[10-Q] Windtree Therapeutics, Inc. Quarterly Earnings Report
Windtree Therapeutics, Inc. (WINT) reported continued operating losses and material financing activity in the quarter. The company recorded net losses of $10.6 million and $14.7 million for the three and six months ended June 30, 2025, compared with net losses of $12.0 million and $1.8 million in the comparable 2024 periods. As of June 30, 2025, Windtree had an accumulated deficit of $861.3 million and expects to incur losses for the foreseeable future.
Management disclosed multiple financing transactions including an equity line of credit (ELOC) up to $35 million under which the company sold 0.7 million shares for net proceeds of $0.4 million during the quarter and subsequently sold 16.8 million shares for net proceeds of $10.1 million. The company raised proceeds from convertible note financings and warrants that produced a $7.3 million loss on debt issuance and a $0.8 million fair-value adjustment recorded in other income (expense). Management stated it does not have sufficient cash and cash equivalents at the report date to support operations for the next 12 months and that these conditions raise substantial doubt about the company’s ability to continue as a going concern.
Windtree Therapeutics, Inc. (WINT) ha riportato perdite operative continue e rilevanti operazioni di finanziamento nel trimestre. La società ha registrato perdite nette di $10.6 milioni e $14.7 milioni rispettivamente per i tre e i sei mesi terminati il 30 giugno 2025, rispetto a perdite nette di $12.0 milioni e $1.8 milioni nei corrispondenti periodi del 2024. Al 30 giugno 2025, Windtree mostrava un deficit accumulato di $861.3 milioni e prevede di sostenere perdite nel prossimo futuro.
La direzione ha comunicato diverse operazioni di finanziamento, inclusa una linea di credito azionaria (ELOC) fino a $35 milioni, nell’ambito della quale la società ha venduto 0.7 milioni di azioni per proventi netti di $0.4 milioni durante il trimestre e successivamente ha venduto 16.8 milioni di azioni per proventi netti di $10.1 milioni. La società ha inoltre ottenuto proventi da finanziamenti tramite note convertibili e warrant che hanno generato una perdita su emissione di debito di $7.3 milioni e una rettifica a valore equo di $0.8 milioni registrata in altri proventi (oneri). La direzione ha dichiarato di non disporre di liquidità e mezzi equivalenti sufficienti alla data del rapporto per sostenere le operazioni nei prossimi 12 mesi, condizione che solleva seri dubbi sulla capacità della società di continuare come azienda in funzionamento.
Windtree Therapeutics, Inc. (WINT) informó pérdidas operativas continuas y actividades de financiación significativas en el trimestre. La compañía registró pérdidas netas de $10.6 millones y $14.7 millones por los tres y seis meses terminados el 30 de junio de 2025, en comparación con pérdidas netas de $12.0 millones y $1.8 millones en los períodos comparables de 2024. Al 30 de junio de 2025, Windtree tenía un déficit acumulado de $861.3 millones y espera incurrir en pérdidas en el futuro previsible.
La dirección reveló múltiples transacciones de financiación, incluida una línea de crédito de capital (ELOC) de hasta $35 millones, bajo la cual la compañía vendió 0.7 millones de acciones por ingresos netos de $0.4 millones durante el trimestre y posteriormente vendió 16.8 millones de acciones por ingresos netos de $10.1 millones. La empresa obtuvo además ingresos por emisiones de notas convertibles y warrants que generaron una pérdida por emisión de deuda de $7.3 millones y un ajuste a valor razonable de $0.8 millones registrado en otros ingresos (gastos). La dirección indicó que no cuenta con efectivo y equivalentes suficientes a la fecha del informe para sostener las operaciones durante los próximos 12 meses, lo que plantea serias dudas sobre la capacidad de la compañía para continuar como negocio en marcha.
Windtree Therapeutics, Inc. (WINT)는 분기 동안 지속적인 영업손실과 중요한 자금조달 활동을 보고했습니다. 회사는 2025년 6월 30일로 끝나는 3개월 및 6개월 동안 각각 $10.6백만 및 $14.7백만의 순손실을 기록했으며, 비교 기간인 2024년에는 각각 $12.0백만 및 $1.8백만의 순손실을 기록했습니다. 2025년 6월 30일 기준 Windtree의 누적 적자는 $861.3백만이며, 회사는 당분간 계속 손실을 입을 것으로 예상하고 있습니다.
경영진은 최대 $35백만의 주식 신용한도(ELOC)를 포함한 여러 자금조달 거래를 공개했으며, 이 한도 하에 분기 동안 0.7백만주를 매각해 순수입 $0.4백만을 확보했고 이후 16.8백만주를 매각해 순수입 $10.1백만을 추가로 확보했습니다. 회사는 전환사채 및 워런트 관련 자금조달로 인해 $7.3백만의 채무발행손실과 기타 수익(비용)에 $0.8백만의 공정가치 조정을 기록했습니다. 경영진은 보고일 현재 향후 12개월간 운영을 뒷받침할 충분한 현금 및 현금성 자산이 없다고 밝혔으며, 이러한 사정은 회사의 계속기업 존속능력에 중대한 의문을 제기한다고 했습니다.
Windtree Therapeutics, Inc. (WINT) a déclaré des pertes d'exploitation continues et des opérations de financement importantes au cours du trimestre. La société a enregistré des pertes nettes de $10.6 millions et $14.7 millions pour les trois et six mois clos le 30 juin 2025, contre des pertes nettes de $12.0 millions et $1.8 millions pour les périodes comparables de 2024. Au 30 juin 2025, Windtree affichait un déficit cumulé de $861.3 millions et s'attend à subir des pertes pour l'avenir prévisible.
La direction a divulgué plusieurs opérations de financement, y compris une ligne de crédit en actions (ELOC) pouvant aller jusqu'à $35 millions, dans le cadre de laquelle la société a vendu 0.7 million d'actions pour un produit net de $0.4 million au cours du trimestre, puis a vendu 16.8 millions d'actions pour un produit net de $10.1 millions. La société a également obtenu des produits de financements par billets convertibles et warrants ayant entraîné une perte liée à l'émission de dette de $7.3 millions et un ajustement à la juste valeur de $0.8 million enregistré en autres produits (charges). La direction a indiqué qu'elle ne disposait pas, à la date du rapport, de liquidités et équivalents de trésorerie suffisants pour soutenir les opérations pendant les 12 prochains mois, ce qui soulève un doute important quant à la capacité de la société à poursuivre son activité.
Windtree Therapeutics, Inc. (WINT) meldete im Quartal anhaltende operative Verluste und bedeutende Finanzierungsaktivitäten. Das Unternehmen verzeichnete für die drei bzw. sechs Monate zum 30. Juni 2025 Nettoversluste in Höhe von $10.6 Millionen bzw. $14.7 Millionen, verglichen mit Nettoverslusten von $12.0 Millionen bzw. $1.8 Millionen in den entsprechenden Zeiträumen 2024. Zum 30. Juni 2025 wies Windtree ein kumuliertes Defizit von $861.3 Millionen auf und erwartet auch künftig Verluste.
Das Management gab mehrere Finanzierungsmaßnahmen bekannt, darunter eine Aktienkreditlinie (ELOC) von bis zu $35 Millionen, im Rahmen derer das Unternehmen während des Quartals 0.7 Millionen Aktien für Nettoerlöse von $0.4 Millionen verkaufte und anschließend 16.8 Millionen Aktien für Nettoerlöse von $10.1 Millionen veräußerte. Zudem generierten wandelbare Schuldverschreibungen und Warrants Erlöse, die zu einem Verlust bei Schuldemissionen in Höhe von $7.3 Millionen und einer Fair-Value-Anpassung von $0.8 Millionen in sonstigen Erträgen (Aufwendungen) führten. Das Management erklärte, dass zum Berichtsdatum nicht ausreichend liquide Mittel vorhanden seien, um den Geschäftsbetrieb für die nächsten 12 Monate zu sichern, wodurch erhebliche Zweifel an der Fortführungsfähigkeit des Unternehmens entstehen.
- ELOC facility up to $35 million provides a committed capital source through equity draws
- Subsequent sale of 16.8 million shares for $10.1 million improved near-term liquidity after quarter end
- Regained Nasdaq minimum bid-price compliance in March 2025, avoiding delisting at that time
- Substantial doubt about going concern: company lacked sufficient cash to support operations for the next 12 months as of the report date
- Persistent operating losses: net loss of $10.6 million (three months) and $14.7 million (six months) ended June 30, 2025
- Heavy dilution and financing costs: $7.3 million loss on debt issuance related to June 2025 notes and warrants and fair value adjustments
- Accumulated deficit of $861.3 million, reflecting long-term cumulative losses
Insights
TL;DR: Significant financing and dilution, persistent losses, and going-concern doubt materially weaken near-term financial position.
Windtree's operating results show persistent net losses and an accumulated deficit of $861.3 million. The company relied heavily on dilutive equity financings and short-term convertible note financings, including June 2025 notes and warrants that generated a $7.3 million loss on debt issuance and a $0.8 million fair-value adjustment. While the ELOC and subsequent $10.1 million raise provide near-term liquidity, management explicitly states insufficient cash to fund operations for 12 months as of the report date, creating substantial doubt about going concern. These factors are materially negative for shareholders unless further non-dilutive financing or operational progress occurs.
TL;DR: Active capital-raising and complex financing arrangements increase governance and stakeholder risk.
The filing documents numerous complex securities, preferred conversions, inducements, and warrants with anti-dilution and ownership cap features, plus restructuring of milestone liabilities. Multiple related-party and holder overlaps (e.g., ELOC purchaser also holding preferred and notes) increase the potential for conflicts of interest and require careful disclosure and oversight. Regaining Nasdaq compliance in March 2025 is positive, but the ongoing discretionary monitoring and continued financing activity warrant heightened board attention and transparent stakeholder communication.
Windtree Therapeutics, Inc. (WINT) ha riportato perdite operative continue e rilevanti operazioni di finanziamento nel trimestre. La società ha registrato perdite nette di $10.6 milioni e $14.7 milioni rispettivamente per i tre e i sei mesi terminati il 30 giugno 2025, rispetto a perdite nette di $12.0 milioni e $1.8 milioni nei corrispondenti periodi del 2024. Al 30 giugno 2025, Windtree mostrava un deficit accumulato di $861.3 milioni e prevede di sostenere perdite nel prossimo futuro.
La direzione ha comunicato diverse operazioni di finanziamento, inclusa una linea di credito azionaria (ELOC) fino a $35 milioni, nell’ambito della quale la società ha venduto 0.7 milioni di azioni per proventi netti di $0.4 milioni durante il trimestre e successivamente ha venduto 16.8 milioni di azioni per proventi netti di $10.1 milioni. La società ha inoltre ottenuto proventi da finanziamenti tramite note convertibili e warrant che hanno generato una perdita su emissione di debito di $7.3 milioni e una rettifica a valore equo di $0.8 milioni registrata in altri proventi (oneri). La direzione ha dichiarato di non disporre di liquidità e mezzi equivalenti sufficienti alla data del rapporto per sostenere le operazioni nei prossimi 12 mesi, condizione che solleva seri dubbi sulla capacità della società di continuare come azienda in funzionamento.
Windtree Therapeutics, Inc. (WINT) informó pérdidas operativas continuas y actividades de financiación significativas en el trimestre. La compañía registró pérdidas netas de $10.6 millones y $14.7 millones por los tres y seis meses terminados el 30 de junio de 2025, en comparación con pérdidas netas de $12.0 millones y $1.8 millones en los períodos comparables de 2024. Al 30 de junio de 2025, Windtree tenía un déficit acumulado de $861.3 millones y espera incurrir en pérdidas en el futuro previsible.
La dirección reveló múltiples transacciones de financiación, incluida una línea de crédito de capital (ELOC) de hasta $35 millones, bajo la cual la compañía vendió 0.7 millones de acciones por ingresos netos de $0.4 millones durante el trimestre y posteriormente vendió 16.8 millones de acciones por ingresos netos de $10.1 millones. La empresa obtuvo además ingresos por emisiones de notas convertibles y warrants que generaron una pérdida por emisión de deuda de $7.3 millones y un ajuste a valor razonable de $0.8 millones registrado en otros ingresos (gastos). La dirección indicó que no cuenta con efectivo y equivalentes suficientes a la fecha del informe para sostener las operaciones durante los próximos 12 meses, lo que plantea serias dudas sobre la capacidad de la compañía para continuar como negocio en marcha.
Windtree Therapeutics, Inc. (WINT)는 분기 동안 지속적인 영업손실과 중요한 자금조달 활동을 보고했습니다. 회사는 2025년 6월 30일로 끝나는 3개월 및 6개월 동안 각각 $10.6백만 및 $14.7백만의 순손실을 기록했으며, 비교 기간인 2024년에는 각각 $12.0백만 및 $1.8백만의 순손실을 기록했습니다. 2025년 6월 30일 기준 Windtree의 누적 적자는 $861.3백만이며, 회사는 당분간 계속 손실을 입을 것으로 예상하고 있습니다.
경영진은 최대 $35백만의 주식 신용한도(ELOC)를 포함한 여러 자금조달 거래를 공개했으며, 이 한도 하에 분기 동안 0.7백만주를 매각해 순수입 $0.4백만을 확보했고 이후 16.8백만주를 매각해 순수입 $10.1백만을 추가로 확보했습니다. 회사는 전환사채 및 워런트 관련 자금조달로 인해 $7.3백만의 채무발행손실과 기타 수익(비용)에 $0.8백만의 공정가치 조정을 기록했습니다. 경영진은 보고일 현재 향후 12개월간 운영을 뒷받침할 충분한 현금 및 현금성 자산이 없다고 밝혔으며, 이러한 사정은 회사의 계속기업 존속능력에 중대한 의문을 제기한다고 했습니다.
Windtree Therapeutics, Inc. (WINT) a déclaré des pertes d'exploitation continues et des opérations de financement importantes au cours du trimestre. La société a enregistré des pertes nettes de $10.6 millions et $14.7 millions pour les trois et six mois clos le 30 juin 2025, contre des pertes nettes de $12.0 millions et $1.8 millions pour les périodes comparables de 2024. Au 30 juin 2025, Windtree affichait un déficit cumulé de $861.3 millions et s'attend à subir des pertes pour l'avenir prévisible.
La direction a divulgué plusieurs opérations de financement, y compris une ligne de crédit en actions (ELOC) pouvant aller jusqu'à $35 millions, dans le cadre de laquelle la société a vendu 0.7 million d'actions pour un produit net de $0.4 million au cours du trimestre, puis a vendu 16.8 millions d'actions pour un produit net de $10.1 millions. La société a également obtenu des produits de financements par billets convertibles et warrants ayant entraîné une perte liée à l'émission de dette de $7.3 millions et un ajustement à la juste valeur de $0.8 million enregistré en autres produits (charges). La direction a indiqué qu'elle ne disposait pas, à la date du rapport, de liquidités et équivalents de trésorerie suffisants pour soutenir les opérations pendant les 12 prochains mois, ce qui soulève un doute important quant à la capacité de la société à poursuivre son activité.
Windtree Therapeutics, Inc. (WINT) meldete im Quartal anhaltende operative Verluste und bedeutende Finanzierungsaktivitäten. Das Unternehmen verzeichnete für die drei bzw. sechs Monate zum 30. Juni 2025 Nettoversluste in Höhe von $10.6 Millionen bzw. $14.7 Millionen, verglichen mit Nettoverslusten von $12.0 Millionen bzw. $1.8 Millionen in den entsprechenden Zeiträumen 2024. Zum 30. Juni 2025 wies Windtree ein kumuliertes Defizit von $861.3 Millionen auf und erwartet auch künftig Verluste.
Das Management gab mehrere Finanzierungsmaßnahmen bekannt, darunter eine Aktienkreditlinie (ELOC) von bis zu $35 Millionen, im Rahmen derer das Unternehmen während des Quartals 0.7 Millionen Aktien für Nettoerlöse von $0.4 Millionen verkaufte und anschließend 16.8 Millionen Aktien für Nettoerlöse von $10.1 Millionen veräußerte. Zudem generierten wandelbare Schuldverschreibungen und Warrants Erlöse, die zu einem Verlust bei Schuldemissionen in Höhe von $7.3 Millionen und einer Fair-Value-Anpassung von $0.8 Millionen in sonstigen Erträgen (Aufwendungen) führten. Das Management erklärte, dass zum Berichtsdatum nicht ausreichend liquide Mittel vorhanden seien, um den Geschäftsbetrieb für die nächsten 12 Monate zu sichern, wodurch erhebliche Zweifel an der Fortführungsfähigkeit des Unternehmens entstehen.
