Quarterly Report for Quarter Ending June 30, 2025 (Form 10-Q)

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, 2024that 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, 2024that 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

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, 2025and 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 comparablefor the three months and six months ended June 30, 2025and 2024 primarily due to ongoing costs related to the istaroxime - cardiogenic shock program as described below.

Istaroxime - cardiogenic shock program costs were comparablefor the three months and six months ended June 30, 2025and2024due 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, 2025compared 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 comparablefor 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 $0.2million 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, netprimarily 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.