Windtree Therapeutics Reports Third Quarter 2024 Financial Results and Provides Key Business Updates
Windtree Therapeutics (WINT) reported Q3 2024 financial results and key updates. The company announced positive Phase 2b results for istaroxime in early cardiogenic shock, showing significant improvements in cardiac function and blood pressure. The company completed two private placements for $13.9 million and secured a $35 million equity line agreement. Q3 operating loss was $4.7 million with cash and equivalents of $2.3 million as of September 30, 2024. The company expects current funding to support operations through January 2025.
Windtree Therapeutics (WINT) ha riportato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti chiave. L'azienda ha annunciato risultati positivi della Fase 2b per l'istaroxime nel trattamento dello shock cardiogenico precoce, mostrando significativi miglioramenti nella funzione cardiaca e nella pressione sanguigna. L'azienda ha completato due collocamenti privati per un totale di 13,9 milioni di dollari e ha assicurato un accordo per una linea di equity di 35 milioni di dollari. La perdita operativa del terzo trimestre è stata di 4,7 milioni di dollari, con disponibilità liquide e equivalenti di 2,3 milioni di dollari al 30 settembre 2024. L'azienda prevede che il finanziamento attuale sosterrà le operazioni fino a gennaio 2025.
Windtree Therapeutics (WINT) reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones clave. La compañía anunció resultados positivos de la Fase 2b para el istaroxime en el choque cardiogénico temprano, mostrando mejoras significativas en la función cardíaca y la presión arterial. La compañía completó dos colocaciones privadas por un total de 13,9 millones de dólares y aseguró un acuerdo de línea de equity de 35 millones de dólares. La pérdida operativa del tercer trimestre fue de 4,7 millones de dólares, con efectivo y equivalentes de 2,3 millones de dólares al 30 de septiembre de 2024. La compañía espera que la financiación actual respalde las operaciones hasta enero de 2025.
Windtree Therapeutics (WINT)는 2024년 3분기 재무 결과 및 주요 업데이트를 보고했습니다. 이 회사는 조기 심인성 쇼크에 대한 이스타록심의 2b상 긍정적인 결과를 발표하며 심장 기능과 혈압에서 상당한 개선을 보였습니다. 이 회사는 1,390만 달러 규모의 두 차례 사모 배정을 완료하였고, 3,500만 달러 규모의 주식 관련 계약을 확보하였습니다. 3분기 운영 손실은 470만 달러였으며 2024년 9월 30일 기준 현금 및 현금성 자산은 230만 달러였습니다. 이 회사는 현재 자금이 2025년 1월까지 운영을 지원할 것으로 예상하고 있습니다.
Windtree Therapeutics (WINT) a publié les résultats financiers du troisième trimestre 2024 ainsi que des mises à jour clés. L'entreprise a annoncé des résultats positifs de la phase 2b pour l'istaroxime dans le choc cardiogénique précoce, montrant des améliorations significatives de la fonction cardiaque et de la pression artérielle. L'entreprise a complété deux placements privés pour un montant de 13,9 millions de dollars et a sécurisé un accord de ligne d'équité de 35 millions de dollars. La perte opérationnelle du troisième trimestre était de 4,7 millions de dollars, avec des liquidités et équivalents s'élevant à 2,3 millions de dollars au 30 septembre 2024. L'entreprise s'attend à ce que le financement actuel soutienne ses opérations jusqu'en janvier 2025.
Windtree Therapeutics (WINT) hat die finanziellen Ergebnisse des dritten Quartals 2024 sowie wichtige Updates veröffentlicht. Das Unternehmen gab positive Ergebnisse der Phase 2b für Istaroxim bei frühzeitigem kardiogenem Schock bekannt, die signifikante Verbesserungen der Herzfunktion und des Blutdrucks zeigten. Das Unternehmen hat zwei Privatplatzierungen in Höhe von 13,9 Millionen Dollar abgeschlossen und eine Eigenkapitallinie in Höhe von 35 Millionen Dollar gesichert. Der operative Verlust im dritten Quartal betrug 4,7 Millionen Dollar, bei einer liquiden Mittel und Äquivalenten von 2,3 Millionen Dollar zum 30. September 2024. Das Unternehmen erwartet, dass die aktuelle Finanzierung die Betriebsabläufe bis Januar 2025 unterstützen wird.
