Windtree Therapeutics Reports Year-End 2024 Financial Results and Provides Key Business Updates
Windtree Therapeutics (WINT) reported its fiscal year 2024 results and key business updates. The company announced positive results from its Phase 2 SEISMiC Extension Study of istaroxime in early cardiogenic shock treatment and initiated the global SEISMiC C trial for more severe cases.
Financial highlights include R&D expenses of $16.3 million (up from $8.3 million in 2023) and reduced G&A expenses of $8.7 million (down from $9.2 million). The company reported a net loss of $1.8 million for 2024, significantly improved from a $20.3 million loss in 2023.
Key developments include a new corporate strategy to become revenue-generating through acquisitions of FDA-approved products, a licensing partnership with Lee's Pharmaceutical for Greater China, and patent developments for istaroxime. Cash position stands at $1.8 million as of December 31, 2024, with funding expected to last through April 2025.
Windtree Therapeutics (WINT) ha comunicato i risultati dell’anno fiscale 2024 e gli aggiornamenti principali sull’attività. L’azienda ha annunciato risultati positivi dallo studio di estensione di Fase 2 SEISMiC sull’istaroxime nel trattamento precoce dello shock cardiogeno, avviando inoltre il trial globale SEISMiC C per i casi più gravi.
Tra i dati finanziari spiccano spese in R&S pari a 16,3 milioni di dollari (in aumento rispetto agli 8,3 milioni del 2023) e spese generali e amministrative ridotte a 8,7 milioni di dollari (in calo rispetto ai 9,2 milioni). La società ha registrato una perdita netta di 1,8 milioni di dollari nel 2024, in netto miglioramento rispetto alla perdita di 20,3 milioni del 2023.
Tra gli sviluppi chiave, una nuova strategia aziendale per generare ricavi tramite acquisizioni di prodotti approvati dalla FDA, una partnership di licenza con Lee's Pharmaceutical per la Grande Cina e progressi sui brevetti relativi all’istaroxime. La liquidità disponibile al 31 dicembre 2024 ammonta a 1,8 milioni di dollari, con finanziamenti previsti fino ad aprile 2025.
Windtree Therapeutics (WINT) informó sus resultados del año fiscal 2024 y actualizaciones clave del negocio. La compañía anunció resultados positivos del estudio de extensión de Fase 2 SEISMiC con istaroxima en el tratamiento temprano del shock cardiogénico e inició el ensayo global SEISMiC C para casos más graves.
Los aspectos financieros incluyen gastos en I+D de 16,3 millones de dólares (frente a 8,3 millones en 2023) y gastos generales y administrativos reducidos a 8,7 millones (desde 9,2 millones). La empresa reportó una pérdida neta de 1,8 millones de dólares en 2024, mejorando significativamente desde una pérdida de 20,3 millones en 2023.
Entre los desarrollos clave se encuentran una nueva estrategia corporativa para generar ingresos mediante adquisiciones de productos aprobados por la FDA, una asociación de licencias con Lee's Pharmaceutical para la Gran China y avances en patentes de istaroxima. La posición de efectivo es de 1,8 millones de dólares al 31 de diciembre de 2024, con financiamiento previsto hasta abril de 2025.
Windtree Therapeutics (WINT)는 2024 회계연도 실적 및 주요 사업 업데이트를 발표했습니다. 회사는 초기 심인성 쇼크 치료에 사용되는 이스타록심(istaroxime)의 2상 SEISMiC 확장 연구에서 긍정적인 결과를 보고했으며, 더 심각한 사례를 위한 글로벌 SEISMiC C 시험을 시작했습니다.
재무 하이라이트로는 연구개발비 1,630만 달러(2023년 830만 달러에서 증가)와 일반관리비 870만 달러로 감소(920만 달러에서 감소)가 포함됩니다. 회사는 2024년에 순손실 180만 달러를 기록했으며, 이는 2023년 2,030만 달러 손실에서 크게 개선된 수치입니다.
주요 발전 사항으로는 FDA 승인 제품 인수를 통한 수익 창출을 목표로 하는 새로운 기업 전략, 중국 대륙을 위한 Lee's Pharmaceutical과의 라이선스 파트너십, 이스타록심 특허 개발이 있습니다. 2024년 12월 31일 기준 현금 보유액은 180만 달러이며, 자금은 2025년 4월까지 지속될 것으로 예상됩니다.
Windtree Therapeutics (WINT) a publié ses résultats pour l’exercice fiscal 2024 ainsi que les principales mises à jour commerciales. La société a annoncé des résultats positifs de son étude d’extension de phase 2 SEISMiC sur l’istaroxime dans le traitement précoce du choc cardiogénique et a lancé l’essai mondial SEISMiC C pour les cas plus graves.