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
| | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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| | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____ to _____
Commission File Number:
WINDTREE THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol(s) | Name of each exchange on which registered |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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| Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of August 19, 2025, there were
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PART I - FINANCIAL INFORMATION
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Financial Statements |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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As of June 30, 2025 (unaudited) and December 31, 2024 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) |
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For the Three and Six Months Ended June 30, 2025 and 2024 |
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CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND STOCKHOLDERS’ EQUITY (unaudited) For the Six Months Ended June 30, 2025 and 2024 |
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) |
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For the Six Months Ended June 30, 2025 and 2024 |
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Notes to Condensed Consolidated Financial Statements (unaudited) |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Quantitative and Qualitative Disclosures about Market Risk |
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Controls and Procedures |
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PART II - OTHER INFORMATION
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Legal Proceedings |
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Risk Factors |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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Defaults Upon Senior Securities |
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Mine Safety Disclosures |
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Other Information |
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Exhibits |
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| Signatures |
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Unless the context otherwise requires, all references to “we,” “us,” “our,” and the “Company” include Windtree Therapeutics, Inc., and its consolidated subsidiaries.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These forward-looking statements provide our current expectations or forecasts of future events and financial performance and may be identified by the use of forward-looking terminology, including such terms as “anticipates,” “believes,” “contemplates,” “continues,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “targets,” or “will” or, in each case, their negative, or other variations or comparable terminology, though the absence of these words does not necessarily mean that a statement is not forward-looking.
We intend that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to many risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. We caution you therefore against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Examples of such risks and uncertainties, which potentially could have a material adverse effect on our development programs, business and/or operations, include, but are not limited to the following:
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our estimates regarding future results of operations, financial position, research and development costs, capital requirements, and our needs for additional financing; |
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how long we can continue to fund our operations with our existing cash and cash equivalents; |
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changes in market conditions, general economic conditions, and the banking sector, and potential constraints in accessing capital or credit if and when needed with favorable terms, if at all; |
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the potential impairment of our intangible assets on our condensed consolidated balance sheet, which could lead to material impairment charges in the future; |
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our ability to repay indebtedness; |
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potential delays and uncertainties in our anticipated timelines and milestones and additional costs associated with the impact of the evolving events in the Israel-Gaza region, the ongoing military conflict between Russian and Ukraine, and trade and political tensions between the United States, or the U.S., and the People’s Republic of China on our clinical trial operations; |
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the costs, timing, and results, of our preclinical studies and clinical trials, as well as the number of required trials for regulatory approval and the criteria for success in such trials; |
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legal and regulatory developments in the U.S. and foreign countries, including any actions or advice that may affect the design, initiation, timing, continuation, progress or outcome of clinical trials or result in the need for additional clinical trials; |
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the difficulties and expenses associated with obtaining and maintaining regulatory approval of our product candidates, and the indication and labeling under any such approval; |
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risks related to manufacturing active pharmaceutical ingredients, drug product, and other materials we need; |
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delays, interruptions or failures in the manufacture and supply of our product candidates; |
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the plans of our licensee, Lee’s Pharmaceutical (HK) Ltd., and its affiliate, Zhaoke Pharmaceutical (Hefei) Co. Ltd., and their ability to successfully source materials, execute necessary clinical and regulatory activities in a timely manner, if at all, to support development and commercialization of the licensed product candidates; |
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the performance of third parties, both foreign and domestic, upon which we depend, including contract research organizations, contract manufacturing organizations, contract laboratories, and independent contractors; |
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the success of competing therapies and products that are or may become available; |
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our ability to limit our exposure under product liability lawsuits; |
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our ability to obtain and maintain intellectual property protection for our product candidates; |
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recently enacted and future legislation, including but not limited to, the Inflation Reduction Act of 2022, regarding the healthcare system in the U.S. or the healthcare systems in foreign jurisdictions; |
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our ability to recruit or retain key scientific, commercial or management personnel or to retain our executive officers; |
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our ability to secure electronically stored work product, including clinical data, analyses, research, communications, and other materials necessary to gain regulatory approval of our product candidates, including those acquired from third parties, and assure the integrity, proper functionality, and security of our internal computer and information systems and prevent or avoid cyber-attacks, malicious intrusion, breakdown, destruction, security incidents, data privacy violations, or other significant disruption; |
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economic uncertainty resulting from inflation and interest rate fluctuations, including concerns involving liquidity, defaults or other non-performance by financial institutions; |
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our expectations regarding the use of proceeds from sales under our equity line of credit, if any; |
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economic uncertainty resulting from geopolitical instability, including the ongoing conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the Middle East, including any escalation or expansion; |
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our ability to successfully implement our new business strategy to generate revenue through acquisitions of small companies and their FDA-approved products; |
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Pharmaceutical, biotechnology, and medical technology companies have suffered significant setbacks conducting clinical trials, even after obtaining promising earlier preclinical and clinical data. In addition, data obtained from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. After gaining approval of a drug product, pharmaceutical and biotechnology companies face considerable challenges in marketing and distributing their products and may never become profitable.
The forward-looking statements contained in this Quarterly Report on Form 10-Q, or the documents incorporated by reference herein, speak only as of their respective dates. Factors or events that could cause our actual results to differ may emerge from time to time and it is not possible for us to predict them all. Except to the extent required by applicable laws, rules or regulations, we do not undertake any obligation to publicly update any forward-looking statements or to publicly announce revisions to any of the forward-looking statements, whether as a result of new information, future events or otherwise.
You should also read carefully the factors described in the “Risk Factors” included in Part II, Item 1A of this Quarterly Report on Form 10-Q in conjunction with Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, to better understand the significant risks and uncertainties inherent in our business and underlying any forward-looking statements.
Trademark Notice
AEROSURF®, AFECTAIR®, SURFAXIN®, SURFAXIN LS™, WINDTREE THERAPEUTICS® (logo), WINDTREE THERAPEUTICS™, and WINDTREE™ are registered and common law trademarks of Windtree Therapeutics, Inc. (Warrington, PA).
ITEM 1. Financial Statements
WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| (in thousands, except share and per share data) |
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses and other current assets | ||||||||
| Note receivable, net | ||||||||
| Deposit | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Restricted cash | ||||||||
| Operating lease right-of-use assets | ||||||||
| Intangible assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Payable for unfunded portion of note receivable | ||||||||
| Operating lease liabilities - current portion | ||||||||
| Convertible notes payable | ||||||||
| ELOC commitment note payable | ||||||||
| Derivative liability - ELOC commitment note | ||||||||
| Common stock warrant liability | ||||||||
| Loans payable | ||||||||
| Other current liabilities | ||||||||
| Total current liabilities | ||||||||
| Operating lease liabilities - non-current portion | ||||||||
| Other liabilities | ||||||||
| Deferred tax liabilities | ||||||||
| Total liabilities | ||||||||
| Mezzanine equity: | ||||||||
| Series B redeemable preferred stock, $0.001 par value; 5,500 shares authorized; 0 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Series C redeemable preferred stock, $0.001 par value; 18,820 shares authorized; 573 and 11,757 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Series D redeemable preferred stock, $0.001 par value; 5,000 shares authorized; 3,688 and 0 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Total mezzanine equity | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value; 4,970,680 shares authorized; 0 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Common stock, $0.001 par value; 120,000,000 shares authorized; 9,247,953 and 256,397 shares issued and 9,247,952 and 256,396 shares outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Treasury stock (at cost); 1 share | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities, mezzanine equity & stockholders’ equity | $ | $ | ||||||
| See notes to condensed consolidated financial statements |
WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited)
| (in thousands, except share and per share data) |
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Expenses: | ||||||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Loss on debt issuances | ( | ) | ( | ) | ||||||||||||
| Gain on debt extinguishment, net | ||||||||||||||||
| Change in fair value of convertible notes payable | ||||||||||||||||
| Change in fair value of common stock warrant liability | ||||||||||||||||
| Change in fair value of derivative liabilities | ||||||||||||||||
| Interest income | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other expense, net | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Total other (expense) income, net | ( | ) | ( | ) | ( | ) | ||||||||||
| Loss before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income tax expense | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Dividends on Series C preferred stock | ( | ) | ( | ) | ||||||||||||
| Dividends on Series D preferred stock | ( | ) | ( | ) | ||||||||||||
| Dividends on warrants | ( | ) | ( | ) | ||||||||||||
| Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share attributable to common stockholders | ||||||||||||||||
| Basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average number of common shares outstanding | ||||||||||||||||
| Basic and diluted | ||||||||||||||||
| See notes to condensed consolidated financial statements |
WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Changes in Mezzanine Equity and Stockholders’ Equity
(Unaudited)
| (in thousands) |
| Mezzanine Equity | Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Series B Preferred Stock | Series C Preferred Stock | Series D Preferred Stock | Common Stock | Treasury Stock | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Total | Shares | Amount | Additional | Accumulated | Shares | Amount | Total | |||||||||||||||||||||||||||||||||||||||||||
| Balance - December 31, 2023 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||
| Net income | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, ATM Program, net of issuance costs of $44 | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, equity consideration in debt extinguishment | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - March 31, 2024 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of preferred stock, net of issuance costs of $68 | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Reverse split adjustments - fractional share round ups | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - June 30, 2024 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||
| Mezzanine Equity | Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Series B Preferred Stock | Series C Preferred Stock | Series D Preferred Stock | Common Stock | Treasury Stock | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Total | Shares | Amount | Additional Paid-in Capital | Accumulated Deficit | Shares | Amount | Total | |||||||||||||||||||||||||||||||||||||||||||
| Balance - December 31, 2024 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Series C preferred stock conversions | ( | ) | ( | ) | ( | ) | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Series C preferred stock redemptions | ( | ) | ( | ) | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on Series C preferred stock | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends on Series C preferred stock | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, ELOC | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, equity consideration in debt extinguishment | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Exercise of common stock warrants | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Settlement of common stock warrant liability | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - March 31, 2025 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Series C preferred stock conversions | ( | ) | ( | ) | ( | ) | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on Series C preferred stock | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on warrants | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends on Series C preferred stock | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of Series D preferred stock, net of issuance costs | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of June 2025 warrants | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividends on Series D preferred stock | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends on Series D preferred stock | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock, ELOC | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Exercise of common stock warrants | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Settlement of common stock warrant liability | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance - June 30, 2025 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||
| See notes to condensed consolidated financial statements |
WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| (in thousands) |
| Six Months Ended | ||||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| In-process research and development expenses in connection with the Varian asset acquisition | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation | ||||||||
| Non-cash lease expense | ||||||||
| Accretion of discount on senior note receivable | ( | ) | ||||||
| Amortization of debt discount and debt issuance costs | ||||||||
| Loss on ELOC commitment note and derivative liability | ||||||||
| Loss on debt issuances | ||||||||
| Gain on debt extinguishment | ( | ) | ( | ) | ||||
| Unrealized loss (gain) on foreign exchange rate changes | ( | ) | ||||||
| Change in fair value of convertible notes | ( | ) | ||||||
| Change in fair value of derivative liabilities | ( | ) | ( | ) | ||||
| Change in fair value of senior secured notes | ||||||||
| Change in fair value of warrant liability | ( | ) | ||||||
| Changes in assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Accounts payable | ||||||||
| Accrued expenses | ||||||||
| Operating lease liabilities | ( | ) | ( | ) | ||||
| Other current liabilities | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Issuance of senior note | ( | ) | ||||||
| Deposit | ( | ) | ||||||
| Purchase of property and equipment | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from convertible notes | ||||||||
| Proceeds from private placement of Series D preferred stock, net of issuance costs | ||||||||
| Proceeds from ELOC Purchase Agreement, net of issuance costs | ||||||||
| Proceeds from senior secured notes payable, net of issuance costs | ||||||||
| Proceeds from exercise of common stock warrants | ||||||||
| Proceeds from ATM Program, net of issuance costs | ||||||||
| Principal payments on senior secured notes payable | ( | ) | ||||||
| Principal payments on loans payable | ( | ) | ( | ) | ||||
| Redemptions of Series C preferred stock | ( | ) | ||||||
| Cash dividend payments on Series C preferred stock | ( | ) | ||||||
| Proceeds from senior convertible notes payable, net of issuance costs | ||||||||
| Issuance costs related to Series B Preferred Stock | ( | ) | ||||||
| Payments on debt extinguishment | ( | ) | ||||||
| Net cash provided by financing activities | ||||||||
| Net decrease in cash, cash equivalents, and restricted cash | ( | ) | ( | ) | ||||
| Cash, cash equivalents, and restricted cash - beginning of period | ||||||||
| Cash, cash equivalents, and restricted cash - end of period | $ | $ | ||||||
| Supplementary disclosure of non-cash activity: | ||||||||
| Conversions of Series C preferred stock | $ | $ | ||||||
| Deemed dividends on Series C preferred stock | ||||||||
| Deemed dividends on Series D preferred stock | ||||||||
| Deemed dividends on warrants | ||||||||
| Cash dividends payable | ||||||||
| Cash dividends converted into common stock | ||||||||
| Fair value upon issuance of convertible notes | ||||||||
| Fair value upon issuance of June 2025 warrants | ||||||||
| Fair value of common stock consideration related to ELOC commitment note extinguishment | ||||||||
| Fair value upon issuance of March 2025 senior secured notes | ||||||||
| Settlement of common stock warrant liability | ||||||||
| Fair value of Series B Preferred Stock issued in connection with the Varian asset acquisition | ||||||||
| Fair value upon issuance of derivative liability related to senior convertible notes payable | ||||||||
| Fair value upon issuance of derivative liability related to ELOC commitment note | ||||||||
| Fair value of common stock consideration related to debt extinguishment | ||||||||
| See notes to condensed consolidated financial statements |
Notes to Condensed Consolidated Financial Statements (unaudited)
Note 1 – The Company and Description of Business
We are a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Our portfolio of product candidates includes istaroxime, a Phase 2 candidate that inhibits the sodium-potassium ATPase and also activates sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, for acute heart failure and/or associated cardiogenic shock; preclinical SERCA2a activators for heart failure; rostafuroxin for the treatment of hypertension in patients with a specific genetic profile; and a preclinical atypical protein kinase C iota, or aPKCi, inhibitor (topical and oral formulations), being developed for potential application in rare and broad oncology indications. We also have a licensing business model with partnership out-licenses currently in place.
In addition, in January 2025, we launched a new corporate strategy to become a revenue generating biotech company through acquisitions of small companies and their FDA-approved products while the Company continues to progress its cardiovascular and oncology development pipeline. The Company will seek acquisition targets to achieve the Company’s new corporate strategy. To capitalize on this opportunity, we plan to become a parent company acquiring strategic subsidiaries utilizing equity and debt. The number of deals, if any, over time will depend upon the valuation and growth potential of the subsidiary companies.
On July 16, 2025, we announced our launch of a crypto treasury strategy utilizing the native token of the BNB chain commonly referred to as “BNB,” including a $
Our lead product candidate, istaroxime, is a first-in-class, dual-mechanism agent being developed to increase blood pressure and improve cardiac function in patients with cardiogenic shock and to improve cardiac function in patients with acute heart failure, or AHF, and reverse the hypotension and hypoperfusion associated with heart failure that deteriorates to cardiogenic shock. Istaroxime demonstrated significant improvement in both systolic and diastolic aspects of cardiac function and was generally well tolerated in four Phase 2 clinical trials and has been granted Fast Track designation for the treatment of AHF by the U.S. Food and Drug Administration, or FDA. Based on the profile observed in our Phase 2 clinical studies in AHF, where istaroxime significantly improved cardiac function and systolic blood pressure, or SBP, in acute decompensated heart failure patients and had a favorable renal profile, we initiated a Phase 2 global clinical study, or the SEISMiC Study, to evaluate istaroxime for the treatment of early cardiogenic shock (Society for Cardiovascular Angiography and Interventions, or SCAI, Stage B shock), a severe form of AHF characterized by very low blood pressure and risk for hypoperfusion to critical organs and mortality. In April 2022, we announced our observations in the SEISMiC Study that istaroxime rapidly and significantly increased SBP while also improving cardiac function and preserving renal function. We believe that istaroxime has the potential to fulfill an unmet need in early and potentially more severe cardiogenic shock. We further believe that the data from the SEISMiC Study supports continued development in both cardiogenic shock and AHF. In September 2024, we announced positive topline results from our Phase 2b SEISMiC Extension Study, or the SEISMiC Extension, which demonstrated that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or clinically significant cardiac rhythm disturbances. Additionally, we initiated a study in more severe SCAI Stage C cardiogenic shock, or the SEISMiC C Study, to evaluate the safety and efficacy of istaroxime in cardiogenic shock patients who are also receiving standard of care rescue therapy for shock. The SEISMiC C Study was planned to enroll up to 100 subjects with SCAI Stage C cardiogenic shock. A planned unblinded review of the data from the first 20 subjects occurred in July 2025. The review of the preliminary interim data suggests that the responses to istaroxime in SCAI Stage C patients, many of whom were also treated with currently available inotropes and vasopressors, is similar to that seen in our previous clinical trials. Because our ability to complete this study with its intended sample size is dependent upon our ability to secure adequate resourcing for the program through financing efforts or business development activities we have decided to terminate the SEISMiC C clinical trial and pursue further development with istaroxime in the much larger market of less severe patients with acute decompensated heart failure with our licensing partner, Lee’s Pharmaceutical (HK) Ltd., who is planning a global phase 3 study in that indication.
