Windtree Therapeutics(WINT) - 2019 Q4 - Annual Report

PART I Business Windtree Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for acute cardiovascular and pulmonary diseases Development Program Status and Milestones | Product Candidate | Indication | Status | Next Expected Milestone | | :--- | :--- | :--- | :--- | | Istaroxime | AHF | Phase 2b | Initiate start-up for second phase 2b trial (~300 patients) in H2 2020 | | Istaroxime | Early Cardiogenic Shock | Phase 2a | Initiate phase 2a trial (~60 patients) mid-year 2020 | | AEROSURF | RDS | Phase 2b | Initiate ~90-patient bridging study with new ADS in Q2 2020 | | Rostafuroxin | Genetically Associated Hypertension | Phase 2b | Out-licensing | | Lyophilized KL4 Surfactant | Lung Injury from COVID-19 | Pilot | Program planning; targeted start mid-year 2020, subject to securing capital | - The company's lead cardiovascular candidate, istaroxime, has been granted Fast Track designation by the FDA for the treatment of AHF[18][21] - The lead pulmonary candidate, AEROSURF®, a drug/device combination for RDS in premature infants, has also received FDA Fast Track designation[18][26] - Windtree is actively pursuing non-dilutive funding opportunities, including from government agencies and private foundations, to initiate a pilot clinical trial of its KL4 surfactant to mitigate the pulmonary effects of severe COVID-19 infection[33][40][81] - The company's strategy includes advancing istaroxime and AEROSURF to a Phase 3-ready position, seeking strategic collaborations for rostafuroxin, and obtaining a listing on The Nasdaq Capital Market®[40][46] Risk Factors The company faces substantial risks, including a history of significant operating losses and the need for additional capital, which could lead to stockholder dilution Financial Condition Risk | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Operating Loss | $25.6 million | $16.2 million | | Accumulated Deficit (as of Dec 31, 2019) | $686.5 million | | - The company will require substantial additional financing to achieve its goals. Existing cash and cash equivalents are expected to fund operations only into the third quarter of 2021[211][212] - The COVID-19 pandemic poses significant risks, including potential delays in clinical trials, disruptions to the supply chain for clinical materials, and adverse effects on the company's ability to access capital markets[317][318][320] - A small group of investors, including Lee's Pharmaceutical Holdings and affiliates of the Chairman, hold significant voting power (approximately 35% and 16% respectively), which could influence corporate actions and deter potential changes in control[387] - The company has applied to list its common stock on Nasdaq, but there is no assurance the application will be approved or that the company can maintain listing requirements if successful[388] Unresolved Staff Comments The company reports no unresolved staff comments from the SEC - There are no unresolved staff comments[402] Properties The company's principal executive offices and development laboratories are located in a 21,189 square foot leased facility in Warrington, Pennsylvania - The main facility is located at 2600 Kelly Road, Suite 100, Warrington, Pennsylvania, consisting of 21,189 square feet of leased space[403] - The company also leases approximately 1,317 square feet of office space in Taipei, Taiwan, and has access to research laboratories in Milan, Italy[403] Legal Proceedings The company is not aware of any pending legal actions that would have a material adverse effect on its business and operations - The company is not aware of any pending legal actions that would materially and adversely affect its business[405] Mine Safety Disclosures This item is not applicable to the company - Not applicable[407] PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock is quoted on the OTCQB market under the symbol "WINT", with 41,091,532 shares outstanding as of April 1, 2020 - The company's common stock is traded on the OTCQB market under the symbol "WINT"[409] Quarterly Stock Price Range (2018-2019) | Period | 2019 High | 2019 Low | 2018 High | 2018 Low | | :--- | :--- | :--- | :--- | :--- | | First Quarter | $5.35 | $2.65 | $5.81 | $2.60 | | Second Quarter | $4.85 | $3.95 | $4.10 | $2.56 | | Third Quarter | $4.60 | $2.66 | $4.35 | $3.15 | | Fourth Quarter | $4.25 | $2.90 | $5.11 | $2.53 | - As of April 1, 2020, there were 