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

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 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 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.

 

Windtree Therapeutics, Inc.

Condensed Consolidated Statement of Operations

(in thousands, except per share data)
















Three Months Ended






March 31,






2019


2018



Revenues:








License revenue with affiliate

$             40


$             204





Total revenue

40


204











Expenses:







Research and development

3,342


3,118




General and administrative

3,355


1,926





Total operating expenses

6,697


5,044











Operating loss

(6,657)


(4,840)












Interest expense, net

(76)


(86)




Other income, net

196


414



Net loss

$    (6,537)


$    (4,512)









Net loss per common share – basic and diluted

$        (0.20)


$        (1.40)









Weighted avg. common shares outstanding – basic
and diluted

 

32,142


 

3,227


















Windtree Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(in thousands)






March 31,








2019

(Unaudited)


December 31,
2018

ASSETS





Current Assets:






Cash and cash equivalents


$                2,053


$                  11,187


Available-for-sale marketable securities


13,514


13,959


Prepaid expenses and other current assets


502


507




Total current assets


16,069


25,653









Property and equipment, net


826


802

Restricted cash


171


171

Operating lease right-of-use assets


1,788


Intangible assets


77,090


77,090

Goodwill


15,682


15,682



Total assets


$              111,626


$                119,398









LIABILITIES AND STOCKHOLDERS' EQUITY





Current Liabilities:






Accounts payable, collaboration and device development payable and accrued expenses


 

$                8,603


 

$                12,461


Operating lease liabilities – current portion


730



Deferred revenue


158


198


Loan payable


7,469


7,974




Total current liabilities


16,960


20,633









Operating lease liabilities – non-current portion


1,251



Restructured debt liability – contingent milestone payments


15,000


15,000

Deferred tax liabilities


15,356


15,476

Other liabilities


63


175

Stockholders' Equity


62,996


68,114



Total liabilities and stockholders' equity


$              111,626


$               119,398


















 

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SOURCE Windtree Therapeutics, Inc.