Our heart failure cardiovascular portfolio also includes other SERCA2a activators. One family of compounds has the dual mechanism of action that includes inhibition of the sodium-potassium ATPase as well as activation of SERCA2a. The other family of compounds are considered selective SERCA2a activators and are devoid of activity against the sodium-potassium ATPase. This research program is evaluating these preclinical product candidates, including oral and intravenous SERCA2a activator heart failure compounds. These candidates would potentially be developed for both acute decompensated and chronic out-patient heart failure. In addition, our cardiovascular drug product candidates include rostafuroxin, a novel product candidate for the treatment of hypertension in patients with a specific genetic profile. We are pursuing potential licensing arrangements and/or other strategic partnerships and do not intend to advance the development of rostafuroxin without securing such an arrangement or partnership.
Our cardiovascular assets and programs are associated with a regional licensed partnership with Lee’s Pharmaceutical (HK) Ltd., or Lee’s (HK), for the development and commercialization of our product candidate, istaroxime, in Greater China. In addition to istaroxime, the agreement also licenses our preclinical next-generation dual mechanism SERCA2a activators, and rostafuroxin. In addition, we are supporting the efforts of Lee’s (HK) in starting a Phase 3 trial in AHF with istaroxime.
On April 2, 2024, we entered into an Asset Purchase Agreement, or the Asset Purchase Agreement, with Varian Biopharmaceuticals, Inc., or Varian. Pursuant to the Asset Purchase Agreement, we purchased all of the assets of Varian’s business associated with a license agreement, dated as of July 5, 2019, by and between Varian and Cancer Research Technology Limited, or the License Agreement, which includes the License Agreement, all rights in molecules and compounds subject to the License Agreement, know-how and inventory of drug substance, or the Transferred Assets. The Transferred Assets include a novel, potential high-potency, specific, aPKCi inhibitor with possible broad use in oncology as well as certain rare malignant diseases. The asset platform includes two formulations (topical and oral) of an aPKCi inhibitor. We plan to advance investigational new drug, or IND, enabling activities and are in the process of determining the expected clinical development plan for the platform.
The reader is referred to, and encouraged to read in its entirety, “Item 1 – Business” in our Annual Report on Form 10-K for the year ended December 31, 2024 that we filed with the Securities and Exchange Commission, or the SEC, on April 15, 2025, which contains a discussion of our business and business plans, as well as information concerning our proprietary technologies and our current and planned development programs.
Note 2 – Basis of Presentation
The interim unaudited condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S., or U.S. GAAP, for interim financial information in accordance with the instructions to Form 10-Q and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete consolidated financial statements. Intercompany balances and transactions have been eliminated in consolidation. All adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. Operating results for the three and six months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025. The consolidated balance sheet at December 31, 2024 has been derived from the Company’s audited consolidated financial statements. There have been no changes to our significant accounting policies since December 31, 2024. The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with our annual audited consolidated financial statements and related notes as of and for the year ended December 31, 2024 contained in our Annual Report on Form 10-K for the year ended December 31, 2024.
The accompanying condensed consolidated financial statements reflect the 1-for-
Note 3 – Going Concern and Management’s Plans
We are subject to risks common to companies in the biotechnology industry, including but not limited to the need for additional capital, risks of failure of preclinical and clinical studies, the need to obtain marketing approval and reimbursement for any drug product candidate that we may identify and develop, the need to successfully commercialize and gain market acceptance of our product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development of technological innovations by competitors, and risks associated with our international operations in Taiwan and activities abroad, including but not limited to having foreign suppliers, manufacturers, and clinical sites in support of our development activities.
With the exception of certain non-recurring items such as gain on debt extinguishment, we have incurred net losses since inception. Our net loss was $
In June 2024, we entered into a Common Stock Purchase Agreement, or the ELOC Purchase Agreement, establishing an equity line of credit with the purchaser, or the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $
As of June 30, 2025, we had cash and cash equivalents of $
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to secure additional capital, potentially through a combination of public or private securities offerings, convertible debt financings, and/or strategic transactions, including potential licensing arrangements, alliances, and drug product collaborations focused on specified geographic markets; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, or identify and enter into any strategic transactions that will provide the capital that we will require. If we fail to raise sufficient capital, we potentially could be forced to limit or cease our development activities, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations. Accordingly, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern for at least 12 months after the issuance of the accompanying financial statements.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
Note 4 – Summary of Significant Accounting Policies
Principles of Consolidation
The interim unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP and include accounts of Windtree Therapeutics, Inc. and its wholly owned subsidiaries, WINT Real Estate, LLC; CVie Investments Limited and its wholly owned subsidiary, CVie Therapeutics Limited; and a presently inactive subsidiary, Discovery Laboratories, Inc. (formerly known as Acute Therapeutics, Inc.).
Intangible Assets
We record acquired intangible assets based on estimated fair value. The identifiable intangible assets resulting from the CVie Therapeutics acquisition in December 2018 relate to in-process research and development, or IPR&D, of istaroxime and rostafuroxin. The IPR&D assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not amortized but reviewed for impairment at least annually, or when events or changes in the business environment indicate the carrying value may be impaired. During the three and six months ended June 30, 2025, no events or changes in circumstances occurred indicating that our IPR&D intangible assets were more likely than not impaired.
The following table represents identifiable intangible assets as of June 30, 2025 and December 31, 2024:
| June 30, | December 31, | |||||||
| (in thousands) | 2025 | 2024 | ||||||
| Istaroxime drug candidate | $ | $ | ||||||
| Rostafuroxin drug candidate | ||||||||
| Intangible assets | $ | $ | ||||||
Convertible Debt and Equity Instruments
We review the terms of convertible debt and equity instruments to determine whether there are conversion features or embedded derivative instruments including embedded conversion options that are required to be bifurcated and accounted for separately as derivative financial instruments under ASC Topic 815, Derivatives and Hedging.
In circumstances where the convertible instrument contains more than one embedded derivative instrument, including conversion options that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single compound instrument. Also, in connection with the sale of convertible debt and equity instruments, we may issue free standing warrants that may, depending on their terms, be accounted for as derivative instrument liabilities, rather than as equity. When convertible debt or equity instruments contain embedded derivative instruments that are to be bifurcated and accounted for separately, the total proceeds allocated to the convertible host instruments are first allocated to the fair value of the bifurcated derivative instrument. The remaining proceeds, if any, are then allocated to the convertible instruments themselves, usually resulting in those instruments being recorded at a discount from their face amount. When we issue debt securities, which bear interest at rates that are lower than market rates, we recognize a discount, which is offset against the carrying value of the debt. Such discount from the face value of the debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to income.
Derivative Financial Instruments
Derivatives are recorded on the consolidated balance sheet at fair value. The conversion features of the convertible notes are embedded derivatives and are separately valued and accounted for on the consolidated balance sheet with changes in fair value recognized during the period of change as a separate component of other income (expense). Fair values for exchange-traded securities and derivatives are based on quoted market prices. The pricing model we use for determining the fair value of non-exchange traded derivatives is the Monte Carlo Model. Valuations derived from this model are subject to ongoing internal and external verification and review. The model uses market-sourced inputs such as interest rates and stock price volatilities.
Foreign Currency Transactions
The functional currency for our foreign subsidiaries is the U.S. Dollar. We remeasure monetary assets and liabilities that are not denominated in the functional currency at exchange rates in effect at the end of each period. Gains and losses from the remeasurement of foreign currency transactions are recognized in other (expense) income, net. Foreign currency transactions resulted in a net loss of approximately $
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including intangible assets, at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Concentration of Credit Risk
Financial instruments, which potentially subject us to credit risk, consist principally of cash and cash equivalents. All cash and cash equivalents are held in U.S. financial institutions and money market funds. At times, we may maintain cash balances in excess of the federally insured amount of $250,000 per depositor, per insured bank, for each account ownership category. Although we currently believe that the financial institutions with whom we do business will be able to fulfill their commitments to us, there is no assurance that those institutions will be able to continue to do so. We have not experienced any credit losses associated with our balances in such accounts.
Research and Development
We account for research and development expense by the following categories: (a) direct clinical and preclinical development programs, (b) product development and manufacturing, and (c) clinical, medical, and regulatory operations. Research and development expense includes personnel, facilities, manufacturing and quality, pharmaceutical development, research, clinical, regulatory, and other preclinical and clinical activities. Research and development costs are charged to operations as incurred in accordance with Accounting Standards Codification, or ASC, Topic 730, Research and Development.
Warrant Accounting
We account for common stock warrants in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging – Contracts in Entity’s Own Equity, or ASC Topic 815, as either derivative liabilities or equity instruments depending on the specific terms of the warrant agreement.
Income Taxes
We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes, which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities.
We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not assured.
Net Loss per Share Attributable to Common Stockholders
Net loss is adjusted for any deemed dividends to preferred stockholders to compute net loss attributable to common stockholders. Net loss is also adjusted for any impact to retained earnings related to the extinguishment of equity securities. The Series C preferred stock is a participating security. Accordingly, in any period in which we report net income attributable to common stockholders, basic earnings per share is computed using the “two-class” method. Under this method, net income is reduced by any dividends earned and the remaining earnings (undistributed earnings) are allocated to common stock and each series of participating securities to the extent that each participating security may share in earnings as if all of the earnings for the period had been distributed. The total earnings allocated to common stock is then divided by the number of outstanding shares to which the earnings are allocated to determine the earnings per share. The two-class method is not applicable during periods with a net loss, as the holders of the participating securities have no obligation to fund losses. Diluted net income per common share is computed under the two-class method by using the weighted-average number of shares of common stock outstanding, plus the effect of any other potentially dilutive securities outstanding for the period. In addition, the Company analyzes the potential dilutive effect of the outstanding participating securities under the “if-converted” method when calculating diluted earnings per share, in which it assumes that the outstanding participating securities convert into common stock at the beginning of the period, or when issued if later. The Company reports the more dilutive of the approaches (two class or “if-converted”) as their diluted net income per share during the period.
For periods in which a net loss exists, basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net loss per share attributable to common stockholders is computed by giving effect to all potentially dilutive securities outstanding for the period.
As of June 30, 2025 and 2024, the number of shares of common stock potentially issuable upon the exercise of certain stock options and warrants, the vesting of restricted stock units, and the conversion of preferred stock and convertible notes payable was
We do not have any components of other comprehensive (loss) income.
Segment and Geographic Information
Operating segments are defined as components of an enterprise for which separate and discrete financial information is available for evaluation by the chief operating decision-maker (the “CODM”) in deciding how to allocate resources and assess performance. The Company has one reportable segment primarily focused on the research and development of cardiovascular diseases. The Company’s CODM is the Chief Executive Officer who manages the Company’s operations on a consolidated basis for the purpose of making operating decisions, assessing financial performance, and allocating resources. When evaluating the Company’s financial performance, the CODM regularly reviews the details of research and development expenses, including program-related and unallocated costs, and general and administrative costs, as part of the overall review of the Company’s consolidated net loss and cash flows as compared to prior quarters and the Company’s operating budget. This financial information assists the CODM in his decision-making process to allocate resources based on the Company’s available cash resources, as well its forecasted expenditures. This information in conjunction with his assessment of the probability of the success of the Company’s research and development activities is used to plan the timing and size of future capital raises. The measure of segment assets is reported on the balance sheet as total consolidated assets. Other segment items included in consolidated net loss consist of gain on debt extinguishment, change in fair value of common stock warrant liability, loss on impairment of goodwill, interest income, interest expense, other income, net and income tax benefit (expense) which are reflected in the consolidated statements of operations.
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued Accounting Standards Update, or ASU, 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures, which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. The Company adopted this standard on January 1, 2025, which will expand our disclosures beginning with our annual consolidated financial statements for the year ended December 31, 2025. ASU 2023-09 is not expected to have an impact on the consolidated financial results of the Company.
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented on the consolidated statement of operations. The guidance in this ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial statements and disclosures.
Note 5 – Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows:
| ● | Level 1 – Quoted prices in active markets for identical assets and liabilities. | |
| ● | Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | |
| ● | Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Fair Value on a Recurring Basis
The tables below categorize assets and liabilities measured at fair value on a recurring basis for the periods presented:
| Fair Value | Fair value measurement using | |||||||||||||||
| June 30, | ||||||||||||||||
| (in thousands) | 2025 | Level 1 | Level 2 | Level 3 | ||||||||||||
| Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total Assets | $ | $ | $ | $ | ||||||||||||
| Liabilities: | ||||||||||||||||
| Convertible notes payable | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Common stock warrant liability | ( | ) | ( | ) | ||||||||||||
| Total Liabilities | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Fair Value | Fair value measurement using | |||||||||||||||
| December 31, | ||||||||||||||||
| (in thousands) | 2024 | Level 1 | Level 2 | Level 3 | ||||||||||||
| Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total Assets | $ | $ | $ | $ | ||||||||||||
| Liabilities: | ||||||||||||||||
| Derivative liability - ELOC commitment note | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
| Common stock warrant liability | ( | ) | ( | ) | ||||||||||||
| Total Liabilities | $ | ( | ) | $ | $ | $ | ( | ) | ||||||||
The money market funds were classified as cash and cash equivalents on the consolidated balance sheets and were within Level 1 of the fair value hierarchy. The aggregate fair value of the Company’s money market funds approximated amortized cost.
