Windtree Announces Partnership with New Growth Advisors to Leverage Positive Phase 2 Istaroxime Study in Cardiogenic Shock for a Potential Strategic Transaction
Windtree Therapeutics (NASDAQ: WINT) has partnered with New Growth Advisors (NGA) to explore strategic opportunities for its cardiovascular portfolio, including potential out-licensing or asset sale. The company aims to capitalize on positive Phase 2 results for istaroxime in cardiogenic shock and acute heart failure.
NGA, which has advised on transactions worth nearly $400 million in 2023-2024, will manage current interest and lead an expanded out-licensing process. Windtree already has a licensing agreement with Lee's Pharmaceuticals for Greater China territory, potentially worth up to $138 million in milestones plus royalties. Lee's plans to initiate Phase 3 trials in acute heart failure in their licensed territory in first half 2025.
Windtree Therapeutics (NASDAQ: WINT) ha stretto una partnership con New Growth Advisors (NGA) per esplorare opportunità strategiche per il suo portafoglio cardiovascolare, inclusi potenziali diritti di licenza o vendita di asset. L'azienda mira a capitalizzare i risultati positivi della Fase 2 per l'istaroxime nel caso di shock cardiogeno e insufficienza cardiaca acuta.
NGA, che ha consigliato transazioni per un valore vicino ai 400 milioni di dollari nel 2023-2024, gestirà l'interesse attuale e guiderà un processo ampliato di out-licensing. Windtree ha già un accordo di licenza con Lee's Pharmaceuticals per il territorio della Grande Cina, potenzialmente del valore di fino a 138 milioni di dollari in traguardi più royalty. Lee's prevede di avviare gli studi di Fase 3 per l'insufficienza cardiaca acuta nel proprio territorio licenziato nella prima metà del 2025.
Windtree Therapeutics (NASDAQ: WINT) se ha asociado con New Growth Advisors (NGA) para explorar oportunidades estratégicas para su cartera cardiovascular, incluyendo la posibilidad de licencias o venta de activos. La empresa busca capitalizar los resultados positivos de la Fase 2 del istaroxime en shock cardiogénico e insuficiencia cardíaca aguda.
NGA, que ha asesorado en transacciones por un valor cercano a 400 millones de dólares en 2023-2024, gestionará el interés actual y liderará un proceso ampliado de licencias. Windtree ya cuenta con un acuerdo de licencia con Lee's Pharmaceuticals para el territorio de Gran China, que podría tener un valor de hasta 138 millones de dólares en hitos más regalías. Lee's planea iniciar ensayos de Fase 3 en insuficiencia cardíaca aguda en su territorio licenciado en la primera mitad de 2025.
Windtree Therapeutics (NASDAQ: WINT)는 New Growth Advisors (NGA)와 협력하여 심혈관 포트폴리오의 전략적 기회를 탐색하고 있으며, 여기에는 잠재적인 라이센스 아웃 또는 자산 매각이 포함됩니다. 이 회사는 심장 쇼크 및 급성 심부전 치료를 위한 이스타록심의 2상 긍정적 결과를 활용하는 것을 목표로 하고 있습니다.
NGA는 2023-2024년에 거의 4억 달러에 달하는 거래에 대해 자문을 제공하며, 현재의 관심을 관리하고 확대된 라이센스 아웃 프로세스를 이끌 것입니다. Windtree는 이미 대만 지역에 대해 Lee's Pharmaceuticals와 라이센스 계약을 체결했으며, 이 계약은 최대 1억 3800만 달러의 이정표와 로열티가 부과될 가능성이 있습니다. Lee's는 2025년 상반기에 면허가 부여된 지역에서 급성 심부전 치료를 위한 3상 시험을 시작할 계획입니다.
Windtree Therapeutics (NASDAQ: WINT) s'est associé à New Growth Advisors (NGA) pour explorer des opportunités stratégiques pour son portefeuille cardiovasculaire, y compris une éventuelle sous-licence ou vente d'actifs. L'entreprise cherche à tirer parti des résultats positifs de la Phase 2 concernant l'istaroxime dans le cadre du choc cardiogénique et de l'insuffisance cardiaque aiguë.
NGA, qui a conseillé des transactions d'une valeur proche de 400 millions de dollars en 2023-2024, gérera l'intérêt actuel et dirigera un processus de sous-licence élargi. Windtree a déjà un accord de licence avec Lee's Pharmaceuticals pour le territoire de la Grande Chine, dont la valeur potentielle peut atteindre jusqu'à 138 millions de dollars en étapes clé plus des redevances. Lee's prévoit de commencer des essais de Phase 3 pour l'insuffisance cardiaque aiguë dans son territoire sous licence au cours de la première moitié de 2025.
Windtree Therapeutics (NASDAQ: WINT) hat eine Partnerschaft mit New Growth Advisors (NGA) geschlossen, um strategische Möglichkeiten für sein kardiovaskuläres Portfolio zu prüfen, einschließlich potenzieller Lizenzvergaben oder Asset Verkäufe. Das Unternehmen verfolgt das Ziel, von den positiven Ergebnisse der Phase 2 für Istaroxim bei kardiogenem Schock und akuter Herzinsuffizienz zu profitieren.
