WINT 10-K & 10-Q changes, risk factors and insider trading

Information concerning the shares of our common stock and related share prices in these risk factors has been adjusted to reflect the 1-for-18 reverse split of our common stock that was made effective on April 19, 2024 and the 1-for-50 reverse split of our common stock that was made effective on February 24,20, 2023.2025.

Risks Related to Our FinancialFinances Conditionand Capital Requirements

Our current cash position, losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings. Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations in the near term.

The auditor’s opinion on our audited financial statements for the year ended December 31, 20232024 includes an explanatory paragraph stating that we have incurred recurring losses from operations that raise substantial doubt about our ability to continue as a going concern. Management has also concluded that substantial doubt exists about our abilitySubsequent to continue as a going concern. As of December 31, 2023,2024 and through April 15, 2025, (i) we hadsold cashan additional 0.2 million shares of common stock under the ELOC Purchase Agreement for net proceeds of $1.5 million following mandatory redemption payments on our Series C Preferred Stock; (ii) 47,799 July 2024 Warrants were converted into 47,799 shares of common stock for gross and cashnet equivalentsproceeds of $4.3$0.3 million; and(iii) currenton liabilitiesMarch of18, $4.0 million. In April 2024, we entered into a Securities Purchase Agreement, or the Purchase Agreement, with the buyers named therein, pursuant to which2025, we agreed to issue and sell to two institutional investors an aggregate principal amount of $312,500, at an original issue discount of 20%, in senior convertiblesecured notes,notes ordue thein Notes,2026 for $1.5net millionproceeds of gross$250,000; proceeds.and (iv) on April 4, 2025, we agreed to issue and sell to two institutional investors senior secured promissory notes in an aggregate principal amount of $312,500, at an original issue discount of 20%, for net proceeds of $250,000. As a result, we believe that we have sufficient resources available to fund our business operations through April 2024.2025, Webut dowill notneed haveadditional sufficientcapital cashto and cash equivalents as of the date of this Annual Report on Form 10-Kcontinue to support our operations for atmore least thethan 12 months following the date thatof theissuance of our consolidated financial statements areas issued.of Theseand conditionsfor raisethe year ended December 31, 2024. As of December 31, 2024, we had cash and cash equivalents of $1.8 million and current liabilities of $5.7 million, and management has concluded that this circumstance raises substantial doubt about our ability to continue as a going concern.

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; and/or potential revenues from any future acquisitions of small companies with FDA-approved products as a result of our new corporate strategy announced in January 2025; 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 none of these alternatives is available, or if available,available and we are unable to raise sufficient capital through such transactions, we will not have sufficient cash resources and liquiditywill toexperience funddifficulty ourin businessoperating operations for at least the next 12 months following the date that the financial statements are issued. In addition, we may be unable to pay our vendors and other service partners on time, or at all. If any of our key vendors and service providers were to cease working with us or subject the delivery of products or services to timing or payment preconditions, our development activities may be adversely affected, which could haveas a materialgoing adverseconcern effectas ona ourresult. business and operations. Additionally,Moreover, if we are unable to regain compliance with the listing standards of Nasdaq, our common stock may become delisted, which could have a material adverse effect on the liquidity of our common stock and our ability to raise funding. Ifsuch additional financing is not available on satisfactory terms, or is not available in sufficient amounts, we may be require required to delay, limit,limit or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce our ability to access capital, which could negatively affect our liquidity and ability to continue as a going concern. Further, theThe perception that we may not be able to continue as a going concern may causeimpede othersour ability to choosepursue notstrategic toopportunities dealor withoperate usour business due to concerns about our ability to meet our contractual obligations.

We have incurred operating losses since our incorporation on November 6, 1992. For the years ended December 31, 20232024 and 2022,2023, we had operating losses of $20.6$26.1 million and $41.3$20.6 million, respectively. As of December 31, 2023,2024, we had an accumulated deficit of $844.8$846.6 million. To date, we have financed our operations primarily through private placements and public offerings of our common and preferred stock and borrowings from investors and financial institutions. As of December 31, 2023,2024, we had cash and cash equivalents of $4.3$1.8 million and current liabilities of $4.0$5.7 million. In April 2024, we entered into the Purchase Agreement pursuant to which we agreed to sell the Notes for $1.5 million of gross proceeds. As a result, we believe that we have sufficient resources available to fund our business operations through April 2024.

We have, and may from time to time in the future have, third-party debt service obligations pursuant to our outstanding indebtedness, which currently includes $1.5 million in aggregate principal amount, or the Notes.indebtedness. The degree to which we are leveraged could have important consequences. For example, it could:

In addition, in some cases, theour Notesdebt instruments may allow for the interest to be paid in a combination of cash and shares of our common stock, and allowsmay allow for the interest to be convertible into shares of our common stock, which may dilute our existing stockholders. Such conversion ismay also subject to adjustment, which may cause further dilution to our existing stockholders.

TheOur Notesdebt areinstruments may also be subject to restrictive and other covenants that may limit our discretion and the discretion of our subsidiaries with respect to certain business matters. A breach of any of these covenants could result in a default under our outstanding indebtedness, which would have a material adverse effect on our business, results of operations and financial condition.