The fair value of the convertible notes payable is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The following table provides a summary of the change in the estimated fair value of the convertible notes payable:
| Six Months Ended June 30, 2025 | ||||
| Issuance of convertible notes payable | ||||
| Change in fair value | ( | ) | ||
| Balance at June 30, 2025 | $ | |||
In determining the initial fair value of the convertible notes payable at their respective issuance dates as well as for the subsequent remeasurement at June 30, 2025, we used a Black Scholes pricing model. The following table provides a summary of the significant inputs used in these valuations:
| June 5, 2025 Issuance Date | June 30, 2025 | |||||||
| Fair value of underlying equity | $ | $ | ||||||
| Conversion price | $ | $ | ||||||
| Volatility | % | % | ||||||
| Risk-free interest rate | % | % | ||||||
| Expected term (in years) | ||||||||
| Discounting factor | ||||||||
The fair value of the common stock warrant liability is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The following table provides a summary of the change in the estimated fair value of the common stock warrant liability:
| Six Months Ended June 30, 2025 | ||||
| Balance at December 31, 2024 | $ | |||
| Change in fair value | ( | ) | ||
| Settlement of common stock warrant liability | ( | ) | ||
| Deemed dividend | ||||
| Balance at June 30, 2025 | $ | |||
In determining the initial fair value of the common stock warrants at their respective issuance dates as well as for the subsequent remeasurement at June 30, 2025, we used a Black Scholes pricing model. For the measurement at December 31, 2024, we used a Monte Carlo simulation. The following table provides a summary of the significant inputs used in these valuations:
| June 30, 2025 | December 31, 2024 | |||||||
| Fair value of underlying equity | $ | $ | ||||||
| Exercise price | $ | $ | ||||||
| Volatility | % | n/a | ||||||
| Risk-free interest rate | % | % | ||||||
| Expected term (in years) | ||||||||
| Discounting factor | n/a | |||||||
The fair value of the derivative liability - ELOC commitment note is also based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The following table provides a summary of the change in the estimated fair value of the derivative liability:
| Six Months Ended June 30, 2025 | ||||
| Balance at December 31, 2024 | $ | |||
| Change in fair value | ( | ) | ||
| Extinguishment of derivative | ( | ) | ||
| Balance at June 30, 2025 | $ | |||
In determining the initial fair value of the derivative liability and for the subsequent measurement at December 31, 2024, we used a Monte Carlo simulation. The following table provides a summary of the significant inputs used in these valuations:
| December 31, 2024 | ||||
| Fair value of underlying equity | | |||
| Volatility | % | |||
| Risk-free interest rate | % | |||
| Conversion price discount | % | |||
| Discounting period (in years) | ||||
| Discount rate | % | |||
| Discounting factor | ||||
Certain of our assets were measured at fair value on a non-recurring basis during the six months ended June 30, 2025 and during the year ended December 31, 2024. The IPR&D intangible asset related to our rostafuroxin drug candidate was recorded at its estimated fair value as a result of the impairment tests performed during 2024. There was
| Fair Value | Fair value measurement using | |||||||||||||||
| December 31, | ||||||||||||||||
| (in thousands) | 2024 | Level 1 | Level 2 | Level 3 | ||||||||||||
| Intangible assets: | ||||||||||||||||
| Rostafuroxin drug candidate | $ | $ | $ | $ | ||||||||||||
Significant factors considered in estimating the fair value of the IPR&D intangible asset related to our rostafuroxin drug candidate include the risks inherent in the development process, including the likelihood of achieving commercial success and the cost and related time to complete the remaining development. Future cash flows for the IPR&D intangible asset were estimated based on forecasted revenue and costs, taking into account the expected product life cycle, market penetration, and growth rates. Other significant estimates and assumptions inherent in this approach include (i) the amount and timing of the projected net cash flows associated with the IPR&D intangible asset; (ii) the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and (iii) the tax rate, which considers geographic diversity of the projected cash flows. Quantitative information about the significant unobservable inputs used in the fair value measurement of the IPR&D intangible asset included a discount rate of
Note 6 - Note Receivable, Net
On June 5, 2025, the Company issued a senior note to Standard Waste Services, LLC, or Standard Waste, in the principal amount of $
The Standard Waste Note has been recorded at its fair value of $
Note 7 - Deposit
On April 19, 2025, WINT Real Estate, LLC, or WINT LLC, a wholly owned subsidiary of Windtree Therapeutics, Inc., entered into an Assignment and Conditional Assumption Agreement, or the Assignment with Way Maker Growth Fund, LLC, or Way Maker, relating to that certain Purchase and Sale Agreement dated June 28, 2024, or the Original Purchase Agreement, as amended by that certain First Amendment to Purchase and Sale Agreement, dated December 19, 2024, or the First Amendment, and that certain Second Amendment to Purchase and Sale Agreement, dated March 25, 2025, the Second Amendment (the Original Purchase Agreement, as amended by the First Amendment and the Second Amendment, is referred to hereafter as the Purchase Agreement), and that certain development services agreement, dated February 4, 2025, or the Development Agreement, and together with the Purchase Agreement, collectively, the Assigned Agreements, each between Way Maker and TBB Crescent Park Drive LLC, or TBB CPD. Pursuant to the Purchase Agreement, TBB CPD agreed to sell to Way Maker real property commonly known as The Aubrey, located at 11755 Southlake, Houston, Texas, or the Property.
Pursuant to the terms of the Assignment, Way Maker agreed to assign to WINT LLC its right, title and interest in the Assigned Agreements. WINT LLC will not be deemed to have assumed or have any liability under the Assigned Agreements until certain conditions have been met, including (i) the Purchase Agreement is amended as required by WINT LLC, (ii) WINT has reviewed and approved the Development Agreement, (iii) WINT LLC has reviewed and approved the title commitment and current permitted encumbrances provided for in the Purchase Agreement, (iv) WINT LLC has reviewed and approved the survey with respect to the Property, and (v) WINT LLC has reviewed and approved all terminated and non-terminable contracts provided for in the Sales Agreement (collectively, the Assumption Conditions).
Notwithstanding the Assumption Conditions, WINT LLC advanced $
Note 8 - Convertible Notes Payable
On June 5, 2025, we entered into a note purchase agreement, or the First June 2025 Purchase Agreement, pursuant to which we issued a convertible promissory note, or the First June 2025 Convertible Note, to an investor, the First June 2025 Purchaser, in the principal amount of $
On each of June 9, June 24, and June 27, 2025, we entered into several note purchase agreements, or the Additional June 2025 Note Purchase Agreements, pursuant to which we issued convertible promissory notes, or the Additional June 2025 Convertible Notes, to investors, each an Additional June 2025 Purchaser and together the Additional June 2025 Purchasers, in the principal amount of $
Subject to certain limitations under the First June 2025 Note Purchase Agreement and the Additional June 2025 Purchase Agreements, or together the Purchase Agreements, while any portion of the First June 2025 Convertible Note and Additional June 2025 Convertible Notes is outstanding, or together the Convertible Notes, we must inform the Purchasers of any proceeds we receive from the issuance of our securities. After receipt of this notice, the Purchasers have ten trading days to require that we apply all proceeds received from the sale of our securities to repay any or all of the amounts outstanding under the Convertible Notes.
The Note Purchase Agreements contain certain covenants and customary representations and warranties of the Company and the parties, piggyback registration rights, restrictions on variable rate transactions, participation rights, indemnification obligations of the parties, termination provisions, and other obligations and rights of the parties.
The Purchasers may exercise their conversion rights under their respective convertible note agreements at any time after the Issue Date, as defined therein, until all amounts owed under the Convertible Notes have been satisfied. The First June 2025 Convertible Note is a senior, unsecured obligation of the Company, with priority over all existing and future indebtedness; the Additional June 2025 Purchasers will not be entitled to any payments of principal or interest until the company has repaid all outstanding obligations under the First June 2025 Convertible Note. Interest for the Convertible Notes will be payable in cash or, at the holder’s election beginning
The holders may not exercise their conversion rights if the conversion would result in the holders (and their affiliates) beneficially owning in excess of
The number of shares of Common Stock to be issued upon each conversion is determined by dividing the Conversion Amount, as defined therein, by the applicable conversion price then in effect on the date specified in the notice of conversion. The Conversion Amount is the sum of the principal to be converted plus, at the holder’s election, any accrued and unpaid interest. The initial conversion price, subject to adjustment, was $
In connection with the Note Financings, we issued the June 2025 Purchasers the June 2025 Warrants to purchase an aggregate of $
We elected to apply the fair value option for all of the June 2025 Notes and June 2025 Warrants as of their issuance date. The fair value of the June 2025 Notes on the dates of issuance was $
Note 9 – ELOC Commitment Note Payable
In June 2024, we entered into an equity line of credit, or ELOC, purchase agreement, or the ELOC Purchase Agreement, establishing an ELOC for the right to sell shares of our common stock to the purchaser, or the Purchaser. The Purchaser is also a holder of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable. As consideration for the Purchaser’s irrevocable commitment to purchase shares of our common stock upon the terms of and subject to satisfaction of the conditions set forth in the ELOC Purchase Agreement, concurrently with the execution and delivery of the ELOC Purchase Agreement, we issued a convertible promissory note, or the ELOC Commitment Note, to the Purchaser in the amount of $
The ELOC Commitment Note in its entirety had an estimated fair value of $
The derivative was adjusted to fair value at each reporting period, with the change in the fair value recorded in change in fair value of derivatives, which is a component of other income (expense) in our condensed consolidated statement of operations. During the three months ended March 31, 2025, the Purchaser converted the ELOC Commitment Note and its related accrued interest into
Note 10 - Senior Secured Notes Payable
April 2025 Convertible Senior Secured Notes
On April 4, 2025, we issued convertible senior secured notes, or the April 2025 Notes, with an aggregate principal amount of $
On May 2, 2025, the holders of the March 2025 Notes and the April 2025 Notes accepted in writing the Company’s payoff letter, pursuant to which the Company made a one-time payment to the foregoing holders in the aggregate amount of $
Note 11 – Common Stock Warrant Liability
In July 2024, we completed two private placements of Series C Preferred Stock and common stock warrants, or the July 2024 Warrants (Refer to Note 13, “Mezzanine Equity and Stockholders' Equity - Accounting for the First and Second Private Placements” for additional details). The July 2024 Warrants were exercisable upon the six month and one day anniversary of the issuance date, or the Initial Exercisability Date, and expire on the fifth anniversary of the Initial Exercisability Date and had an initial exercise price of $
The July 2024 warrants had an initial fair value of $
Note 12 – Loans Payable
In August 2024, we entered into an insurance premium financing and security agreement with IPFS Corporation. Under the agreement, we financed $
Note 13 - Other Current Liabilities
In 2008, we entered into an Amended and Restated License Agreement with Philip Morris USA, Inc., or PMUSA, with respect to the U.S., or the U.S. License Agreement, and, as PMUSA had assigned its ex-U.S. rights to Philip Morris Products S.A., or PMPSA, effective on the same date and on substantially the same terms and conditions, we entered into a license agreement with PMPSA with respect to rights outside of the U.S., which we refer to, together with the U.S. License Agreement, as the PM License Agreements. Under amendment no. 2 to each of these agreements, we owe $
Note 14 – Restructured Debt Liability
On October 27, 2017, we and Deerfield entered into the Milestone Agreement pursuant to which (i) promissory notes evidencing a loan with affiliates of Deerfield in the aggregate principal amount of $
On January 24, 2024, we and Deerfield entered into an Exchange and Termination Agreement wherein Deerfield agreed to terminate its rights to receive the Milestone Payments.
Pursuant to the Exchange and Termination Agreement, Deerfield agreed to terminate its rights to receive the Milestone Payments and all related rights and obligations in respect of such Milestone Payments in exchange for (i) cash in the aggregate amount of $
Contemporaneously with the execution of the Exchange and Termination Agreement, we and Deerfield entered into a Registration Rights Agreement pursuant to which we agreed to, among other matters, register for resale with the SEC the shares of the common stock issued to Deerfield pursuant to the Exchange and Termination Agreement. On February 14, 2024, we filed a resale registration statement on Form S-3 (File No. 333-277073) with respect to
The Exchange and Termination Agreement was accounted for as an extinguishment of debt in accordance with ASC Topic 470, Debt – Modifications and Extinguishments, and, as a result, we recognized a $
Note 15 – Mezzanine Equity and Stockholders’ Equity
Private Placement of Series D Preferred Stock
On April 29, 2025, we entered into a Securities Purchase Agreement, or the Purchase Agreement, with the buyers named therein, or the Initial Buyers, pursuant to which we agreed to the private placement of
During May 2025, certain additional buyers, or the Additional Buyers, each executed a joinder to the Purchase Agreement, pursuant to which the Additional Buyers agreed to purchase, and the Company agreed to sell, an aggregate of
We agreed to seek stockholder approval for the issuance of all of the shares of our common stock issuable upon conversion of the Series D Preferred Stock in connection with the above private placements in accordance with the rules and regulations of The Nasdaq Stock Market.
Series D Preferred Stock
The terms of the Series D Preferred Stock are as set forth in the Certificate of Designation of Series D Convertible Preferred Stock, or the Series D Certificate of Designation, as filed with the Delaware Secretary of State and effective on April 30, 2025. The Series D Certificate of Designation authorizes a total of
From and after April 29, 2025, each holder of a share of Series D Preferred Stock is entitled to receive dividends, which are computed on the basis of a 360-day year and twelve 30-day months and will increase the stated value of the Series D Preferred Stock on each dividend date (as defined in the Series D Certificate of Designation).
Dividends on the Series D Preferred Stock will accrue at
The Series D Preferred Conversion Price is subject to adjustment upon the occurrence of specified events and subject to price-based adjustment in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transactions involving our common stock at a price below the then-applicable Series D Preferred Conversion Price, as described in further detail in the Series D Certificate of Designation. In July 2025, due to an inducement related to the Series C preferred stock, the conversion price of the Series D Preferred Stock was adjusted to $
In addition, pursuant to the Purchase Agreement, the Company agreed (i) in lieu of the payments required pursuant to Sections 10, 6 and 2(d) of the that certain certificate of designation (as amended, modified, or supplemented, the “Series C COD”) filed by the Company with the Secretary of State of the State of Delaware on July 19, 2024, for the purpose of establishing and designating the Company’s Series C Convertible Preferred Stock, par value $
January 2025 Series C Preferred Stock Inducement
On January 24, 2025, the Company made an inducement offer to all holders of the Company’s Series C Convertible Preferred Stock, par value $
Pursuant to the Transaction, approximately
April 2025 Down Round
During April 2025, the Company issued the April 2025 Notes with a conversion price of $
The Company calculated the value of the conversion feature before and after the adjustment and recorded the incremental value as an increase to the carrying value of the affected Series C Preferred Stock of $
May 2025 Series C Preferred Stock Inducement
In May 2025, the Company made an inducement offer to certain holders of its Series C Preferred Stock (the “May 2025 Inducement”) to reduce the conversion price from the previously effective price of $
In connection with the May 2025 Inducement, the converted Series C Preferred Stock was converted into
July 2024 Warrant Exercises
During the three and six months ended June 30, 2025,
First Private Placement
On July 18, 2024, we entered into a Securities Purchase Agreement, or the First Purchase Agreement, with the buyers named therein, pursuant to which we agreed to the private placement, or the First PIPE, of (i)
Additionally, we issued
We agreed to seek stockholder approval for the issuance of all of the shares of our common stock issuable upon conversion of the Preferred Shares and exercise of the July 2024 Warrants in connection with the First PIPE in accordance with the rules and regulations of The Nasdaq Stock Market, which approval was obtained on September 24, 2024.
Series C Preferred Stock
The terms of the Series C Preferred Stock are as set forth in the Series C Certificate of Designation of Series C Preferred Stock, as filed with the Delaware Secretary of State and effective on July 19, 2024. The Series C Certificate of Designation authorizes a total of
From and after July 19, 2024, each holder of a share of Series C Preferred Stock is entitled to receive dividends, which are computed on the basis of a 360-day year and twelve 30-day months and will increase the stated value of the Series C Preferred Stock on each dividend date (as defined in the Series C Certificate of Designation).
Dividends on the Series C Preferred Stock will accrue at
The Preferred Conversion Price is subject to adjustment upon the occurrence of specified events and subject to price-based adjustment in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transactions involving our common stock at a price below the then-applicable Preferred Conversion Price, as described in further detail in the Series C Certificate of Designation. In July 2025, due to an inducement related to the Series C preferred stock, the conversion price was adjusted to $
July 2024 Warrants
The July 2024 Warrants were exercisable upon the six month and one day anniversary of the issuance date, or the Initial Exercisability Date, and expire on the fifth anniversary of the Initial Exercisability Date and had an initial exercise price of $
Related Party Participation
Our former CEO and our CMO each participated in the First PIPE, with Mr. Fraser making a $
Second Private Placement
On July 26, 2024, we entered into a Securities Purchase Agreement, or the Second Purchase Agreement, with the buyer named therein, pursuant to which we agreed to a second tranche of the private placement, or the Second PIPE, of (i)
Additionally, we issued
We agreed to seek stockholder approval for the issuance of all of the shares of our common stock issuable upon conversion of the Preferred Shares and exercise of the July 2024 Warrants in connection with the Second PIPE in accordance with the rules and regulations of The Nasdaq Stock Market, which approval was obtained on September 24, 2024.
The rights and preferences of the Series C Preferred Stock issued in connection with the Second PIPE, including the terms pursuant to which they are convertible into our common stock, are consistent with the rights and preferences of the Series C Preferred Stock issued in connection with the First PIPE. Similarly, the terms of the warrants issued in connection with the Second PIPE are consistent with the terms of the warrants issued in connection with the First PIPE.
Accounting for the First and Second Private Placements
The July 2024 Warrants are considered a freestanding financial instrument as they are separable and legally detachable from the Series C Preferred Stock. These warrants have been classified as a liability in the Company’s condensed consolidated balance sheet due to the inclusion of put option election available to the holders that is contingently exercisable if the Company enters into a change of control transaction, or the Change of Control Put (the "Put"). If the Put is exercised by the holder of a July 2024 Warrant, they may elect to receive cash as determined by the Black Scholes pricing model, based on terms and timing specified in the July 2024 Warrants. The potential for a cash settlement for the July 2024 Warrants is outside the control of the Company requiring the July 2024 Warrants to be treated as financial liabilities measured at fair value through profit or loss.
Cash proceeds from the issuance of
Upon issuance of the Series C Preferred Stock, the Company was not solely in control of the redemption of the shares due to them having multiple redemption features that are outside of our control, including time-based maturity redemption and change of control redemption. As a result, the shares of Series C Preferred Stock are classified within mezzanine equity.
In connection with the First PIPE, we issued
In addition, we issued
Also in connection with the First PIPE, we issued
We incurred approximately $
Conversions of Series C Preferred Stock
During the three months ended June 30, 2025,
Common Stock Purchase Agreement
In June 2024, we entered into the ELOC Purchase Agreement establishing an equity line of credit with the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $
is also a holder of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable.