- Positive Phase 2b clinical results for istaroxime meeting primary endpoint
- Secured $13.9 million through private placements
- Obtained $35 million equity line agreement
- Expanded patent estate for istaroxime in key markets
- Operating loss of $4.7 million in Q3 2024
- Low cash position of $2.3 million against $14.4 million current liabilities
- Funding only sufficient through January 2025
- Significant warrant liability of $8.6 million
Insights
The Q3 results reveal significant financial challenges. With only
Recent financing efforts, including two private placements totaling
While istaroxime's positive Phase 2b results are promising, the company's immediate focus on business development and partnership opportunities signals a critical need for non-dilutive funding to advance clinical programs.
The Phase 2b SEISMiC B study results for istaroxime demonstrate compelling efficacy in early cardiogenic shock patients. Key positive outcomes include significant improvements in systolic blood pressure, cardiac output and kidney function, with benefits sustained through 96 hours. The favorable safety profile, particularly regarding cardiac arrhythmia risk, is noteworthy.
The initiation of the SEISMiC C study in more severe SCAI Stage C cardiogenic shock patients represents a strategic expansion of the clinical program. The study design, evaluating istaroxime as an add-on to standard care, could position it as a valuable treatment option in this high-mortality condition.
The expanded patent estate, including new territories like Japan and Hong Kong, strengthens the commercial potential of istaroxime.
WARRINGTON, Pa., Nov. 27, 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, today reported financial results for the third quarter ended September 30, 2024 and provided key business updates.
“The third quarter of 2024 was marked with significant progress. We were very pleased with the SEISMiC B study results in early cardiogenic shock showing significant improvement in many measures of cardiac function and blood pressure along with a favorable safety profile in patients with heart failure and cardiogenic shock. There have been four positive Phase 2 studies with over 300 patients treated with istaroxime resulting in a consistent, unique and attractive drug profile across a wide range of severities,” said Craig Fraser, Chairman and CEO. “With trial execution and active operations comes the need for capital and we successfully completed transactions providing resources for our near-term needs as well as secured an equity line of credit to potentially support future requirements,” Mr. Fraser added. “Looking forward, we plan to accelerate enrollments in the istaroxime SCAI Stage C cardiogenic shock study with a planned interim data read out in early Q2 2025 as well as providing guidance on our strategy and planned activities with our oncology preclinical aPKCi inhibitor assets. Given what we believe to be strong data and market need, the Company is turning attention to business development activities to secure additional licenses and partnerships for our multi-asset cardiovascular platform with the objective to secure non-dilutive capital and partner resources to advance the assets to potential commercialization.”
Key Business Updates
- Announced positive Phase 2b topline clinical results with istaroxime significantly improving cardiac function and blood pressure in heart failure patients with early cardiogenic shock. The study met its primary endpoint in significantly improving systolic blood pressure over six hours (SBP AUC) for the combined Part A and Part B SEISMiC istaroxime group compared to placebo as well as for SEISMiC Part B alone. The improvements in SBP AUC at 24 hours were also significantly increased by istaroxime and the improvements were sustained through 96 hours of measurement. Cardiac output (the amount of blood pumped by the heart over a minute) and filling pressures in the heart significantly improved as did measured kidney function. Heart failure severity as assessed by the NYHA classification decreased significantly up to 72 hours compared to placebo. A favorable safety and tolerability profile, including risk for cardiac arrythmias, was also observed. The clinical study data was presented in a late-breaker session at the Heart Failure Society of America conference and the Company reviewed the clinical results along with the program strategy and plans at a virtual Investor Meeting which has been posted to the Company website.