The acquisition of a product is a highly competitive area, and many other companies are pursuing the same or similar product candidates to those that we may consider attractive. In particular, larger companies with more well-established and diverse revenue streams may have a competitive advantage over us due to their size, financial resources and more extensive clinical development and commercialization capabilities. Furthermore, companies that perceive us to be a competitor may be unwilling to assign rights to us. The success of this strategy depends partly upon our ability to identify, select and acquire promising product candidates. The process of proposing, negotiating and implementing an acquisition of a product candidate is lengthy and complex, and we may be unable to acquire the rights to any such products or product candidates from third parties for several reasons. We may also be unable to acquire additional relevant product candidates on acceptable terms. Further, even if we identify acquisition targets, we may not be able to complete the transactions or we may determine after due diligence investigation not to pursue identified targets. Even if we succeed in our efforts to obtain rights to suitable product candidates, the success of our investments in these areas, our investment strategyareas will remain subject to the inherent risks associated with the development and commercialization of the product,product and with the competitive business environment in which we operate In addition, acquisitions may entail numerous operational, financial and legal risks, including:operate.

In addition, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies, including in connection with the COVID-19 pandemic, which resulted in decreased stock prices for many companies notwithstanding the lack of a fundamental change in their underlying business models or prospects. These fluctuations have often been unrelated or disproportionate to the operating performance of those companies. For additional information regarding the impact of the COVID-19any pandemic, please see the risk factor captioned “RiskOur Factors—The COVID-19 pandemic has negatively impacted, andbusiness may continuebe toadversely negativelyaffected impact,by oura abilitypandemic, toepidemic, developor ouroutbreak productof candidates.an infectious disease.”

Events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. Most recently, on March 10, 2023, Silicon Valley Bank was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation as receiver. Similarly, on March 12, 2023, Signature Bank and Silvergate Capital Corp. were each swept into receivership. Although we assess our banking and customer relationships as we believe necessary or appropriate, our access to funding sources and other credit arrangements in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect us, the financial services industry or economy in general. These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry.

Due to the significant resources required to develop our product candidates, we must prioritize development of certain product candidates and/or certain disease indications. We may be delayed in advancing a product candidate or potential indication if our plan does not include sufficient funding to execute a clinical program. If we expend our limited resources on candidates or indications that do not yield a successful product and fail to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of success, such failure could have a material adverse effect on our business, financial condition, results of operations, and prospects.success.

As a result of the acquisition of CVie Therapeutics in December 2018, we have recorded significant intangible assets on our consolidated balance sheets, which could become impaired and lead to material charges in the future. The identifiable intangible assets resulting from the CVie Therapeutics acquisition relate to IPR&D of istaroxime and rostafuroxin, which, as of December 31, 2023,2024, were $22.3 million and $2.9$1.8 million, respectively, recorded in aggregate on our consolidated balance sheet as intangible assets of $25.3$24.1 million. As of December 31, 2023, goodwill was zero on our consolidated balance sheet.

Throughout the year, we consider whether any events or changes in the business environment have occurred which indicate that intangible assets or goodwill may be impaired. If an impairment exists, we would be required to take an impairment charge with respect to the impaired asset. Events giving rise to impairment are difficult to predict, including the uncertainties associated with the development of product candidates and the success of business development activities, and are an inherent risk in the pharmaceutical industry. BasedAs onpart of our annual quantitative impairment assessment of our indefinite-lived IPR&D intangible assets as of December 1, 2023,2024, we reassessed certain assumptions related to our rostafuroxin drug candidate due to the continued difficulties in current macroeconomic conditions which have continued to make it more challenging to secure the funding needed to conduct the additional Phase 2 clinical trial and have therefore further delayed our intended development of rostafuroxin. As a result, we concluded that the fair value of the IPR&D related to our rostafuroxin drug candidate was less than its carrying value. We estimated the fair value of the asset using multi-period excess earnings method, or MPEEM, and determined that the fair value as of December 1, 2024 was approximately $1.8 million. We then compared this fair value to the carrying value of approximately $2.9 million, and recorded a loss on impairment of intangible assets wereof not$1.1 impaired.million related to the IPR&D of our rostafuroxin drug candidate. We also reassessed the assumptions related to the fair value of the IPR&D related to our istaroxime drug candidate. The estimated fair value exceeded the carrying value of that asset. As a result, no impairment charge was recognized related to the IPR&D of our istaroxime drug candidate.

Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, as amended, we are required to furnish a report by our management on our internal control over financial reporting. We cannot assure you that there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows. If our financial statements are not accurate, investors may not have a complete understanding of our operations. If we do not file our financial statements on a timely basis as required by the SEC, we could face severe consequences. For example, as a result of our failure to timely file our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024 with the SEC, we are currently ineligible to file new registration statements on Form S-3, which may impair our ability to raise capital in a timely manner or at all. However, such failure to timely file such Quarterly Report was determined not to be a result of any material weakness or significant deficiency in our internal control over financial reporting. If we are unable to conclude that our internal control over financial reporting is effective, investors may lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by theThe Nasdaq Stock Market LLC, or Nasdaq, the SEC or other regulatory authorities. Moreover, responding to such investigations, are likely to consume a significant amount of our management resources and cause us to incur significant legal and accounting expense. Failure to remedy any material weakness in our internal control over financial reporting, or to maintain effective control systems, could also restrict our future access to the capital markets. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

TheOur business could be adversely affected by health epidemics in regions where we have concentrations of clinical trial sites or other business activities and could cause significant disruption in the operations of third-party contract manufacturers and contract research organizations upon whom we rely, as well as our ability to recruit patients for our clinical trials. For example, the impact of the COVID-19 pandemic resulted in, and may in the future result in, significant disruptions to the global economy, as well as businesses and capital markets around the world. EffortsHealth to contain the spread of COVID-19 have intensified at times to manage surges in the infection rate and deaths, and many countries have at times implemented severe travel restrictions, social distancing, and delays or cancellations of elective surgeries at different times. Notwithstanding the introduction of effective vaccines, COVID-19epidemics may in the future affect our ability and the ability of our employees, contractors, suppliers, and other partners in the U.S. and abroad to conduct normal business activities from time to time, including due to shutdowns that may be requested or mandated by governmental authorities.