Les points financiers clés comprennent des dépenses en R&D de 16,3 millions de dollars (en hausse par rapport à 8,3 millions en 2023) et des frais généraux et administratifs réduits à 8,7 millions de dollars (en baisse par rapport à 9,2 millions). La société a enregistré une perte nette de 1,8 million de dollars pour 2024, une nette amélioration par rapport à la perte de 20,3 millions en 2023.
Les développements majeurs incluent une nouvelle stratégie d’entreprise visant à générer des revenus via des acquisitions de produits approuvés par la FDA, un partenariat de licence avec Lee's Pharmaceutical pour la Grande Chine, ainsi que des avancées en matière de brevets pour l’istaroxime. La trésorerie s’élève à 1,8 million de dollars au 31 décembre 2024, avec des financements prévus jusqu’en avril 2025.
Windtree Therapeutics (WINT) veröffentlichte die Ergebnisse für das Geschäftsjahr 2024 sowie wichtige Unternehmensupdates. Das Unternehmen gab positive Ergebnisse der Phase-2-SEISMiC-Verlängerungsstudie mit Istaroxim zur Behandlung des frühen kardiogenen Schocks bekannt und startete die globale SEISMiC-C-Studie für schwerere Fälle.
Finanzielle Highlights umfassen F&E-Ausgaben von 16,3 Millionen US-Dollar (im Vergleich zu 8,3 Millionen im Jahr 2023) und reduzierte Verwaltungs- und Gemeinkosten von 8,7 Millionen US-Dollar (gegenüber 9,2 Millionen). Das Unternehmen meldete für 2024 einen Nettoverlust von 1,8 Millionen US-Dollar, was eine deutliche Verbesserung gegenüber dem Verlust von 20,3 Millionen im Jahr 2023 darstellt.
Zu den wichtigsten Entwicklungen zählen eine neue Unternehmensstrategie, durch Übernahmen von FDA-zugelassenen Produkten Umsätze zu erzielen, eine Lizenzpartnerschaft mit Lee's Pharmaceutical für Großchina sowie Patententwicklungen für Istaroxim. Die Barreserve beträgt zum 31. Dezember 2024 1,8 Millionen US-Dollar, mit erwarteter Finanzierung bis April 2025.
- Net loss significantly improved to $1.8 million in 2024 from $20.3 million in 2023
- Positive Phase 2 SEISMiC Extension Study results for istaroxime
- Secured licensing partnership with Lee's Pharmaceutical worth up to $138 million plus royalties
- Regained Nasdaq compliance with minimum bid price requirement
- Reduced G&A expenses by $0.5 million year-over-year
- R&D expenses increased significantly to $16.3 million from $8.3 million in 2023
- cash runway only through April 2025
- Net loss to common stockholders of $5.5 million including $3.6 million deemed dividend
- Low cash position of $1.8 million as of December 31, 2024
Insights
Windtree's financial results reveal a mixed picture with meaningful clinical progress counterbalanced by financial constraints. The company reported a net loss of
The clinical progress for istaroxime in cardiogenic shock represents genuine advancement with positive Phase 2 results in early cardiogenic shock patients (SCAI Stage B) and progression to studying more severe patients (SCAI Stage C). The ongoing SEISMiC C study with planned interim analysis in Q3 2025 could provide significant validation for this program addressing a critical condition with high mortality rates and treatment options.
However, the critical concern is Windtree's cash position of just
The licensing partnership with Lee's Pharmaceutical for Greater China (worth up to
WARRINGTON, Pa., April 15, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the fiscal year ended December 31, 2024 and provided key business updates.
“The year 2024 saw Windtree make great progress in many key areas including clinical development of our lead drug candidate istaroxime in cardiogenic shock, business development and the future strategy of the Company,” said Jed Latkin, CEO of Windtree. “Cardiogenic shock is a critical condition with high morbidity and mortality where clinicians express a high need for drug innovation. During the year, we announced positive results of our SEISMiC Extension Phase 2 istaroxime clinical study in early cardiogenic shock (SCAI Stage B) and also began our cardiogenic shock SEISMiC C (SCAI Stage C) Phase 2 study with an interim assessment planned for Q3 2025. In addition, we added a regional licensing partnership with Lee’s Pharmaceutical for greater China.for istaroxime, our preclinical dual mechanism SERCA2a activators and rostafuroxin. We are also continuing discussions with potential partners for our cardiovascular drug candidates.” Mr. Latkin further added, “Importantly, we also announced our new corporate strategy in early 2025 to become a revenue-generating biotech by using Company equity to acquire small biotech companies struggling to maximize the commercial potential of their FDA-approved products. We believe this could be a positive transformation and an opportunity to provide near-term value to our shareholders. As part of our strategy, we are actively evaluating revenue-generating opportunities across various sectors that align with our capabilities and strategic vision.”
