Windtree Therapeutics Reports Second Quarter 2023 Financial Results and Provides Key Business Updates
Aug 07, 2023
Company plans to initiate a Phase 2 SEISMiC extension study of istaroxime in early cardiogenic shock in Q3;
Study start-up for a Phase 2 SCAI Stage C cardiogenic shock study underway
“During the second quarter, we completed a successful
Key Business Updates
$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, which includes the full exercise of the underwriter’s overallotment option. Net proceeds from the offering were approximately $10.8 million. Cash and cash equivalents as of June 30, 2023were $11.5 million.
- Hosted a virtual R&D and Investor Day on
June 14, 2023, focusing on the cardiogenic shock market, including company strategy and upcoming milestones for lead compound istaroxime.
European Patent Officegranted Patent No. 3599243, providing patent coverage for the dual mechanism SERCA2a activator class of drug candidates. The new patent, titled “17BETA-HETEROCYCLYL-DIGITALIS LIKE COMPOUNDS FOR THE TREATMENT OF HEART FAILURE,” is expected to provide patent protection until July 2038for the family of compounds with a dual mechanism of action.
- Announced Notice of Allowance from the
U.S. Patent and Trademark Office(USPTO) for its patent application covering the Company’s dual mechanism SERCA2a Activators. A notice of allowance is issued by the USPTO to indicate that the application has passed examination.
Mark Strobeck, Ph.D. to the Board of Directors. Dr. Strobeckbrings over 20 years of operating, business development, capital raising and investing experience in the life sciences industry for both private and public biotechnology companies. Dr. Strobeckcurrently serves as President and Chief Executive Officer of Rockwell Medical, Inc., a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management.
Select Second Quarter 2023 Financial Results
- For the second quarter ended
June 30, 2023, the Company reported an operating loss of $6.8 million, compared to an operating loss of $17.5 millionin the second quarter of 2022. Included in the operating loss for the second quarter of 2023 is non-cash expense of $2.6 millionrelated to the impairment of goodwill. Included in operating loss for the second quarter of 2022 is non-cash expense of $11.6 millionrelated to the impairment of goodwill.
- Research and development expenses were
$1.8 millionfor the second quarter of 2023, compared to $3.0 millionfor the second quarter of 2022. The decrease in research and development expenses is primarily due to (i) a decrease of $0.8 millionrelated to the KL4 surfactant platform as the Company continues to focus its resources on the development of its istaroxime program; (ii) a decrease of $0.3 millionfollowing the completion of enrollment in the SEISMiC study in March 2022; and (iii) a decrease of $0.1 millionfor expenditures related to the development of istaroxime for AHF primarily due to toxicology studies that were completed in 2022.
- General and administrative expenses for the second quarter of 2023 were $2.4 million, compared to
$2.9 millionfor the second quarter of 2022. The decrease in general and administrative expenses is primarily due to (i) a decrease of $0.3 millionin non-cash stock-based compensation expense as we have not granted equity to employees as of June 2023; (ii) a decrease of $0.2 millionin incentive bonus expense; (iii) a decrease of $0.1 millionin personnel costs; and (iv) a decrease of $0.1 millionin insurance costs; partially offset by (v) an increase of $0.2 millionin professional fees.
- The Company reported a net loss of
$6.6 million( $1.64per basic share) on 4.0 million weighted-average common shares outstanding for the quarter ended June 30, 2023, compared to a net loss of $17.3 million( $29.68per basic share) on 0.6 million weighted average common shares outstanding for the comparable period in 2022.
- As of
June 30, 2023, the Company reported cash and cash equivalents of $11.5 million, which is expected to be sufficient to support our development activities and 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 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; the rate and degree of market acceptance of the Company’s product candidates, if approved; and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between
Kendall Investor Relations, LLC
|Consolidated Balance Sheets|
|(in thousands, except share and per share data)|
|Cash and cash equivalents||$||11,467||$||6,172|
|Prepaid expenses and other current assets||1,852||1,205|
|Total current assets||13,319||7,377|
|Property and equipment, net||216||262|
|Operating lease right-of-use assets||1,640||1,853|
|LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY|
|Operating lease liabilities - current portion||399||404|
|Total current liabilities||3,794||2,457|
|Operating lease liabilities - non-current portion||1,397||1,624|
|Restructured debt liability - contingent milestone payments||15,000||15,000|
|Deferred tax liabilities||4,980||5,061|
|Series A redeemable preferred stock,
|Additional paid-in capital||849,897||837,598|
|Total stockholders’ equity||11,604||10,012|
|Total liabilities, mezzanine equity & stockholders’ equity||$||40,575||$||37,954|
|Consolidated Statements of Operations|
|(in thousands, except per share data)|
|Three Months Ended||Six Months Ended|
|Research and development||$||1,763||$||2,995||$||3,178||$||8,340|
|General and administrative||2,420||2,907||4,712||5,895|
|Loss on impairment of goodwill||2,574||11,636||3,058||11,636|
|Total operating expenses||6,757||17,538||10,948||25,871|
|Other income (expense):|
|Other income, net||61||201||109||419|
|Total other income, net||156||205||236||411|
|Net loss per common share|
|Basic and diluted||$||(1.64||)||$||(29.68||)||$||(4.36||)||$||(44.28||)|
|Weighted average number of common shares outstanding|
|Basic and diluted||4,030||584||2,455||575|
Source: Windtree Therapeutics