Over the 36-month period from and after the Commencement Date, we will control the timing and amount of any sales of common stock to the Purchaser. Actual sales of shares of our common stock to the Purchaser under the ELOC Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of our common stock and determinations by us as to the appropriate sources of funding and our operations. For the six months ended June 30, 2025, we sold
Subsequent to quarter end and through August 19, 2025, we sold
We have determined that the put option in the ELOC Purchase Agreement is a derivative within the scope of ASC Topic 815, Derivatives and Hedging, to be initially measured and recorded at fair value with subsequent changes in fair value to be recorded in earnings. However, as the exercise price is floating and is a discounted price to the exercise date fair value of the common stock, we have determined that the put option has a de minimis value (effectively zero value) and will not be recorded.
Series B Preferred Stock
The terms of the Series B Preferred Stock are as set forth in the Series B Certificate of Designation of Series B Preferred Stock, as filed with the Delaware Secretary of State and effective on April 3, 2024. The Series B Certificate of Designation authorizes a total of
Upon issuance of the Series B Preferred Stock, the Company was not solely in control of the redemption of the shares of Series B Preferred Stock due to multiple redemption features that are outside of our control, including time-based maturity redemption and change of control redemption. Accordingly, the shares of Series B Preferred Stock are classified within mezzanine equity at their fair value of $
As of June 30, 2025 and December 31, 2024, there are no shares of Series B Preferred Stock outstanding as all shares were exchanged in the First PIPE. (See the section titled, Note 15 “Mezzanine Equity and Stockholders’ Equity - First Private Placement”).
At-The-Market Program
On November 9, 2023, we entered into the 2023 ATM Program with Ladenburg. We were not obligated to make any sales under the 2023 ATM Program.
Sales under the 2023 ATM Program were made pursuant to our “shelf” registration statement on Form S-3 (No. 333-261878) filed with the SEC on December 23, 2021, and declared effective on January 3, 2022, and a prospectus supplement related thereto, and subsequently expired on January 3, 2025.
During the three months ended March 31, 2024, we sold
Note 16 – Stock-Based Compensation
We recognize expense in our interim unaudited condensed consolidated financial statements related to all stock-based awards granted to employees and non-employee directors based on their fair value on the grant date. Compensation expense related to stock options is calculated using the Black-Scholes option-pricing model and is recognized ratably over the vesting period. While individual grants may vary, option awards generally have a
A summary of activity under our long-term incentive plans is presented below:
| (in whole numbers) | ||||||||||||
| Stock Options | Shares | Weighted- | Weighted- | |||||||||
| Outstanding at January 1, 2025 | $ | |||||||||||
| Forfeited or expired | ( | ) | ||||||||||
| Outstanding at June 30, 2025 | $ | |||||||||||
| Vested and exercisable at June 30, 2025 | $ | |||||||||||
| Vested and expected to vest at June 30, 2025 | $ | |||||||||||
During the six months ended June 30, 2025, there were no RSUs granted or forfeited. As of June 30, 2025, there were
The table below summarizes the total stock-based compensation expense included in the interim unaudited condensed consolidated statements of operations for the periods presented:
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| (in thousands) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
The fair value of each option award is estimated on the grant date using the Black-Scholes option-pricing formula. Expected volatilities are based upon the historical volatility of our common stock and other factors. We also use historical data and other factors to estimate option exercises, employee terminations and forfeiture rates. The risk-free interest rates are based upon the U.S. Treasury yield curve in effect at the time of the grant.
Note 17 – Licensing and Research Funding Agreements
License and Supply Agreement with Evofem Biosciences, Inc.
On March 20, 2025, we entered into a License and Supply Agreement, as amended on March 28, 2025, or the L&S Agreement, with Evofem Biosciences, Inc., a Delaware corporation, or Evofem. Pursuant to the L&S Agreement, we will act as the supplier to Evofem of its Phexxi® product outside of the United States. The term of the L&S Agreement is for an initial three-year period and is automatically renewed thereafter for successive two-year periods unless either party provides 180 days’ notice of non-renewal or the L&S Agreement is otherwise terminated in accordance with the termination provisions provided therein. Our manufacturing and supply obligations under the L&S Agreement will commence the later of the termination of Evofem’s exclusivity obligations with its current supplier or within 90 days of the our notification to Evofem that we have established manufacturing capabilities for the Products (as defined in the L&S Agreement). We may subcontract, with any third party including an affiliate of the Company, to perform any of our obligations under the L&S Agreement without the prior written consent of Evofem.
Evofem is generally obligated to purchase the Products from us at a specified price during the first three years of the Term (as defined in the L&S Agreement). Evofem also granted us a limited, nonexclusive, royalty-free right to use Evofem’s Intellectual Property Rights (as defined in the L&S Agreement) solely as necessary to manufacture the Products exclusively for Evofem during the Term, subject to the terms of the L&S Agreement. The L&S Agreement contains representations and warranties of both parties, insurance requirements, mutual indemnification provisions, and confidentiality provisions.
Term Sheet and Project Financing Agreement with Lee’s (HK)
In March 2020, we entered into the Term Sheet with Lee’s (HK), pursuant to which Lee’s (HK) provided financing for the development of AEROSURF. In August 2020, we entered into a Project Financing Agreement with Lee’s (HK), or the PF Agreement, formalizing the terms of the Term Sheet, and under which we received payments totaling $
Since the 2018 acquisition of CVie Investments Limited and CVie Therapeutics, istaroxime has become our primary focus for investment and execution due to what we believe represents a greater potential value opportunity for us and our stockholders. Since completing our Phase 2 study of lucinactant (KL4 surfactant) for patients with severe COVID-19 associated ARDS and lung injury in January 2022, in order to preserve resources for the highest priority programs, we have begun to reduce costs not already being performed by our licensee, Lee’s (HK) and Zhaoke, under the terms of our Original License Agreement. These costs include certain reductions in headcount dedicated to KL4 surfactant and the decommissioning of both our analytical and technical support laboratory, which previously conducted release testing of APIs and supportive research for our lyophilized and aerosolized KL4 surfactant, and our medical device development laboratory, which was previously used to conduct development activities and testing for our ADS technologies. To support the future development of our KL4 surfactant platform in markets outside of Asia, including the U.S., we are pursuing one or more licensing transactions.
To repay the funds provided under the terms of the PF Agreement, until such time as we have repaid
As of June 30, 2025, the liability balance related to the payments under the PF Agreement was $
Note 18 – Income Taxes
During the three and six months ended June 30, 2024, we recorded income tax expense of $
Note 19 – Subsequent Events
June and July 2025 Note Purchase Agreements
On July 2, 2025, we entered into note purchase agreements (the “July Note Purchase Agreements”) with two purchasers (the “July Purchasers,” and each a “July Purchaser”) who are also a holders of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable. Pursuant to the July Note Purchase Agreements, we issued two Convertible Promissory Notes to the July Purchasers, each in a principal amount of $
The June and July Promissory Notes accrue interest at
Pursuant to the June and July Note Purchase Agreements, each of the June Purchasers and July Purchasers warrants to purchase shares of our common stock in an amount equal to
The June and July Promissory Notes and the Note Warrants were sold in reliance upon an exemption from the registration requirement of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgated thereunder. We received gross proceeds of $
BNB Treasury Strategy Private Placement
Securities Purchase Agreements
On July 16, 2025 (the “Execution Date”), we entered into a securities purchase agreement (the “Treasury Strategy Securities Purchase Agreement”) with the purchasers named therein (the “Treasury Strategy Purchasers,” and each, a “Treasury Strategy Purchaser”) pursuant to which we agreed to sell and issue to the Treasury Strategy Purchasers in a private placement offering (the “Treasury Strategy Offering”) an aggregate of (i) approximately
The aggregate offering price of the Treasury Strategy Offering was approximately $
The Series E Preferred Stock, the Treasury Strategy Conversion Shares, the Treasury Strategy Warrants, and the Treasury Strategy Warrant Shares are being offered in reliance upon the exemption from the registration requirement of the Securities Act, pursuant to Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgated thereunder, and applicable state securities laws. The issuance of Series E Preferred Stock, the Treasury Strategy Conversion Shares, the Treasury Strategy Warrants, and the Treasury Strategy Warrant Shares have not been registered under the Securities Act and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.
The Treasury Strategy Offering is expected to close upon satisfying customary closing conditions, including obtaining requisite stockholder approval in accordance with Nasdaq Listing Rule 5635(b) and (d) (“Stockholder Approval”). Pursuant to the Treasury Strategy Securities Purchase Agreement, the Company has agreed to use its reasonable best efforts to obtain Stockholder Approval within sixty (60) days following the Treasury Strategy Execution Date. If despite the Company’s reasonable best efforts Stockholder Approval is not obtained within sixty (60) days following the Treasury Strategy Execution Date, the Company will cause a special meeting of stockholders to be held within one-hundred and twenty (120) days following the Treasury Strategy Execution Date to obtain Stockholder Approval. In the event Stockholder Approval is not obtained within one-hundred and twenty (120) days following the Treasury Strategy Execution Date, the Treasury Strategy Securities Purchase Agreement will become null and void. However, the Treasury Strategy Purchasers will not have the right to terminate the Securities Purchase Agreement within the one-hundred and twenty (120) day period following the Execution Date except upon the terms and conditions specified in the Treasury Strategy Securities Purchase Agreement. In addition, the Company has agreed not to issue, enter into any agreement to issue, or announce the issuance or proposed issuance of any shares of its common stock or common stock equivalents, or file any registration statement or any amendment or supplement thereto, for a period commencing on the Treasury Strategy Execution Date, and ending immediately following the thirtieth (30th) trading day after the later of (a) the effective date of the Stockholder Approval and (b) 360 calendar days after the earlier to occur of (I) the first date on which the registration statement registering the resale by the Treasury Strategy Purchasers of the all the Series E Preferred Stock, the Treasury Strategy Conversion Shares, the Treasury Strategy Warrants, and the Treasury Strategy Warrant Shares is declared effective by the Securities and Exchange Commission (and each prospectus contained therein is available for use on such date) or (II) the first date on which all of the Series E Preferred Stock, the Treasury Strategy Conversion Shares, the Treasury Strategy Warrants, and the Treasury Strategy Warrant Shares are eligible to be resold by the Treasury Strategy Purchasers pursuant to Rule 144.
Upon closing of the Treasury Strategy Securities Purchase Agreement, the lead investor, Build and Build Corp. (the “Lead Investor”), will have the right to nominate two members to the Company’s Board of Directors (the “Board”), one of whom, if duly elected by our stockholders, shall become Chairman of the Board, so long as (i) the Lead Investor, its affiliates, and/or designees, directly or indirectly, hold at least
The Treasury Strategy Warrants will have an exercise price of $
Prior to the closing of the Treasury Strategy Securities Purchase Agreement, the Company must enter into (i) a Registration Rights Agreement with the Treasury Strategy Purchasers; (ii) a Strategic Advisor Agreement with an affiliate of the Lead ; and (iii) an Asset Management Agreement with an affiliate of the Lead Investor. The Company must also file a Certificate of Designations establishing the Series E Preferred Stock prior to the closing of the Treasury Strategy Securities Purchase Agreement.
Equity Line of Credit
On July 23, 2025, we entered into the ELOC Purchase Agreement with Seven Knots, LLC, or Seven Knots, establishing an equity line of credit, or the Committed Equity Financing, pursuant to which we may sell shares of common stock to Seven Knots from time to time. Seven Knots is also a holder of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable.
Pursuant to the ELOC Purchase Agreement, Seven Knots shall purchase from us up to the lesser of (i) $
Sales of common stock to Seven Knots under the ELOC Purchase Agreement, and the timing of any sales, will be determined by us from time to time in our sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of our common stock and determinations by us regarding the use of proceeds from any sale of such common stock.
Pursuant to the ELOC Purchase Agreement, on any business day on which the closing sale price of our common stock is equal to or greater than $
Discontinuation of SEISMiC C study
On August 8, 2025, we announced the termination of our SEISMiC C study after
The One Big Beautiful Bill Act
The One Big Beautiful Bill Act, or the OBBBA, was enacted on July 4, 2025. The Company is currently assessing the impact of this legislation on its financial statements.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing activities, includes forward-looking statements that involve risks, uncertainties and assumptions. These statements are based on our beliefs and expectations about future outcomes and are subject to risks and uncertainties that could cause our actual results to differ materially from anticipated results. We undertake no obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise. The reader should review the section titled “Forward-Looking Statements” and any risk factors discussed elsewhere in this Quarterly Report on Form 10-Q, which are in addition to and supplement the risk factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2024 that we filed with the Securities and Exchange Commission, or SEC, on April 15, 2025, as supplemented by our Quarterly Report on Form 10-Q for the three months ended March 31, 2025 filed thereafter, and our other filings with the SEC, and any amendments thereto, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis or elsewhere in this Quarterly Report on Form 10-Q.
This Management’s Discussion and Analysis, or MD&A, is provided as a supplement to the accompanying interim unaudited Condensed Consolidated Financial Statements (including the notes thereto) to help provide an understanding of our financial condition and changes in our financial condition and our results of operations. This item should be read in connection with our accompanying interim unaudited Condensed Consolidated Financial Statements (including the notes thereto) and our Annual Report on Form 10-K for the year ended December 31, 2024. Unless otherwise specified, references to Notes in this MD&A refer to the Notes to Condensed Consolidated Financial Statements (unaudited) in this Quarterly Report on Form 10-Q.
OVERVIEW
We are a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Our portfolio of product candidates includes istaroxime, a Phase 2 candidate that inhibits the sodium-potassium ATPase and also activates sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, for acute heart failure and/or associated cardiogenic shock; preclinical SERCA2a activators for heart failure; rostafuroxin for the treatment of hypertension in patients with a specific genetic profile; and a preclinical atypical protein kinase C iota, or aPKCi, inhibitor (topical and oral formulations), being developed for potential application in rare and broad oncology indications. We also have a licensing business model with partnership out-licenses currently in place.
In addition, in January 2025, we launched a new corporate strategy to become a revenue generating biotech company through acquisitions of small companies and their FDA-approved products while the Company continues to progress its cardiovascular and oncology development pipeline. The Company will seek acquisition targets to achieve the Company’s new corporate strategy. To capitalize on this opportunity, we plan to become a parent company acquiring strategic subsidiaries utilizing equity and debt. The number of deals, if any, over time will depend upon the valuation and growth potential of the subsidiary companies.
On July 16, 2025, we announced our launch of a crypto treasury strategy utilizing the native token of the BNB chain commonly referred to as “BNB,” including a $60 million securities purchase agreement led by Build and Build, Corp. with the potential for up $200 million of total subscriptions. For additional details, refer to Note 19 - Subsequent Events.
Our lead product candidate, istaroxime, is a first-in-class, dual-mechanism agent being developed to increase blood pressure and improve cardiac function in patients with cardiogenic shock and to improve cardiac function in patients with acute heart failure, or AHF, and reverse the hypotension and hypoperfusion associated with heart failure that deteriorates to cardiogenic shock. Istaroxime demonstrated significant improvement in both systolic and diastolic aspects of cardiac function and was generally well tolerated in four Phase 2 clinical trials. Istaroxime has been granted Fast Track designation for the treatment of AHF by the U.S. Food and Drug Administration, or FDA. Based on the profile observed in our Phase 2 clinical studies in AHF, where istaroxime significantly improved cardiac function and systolic blood pressure, or SBP, in acute decompensated heart failure patients and had a favorable renal profile, we initiated a Phase 2 global clinical study, or the SEISMiC Study, to evaluate istaroxime for the treatment of early cardiogenic shock (Society for Cardiovascular Angiography and Interventions, or SCAI, Stage B shock), a severe form of AHF characterized by very low blood pressure and risk for hypoperfusion to critical organs and mortality. In April 2022, we announced our observations in the SEISMiC Study that istaroxime rapidly and significantly increased SBP while also improving cardiac function and preserving renal function. We believe that istaroxime has the potential to fulfill an unmet need in early and potentially more severe cardiogenic shock. We further believe that the data from the SEISMiC Study supports continued development in both cardiogenic shock and AHF. In September 2024, we announced positive topline results from our Phase 2b SEISMiC Extension Study, or the SEISMiC Extension, which demonstrated that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or clinically significant cardiac rhythm disturbances. Additionally, we initiated a study in more severe SCAI Stage C cardiogenic shock, or the SEISMiC C Study, to evaluate the safety and efficacy of istaroxime in cardiogenic shock patients who are also receiving standard of care rescue therapy for shock. The SEISMiC C Study was planned to enroll up to 100 subjects with SCAI Stage C cardiogenic shock. A planned unblinded review of the data from the first 20 subjects occurred in July 2025. The review of the preliminary interim data suggests that the responses to istaroxime in SCAI Stage C patients, many of whom were also treated with currently available inotropes and vasopressors, is similar to that seen in our previous clinical trials. Because our ability to complete this study with its intended sample size is dependent upon our ability to secure adequate resourcing for the program through financing efforts or business development activities we have decided to terminate the SEISMiC C clinical trial and pursue further development with istaroxime in the much larger market of less severe patients with acute decompensated heart failure with our licensing partner, Lee’s Pharmaceutical (HK) Ltd., who is planning a global phase 3 study in that indication.
