Galectin Therapeutics(GALT)
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Galectin Therapeutics(GALT) - 2020 Q4 - Annual Report
2021-03-31 11:51
Financial Performance - Net cash used in operations increased by $9,753,000 to $20,601,000 in 2020, compared to $10,848,000 in 2019, driven by higher research and development activities [196]. - The company raised a net total of $197.7 million from public and private offerings since inception, with $27.1 million in unrestricted cash available as of December 31, 2020 [195]. - Other income for 2020 included $66,000 in interest income, offset by $87,000 in interest expense related to debt discount amortization [189]. - The company has not generated any revenue to date and is dependent on additional outside capital for future operations [182]. Research and Development - Research and development expenses increased by 141% from $7,467,000 in 2019 to $17,976,000 in 2020, primarily due to costs related to the NAVIGATE clinical trial [185]. - Clinical program expenses rose from $4,826,000 in 2019 to $14,229,000 in 2020, reflecting increased activities in clinical trials [186]. - The company expects to require an additional $45-$50 million to cover costs for the NAVIGATE Phase 2b/3 clinical trial, with an interim analysis estimated for the second half of 2023 [195]. - The impact of COVID-19 has caused delays in clinical trials and development efforts, affecting the company's operations and capital market access [187]. Administrative Expenses - General and administrative expenses decreased by 8% from $5,971,000 in 2019 to $5,468,000 in 2020, mainly due to reductions in legal and investor relations expenses [188]. Financial Reporting and Estimates - Significant estimates in financial reporting include stock option valuations, accrued liabilities, and deferred income taxes, which require management's judgment [207]. - Research and development expenses are charged as incurred, with significant factors for estimating accruals including patient enrollment and active clinical sites [210]. - Stock-based compensation is measured at grant date fair value and recognized as expense over the service period, including estimates for forfeitures [211]. Liquidity and Capital Resources - The Company has not created any off-balance sheet entities that could materially affect liquidity or capital resources [206]. - The Company is not exposed to significant market risks due to the nature of its operations and absence of debt as of December 31, 2020 [212]. - The Company has not drawn on a $10 million unsecured line of credit available from a stockholder and director [195]. Lease Obligations - The Company entered into a one-year operating lease for office and lab space in Natick, MA, at a rate of $15,000, which has continued on a month-to-month basis since October 1, 2013 [204].
Galectin Therapeutics(GALT) - 2020 Q3 - Quarterly Report
2020-11-09 12:41
Clinical Development - Galectin Therapeutics is focused on developing belapectin (GR-MD-02) as a treatment for liver fibrosis associated with non-alcoholic steatohepatitis (NASH), with significant preclinical evidence supporting its efficacy[55]. - The company has completed two Phase 1 clinical studies and two Phase 2 clinical trials (NASH-FX and NASH-CX) for belapectin, with top line results from the NASH-CX trial published in Gastroenterology in 2020[55][62]. - A seamless adaptively-designed Phase 2b/3 clinical study, the NASH-RX trial, has been initiated to evaluate the safety and efficacy of belapectin for preventing esophageal varices in NASH cirrhosis patients, with patient enrollment starting in June 2020[58][62]. - Belapectin has shown promise in treating moderate to severe plaque psoriasis and severe atopic dermatitis, with positive interim data reported from early trials[61][63]. - The Phase 2b NASH-CX trial enrolled 162 patients with compensated cirrhosis, randomized to receive either 2 mg/kg or 8 mg/kg of belapectin, or placebo, with a primary endpoint of reducing hepatic venous pressure gradient (HVPG)[68]. - In the total patient population, the mean change in HVPG from baseline was -0.37 mm Hg for the 2 mg/kg dose and -0.42 mm Hg for the 8 mg/kg dose, compared to a 0.3 mm Hg change in placebo[69]. - In patients without varices at baseline, the 2 mg/kg dose of belapectin showed a statistically significant effect on HVPG with a change of -1.08 mm Hg (p<0.01)[70]. - The NASH-CX trial demonstrated a statistically significant reduction in the development of new esophageal varices in drug-treated patients compared to placebo (0% and 4% in the belapectin groups vs 18% in placebo)[72]. - The NASH-RX trial is designed to evaluate the safety and efficacy of belapectin for preventing esophageal varices in NASH cirrhosis patients, with a primary endpoint focused on the incidence of new varices[76]. - The NASH-RX trial will compare two belapectin doses (2 mg/kg and 4 mg/kg) against placebo, with an interim analysis planned after 18 months of treatment[76]. - A Hepatic Impairment Study will run in parallel with the NASH-RX trial, involving approximately 40 patients to assess the effects of cirrhosis on serum belapectin levels[85]. - Preclinical studies indicate that belapectin enhances immune response against cancer cells, showing increased tumor shrinkage and survival in mice when combined with immune checkpoint inhibitors[86]. - The company has initiated Phase 1B studies of belapectin in combination with Yervoy® and KEYTRUDA in patients with metastatic melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma[86]. - The NASH-CX trial results support further development of belapectin in NASH, with a favorable safety profile and evidence of pharmacodynamic effects[67]. - The Phase 1b trial combining belapectin with pembrolizumab (KEYTRUDA®) showed a 50% objective response rate in advanced melanoma patients[88]. - In the ongoing trial, 14 advanced melanoma patients have data on Objective Response Rate (ORR) and Disease Control Rate (DCR), with cohort 2 showing a 100% ORR[88]. - A patient in the NASH fibrosis trial experienced complete resolution of plaque psoriasis after treatment with belapectin, remaining symptom-free for 17 months[89]. - The Phase 2a trial for moderate to severe plaque psoriasis reported an average improvement of 50% across five patients, with one patient achieving an 82% improvement[91]. Financial Performance - Galectin Therapeutics has incurred significant operating losses since inception and relies on external capital for continued development and commercialization of its product candidates[54]. - Research and development expenses for the three months ended September 30, 2020, increased by 218% to $4,780,000 compared to $1,503,000 in 2019[94]. - General and administrative expenses decreased by 16% to $1,146,000 for the three months ended