false 0000946486 0000946486 2022-08-11 2022-08-11
Washington, DC 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 11, 2022
Windtree Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
incorporation or organization)
File Number)
(I.R.S. Employer
Identification No.)
2600 Kelly Road, Suite 100, Warrington, Pennsylvania
(Address of principal executive offices)
(Zip Code)
Registrants telephone number, including area code: (215) 488-9300
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange
on which registered
Common Stock, par value $0.001 per share
The Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 2.02
Results of Operations and Financial Condition
On August 11, 2022, Windtree Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 8.01
Other Events
On August 11, 2022, the Company updated information reflected in a slide presentation, which is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. Representatives of the Company will use the updated presentation in various meetings with investors from time to time.
Item 9.01
Financial Statements and Exhibits
(d) Exhibits
The following exhibits are being filed herewith:
Cover Page Interactive Data File (embedded within the Inline XBRL document).

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Windtree Therapeutics, Inc.
/s/ Craig E. Fraser
Craig E. Fraser
President and Chief Executive Officer
Date: August 11, 2022

Exhibit 99.1



Windtree Therapeutics Reports Second Quarter 2022
Financial Results and Provides Key Business Updates



WARRINGTON, PA August 11, 2022  Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today reported financial results for the second quarter ended June 30, 2022 and provided key business updates.


“Since announcing the positive topline results from our Phase 2 SEISMiC study of istaroxime in early cardiogenic shock, we have received notable interest and positive scientific and biopharma industry responses in what has been widely recognized as a differentiated and desirable therapeutic profile to address a significant opportunity in the major markets of cardiogenic shock and heart failure,” said Craig Fraser, President and Chief Executive Officer of Windtree. “Positive SEISMiC study results have paved the way for what we believe could be a relatively fast and less expensive developmental and regulatory pathway and as such, we are executing study start-up for an extension to the SEISMiC study designed to optimize dosing for Phase 3. To support this opportunity, we have optimized our cash runway and aligned our resources and activities to focus on our cardiogenic shock program. We believe istaroxime presents a compelling opportunity to build value and help critically ill patients. We look forward to delivering additional clinical milestones and meeting with regulatory agencies to define the next steps in our development path to potential approval.”


Key Business Updates


Announced the SEISMiC early cardiogenic shock study of istaroxime met its primary endpoint in systolic blood pressure (SBP) profile over six hours with the istaroxime treated group performing significantly better compared to the control group and significant improvements through the 24-hour SBP profile measurement. The SBP increases were rapid, appearing within the first hour and sustained through the last measure at 96 hours. Istaroxime treatment also demonstrated improvement in cardiac index compared to control, and other key secondary measurements associated with cardiac function were significantly improved as well. Importantly, renal function and heart rate were maintained.


Presented the results of SEISMiC as a late-breaker presentation at the European Society of Cardiology Heart Failure Conference in Madrid, Spain. The presentation, entitled: “The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock,” was given by Dr. Marco Metra, Professor of Cardiology and Director of the Institute of Cardiology of the Department of Medical and Surgical Specialties, Radiological Sciences and Public Health of the University and Civil Hospitals of Brescia, Italy, and Principal Investigator of the Company’s Phase 2 SEISMiC study of istaroxime in early cardiogenic shock. Dr. Metra highlighted key details and results of the study, a summary of which can be found on the company’s Events page:


SEISMiC was also presented at the Critical Care Clinical Trialists meeting in Washington, DC by Dr. Alex Mebazza, Professor of Anesthesiology and Critical Care Medicine, Paris Diderot School of Medicine. Additionally, the trial was presented and discussed at an accompanying cardiogenic shock workshop.


The Company announced that it is leveraging positive istaroxime early cardiogenic shock results, and the interest from potential partners that it created, to proactively engage in formal licensing discussions and explore strategic opportunities that may lead to greater shareholder value.



Select Financial Results for the Second Quarter ended June 30, 2022


For the second quarter ended June 30, 2022, the Company reported an operating loss of $17.5 million, compared to an operating loss of $45.4 million in the second quarter of 2021. Included in operating loss for the second quarter of 2022 is non-cash expense of $11.6 million related to the impairment of goodwill. Included in operating loss for the second quarter of 2021 is non-cash expense of $37.8 million related to the impairment of the Company’s rostafuroxin intangible asset.


Research and development expenses were $3.0 million for the second quarter of 2022, compared to $4.2 million for the second quarter of 2021. The decrease in research and development expenses is primarily due to (i) a decrease of $0.5 million related to our decision in January 2022 to begin to reduce costs related to the KL4 surfactant platform; (ii) a decrease of $0.5 million in non-cash stock-based compensation expense; and (iii) a decrease of $0.2 million in direct clinical costs following the completion of enrollment in our Phase 2b study of lucinactant for patients with severe COVID-19 associated ARDS.