Our heart failure cardiovascular portfolio also includes other SERCA2a activators. One family of compounds has the dual mechanism of action that includes inhibition of the sodium-potassium ATPase as well as activation of SERCA2a. The other family of compounds are considered selective SERCA2a activators and are devoid of activity against the sodium-potassium ATPase. This research program is evaluating these preclinical product candidates, including oral and intravenous SERCA2a activator heart failure compounds. These candidates would potentially be developed for both acute decompensated and chronic out-patient heart failure. In addition, our cardiovascular drug product candidates include rostafuroxin, a novel product candidate for the treatment of hypertension in patients with a specific genetic profile. We are pursuing potential licensing arrangements and/or other strategic partnerships and do not intend to advance the development of rostafuroxin without securing such an arrangement or partnership.
Our cardiovascular assets and programs are associated with a regional licensed partnership with Lee’s Pharmaceutical (HK) Ltd., or Lee’s (HK), for the development and commercialization of our product candidate, istaroxime, in Greater China. In addition to istaroxime, the agreement also licenses our preclinical next-generation dual mechanism SERCA2a activators, and rostafuroxin. In addition, we are supporting the efforts of Lee’s (HK) in starting a Phase 3 trial in AHF with istaroxime.
On April 2, 2024, we entered into an Asset Purchase Agreement, or the Asset Purchase Agreement, with Varian Biopharmaceuticals, Inc., or Varian. Pursuant to the Asset Purchase Agreement, we purchased all of the assets of Varian’s business associated with a license agreement, dated as of July 5, 2019, by and between Varian and Cancer Research Technology Limited, or the Licence Agreement, which includes the Licence Agreement, all rights in molecules and compounds subject to the Licence Agreement, know-how and inventory of drug substance, or the Transferred Assets. The Transferred Assets include a novel, potential high-potency, specific, aPKCi inhibitor with possible broad use in oncology as well as certain rare malignant diseases. The asset platform includes two formulations (topical and oral) of an aPKCi inhibitor. We plan to advance investigational new drug enabling activities and are in the process of determining the expected clinical development plan for the platform.
We have incurred net losses since inception. Our net loss was $10.6 million for the three months ended June 30, 2025. For the three and six months ended June 30, 2024, our net loss was $12.0 million. As of June 30, 2025, we had an accumulated deficit of $861.3 million. To date, we have financed our operations primarily through private placements and public offerings of our common and preferred stock, warrants to purchase common stock, and borrowings from investors and financial institutions.
We expect to continue to incur significant research and clinical development, regulatory, and other expenses as we (i) continue to develop our product candidates; (ii) seek regulatory clearances or approvals for our product candidates; (iii) conduct clinical trials on our product candidates; and (iv) manufacture, market, and sell any product candidates for which we may obtain regulatory approval.
Our ability to advance our development programs is dependent upon our ability to secure additional capital in both the near and long-term, through public or private securities offerings; convertible debt financings; and/or potential strategic opportunities, including licensing agreements, drug product development, marketing collaboration arrangements, pharmaceutical research cooperation arrangements, and/or other similar transactions in geographic markets, including the U.S., and/or through potential grants and other funding commitments from U.S. government agencies, in each case, if available. We have engaged with potential counterparties in various markets and will continue to pursue non-dilutive sources of capital as well as potential private and public securities offerings. There can be no assurance, however, that we will be able to identify and enter into public or private securities offerings on acceptable terms and in amounts sufficient to meet our needs or qualify for non-dilutive funding opportunities under any grant programs sponsored by U.S. government agencies, private foundations, and/or leading academic institutions, or identify and enter into any strategic transactions that will provide the additional capital that we will require. If none of these alternatives is available, or if available and we are unable to raise sufficient capital through such transactions, we potentially could be forced to limit or cease our development activities, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations.
Business and Program Updates
The reader is referred to, and encouraged to read in its entirety, “Item 1 – Business” in our Annual Report on Form 10-K for the year ended December 31, 2024 that we filed with the SEC on April 15, 2025, which contains a discussion of our business and business plans, as well as information concerning our proprietary technologies and our current and planned development programs.
Istaroxime (Cardiogenic Shock)
In September 2020, we initiated a Phase 2 clinical study of istaroxime for the acute treatment of cardiogenic shock in more severe heart failure patients than previously studied to evaluate the potential to improve blood pressure (primary measure) and cardiac function (secondary measure). The study also evaluated the safety and side effect profile of istaroxime in this patient population. In April 2022, we announced positive topline results with istaroxime in rapidly and significantly raising SBP. In May 2022, we presented data from our positive Phase 2 study of istaroxime in early cardiogenic shock in a late-breaker presentation at the European Society of Cardiology Heart Failure Meeting in Madrid, Spain and, in September 2022, the results were published in the European Journal of Heart Failure. There is a significant unmet medical need in the area of early cardiogenic shock and severe heart failure. Istaroxime demonstrated a meaningful increase in blood pressure while simultaneously increasing cardiac output and preserving renal function in clinical trials of this condition.
In September 2024, we announced positive topline results from our SEISMiC Extension study which enrolled 30 patients with SCAI Stage B cardiogenic shock and demonstrated significant improvement in systolic blood pressure and cardiac function as well as improving pulmonary congestion and renal function. This study evaluated lower doses and longer duration of dosing than in previous studies. These data were presented at the Heart Failure Society of America meeting in September 2024. This study contributed to optimizing the istaroxime dosing regimen and extended the favorable safety and tolerability profile for the istaroxime program. Multiple secondary endpoints supported the positive outcome on the primary endpoint of systolic blood pressure AUC over the first 6 hours of study drug infusion. These included assessments from invasive hemodynamics (from a pulmonary artery catheter), echocardiography and Holter monitoring. The most commonly reported adverse events were gastrointestinal (nausea and vomiting) and infusion site discomfort, both known to occur with istaroxime administration from previous clinical trials. Additionally, we initiated a study in more severe SCAI Stage C cardiogenic shock, or the SEISMiC C Study, to evaluate the safety and efficacy of istaroxime in cardiogenic shock patients who are also receiving standard of care rescue therapy for shock. The SEISMiC C Study was planned to enroll up to 100 subjects with SCAI Stage C cardiogenic shock. A planned unblinded review of the data from the first 20 subjects occurred in July 2025. The review of the preliminary interim data suggests that the responses to istaroxime in SCAI Stage C patients, many of whom were also treated with currently available inotropes and vasopressors, is similar to that seen in our previous clinical trials. Because our ability to complete this study with its intended sample size is dependent upon our ability to secure adequate resourcing for the program through financing efforts or business development activities we have decided to terminate the SEISMiC C clinical trial and pursue further development with istaroxime in the much larger market of less severe patients with acute decompensated heart failure with our licensing partner, Lee’s Pharmaceutical (HK) Ltd., who is planning a global phase 3 study in that indication. We believe that the SEISMiC Extension and SEISMiC C studies have contributed to dose selection and to the characterization of the effects associated with SERCA2a activation and will support our clinical and regulatory strategy for istaroxime.
Istaroxime (AHF)
There is substantial potential synergy between our clinical trial program in early cardiogenic shock and our development program in acute decompensated heart failure. Both programs are focused on treating heart failure patients with acute congestion and low blood pressure requiring hospitalization. We believe that this category of heart failure patients (whether they are in shock or not) could particularly benefit from the unique profile and potential ability of istaroxime to improve cardiac function and increase blood pressure while maintaining or improving renal function. Our strategy has been to advance istaroxime in cardiogenic shock as the lead indication and utilize this data and experience, along with the positive Phase 2a and 2b AHF studies, already completed, to potentially enter Phase 3 for acute decompensated heart failure in the normal to low SBP population. Our licensing partner, Lee’s (HK) is preparing to initiate a phase 3 study in less severe patients with acute decompensated heart failure in China. We believe we can join that study and create a global phase 3 program in this population that may or may not include patients with cardiogenic shock. We currently do not have sufficient capital to execute our clinical trial in AHF and are seeking partnership opportunities to advance our portion of the program.
SERCA2a Activators – Preclinical Oral, Chronic, and Acute Heart Failure Product Candidates
We are pursuing several early exploratory research programs to assess potential product candidates, including oral and intravenous dual mechanism or selective SERCA2a activator heart failure compounds, and believe that we can add value to our cardiovascular portfolio by advancing these SERCA2a activator candidates through preclinical studies. In April 2023, we announced that the European Patent Office has granted Patent No. 3599243, providing patent coverage for the dual mechanism SERCA2a Activator class of drug candidates. This patent provides protection until July 2038 for the family of compounds with a dual mechanism of action. To further advance these product candidates, we are actively exploring potential licensing transactions, research partnership arrangements, or other strategic opportunities. Additionally, the United States Patent and Trademark Office has issued U.S. Patent No. 11,730,746 covering our dual mechanism SERCA2a activators. The new composition of matter patent provides patent protection through late 2039. Further, the European Patent Office has granted Patent No. 3805243, providing composition of matter patent coverage for the pure SERCA2a Activator class of drug candidates. The pure SERCA2a Activators are one of two families of preclinical drug candidates that act on SERCA2a in the Company’s pipeline. The pure SERCA2a Activators are devoid of action on the Na+/K+ pump while activating SERCA2a. The new European patent provides patent protection until October 9, 2039 for the family of compounds with the pure SERCA2a mechanism of action.
Rostafuroxin
Rostafuroxin has demonstrated efficacy in Caucasian patients in treatment naïve hypertension in a Phase 2b trial. During the second quarter of 2021, we concluded an initial process to test the industry’s interest in investing in our product candidate. We currently have not been able to secure a licensing transaction or other strategic opportunity. Based on feedback received from potential licensing partners, we have determined that there is a need for an additional Phase 2 clinical trial to demonstrate efficacy in African American patients in treatment resistant hypertension. We are continuing to pursue licensing arrangements and/or other strategic partnerships for rostafuroxin. We do not intend to conduct the additional Phase 2 clinical trial without securing such an arrangement or partnership.
aPKCi inhibitor (topical formulation previously designated as VAR-101)
The topical (cutaneous) formulation is a small molecule that may have potential for the treatment of basal cell carcinoma, or BCC. The active pharmaceutical ingredient, or API, in aPKCi inhibitor (topical) has demonstrated dose dependent anti-tumor activity in murine and human BCC cell lines, in studies performed at Cancer Research UK, or CRUK, a charity registered in England and Scotland, and based in London, United Kingdom. CRUK collaborators, including Stanford University under a sponsored research agreement with CRUK, completed the preclinical tumor cell line data and the BCC cell line data that formed the basis for additional “method of use” patents that are included in the License Agreement. These types of in vitro studies in tumor cell lines are typical early-stage models of activity or efficacy when testing a new chemical compound, the data from which is used in regulatory filings for first-in-man clinical trials. These mouse models of BCC and lung cancer were performed by CRUK and their collaborators.
aPKCi inhibitor (oral formulation previously designated as VAR-102)
The oral formulation is a small molecule that may have potential for the treatment of solid tumors. The API in the aPKCi inhibitor (oral) is the same as the API in aPKCi inhibitor (topical). In the scientific literature, the presence and activation of aPKCi has been implicated in the growth of multiple human cancers including non-small cell lung cancer, or NSCLC, pancreatic, and ovarian cancer. The API in aPKCi inhibitor (oral) has demonstrated dose dependent anti-tumor activity in a mouse model of NSCLC (squamous cell lung carcinoma), in studies performed at CRUK and with its collaborators. Preclinical experiments of the API in aPKCi inhibitor (oral), appears to show dose dependent anti-tumor activity in a xenograft NSCLC model.
Continued Listing on The Nasdaq Capital Market
December 2024 Deficiency
June 2025 Deficiency
On June 18, 2025, we received a deficiency letter from the Nasdaq Listing Qualifications Department, or the Nasdaq Staff, notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock had been below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2), or the Minimum Bid Price Requirement.
Normally, a company would be afforded a 180-calendar day period to demonstrate compliance with the Minimum Bid Price Requirement. However, as disclosed above, the Company is subject to a Discretionary Panel Monitor until March 20, 2026, pursuant to Listing Rule 5815(4)(A). Moreover, pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) because the Company effected two reverse stock splits over the prior two-year period with a cumulative ratio of more than 250 shares to one.
Accordingly, unless the Company requested by June 25, 2025, a hearing before a Hearings Panel (the “Panel”), or the Company’s securities would be subject to suspension/delisting. The Company timely requested a hearing before the Panel.
The hearing request automatically stayed any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. The hearing was held on July 31, 2025. There can be no assurance that the Panel will grant the Company an additional extension period or that the Company will ultimately regain compliance with all applicable requirements for continued listing on The Nasdaq Capital Market.
CRITICAL ACCOUNTING POLICIES
For a discussion of our accounting policies, see the section titled, “Note 4 – Summary of Significant Accounting Policies” and, in the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2024, Note 4 – Accounting Policies and Recent Accounting Pronouncements. Readers are encouraged to review those disclosures in conjunction with this Quarterly Report on Form 10-Q.
Intangible Assets
We record acquired intangible assets and goodwill based on estimated fair value. The identifiable intangible assets resulting from the CVie Therapeutics acquisition in December 2018 relate to in-process research and development, or IPR&D, of istaroxime and rostafuroxin. The IPR&D assets are considered indefinite-lived intangible assets until completion or abandonment of the associated research and development efforts. IPR&D is not amortized but reviewed for impairment at least annually, or when events or changes in the business environment indicate the carrying value may be impaired. During the three and six months ended June 30, 2025, no events or changes in circumstances occurred indicating that our IPR&D intangible assets were more likely than not impaired.
The following table represents identifiable intangible assets as of June 30, 2025 and December 31, 2024:
| June 30, | December 31, | |||||||
| (in thousands) |
2025 |
2024 |
||||||
| Istaroxime drug candidate |
$ | 22,340 | $ | 22,340 | ||||
| Rostafuroxin drug candidate |
1,790 | 1,790 | ||||||
| Intangible assets |
$ | 24,130 | $ | 24,130 | ||||
Convertible Debt and Equity Instruments
We review the terms of convertible debt and equity instruments to determine whether there are conversion features or embedded derivative instruments including embedded conversion options that are required to be bifurcated and accounted for separately as derivative financial instruments under ASC Topic 815, Derivatives and Hedging.
In circumstances where the convertible instrument contains more than one embedded derivative instrument, including conversion options that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single compound instrument. Also, in connection with the sale of convertible debt and equity instruments, we may issue free standing warrants that may, depending on their terms, be accounted for as derivative instrument liabilities, rather than as equity. When convertible debt or equity instruments contain embedded derivative instruments that are to be bifurcated and accounted for separately, the total proceeds allocated to the convertible host instruments are first allocated to the fair value of the bifurcated derivative instrument. The remaining proceeds, if any, are then allocated to the convertible instruments themselves, usually resulting in those instruments being recorded at a discount from their face amount. When we issue debt securities, which bear interest at rates that are lower than market rates, we recognize a discount, which is offset against the carrying value of the debt. Such discount from the face value of the debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to income.
RESULTS OF OPERATIONS
As we continue to explore commercial opportunities, and plan to work with business partners, in both U.S. and international markets, we remain attentive to evolving global economic conditions, including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Although these factors have not had a material impact on our operations to date, future changes in trade regulations, tariff structures, or logistical constraints could include the cost, availability, or timing of materials, services and other components associated with the development of our tablet vaccines and manufacturing capabilities. We continue to monitor these developments closely to maintain operational efficiency and help mitigate potential future impacts.