Mr. Latkin was appointed CEO in December of 2024. He has nearly three decades of financial and biotech experience including prior experience as the CEO of a public biotech company. Mr. Latkin served as the CEO of Navidea Biopharmaceuticals where he started as Chief Financial Officer and executed multiple deals and raised substantial funding. He has also served as CEO of Black Elk Energy Offshore in 2014 as part of Nagel Avenue Capital which he joined after ten years on Wall Street with a variety of investment banking organizations and funds, including ING, Morgan Stanley and Citigroup Securities. Most recently, Mr. Latkin served as the Chief Operating Officer and head of finance at ProPhase Labs, conducting deals and managing broad aspects of the business.
Key Business Update
- Announced positive results from its Phase 2 SEISMiC Extension Study of istaroxime in the treatment of early cardiogenic shock in September 2024.
- Initiated enrollment in the global SEISMiC C trial evaluating istaroxime in SCAI Stage C cardiogenic shock—a more severely ill population than previously studied—building on positive SEISMiC A and B results; the placebo-controlled, double-blind study will assess istaroxime’s impact on systolic blood pressure and cardiac function alongside standard inotropic/vasopressor therapy, with a planned interim data review in Q3 2025 to inform Phase 3 readiness and regulatory discussions in early 2026.
- Launched a new corporate strategy to become a revenue generating biotech company through acquisitions of small companies and their FDA-approved products while continuing to progress the Company’s cardiovascular and oncology development pipeline.
- Entered into a license and supply agreement to become the sourcing partner for Evofem Biosciences, Inc. (OTCQB: EVFM) for PHEXXI® (lactic acid, citric acid and potassium bitartrate), a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. The Company will leverage its manufacturing contacts to reduce pharmaceutical product cost of goods for PHEXXI.
- Regained Nasdaq compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. The Company will be subject to a mandatory panel monitor until March 20, 2026.
- Completed istaroxime cardiogenic shock national phase filings of patent applications around the world, including in the U.S., Germany, France, Italy, Japan and China. These filings claimed priority to PCT/US2023/018998 entitled, “Istaroxime-Containing Intravenous Formulation for the Treatment of Pre-Cardiogenic Shock and Cardiogenic Shock”. This application is currently pending before the United States Patent and Trademark Office (USPTO), Application no. 18/858,086. Filed a new PCT patent application for istaroxime and its derivatives targeting the prevention of acute myocardial arrhythmias—building on encouraging data from clinical trials in acute heart failure and early cardiogenic shock, as well as preclinical models showing enhanced efficacy of istaroxime metabolites in improving cardiac function and reducing ischemia-induced arrhythmias.
- Received a Notice of Allowance from the USPTO for a patent covering an intravenous istaroxime formulation for acute heart failure, and filed a related patent application in India targeting the prevention of life-threatening arrhythmias in heart failure patients—further strengthening the company’s global intellectual property portfolio. Completed national phase filings for the istaroxime patent titled “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF PRE-CARDIOGENIC SHOCK AND CARDIOGENIC SHOCK” (PCT/US2023/018998; U.S. Application No. 18/858,086) in key global markets including the U.S., Germany, France, Italy, Japan, and China—further strengthening international IP protection for its lead cardiovascular asset.
- Issued Japanese patent (No. 7603605, expiring 2040) for its novel aPKCi inhibitor platform targeting hedgehog pathway-dependent cancers—covering both topical and oral formulations, with potential applications in cancers such as basal cell carcinoma and small cell lung cancer, including use in combination therapies with HDAC inhibitors to enhance anti-cancer efficacy.
- Seeking to leverage positive Phase 2b results in early cardiogenic shock to secure non-dilutive funding through partnerships for istaroxime and next-generation oral SERCA2a activators outside Greater China; engaged New Growth Advisors to manage inbound interest and lead a broader out-licensing effort, while existing partner Lee’s Pharmaceuticals progresses toward a planned Phase 3 trial in acute heart failure in 1H 2025 under a deal worth up to
$138 million in milestones plus royalties. - Licensing partner Lee’s Pharmaceutical (HK) Ltd. is preparing to initiate a Phase 3 program for acute heart failure in Greater China, fully funding all development activities in the region; Windtree retains final protocol approval and is collaborating closely with Lee’s as it advances its global cardiogenic shock program in parallel.
