Press Release
Windtree Therapeutics Reports Second Quarter 2022 Financial Results and Provides Key Business Updates
Aug 11, 2022
“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
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 inMadrid, 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 theInstitute of Cardiology of the Department of Medical and Surgical Specialties,Radiological Sciences and Public Health of the University and Civil Hospitals ofBrescia, 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: https://ir.windtreetx.com/events - 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
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
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
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
The Company reported a net loss of $17.3 million (
As 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
About
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
Contact Information:
212.915.3820 or monique@lifesciadvisors.com
+++++ Tables to Follow +++++
Consolidated Balance Sheets
(in thousands, except share and per share data) |
Unaudited | |||||||
ASSETS | |||||||
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 | |||
LIABILITIES & STOCKHOLDERS’ EQUITY | |||||||
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, |
- | - | |||||
Common stock, |
29 | 28 | |||||
Additional paid-in capital | 833,006 | 830,231 | |||||
Accumulated deficit | (810,784 | ) | (785,324 | ) | |||
(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 | |||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
Expenses: | ||||||||||||
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 (expense) income: | ||||||||||||
Interest income | 17 | 39 | 18 | 89 | ||||||||
Interest expense | (13 | ) | (46 | ) | (26 | ) | (87 | ) | ||||
Other (expense) income, net | 201 | (352 | ) | 419 | (243 | ) | ||||||
Total other (expense) income, 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 |
Source: Windtree Therapeutics