- Completed two private placements in July 2024 for aggregate proceeds of approximately
$13.9 million , which consisted of approximately$4.4 million of new funding (with$2.3 million of net proceeds) and a$9.5 million payment through the full cancellation and extinguishment of certain holders outstanding senior notes, including secured notes, and shares of the Company’s Series B Convertible Preferred Stock. - Entered into a Common Stock Purchase Agreement with an equity line investor, whereby the Company has the right, but not the obligation, to sell such investor, and, subject to limited exceptions, the investor is obligated to purchase for up to
$35 million of newly issued shares of the Company’s common stock. - Announced initiation of the SEISMiC C study of istaroxime in SCAI Stage C cardiogenic shock to complete Phase 2b and advance the transition to Phase 3. This is a global trial including sites in the U.S., Europe and Latin America. It is a placebo-controlled, double-blinded study with istaroxime being added to current standard of care with inotropes and/or vasopressors. The effect of istaroxime in addition to these therapies will be assessed for 6 hours and based on the patient’s condition, the ability to remove standard of care therapies while on istaroxime will also be assessed. The primary endpoint of the study is assessment of systolic blood pressure (SBP) profile over the first 6 hours of treatment.
- Expanded patent estate with new patents with istaroxime in cardiogenic shock and acute heart failure. Cardiogenic shock national phase filings were completed for patent applications around the world, including in the United States, Germany, France, Italy, Japan and China. A patent was issued for istaroxime for Japan entitled, “Istaroxime-containing intravenous formulation for the treatment of heart failure and it has been accorded Patent No. 7560134. A patent was issued for istaroxime for Hong Kong, and it is entitled, “Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF).” The claims are directed formulations comprising istaroxime, pharmaceutically acceptable salts thereof, and methods of use, alone, or in combination with other agents useful for the treatment and management of acute heart failure.
Select Third Quarter 2024 Financial Results
For the third quarter ended September 30, 2024, the Company reported an operating loss of
Research and development expenses were
General and administrative expenses for the third quarter of 2024 were
The Company reported a net loss attributable to common stockholders of
As of September 30, 2024, the Company reported cash and cash equivalents 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 September 30, 2024, which was filed with the Securities and Exchange Commission on November 26, 2024, and includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations.
Nasdaq Update
On November 21, 2024, the Company received a letter from the Nasdaq Listing Qualifications Staff (“Staff”) of The Nasdaq Stock Market LLC stating that it was not in compliance with Nasdaq Listing Rule 5250(c)(1) as a result of it not having timely filed its Quarterly Report on Form 10-Q (“Form 10-Q”) for the quarter ended September 30, 2024 with the Securities and Exchange Commission. Based on the November 26, 2024 filing of the Company’s Form 10-Q and a subsequent letter received from Nasdaq on November 27, 2024 stating the Staff has determined that the Company complies with Nasdaq Listing Rule 5250(c)(1), this matter is now closed.
