $12.5 million. Prior to the restructuring, the current portion of long-term debt was due in February 2018 and the non-current portion of long-term debt was due in February 2019.  Both obligations were eliminated as part of the financial restructuring.

Financial Restructuring Program

The Company recently announced completion of a financial restructuring plan to provide short-term financing and improve the Company's capital structure, including through a purchase by LPH Investments Limited ("LPHIL"), a wholly-owned subsidiary of Lee's Pharmaceutical Holdings Limited ("Lee's Pharm) of $10 million of the Company's common stock, giving Lee's Pharm a controlling interest in the Company, and a simultaneous restructuring and retirement of $25 million of long-term debt under the 2013 secured loan facility agreement between the Company and affiliates of Deerfield Management Company, L.P. ("Deerfield").

Under terms of the share purchase agreement, LPHIL purchased from the Company $10 million of newly-issued common stock to acquire a controlling interest of the Company at a price per share of $0.2163, representing a 15 percent premium to the average 10-day volume weighted average price per share (VWAP) through October 27, 2017. As partial consideration for the share purchase, Lee's Pharm cancelled $3.9 million principal outstanding under an August 2017 loan agreement, which Lee's Pharm had advanced in three equal installments in August, September, and October 2017, to support AEROSURF development activities and sustain the Company's operations through October 31, 2017, while the parties negotiated the share purchase agreement. 

To facilitate the share purchase by Lee's Pharm, Deerfield agreed to restructure its $25 million secured loan to the Company effective as of the closing of the share purchase agreement. Under the loan restructuring agreement, in exchange for return and cancellation of the Deerfield notes, the Company paid to Deerfield $2.5 million in cash, and issued to Deerfield shares of common stock representing two percent of the Company's common stock post-closing on a fully-diluted basis, as defined in the loan restructuring agreement. In addition, Deerfield will be entitled to receive up to $15 million in future AEROSURF regulatory and commercial milestones, beginning with the filing for marketing approval in the United States.

In addition, the Company entered into a nonbinding memorandum of understanding with Battelle Memorial Institute (Battelle MOU) outlining potential terms to restructure payment terms of certain accounts payable related to the Company's device development activities with Battelle.  In connection with the Battelle MOU, Battelle executed and delivered a waiver of its rights to receive payments under a liquidation preference pursuant to Series A Convertible Preferred Stock held by Battelle and the related Certificate of Designation of Preferences, Rights and Limitations effective February 15, 2017.

After implementation of the financial restructuring, as of November 1, 2017, the Company had cash and cash equivalents of $5.4 million.  The Company believes that, before any additional financings, it will have sufficient cash resources to support development activities, partially satisfy existing obligations and fund operations into January 2018.

Readers are referred to, and encouraged to read in its entirety, the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 which was filed with the Securities Exchange Commission on November 14, 2017, and includes discussion about the Company's business plans and operations, financial condition and results of operations.

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, 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 the success of AEROSURF clinical trials and whether they are sufficient to support a strategic or financing transaction and enable initiation of phase 3 development; risks that Windtree will be unable to secure significant additional capital as and when needed, if at all, whether through debt or equity financings or other strategic transaction; risks related to having the Company's common stock quoted on the  OTCQB® market; risks related to Windtree's  AEROSURF development program and other development programs in the future, 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 the development of aerosol delivery systems (ADS) and related components; risks related to technology transfers to contract manufacturers and problems or delays encountered by Windtree, contract manufacturers or suppliers in manufacturing, testing and releasing drug products, drug substances, and ADS on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including those of: (i) the FDA 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 (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals; 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.

				Windtree Therapeutics, Inc.
				Condensed Consolidated Statement of Operations
				(in thousands, except per share data)
				Three Months Ended				Nine Months Ended
				September 30,				September 30,
				(unaudited)				(unaudited)
				2017		2016		2017		2016
Revenues:
	Grant revenue			$         17		$             961		$         1,383		$        1,142
Operating expenses:
	Research and development			3,062		7,081		14,958		25,757
	General and administrative			1,749		1,613		5,475		7,053
	Total expenses			4,811		8,694		20,433		32,810
Operating loss				(4,794)		(7,733)		(19,050)		(31,668)
Change in fair value of common stock warrant liability				–		–		–		223
Other income / (expense):
	Interest income			3		3		9		15
	Interest expense			(652)		(648)		(1,878)		(1,907)
	Other income			–		15		–		449
Net loss				$      (5,443)		$    (8,363)		$    (20,919)		$    (32,888)
Deemed dividend on preferred stock				(1,915)		–		(6,051)		– Werbung Mehr Nachrichten zur Windtree Therapeutics Aktie kostenlos abonnieren E-Mail-Adresse Bitte überprüfe deine die E-Mail-Adresse. Benachrichtigungen von ARIVA.DE (Mit der Bestellung akzeptierst du die Datenschutzhinweise) -1 Vielen Dank, dass du dich für unseren Newsletter angemeldet hast. Du erhältst in Kürze eine E-Mail mit einem Aktivierungslink. Hinweis: ARIVA.DE veröffentlicht in dieser Rubrik Analysen, Kolumnen und Nachrichten aus verschiedenen Quellen. Die ARIVA.DE AG ist nicht verantwortlich für Inhalte, die erkennbar von Dritten in den „News“-Bereich dieser Webseite eingestellt worden sind, und macht sich diese nicht zu Eigen. Diese Inhalte sind insbesondere durch eine entsprechende „von“-Kennzeichnung unterhalb der Artikelüberschrift und/oder durch den Link „Um den vollständigen Artikel zu lesen, klicken Sie bitte hier.“ erkennbar; verantwortlich für diese Inhalte ist allein der genannte Dritte. Andere Nutzer interessierten sich auch für folgende News 18.04.24 - PR Newswire BlackRock Sustainable American Income Trust Plc - Transaction in Own Shares 18.04.24 - PR Newswire Norges Bank - Form 8.3 - International Distributions Services plc 18.04.24 - PR Newswire Miton UK Microcap Trust Plc - Director/PDMR Shareholding Auf zur INVEST am 26.+ 27.04.2024    Foto: Landesmesse Stuttgart GmbH - Jetzt kostenloses Ticket sichern! weiterlesen» Anzeige wo-site-teaser-box-16688_site-teaser-box_2024-04-17_09%253A00%253A00_2024-04-22_09%253A00%253A59