September 30, 2020, compared to $1,360,000 in 2019[99]. - As of September 30, 2020, the company had $32.6 million in unrestricted cash and cash equivalents available for future operations[100]. - Net cash used in operations increased by $8,098,000 to $15,187,000 for the nine months ended September 30, 2020, compared to $7,089,000 in 2019[101]. - The company anticipates requiring an additional approximately $40 million to cover costs for a planned Phase 2b/3 clinical trial[100]. - Net cash provided by financing activities for the nine months ended September 30, 2020, was $263,000, significantly lower than $49,173,000 in the same period of 2019[102]. Regulatory Environment - The company is subject to extensive regulation by the FDA and other authorities, which could impact the approval and marketing of its products[54]. - The company has received FDA feedback on its clinical trial protocols, which has been incorporated into the study designs to ensure compliance and feasibility[56][58]. Strategic Collaborations - The company has established collaborations with external experts to enhance drug development efficiency and has filed multiple patents for new carbohydrate molecules targeting galectin proteins[59]. - Galectin Therapeutics aims to leverage its scientific expertise and established relationships to achieve cost-effective drug development and expand its product pipeline[59]. Future Directions - Galectin Therapeutics is exploring additional indications for belapectin, including lung and kidney fibrosis, as well as cancer immunotherapy[62][63].
Galectin Therapeutics(GALT) - 2020 Q2 - Quarterly Report
2020-08-10 11:51
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2020 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. Nevada 04-3562325 (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd ...
Galectin Therapeutics(GALT) - 2020 Q1 - Quarterly Report
2020-05-11 10:31
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2020 Securities registered or to be registered pursuant to Section 12(b) of the Act. | | Trading | Name of each exchange | | --- | --- | --- | | Title of each class | Symbol(s) | on which registered | | Common Stock | GALT | Nasdaq | ☐ Transition report pursuant to Section 13 or 1 ...
Galectin Therapeutics(GALT) - 2019 Q4 - Annual Report
2020-03-16 11:52
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2019 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd., Suite 240, Norcross ...
Galectin Therapeutics(GALT) - 2019 Q3 - Quarterly Report
2019-11-12 12:52
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2019 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd., Suite 240, ...
Galectin Therapeutics(GALT) - 2019 Q2 - Quarterly Report
2019-08-09 11:53
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. Nevada 04-3562325 (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd., Suite 240, Norcross, GA 30071 (Address of Principal Executive Offices) (Zip Code) (I.R.S. Employer Identification No.) Washington, D.C. 20549 FORM 10-Q ☒ Quarterly r ...
Galectin Therapeutics(GALT) - 2019 Q1 - Quarterly Report
2019-05-10 11:52
[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) 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](index=3&type=section&id=ITEM%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) 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](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) 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](index=20&type=chunk) - 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](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) - 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](index=25&type=chunk)[26](index=26&type=chunk) - 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](index=36&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=14&type=section&id=Overview%20and%20Drug%20Development%20Programs) 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](index=51&type=chunk) - 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](index=56&type=chunk)[73](index=73&type=chunk) - 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](index=64&type=chunk)[66](index=66&type=chunk)[69](index=69&type=chunk) - 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](index=79&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) 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](index=86&type=chunk) 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](index=89&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=91&type=chunk) - 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](index=91&type=chunk) - 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](index=91&type=chunk) - Net cash used in operations was **$3.3 million** for Q1 2019, a slight decrease from **$3.5 million** in Q1 2018[92](index=92&type=chunk) - 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](index=93&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) 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](index=98&type=chunk) [Controls and Procedures](index=23&type=section&id=ITEM%204.%20Controls%20and%20Procedures) 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](index=99&type=chunk) [PART II — OTHER INFORMATION](index=24&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This section addresses legal proceedings, refers to comprehensive risk factors, details equity security sales, and lists filed exhibits [Legal Proceedings](index=24&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reported no significant pending legal proceedings - There are no significant pending legal proceedings[41](index=41&type=chunk)[102](index=102&type=chunk) [Risk Factors](index=24&type=section&id=ITEM%201A.%20Risk%20Factors) 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](index=103&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None reported[104](index=104&type=chunk) [Exhibits](index=24&type=section&id=ITEM%206.%20Exhibits) 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](index=104&type=chunk)
Galectin Therapeutics (GALT) Presents At H.C. Wainwright & Co. Annual Global Life Sciences Conference - Slideshow
2019-04-09 18:19
Corporate Overview H.C. Wainwright Global Life Sciences Conference London, UK April 9, 2019 NASDAQ: GALT www.galectintherapeutics.com Harold H. Shlevin, Ph.D. Chief Executive Officer 2019 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com Forward-Looking Statements This presentation contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future event ...
Galectin Therapeutics(GALT) - 2018 Q4 - Annual Report
2019-03-06 12:53
Commission File No. 001-31791 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2018 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to GALECTIN THERAPEUTICS INC. Nevada 04-3562325 (State or other jurisdiction of incorporation) 4960 Peachtree Industrial Blvd., S ...