Select 2024 Year-End Financial Results
Research and development (“R&D”) expenses were
General and administrative expenses for the year ended December 31, 2024 were
For the year ended December 31, 2024, the Company reported a net loss of
The Company reported a net loss attributable to common stockholders of
As of December 31, 2024, the Company reported cash and cash equivalents of
Readers are referred to, and encouraged to read in its entirety, the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which will be filed with the Securities and Exchange Commission on April 15, 2025 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 a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase II candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place.
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: the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian; risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; 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; the economic and social consequences of the COVID-19 pandemic and 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 the evolving events in Israel and Gaza, 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. 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:
Eric Curtis
ecurtis@windtreetx.com
| WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Balance Sheets | ||||||||
| (in thousands, except share and per share data) | ||||||||
| December 31, 2024 | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,779 | $ | 4,319 | ||||
| Prepaid expenses and other current assets | 795 | 1,060 | ||||||
| Total current assets | 2,574 | 5,379 | ||||||
| Property and equipment, net | 111 | 183 | ||||||
| Restricted cash | 9 | 150 | ||||||
| Operating lease right-of-use assets | 1,051 | 1,444 | ||||||
| Intangible assets | 24,130 | 25,250 | ||||||
| Total assets | $ | 27,875 | $ | 32,406 | ||||
| LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,879 | $ | 809 | ||||
| Accrued expenses | 1,706 | 1,618 | ||||||
| Operating lease liabilities - current portion | 508 | 436 | ||||||
| ELOC commitment note payable | 328 | - | ||||||
| Derivative liability - ELOC commitment note | 299 | - | ||||||
| Common stock warrant liability | 305 | - | ||||||
| Loans payable - current portion | 333 | 233 | ||||||
| Other current liabilities | 359 | 900 | ||||||
| Total current liabilities | 5,717 | 3,996 | ||||||
| Operating lease liabilities - non-current portion | 653 | 1,161 | ||||||
| Restructured debt liability - contingent milestone payments | - | 15,000 | ||||||
| Other liabilities | 3,800 | 3,800 | ||||||
| Deferred tax liabilities | 4,528 | 5,058 | ||||||
| Total liabilities | 14,698 | 29,015 | ||||||
| Mezzanine equity: | ||||||||
| Series C redeemable preferred stock, | 3,181 | - | ||||||
| Series B redeemable preferred stock, | - | - | ||||||
| Total mezzanine equity | 3,181 | - | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | - | - | ||||||
| Common stock, | - | - | ||||||
| Additional paid-in capital | 859,660 | 851,268 | ||||||
| Accumulated deficit | (846,610 | ) | (844,823 | ) | ||||
| Treasury stock (at cost); 1 share | (3,054 | ) | (3,054 | ) | ||||
| Total stockholders’ equity | 9,996 | 3,391 | ||||||
| Total liabilities, mezzanine equity & stockholders’ equity | $ | 27,875 | $ | 32,406 | ||||
| WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Statements of Operations | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Year Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Expenses: | ||||||||
| Research and development | $ | 16,276 | $ | 8,341 | ||||
| General and administrative | 8,743 | 9,198 | ||||||
| Impairment of goodwill | - | 3,058 | ||||||
| Impairment of intangible assets | 1,120 | - | ||||||
| Total operating expenses | 26,139 | 20,597 | ||||||
| Operating loss | (26,139 | ) | (20,597 | ) | ||||
| Other (expense) income: | ||||||||
| Gain on debt extinguishment | 14,437 | - | ||||||
| Change in fair value of common stock warrant liability | 10,482 | - | ||||||
| Interest income | 70 | 325 | ||||||
| Interest expense | (235 | ) | (50 | ) | ||||
| Other (expense) income, net | (408 | ) | 31 | |||||
| Total other income, net | 24,346 | 306 | ||||||
| Loss before income taxes | (1,793 | ) | (20,291 | ) | ||||
| Deferred income tax benefit | 6 | - | ||||||
| Net loss | $ | (1,787 | ) | $ | (20,291 | ) | ||
| Exchange of Series B preferred stock | (79 | ) | - | |||||
| Deemed dividend on Series C preferred stock | (3,621 | ) | - | |||||
| Net loss attributable to common stockholders | $ | (5,487 | ) | $ | (20,291 | ) | ||
| Net loss per share attributable to common stockholders | ||||||||
| Basic and diluted | $ | (104.35 | ) | $ | (4,718.84 | ) | ||
| Weighted average number of common shares outstanding | ||||||||
| Basic and diluted | 52,583 | 4,300 | ||||||
FAQ
What were Windtree Therapeutics (WINT) key financial results for 2024?
What is the status of WINT's istaroxime clinical trials in 2024-2025?
What strategic changes did Windtree Therapeutics announce for 2025?
What major partnerships did WINT secure in 2024?
How long will WINT's current funding last according to their 2024 report?