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
| Three Months Ended |
Six Months Ended |
|||||||||||||||||||||||
| June 30, |
June 30, |
|||||||||||||||||||||||
| (in thousands) |
2025 |
2024 |
Change |
2025 |
2024 |
Change |
||||||||||||||||||
| Expenses: |
||||||||||||||||||||||||
| Research and development |
$ | 2,182 | $ | 9,863 | $ | (7,681 | ) | $ | 4,452 | $ | 12,116 | $ | (7,664 | ) | ||||||||||
| General and administrative |
1,802 | 1,589 | 213 | 3,622 | 3,741 | (119 | ) | |||||||||||||||||
| Total operating expenses |
3,984 | 11,452 | (7,468 | ) | 8,074 | 15,857 | (7,783 | ) | ||||||||||||||||
| Operating loss |
(3,984 | ) | (11,452 | ) | 7,468 | (8,074 | ) | (15,857 | ) | 7,783 | ||||||||||||||
| Other income (expense): |
||||||||||||||||||||||||
| Loss on debt issuance |
(7,313 | ) | - | (7,313 | ) | (7,437 | ) | - | (7,437 | ) | ||||||||||||||
| Gain on debt extinguishment |
74 | - | 74 | 52 | 14,520 | (14,468 | ) | |||||||||||||||||
| Change in fair value of convertible notes payable |
785 | - | 785 | 785 | - | 785 | ||||||||||||||||||
| Change in fair value of common stock warrant liability |
108 | - | 108 | 242 | - | 242 | ||||||||||||||||||
| Interest income |
198 | 20 | 178 | 205 | 50 | 155 | ||||||||||||||||||
| Interest expense |
(79 | ) | (110 | ) | 31 | (99 | ) | (123 | ) | 24 | ||||||||||||||
| Other expense, net |
(420 | ) | (285 | ) | (135 | ) | (538 | ) | (84 | ) | (454 | ) | ||||||||||||
| Total other (expense) income, net |
(6,647 | ) | (375 | ) | (6,272 | ) | (6,790 | ) | 14,363 | (21,153 | ) | |||||||||||||
| Loss before income taxes |
(10,631 | ) | (11,827 | ) | 1,196 | (14,864 | ) | (1,494 | ) | (13,370 | ) | |||||||||||||
| Income tax expense |
- | (197 | ) | 197 | - | (311 | ) | 311 | ||||||||||||||||
| Net loss |
$ | (10,631 | ) | $ | (12,024 | ) | $ | 1,393 | $ | (14,864 | ) | $ | (1,805 | ) | $ | (13,059 | ) | |||||||
Research and Development Expenses
Our research and development expenses are charged to operations as incurred and we incur both direct and indirect expenses for each of our programs. We track direct research and development expenses by preclinical and clinical programs, which include third-party costs such as contract research organization, contract manufacturing organizations, contract laboratories, consulting, and clinical trial costs. We do not allocate indirect research and development expenses, which include product development and manufacturing expenses and clinical, medical, and regulatory operations expenses, to specific programs. We also account for research and development and report annually by major expense category as follows: (i) contracted services; (ii) salaries and benefits; (iii) rents and utilities; (iv) stock-based compensation; (v) depreciation; and (vi) other. We expect that our research and development expenses related to the istaroxime – cardiogenic shock program will continue to increase to the extent that we continue the SEISMiC C study in patients with more severe SCAI Stage C cardiogenic shock. We currently do not have sufficient capital to fully complete this clinical trial. At this time, we cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales of our product candidates.
Research and development expenses are as follows:
| Three Months Ended June 30, |
Increase |
Six Months Ended June 30, |
Increase |
|||||||||||||||||||||
| (in thousands) |
2025 |
2024 |
(Decrease) |
2025 |
2024 |
(Decrease) |
||||||||||||||||||
| Acquired IPR&D from Varian asset purchase |
$ | - | $ | 7,495 | $ | (7,495 | ) | $ | - | $ | 7,495 | $ | (7,495 | ) | ||||||||||
| Istaroxime – cardiogenic shock program |
1,551 | 1,684 | $ | (133 | ) | 2,959 | 3,159 | (200 | ) | |||||||||||||||
| Istaroxime – AHF |
(4 | ) | - | (4 | ) | - | - | - | ||||||||||||||||
| Total direct clinical and preclinical programs |
1,547 | 1,684 | (137 | ) | 2,959 | 3,159 | (200 | ) | ||||||||||||||||
| Product development and manufacturing |
201 | 215 | (14 | ) | 517 | 439 | 78 | |||||||||||||||||
| Clinical, medical, and regulatory operations |
434 | 469 | (35 | ) | 976 | 1,023 | (47 | ) | ||||||||||||||||
| Total research and development expenses |
$ | 2,182 | $ | 9,863 | $ | (7,681 | ) | $ | 4,452 | $ | 12,116 | $ | (7,664 | ) | ||||||||||
For the three and six months ended June 30, 2024, research and development expenses include non-cash charges of $7.5 million associated with the acquired IPR&D related to the Asset Purchase Agreement with Varian Biopharmaceuticals in the second quarter of 2024.
Direct Clinical and Preclinical Programs
Direct clinical and preclinical programs include: (i) activities associated with conducting clinical trials, including contract research organization costs, patient enrollment costs, clinical site costs, clinical drug supply, and related external costs, such as consultant fees and expenses; and (ii) development activities, toxicology studies, and other preclinical studies.
Total direct clinical and preclinical programs expenses were comparable for the three months and six months ended June 30, 2025 and 2024 primarily due to ongoing costs related to the istaroxime – cardiogenic shock program as described below.
Istaroxime – cardiogenic shock program costs were comparable for the three months and six months ended June 30, 2025 and 2024 due to the ongoing trial execution costs for the istaroxime - cardiogenic shock program, which included clinical trial costs for the SEISMiC C study in patients with more sever SCAI Stage C cardiogenic shock in 2025 and clinical trial costs for the SEISMiC Extension study in 2024.
Istaroxime – AHF costs have been limited as we focus our resources on the execution of the istaroxime – cardiogenic shock program.
Product Development and Manufacturing
Product development and manufacturing includes (i) manufacturing operations with our contract manufacturing organization, validation activities, quality assurance; and (ii) pharmaceutical and manufacturing development activities of our drug product candidates, including development of istaroxime. These costs include employee expenses, facility-related costs, depreciation, costs of drug substances (including raw materials), supplies, quality assurance activities, and expert consultants and outside services to support pharmaceutical development activities.
Product development and manufacturing expenses increased $0.1 million for the six months ended June 30, 2025 compared to the same period in 2024 due to an increase in quality assurance costs related to a GMP server validation during the first quarter of 2025.
Clinical, Medical, and Regulatory Operations
Clinical, medical, and regulatory operations include medical, scientific, preclinical and clinical, regulatory, data management, and biostatistics activities in support of our research and development programs. These costs include personnel, expert consultants, outside services to support regulatory and data management, symposiums at key medical meetings, facilities-related costs, and other costs for the management of clinical trials.
Clinical, medical, and regulatory operations expenses are comparable for the three months and six months ended June 30, 2025 compared to the same period in 2024 and primarily relate to personnel and consulting expenses during both periods.
General and Administrative Expenses
General and administrative expenses consist of costs for executive management, business development, intellectual property, finance and accounting, legal, insurance, human resources, information technology, facilities, and other administrative costs.
General and administrative expenses increased $0.2 million for the three months ended June 30, 2025 due to a $0.2 million increase in professional fees and insurance costs related to WINT Real Estate, LLC, and decreased $0.1 million for the six months ended June 30, 2025 compared to the same periods in 2024 due to a decrease of $0.2 million in professional fees, primarily related to reduced legal fees; and a decrease of $0.1 million in non-cash stock-based compensation expense, partially offset by the $0.2 million increase in in professional fees and insurance costs related to WINT Real Estate, LLC.
Other (Expense) Income, Net
In June 2025, we entered into certain Note Purchase Agreements for which we elected to apply the fair value option for all of the June 2025 Notes and June 2025 Warrants as of their issuance date. The fair value of the June 2025 Notes on the dates of issuance was $8.6 million and the fair value as of June 30, 2025 was $7.8 million. Accordingly, a change in fair value adjustment of $0.8 million is reflected in other income (expense) for the three and six months ended June 30, 2025. The fair value of the June 2025 Warrants on the dates of issuance was $2.9 million. The June 2025 Warrants are considered permanent equity and do not need to be remeasured. Given the fair value at issuance of the June 2025 Notes and June 2025 Warrants were in excess of the cash proceeds received, we incurred a loss on debt issuance of $7.3 million for the three months ended June 30, 2025. The loss on debt issuance of $7.4 million for the six months ended June 30, 2025 includes an additional $0.1 million loss related to the issuance of the March 2025 Notes.
On January 24, 2024, we and affiliates of Deerfield Management Company L.P., or Deerfield, entered into an Exchange and Termination Agreement, or the Exchange and Termination Agreement, wherein Deerfield agreed to terminate its rights to receive certain milestone payments in exchange for (i) cash in the aggregate amount of $0.2 million and (ii) an aggregate of 676 shares of our common stock, par value $0.001 per share (See the section titled, “Note 14 - Restructured Debt Liability”). This transaction was accounted for as an extinguishment of debt in accordance with ASC 470, Debt-Modifications and Extinguishments, and as a result, we recognized a $14.5 million non-cash gain on debt extinguishment.
Change in fair value of common stock warrant liability relates to the change in fair value of the July 2024 Warrants, which are classified as a liability on our condensed consolidated balance sheet and are recorded at fair value at the end of each period. For the three and six months ended June 30, 2025, the change in the estimated fair value of the July 2024 warrants was $0.1 million and $0.2 million, respectively. For further details, refer to “Note 11 - Common Stock Warrant Liability.”
For the six months ended June 30, 2025, change in fair value of derivative liabilities is related to the final remeasurement of the fair value of the derivative liability associated with our ELOC commitment note.
Interest income relates primarily to interest related to the accretion of the debt discount for our note receivable with Standard Waste for the three and six months ended June 30, 2025 and 2024.
For the three and six months ended June 30, 2025, interest expense consists primarily of interest expense associated with our ELOC commitment note and the interest accruing related to PMUSA and PMPSA. For the three and six months ended June 30, 2024, interest expense consists primarily of interest expense associated with the amortization of the issuance costs and the debt discount related to our senior convertible notes payable.
For the three and six months ended June 30, 2025, other (expense) income, net primarily consists of $0.4 million and $0.5 million, respectively, in net loss on foreign currency translation. For the three and six months ended June 30, 2024, other (expense) income, net primarily consists of initial recognition and remeasurement changes in the fair value of derivative liabilities associated with our senior convertible notes payable and our ELOC commitment note, partially offset by net gains on foreign currency translation. Foreign currency gains and losses are primarily due to changes in the New Taiwan dollar exchange rate related to activities of our wholly-owned subsidiary, CVie Therapeutics Limited, in Taiwan.
Income Tax Expense
For the three months and six months ended June 30, 2025, there was no income tax expense due to losses incurred and forecasted for 2025 as well as a full valuation allowance against deferred tax assets. During the three and six months ended June 30, 2024, we recorded an income tax provision of $0.2 million and $0.3 million, respectively, related to the tax on our estimated taxable income for the year, primarily due to the gain on debt extinguishment (See the section titled, “Note 14 – Restructured Debt Liability”).
LIQUIDITY AND CAPITAL RESOURCES
We are subject to risks common to companies in the biotechnology industry, including but not limited to the need for additional capital, risks of failure of preclinical and clinical studies, the need to obtain marketing approval and reimbursement for any drug product candidate that we may identify and develop, the need to successfully commercialize and gain market acceptance of our product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development of technological innovations by competitors, and risks associated with our international operations in Taiwan and activities abroad, including but not limited to having foreign suppliers, manufacturers, and clinical sites in support of our development activities.
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to secure additional capital, potentially through a combination of public or private securities offerings, convertible debt financings, and/or strategic transactions, including potential licensing arrangements, alliances, and drug product collaborations focused on specified geographic markets; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, or identify and enter into any strategic transactions that will provide the capital that we will require. If we fail to raise sufficient capital, we potentially could be forced to limit or cease our development activities, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations. Accordingly, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern for at least 12 months after the issuance of the accompanying financial statements.
Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented:
| Six Months Ended |
||||||||
| June 30, |
||||||||
| (in thousands) |
2025 |
2024 |
||||||
| Net cash provided by (used in): |
||||||||
| Operating activities |
$ | (5,064 | ) | $ | (5,273 | ) | ||
| Investing activities |
(5,183 | ) | (12 | ) | ||||
| Financing activities |
8,770 | 2,628 | ||||||
| Change in cash and cash equivalents |
$ | (1,477 | ) | $ | (2,657 | ) | ||
Operating Activities
Cash used in operating activities resulted primarily from our net loss adjusted for non-cash charges and changes in components of working capital. Net cash used in operating activities was $5.1 million for the six months ended June 30, 2025 compared to $5.3 million for the six months ended June 30, 2024. The decrease in cash used in operating activities of $0.2 million was primarily attributable to a change in operating assets and liabilities of $0.2 million and a $12.9 million increase in our net loss, partially offset by a $14.5 million change in gain on debt extinguishment.
Investing Activities
Cash used in investing activities resulted from $3.7 million in senior note receivable issuance and $1.4 million in a deposit on the Aubrey property.
Financing Activities
Net cash provided by financing activities was $8.8 million for the six months ended June 30, 2025. Cash provided by financing activities for the six months ended June 30, 2025 was attributable to net proceeds from the issuance of private placement notes and Series D Preferred stock of $7.0 million, ELOC Purchase agreement of $2.4 million, proceeds from senior secured notes of $0.5 million, proceeds from warrant exercises of $0.3 million, partially offset by redemption and cash dividend payments on our Series C Preferred Stock of $0.6 million and $0.9 million in principal payments for senior secured notes payable and loans payable.
Net cash provided by financing activities of $2.6 million for the six months ended June 30, 2024 was attributable to net proceeds of $1.4 million related to our 2023 ATM Program and $0.3 million in proceeds from the issuance of senior secured notes, and $1.3 million in proceeds from the issuance of senior convertible notes payable, partially offset by $0.2 million in principal payments for loans payable, $0.1 million paid for Series B preferred stock issuance costs, and $0.1 million in payments on debt extinguishment.
The following sections provide a more detailed discussion of our available financing facilities.
Common Stock Purchase Agreement
Loans Payable
In August 2024, we entered into an insurance premium financing and security agreement with IPFS Corporation. Under the agreement, we financed $0.5 million of certain premiums at a 7.94% fixed annual interest rate. Payments of approximately $56,000 are due monthly from August 2024 through May 2025. As of June 30, 2025, there was no amount outstanding under the loan.
Supplementary Disclosure of Non-Cash Activity
During the six months ended June 30, 2025, 10,781 shares of Series C Convertible Preferred Stock and $105,000 of accrued and unpaid dividends were converted into 8,054,644 shares of common stock. Upon conversion, the excess of the stated value of $1,000 per share over the current the carrying value of the shares of the Series C Preferred Stock converted was reclassified to common stock $0.001 par value and additional paid-in capital in the aggregate amount of $3.3 million. There was no gain or loss recognized on the transaction as the shares were converted in accordance with the original terms of the Certificate of Designation of Series C Preferred Stock. In addition, related to the January 2025 Inducement and the May 2025 Inducement, an additional $3.4 million of aggregate value was attributed to the conversions of Series C Preferred Stock related to the inducements.
The Company accretes to Series C Preferred Stock against additional paid-in capital as a deemed dividend for the difference between the initial net carrying value and the full redemption price of $1,000 per share. The Company uses the effective interest method to calculate the accretion amount for each period. During the six months ended June 30, 2025, we recognized $4.9 million in deemed dividends on Series C preferred stock, inclusive of $3.4 million related to the January 2025 Inducement and the May 2025 Inducement.
The Company accretes to Series D Preferred Stock against additional paid-in capital as a deemed dividend for the difference between the initial net carrying value and the full redemption price of $1,000 per share. The Company uses the effective interest method to calculate the accretion amount for each period. During the six months ended June 30, 2025, we recognized $0.1 million in deemed dividends on Series D preferred stock.
During the six months ended June 30, 2025, we recognized a fair value upon issuance of the June 2025 Notes of $8.6 million and a fair value upon issuance of the June 2025 Warrants of $2.9 million. The June 2025 Notes will be remeasured at each balance sheet date. The June 2025 Warrants are considered permanent equity and do not need to be remeasured.
During the six months ended June 30, 2025, the Purchaser converted the ELOC Commitment Note and its related accrued interest into 56,769 shares of our common stock with a fair value of $0.5 million.
During the first quarter of 2025, we issued the March 2025 Notes for aggregate gross proceeds of $0.25 million. The March 2025 Notes include a 20% original issue discount and bear interest at 10% per annum with such interest compounded each calendar month. Certain conversion and redemption features of the March 2025 Notes would typically be considered derivatives that would require bifurcation. In lieu of bifurcating various features in the agreement, we elected the fair value option for the March 2025 Notes and recognized a fair value upon issuance of $0.4 million.
During the six months ended, we recorded a $20,000 reduction to our common stock warrant liability related to exercises of July 2024 Warrants during the period.