The global spread of COVID-19 globally has previouslyhad adversely impacted trial conduct and operations and may do so again in the future. We have, in the past, initiated several clinical trials for istaroxime in the EU and other worldwide locations impacted by the COVID-19 outbreak. Our clinical trials have suffered delays and interruptions and our previous decision to cease enrollment in the AEROSURF clinical trial was partially due to such delays and escalating expenses. Our efforts to conduct trials could be materially delayed in the future by governmental restrictions and enrollment difficulties as hospitals reduce and divert staffing, divert resources to patients suffering from the infectious disease and limit hospital access for nonpatients.nonpatients, whether as a result of COVID-19 or other health epidemics.

Similarly, there is a risk that clinical supplies of our product candidates may be significantly delayed or may become unavailable as a result of COVID-19any pandemic and the resulting impact on our suppliers’ labor forces and operations, including as a result of governmental restrictions on business operations and the movement of people and goods in an effort to curtail the spread of the virus. There can be no assurance that we would be able to timely implement any mitigation plans. Disruptions in our supply chain, whether as a result of restricted travel, quarantine requirements or otherwise, could negatively impact clinical supplies of our product candidates, which could materially adversely impact our clinical trial and development timelines.

The effects of COVID-19 or any other pandemic, including identification of potential new variants, has led and may in the future lead to periodic disruption and volatility in the global capital markets, which could increase our cost of capital and adversely affect our ability to access the capital markets in the future. It is possible that the spread of COVID-19an infectious disease, including COVID-19, in the future could cause an economic slowdown or recession or cause other unpredictable events, each of which could adversely affect our business, results of operations or financial condition.

The extent to which COVID-19 or any other pandemic impacts our financial results going forward will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the COVID-19 outbreak, the rise of variants, which may be more contagious and potentially more lethal, and the actions recommended to contain the outbreak or treat its impact, among others.predicted. Moreover, theepidemics COVID-19 outbreak hashave had and may in the future have indeterminable adverse effects on general commercial activity and the world economy, and our business and results of operations could be adversely affected to the extent that COVID-19 or any other pandemic harms the global economy generally.

Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe the nonclinical or clinical data for our product candidates are promising, such data may not be sufficient to support approval by the FDA and comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authorities, as the case may be, may also require us to conduct additional preclinical studies or clinical trials for our product candidates either prior to or post-approval, or may object to elements of our clinical development program.

We may conduct clinical development in the U.S., Canada, the EU, Eastern Europe, Latin America, and Asia Pacific regions and sell our products, if approved, in the U.S. and potentially in other major markets. To accomplish this objective, we must first obtain and maintain regulatory approvals and comply with regulatory requirements in each jurisdiction. To avoid the significant expense and lengthy time required to complete multiple regional clinical development programs, we expect to meet with relevant regulatory authorities. While we would prefer to design a single, global clinical development program that wouldcould satisfy the regulators in all of our target markets, there can be no assurance that our efforts will be successful. If we are unable to reach agreement with the various regulatory authorities, we may not be able to pursue regulatory approval of our product candidates in all of our selected markets.

With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional product testing, administrative review periods and agreements with pricing authorities. In addition, events raising questions about the safety of certain marketed pharmaceuticals may result in increased cautiousness by the FDA and comparable foreign regulatory authorities in reviewing new drugs based on safety, efficacy or other regulatory considerations and may result in significant delays in obtaining regulatory approvals. Any delay in obtaining, or inability to obtain, applicable regulatory approvals would prevent us or any of our potential future collaborators from commercializing our product candidates. In addition, delays associated with COVID-19 may impact local regulatory reviews occurring in a timely manner and result in delays for trial and site initiations.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off- labeloff-label uses. If we are found or alleged to have improperly promoted any of our products, if approved, for off-label uses, we may become subject to significant liability.

We rely on third parties, primarily outside of the U.S., to conduct many of our preclinical studies and clinical trials. Any failure by a third party to conduct the clinical trials according to GCPsgood clinical practices, or GCPs, and other requirements and in a timely and quality manner may delay or prevent our ability to seek or obtain regulatory approval for or commercialize our product candidates.

If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties or do so on commercially reasonable terms. Switching or adding additional CROs, investigators and other third parties involves additional costs and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects. Our agreement with Universita Degli Studi di Milano-Bicocca, the institution that has performed many preclinical studies with istaroxime and our preclinical families of compounds, expired on July 31, 2022. If additional preclinical work is required for any reason, we will need to re-engage with Bicocca or find another vendor to provide those services.