NGA, das 2023-2024 bei Transaktionen im Wert von fast 400 Millionen Dollar beraten hat, wird das aktuelle Interesse verwalten und einen erweiterten Lizenzvergabeprozess leiten. Windtree hat bereits einen Lizenzvertrag mit Lee's Pharmaceuticals für das Großchina-Gebiet, der potenziell bis zu 138 Millionen Dollar an Meilensteinen plus Lizenzgebühren wert sein könnte. Lee's plant, in der ersten Hälfte von 2025 Phase-3-Studien zur akuten Herzinsuffizienz in ihrem lizenzierten Gebiet zu beginnen.
- Four positive Phase 2 istaroxime studies completed, including recent Phase 2b SEISMiC study
- Existing licensing agreement with Lee's Pharmaceuticals worth up to $138 million plus royalties
- Lee's Pharmaceuticals to initiate Phase 3 trials in H1 2025
- Company seeking non-dilutive funding through partnerships, indicating potential financial constraints
Insights
The partnership with New Growth Advisors represents a significant strategic move for Windtree Therapeutics. With
The strategy to monetize their cardiovascular portfolio while leveraging positive Phase 2 results could provide essential capital for both cardiovascular and oncology programs. Lee's commitment to fund development costs in Greater China and their planned Phase 3 trial in 2025 adds credibility to the asset's potential value. The timing appears strategic, capitalizing on increased big pharma interest in cardiovascular assets.
The clinical development progress of istaroxime is noteworthy, with four successful Phase 2 studies, including the recent positive Phase 2b SEISMiC study in early cardiogenic shock. This comprehensive data package, combined with the first-in-class status of their cardiovascular assets, strengthens their negotiating position for potential partnerships. The dual focus on both acute conditions (cardiogenic shock) and chronic applications (heart failure) through oral SERCA2a activators demonstrates a well-rounded therapeutic approach.
The advancement to Phase 3 trials in acute heart failure by Lee's Pharmaceuticals provides validation of the technology's potential. The company's strategy to potentially expand partnerships beyond the Greater China territory could accelerate global development and commercialization timelines.
WARRINGTON, Pa., Dec. 04, 2024 (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 and diseases, today announced that it has engaged New Growth Advisors (“NGA”), a leading life sciences consulting firm chosen by companies seeking discreet, conflict-free, and knowledgeable advice on complex M&A, asset sale, research, capital markets, and licensing transactions, as its strategic advisor to lead a process in respect of Windtree’s cardiovascular portfolio, including a potential out-licensing transaction or asset sale. NGA has advised on transactions with an aggregate value approaching
The Company seeks to leverage the positive early cardiogenic shock and acute heart failure results (including the recent positive Phase 2b in early cardiogenic shock) to better address the breadth of opportunities and secure potentially non-dilutive funding via a partnership for istaroxime as well as the next generation, oral SERCA2a activators for all global territory ex-Greater China. NGA has been engaged to manage the current inbound interest as well as to run an expanded out-licensing process.
The Company currently has a licensing agreement for the Greater China territory for istaroxime, dual mechanism SERCA2a activators and rostafuroxin with Lee’s Pharmaceuticals (HK) Limited (“Lee’s”) for which it may receive up to
“It seems that there has been a heightened focus on cardiovascular assets and programs by the larger pharmaceutical companies and with our four positive Phase 2 istaroxime studies, including the recent positive Phase 2b SEISMiC study in early cardiogenic shock, we believe it is a good time to run a rigorous outreach and process with an experienced, well-connected business development advisor,” said Jed Latkin, CEO of Windtree. “We look forward to discussions with pharmaceutical companies to evaluate the opportunities with our first-in-class cardiovascular assets. If a deal is consummated, Windtree plans to leverage the partner to progress the cardiovascular program and use some of the proceeds to support advancement of its novel, preclinical oncology platform.”
About New Growth Advisors
NGA is a strategic advisor to emerging companies in the life sciences industry. Partners and team members are veteran bankers and executives with deep industry experience, knowledge, and networks. NGA is chosen by companies seeking discreet, conflict-free, and knowledgeable advice on complex M&A, asset sale, research, capital markets, and licensing transactions. The firm is further differentiated from boutique life sciences advisory practices by the breadth of global relations – clients and strategic partners. Approximately 1/3 of transactions advised on are cross-border. NGA has advised on transactions with an aggregate value approaching
About Istaroxime
Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is designed as a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure have demonstrated that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
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 2 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 statements related to the potential clinical effects of istaroxime; the potential benefits and safety of istaroxime; the clinical development of istaroxime; and our research and development program for treating patients in early cardiogenic shock due to heart failure. Such statements constitute 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, among other things: 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 Biopharmaceuticals, Inc.; the Company’s 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 secure and successfully complete an out-licensing or asset acquisition transaction; 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 the Middle East, 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:
Windtree:
Eric Curtis
ecurtis@windtreetx.com
New Growth Advisors:
Stephen Cervieri
scervieri@ngadvisorsltd.com
FAQ
What are the results of Windtree's (WINT) Phase 2 istaroxime trials?
What is the value of Windtree's (WINT) licensing agreement with Lee's Pharmaceuticals?
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