Off-Balance Sheet Arrangements
We did not have any material off-balance sheet arrangements as of June 30, 2025 or 2024 or during the periods then ended.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
Item 4. Controls and Procedures
Evaluation of disclosure controls and procedures
Our management, including our President and Chief Executive Officer (principal executive officer and principal financial officer), do not expect that our disclosure controls or our internal control over financial reporting will prevent all error and all fraud. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our President and Chief Executive Officer has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our President and Chief Executive Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our President and Chief Executive Officer, to allow for timely decisions regarding required disclosures, and recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms.
Changes in internal control
There were no changes in our internal control over financial reporting identified in connection with the evaluation described above that occurred during the quarter ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not aware of any pending legal actions that would, if determined adversely to us, have a material adverse effect on our business and operations.
We have from time to time been involved in disputes and proceedings arising in the ordinary course of business, including in connection with the conduct of our clinical trials. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if not resolved, could be time-consuming and result in costly litigation. There can be no assurance that an adverse result in any future proceeding would not have a potentially material adverse effect on our business, results of operations and financial condition.
ITEM 1A. RISK FACTORS
Investing in our securities involves certain risks. In addition to any risks and uncertainties described elsewhere in this Quarterly Report on Form 10-Q, investors should carefully consider the risks and uncertainties discussed in Part I, Item 1A. "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by risk factors included in our Quarterly Report on Form 10-Q filed thereafter. These risks are not the only risks that could materialize. Other than as set forth below, there have been no material changes in our risk factors from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024 or our Quarterly Report on Form 10-Q filed thereafter. Additional risks and uncertainties not presently known to us or that we currently consider to be immaterial may also impair our business operations and development activities. Should any of the risks and uncertainties described in our Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by our subsequent filings with the SEC, actually materialize, our business, financial condition, and/or results of operations could be materially adversely affected, the trading price of our common stock could decline, and an investor could lose all or part of his or her investment. In particular, the reader’s attention is drawn to the discussion in Part I, Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources.
Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations in the near term.
We do not have sufficient resources available to fund our business beyond December 2025. To increase our cash runway, management plans to secure additional capital, potentially through a combination of public or private securities offerings, convertible debt financings, and/or strategic transactions, including potential licensing arrangements, alliances, and drug product collaborations focused on specified geographic markets; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding, or that such funding will be available on terms acceptable to us, to fund continuing operations, if at all, or identify and enter into any strategic transactions that will provide the capital that we will require.
Further, under the terms of the Purchase Agreements, we are subject to certain restrictive covenants that may make it difficult to procure additional financing. As a result of these covenants, our ability to respond to changes in business and economic conditions and engage in beneficial transactions, including to obtain additional debt or equity financing as needed in the future, on favorable terms or at all, may be limited, which could adversely affect our business, financial condition, and results of operations.
If we fail to raise sufficient capital, we potentially could be forced to limit or cease our development activities, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations. In addition, sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur, including pursuant to our existing equity line of credit, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. These conditions raise substantial doubt regarding our ability to continue as a going concern.
Our common stock is listed on The Nasdaq Capital Market, or Nasdaq. We can provide no assurance that we will be able to comply with the continued listing requirements over time and that our common stock will continue to be listed on Nasdaq.
In May 2020, we successfully listed our common stock on Nasdaq. However, we can give no assurance that we will be able to satisfy the continued listing requirements of Nasdaq in the future, including but not limited to the corporate governance requirements and the minimum closing bid price requirement or the minimum equity requirement.
On December 4, 2024, we received a deficiency letter from the Nasdaq Listing Qualifications Department, or the Nasdaq Staff, notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock had been below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2), or the Minimum Bid Price Requirement. The Company timely requested a hearing before the Hearings Panel, or the Nasdaq Panel. On March 20, 2025, we received written confirmation from Nasdaq notifying us that we had regained compliance with the Minimum Bid Price Requirement. Nasdaq also stated that the Nasdaq Panel was imposing a Discretionary Panel Monitor until March 20, 2026, which generally will require the Nasdaq Staff to issue a Delist Determination Letter in the event that we fail to maintain compliance with any continued listing requirement.
here can be no assurance that we will be able to continue to maintain compliance with Nasdaq’s continued listing requirements, the Minimum Bid Price Requirement, or other Nasdaq listing requirements. If we are not able to comply with applicable listing standards, our shares of common stock may be subject to delisting.
Significant volatility in the market price of BNB may cause material losses and adversely affect our financial position.
We are in the process of implementing BNB as our primary reserve asset.
We expect to adopt BNB as a reserve asset and intend to acquire BNB, exposing us to extreme price fluctuations inherent in digital assets. The market value of BNB may experience rapid, severe, and unpredictable declines due to factors including regulatory actions, market sentiment, technological changes, macroeconomic conditions, or liquidity constraints. A material decline in BNB’s value could substantially reduce the value of our reserve assets, adversely affecting our liquidity, financial position, and results of operations.
BNB’s value and utility are heavily dependent on the ongoing operation, success, and reputation of Binance and its affiliates, exposing our reserves to material devaluation.
BNB derives significant value from its association with and utility across platforms operated by Binance. Adverse developments affecting Binance, including regulatory sanctions, legal proceedings, operational failures, financial instability, reputational damage, loss of market share, or a decline in the adoption of Binance-related services, could rapidly erode confidence in and demand for BNB, causing its market price to decline substantially and materially harming the value of our holdings.
As the issuer and primary governing authority of BNB, Binance exerts centralized control over critical token attributes including burn mechanisms, distribution protocols, utility features, staking rewards, and technological infrastructure. Binance may implement changes without our consent that reduce token scarcity, diminish utility, alter fee structures, or disadvantage holders. Such actions could materially erode BNB’s market value and directly impair our reserve assets. Furthermore, adverse developments affecting Binance’s financial stability, regulatory, reputation, or operational integrity may severely undermine market confidence in BNB, triggering price declines that disproportionately impact our concentrated holdings.
Significant concentration of reserve value in BNB amplifies exposure to token-specific failures. Competition and potential technological obsolescence may adversely impact BNB’s value.
Our reserve asset strategy concentrates significant value in BNB. This concentration amplifies our exposure to BNB-specific risks, including technological obsolescence, competition from other digital assets, reputational damage to Binance or the BNB ecosystem, protocol failures, or governance disputes. Failure of BNB to maintain its functionality, market position, or value will disproportionately and adversely affect the value of our reserves compared to a more diversified portfolio.
BNB faces intense competition and rapid technological change. Numerous other blockchain platforms, tokens, and cryptocurrencies compete with BNB Chain and BNB for users, developers, and market share. The emergence of superior technology, more popular platforms, or changes in developer or user preferences could render BNB or the BNB Chain ecosystem less competitive or obsolete, materially reducing demand for and the value of our BNB holdings.
Our BNB holdings may face unique liquidity challenges or devaluation due to concentration or market perception. Liquidity constraints may prevent us from converting BNB holdings into fiat currency or stable value when needed, or without significant losses.
If we become a significant holder of BNB, our attempts to sell large quantities could materially exceed market depth at desired prices, especially during periods of stress, forcing us to accept significant discounts. Furthermore, market perception of our holdings as a potential overhang or association with Binance-related risks could independently exert downward pressure on BNB’s price, adversely affecting the value of our entire reserve position.
Our ability to convert BNB holdings into liquid assets may be constrained. BNB markets may lack sufficient depth to execute large transactions without significantly impacting its price. Exchange failures, trading suspensions, withdrawal restrictions, or operational disruptions at major trading platforms could impede our ability to liquidate BNB promptly or at desired prices. Inability to access or liquidate our BNB reserves at necessary times, or only at distressed prices, may materially impair our treasury management and ability to fund operations.
Technical flaws, security breaches, or failures within the BNB blockchain ecosystem could impair the utility value of our BNB holdings.
The BNB token operates on blockchain technology and networks, including the BNB Chain, which may contain undetected bugs, vulnerabilities, or experience operational disruptions. A significant security breach, network failure, consensus mechanism flaw, or successful attack targeting the BNB Chain or associated infrastructure could compromise the integrity of the network, disrupt transactions, or lead to loss of tokens, materially diminishing the value or usability of our BNB holdings.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Rule 10b5-1 and Non-Rule 10b5-1 Trading Arrangements
During the six months ended June 30, 2025, none of our directors or officers adopted, terminated or modified a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as defined in Item 408(a) of Regulation S-K of the Exchange Act.
ITEM 6. EXHIBITS
Exhibits are listed on the Index to Exhibits at the end of this Quarterly Report on Form 10-Q. The exhibits required by Item 601 of Regulation S-K, listed on such Index in response to this Item, are incorporated herein by reference.
INDEX TO EXHIBITS
The following exhibits are included with this Quarterly Report on Form 10-Q.
| Exhibit No. |
Description |
|
Method of Filing |
| 3.1 | Amended and Restated Certificate of Incorporation, including Certificate of Designation of Designations of Series B Convertible Preferred Stock of Windtree. | Incorporated by reference to Exhibit 3.1 to Windtree's Registration Statement on Form S-1, as filed with the SEC on May 9, 2024. | |
| 3.2 | Amended and Restated By-Laws. | Incorporated by reference to Exhibit 3.1 to Windtree’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as filed with the SEC on August 11, 2022. | |
| 3.3 | Certificate of Designations of Series C Convertible Preferred Stock. | Incorporated by reference to Exhibit 3.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 22, 2024. | |
| 3.4 | Certificate of Amendment filed with the Delaware Secretary of State on February 14, 2025. | Incorporated by reference to Exhibit 3.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on February 18, 2025. | |
| 3.5 | Certificate of Designation for Series D Convertible Preferred Stock | Incorporated by reference to Exhibit 3.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on April 30, 2025. | |
| 4.1 |
Form of Conversion Notice for Series C Convertible Preferred Stock. |
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Incorporated by reference to Exhibit 4.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on January 27, 2025. |
| 4.2 |
Form of Senior Secured Note due in 2026. |
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Incorporated by reference to Exhibit 4.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on March 24, 2025. |
| 4.3 | Form of 20% OID Senior Secured Promissory Note. | Incorporated by reference to Exhibit 4.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on April 10, 2025. | |
| 4.4 | Form of Convertible Note issued to DFU, LLC on June 5, 2025. | Incorporated by reference to Exhibit 4.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 11, 2025. | |
| 4.5 | Form of Convertible Note issued on June 9, 2025. | Incorporated by reference to Exhibit 4.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 11, 2025. | |
| 4.6 | Form of Common Stock Purchase Warrant issued to DFU, LLC on June 5, 2025. | Incorporated by reference to Exhibit 4.3 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 11, 2025. |
| 4.7 | Form of Common Stock Purchase Warrant issued on June 9, 2025. | Incorporated by reference to Exhibit 4.4 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 11, 2025. | |
| 4.8 | Form of Senior Note issued to Standard Waste Services, LLC on June 5, 2025. | Incorporated by reference to Exhibit 4.5 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 11, 2025. | |
| 4.9 | Form of Convertible Note issued on June 24, 2025. | Incorporated by reference to Exhibit 4.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 27, 2025. | |
| 4.10 | Form of Common Stock Purchase Warrant issued on June 24, 2025. | Incorporated by reference to Exhibit 4.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 27, 2025. | |
| 4.11 | Form of Convertible Note issued on June 27, 2025. | Incorporated by reference to Exhibit 4.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 3, 2025. | |
| 4.12 | Form of Common Stock Purchase Warrant issued on June 27, 2025. | Incorporated by reference to Exhibit 4.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 3, 2025. | |
| 4.13 | Form of Convertible Note issued on July 2, 2025. | Incorporated by reference to Exhibit 4.3 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 3, 2025. | |
| 4.14 | Form of Common Stock Purchase Warrant issued on July 2, 2025. | Incorporated by reference to Exhibit 4.4 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 3, 2025. | |
| 4.15 | Form of Convertible Promissory Note by and between the Company and the Purchaser, dated as of July 23, 2025. | Incorporated by reference to Exhibit 4.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 24, 2025. | |
| 10.1 | Amendment No. 1 to License and Supply Agreement, by and between Windtree and Evofem Biosciences, Inc., dated as of March 28, 2025. | Incorporated by reference to Exhibit 10.77 to Windtree’s Annual Report on Form 10-K, as filed on April 15, 2025. | |
| 10.2 | Form of Securities Purchase Agreement. | Incorporated by reference to Exhibit 10.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on April 30, 2025. | |
| 10.3 | Form of Registration Rights Agreement. | Incorporated by reference to Exhibit 10.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on April 30, 2025. | |
| 10.4 | Form of Assignment and Conditional Assumption Agreement. | Incorporated by reference to Exhibit 10.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on May 1, 2025. | |
| 10.5 | Purchase Agreement. | Incorporated by reference to Exhibit 10.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on May 1, 2025. |
| 10.6 | First Amendment to Purchase Agreement. | Incorporated by reference to Exhibit 10.3 to Windtree’s Current Report on Form 8-K, as filed with the SEC on May 1, 2025. | |
| 10.7 | Second Amendment to Purchase Agreement. | Incorporated by reference to Exhibit 10.4 to Windtree’s Current Report on Form 8-K, as filed with the SEC on May 1, 2025. | |
| 10.8 | Form of Note Purchase Agreement date June 5, 2025. | Incorporated by reference to Exhibit 10.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 11, 2025. | |
| 10.9 | Form of Note Purchase Agreement date June 9, 2025. | Incorporated by reference to Exhibit 10.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 11, 2025. | |
| 10.10 | Form of Note Purchase Agreement dated June 24, 2025. | Incorporated by reference to Exhibit 10.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 27, 2025. | |
| 10.11 | Form of Note Purchase Agreement dated June 27, 2025. | Incorporated by reference to Exhibit 10.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 3, 2025. | |
| 10.12 | Form of Note Purchase Agreement dated July 2, 2025. | Incorporated by reference to Exhibit 10.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 3, 2025. | |
| 10.13 | Form of Securities Purchase Agreement, dated as of July 16, 2025. | Incorporated by reference to Exhibit 10.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 17, 2025. | |
| 10.14 | Form of Common Stock Purchase Agreement, dated as of July 23, 2025, by and between Windtree Therapeutics, Inc. and the Purchaser. | Incorporated by reference to Exhibit 10.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 24, 2025. | |
| 10.15 | Form of Registration Rights Agreement, dated as of July 23, 2025, by and between Windtree Therapeutics, Inc. and the Purchaser. | Incorporated by reference to Exhibit 10.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on July 24, 2025. | |
| 31.1 |
Certification of Chief Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act. |
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Filed herewith. |
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| 32.1 |
Certification of Chief Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
Furnished herewith. |
| 99.1 | Non-binding Letter of Intent entered into on June 7, 2025 | Incorporated by reference to Exhibit 99.1 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 11, 2025. | |
| 99.2 | Letter of Intent entered into with Titan Environmental Services, Inc. on June 6, 2025 | Incorporated by reference to Exhibit 99.2 to Windtree’s Current Report on Form 8-K, as filed with the SEC on June 11, 2025. |
| 101.1 |
The following condensed consolidated financial statements from Windtree Therapeutics, Inc. Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, formatted in Inline Extensive Business Reporting Language (XBRL): (i) Balance Sheets as of June 30, 2025 (unaudited) and December 31, 2024, (ii) Statements of Operations (unaudited) for the three and six months ended June 30, 2025 and June 30, 2024, (iii) Statements of Cash Flows (unaudited) for the six months ended June 30, 2025 and June 30, 2024, and (iv) Notes to Condensed Consolidated Financial Statements. | ||
| 101.INS |
Inline XBRL Instance Document (the Instance Document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) (1). |
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Filed herewith. |
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| 101.SCH |
Inline XBRL Taxonomy Extension Schema Document (1). |
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Filed herewith. |
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| 101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document (1). |
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Filed herewith. |
| 101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document (1). |
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Filed herewith. |
| 101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document (1). |
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Filed herewith. |
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| 101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document (1). |
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Filed herewith. |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and combined in Exhibit 101.1) | Filed herewith. |
(1) These Interactive Data Files shall not be deemed filed for purposes of Section 11 or 12 of the Securities Act of 1933, as amended, or Section 18 of the Securities Act of 1934, as amended, or otherwise subject to liability under those sections.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Windtree Therapeutics, Inc. |
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(Registrant) |
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| Date: August 19, 2025 |
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By: /s/ Jed Latkin |
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Jed Latkin |
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President and Chief Executive Officer |
| (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) | ||
FAQ
What were Windtree Therapeutics (WINT) net losses for the quarter?
Does Windtree have enough cash to operate for the next 12 months?
What financing did Windtree complete after the quarter end?
What material losses from financing were recorded in the period?
Is Windtree still listed on Nasdaq?