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 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 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 Company’s ability to maintain compliance with the continued listing requirements of Nasdaq; 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:
Eric Curtis
ecurtis@windtreetx.com
| WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Balance Sheets (in thousands, except share and per share data) | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| (Unaudited) | |||||||
| ASSETS | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 2,300 | $ | 4,319 | |||
| Prepaid expenses and other current assets | 1,628 | 1,060 | |||||
| Total current assets | 3,928 | 5,379 | |||||
| Property and equipment, net | 128 | 183 | |||||
| Restricted cash | 9 | 150 | |||||
| Operating lease right-of-use assets | 1,133 | 1,444 | |||||
| Intangible assets | 25,250 | 25,250 | |||||
| Total assets | $ | 30,448 | $ | 32,406 | |||
| LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY | |||||||
| Current Liabilities: | |||||||
| Accounts payable | $ | 2,054 | $ | 809 | |||
| Accrued expenses | 1,650 | 1,618 | |||||
| Operating lease liabilities - current portion | 468 | 436 | |||||
| ELOC commitment note payable | 317 | - | |||||
| Derivative liability - ELOC commitment note | 347 | - | |||||
| Common stock warrant liability | 8,621 | - | |||||
| Loans payable | 444 | 233 | |||||
| Other current liabilities | 525 | 900 | |||||
| Total current liabilities | 14,426 | 3,996 | |||||
| Operating lease liabilities - non-current portion | 784 | 1,161 | |||||
| Restructured debt liability - contingent milestone payments | - | 15,000 | |||||
| Other liabilities | 3,800 | 3,800 | |||||
| Deferred tax liabilities | 4,887 | 5,058 | |||||
| Total liabilities | 23,897 | 29,015 | |||||
| Mezzanine Equity: | |||||||
| Series C redeemable preferred stock, | 2,142 | - | |||||
| Series B redeemable preferred stock, | - | - | |||||
| Total mezzanine equity | 2,142 | - | |||||
| Stockholders’ Equity: | |||||||
| Preferred stock, | - | - | |||||
| Common stock, | 2 | - | |||||
| Additional paid-in capital | 856,267 | 851,268 | |||||
| Accumulated deficit | (848,806 | ) | (844,823 | ) | |||
| Treasury stock (at cost); 1 share | (3,054 | ) | (3,054 | ) | |||
| Total stockholders’ equity | 4,409 | 3,391 | |||||
| Total liabilities, mezzanine equity & stockholders’ equity | $ | 30,448 | $ | 32,406 | |||
| WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Statements of Operations (in thousands, except per share data) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Expenses: | |||||||||||||||
| Research and development | $ | 1,968 | $ | 2,110 | $ | 14,084 | $ | 5,288 | |||||||
| General and administrative | 2,773 | 2,580 | 6,514 | 7,292 | |||||||||||
| Loss on impairment of goodwill | - | - | - | 3,058 | |||||||||||
| Total operating expenses | 4,741 | 4,690 | 20,598 | 15,638 | |||||||||||
| Operating loss | (4,741 | ) | (4,690 | ) | (20,598 | ) | (15,638 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Gain on debt extinguishment | 71 | - | 14,591 | - | |||||||||||
| Change in fair value of common stock warrant liability | 2,166 | - | 2,166 | - | |||||||||||
| Interest income | 12 | 112 | 62 | 264 | |||||||||||
| Interest expense | (51 | ) | (13 | ) | (174 | ) | (38 | ) | |||||||
| Other (expense) income, net | (446 | ) | 166 | (530 | ) | 275 | |||||||||
| Total other income, net | 1,752 | 265 | 16,115 | 501 | |||||||||||
| Loss before income taxes | (2,989 | ) | (4,425 | ) | (4,483 | ) | (15,137 | ) | |||||||
| Income tax benefit (expense) | 240 | - | (71 | ) | - | ||||||||||
| Net loss | $ | (2,749 | ) | $ | (4,425 | ) | $ | (4,554 | ) | $ | (15,137 | ) | |||
| Extinguishment of Series B Preferred Stock | 572 | - | 572 | - | |||||||||||
| Deemed dividend on Series C Preferred Stock | (1,573 | ) | - | (1,573 | ) | - | |||||||||
| Net loss attributable to common stockholders | $ | (3,750 | ) | $ | (4,425 | ) | $ | (5,555 | ) | $ | (15,137 | ) | |||
| Net loss per share attributable to common stockholders | |||||||||||||||
| Basic and diluted | $ | (4.23 | ) | $ | (15.47 | ) | $ | (8.64 | ) | $ | (80.95 | ) | |||
| Weighted average number of common shares outstanding | |||||||||||||||
| Basic and diluted | 887 | 286 | 643 | 187 | |||||||||||
FAQ
What were Windtree Therapeutics (WINT) Q3 2024 financial results?
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