Windtree Therapeutics Reports First Quarter 2023 Financial Results and Provides Key Business Updates
May 15, 2023
“We are excited with the progress made during the first quarter, particularly related to the strengthening of our balance sheet by securing additional capital and moving forward with our plans to begin our SEISMiC extension study to advance istaroxime in cardiogenic shock,” said Craig Fraser, President and Chief Executive Officer of Windtree. “In addition, we are realizing the financial benefits of the portfolio prioritization undertaken in 2022, which along with other cost-cutting measures, resulted in a 58% reduction in average monthly cash burn for the first quarter of 2023 compared to the first quarter of 2022. We plan to leverage the cost savings and successful financing to build on the positive Phase 2 data for istaroxime with significant development activity to deliver meaningful milestones over the next several quarters. We look forward to planned events and communication to keep our shareholders and the market updated on our progress with istaroxime and potential opportunities with the next generation SERCA2a activators.”
Key Business Update
$12.4 millionin gross proceeds, before deducting underwriting discounts, commissions and other estimated offering expenses, in an April 2023underwritten public offering of 4,238,906 shares of its common stock and warrants to purchase up to 4,238,906 shares of common stock including full exercise of the underwriter overallotment option. Net proceeds from the offering were approximately $10.8 million. Cash and cash equivalents as of March 31, 2023were $4.2 million.
- Announced that the European Patent Office had granted patent coverage for its dual mechanism SERCA2a Activator class of drug candidates. Windtree has preclinical drug candidates with dual mechanisms of action (inhibition of the Na+/K+ pump and activation of SERCA2a) as well as pure SERCA2a activators (devoid of action on the Na+/K+ pump). The new patent, titled: “17BETA-HETEROCYCLYL-DIGITALIS LIKE COMPOUNDS FOR THE TREATMENT OF HEART FAILURE,” provides patent protection until July 2038 for a family of compounds with a dual mechanism of action.
- Announced publication of a paper entitled: “Safety and Efficacy of Istaroxime 1.0 and 1.5 µg/kg/min for Patients with Pre Cardiogenic Shock,” in the
Journal of Cardiac Failure. The paper describes additional dose-response analysis from the SEISMiC Study on the primary endpoint systolic blood pressure (SBP) area under the curve and on biomarkers and other clinical endpoints. This analysis indicated that for the endpoints measured in this study, the desired effects of istaroxime can be achieved at a dose less than 1.5 µg/kg/min.
- Announced it received a Bid Price Compliance Letter from the
Nasdaq Stock Market LLCinforming the company that it regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market.
Select First Quarter 2023 Financial Results
- Research and development expenses were $1.4 million for the first quarter of 2023, compared to $5.3 million for the first quarter of 2022. The decrease in research and development expenses is primarily due to (i) a decrease of
$2.4 millionrelated to the KL4 surfactant platform as the Company continues to focus its resources on the development of its istaroxime pipeline; (ii) a decrease of $0.8 millionfollowing the completion of enrollment in the SEISMiC study in March 2022; (iii) a decrease of $0.6 millionfor expenditures related to the development of istaroxime for AHF primarily due to toxicology studies that were completed in 2022; and (iv) a decrease of $0.1 millionin non-cash stock-based compensation expense.
- General and administrative expenses for the first quarter of 2023 were $2.3 million, compared to $3.0 million for the first quarter of 2022. The decrease in general and administrative expenses is primarily due to (i) a decrease of
$0.4 million in non-cash stock-based compensation expense; and (ii) a decrease of $0.3 million in personnel costs.
- For the first quarter ended March 31, 2023, the Company reported an operating loss of $4.2 million, compared to an operating loss of $8.3 million in the first quarter of 2022. Included in the operating loss for the first quarter of 2023 is non-cash expense of
$0.5 million related to the impairment of goodwill.
- The Company reported a net loss of $4.1 million (
$4.76per basic share) on 0.9 million weighted-average common shares outstanding for the quarter ended March 31, 2023, compared to a net loss of $8.1 million ( $14.36per basic share) on 0.6 million weighted average common shares outstanding for the comparable period in 2022.
- As of
March 31, 2023, the Company reported cash and cash equivalents of $4.2 million which, along with the $10.8 millionof proceeds received from the April 2023underwritten public offering, is expected to be sufficient to fund our business operations through the first quarter of 2024.
Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended
Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company’s clinical trials, clinical trial timelines or disruption in supply chain; the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates; the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (
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Consolidated Balance Sheets
|(in thousands, except share and per share data)|
|Cash and cash equivalents||$||4,235||$||6,172|
|Prepaid expenses and other current assets||987||1,205|
|Total current assets||5,222||7,377|
|Property and equipment, net||239||262|
|Operating lease right-of-use assets||1,737||1,853|
|LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY|
|Operating lease liabilities - current portion||389||404|
|Loans payable - current portion||-||252|
|Total current liabilities||2,763||2,457|
|Operating lease liabilities - non-current portion||1,512||1,624|
|Restructured debt liability - contingent milestone payments||15,000||15,000|
|Deferred tax liabilities||5,081||5,061|
|Series A redeemable preferred stock,
|Additional paid-in capital||838,725||837,598|
|Total stockholders’ equity||7,029||10,012|
|Total liabilities, mezzanine equity & stockholders’ equity||$||35,185||$||37,954|
Consolidated Statements of Operations
|(in thousands, except per share data)|
|Three Months Ended|
|Research and development||$||1,415||$||5,345|
|General and administrative||2,292||2,988|
|Loss on impairment of goodwill||484||-|
|Total operating expenses||4,191||8,333|
|Other income (expense):|
|Other income, net||48||218|
|Total other income, net||80||206|
|Net loss per common share|
|Basic and diluted||$||(4.76||)||$||(14.36||)|
|Weighted average number of common shares outstanding|
|Basic and diluted||863||566|
Source: Windtree Therapeutics