41,091,532 shares of common stock outstanding held by 74 holders of record[411] - The company has never paid dividends and does not anticipate paying any in the foreseeable future[412] Selected Financial Data This item is not applicable as the company is a smaller reporting company - Not applicable[417] Management's Discussion and Analysis of Financial Condition and Results of Operations Operating loss increased to $24.9 million in 2019 due to higher R&D and G&A expenses, with management expecting current cash and new funding to cover operations for the next twelve months Comparison of Operations (Years Ended Dec 31) | (in millions) | 2019 | 2018 | | :--- | :--- | :--- | | Total Revenues | $0.2 | $1.8 | | Research and Development | $12.7 | $10.6 | | General and Administrative | $12.4 | $7.4 | | Operating Loss | ($24.9) | ($16.2) | | Net Loss | ($27.5) | ($20.5) | - Research and development expenses increased by $2.1 million year-over-year, primarily due to a $1.3 million increase in non-cash stock compensation and a $0.7 million increase in personnel costs related to clinical, medical, and regulatory operations[430][434] - General and administrative expenses increased by $5.0 million, mainly due to a $4.1 million increase in non-cash stock-based compensation expense[442][443] - The company secured $21.8 million in net cash from financing activities in 2019, primarily from a private placement in December 2019 that raised approximately $23.0 million in net proceeds[461][463] - Management believes its cash and cash equivalents are sufficient to fund operations for at least the next twelve months, relying on a binding commitment from Lee's (HK) to finance AEROSURF development and plans to manage uncommitted spending[454][678] Quantitative and Qualitative Disclosures About Market Risk This item is not applicable as the company is a smaller reporting company - Not applicable[508] Financial Statements and Supplementary Data This section refers to the company's consolidated financial statements and supplementary data, which are included from page F-1 onwards in the report - This section directs to the Index to Consolidated Financial Statements on Page F-1[509] Changes in and Disagreements with Accountants on Accounting and Financial Disclosure This item is not applicable to the company - Not applicable[510] Controls and Procedures Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2019, with no material changes identified - The President and Chief Executive Officer and the Senior Vice President and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[513] - Management conducted an evaluation and believes the company's internal control over financial reporting was effective as of December 31, 2019, based on the COSO 2013 framework[515] - No changes in internal control over financial reporting occurred during the quarter ended December 31, 2019, that have materially affected, or are reasonably likely to materially affect, these controls[517] Other Information This item is not applicable to the company - Not applicable[518] PART III Directors, Executive Officers and Corporate Governance This section details executive officers and non-employee directors, outlining the board's independent leadership structure and risk oversight through its Audit, Compensation, and Nominating and Governance committees Executive Officers and Directors (as of April 1, 2020) | Name | Age | Position(s) | | :--- | :--- | :--- | | Craig Fraser | 55 | President and Chief Executive Officer, Director | | Steven G. Simonson, M.D. | 61 | Senior Vice President and Chief Medical Officer | | John A. Tattory | 54 | Senior Vice President and Chief Financial Officer | | Eric Curtis | 52 | Senior Vice President and Chief Operating Officer | | Mary B. Templeton, Esq. | 73 | Senior Vice President, General Counsel and Corporate Secretary | | James Huang | 54 | Chairman of the Board of Directors | | John R. Leone | 72 | Director | | Joseph M. Mahady | 66 | Director | | Bruce A. Peacock | 68 | Director | | Brian D. Schreiber, M.D. | 66 | Director | | Daniel E. Geffken | 63 | Director | - The Board of Directors has determined that all directors, except for CEO Craig Fraser, are independent under Nasdaq listing rules[548] - The Board has established an Audit Committee, a Compensation Committee, and a Nominating and Governance Committee, with charters and compositions intended to comply with Nasdaq and SEC