▸ In the event we are unable to obtain additional capital as needed or execute on an alternative strategic path, we may further delay, limit, reduce or terminate our current development efforts and business operations.· · · ● ● 2 ▸ Investors may experience dilution of their ownership interests because of the future issuance of additional shares of our common stock or securities convertible into common stock.· · · ● ● 2 ▸ We expect to need to increase the size of our organization to further develop our product candidates, and we may experience difficulties in managing growth.· · · ● ● 2 ▸ We do not own or operate any manufacturing facilities for the clinical- or commercial-scale production of our products.· ● ● ● ● 4 ▸ Our ongoing exploration of alternative strategic paths may not result in entering into or completing transactions, when necessary, and the process of reviewing alternative strategic paths or their conclusion could adversely affect our stock price.· ● ● · · 2 ▸ A delisting would also reduce the value of our equity compensation plans, which could negatively impact our ability to retain employees.● ● ● · · 3 rw ▸ A pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19, or another coronavirus or similar disrupting illness, may materially and adversely affect our business and our financial results.● ● ● · · 3 ▸ Future sales or issuances of common stock, convertible securities or other equity securities, may cause investors to be materially diluted, and new investors could gain rights, preferences and privileges senior to our existing stockholders.● · · · · 1 ▸ Our failure to comply with any of these federal and state health care laws and regulations, or health care laws in foreign jurisdictions, could have a material adverse effect on our business, financial condition, result of operations and cash flows.● ● ● ● · 4 ▸ Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.● ● ● · · 3 ▸ Our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern.● ● ● · · 3 rw ▸ group Risks Related to Drug Development and Commercialization● ● ● · · 3 ▸ We have a significant security holder, which could exert substantial influence over our business.● · · · · 1 ▸ Any breach of our confidentiality agreements or our failure to effectively enforce such agreements would have a material adverse effect on our business and competitive position.● ● ● ● ● 5 ▸ Delays in the enrollment and completion of clinical testing could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates.● ● ● ● ● 5 ▸ Due to the various factors mentioned above, and others, the results of any prior quarterly or annual periods should not be relied upon as indications of our future operating performance.● ● ● ● ● 5 ▸ Governments outside the United States tend to impose strict price controls and reimbursement approval policies, which may adversely affect our prospects for generating revenue outside the United States.● ● ● ● ● 5 ▸ If we fail to attract and retain senior management and key scientific personnel, we may be unable to successfully develop and commercialize our product candidates.● ● ● ● ● 5 ▸ Intense competition might render our cardiovascular and pulmonary product candidates noncompetitive or obsolete.● ● ● ● ● 5 ▸ Our Bylaws contain an exclusive forum provision, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees, or agents.● ● ● ● ● 5 ▸ Our ability to use our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be subject to certain limitations.● ● ● ● ● 5 ▸ Our activities are and will continue to be subject to extensive government regulation, which is difficult to predict, expensive and time-consuming, and we will not be able to sell our products without regulatory approval.● ● ● ● ● 5 rw ▸ Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cybersecurity.● ● ● ● ● 5 rw ▸ Our share price has been volatile, and may continue to be volatile, which may subject us to securities class action litigation in the future.● ● ● ● ● 5 ▸ Our success will depend in part on obtaining and maintaining effective patent and other intellectual property protection for our product candidates and proprietary technology.● ● ● ● ● 5 ▸ Product liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing products and limit commercialization of any products that we may develop.● ● ● ● ● 5 ▸ group Risks Related to Intellectual Property● ● ● ● ● 5 ▸ group Risks Related to Our Business and Our Operations● ● ● ● ● 5 rw ▸ group Risks Related to Our Dependence on Third Parties● ● ● ● ● 5 ▸ Risks Related to Our Financial Position and Need for Additional Capital● ● ● ● ● 5 ▸ group Risks Related to Owning Our Common Stock● ● ● ● ● 5 ▸ group Risks Relating to Our Industry● ● ● ● ● 5 ▸ The market may not accept our products.● ● ● ● ● 5 ▸ Under current law, we may not be able to enforce all employees’ covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.● ● ● ● ● 5 ▸ We are conducting two Phase 3 clinical trials, LEVEL and LEVEL-2 for oral levosimendan, which are expensive and time consuming, and the outcome of the clinical trials is uncertain.● ● ● ● ● 5 rw ▸ We are limited in the number of products we can simultaneously pursue and therefore our survival depends on our success with a small number of product opportunities.● ● ● ● ● 5 ▸ We are subject to uncertainty relating to healthcare reform measures and reimbursement policies that, if not favorable to our products, could hinder or prevent our products’ commercial success, if any of our product candidates are approved.● ● ● ● ● 5 ▸ We currently have no approved drug products for sale, and we cannot guarantee that we will ever have marketable drug products.● ● ● ● ● 5 ▸ We depend on third parties to formulate and manufacture our products.● ● ● ● ● 5 ▸ We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.● ● ● ● ● 5 ▸ We have incurred losses since our inception, expect to continue to incur losses in the foreseeable future, and may never become profitable.● ● ● ● ● 5 ▸ We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use, our technology.● ● ● ● ● 5 ▸ We may infringe or be alleged to infringe intellectual property rights of third parties.● ● ● ● ● 5 ▸ We may not receive all of the anticipated market exclusivity benefits of imatinib’s orphan drug designation, if we prioritize imatinib development in the future.● ● ● ● ● 5 rw ▸ We rely on confidentiality agreements that, if breached, may be difficult to enforce and could have a material adverse effect on our business and competitive position.● ● ● ● ● 5 