We currently do not have a back-up facility for our CMOcontract manufacturing organization, or CMO, for our drug product candidates, or our suppliers of API. If the parties we depend on for supplying our APIs and manufacturing our drug product candidates do not supply these products in a timely and quality manner, it may delay or impair our ability to execute our development plans for our current and potential pipeline products. Such delays could adversely impact our operations and financial condition.

We plan to continually evaluate our business strategy and will modify our plans as necessary to achieve our objectives. As part of our shift in priorities, we entered into a global licensing agreement in 2022 to support the development of our KL4 surfactant platform and were able to eliminate the remaining costs associated with the KL4 surfactant platform. If for any reason, our licensee does not proceed with development of the KL4 surfactant platform, such action could have a material adverse effect on our potential to realize licensing revenue. 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. See the risk factor above captioned “Our new corporate strategy may not be successful.”

A number of USU.S. states have proposed new privacy laws. Such proposed legislation, if enacted, may add additional complexity, variation in requirements, restrictions and potential legal risk, require additional investment of resources in compliance programs, impact strategies and the availability of previously useful data and could result in increased compliance costs and/or changes in business practices and policies. The existence of comprehensive privacy laws in different states in the country would make our compliance obligations more complex and costly and may increase the likelihood that we may be subject to enforcement actions or otherwise incur liability for noncompliance.

The GDPR and UK GDPR impose strict rules on the transfer of personal data to countries outside the European Economic Area, including the U.S. The UK and Switzerland have adopted similar restrictions. Although the UK is regarded as a third country under the EU’s GDPR, the EC has now issued a decision recognizing the UK as providing adequate protection under the EUEU’s GDPR and, therefore, transfers of personal data originating in the EU to the UK remain unrestricted. Like the EUEU’s GDPR, the UKUK’s GDPR restricts personal data transfers outside the UK to countries not regarded by the UK as providing adequate protection. The UK government has confirmed that personal data transfers from the UK to the EEA remain free flowing.

We are exposed to trade and economic sanctions and other restrictions imposed by the U.S. and other governments and organizations. The U.S. Departments of Justice, Commerce, State and Treasury and other federal agencies and authorities have a broad range of civil and criminal penalties they may seek to impose against corporations and individuals for violations of economic sanctions laws, export control laws, the U.S. Foreign Corrupt Practices Act, or the FCPA, and other federal statutes and regulations, including those established by the Office of Foreign Assets Control. The Department of Justice, or DOJ, also in the past has increased its focus on the enforcement of the FCPA, particularly as it relates to the conduct of pharmaceutical companies.

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 withthat inhibits the sodium-potassium ATPase and also activates sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, activating properties for acute heart failure and/or associated cardiogenic shock,shock; preclinical SERCA2a activators for heart failure,failure; rostafuroxin for the treatment of hypertension in patients with a specific genetic profile,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.

Our lead product candidate, istaroxime, is a first-in-class, dual-actingdual-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 threefour 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 theSeptember fourth quarter of 2023,2024, we initiatedannounced anpositive extensiontopline toresults thefrom our Phase 2b SEISMiC Extension Study, or the SEISMiC Extension, towhich evaluatedemonstrated athat longeristaroxime dosinginfused periodintravenously significantly improves cardiac function and toblood continuepressure towithout characterizeincreasing theheart effectsrate ofor istaroxime,clinically includingsignificant activationcardiac ofrhythm SERCA2a. The SEISMiC Extension study is expected to enroll up to 30 subjects with SCAI Stage B cardiogenic shock with data anticipated in the second half of 2024.disturbances. Additionally, we have recently initiated a small study in more severe SCAI Stage C cardiogenic shock, or the SEISMiC C,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 studyStudy is expected to enroll up to 20100 subjects with SCAI Stage C cardiogenic shock with enrollment anticipated to be completed in lateQ1 2024.2026. An unblinded review of the data from the first 20 subjects is planned to take place in Q3 2025. Our ability to complete boththis of these studiesstudy with theirits intended sample size is dependent upon usour securingability to secure adequate resourcing for the program through financing efforts or business development activities.

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 SERCA2a activators, known as dual mechanism SERCA2a activators, and rostafuroxin, a Phase 2 product candidate for hypertension associated with specific genotypes.rostafuroxin. In addition, we are supporting the efforts of Lee’s (HK) in starting a Phase 3 trial in AHF with istaroxime. Further, we are engaged in discussions regarding potential global licensing partnerships outside of Lee’s (HK) territory.

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 Licence Agreement, dated as of July 5, 2019, by and between Varian and Cancer Research Technology Limited, or the Licence Agreement, includingwhich 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, or IND, enabling activities and are in the process of determining the expected clinical development plan for the platform.

