Windtree Therapeutics Reports Third Quarter 2021 Financial Results and Provides Key Business Updates
Nov 10, 2021
“I am very pleased to report on another productive quarter for Windtree. We continue to make progress with istaroxime, our lead clinical product candidate, and are focused on completing our phase 2 global study for the treatment of early cardiogenic shock, where we plan to announce topline data in Q1 2022. The need for new critical care cardiovascular therapies was clearly articulated during our KOL event held in October as well as in market research, and we believe istaroxime has the potential to be a meaningful new therapeutic innovation. The team is also busy preparing for the next study in our foundational program, acute heart failure with istaroxime. Concurrently, we are advancing an open-label phase 2 study of lucinactant (KL4) in patients with COVID-19 associated acute respiratory distress syndrome (ARDS) and anticipate topline data from this study in Q1 2022,” said Craig Fraser, President and Chief Executive Officer of Windtree. “Our business development group continues to be very active as we explore opportunities and engage with potential partners. Our balance sheet provides sufficient support of our upcoming clinical and regulatory milestones as well as company operations through 2022.”
Key Business and Financial Updates
- Hosted Key Opinion Leader (KOL) webinar on istaroxime for the treatment of acute heart failure and the upcoming data in early cardiogenic shock, featuring a presentation by
John Teerlink, M.D., University of California, San Francisco. Dr. Teerlinkpresented the current treatment landscape, highlighted the unmet medical need in treating patients with acute heart failure, and discussed the potential role for istaroxime based on clinical data he presented. Management followed with a presentation covering the clinical development program for istaroxime in early cardiogenic shock, which is currently in a phase 2 global study with data expected in the first quarter of 2022.
- Continued executing the Company’s lead program for istaroxime in the treatment of patients in early cardiogenic shock due to heart failure. These patients are characterized by very low blood pressure and risk for hypo-perfusion to critical organs. The ongoing phase 2 global study is designed to build upon data which showed istaroxime improved cardiac function and dose-related increases in systolic blood pressure in acute heart failure patients.
- Shared results from a
U.S.physician survey and market research estimating that the worldwide total market value of cardiogenic shock is $1.25 billion. In the survey results, 99 out of 100 U.S.-based cardiologists responded that there was high need for pharmacologic (drug) treatment for early cardiogenic shock patients. Additionally, 84% of the cardiologists responded that for early cardiogenic shock patients they would be “likely to extremely likely” to use a drug with the observed characteristics of istaroxime.
- Announced that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance of new patent claims for istaroxime administration. A notice of allowance is issued by the USPTO to indicate that the application has passed examination. When the new patent is issued by the USPTO, it will provide new intellectual property protection for istaroxime until late 2039.
- Presented a corporate overview at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit.
Select Financial Results for the Third Quarter ended
For the third quarter ended
Research and development expenses were
General and administrative expenses for the third quarter of 2021 were
The Company reported a net loss of
Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended
For more information, please visit the Company’s website at www.windtreetx.com.
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, KL4 surfactant and the Company’s other product candidates; 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, 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 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 the 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 www.sec.gov. 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.
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|Condensed Consolidated Balance Sheets|
|(in thousands, except share and per share data)|
|Cash and cash equivalents||$||24,541||$||16,930|
|Prepaid expenses and other current assets||1,826||1,188|
|Total current assets||26,367||18,118|
|Property and equipment, net||890||924|
|Operating lease right-of-use assets||2,412||917|
|LIABILITIES & STOCKHOLDERS’ EQUITY|
|Operating lease liabilities - current portion||278||805|
|Loans payable - current portion||734||352|
|Total current liabilities||5,143||6,131|
|Operating lease liabilities - non-current portion||2,196||201|
|Loans payable - non-current portion||-||2,423|
|Restructured debt liability - contingent milestone payments||15,000||15,000|
|Deferred tax liabilities||8,707||16,778|
|Additional paid-in capital||825,457||790,277|
|Total stockholders’ equity||50,179||69,552|
|Total liabilities & stockholders’ equity||$||84,825||$||112,885|
|Condensed Consolidated Statements of Operations|
|(in thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|Research and development||$||4,680||$||3,882||$||13,311||$||11,838|
|General and administrative||3,467||4,823||11,507||11,518|
|Loss on impairment of intangible assets||-||-||37,770||-|
|Total operating expenses||8,147||8,705||62,588||23,356|
|Other income (expense):|
|Other (expense), net||(53||)||(290||)||(296||)||(1,750||)|
|Total other (expense), net||(66||)||(315||)||(307||)||(1,756||)|
|Loss before income taxes||(8,213||)||(9,020||)||(62,895||)||(25,112||)|
|Deferred income tax benefit||-||-||8,332||-|
|Net loss per common share|
|Basic and diluted||$||(0.31||)||$||(0.54||)||$||(2.31||)||$||(1.65||)|
|Weighted average number of common shares outstanding|
|Basic and diluted||26,704||16,579||23,616||15,228|
Source: Windtree Therapeutics