Galectin Therapeutics(GALT) - 2019 Q1 - Quarterly Report

PART I — FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements, management's analysis of operations, market risk disclosures, and internal controls for the period Unaudited Condensed Consolidated Financial Statements This section presents the unaudited condensed consolidated financial statements for the three months ended March 31, 2019, compared with the corresponding period in 2018 and the year-end 2018 balance sheet, including balance sheets, statements of operations, cash flows, changes in stockholders' equity, and accompanying notes Condensed Consolidated Balance Sheets The balance sheet as of March 31, 2019, shows a decrease in total assets and total liabilities compared to December 31, 2018, primarily driven by a reduction in cash and cash equivalents and accrued expenses Balance Sheet Highlights (in thousands) | Account | March 31, 2019 | December 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $6,972 | $8,253 | | Total current assets | $7,483 | $8,832 | | Total assets | $7,830 | $9,006 | | Total current liabilities | $907 | $2,108 | | Total liabilities | $988 | $2,108 | | Total stockholders' equity | $5,119 | $5,175 | Condensed Consolidated Statements of Operations For the three months ended March 31, 2019, the company reported a lower operating loss and net loss compared to the same period in 2018, mainly due to a significant reduction in research and development expenses, though a large non-cash charge for a warrant modification resulted in a higher net loss applicable to common stockholders Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2019 | Q1 2018 | | :--- | :--- | :--- | | Research and development | $646 | $2,298 | | General and administrative | $1,721 | $1,880 | | Total operating loss | $(2,367) | $(4,178) | | Net loss | $(2,375) | $(4,258) | | Warrant modification | $(6,622) | $— | | Net loss applicable to common stockholders | $(9,093) | $(4,543) | | Net loss per common share | $(0.20) | $(0.12) | Condensed Consolidated Statements of Cash Flows Cash flows for the first quarter of 2019 show a net decrease in cash, with cash used in operations slightly lower than the prior year, while financing activities provided less cash compared to Q1 2018, which had benefited from significant warrant exercises Cash Flow Summary (in thousands) | Metric | Q1 2019 | Q1 2018 | | :--- | :--- | :--- | | Net cash from operating activities | $(3,284) | $(3,516) | | Net cash from financing activities | $2,003 | $4,451 | | Net (decrease) increase in cash | $(1,281) | $935 | | Cash and cash equivalents, end of period | $6,972 | $3,988 | Notes to Unaudited Condensed Consolidated Financial Statements The notes provide critical context to the financial statements, including the company's basis of presentation, going concern considerations, details on its line of credit, stock-based compensation, and a significant preferred stock conversion and warrant modification - The company believes its existing cash of $7.0 million and available line of credit are sufficient to fund planned operations through at least June 30, 2020, but this does not include the costs for a planned Phase 3 clinical trial, which will require substantial additional funding[20] - In January 2019, all Series B Convertible Preferred Stock was converted into 3,789,346 shares of common stock, and in connection with this, warrants for approximately 3.6 million shares were extended, resulting in a one-time, non-cash charge of $6.6 million[38][39][40] - The company has a $10 million line of credit from a director, extended to allow borrowings through December 31, 2021, with maturity on December 31, 2022, and no amounts have been drawn on this line of credit to date[25][26] - During Q1 2019, the company issued 395,233 shares of common stock under its At Market Issuance Sales Agreement, generating net proceeds of approximately $1.87 million[36] Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, detailing its business as a clinical-stage biopharmaceutical firm focused on galectin-3 inhibitors for fibrotic diseases and cancer, discussing drug development programs, analyzing operational results, and outlining liquidity and capital resource needs Overview and Drug Development Programs The company is a clinical-stage biopharmaceutical firm developing therapies for fibrotic diseases, skin diseases, and cancer by targeting galectin proteins, with its lead candidate, GR-MD-02, being developed for NASH cirrhosis, with a Phase 3 trial (NASH-RX) in planning following positive Phase 2b (NASH-CX) results, and other programs including cancer immunotherapy and psoriasis - The lead