rules[549] Executive Compensation Executive compensation includes base salary, cash bonuses, and equity awards, with non-employee directors receiving cash retainers and equity for their service 2019 Summary Compensation for Named Executive Officers | Name | Position | Salary ($) | Bonus ($) | Stock Awards ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Craig Fraser | President & CEO | 452,381 | 226,038 | 31,695 | 345,130 | 1,063,644 | | Steven G. Simonson, M.D. | SVP & CMO | 377,437 | 149,420 | 15,085 | 172,565 | 722,907 | | John A. Tattory | SVP & CFO | 336,944 | 151,522 | 14,164 | 172,565 | 683,595 | - In 2018, the company approved a Strategic and Retention Bonus Program tied to the completion of a significant financing and strategic transaction. The second installment of this bonus was paid in October 2019[565] - In March 2019, the compensation committee granted stock options to the named executive officers: 100,000 shares for the CEO and 50,000 shares each for the CFO and CMO, all vesting over three years[568] - Non-employee directors receive quarterly cash compensation and equity awards. In 2019, new and existing directors received option grants to purchase between 40,000 and 60,000 shares of common stock[591][593][594] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters This section details beneficial ownership, with Lee's Pharmaceutical Holdings Limited as the largest owner at 36.87%, and outlines securities authorized under equity compensation plans Security Ownership of Major Beneficial Owners (as of April 1, 2020) | Name of Beneficial Owner | Number of Shares | Percentage | | :--- | :--- | :--- | | Lee's Pharmaceutical Holdings Limited | 15,558,385 | 36.87% | | Panacea Venture Healthcare Fund I L.P. | 8,634,147 | 19.83% | | Bioengine Capital | 4,683,586 | 11.09% | | Ivy Blue Holding Limited | 4,336,790 | 10.55% | | Tyrus-DA Global Healthcare No. 1 | 3,795,205 | 8.96% | | Hongtao Investment-I Ltd | 2,980,132 | 7.25% | - All executive officers and directors as a group beneficially own 10,368,518 shares, representing 23.98% of the company's outstanding common stock[604] - As of December 31, 2019, there were 5,411,564 securities to be issued upon exercise of outstanding options under equity compensation plans approved by security holders, with 447,684 securities remaining available for future issuance[600] Certain Relationships and Related Transactions, and Director Independence The company has extensive related party transactions, primarily with Lee's Pharmaceutical Holdings Limited and its affiliates, involving significant debt, equity financings, and licensing agreements - In March 2020, the company entered into a binding term sheet with Lee's (HK) for up to $3.9 million in non-refundable payments to fund the development of AEROSURF through September 2020[610] - Lee's and its affiliates participated significantly in the December 2019 Private Placement, investing approximately $5 million, which included the conversion of $2.95 million in existing debt[611] - The 2018 CVie Acquisition involved Lee's, which owned approximately 49% of CVie Therapeutics. As part of the transaction, a Lee's affiliate received 8,063,861 shares of the company's common stock[616][617] - Panacea Venture Healthcare Fund I L.P., an affiliate of Chairman James Huang, invested approximately $5.0 million in the December 2019 Private Placement[620] Principal Accountant Fees and Services Ernst & Young LLP served as the independent auditor, with total fees of $797,940 in 2019 and $920,000 in 2018, all pre-approved by the Audit Committee Accountant Fees (2018-2019) | Fee Category | 2019 | 2018 | | :--- | :--- | :--- | | Audit fees | $796,000 | $475,000 | | Audit-related fees | $0 | $445,000 | | Other | $1,940 | $0 | | Total fees | $797,940 | $920,000 | - The Audit Committee has pre-approval policies for all audit and permissible non-audit services provided by the independent registered public accounting firm[626] PART IV Exhibits and Financial Statement Schedules This section lists the consolidated financial statements and exhibits filed as part of the Annual Report on Form 10-K, with financial statements indexed on page F-1 - This item lists the consolidated financial statements and exhibits filed with the Form 10-K[630] Form 10-K Summary The company has elected not to include a summary of the Form 10-K information - The company has elected not to include a summary under this item[631]