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WARRINGTON, Pa., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for cardiovascular disorders, today reported financial results for the third quarter ended September 30, 2022 and provided key business updates.
“The Company had several notable deliverables this quarter and continues to focus on progressing its planned development of istaroxime. The positive results of the SEISMiC study of istaroxime in early cardiogenic shock have been well received in many scientific forums. At the same time, our team has been active in working to advance istaroxime into the next clinical trial in early cardiogenic shock. To support development and company operations, we are addressing our resources by exploring options for financing, as well as actively engaging in business development activities, both licensing and strategic,” said Craig Fraser, President and Chief Executive Officer of Windtree. “Additionally, the out-licensing of our acute pulmonary KL4 surfactant platform this quarter supports our portfolio and resource prioritization strategy as we focus on istaroxime and the significant opportunity in the major markets of cardiogenic shock and heart failure. With all that we are executing, we look forward to providing our shareholders with updates on our plans and progress.”
Key Business Updates
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Select Financial Results for the Third Quarter ended September 30, 2022
For the third quarter ended September 30, 2022, the Company reported an operating loss of $4.7 million, compared to an operating loss of $8.1 million in the third quarter of 2021. Included in operating loss for the third quarter of 2022 is non-cash expense of $0.5 million related to the impairment of goodwill
Research and development expenses were $1.5 million for the third quarter of 2022, compared to $4.7 million for the third quarter of 2021. The decrease in research and development expenses is primarily due to (i) a decrease of $1.9 million related to the KL4 surfactant platform as we continue to focus our resources on the development of our istaroxime pipeline; (ii) a decrease of $0.5 million in non-cash stock-based compensation expense; (iii) a decrease of $0.5 million for expenditures related to the development of istaroxime for AHF; and (iv) a decrease of $0.3 million following the completion of enrollment in the SEISMiC study in March 2022.
General and administrative expenses for the third quarter of 2022 were $2.7 million, compared to $3.5 million for the third quarter of 2021. The decrease in general and administrative expenses is primarily due to (i) a decrease of $0.4 million in professional fees; and (ii) a decrease of $0.4 million in non-cash stock-based compensation expense.
The Company reported a net loss of $4.1 million ($0.13 per basic share) on 31.1 million weighted-average common shares outstanding for the quarter ended September 30, 2022, compared to a net loss of $8.2 million ($0.31 per basic share) on 26.7 million weighted average common shares outstanding for the comparable period in 2021.
As of September 30, 2022, the Company reported cash and cash equivalents of $8.4 million, which is expected to be sufficient to fund operations into the second 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 September 30, 2022, which will be filed with the Securities and Exchange Commission on November 14, 2022, and 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 cardiovascular 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 KL4 surfactant platform, to its licensee, 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 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 of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and any 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 U.S. Food and Drug Administration 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 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.
Contact Information:
Monique Kosse
LifeSci Advisors
212.915.3820 or monique@lifesciadvisors.com
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WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
| (in thousands, except share and per share data) |
| September 30, 2022 | December 31, 2021 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 8,436 | $ | 22,348 | ||||
| Prepaid expenses and other current assets | 1,596 | 1,143 | ||||||
| Total current assets | 10,032 | 23,491 | ||||||
| Property and equipment, net | 286 | 1,011 | ||||||
| Restricted cash | 154 | 154 | ||||||
| Operating lease right-of-use assets | 1,964 | 2,381 | ||||||
| Intangible assets | 32,070 | 32,070 | ||||||
| Goodwill | 3,592 | 15,682 | ||||||
| Total assets | $ | 48,098 | $ | 74,789 | ||||
| LIABILITIES & STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 410 | $ | 693 | ||||
| Accrued expenses | 2,496 | 3,408 | ||||||
| Operating lease liabilities - current portion | 416 | 528 | ||||||
| Loans payable - current portion | 629 | 294 | ||||||
| Total current liabilities | 3,951 | 4,923 | ||||||
| Operating lease liabilities - non-current portion | 1,732 | 2,071 | ||||||
| Restructured debt liability - contingent milestone payments | 15,000 | 15,000 | ||||||
| Other liabilities | 3,800 | 3,800 | ||||||
| Deferred tax liabilities | 6,195 | 7,114 | ||||||
| Total liabilities | 30,678 | 32,908 | ||||||
| Stockholders’ Equity: | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value; 120,000,000 shares authorized at September 30, 2022 and December 31, 2021; 32,646,735 and 28,268,950 shares issued at September 30, 2022 and December 31, 2021, respectively; 32,646,711 and 28,268,926 shares outstanding at September 30, 2022 and December 31, 2021, respectively | 33 | 28 | ||||||
| Additional paid-in capital | 835,281 | 830,231 | ||||||
| Accumulated deficit | (814,840 | ) | (785,324 | ) | ||||
| Treasury stock (at cost); 24 shares | (3,054 | ) | (3,054 | ) | ||||
| Total stockholders’ equity | 17,420 | 41,881 | ||||||
| Total liabilities & stockholders’ equity | $ | 48,098 | $ | 74,789 | ||||
WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
| (in thousands, except per share data) |
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Expenses: | ||||||||||||||||
| Research and development | $ | 1,543 | $ | 4,680 | $ | 9,883 | $ | 13,311 | ||||||||
| General and administrative | 2,653 | 3,467 | 8,548 | 11,507 | ||||||||||||
| Loss on impairment of goodwill | 454 | - | 12,090 | - | ||||||||||||
| Loss on impairment of intangible assets | - | - | - | 37,770 | ||||||||||||
| Total operating expenses | 4,650 | 8,147 | 30,521 | 62,588 | ||||||||||||
| Operating loss | (4,650 | ) | (8,147 | ) | (30,521 | ) | (62,588 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 39 | 1 | 57 | 90 | ||||||||||||
| Interest expense | (14 | ) | (14 | ) | (40 | ) | (101 | ) | ||||||||
| Other income (expense), net | 569 | (53 | ) | 988 | (296 | ) | ||||||||||
| Total other income (expense), net | 594 | (66 | ) | 1,005 | (307 | ) | ||||||||||
| Loss before income taxes | (4,056 | ) | (8,213 | ) | (29,516 | ) | (62,895 | ) | ||||||||
| Deferred income tax benefit | - | - | - | 8,332 | ||||||||||||
| Net loss | $ | (4,056 | ) | $ | (8,213 | ) | $ | (29,516 | ) | $ | (54,563 | ) | ||||
| Net loss per common share | ||||||||||||||||
| Basic and diluted | $ | (0.13 | ) | $ | (0.31 | ) | $ | (1.00 | ) | $ | (2.31 | ) | ||||
| Weighted average number of common shares outstanding | ||||||||||||||||
| Basic and diluted | 31,135 | 26,704 | 29,554 | 23,616 | ||||||||||||