We have incurred operating losses since our incorporation on November 6, 1992. For the years ended December 31, 20232024 and 2022,2023, we had operating losses of $20.6$26.1 million and $41.3$20.6 million, respectively. As of December 31, 2023,2024, we had an accumulated deficit of $844.8$846.6 million. To date, we have financed our operations primarily through private placements and public offerings of our common and preferred stock and borrowings from investors and financial institutions. As of December 31, 2023,2024, we had cash and cash equivalents of $4.3$1.8 million and current liabilities of $4.0$5.7 million. InSubsequent to December 31, 2024 and through April 2024,15, 2025, (i) we enteredsold an additional 0.2 million shares of Common Stock under the ELOC Purchase Agreement for net proceeds of $1.5 million following mandatory redemption payments on our Series C Preferred Stock; (ii) 47,799 July 2024 Warrants were converted into a47,799 Securitiesshares Purchaseof Agreement,common orstock thefor Purchasegross Agreement,and withnet theproceeds buyersof named$0.3 therein,million; or(iii) theon Buyers,March pursuant18, to which2025, we agreed to issue and sell to two institutional investors an aggregate principal amount of $312,500, at an original issue discount of 20%, in senior convertiblesecured notes,notes ordue thein Notes,2026 for $1.5net millionproceeds of gross$250,000; proceeds.and (iv) on April 4, 2025, we agreed to issue and sell to two institutional investors senior secured promissory notes in an aggregate principal amount of $312,500, at an original issue discount of 20%, for net proceeds of $250,000. As a result, we believe that we have sufficient resources available to fund our business operations through April 2024.2025.

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, and 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 (See the section titled, “Liquidity and Capital Resources”).

On FebruaryApril 22,19, 2023,2024, we filed an amendment to our Amended and Restated Certificate of Incorporation to implement a 1-for-501-for-18 reverse stock split stock of our issued and outstanding common stock. The reverse stock split of our outstanding common stock was effected at a ratio of 1 post-split share for every 5018 pre-split shares as of 1211:0159 a.m.p.m. Eastern Time on FebruaryApril 24,19, 2023.2024. The reverse stock split correspondingly adjusted the per share exercise price and the number of shares issuable upon the exercise of all outstanding options and the per share exercise price of all outstanding options and all shares underlying any of our outstanding warrants by reducing the conversion ratio for each outstanding warrant and increasing the applicable exercise price or conversion price in accordance with the terms of each outstanding warrant and based on the reverse stock split ratio. No fractional shares were issued in connection with the reverse stock split. The number of shares of common stock authorized under our Amended and Restated Certificate of Incorporation is unchanged at 120 million shares. The accompanying consolidated financial statements reflect the 1-for-501-for-18 reverse split of our common stock. All share and per share information data herein that relates to our common stock prior to the effective date has been retroactively restated to reflect the reverse stock split.

Our net loss was $20.3$1.8 million and $39.2$20.3 million, respectively, for the years ended December 31, 20232024 and 2022.2023. Included in our net loss for the year ended December 31, 2024 is a $14.4 million non-cash gain on debt extinguishment, $10.5 million related to the change in fair value of our common stock warrant liability, $7.5 million of R&D expense related to the Varian asset acquisition, and a loss on impairment of intangible assets of $1.1 million. Included in our net loss for the year ended December 31, 2023 is a non-cash loss on impairment of goodwill of $3.1 million. Included in our net loss for the year ended December 31, 2022 are a non-cash loss on impairment of goodwill of $12.6 million, a non-cash loss on impairment of intangible assets related to rostafuroxin of $6.8 million and a related $1.4 million deferred income tax benefit.

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 CROs, CMOs, 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 Extension trial of istaroxime for the treatment of early cardiogenic shock and start-up procedures for a smallC study in subjects with more severe SCAI Stage C cardiogenic shock. We currently do not have sufficient capital to fully complete these clinical trials. 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.

Total direct clinical and preclinical programs expenses decreasedincreased $0.6$2.2 million from 20222023 to 20232024 primarily due to decreases in expenses in our istaroxime – AHF costs andrelated KL4to surfactant costs, partially offset by an increase inthe istaroxime – cardiogenic shock program costs as described below.

Istaroxime – cardiogenic shock program costs increased $0.4$2.2 million from 20222023 to 20232024 due to (i) the start-up procedures for the small study in more severe SCAI Stage C cardiogenic shock, which began in the second quartertiming of 2023; and (ii) the trial execution costs for the SEISMiC Extension study, which wasbegan initiated during the third quarter of 2023, and in which the first patient was enrolledenrollment in the fourth quarter of 2023 and completed enrollment in the third quarter of 2024; partially offset byand (iiiii) the start-up procedures for the SEISMiC study,C which was completedstudy in mid-2022.patients with more severe SCAI Stage C cardiogenic shock.

Istaroxime – AHF costs decreasedhave $0.7been millionlimited fromas 2022we to 2023 due to focusingfocus our resources on the start-up and initiationexecution of the SEISMiCistaroxime Extension– study.cardiogenic shock program.

Product development and manufacturing includes (i) manufacturing operations,operations with our CMO,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.

Clinical, medical, and regulatory operations expenses decreased $0.6$1.7 million from 20222023 to 20232024 due to (i) a decrease of $1.4$0.6 million in personnel costs related to reductions in headcount for the KL4 surfactant platform; and (ii) a decrease of $0.3$0.2 million in non-cash stock-based compensation expense relateddue to headcount reductions as well as the timing of the stock-based compensation grants that were granted in the first quarter of 2022 compared to the third quarter of 2023 with no grants made in 2024; partially offset byand (iii) a $1.1$0.9 million changedecrease in royalty expense relating to $0.9 million in accrued payments to Philip Morris USA Inc., or PMUSA, and Philip Morris Products S.A., or PMPSA, in 2023 related to amendments to our license agreements and a reversal of royalty expense in 2022 after entering into an outlicensing agreement under which the licensee had agreed to assume certain of our obligations under the PMUSA and PMPSA license agreements (See the section titled, “Note 913 –- Other Current Liabilities”).