drug candidate is GR-MD-02, a galectin-3 inhibitor being developed for advanced liver fibrosis and cirrhosis in NASH patients[51] - The company is planning a Phase 3 trial (NASH-RX) for NASH cirrhosis patients, and following meetings with the FDA, the agency is supportive of using 'progression to varices' as a potential surrogate endpoint for accelerated approval[56][73] - The Phase 2b NASH-CX trial demonstrated clinically meaningful results, particularly in NASH cirrhosis patients without esophageal varices at baseline, where GR-MD-02 showed a statistically significant effect on reducing hepatic venous pressure gradient (HVPG)[64][66][69] - In cancer immunotherapy, a Phase 1b trial combining GR-MD-02 with KEYTRUDA showed a 50% objective response rate in advanced melanoma patients across three dose cohorts[79] Results of Operations Comparing Q1 2019 to Q1 2018, total operating expenses decreased significantly due to lower research and development costs as Phase 2 clinical trials wound down, while general and administrative expenses saw a slight decrease, primarily from reduced stock-based compensation Research and Development Expense (in thousands) | Period | Amount | % Change YoY | | :--- | :--- | :--- | | Q1 2019 | $646 | (72)% | | Q1 2018 | $2,298 | N/A | - The decrease in R&D expenses was primarily due to the winding down of costs related to the company's Phase 2 clinical trials and a $448,000 decrease in non-cash stock-based compensation[86] General and Administrative Expense (in thousands) | Period | Amount | % Change YoY | | :--- | :--- | :--- | | Q1 2019 | $1,721 | (8)% | | Q1 2018 | $1,880 | N/A | - The decrease in G&A expenses was mainly due to a $327,000 reduction in non-cash stock-based compensation, partially offset by a $260,000 increase in legal expenses[89] Liquidity and Capital Resources As of March 31, 2019, the company had $7.0 million in cash, and management believes this, along with an available $10 million line of credit, is sufficient to fund operations through June 30, 2020, though the planned Phase 3 trial, estimated to cost around $100 million, will require significant additional financing, for which the company has initiated a Rights Offering - The company had $7.0 million in cash and cash equivalents as of March 31, 2019[91] - Existing cash and a $10 million line of credit are expected to fund operations through at least June 30, 2020, excluding Phase 3 trial costs[91] - The planned Phase 3 trial is expected to cost approximately $100 million and will require additional financing, with the company having commenced a Rights Offering targeting $50 to $70 million[91] - Net cash used in operations was $3.3 million for Q1 2019, a slight decrease from $3.5 million in Q1 2018[92] - Net cash provided by financing activities was $2.0 million in Q1 2019, primarily from stock sales under the At The Market (ATM) agreement[93] Quantitative and Qualitative Disclosures about Market Risk The company states that it is not subject to any material market risk exposure, as its cash and cash equivalents are held in operating bank accounts and money market funds, minimizing risk from interest rate changes - The company's primary market risk is related to changes in U.S. interest rates, but this risk is considered immaterial as investments are short-term and held in cash and cash equivalents to preserve capital[98] Controls and Procedures Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2019, with no material changes to internal control over financial reporting occurring during the quarter - Management concluded that as of March 31, 2019, the company's disclosure controls and procedures were effective at a reasonable assurance level[99] PART II — OTHER INFORMATION This section addresses legal proceedings, refers to comprehensive risk factors, details equity security sales, and lists filed exhibits Legal Proceedings The company reported no significant pending legal proceedings - There are no significant pending legal proceedings[41][102] Risk Factors This section refers readers to the detailed risk factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2018 - The report directs stakeholders to the Risk Factors section of the Annual Report on Form 10-K for the year ended December 31, 2018 for a comprehensive discussion of potential risks[103] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - None reported[104] Exhibits This section lists the exhibits filed with the Form 10-Q, which include CEO and CFO certifications and XBRL interactive data files - Exhibits filed include certifications pursuant to Rule 13a-14(a) and Section 906 of the Sarbanes-Oxley Act, as well as XBRL data files[104]