General and administrative expenses for the second quarter of 2022 were $2.9 million, compared to $3.4 million for the second quarter of 2021. The decrease in general and administrative expenses is primarily due to (i) a decrease of $0.3 million in non-cash stock-based compensation expense; and (ii) a decrease of $0.3 million in professional fees; partially offset by (iii) an increase of $0.1 million in personnel costs.


The Company reported a net loss of $17.3 million ($0.59 per basic share) on 29.2 million weighted-average common shares outstanding for the quarter ended June 30, 2022, compared to a net loss of $37.4 million ($1.42 per basic share) on 26.4 million weighted average common shares outstanding for the comparable period in 2021.


As of June 30, 2022, the Company reported cash and cash equivalents of $11.4 million, which is expected to be sufficient to fund operations into the first quarter of 2023.


Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, which will be filed with the Securities and Exchange Commission on August 11, 2022, which includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations.



About Windtree Therapeutics

Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for acute cardiovascular and acute pulmonary disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for acute heart failure and for early cardiogenic shock. Windtree’s heart failure platform includes follow-on oral pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the clinical development of AEROSURF®, to its licensee in Asia, Lee’s HK. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company’s clinical trials, clinical trial timelines or disruption in supply chain; the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates; the impacts of political unrest, including as a result geopolitical tension, including escalation in the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and any additional resulting sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, 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 the Company 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 the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; and the rate and degree of market acceptance of the Company’s product candidates, if approved. These and other risks are described in the Company’s periodic reports, including its annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


Contact Information:

Monique Kosse

LifeSci Advisors

212.915.3820 or




+++++ Tables to Follow +++++




Consolidated Balance Sheets


(in thousands, except share and per share data)



June 30, 2022


December 31, 2021






Current Assets:


Cash and cash equivalents

  $ 11,378     $ 22,348  

Prepaid expenses and other current assets

    1,784       1,143  

Total current assets

    13,162       23,491  

Property and equipment, net

    307       1,011  

Restricted cash

    154       154  

Operating lease right-of-use assets

    2,074       2,381  

Intangible assets

    32,070       32,070  


    4,046       15,682  

Total assets

  $ 51,813     $ 74,789  



Current Liabilities:


Accounts payable

  $ 1,072     $ 693  

Accrued expenses

    2,823       3,408  

Operating lease liabilities - current portion

    432       528  

Loans payable - current portion

    1,007       294  

Total current liabilities

    5,334       4,923  

Operating lease liabilities - non-current portion

    1,839       2,071  

Restructured debt liability - contingent milestone payments

    15,000       15,000  

Other liabilities

    3,800       3,800  

Deferred tax liabilities

    6,643       7,114  

Total liabilities

    32,616       32,908  

Stockholders’ Equity:


Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding at June 30, 2022 and December 31, 2021

    -       -  

Common stock, $0.001 par value; 120,000,000 shares authorized at June 30, 2022 and December 31, 2021; 29,406,196 and 28,268,950 shares issued at June 30, 2022 and December 31, 2021,

respectively; 29,406,172 and 28,268,926 shares outstanding at June 30, 2022 and December 31, 2021, respectively

    29       28  

Additional paid-in capital

    833,006       830,231  

Accumulated deficit

    (810,784 )     (785,324 )

Treasury stock (at cost); 24 shares

    (3,054 )     (3,054 )

Total stockholders’ equity

    19,197       41,881  

Total liabilities & stockholders’ equity

  $ 51,813     $ 74,789  




Consolidated Statements of Operations


(in thousands, except per share data)



Three Months Ended


Six Months Ended


June 30,


June 30,










Research and development

$ 2,995 $ 4,221   $ 8,340 $ 8,631  

General and administrative

  2,907   3,371     5,895   8,040  

Loss on impairment of goodwill

  11,636   -     11,636   -  

Loss on impairment of intangible assets

  -   37,770     -   37,770  

Total operating expenses

  17,538   45,362     25,871   54,441  

Operating loss

  (17,538)   (45,362 )   (25,871)   (54,441 )

Other income (expense):


Interest income

  17   39     18   89  

Interest expense

  (13)   (46 )   (26)   (87 )

Other income (expense), net

  201   (352 )   419   (243 )

Total other income (expense), net

  205   (359 )   411   (241 )

Loss before income taxes

  (17,333)   (45,721 )   (25,460)   (54,682 )

Deferred income tax benefit

  -   8,332     -   8,332  

Net loss

$ (17,333) $ (37,389 ) $ (25,460) $ (46,350 )

Net loss per common share


Basic and diluted

$ (0.59) $ (1.42 ) $ (0.87) $ (2.10 )

Weighted average number of common shares outstanding


Basic and diluted

  29,200   26,350     29,236   22,047  


Image Exhibit

Exhibit 99.2