Contracted services include third-party costs of preclinical studies, clinical trial activities, quality control and analytical stability and release testing of our drug products, and consulting services. The decreaseincrease of $1.3$2.3 million from 20222023 to 20232024 is primarily due to (i)costs a decrease in consulting services related to clinical operations as a part ofwith our cost reduction initiatives; (ii) a decrease in costs related to analytical and technical support laboratories, both in-house and external, that previously supported the KL4 surfactant platform; and (iii) a decrease in outside servicesCRO related to the SEISMiC Extension study whichand wasthe completedSEISMiC inC mid-2022.study.

The $1.5$0.7 million decrease in salaries and benefits expense from 20222023 to 20232024 is primarily due to reductions in headcount that previously supported the KL4 surfactant platform as well as certain other headcount reductions.headcount.

Historically, royalties represented minimum royalties in connection with licensing agreements with PMUSA and PMPSA. In 2023, we accrued payments of $0.9 million to PMUSA and PMPSA related to amendments to our license agreements. In 2022, we reversed $0.2 million in royalty expense after entering into an outlicensing agreement under which the licensee had agreed to assume certain of our obligations under the PMUSA and PMPSA license agreements (See the section titled, “Note 913 –- Other Current Liabilities”).

The $0.4$0.2 million decrease in stock-based compensation expense from 20222023 to 20232024 is related to implementing certain reductions in headcount in 2023. The decrease is also due to the timing of the stock-based compensation grants that were granted in the first quarter of 2022 compared to the third quarter of 2023.2023 with no grants made in 2024.

General and administrative expenses include non-cash charges associated with stock-based compensation of $0.9 million and $2.3 million, respectively, for the years ended December 31, 2023 and 2022. General and administrative expenses decreased $1.6$0.5 million from 20222023 to 20232024 due to (i) a decrease of $1.4$0.6 million in non-cash stock-based compensation expense relateddue to implementing certain headcount reductions in 2023 as well as the timing of the stock-based compensation grants that were granted in the first quarter of 2022 compared to the third quarter of 2023 with no grants made in 2024; (ii) a decrease of $0.6$0.4 million in personnel costs due to headcount reductions; (iii) a decrease of $0.3 million in severance expense related to a former executive; and (iiiiv) a decrease of $0.4 million in insurance costs; partially offset by (iv) an increase of $0.4 million in professional fees; and (v) an increase of $0.4$1.2 million in severanceprofessional expensefees, primarily related to aincreased formerlegal executive.fees and costs associated with the First and Second PIPEs that were allocated to the July 2024 Warrants and expensed immediately.

Interest income relates to incomeinterest earned on our money market funds.account.

We have incurred net losses since inception. Our net loss was $20.3 $1.8 million and $39.2 $20.3 million, respectively, for the years ended December 31, 20232024 and 2022.2023 . Included in our net loss for the year ended December 31, 20232024 is a $14.4 million non-cash gain on debt extinguishment, $10.5 million related to the change in fair value of our common stock warrant liability, $7.5 million of R&D expense related to the Varian asset acquisition, a nd a loss on impairment of goodwillintangible assets of $3.1$1.1 million. Included in our net loss for the year ended December 31, 20222023 areis a non-cash loss on impairment of goodwill of $12.6 million, a non-cash loss on impairment of intangible assets related to rostafuroxin of $6.8$3.1 million and a related $1.4 million deferred income tax benefit (See the section titled, “ Note 4 – Accounting Policies ”). We expect to continue to incur operating losses for at least the next several years. As of December 31, 2023,2024 , we had an accumulated deficit of $844.8 $846.6 million. Our future success is dependent on our ability to fund and develop our product candidates, and ultimately upon our ability to attain profitable operations. We have devoted substantially all of our financial resources and efforts to research and development expense and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital, and accordingly, our ability to execute our future operating plans.

As of December 31, 2023,2024 , we had cash and cash equivalents of $4.3 $1.8 million and current liabilities of $4.0 $5.7 million. InSubsequent to December 31, 2024 and through April 2024,15, 2025, (i) we enteredsold intoan additional 0.2 million shares of Common Stock under the ELOC Purchase Agreement pursuantfor tonet whichproceeds of $1.5 million following mandatory redemption payments on our Series C Preferred Stock; (ii) 47,799 July 2024 Warrants were converted into 47,799 shares of common stock for gross and net proceeds of $0.3 million; (iii) on March 18, 2025, we agreed to issue and sell theto Notestwo institutional investors an aggregate principal amount of $312,500, at an original issue discount of 20%, in senior secured notes due in 2026 for $1.5net millionproceeds of gross$250,000; proceeds.and (iv) on April 4, 2025, we agreed to issue and sell to two institutional investors senior secured promissory notes in an aggregate principal amount of $312,500, at an original issue discount of 20%, for net proceeds of $250,000. As a result, we believe that we have sufficient resources available to fund our business operations through April 2024.2025. We do not have sufficient cash and cash equivalents as of the date of this Annual Report on Form 10-K to support our operations for at least the 12 months following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern.

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. TheIf failurewe fail to obtainraise sufficient additionalcapital, capitalwe onpotentially acceptablecould termsbe whenforced neededto 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, and financial condition.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.

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 ReportReports 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 ReportReports 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.

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; and/or potential revenues from any future acquisitions of small companies with FDA approved products as a result of our new corporate strategy 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 various Note 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.

OurNasdaq has delisted the our stock from the Nasdaq Capital Market. As a result, our common stock is now listed on Thethe Nasdaqover-the-counter Capitalmarket Market,(‘OTCID’) oras Nasdaq.of August 22, 2025. 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.the OTCID.

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 ReportReports on Form 10-Q for the three months ended March 31, 2025 and the three and six months ended June 30, 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.

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.

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.trials Istaroximeand 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 unblindedinterim analysis 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 phasePhase 3 study in that indication.

Our heart failure cardiovascular portfolio also includes othernext generation 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,candidates includingthat includes oral and intravenous SERCA2aadministration 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, weWe are supporting the efforts of Lee’s (HK) in starting a Phase 3 trial in AHFacute heart failure 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 LicenceLicense Agreement, which includes the LicenceLicense Agreement, all rights in molecules and compounds subject to the LicenceLicense 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$28.1 million and $42.8 million for the three and nine months ended JuneSeptember 30, 2025. For the three and sixnine months ended JuneSeptember 30, 2024, our net loss was $12.0$2.7 million and $4.6 million. As of JuneSeptember 30, 2025, we had an accumulated deficit of $861.3$889.4 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 expectintend to seek partnership to continue development of our biotechnology pipeline to incur significantreduce 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 partnerships for additional capitalcapital. inWe bothmay thealso near and long-term, throughconsider 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.

ContinuedDelisting Listingfrom on Thethe Nasdaq Capital Market

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’sour 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 CompanyWe 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.

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’sour 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.

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 JuneSeptember 30, 2025 and December 31, 2024:

Comparison of the Three and SixNine Months Ended JuneSeptember 30, 2025 and 2024

For the three and sixnine months ended JuneSeptember 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.

Total direct clinical and preclinical programs expenses weredecreased comparable$0.2 million for the three months and sixnine months ended JuneSeptember 30, 2025 andcompared to the same period in 2024 primarily due to ongoingthe winddown of costs related to the istaroxime – cardiogenic shock program as described below.

Istaroxime – cardiogenic shock program costs weredecreased comparable$0.2 million for the three months and sixnine months ended JuneSeptember 30, 2025 andcompared to the same period in 2024 due to the ongoingwinddown of trial execution costs for the istaroxime - cardiogenic shock program, which included clinical trial costs for the SEISMiC C study in patients with more seversevere SCAI Stage C cardiogenic shock in 2025 and clinical trial costs for the SEISMiC Extension study in 2024.

Product development and manufacturing expenses increased $0.1 million for the sixnine months ended JuneSeptember 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 expenses aredecreased comparable$0.1 million for the three months and sixnine months ended JuneSeptember 30, 2025 compared to the same period in 2024 and primarily relatedue to a $0.2 million decrease in personnel andcosts related to the reduction in headcount during the quarter, partially offset by a $0.1 increase in regulatory CMC consulting expenses during boththe periods.first quarter of 2025.

General and administrative expenses increaseddecreased $0.2$0.9 million for the three months ended JuneSeptember 30, 2025 due to (i) a $0.2decrease of $0.8 million increase in professional feesfees, primarily related to costs associated with the First and Second PIPEs that were allocated to the July 2024 Warrants and expensed immediately; (ii) a decrease of $0.1 million in insurance costs related to WINTa Reallower Estate,D&O LLC,premium. General and Administrative expenses decreased $0.1$1.0 million for the sixnine months ended JuneSeptember 30, 2025 compared to the same periods in 2024 due to a decrease of $0.2$0.8 million in professional fees, primarily related to reducedcosts legalassociated fees;with the First and Second PIPEs that were allocated to the July 2024 Warrants and expensed immediately and a decrease of $0.1$0.2 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 WINTa Reallower Estate,D&O LLC.premium.

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 $7.8 million at June 30, 2025. In July 2025, we entered into two additional Note Purchase Agreements for which we also elected to apply the fair value option for the July 2025 Notes. The fair value of the June 2025 and July 2025 as of JuneSeptember 30, 2025 was $7.8$2.6 million. Accordingly, a change in fair value adjustment of $0.8$2.7 million and $3.5 million is reflected in other income (expense) for the three and sixnine months ended JuneSeptember 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.

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 sixnine months ended JuneSeptember 30, 2025, the change in the estimated fair value of the July 2024 warrants was $0.1 million and $0.2$0.3 million, respectively. For further details, refer to “Note 11 - Common Stock Warrant Liability.”

For the sixnine months ended JuneSeptember 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 sixnine months ended JuneSeptember 30, 2025 and 2024.

For the three and sixnine months ended JuneSeptember 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 sixnine months ended JuneSeptember 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 sixnine months ended JuneSeptember 30, 2025, other (expense) income,expense, net primarily consists of $0.4$0.2 million gain on foreign currency translation and $0.5$0.3 million, respectively, in netmillion loss on foreign currency translation. For the three and sixnine months ended JuneSeptember 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.

For the three months and sixnine months ended JuneSeptember 30, 2025, therewe wasrealized noan income tax expensebenefit of $3.4 million from the reversal of deferred taxes due to lossesthe incurredintangible andasset forecastedimpairment forcharge 2025of as$16.0 well as a full valuation allowance against deferred tax assets.million. During the three and sixnine months ended JuneSeptember 30, 2024, we recorded an income tax provisionbenefit of $0.2 million and $0.3income tax expense of $0.1 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 1412 – Restructured Debt Liability”).

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 $10.6$28.1 million and $14.7$42.3 million, respectively, for the three and sixnine months ended June September 30, 2025 . Our net loss was $12.0$2.7 million and $1.8$4.6 million, respectively, for the three and sixnine months ended JuneSeptember 30, 2024. We expect to continue to incur operating losses for at least the next several years. As of JuneSeptember 30, 2025 , we had an accumulated deficit of $861.3$889.4 million. Our future success is dependent on our ability to fund and develop our product candidates, and ultimately upon our ability to attain profitable operations. We have devoted substantially all of our financial resources and efforts to research and development expense and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital, and accordingly, our ability to execute our future operating plans.

In JuneJuly 2024,2025, we entered into a Common Stock Purchase Agreement, or the 2025 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 $35$500 million of newly issued shares of our common stock. 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. For On October 24, 2025, pursuant to the three2025 monthsELOC endedPurchase June 30, 2025,Agreement, we soldfiled 0.7a millionForm S-1 Registration Statement under the Securities Act of 1933 with the U.S. Securities and Exchange Commission registering up to 555,555,556 shares of Commoncommon Stockstock under the 2025 ELOC Purchase Agreement forand net(ii) proceedsup to 166,687,215 shares of $0.4common million.stock (the “Note Shares,” and together with the Purchase Shares, the “ELOC Shares”), issuable upon the conversion of the outstanding unpaid principal balance, together with all accrued and unpaid interest, if any, of the convertible promissory note (the “Commitment Note”), issued to Seven Knots as consideration for it entering into the 2025 ELOC Purchase Agreement.

As of JuneSeptember 30, 2025 , we had cash and cash equivalents of $0.3$0.2 million and current liabilities of $15.7$21.9 million. During July 2025, we sold 16.821.1 million shares of common stock for net proceeds of $10.1$13.4 million following mandatory redemption payments on our preferred stock (See the section titled, “Note 15 - Mezzanine Equity and Stockholders' Equity - Common Stock Purchase Agreement” for further details). We believe that we have sufficient resources available to fund our business operations through December 2025. We do not have sufficient cash and cash equivalents as of the date of this Quarterly Report on Form 10-Q to support our operations for at least the 12 months following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern.

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 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$11.4 million for the sixnine months ended JuneSeptember 30, 2025 compared to $5.3$11.7 million for the sixnine months ended JuneSeptember 30, 2024. The decrease in cash used in operating activities of $0.2$0.3 million was primarily attributable to a changedecrease in operatingcash assetspaid for research and liabilities of $0.2 milliondevelopment and ageneral $12.9administrative millionexpense offset by an increase in ourthe netamount loss,of partiallycash offset by a $14.5 million changeused in gainworking oncapital debtprimarily extinguishment.related to the settlement of accounts payable.

Net cash provided by financing activities was $8.8$15.8 million for the sixnine months ended JuneSeptember 30, 2025. Cash provided by financing activities for the sixnine months ended JuneSeptember 30, 2025 was attributable to net proceeds from the issuance of private placement notes and Series D Preferred stock of $7.0$7.1 million, ELOC Purchase agreement of $2.4$15.9 million, proceeds from senior secured notes of $0.5 million, proceeds from warrant exercises of $0.3$0.4 million, partially offset by redemption and cash dividend payments on our Series C and Series D Preferred Stock of $0.6$4.7 million and $0.9$2.2 million in principal payments for senior secured notes payable and loans payable.

Net cash provided by financing activities of $2.6$9.6 million for the sixnine months ended JuneSeptember 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.

Common Stock Purchase AgreementAgreements

In JuneJuly 2024,2025, we entered into a Common Stock Purchase Agreement, or the 2025 ELOC Purchase AgreementAgreement, 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 $35$500 million of newly issued shares of our common stock. 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. On October 24, 2025, pursuant to the Common Stock Purchase Agreement, we filed a Form S-1 Registration Statement under the Securities Act of 1933 with the U.S. Securities and Exchange Commission (the “SEC”) SEC registering up to 555,555,556 shares of common stock (the “Purchase Shares”) under the 2025 ELOC Purchase Agreement and (ii) up to 166,687,215 shares of common stock (the “Note Shares,” and together with the Purchase Shares, the “ELOC Shares”), issuable upon the conversion of the outstanding unpaid principal balance, together with all accrued and unpaid interest, if any, of the convertible promissory note (the “Commitment Note”), issued to Seven Knots as consideration for it entering into the ELOC Purchase Agreement.

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 sixnine months ended JuneSeptember 30, 2025, we sold 0.821.9 million shares of common stock under the ELOC Purchase Agreement for gross proceeds of $2.4$15.8 million. Pursuant to the Company’s Certificate of Designations of Rights and Preferences of Series C Convertible Preferred Stock, we are required to use 30% of the proceeds from sales pursuant to the ELOC Purchase Agreement to pay outstanding Series C Preferred Stock dividends and to redeem Series C Preferred Stock at a 20% premium to the $1,000 stated price per share. For the sixnine months ended JuneSeptember 30, 2025, we paid an aggregate redemption price of $0.6 million with $0.1 million applied to accrued and unpaid dividends and $0.5 million to redeem 402 Series C Preferred Shares.